预约演示
更新于：2025-11-01
Penicillamine
青霉胺
更新于：2025-11-01
概要
基本信息
非在研机构- |
权益机构- |
最高研发阶段批准上市 |
最高研发阶段(中国)批准上市 |
特殊审评- |
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结构/序列
分子式C5H11NO2S |
InChIKeyVVNCNSJFMMFHPL-VKHMYHEASA-N |
CAS号52-67-5 |
关联
14
项与 青霉胺 相关的临床试验NCT06103617
Safety and Superiority of Penicillamine in Radiosensitization of Recurrent Head and Neck Cancer: a Single-center, Single-arm, Phase II Clinical Trial
Our preclinical study confirmed that copper accumulation can lead to radioresistance in vitro and in vivo, and reducing the concentration of copper with copper chelator help to overcome radioresistance. Therefore, the investigators plan to carry out a prospective interventional phase II clinical trial to explore the safety and efficacy of penicillamine (a common copper chelator) as a radiosensitizer in the treatment of recurrent head and neck cancer.
开始日期2023-11-15 |
申办/合作机构 |
IRCT20200407046981N49
Comparative bioequivalence study of the Penicillamine 250-mg Capsules manufactured by Vana Darou Gostar Company with Penicillamine brand capsules (Cupripen®) by Laboratorios Rubio company
开始日期2022-12-11 |
申办/合作机构- |
ChiCTR2200058434
The study of migration learning-quantitative MRI intelligent model for predicting the prognosis of neurological Wilson's disease
开始日期2022-04-01 |
申办/合作机构- |
100 项与 青霉胺 相关的临床结果
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100 项与 青霉胺 相关的转化医学
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100 项与 青霉胺 相关的专利（医药）
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7,215
项与 青霉胺 相关的文献（医药）2025-12-01·ENVIRONMENTAL TOXICOLOGY AND PHARMACOLOGY
Protective effects of N-acetylcysteine and its amide derivative against toxic metals in vitro: Potential alternatives/adjuncts to traditional chelators
Article
作者: Sawyer, Thomas W ; Song, Yanfeng
The protective efficacies of N-acetylcysteine (NAC) and N-acetylcysteine amide (NACA) against the toxicity of compounds containing arsenic, cadmium, cobalt, chromium and mercury, were compared to those of dimercaprol, dimercaptosuccinic acid, 2,3-dimercaptopropanesulphonate, D-penicillamine, and derivatives of ethylenediamine tetraacetic acid and diethylenetriaminepentaacetic in CHO-K1 cells. Both NAC and NACA were found to confer protection against these metals, with comparable or better efficacy than many of the test chelators. Results from studies using the glutathione synthesis inhibitor buthionine sulphoximine were consistent with NAC/NACA protection being mediated through both GSH up-regulation and chelation. Given NAC's activity against metal toxicity, widespread clinical use, parenteral or oral routes of administration, high clinical safety, low cost and ease of accessibility, it should be given consideration as a broad-spectrum protectant against toxic metal poisoning as a treatment or adjunct/combination treatment. Its more lipophilic derivative NACA, also warrants attention, especially in those cases where brain toxicity is a concern.
2025-12-01·THERIOGENOLOGY
Blastocyst production by conventional in vitro fertilization (cIVF) in horses: Effects of sperm storage method, incubation timing of cool-stored semen before gamete co-incubation, and comparisons between cIVF and intracytoplasmic sperm injection (ICSI)
Article
作者: Crowley, Jarred B ; Hernández-Avilés, Camilo ; Love, Charles C ; Ramírez-Agámez, Luisa
Currently, Intracytoplasmic Sperm Injection (ICSI) on in vitro-matured equine oocytes obtained by transvaginal oocyte aspiration (TVA) is the method of choice for in vitro production of equine blastocysts in a clinical setting. A protocol for conventional in vitro fertilization (cIVF) using either fresh or frozen/thawed stallion sperm incubated under capacitating conditions (Tyrode's Albumin Lactate Pyruvate medium + penicillamine, hypotaurine, epinephrine; FERT-PHE) has been recently reported. Several factors that may impact the clinical applicability of this cIVF protocol have yet to be studied. In Experiment 1, a comparison between fresh, cool-stored, or frozen/thawed sperm from a fertile stallion (OP) for cIVF was performed. Differences on cleavage rate (embryos with ≥8 blastomeres at day 5 of culture), blastocyst rate (blastocysts/cleaved embryos), and the number of blastocysts per mare TVA/cIVF cycle were not detected among fresh (68 % [38/56]; 18 % [7/38]; 1), cool-stored (61 % [34/56]; 21 % [7/34]; 1), and frozen/thawed sperm (54 % [29/54]; 21 % [6/29]; 1), respectively (P > 0.05). In Experiment 2, the effect of incubation time (22 vs. 10 h) that cool-stored sperm were exposed to the FERT-PHE medium before gamete co-incubation was studied. Differences on cleavage rate (45 % [29/64] vs. 56 % [47/84]), blastocyst rate/cleaved embryos (28 % [8/29] vs. 19 % [9/47]), and number of blastocysts per mare TVA/cIVF cycle (1.1 vs. 1.3) were not detected between treatment groups (P > 0.05). In Experiment 3, frozen/thawed sperm from 2 fertile stallions (OP vs. HW) was processed to compare cIVF and ICSI cycles. Differences on cleavage rates were not detected between stallions in cIVF (OP: 41 % [16/39] vs. HW: 52 % [34/65]; P > 0.05) or ICSI cycles (OP: 34 % [22/64] vs. HW: 53 % [19/36]; P > 0.05); nor detected when the stallion values were combined: cIVF (48 % [50/104]) vs. ICSI (41 % [41/100]; P > 0.05). Differences on blastocyst rate/cleaved embryos were not detected between stallions in cIVF (OP: 13 % [2/16] vs. HW: 26 % [9/34]) or ICSI cycles (OP: 45 % [10/22] vs. HW 42 % [8/19]; P > 0.05); but when stallion values were combined, blastocyst rate/cleaved embryos was lower for cIVF (22 % [11/50]) than for ICSI (44 % [18/41]) cycles (P < 0.05). The number of blastocysts per mare TVA cycle was lower for stallion OP in cIVF (0.4) than for stallion HW in ICSI (2; P < 0.05), while similar for stallions OP and HW in cIVF cycles (1.5), and stallion OP in ICSI cycles (1.4; P > 0.05). Six blastocysts from cIVF (n = 3) or ICSI (n = 3) cycles produced with frozen/thawed sperm from stallion HW were vitrified, warmed, and transferred into recipient mares. All mares were confirmed pregnant at days 14, 28, and 45 of gestation. In conclusion, in this study, the production of cIVF-derived blastocysts was similar for fresh, cool-stored, or frozen/thawed sperm from a fertile stallion. Reducing the sperm incubation timing in FERT-PHE from 22 to 10 h did not affect blastocyst production by cIVF using cool-stored sperm. Finally, in this study, an overall lower blastocyst rate per cleaved embryo was observed in two fertile stallions when utilizing frozen/thawed sperm for cIVF compared to ICSI. Further studies are warranted to understand additional factors that may affect the production of equine blastocysts by cIVF in a clinical setting.
2025-12-01·SPECTROCHIMICA ACTA PART A-MOLECULAR AND BIOMOLECULAR SPECTROSCOPY
Dual-mode colorimetric and fluorometric detection of D-penicillamine via inhibition of peroxidase-mimetic activity of bimetallic N-doped carbon dots
Article
作者: El-Wekil, Mohamed M ; Ali, Al-Montaser Bellah H ; Alqarni, Laila S ; Ibrahim, Hossieny ; Goda, Mohamed N
D-penicillamine (D-PEN) is used to treat Wilson's disease, rheumatoid arthritis, and cystinuria but requires careful monitoring due to its narrow therapeutic window and risks of nephrotoxicity, hematological disorders, and autoimmune reactions. To enable reliable detection, bimetallic FeCu co-doped carbon dots (FeCu@CDs) were developed as multifunctional nanozymes for dual-mode sensing of D-PEN. These nanozymes integrate peroxidase-like catalytic activity, intrinsic fluorescence, and selective thiol-binding affinity, allowing simultaneous colorimetric and ratiometric fluorescence detection. Fe and Cu doping enhanced the peroxidase-like activity and fluorescence emission of the CDs by promoting H₂O₂ activation into HO• and 1O₂ and improving charge mobility. D-PEN inhibited this catalytic activity by binding metal centers and altered the inner filter effect (IFE) between FeCu@CDs and 2, 3-diaminophenazine (DAP), enabling selective signal modulation. The assay achieved detection limits of 0.13 μM (colorimetric) and 0.03 μM (fluorescence), with recoveries ranging from 95.6 % to 105.1 % in real samples, highlighting its importance in clinical monitoring and bioanalytical applications.
65
项与 青霉胺 相关的新闻（医药）2025-10-31
注册号：
Registration number：
ChiCTR2500111463 最近更新日期：
Date of Last Refreshed on：
2025-10-31 15:21:54 注册时间：
Date of Registration：
2025-10-31 00:00:00 注册号状态：
预注册Registration Status：
Prospective registration注册题目：
司普奇拜(CM310)治疗非变应性鼻炎伴嗜酸粒细胞增多综合征的有效性与安全性评价：一项研究者发起的前瞻性、随机、双盲、安慰剂对照临床研究Public title：
Efficacy and Safety of Stapokibart (CM310) in Non-Allergic Rhinitis with Eosinophilia Syndrome (ESSNARES): An Investigator-initiated, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial注册题目简写：English Acronym：研究课题的正式科学名称：
司普奇拜(CM310)治疗非变应性鼻炎伴嗜酸粒细胞增多综合征的有效性与安全性评价：一项研究者发起的前瞻性、随机、双盲、安慰剂对照临床研究Scientific title：
Efficacy and Safety of Stapokibart (CM310) in Non-Allergic Rhinitis with Eosinophilia Syndrome (ESSNARES): An Investigator-initiated, Prospective, Randomized, Double-Blind, Placebo-Controlled Trial研究课题代号(代码)：
Study subject ID：在二级注册机构或其它机构的注册号：
The registration number of the Partner Registry or other
register：申请注册联系人：
刘争
研究负责人：
刘争 Applicant：
Zheng Liu
Study leader：
Zheng Liu 申请注册联系人电话：
Applicant telephone：
+86 186 0711 0505
研究负责人电话：
Study leader's telephone：
+86 27 6781 3009申请注册联系人传真 ：
Applicant Fax：
研究负责人传真：
Study leader's fax：申请注册联系人电子邮件：
Applicant E-mail：
zhengliuent@hotmail.com
研究负责人电子邮件：
Study leader's E-mail：
zhengliuent@hotmail.com申请单位网址(自愿提供)：
Applicant website(voluntary supply)：
研究负责人网址(自愿提供)：
Study leader's website(voluntary supply)：申请注册联系人通讯地址：
湖北省武汉市武昌区东湖路169号
研究负责人通讯地址：
湖北省武汉市武昌区东湖路169号Applicant address：
No. 169, Donghu Road, Wuchang District, Wuhan City, Hubei Province
Study leader's address：
No. 169, Donghu Road, Wuchang District, Wuhan City, Hubei Province申请注册联系人邮政编码：
Applicant postcode：
研究负责人邮政编码：
Study leader's postcode：申请人所在单位：
武汉大学中南医院Applicant's institution：
Zhongnan Hospital of Wuhan University研究负责人所在单位：
武汉大学中南医院Affiliation of the Leader：
Zhongnan Hospital of Wuhan University是否获伦理委员会批准：
是Approved by ethic committee：
Yes伦理委员会批件文号：
Approved No. of ethic committee：
临研伦2025184
伦理委员会批件附件：
Approved file of Ethical Committee：
查看附件View批准本研究的伦理委员会名称：
武汉大学中南医院医学伦理委员会Name of the ethic committee：
Medical Ethics Committee of Zhongnan Hospital of Wuhan University伦理委员会批准日期：
Date of approved by ethic committee：
2025-07-17 00:00:00伦理委员会联系人：
郑磊Contact Name of the ethic committee：
Zheng Lei伦理委员会联系地址：
东湖路169号Contact Address of the ethic committee：
No.169 Donghu Road, Wuchang District, Wuhan, Hubei, China伦理委员会联系人电话：
Contact phone of the ethic committee：
+86 27 67812787
伦理委员会联系人邮箱：
Contact email of the ethic committee：
znyyll@126.com研究实施负责（组长）单位：
武汉大学中南医院Primary sponsor：
Zhongnan Hospital of Wuhan University研究实施负责（组长）单位地址：
湖北省武汉市武昌区东湖路169号Primary sponsor's address：
No.169 Donghu Road, Wuchang District, Wuhan, Hubei, China试验主办单位(项目批准或申办者)：
Secondary sponsor：
国家：
中国
省(直辖市)：
湖北省
市(区县)：
Country：
China
Province：
Hubei
City：
单位(医院)：
武汉大学中南医院
具体地址：
湖北省武汉市武昌区东湖路169号
Institution
hospital：
Zhongnan Hospital of Wuhan University
Address：
No.169 Donghu Road, Wuchang District, Wuhan, Hubei, China经费或物资来源：
重大慢性非传染性疾病防控研究;同济医院高质量临床研究基金Source(s) of funding：
National Key Research and Development Program of China;High-quality Clinical trail Fund of Tongji Hospital研究疾病：
非变应性鼻炎伴嗜酸粒细胞增多综合征 Target disease：
Non-Allergic Rhinitis with Eosinophilia Syndrome研究疾病代码：Target disease code：研究类型：
干预性研究Study type：
Interventional study研究所处阶段：
其它 Study phase：
N/A研究设计：
随机平行对照 Study design：
Parallel 研究目的：
主要目的：
评价司普奇拜(CM310)注射液在非变应性鼻炎伴嗜酸粒细胞增多综合征患者(Non-Allergic Rhinitis with Eosinophilia Syndrome，NARES)中的疗效。
次要目的：
评价司普奇拜(CM310)注射液在非NARES患者中的安全性。
探索性目的：
探索司普奇拜(CM310)注射液对NARES患者的生物标志物的改变。 Objectives of Study：
Main purpose:
To evaluate the efficacy of Stapokibart (CM310) injection in patients with Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES).
Secondary objective
To evaluate the safety of Stapokibart (CM310) injection in non-NARES patients.
Exploratory purpose
To explore the changes in biomarkers of patients with NARES caused by Stapokibart (CM310) injection.药物成份或治疗方案详述：
Description for medicine or protocol of treatment in
detail：
纳入标准：
1. 受试者必须了解本研究的试验性质，且在签署一份经机构审查委员会 (Institutional Review Board, IRB)/独立伦理委员会 (Independent Ethics Committee, IEC) 批准的知情同意书后才能接受任何研究相关程序；
2. 年龄>=18 且<=65 周岁，性别不限；
3. 根据诊断标准诊断为NARES：长期慢性病程，症状持续2年，表现为间断性发作的鼻部症状，包括交替性鼻塞、清水样鼻分泌物、阵发性喷嚏、鼻痒、鼻涕倒流及嗅觉减退，并排除变应性鼻炎证据；
4. 实验室依据：血清特异性IgE（Specific Immunoglobulin E, sIgE）阴性且皮肤点刺试验（Skin prick test, SPT）阴性；鼻分泌物嗜酸性粒细胞比例＞20%（排除上皮细胞后）；
5. 受试者在筛查期前的病史表明，症状发作后使用鼻腔皮质类固醇或其他药物（抗组胺药、白三烯受体拮抗剂等），NARES症状控制不佳（iTNSS评分>=4分，鼻塞、流涕、鼻痒和打喷嚏至少一项≥2分）;
6. 基线访视时（筛选导入期治疗后），iTNSS评分>=4分，最近6次的每日回顾性鼻部症状评分（rTNSS）>=4分，鼻塞、流涕、鼻痒和打喷嚏至少一项>=2分（即最后三个24小时期间的3次晨间评估和3次晚间评估，包括基线访视时的即时TNSS评估）;
7. 愿意并能够依从所有访视、研究相关程序和问卷调查，重要事项包括接受必需的背景药物和填写每日电子日记 (eDiary)，在筛选/导入期期间，受试者必须完成日记卡中至少80%的评估记录；
8. 受试者同意整个研究期间（从签署 ICF 到末次研究药物给药后 3 个月）采取高效避孕措施（包括：输精管结扎术、禁欲等）。Inclusion criteria
1. The subject must understand the investigational nature of this study and must provide written informed consent, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to undergoing any study-related procedures.
2. Aged ≥18 and ≤65 years, regardless of gender.
3. Diagnosed with Non-Allergic Rhinitis with Eosinophilia Syndrome (NARES) according to the following criteria: chronic course lasting ≥2 years, with intermittent nasal symptoms including alternating nasal congestion, watery rhinorrhea, paroxysmal sneezing, nasal itching, postnasal drip, and hyposmia; with evidence against allergic rhinitis.
4. Laboratory evidence: negative serum Specific Immunoglobulin E (sIgE) and negative Skin Prick Test (SPT); nasal secretion eosinophil proportion >20% (after excluding epithelial cells).
5. The subject's history prior to the screening period indicates inadequate control of NARES symptoms (with an iTNSS ≥4 and at least one of the symptoms - nasal congestion, rhinorrhea, nasal itching, or sneezing - scoring ≥2) despite the use of intranasal corticosteroids or other medications (e.g., antihistamines, leukotriene receptor antagonists) following symptom onset.
6. At the baseline visit (after run-in treatment), the subject must meet the following criteria: an iTNSS ≥4, the average of the most recent 6 daily Reflective Total Nasal Symptom Scores (rTNSS) ≥4, and at least one of the symptoms - nasal congestion, rhinorrhea, nasal itching, or sneezing - scoring ≥2 in these assessments (i.e., the 3 morning and 3 evening evaluations over the last three 24-hour periods, including the iTNSS assessment at the baseline visit).
7. Willing and able to comply with all visits, study-related procedures, and questionnaires, including adherence to required background medications and completion of a daily electronic diary (eDiary). During the screening/run-in period, subjects must complete at least 80% of the diary assessments.
8. Subjects agree to use highly effective contraception (including vasectomy, abstinence, etc.) throughout the study period (from signing the ICF until 3 months after the last dose of study drug).排除标准：
1. 研究药物过敏史：对糠酸莫米松及氯雷他定、CM310注射液或安慰剂成分过敏或不耐受；
2. 实验室检查异常：严重肝肾功能不全，肝功能异常[丙氨酸氨基转移酶（Alanine Aminotransferase, ALT）/天冬氨酸氨基转移酶（Aspartate Transaminase, AST）＞1.5×正常值上限（Upper Limit of Mormal, ULN），或总胆红素（Total Bilirubin, TBIL）＞1.5×ULN伴AST异常]或肾功能异常（血清肌酐＞1.2×ULN），筛选时（访视 1）或基线时（访视 3）存在研究者认为具有临床意义的实验室血生化或血液学检查结果异常。
3. 不良行为史：筛选前2年内有药物滥用、酒精依赖史（日均酒精摄入＞40g）或吸毒者；
4. 目前正在接受过敏原免疫治疗（皮下或舌下免疫治疗 [Subcutaneous Immunotherapy, SCIT/ Sublingual Immunotherapy, SLIT]）。随机分组前已停用 SCIT/SLIT ≥ 3 年且未接受过敏原免疫治疗维持方案的受试者符合入选资格。
5.在筛选期和导入期内，接受过任何补救药物治疗。
6. 筛选（访视 1）鼻部操作史：筛选前1年内接受鼻窦手术或存在未愈合的鼻创伤；
7. 筛选（访视 1）药物暴露：前3个月内参加过其它药物临床试验，且使用研究药物者，或研究期间拟使用其他研究药物者；
8. 筛选（访视 1）疫苗接种：前12周内接种过减毒活疫苗或计划在试验期间接种减毒活疫苗者；
9. 筛选（访视 1）眼部疾病：存在青光眼、白内障、眼部单纯性疱疹、感染性结膜炎或其他眼部感染者；
10. 筛选（访视 1）感染史：存在活动性或非活动性肺部结核感染，未治愈且仍需持续治疗的局部或全身性真菌、细菌、病毒或寄生虫感染，经研究者判断受试者可能会处于不适风险或影响试验结果判断者，例如需要住院治疗和/或静脉注射或等效口服抗生素治疗的严重感染（需要住院治疗和/或静脉注射或等效口服抗生素治疗）；筛选时尚未消退的有症状带状疱疹感染；复发性感染（包括但不限于复发性蜂窝织炎、慢性骨髓炎），仅存在复发性、轻度且无并发症的口唇疱疹和/或生殖器疱疹的受试者入选本研究；有活动性结核或潜伏性结核病史，且有经过适当治疗的书面证据，自上次完成治疗以来无再暴露史，并且胸部 X 线检查筛选显示无活动性结核证据可纳入研究。
11. 合并哮喘（包括疑似诊断哮喘）的受试者如满足以下条件，将被排除：FEV1≤60%的预测值；或筛选前 3 个月内出现哮喘急性发作，需要全身性糖皮质激素治疗或住院（＞24小时）；或吸入性糖皮质激素用量需＞1000μg丙酸氟替卡松或为相当剂量的其他吸入性糖皮质激素；
12. 已知具有复发性急性或慢性鼻窦炎病史，定义为在筛选前 3 个月内需要接受全身性抗生素治疗，或在筛选前 2 年内出现过大于 4 次复发；
13. 影响药物沉积的病变：筛选期或随机前鼻部检查结果经研究者判断存在可能影响鼻内药物沉积的鼻部疾病或症状/体征，例如急性或慢性鼻窦炎、慢性化脓性鼻后滴漏的症状或体征、药物性鼻炎、鼻息肉、血管舒缩性鼻炎、其他具有临床意义的呼吸道畸形/鼻结构异常、显著的鼻创伤（例如鼻贯通伤）或显著的鼻中隔偏曲者；在筛选期或随机前的鼻部检查中，存在任何鼻黏膜糜烂，鼻中隔溃疡或鼻中隔穿孔者；近期接受过鼻穿孔，且尚未完全愈合，可能引起鼻部症状，或者受试者计划在参加研究期间接受新的鼻穿孔；
14. 导入期前药物使用限制：导入期前一定时间内或药物的5个半衰期内使用过以下药物和/或治疗者：接受过IL-4Rα拮抗剂治疗（10周内或5个半衰期内）、血管收缩药（3天）、强镇静药（3天）、抗组胺药（10 天）、减充血剂（3天）、白三烯受体拮抗剂（7天）、抗胆碱药（7 天）、色甘酸类（14天）、全身性抗生素（14天）、眼用肥大细胞稳定剂（14天）、单胺氧化酶抑制剂（14天）、三环类抗抑郁剂（14天）、强效CYP3A4 诱导/抑制剂（14天）、抗过敏中草药（14天）、中短效全身皮质类固醇（4周）、长效全身皮质类固醇（6周）、免疫治疗如脱敏治疗及其他生物制剂单抗治疗（3个月）等；
15. 免疫抑制：在随机分组前的8周内或5个半衰期内（以较长者为准），因炎症性疾病或自身免疫性疾病（如类风湿性关节炎、炎症性肠病、原发性胆汁性胆管炎、系统性红斑狼疮、多发性硬化症等）接受过生物制剂/全身性免疫抑制剂治疗（包括但不限于甲氨蝶呤、环孢素、霉酚酸酯、他克莫司、青霉胺、柳氮磺吡啶、羟氯喹、硫唑嘌呤、环磷酰胺）；有已知或疑似免疫抑制病史，包括侵袭性机会性感染史（例如组织胞浆菌病、李斯特菌病、球孢子菌病、肺孢子虫病、曲霉病），尽管感染已消退；或研究者认为存在异常频繁、反复或长期感染。
16. 试验期间药物使用限制：计划在试验期间使用以下药物或/和治疗者：a.强效 CYP3A4 诱导/抑制剂； b.慢性或间歇性使用糖皮质激素（试验用药品除外）；c.抗组胺药；d.白三烯受体拮抗剂；e.肥大细胞膜稳定剂；f. 全身或鼻内减充血剂；g.抗胆碱药；h.免疫抑制剂；i.抗过敏中草药/中成药/保健品；j.抗 IgE 抗体（如注射用奥马珠单抗）；k.鼻腔冲洗剂（包括盐水）；
17. 女性受试者处于妊娠期、哺乳期，或者计划在研究期间怀孕或哺乳；
18. 存在任何其他医学或心理病症，研究者认为这种病症可能提示一种新的和/或尚未充分了解的疾病，参加本临床研究可能给研究受试者带来不合理的风险，可能使受试者无法稳定参加研究，或可能干扰研究评估；
19. 地理限制：试验期间计划长期到居住地以外地区旅行连续4周及以上者，或计划到和长期居住地气候差异较大的地区居住；
20. 既往参加过CM310临床试验者；
21. 既往使用过任何抗IL-4Rα单抗（如度普利尤单抗）但治疗应答不佳（如治疗失败或受试者不耐受治疗）的患者；
22. 存在其他控制不佳的严重疾病或反复发作的慢性疾病合并症，包括但不限于活动性感染、心脑血管疾病、肺结核或其他病原体感染、糖尿病、自身免疫性疾病、人类免疫缺陷病毒感染、梅毒螺旋体感染、活动性乙型肝炎、丙型肝炎或寄生虫病；
23. 筛选前5年内患恶性肿瘤；
24. 研究者认为受试者存在其他不适合参加本研究的医学或非医学情况。Exclusion criteria：
1. History of allergy to study drugs: hypersensitivity or intolerance to mometasone furoate, loratadine, CM310 injection, or any component of the placebo.
2. Laboratory abnormalities: severe hepatic or renal dysfunction, abnormal liver function [Alanine Aminotransferase (ALT)/Aspartate Transaminase (AST) >1.5 × Upper Limit of Normal (ULN), or Total Bilirubin (TBIL) >1.5 × ULN with abnormal AST] or abnormal renal function (serum creatinine >1.2 × ULN); clinically significant abnormalities in laboratory blood chemistry or hematology results at screening (Visit 1) or baseline (Visit 2) as judged by the investigator.
3. History of harmful behavior: history of drug abuse, alcohol dependence (average daily alcohol intake >40 g) within 2 years prior to screening, or current drug user.
4. Currently receiving allergen immunotherapy (subcutaneous or sublingual immunotherapy [SCIT/SLIT]). Subjects who discontinued SCIT/SLIT ≥3 years prior to randomization and are not on a maintenance regimen are eligible.
5. Use of any rescue medication during the screening and run-in periods.
6. Nasal procedure history at screening (Visit 1): nasal sinus surgery within 1 year prior to screening or presence of unhealed nasal trauma.
7. Drug exposure at screening (Visit 1): participation in another drug clinical trial and use of an investigational drug within 3 months prior to screening, or planned use of another investigational drug during the study.
8. Vaccination at screening (Visit 1): receipt of a live attenuated vaccine within 12 weeks prior to screening or planned vaccination with a live attenuated vaccine during the trial.
9. Ocular disease at screening (Visit 1): presence of glaucoma, cataract, ocular herpes simplex, infectious conjunctivitis, or other ocular infections.
10. Infection history at screening (Visit 1): active or inactive pulmonary tuberculosis infection; untreated localized or systemic fungal, bacterial, viral, or parasitic infection requiring ongoing treatment which, in the investigator’s judgment, may place the subject at undue risk or affect result interpretation (e.g., severe infection requiring hospitalization and/or IV or equivalent oral antibiotics); symptomatic herpes zoster infection not resolved at screening; recurrent infections (including but not limited to recurrent cellulitis, chronic osteomyelitis). Subjects with only recurrent, mild, uncomplicated herpes labialis and/or genital herpes may be enrolled. Subjects with a history of active or latent tuberculosis with written evidence of adequate treatment, no history of re-exposure since completion of treatment, and no evidence of active tuberculosis on chest X-ray at screening may be enrolled.
11. Subjects with comorbid asthma (including suspected asthma) are excluded if they meet any of the following: FEV1 ≤60% of predicted; or an asthma exacerbation within 3 months prior to screening requiring systemic corticosteroids or hospitalization (>24 hours); or required inhaled corticosteroid dosage >1000 μg fluticasone propionate or equivalent.
12. Known history of recurrent acute or chronic rhinosinusitis, defined as requiring systemic antibiotic treatment within 3 months prior to screening, or >4 recurrences within 2 years prior to screening.
13. Conditions affecting drug deposition: nasal disease or symptoms/signs identified during screening or prior to randomization that, in the investigator’s judgment, may affect intranasal drug deposition, such as acute or chronic sinusitis, symptoms/signs of chronic purulent postnasal drip, rhinitis medicamentosa, nasal polyps, vasomotor rhinitis, other clinically significant respiratory tract deformities/nasal structural abnormalities, significant nasal trauma (e.g., penetrating injury), or significant nasal septum deviation; any nasal mucosal erosion, nasal septum ulcer, or perforation at screening or prior to randomization; recent nasal piercing not fully healed that may cause nasal symptoms, or planned new nasal piercing during the study.
14. Restricted medication use prior to run-in period: use of the following medications and/or treatments within a specified time prior to the run-in period or within 5 half-lives of the drug: IL-4Rα antagonists (within 10 weeks or 5 half-lives), vasoconstrictors (3 days), strong sedatives (3 days), antihistamines (10 days), decongestants (3 days), leukotriene receptor antagonists (7 days), anticholinergics (7 days), cromolyn-like drugs (14 days), systemic antibiotics (14 days), ocular mast cell stabilizers (14 days), monoamine oxidase inhibitors (14 days), tricyclic antidepressants (14 days), strong CYP3A4 inducers/inhibitors (14 days), anti-allergy Chinese herbal medicines (14 days), short- or medium-acting systemic corticosteroids (4 weeks), long-acting systemic corticosteroids (6 weeks), immunotherapy such as desensitization therapy and other biologic monoclonal antibody therapies (3 months), etc.
15. Immunosuppression: treatment with biologics/systemic immunosuppressants (including but not limited to methotrexate, cyclosporine, mycophenolate mofetil, tacrolimus, penicillamine, sulfasalazine, hydroxychloroquine, azathioprine, cyclophosphamide) for inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, inflammatory bowel disease, primary biliary cholangitis, systemic lupus erythematosus, multiple sclerosis) within 8 weeks prior to randomization or within 5 half-lives (whichever is longer); known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, aspergillosis) even if resolved; or abnormally frequent, recurrent, or prolonged infections as judged by the investigator.
16. Restricted medication use during the trial: planned use during the trial of the following drugs and/or treatments: a. strong CYP3A4 inducers/inhibitors; b. chronic or intermittent use of corticosteroids (except investigational product); c. antihistamines; d. leukotriene receptor antagonists; e. mast cell membrane stabilizers; f. systemic or intranasal decongestants; g. anticholinergics; h. immunosuppressants; i. anti-allergy Chinese herbal medicines/proprietary Chinese medicines/health products; j. anti-IgE antibodies (e.g., omalizumab for injection); k. nasal irrigations (including saline).
17. Female subjects who are pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study.
18. Presence of any other medical or psychological condition that, in the investigator’s opinion, may indicate a new and/or insufficiently understood disease, participation in this clinical study may pose an unreasonable risk to the subject, may make the subject unable to participate stably in the study, or may interfere with study evaluations.
19. Geographical restrictions: planned long-term travel away from the place of residence for ≥4 consecutive weeks during the trial, or planned residence in an area with a significantly different climate from the long-term place of residence.
20. Previous participation in a CM310 clinical trial.
21. Previous use of any anti-IL-4Rα monoclonal antibody (e.g., dupilumab) with inadequate treatment response (e.g., treatment failure or intolerance).
22. Presence of other uncontrolled severe diseases or recurrent chronic comorbidities, including but not limited to active infection, cardiovascular and cerebrovascular diseases, tuberculosis or other pathogen infections, diabetes, autoimmune diseases, human immunodeficiency virus (HIV) infection, Treponema pallidum infection, active hepatitis B or C, or parasitic diseases.
23. History of malignancy within 5 years prior to screening.
24. Any other medical or non-medical condition that, in the investigator’s opinion, makes the subject unsuitable for participation in this study;研究实施时间：
Study execute time：
从
From
2025-09-23 00:00:00至
To
2027-01-31 00:00:00
征募观察对象时间：
Recruiting time：
从
From
2025-10-31 00:00:00
至
To
2026-12-31 00:00:00干预措施：
Interventions：
组别：
对照组
样本量：
45
Group：
Placebo group
Sample size：
干预措施：
CM310注射液安慰剂
干预措施代码：
Intervention：
CM310 Injection Placebo
Intervention code：
组别：
试验组
样本量：
45
Group：
Experimental group
Sample size：
干预措施：
CM310注射液
干预措施代码：
Intervention：
CM310 Injection
Intervention code：研究实施地点：
Countries of recruitment and research settings：
国家：
中国
省(直辖市)：
湖北省
市(区县)：
Country：
China
Province：
Hubei
City：
单位(医院)：
武汉大学中南医院
单位级别：
三级甲等
Institution
hospital：
Zhongnan Hospital of Wuhan University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
湖北省
市(区县)：
Country：
China
Province：
Hubei
City：
单位(医院)：
武汉市中心医院
单位级别：
三级甲等
Institution
hospital：
The Central Hospital of Wuhan
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
四川省
市(区县)：
Country：
China
Province：
Sichuan
City：
单位(医院)：
四川大学华西医院
单位级别：
三级甲等
Institution
hospital：
West China Hospital of Sichuan University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
广东省
市(区县)：
Country：
China
Province：
Guangdong
City：
单位(医院)：
广东祈福医院
单位级别：
三级甲等
Institution
hospital：
Guangdong Clifford Hospital
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
北京市
市(区县)：
Country：
China
Province：
Beijing
City：
单位(医院)：
北京清华长庚医院
单位级别：
三级医院
Institution
hospital：
Beijing Tsinghua Changgung Hospital
Level of the institution：
Tertiary
国家：
中国
省(直辖市)：
江西省
市(区县)：
Country：
China
Province：
Jiangxi
City：
单位(医院)：
南昌大学第一附属医院
单位级别：
三级甲等
Institution
hospital：
The first affiliated hostipal of nanchang university
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
湖北省
市(区县)：
Country：
China
Province：
Hubei
City：
单位(医院)：
武汉大学人民医院
单位级别：
三级甲等
Institution
hospital：
Renmin Hospital of Wuhan University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
上海市
市(区县)：
Country：
China
Province：
Shanghai
City：
单位(医院)：
复旦大学附属眼耳鼻喉科医院
单位级别：
三级甲等
Institution
hospital：
Eye & ENT hospital of Fudan University
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
湖北省
市(区县)：
Country：
China
Province：
Hubei
City：
单位(医院)：
华中科技大学同济医学院附属同济医院
单位级别：
三级甲等
Institution
hospital：
Tongji Hospital, Tongji Medical College ,Huazhong University of Science and Technology
Level of the institution：
Tertiary A
国家：
中国
省(直辖市)：
湖北省
市(区县)：
Country：
China
Province：
Hubei
City：
单位(医院)：
湖北省中西医结合医院
单位级别：
三级甲等
Institution
hospital：
Hubei Provincial Hospital of Integrated Chinese and Western Medicine
Level of the institution：
Tertiary A测量指标：
Outcomes：
指标中文名：
体格检查
指标类型：
次要指标
Outcome：
Physical Examination
Type：
Secondary indicator
测量时间点：
访视1到访视10
测量方法：
进行包括生命体征在内的鼻部，眼部，面部以及全身各个系统的体格检查
Measure time point of outcome：
Visits 1 to Visit 10
Measure method：
Examinations will include the nasal cavity, eyes, face, and all other body systems, including vital signs.
指标中文名：
安全性实验室检查
指标类型：
次要指标
Outcome：
Safety Laboratory Tests
Type：
Secondary indicator
测量时间点：
访视1，访视2，访视4，访视6，访视8，访视9和访视10
测量方法：
检测患者血常规，血生化，尿常规
Measure time point of outcome：
At Visits 1, 2, 4, 6, 8, 9, and 10
Measure method：
Tests will include complete blood count, blood chemistry, and urinalysis.
指标中文名：
治疗12周每日回顾性鼻部症状评分（Reflective Total Nasal Symptom Score, rTNSS）与基线相比的平均变化
指标类型：
主要指标
Outcome：
Mean Change from Baseline in the daily Reflective Total Nasal Symptom Score (rTNSS) at Week 12
Type：
Primary indicator
测量时间点：
从访视2开始，每日由患者记录并上传
测量方法：
评估内容包括4个鼻部症状（喷嚏、流涕、鼻痒和鼻塞），症状严重程度按4分法评定：0分为无症状；1分为轻度症状（症状轻微，易于忍受）；2分为中度症状（症状明显，令人厌烦，但可以忍受）；3分为重度症状（症状不能忍受，影响日常生活和/或睡眠）。总分为各症状评分之和，范围为0~12。
Measure time point of outcome：
Recorded and uploaded daily by the patient starting from Visit 2.
Measure method：
The rTNSS assesses four nasal symptoms (sneezing, rhinorrhea, nasal itching, and nasal congestion). Symptom severity is rated on a 4-point scale: 0 = absent (no symptom); 1 = mild (mild symptom, easily tolerated); 2 = moderate (bothersome symptom, but tolerable); 3 = severe (severe symptom, hard to tolerate, interfering with daily activities and/or sleep). The total score is the sum of the individual symptom scores, ranging from 0 to 12.
指标中文名：
鼻结膜炎相关生活质量问卷(rhino-conjunctivitis quality of life questionnaire, RQLQ)
指标类型：
次要指标
Outcome：
Rhino-Conjunctivitis Quality of Life Questionnaire (RQLQ)
Type：
Secondary indicator
测量时间点：
访视2，访视5，访视8，访视9，访视10
测量方法：
RQLQ用于测量鼻结膜炎成人在日常生活中遇到的问题。它有7个领域（活动限制、睡眠障碍、非鼻/眼症状、实际问题、鼻症状、眼症状和情绪问题）的28个问题。受试者回忆他们在前一周被鼻结膜炎困扰的程度，并以7分制回答每个问题（0-完全没有受损~6-严重受损）。总体RQLQ得分是所有28个回答的平均值，而个别领域得分是这些领域中项目的平均值。
Measure time point of outcome：
Visits 2, 5, 8, 9, and 10.
Measure method：
The RQLQ is used to measure problems experienced by adults with rhino-conjunctivitis in their daily lives. It contains 28 items in 7 domains (activity limitation, sleep problems, non-nose/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotional problems). Subjects recall how bothered they have been by their rhino-conjunctivitis during the previous week and answer each question on a 7-point scale (0 = not impaired at all to 6 = severely impaired). The overall RQLQ score is th
指标中文名：
治疗期间和随访期间不良事件（Adverse Event, AE）/严重不良事件（Serious Adverse Event, SAE）发生情况
指标类型：
次要指标
Outcome：
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) During the Treatment and Follow-up Periods
Type：
Secondary indicator
测量时间点：
访视1到访视10所有时间
测量方法：
所有不良事件和严重不良事件均填写不良事件表或严重不良事件表并上传
Measure time point of outcome：
Throughout Visits 1 to 10.
Measure method：
All AEs and SAEs will be documented in AE forms or SAE forms and uploaded.
指标中文名：
12导联心电图（electrocardiogram, ECG）
指标类型：
次要指标
Outcome：
12-Lead Electrocardiogram (ECG)
Type：
Secondary indicator
测量时间点：
访视1，访视2，访视4，访视6和访视8
测量方法：
采用12导联心电图检测
Measure time point of outcome：
Visits 1, 2, 4, 6, and 8.
Measure method：
A 12-lead ECG will be performed.
指标中文名：
嗅觉评估
指标类型：
次要指标
Outcome：
Olfactory Assessment
Type：
Secondary indicator
测量时间点：
访视2-访视10
测量方法：
采用视觉模拟量表（Visual Analogue Scale，VAS）评估患者的嗅觉情况
Measure time point of outcome：
From visit 2 to visit10
Measure method：
A Visual Analogue Scale (VAS) will be used to assess the patient's sense of smell.
指标中文名：
治疗期间每日rTNSS基线变化曲线下面积（Area Under Curve, AUC）
指标类型：
次要指标
Outcome：
Area Under the Curve (AUC) for the Change from Baseline in Daily rTNSS During the Treatment Period
Type：
Secondary indicator
测量时间点：
访视2-访视10，每日上传后计算
测量方法：
访视2-访视10每日患者情况上传后计算
Measure time point of outcome：
Calculated after daily uploads from Visit 2 to Visit 10.
Measure method：
Calculated after daily uploads from Visit 2 to Visit 10.
指标中文名：
治疗反应的整体评价
指标类型：
次要指标
Outcome：
Overall Evaluation of Treatment Response
Type：
Secondary indicator
测量时间点：
访视2，访视8和访视10
测量方法：
对治疗反应的总体评估基于7分分类量表，受试者在研究结束时评估NARES症状变化或缺乏变化，分为显著改善、中度改善、轻度改善、无变化、轻度恶化、中度恶化、明显恶化等7个类别。
Measure time point of outcome：
Visits 2, 8, and 10.
Measure method：
The overall assessment of treatment response is based on a 7-point categorical scale. Subjects rate the change in NARES symptoms at the end of the study as: significantly improved, moderately improved, mildly improved, no change, mildly worsened, moderately worsened, or significantly worsened.
指标中文名：
治疗期间给药前即时鼻部症状评分（Instant Total Nasal Symptom Score, iTNSS）较基线的平均变化；
指标类型：
次要指标
Outcome：
Mean Change from Baseline in the Instant Total Nasal Symptom Score (iTNSS) Prior to Dosing During the Treatment Period
Type：
Secondary indicator
测量时间点：
访视2-访视8
测量方法：
评估内容包括4个鼻部症状（喷嚏、流涕、鼻痒和鼻塞），症状严重程度按4分法评定：0分为无症状；1分为轻度症状（症状轻微，易于忍受）；2分为中度症状（症状明显，令人厌烦，但可以忍受）；3分为重度症状（症状不能忍受，影响日常生活和/或睡眠）。总分为各症状评分之和，范围为0~12。
Measure time point of outcome：
From visit 2 to visit8
Measure method：
The iTNSS assesses four nasal symptoms (sneezing, rhinorrhea, nasal itching, and nasal congestion). Symptom severity is rated on a 4-point scale: 0 = absent (no symptom); 1 = mild (mild symptom, easily tolerated); 2 = moderate (bothersome symptom, but tolerable); 3 = severe (severe symptom, hard to tolerate, interfering with daily activities and/or sleep). The total score is the sum of the individual symptom scores, ranging from 0 to 12.
指标中文名：
治疗期间眼部症状（Total Ocular Symptom Score，TOSS）评分
指标类型：
次要指标
Outcome：
Total Ocular Symptom Score (TOSS) During the Treatment Period
Type：
Secondary indicator
测量时间点：
从访视2开始到访视10，每日由患者记录并上传
测量方法：
评估内容包括3个眼部症状（眼睛发痒/灼热、眼睛流泪/流水、眼睛发红），症状严重程度分级同TNSS。总分为各症状评分之和，范围为0~9。
Measure time point of outcome：
Recorded and uploaded daily by the patient from Visit 2 to Visit 10.
Measure method：
The TOSS assesses three ocular symptoms (ocular itching/burning, tearing/watering, eye redness). Symptom severity is graded identically to the TNSS. The total score is the sum of the individual symptom scores, ranging from 0 to 9.
指标中文名：
治疗期间给药前瞬时总眼症状评分（Instant Total Ocular Symptom Score, iTOSS）较基线的平均变化：
指标类型：
次要指标
Outcome：
Mean Change from Baseline in the Instant Total Ocular Symptom Score (iTOSS) Prior to Dosing During the Treatment Period
Type：
Secondary indicator
测量时间点：
访视2-访视8
测量方法：
评估内容包括3个眼部症状（眼睛发痒/灼热、眼睛流泪/流水、眼睛发红），症状严重程度分级同TNSS。总分为各症状评分之和，范围为0~9。
Measure time point of outcome：
From visit 2 to visit8
Measure method：
The iTOSS assesses three ocular symptoms (ocular itching/burning, tearing/watering, eye redness). Symptom severity is graded identically to the TNSS. The total score is the sum of the individual symptom scores, ranging from 0 to 9.
指标中文名：
治疗期间鼻部症状（TNSS）评分
指标类型：
次要指标
Outcome：
Total Nasal Symptom Score (TNSS) During the Treatment Period
Type：
Secondary indicator
测量时间点：
从访视2开始到访视10，每日由患者记录并上传
测量方法：
评估内容包括4个鼻部症状（喷嚏、流涕、鼻痒和鼻塞），症状严重程度按4分法评定：0分为无症状；1分为轻度症状（症状轻微，易于忍受）；2分为中度症状（症状明显，令人厌烦，但可以忍受）；3分为重度症状（症状不能忍受，影响日常生活和/或睡眠）。总分为各症状评分之和，范围为0~12。
Measure time point of outcome：
Recorded and uploaded daily by the patient from Visit 2 to Visit 10.
Measure method：
The TNSS assesses four nasal symptoms (sneezing, rhinorrhea, nasal itching, and nasal congestion). Symptom severity is rated on a 4-point scale: 0 = absent (no symptom); 1 = mild (mild symptom, easily tolerated); 2 = moderate (bothersome symptom, but tolerable); 3 = severe (severe symptom, hard to tolerate, interfering with daily activities and/or sleep). The total score is the sum of the individual symptom scores, ranging from 0 to 12.
指标中文名：
治疗期间患者无症状或轻度症状的天数
指标类型：
次要指标
Outcome：
Number of Days with No or Mild Symptoms During the Treatment Period
Type：
Secondary indicator
测量时间点：
访视2-访视10每日上传后计算
测量方法：
对于每日rTNSS和rTOSS，按以下定义计算治疗期间无症状或轻度症状的天数：
无症状或轻度鼻部症状：流涕、鼻塞、鼻痒、喷嚏各症状评分均≤1分
无症状或轻度眼部症状：眼痒、流泪、眼红各症状评分均≤1分
Measure time point of outcome：
Calculated after daily uploads from Visit 2 to Visit 10.
Measure method：
For the daily rTNSS and rTOSS, the number of days with no or mild symptoms during the treatment period is defined as follows:
No or mild nasal symptoms: each individual symptom score (rhinorrhea, nasal congestion, nasal itching, sneezing) is ≤1.
No or mild ocular symptoms: each individual symptom score (ocular itching, tearing, eye redness) is ≤1.采集人体标本：
Collecting sample(s)
from participants：
标本中文名：
外周血
组织：
Sample Name：
Peripheral Blood
Tissue：
人体标本去向
使用后销毁
说明
Fate of sample：
Destruction after use
Note：
标本中文名：
鼻刷细胞
组织：
Sample Name：
Nasal Brush Cytology
Tissue：
人体标本去向
使用后销毁
说明
Fate of sample：
Destruction after use
Note：
标本中文名：
鼻分泌物
组织：
Sample Name：
Nasal Secretion
Tissue：
人体标本去向
使用后销毁
说明
Fate of sample：
Destruction after use
Note：征募研究对象情况：
Recruiting status：
正在进行
Recruiting
年龄范围：
Participant age：
最小
Min age
18
岁
years
最大
Max age
65
岁
years性别：
男女均可
Gender：
Both随机方法（请说明由何人用什么方法产生随机序列）：
由独立的随机化统计师采用SAS® 9.4或更高版本软件分别产生受试者随机表和药物随机表。受试者随机表和药物随机表由IWRS系统工程师导入系统，以实现随机化和药物号的发放。试验人员或其授权人员登陆随机系统申请随机号，将随机系统的随机化信息打印或下载保存。Randomization Procedure (please state who
generates the
random number sequence and by what method)：
An independent randomization statistician will generate the subject randomization list and drug randomization list separately using SAS® 9.4 or higher software. The subject and drug randomization lists will be imported into the IWRS (Interactive Web Response System) by the system engineer to implement the randomization and dispense drug assignment numbers. Investigators or their authorized personnel will log into the randomization system to request a randomization number, and shall print or download and save the randomization information.是否公开试验完成后的统计结果:
Calculated Results after the Study Completed public access:
不公开/Private盲法：
双盲Blinding：
Double blind是否共享原始数据：
IPD sharing
是Yes共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：
在完成全部试验并完成数据清理后随文章发表公开原始数据The way of sharing IPD”(include metadata and
protocol,
If use web-based public database, please provide
the
url)：
Upon completion of the entire trial and final database lock, the raw data will be made publicly available alongside the publication of the manuscript.数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case
Record Form, CRF)，二为电子采集和管理系统(Electronic Data
Capture, EDC)，如ResMan即为一种基于互联网的EDC：
EDC系统根据原始CRF表制作，通过EDC系统产生电子CRF表，并收集和管理信息Data collection and Management (A
standard data collection and management system
include a CRF and an electronic data capture：
The Electronic Data Capture (EDC) system, which is developed based on the original Case Report Form (CRF), is utilized to generate electronic CRFs and is responsible for the collection and management of all study data.数据与安全监察委员会：
Data and Safety Monitoring Committee：
有/Yes注册人：
Name of Registration：
2025-10-31 15:21:44
一致性评价
2025-10-28
Hepatology[Jour] AND 82[volume] AND 1[issue]
肝脏病学82卷1期
https://journals-lww-com.libproxy1.nus.edu.sg/hep/pages/currenttoc.aspx
Hepatology Highlights（肝病学亮点）
1
The dynamic duo: How tumor-associated macrophages and tumor cells team up in cholangiocarcinoma
“黄金搭档”：胆管癌中肿瘤相关巨噬细胞与肿瘤细胞如何协同作用
Li, Binbin; Ilyas, Sumera I.
Hepatology. 82(1):1-2, July 2025.
2
Two heads are better than one: The synergy of carvedilol and simvastatin
双剑合璧：卡维地洛与辛伐他汀的协同作用
Kumar, Prabhat; Arab, Juan Pablo
Hepatology. 82(1):3-4, July 2025.
3
Not so subclinical: Is early thyroid disease an untapped avenue to protect children from MASLD?
并非那么“亚临床”：早期甲状腺疾病是否是保护儿童免受代谢障碍相关脂肪性肝病（MASLD）侵害的未开发途径？
Marek, George
Hepatology. 82(1):5-6, July 2025.
4
Genes that fit just right: Unzipping the genome of fatty liver disease
基因恰到好处：解开脂肪肝疾病的基因组密码
Sample, Jack W.
Hepatology. 82(1):7-8, July 2025.
Editorials（社论）
5
New ubiquitomic subtypes in HCC: Insights for future therapeutic approaches
肝细胞癌（HCC）中新的泛素组学亚型：为未来治疗策略提供见解
Nakagawa, Hayato
Hepatology. 82(1):9-11, July 2025.
6
Mitochondrial genome diversity drives heterogeneity in HCC
线粒体基因组多样性驱动肝细胞癌的异质性
Shibata, Tatsuhiro; Hoshida, Yujin
Hepatology. 82(1):12-13, July 2025.
7
Cell-to-cell signaling cross-talk in liver regeneration: A prostaglandin-Wnt axis
肝脏再生中的细胞间信号串扰：前列腺素-Wnt轴
Apte, Udayan
Hepatology. 82(1):14-15, July 2025.
8
Utilizing viral RNA fragments to limit acute inflammation
利用病毒RNA片段限制急性炎症
Zhao, Chunyuan; Zhao, Wei
Hepatology. 82(1):16-18, July 2025.
9
Functional humoral immunity is crucial to outcomes in severe alcohol-associated hepatitis
功能性体液免疫对严重酒精相关性肝炎的预后至关重要
McGettigan, Brett M.; A. Osna, Natalia
Hepatology. 82(1):19-21, July 2025.
10
Fine-tuning of hepatitis C virus immune evasion through hypervariable region 1 insertions
通过超变区1插入对丙型肝炎病毒免疫逃逸的精细调控
Colpitts, Che C.; Baumert, Thomas F.
Hepatology. 82(1):22-24, July 2025.
Original Articles（论著）
Liver Cancer（肝癌）
11
The co-location of MARCO+ tumor-associated macrophages and CTSE+ tumor cells determined the poor prognosis in intrahepatic cholangiocarcinoma
MARCO+肿瘤相关巨噬细胞与CTSE+肿瘤细胞的共定位决定肝内胆管癌的不良预后
Fan, Guangyu; Tao, Changcheng; Li, Lin; More
Hepatology. 82(1):25-41, July 2025.
12
Integrated ubiquitomics characterization of hepatocellular carcinomas
肝细胞癌的整合泛素组学特征分析
Lin, Xiao-Tong; Luo, Yuan-Deng; Mao, Cui; More
Hepatology. 82(1):42-58, July 2025.
13
Unraveling bidirectional evolution of unstable mitochondrial DNA mutations in hepatocellular carcinoma at single-cell resolution
单细胞分辨率下揭示肝细胞癌中不稳定线粒体DNA突变的双向进化
Zhou, Kaixiang; Wang, Zhenni; Guo, Wenjie; More
Hepatology. 82(1):59-76, July 2025.
Liver Pathobiology（肝脏病理生物学）
14
PGD2/DP1 axis promotes liver regeneration by secreting Wnt2 in KCs in mice
PGD2/DP1轴通过在小鼠库普弗细胞（KCs）中分泌Wnt2促进肝脏再生
Li, Juanjuan; Zheng, Yinghong; Duan, Zhenzhen; More
Hepatology. 82(1):77-91, July 2025.
15
The desulfinylation enzyme sulfiredoxin-1 attenuates HSC activation and liver fibrosis by modulating the PTPN12-NLRP3 axis
脱亚磺酰化酶硫氧还蛋白还原酶-1通过调节PTPN12-NLRP3轴减弱肝星状细胞（HSC）活化和肝纤维化
Kim, Jong-Won; Tung, Hung-Chun; Ke, Mengyun; More
Hepatology. 82(1):92-109, July 2025.
16
Harnessing ZIKV NS2A RNA for alleviating acute hepatitis and cytokine release storm by targeting translation machinery
利用寨卡病毒NS2A RNA通过靶向转化机制缓解急性肝炎和细胞因子释放风暴
Zhu, Jingfei; Wu, Rongsheng; Yang, Tao; More
Hepatology. 82(1):110-126, July 2025.
Liver Failure/Cirrhosis/Portal Hypertension（肝衰竭/肝硬化/门静脉高压）
17
Viral antibody response predicts morbidity and mortality in alcohol-associated hepatitis
病毒抗体反应可预测酒精相关性肝炎的发病率和死亡率
Hsu, Cynthia L.; Wang, Limin; Maestri, Evan; More
Hepatology. 82(1):127-139, July 2025.
18
Hemodynamic effects of carvedilol plus simvastatin in cirrhosis with severe portal hypertension and suboptimal response to β-blockers: A double-blind, placebo-controlled, randomized trial
卡维地洛联合辛伐他汀对β受体阻滞剂反应不佳的严重门静脉高压肝硬化患者的血流动力学影响：一项双盲、安慰剂对照、随机试验
Alvarado-Tapias, Edilmar; Brujats, Anna; Puente, Angela; More
Hepatology. 82(1):140-154, July 2025.
Pediatrics（儿科）
19
Prevalence of subclinical hypothyroidism and longitudinal thyroid-stimulating hormone changes in youth with metabolic dysfunction–associated steatotic liver disease: An observational study
代谢功能障碍相关脂肪性肝病青少年中亚临床甲状腺功能减退症的患病率及纵向促甲状腺激素变化：一项观察性研究
Untalan, Matthew; A. Crimmins, Nancy; Yates, Katherine P.; More
Hepatology. 82(1):155-164, July 2025.
Steatohepatitis（脂肪性肝炎）
20
A functional genomic framework to elucidate novel causal metabolic dysfunction–associated fatty liver disease genes
功能基因组学框架用于阐明新型代谢功能障碍相关脂肪性肝病致病基因
Saliba-Gustafsson, Peter; Justesen, Johanne M.; Ranta, Amanda; More
Hepatology. 82(1):165-183, July 2025.
21
Intestinal IL-33 promotes microbiota-derived trimethylamine N-oxide synthesis and drives metabolic dysfunction–associated steatotic liver disease progression by exerting dual regulation on HIF-1α
肠道白细胞介素-33（IL-33）通过对缺氧诱导因子-1α（HIF-1α）的双重调控，促进微生物群来源的氧化三甲胺（TMAO）合成，并驱动代谢功能障碍相关脂肪性肝病（MASLD）的进展
Hai, Suping; Li, Xitang; Xie, Erliang; More
Hepatology. 82(1):184-198, July 2025.
Viral Hepatitis（病毒性肝炎）
22
Prevalence of HCV HVR1 insertions and their role in antibody evasion
丙型肝炎病毒（HCV）超变区1（HVR1）插入的流行情况及其在抗体逃逸中的作用
Olesen, Christina Holmboe; Collignon, Laura; Velázquez-Moctezuma, Rodrigo; More
Hepatology. 82(1):199-211, July 2025.
Reviews（综述）
23
Benefit and harm of waiting time in liver transplantation for HCC
肝细胞癌（HCC）肝移植等待时间的利弊
van der Meeren, Pam Elisabeth; de Wilde, Roeland Frederik; Sprengers, Dave; More
Hepatology. 82(1):212-231, July 2025.
24
Emerging and potential use of CRISPR in human liver disease
CRISPR在人类肝脏疾病中的新兴应用及潜在用途
Adlat, Salah; Vázquez Salgado, Alexandra M.; Lee, Markcus; More
Hepatology. 82(1):232-253, July 2025.
25
New insights into the molecular basis of alcohol abstinence and relapse in alcohol-associated liver disease
酒精相关性肝病中酒精戒断和复饮的分子基础新见解
Diaz, Luis Antonio; Winder, Gerald Scott; Leggio, Lorenzo; More
Hepatology. 82(1):254-271, July 2025.
Practice Guidance（实践指南）
26
Critical Update: AASLD Practice Guidance on prevention, diagnosis, and treatment of hepatocellular carcinoma
重要更新：美国肝病研究学会（AASLD）关于肝细胞癌预防、诊断和治疗的实践指南
Taddei, Tamar H.; Brown, Daniel B.; Yarchoan, Mark; More
Hepatology. 82(1):272-274, July 2025.
Correspondence（读者来信）
27
Letter to the Editor: Prevalence of subclinical hypothyroidism and longitudinal thyroid stimulating hormone changes in youth with metabolic dysfunction–associated steatotic liver disease: An observational study
致编辑的信：代谢功能障碍相关脂肪性肝病青少年中亚临床甲状腺功能减退症的患病率及纵向促甲状腺激素变化：一项观察性研究
Di Sessa, Anna; Miraglia del Giudice, Emanuele
Hepatology. 82(1):E1-E2, July 2025.
28
Reply: Prevalence of subclinical hypothyroidism and longitudinal thyroid stimulating hormone changes in youth with metabolic dysfunction–associated steatotic liver disease: An observational study
回复：代谢功能障碍相关脂肪性肝病青少年中亚临床甲状腺功能减退症的患病率及纵向促甲状腺激素变化：一项观察性研究
Thaker, Vidhu V.; Crimmins, Nancy; Yates, Katherine P.; More
Hepatology. 82(1):E3-E4, July 2025.
29
Letter to the Editor: Mean arterial pressure as a complex treatment target in patients with cirrhosis and acute kidney injury
致编辑的信：肝硬化合并急性肾损伤患者的平均动脉压作为复杂治疗目标
Cardoso, Filipe S.
Hepatology. 82(1):E5-E6, July 2025.
30
Letter to the Editor: Considerations on the use of LPCN 1148 in cirrhotic patients with sarcia
致编辑的信：关于在肝硬化合并肌少症患者中使用LPCN 1148的考量
Tantai, Xinxing; Li, Lu; Dai, Shejiao
Hepatology. 82(1):E7-E8, July 2025.
31
Reply: Considerations on the use of LPCN 1148 in cirrhotic patients with sarcia
回复：关于在肝硬化合并肌少症患者中使用LPCN 1148的考量
Bruno, Benjamin J.; Weavil, Joshua C.; Ogle, Jonathan; More
Hepatology. 82(1):E9-E10, July 2025.
32
Letter to the Editor: Different phenotypes of CMRFs lead to different pathophysiological processes among individuals with MASLD/MetALD
致编辑的信：代谢功能障碍相关脂肪性肝病（MASLD）/代谢相关酒精性肝病（MetALD）患者中细胞因子调节因子（CMRFs）的不同表型导致不同的病理生理过程
Li, Zheng; Tang, Xiaolong; Li, Zhiping; More
Hepatology. 82(1):E11-E12, July 2025.
33
Reply: Different phenotypes of CMRFs lead to different pathophysiological processes among individuals with MASLD/MetALD
回复：代谢功能障碍相关脂肪性肝病（MASLD）/代谢相关酒精性肝病（MetALD）患者中细胞因子调节因子（CMRFs）的不同表型导致不同的病理生理过程
Kim, Hyun-seok; Kwak, Minsun; Yang, Ju Dong
Hepatology. 82(1):E13-E14, July 2025.
34
Letter to the Editor: Targeted enteral feeding for malnutrition in liver transplant candidates
致编辑的信：针对肝移植候选人的营养不良进行靶向肠内喂养
Chen, Qingyu
Hepatology. 82(1):E15, July 2025.
35
Reply: Targeted enteral feeding for malnutrition in liver transplant candidates
回复：针对肝移植候选人的营养不良进行靶向肠内喂养
Chapman, Brooke; Wong, Darren; Sinclair, Marie; More
Hepatology. 82(1):E16-E17, July 2025.
36
Letter to the Editor: Primary sclerosing cholangitis and autoimmune hepatitis—Distinct or common autoimmune penetrance?
致编辑的信：原发性硬化性胆管炎与自身免疫性肝炎——是截然不同还是存在共同的自身免疫倾向？
Grønbæk, Lisbet; Vilstrup, Hendrik; Jepsen, Peter
Hepatology. 82(1):E18-E19, July 2025.
37
Reply: Primary sclerosing cholangitis and autoimmune hepatitis—Distinct or common autoimmune penetrance?
回复：原发性硬化性胆管炎与自身免疫性肝炎——是截然不同还是存在共同的自身免疫倾向？
Lundberg Båve, Aiva; von Seth, Erik; Ingre, Michael; More
Hepatology. 82(1):E20, July 2025.
Retractions（撤稿声明）
38
Retraction: α-1 adrenergic receptor agonists modulate ductal secretion of BDL rats via Ca2+- and PKC-dependent stimulation of cAMP
撤稿声明：α-1肾上腺素能受体激动剂通过钙离子（Ca2+）和蛋白激酶C（PKC）依赖的环磷酸腺苷（cAMP）刺激调节胆总管结扎（BDL）大鼠的胆管分泌
LeSage, Gene D.; Alvaro, Domenico; Glaser, Shannon; More
Hepatology. 82(1):E21, July 2025.
39
Retraction: GABA induces the differentiation of small into large cholangiocytes by activation of Ca2+/CaMK I-dependent adenylyl cyclase 8
撤稿声明：γ-氨基丁酸（GABA）通过激活钙离子/钙调蛋白激酶I（Ca2+/CaMK I）依赖的腺苷酸环化酶8诱导小胆管细胞向大胆管细胞分化
Mancinelli, Romina; Franchitto, Antonio; Glaser, Shannon; More
Hepatology. 82(1):E22, July 2025.
Hepatology[Jour] AND 82[volume] AND 2[issue]
肝脏病学82卷2期
https://journals-lww-com.libproxy1.nus.edu.sg/hep/pages/currenttoc.aspx
Hepatology Highlights（肝病学亮点）
1
Deep learning’s crystal ball: Predicting HCC surgery success with multimodal imaging
深度学习的“水晶球”：利用多模态成像预测肝细胞癌（HCC）手术成功
Chodha, Ankit
Hepatology. 82(2):275-276, August 2025.
2
Better late than resectable: Combination therapy finds its moment
对于晚期，优于可切除的情况：联合疗法迎来高光时刻
Khan, Sarah
Hepatology. 82(2):277-278, August 2025.
3
Decoding liver risk: A deep dive into the Baveno VII “Rule-of-Five”criteria
解读肝脏风险：深入剖析Baveno VII“五规则”标准
Rama, Kaanthi; Arab, Juan Pablo
Hepatology. 82(2):279-280, August 2025.
4
2D-SWE in MASLD: Should we utilize it more with these new cutoffs?
代谢障碍相关脂肪性肝病（MASLD）中的二维剪切波弹性成像（2D-SWE）：是否应采用这些新临界值以扩大其应用？
Udompap, Prowpanga
Hepatology. 82(2):281-282, August 2025.
Editorials（社论）
5
Cracking HCC: Targeting diacylglycerol kinase eta to tackle therapy resistance and cancer stemness
破解肝细胞癌：靶向二酰甘油激酶η以应对治疗耐药性和癌症干细胞特性
Song, Guisheng
Hepatology. 82(2):283-285, August 2025.
6
Mechanocrine signaling, Yap, HB-EGF, and liver regeneration
机械分泌信号传导、Yap、肝素结合表皮生长因子（HB-EGF）与肝脏再生
Michalopoulos, George K.
Hepatology. 82(2):286-288, August 2025.
7
From micronutrient to mechanism: Magnesium and the CNNM4 puzzle in alcohol-associated liver disease
从微量元素到作用机制：酒精相关肝病中镁与CNNM4的谜团
Rungratanawanich, Wiramon; Liangpunsakul, Suthat; Ma, Jing
Hepatology. 82(2):289-292, August 2025.
Original Articles（论著）
Immune-Mediated Diseases, DILI, and Biliary Tract Disease（免疫介导疾病、药物性肝损伤和胆道疾病）
8
Stard1 promotes cholestatic liver injury and disease progression by sensitizing to bile acid hepatotoxicity
Stard1通过增强对胆汁酸肝毒性的敏感性促进胆汁淤积性肝损伤和疾病进展
Conde de la Rosa, Laura; Fàbrega, Laura; Torres, Sandra; More
Hepatology. 82(2):293-307, August 2025.
Liver Cancer（肝癌）
9
DGKH-mediated phosphatidic acid oncometabolism as a driver of self-renewal and therapy resistance in HCC
二酰甘油激酶η（DGKH）介导的磷脂酸肿瘤代谢是肝细胞癌自我更新和治疗耐药的驱动因素
Loh, Jia Jian; Ng, Kai Yu; Huang, Ianto Bosheng; More
Hepatology. 82(2):308-325, August 2025.
10
Human T cells engineered with an HLA-A2-restricted murine T-cell receptor targeting glypican 3 effectively control human hepatocellular carcinoma in mice
用针对磷脂酰肌醇蛋白聚糖3（glypican 3）的人白细胞抗原A2（HLA-A2）限制性小鼠T细胞受体工程化改造的人T细胞可有效控制小鼠体内的人肝细胞癌
Vercher, Enric; Covo-Vergara, Ángela; Conde, Enrique; More
Hepatology. 82(2):326-343, August 2025.
11
Multimodal multiphasic preoperative image-based deep-learning predicts HCC outcomes after curative surgery
基于多模态多期术前影像的深度学习预测肝细胞癌根治术后的预后
Hui, Rex Wan-Hin; Chiu, Keith Wan-Hang; Lee, I-Cheng; More
Hepatology. 82(2):344-356, August 2025.
12
Multicenter, retrospective GUIDANCE001 study comparing transarterial chemoembolization with or without tyrosine kinase and immune checkpoint inhibitors as conversion therapy to treat unresectable hepatocellular carcinoma: Survival benefit in intermediate or advanced, but not early, stages
多中心回顾性GUIDANCE001研究：比较经动脉化疗栓塞术联合或不联合酪氨酸激酶抑制剂和免疫检查点抑制剂作为转化疗法治疗不可切除肝细胞癌——在中期或晚期而非早期患者中显示生存获益
Yang, Da-Long; Ye, Lin; Zeng, Fan-Jian; More
Hepatology. 82(2):357-369, August 2025.
Liver Pathobiology（肝脏病理生物学）
13
Stretch-induced hepatic endothelial mechanocrine promotes hepatocyte proliferation
牵张诱导的肝内皮细胞机械分泌促进肝细胞增殖
Wu, Yi; Li, Linda; Li, Wang; More
Hepatology. 82(2):370-387, August 2025.
14
Modulatory effects of CNNM4 on protein-l-isoaspartyl-O-methyltransferase repair function during alcohol-induced hepatic damage
酒精性肝损伤期间CNNM4对蛋白质-L-异天冬氨酰-O-甲基转移酶修复功能的调节作用
González-Recio, Irene; Goikoetxea-Usandizaga, Naroa; Rejano-Gordillo, Claudia M.; More
Hepatology. 82(2):388-404, August 2025.
Liver Failure/Cirrhosis/Portal Hypertension（肝衰竭/肝硬化/门静脉高压）
15
Comparing the cost of cirrhosis to other common chronic diseases: A longitudinal study in a large national insurance database
肝硬化与其他常见慢性疾病成本的比较：一项基于大型国家保险数据库的纵向研究
Obradović, Filip; Vitello, Dominic J.; Hasjim, Bima J.; More
Hepatology. 82(2):405-421, August 2025.
16
Validation and expansion of Baveno VII criteria for cACLD and CSPH based on liver stiffness and platelet count: Correlation with risk of hepatic decompensation and death
基于肝脏硬度和血小板计数对代偿期进展性慢性肝病（cACLD）和临床显著性门静脉高压（CSPH）的Baveno VII标准的验证与扩展：与肝失代偿和死亡风险的相关性
Vutien, Philip; Barnard Giustini, Abbey; Kim, Nicole J.; More
Hepatology. 82(2):422-437, August 2025.
Steatohepatitis（脂肪性肝炎）
17
HAF prevents hepatocyte apoptosis and progression to MASH and HCC through transcriptional regulation of the NF-κB pathway
HAF通过转录调控核因子-κB（NF-κB）通路防止肝细胞凋亡和向代谢相关脂肪性肝炎（MASH）及肝细胞癌进展
Acuña-Pilarte, Karen; Reichert, Ethan C.; Green, Yangsook Song; More
Hepatology. 82(2):438-453, August 2025.
18
Diagnostic accuracy of 2D-SWE ultrasound for liver fibrosis assessment in MASLD: A multilevel random effects model meta-analysis
二维剪切波弹性成像超声在代谢相关脂肪性肝病（MASLD）肝纤维化评估中的诊断准确性：一项多水平随机效应模型荟萃分析
Indre, Madalina-Gabriela; Leucuta, Dan-Corneliu; Lupsor-Platon, Monica; More
Hepatology. 82(2):454-469, August 2025.
Viral Hepatitis（病毒性肝炎）
19
Enhanced hepatitis B virus–specific immunity by combining neutralizing antibody therapy and DNA vaccination in a murine model of chronic hepatitis B virus infection
在慢性乙型肝炎病毒感染小鼠模型中，联合中和抗体疗法和DNA疫苗接种增强乙型肝炎病毒特异性免疫
Beretta, Maxime; Vesin, Benjamin; Wei, Yu; More
Hepatology. 82(2):470-486, August 2025.
Reviews（综述）
20
Metabolic dysfunction-associated steatotic liver disease and the heart
代谢功能障碍相关脂肪性肝病与心脏
Driessen, Stan; Francque, Sven M.; Anker, Stefan D.; More
Hepatology. 82(2):487-503, August 2025.
21
Navigating the “specific etiology” steatohepatitis category: Evaluation and management of nonalcohol/nonmetabolic dysfunction–associated steatohepatitis
“特定病因”脂肪性肝炎类别的探索：非酒精/非代谢功能障碍相关脂肪性肝炎的评估与治疗
Khan, Mohammad Qasim; Hassan, Sara; Lizaola-Mayo, Blanca C.; More
Hepatology. 82(2):504-521, August 2025.
22
Immunogenomics of cholangiocarcinoma
胆管癌的免疫基因组学
Gehl, Virag; O’Rourke, Colm J.; Andersen, Jesper B.
Hepatology. 82(2):522-539, August 2025.
Correspondence（通信）
23
Letter to the Editor: Comprehensive profiling of lipid metabolic reprogramming expands precision medicine for HCC
致编辑的信：脂质代谢重编码的综合分析拓展了肝细胞癌的精准医疗
Du, Rui; Yang, Yanfei; Su, Yuzhe; More
Hepatology. 82(2):E23-E24, August 2025.
24
Reply: Comprehensive profiling of lipid metabolic reprogramming expands precision medicine for HCC
回复：脂质代谢重编码的综合分析拓展了肝细胞癌的精准医疗
Liu, Qingbin; Qi, Jingjing; Yu, Yong; More
Hepatology. 82(2):E25-E26, August 2025.
25
Letter to the Editor: Fiber and whole grain intakes in relation to liver cancer risk—An analysis in 2 prospective cohorts and systematic review and meta-analysis of prospective studies
致编辑的信：膳食纤维和全谷物摄入量与肝癌风险的关系——两项前瞻性队列研究及前瞻性研究的系统回顾和荟萃分析
Huang, Wang; Sun, Hao
Hepatology. 82(2):E27, August 2025.
26
Reply: Fiber and whole grain intakes in relation to liver cancer risk—An analysis in 2 prospective cohorts and systematic review and meta-analysis of prospective studies
回复：膳食纤维和全谷物摄入量与肝癌风险的关系——两项前瞻性队列研究及前瞻性研究的系统回顾和荟萃分析
Watling, Cody Z.; Wojt, Aika; Florio, Andrea A.; More
Hepatology. 82(2):E28-E29, August 2025.
27
Letter to the Editor: Dynamic frailty trajectories and temporal measurement challenges in assessing liver transplantation survival benefit
致编辑的信：评估肝移植生存获益时的动态衰弱轨迹和时间测量挑战
Zhang, Yazhen
Hepatology. 82(2):E30, August 2025.
28
Letter to the Editor: How to count from 0 to 4 without skipping a number
致编辑的信：如何从0数到4而不跳过数字
Kim, W. Ray; Sripongpun, Pimsiri; Mannalithara, Ajitha; More
Hepatology. 82(2):E31-E32, August 2025.
29
Reply: How to count from 0 to 4 without skipping a number
回复：如何从0数到4而不跳过数字
Sterling, Richard K.; Patel, Keyur; Duarte-Rojo, Andres; More
Hepatology. 82(2):E33-E34, August 2025.
Errata（勘误）
30
Erratum: Insufficient radiofrequency ablation promotes hepatocellular carcinoma metastasis through N6-methyladenosine mRNA methylation-dependent mechanism
勘误：射频消融不足通过N6-甲基腺苷mRNA甲基化依赖机制促进肝细胞癌转移
Su, Tianhong; Huang, Manling; Liao, Junbin; More
Hepatology. 82(2):E35-E36, August 2025.
31
Erratum: Effects of trientine and penicillamine on intestinal copper uptake: A mechanistic 64Cu PET/CT study in healthy humans
勘误：三乙烯四胺和青霉胺对肠道铜吸收的影响：一项在健康人群中进行的64Cu PET/CT机制研究
Kirk, Frederik Teicher; Munk, Ditte Emilie; Swenson, Eugene Scott; More
Hepatology. 82(2):E37, August 2025.
32
Erratum: Activation of the p62-Keap1-NRF2 pathway protects against ferroptosis in hepatocellular carcinoma cells
勘误：激活p62-Keap1-NRF2通路可保护肝细胞癌细胞免受铁死亡
Xiaofang, Sun; Zhanhui, Ou; Ruochan, Chen; More
Hepatology. 82(2):E38-E39, August 2025.
33
Erratum: Multicenter, retrospective GUIDANCE001 study comparing transarterial chemoembolization with or without tyrosine kinase and immune checkpoint inhibitors as conversion therapy to treat unresectable hepatocellular carcinoma: Survival benefit in intermediate or advanced, but not early, stages
勘误：多中心回顾性GUIDANCE001研究比较经动脉化疗栓塞术联合或不联合酪氨酸激酶抑制剂和免疫检查点抑制剂作为转化疗法治疗不可切除肝细胞癌——在中期或晚期而非早期患者中显示生存获益
Yang, Da-Long; Ye, Lin; Zeng, Fan-Jian; More
Hepatology. 82(2):E40, August 2025.
Hepatology[Jour] AND 82[volume] AND 3[issue]
肝脏病学 82卷 3期
https://journals-lww-com.libproxy1.nus.edu.sg/hep/pages/currenttoc.aspx
Hepatology Highlights（肝病学亮点）
1
Honey, I shrunk the tumor: Downstaging HCC before liver transplantation
亲，我缩小了肿瘤：肝移植前肝细胞癌（HCC）的降期治疗
Grady, John; Arab, Juan Pablo
Hepatology. 82(3):541-542, September 2025.
2
Surging sludge: Intrahepatic cholangiocarcinoma mortality on the rise worldwide
泥沙涌动：全球肝内胆管癌死亡率上升
Wilechansky, Robert M.
Hepatology. 82(3):543-544, September 2025.
3
Hepatic stellate cells and macrophages: Key players in HCC immune suppression
肝星状细胞和巨噬细胞：肝细胞癌免疫抑制的关键参与者
Erickson, Hanna
Hepatology. 82(3):545-546, September 2025.
4
Unlocking immunity’s memory: Epigenetic keys to HBV control
解锁免疫记忆：乙型肝炎病毒（HBV）控制的表观遗传关键
McGettigan, Brett M.
Hepatology. 82(3):547-548, September 2025.
Editorial（社论）
5
Unveiling the immune landscape of IDH1-mutant cholangiocarcinoma: Pathways to new therapies
揭示IDH1突变型胆管癌的免疫格局：通向新疗法的途径
Li, Binbin; Ilyas, Sumera I.
Hepatology. 82(3):549-551, September 2025.
Original Articles（论著）
Immune-Mediated Diseases, DILI, and Biliary Tract Disease（免疫介导疾病、药物性肝损伤和胆道疾病）
6
Interleukin 8-CXCR2–mediated neutrophil extracellular trap formation in biliary atresia associated with neutrophil extracellular trap–induced stellate cell activation
白细胞介素8-CXCR2介导的胆道闭锁相关中性粒细胞胞外诱捕网形成及中性粒细胞胞外诱捕网诱导的星状细胞激活
Luo, Yuhuan; Fraser, Lisa; Jezykowski, Julia; More
Hepatology. 82(3):552-565, September 2025.
Liver Cancer（肝癌）
7
Distinct immune microenvironment of venous tumor thrombus in hepatocellular carcinoma at single-cell resolution
单细胞分辨率下肝细胞癌静脉肿瘤血栓的独特免疫微环境
Zhou, Kai-Qian; Zhong, Yu-Chen; Song, Min-Fang; More
Hepatology. 82(3):566-581, September 2025.
8
Genomic and the tumor microenvironment heterogeneity in multifocal hepatocellular carcinoma
多灶性肝细胞癌的基因组和肿瘤微环境异质性
Yang, Yongheng; Ni, Qingqiang; Li, Hongguang; More
Hepatology. 82(3):582-598, September 2025.
9
Tumor-derived CCL2 drives tumor growth and immunosuppression in IDH1-mutant cholangiocarcinoma
肿瘤来源的CCL2驱动IDH1突变型胆管癌肿瘤生长和免疫抑制
Zabransky, Daniel J.; Kartalia, Emma; Lee, Jae W.; More
Hepatology. 82(3):599-611, September 2025.
10
Downstaging of hepatocellular carcinoma before liver transplantation: Results from a national multicenter prospective cohort study
肝移植前肝细胞癌降期治疗：一项全国多中心前瞻性队列研究的结果
Xu, Edison; Tabrizian, Parissa; Gutierrez, Julio; More
Hepatology. 82(3):612-625, September 2025.
11
International trends in biliary tract cancer–related mortality, 2000–2022: An observational study of the World Health Organization Mortality Database
2000 - 2022年胆道癌相关死亡率的国际趋势：世界卫生组织死亡数据库的观察性研究
Vu, Quynh Thi; Nishimura, Yoshito; Harada, Ko; More
Hepatology. 82(3):626-637, September 2025.
Liver Pathobiology（肝脏病理生物学）
12
Human-induced pluripotent stem cell–based hepatic modeling of lipid metabolism–associated TM6SF2-E167K variant
基于人类诱导多能干细胞模拟脂质代谢相关TM6SF2-E167K变异的肝脏模型
Faccioli, Lanuza A.P.; Sun, Yiyue; Animasahun, Olamide; More
Hepatology. 82(3):638-654, September 2025.
13
CX3CR1+ macrophages interact with HSCs to promote HCC through CD8+ T-cell suppression
CX3CR1+巨噬细胞与肝星状细胞相互作用通过抑制CD8+ T细胞促进肝细胞癌
Jeong, Jong-Min; Choi, Sung Eun; Shim, Young-Ri; More
Hepatology. 82(3):655-668, September 2025.
Liver Failure/Cirrhosis/Portal Hypertension（肝衰竭/肝硬化/门静脉高压）
14
Plasma FSTL-1 as a noninvasive diagnostic biomarker for patients with advanced liver fibrosis
血浆FSTL-1作为晚期肝纤维化患者的无创诊断生物标志物
Li, Wenzhu; Chi, Yongquan; Xiao, Xuan; More
Hepatology. 82(3):669-682, September 2025.
15
Lhx2 specifically expressed in HSCs promotes liver regeneration and inhibits liver fibrosis
肝星状细胞特异性表达的Lhx2促进肝再生并抑制肝纤维化
Tao, Jiawang; Wu, Zichao; Liang, Yanran; More
Hepatology. 82(3):683-701, September 2025.
Steatohepatitis（脂肪性肝炎）
16
HNF4α-CDKL3 axis restricts MASLD progression by targeting FoxO1 via noncanonical phosphorylation
HNF4α-CDKL3轴通过非经典磷酸化靶向FoxO1限制代谢相关脂肪性肝病（MASLD）进展
Pang, Zhongqiu; Zhang, Hui; Zheng, Shaoqin; More
Hepatology. 82(3):702-721, September 2025.
17
Platelet-derived mitochondria regulate lipid metabolism in nonalcoholic steatohepatitis through extracellular vesicles
血小板来源的线粒体通过细胞外囊泡调节非酒精性脂肪性肝炎的脂质代谢
Liao, Tsai-Ling; Chen, Der-Yuan; Hsieh, Shie-Liang; More
Hepatology. 82(3):722-738, September 2025.
Viral Hepatitis（病毒性肝炎）
18
Enhancing HBV-specific T cell responses through a combination of epigenetic modulation and immune checkpoint inhibition
通过表观遗传调控和免疫检查点抑制的联合增强HBV特异性T细胞反应
Urbanek-Quaing, Melanie; Chou, Yin-Han; Gupta, Manoj Kumar; More
Hepatology. 82(3):739-754, September 2025.
Reviews（综述）
19
Reappraisal of the conventional hemostasis tests as predictors of perioperative bleeding in the era of rebalanced hemostasis in cirrhosis
重新评估传统凝血试验作为肝硬化再平衡凝血时代围手术期出血预测指标的价值
Tripodi, Armando; Primignani, Massimo; D’Ambrosio, Roberta; More
Hepatology. 82(3):755-765, September 2025.
20
Defining an approach for therapeutic strategies in metabolic dysfunction–associated steatotic liver disease after liver transplantation
定义肝移植后代谢功能障碍相关脂肪性肝病的治疗策略方法
Siddiqui, Mohammad Shadab; Muthiah, Mark; Satapathy, Sanjaya K.; More
Hepatology. 82(3):766-776, September 2025.
21
Adjuvant and neoadjuvant therapies for hepatocellular carcinoma
肝细胞癌的辅助治疗和新辅助治疗
Vogel, Arndt; Grant, Robert C.; Meyer, Tim; More
Hepatology. 82(3):777-793, September 2025.
Special Article（专题）
22
Value of HCC surveillance in a landscape of emerging surveillance options: Perspectives of a multi-stakeholder modified Delphi panel
新兴监测选择背景下肝细胞癌监测的价值：多利益相关者改良德尔菲小组的观点
Singal, Amit G.; Quirk, Lisa; Boike, Justin; More
Hepatology. 82(3):794-809, September 2025.
Practice Guidance（实践指南）
23
A multidisciplinary approach to the diagnosis and management of Wilson disease: 2022 Practice Guidance on Wilson disease from the American Association for the Study of Liver Diseases
多学科方法诊断和管理威尔逊病：2022年美国肝病研究协会威尔逊病实践指南
Schilsky, Michael L.; Roberts, Eve A.; Bronstein, Jeff M.; More
Hepatology. 82(3):E41-E90, September 2025.
Correspondence（通信）
24
Letter to the Editor: Can plasma FSTL-1 levels serve as a reliable biomarker for advanced fibrosis?
致编辑的信：血浆FSTL-1水平能否作为晚期纤维化的可靠生物标志物？
Emanuele, Enzo; Minoretti, Piercarlo
Hepatology. 82(3):E91, September 2025.
25
Reply: Can plasma FSTL-1 levels serve as a reliable biomarker for advanced fibrosis?
回复：血浆FSTL-1水平能否作为晚期纤维化的可靠生物标志物？
Chi, Yongquan; Qi, Xiaolong; Rao, Jianhua
Hepatology. 82(3):E92-E93, September 2025.
26
Letter to the Editor: Downstaging of hepatocellular carcinoma before liver transplantation—More details, more significance
致编辑的信：肝移植前肝细胞癌的降期治疗——更多细节，更多意义
Wang, Pusen; Zhong, Lin
Hepatology. 82(3):E94-E95, September 2025.
27
Reply: Downstaging of hepatocellular carcinoma before liver transplantation—More details, more significance
回复：肝移植前肝细胞癌的降期治疗——更多细节，更多意义
Xu, Edison; Mehta, Neil
Hepatology. 82(3):E96-E97, September 2025.
28
Letter to the Editor: Refining epigenetic insights in HBV-specific T-cell restoration
致编辑的信：完善HBV特异性T细胞恢复的表观遗传见解
Qiu, Yue
Hepatology. 82(3):E98, September 2025.
29
Reply: Refining epigenetic insights in HBV-specific T-cell restoration
回复：完善HBV特异性T细胞恢复的表观遗传见解
Chou, Yin-Han; Cornberg, Markus
Hepatology. 82(3):E99-E100, September 2025.
30
Letter to the Editor: Reflections on the predictors of long-term transplant-free survival after TIPS
致编辑的信：关于经颈静脉肝内门体分流术（TIPS）后长期无移植生存预测因素的思考
Qiu, Zhenkang; Yang, Guang; Gao, Fei
Hepatology. 82(3):E101-E102, September 2025.
31
Letter to the Editor: Survival benefit of transarterial chemoembolization combined with tyrosine kinase and immune checkpoint inhibitors as conversion therapy for unresectable hepatocellular carcinoma needs more details
致编辑的信：经动脉化疗栓塞联合酪氨酸激酶抑制剂和免疫检查点抑制剂作为不可切除肝细胞癌转化治疗的生存获益需要更多细节
Wang, Dan; Yi, Shiming; Liu, Xia
Hepatology. 82(3):E103-E104, September 2025.
32
Reply: Survival benefit of transarterial chemoembolization combined with tyrosine kinase and immune checkpoint inhibitors as conversion therapy for unresectable hepatocellular carcinoma needs more details
回复：经动脉化疗栓塞联合酪氨酸激酶抑制剂和免疫检查点抑制剂作为不可切除肝细胞癌转化治疗的生存获益需要更多细节
Yang, Da-Long; Li, Yi-Fan; Li, Yao-Jie; More
Hepatology. 82(3):E105-E106, September 2025.
33
Letter to the Editor: TIPS for noncirrhotic adults with chronic mesenteric venous thrombosis and EHPVO refractory to standard-of-care therapy—How are they doing in 2025?
致编辑的信：非肝硬化成人慢性肠系膜静脉血栓形成和肝外门静脉阻塞（EHPVO）对标准治疗耐药的TIPS治疗——2025年情况如何？
Knight, Gabriel M.; Boike, Justin; Thornburg, Bartley; More
Hepatology. 82(3):E107-E108, September 2025.
34
Letter to the Editor: Liver stiffness progression comparison between diabetics and non-diabetics with biopsy-proven metabolic dysfunction–associated steatosis
致编辑的信：糖尿病和非糖尿病患者经活检证实的代谢功能障碍相关脂肪变性的肝脏硬度进展比较
Zuo, Zhongbao; Yang, Chunli; Wang, Miaochan; More
Hepatology. 82(3):E109-E110, September 2025.
35
Reply: Liver stiffness progression comparison between diabetics and non-diabetics with biopsy-proven metabolic dysfunction–associated steatosis
回复：糖尿病和非糖尿病患者经活检证实的代谢功能障碍相关脂肪变性的肝脏硬度进展比较
Huang, Daniel Q.; Loomba, Rohit
Hepatology. 82(3):E111-E112, September 2025.
Erratum（勘误）
36
Erratum: HAF prevents hepatocyte apoptosis and progression to MASH and HCC through transcriptional regulation of the NF-κB pathway
勘误：HAF通过NF-κB通路的转录调控防止肝细胞凋亡和进展为代谢相关脂肪性肝炎（MASH）和肝细胞癌
Acuña-Pilarte, Karen; Reichert, Ethan C.; Green, Yangsook Song; More
Hepatology. 82(3):E113, September 2025.
Retraction（撤稿）
37
Retraction: Blocking H1/H2 histamine receptors inhibits damage/fibrosis in Mdr2−/− mice and human cholangiocarcinoma tumorigenesis
撤稿：阻断H1/H2组胺受体可抑制Mdr2−/−小鼠的损伤/纤维化和人胆管癌肿瘤发生
Kennedy, Lindsey; Hargrove, Laura; Demieville, Jennifer; More
Hepatology. 82(3):E114, September 2025.
Hepatology[Jour] AND 82[volume] AND 4[issue]
肝脏病学 82卷4期
https://journals-lww-com.libproxy1.nus.edu.sg/hep/pages/currenttoc.aspx
Editorial（社论）
1
The dynamic landscape of cholestatic liver disease
胆汁淤积性肝病的动态变化特征
Gores, Gregory J.; Malhi, Harmeet
Hepatology. 82(4):811-812, October 2025.
Reviews（综述）
2
Epidemiological and economical burden of cholestatic liver disease
胆汁淤积性肝病的流行病学及经济负担
Mol, Bregje; Werner, Ellen; Culver, Emma L.; More
Hepatology. 82(4):813-833, October 2025.
3
Central role for cholangiocyte pathobiology in cholestatic liver diseases
胆管细胞病理生物学在胆汁淤积性肝病中的核心作用
Jalan-Sakrikar, Nidhi; Guicciardi, Maria Eugenia; O’Hara, Steven P.; More
Hepatology. 82(4):834-854, October 2025.
4
Benefits and challenges to therapeutic targeting of bile acid circulation in cholestatic liver disease
胆汁淤积性肝病中胆汁酸循环治疗靶点的益处与挑战
Trauner, Michael; Karpen, Saul J.; Dawson, Paul A.
Hepatology. 82(4):855-876, October 2025.
5
The immunological landscape of primary biliary cholangitis: Mechanisms and therapeutic prospects
原发性胆汁性胆管炎的免疫学特征：机制与治疗前景
Ronca, Vincenzo; Davies, Scott P.; Oo, Ye Htun; More
Hepatology. 82(4):877-894, October 2025.
6
Primary biliary cholangitis: Personalizing second-line therapies
原发性胆汁性胆管炎：二线治疗的个体化选择
Levy, Cynthia; Bowlus, Christopher L.
Hepatology. 82(4):895-910, October 2025.
7
Immunobiology of primary sclerosing cholangitis
原发性硬化性胆管炎的免疫生物学
Cornillet, Martin; Geanon, Daniel; Bergquist, Annika; More
Hepatology. 82(4):911-926, October 2025.
8
Medical treatment of primary sclerosing cholangitis: What have we learned and where are we going?
原发性硬化性胆管炎的药物治疗：我们学到了什么以及未来方向何在？
Karlsen, Tom H.; Kaasen Jørgensen, Kristin; Bergquist, Annika
Hepatology. 82(4):927-948, October 2025.
9
Identifying a therapeutic window of opportunity for people living with primary sclerosing cholangitis: Embryology and the overlap of inflammatory bowel disease with immune-mediated liver injury
为原发性硬化性胆管炎患者确定治疗时机窗口：胚胎学与炎症性肠病和免疫介导的肝损伤重叠
Kellermayer, Richard; Carbone, Marco; Horvath, Thomas D.; More
Hepatology. 82(4):949-959, October 2025.
10
PSC and colitis: A complex relationship
原发性硬化性胆管炎与结肠炎：复杂的关系
Horst, Ludwig J.; Kempski, Jan; Walmsley, Martine; More
Hepatology. 82(4):960-984, October 2025.
11
IBAT inhibitors in pediatric cholestatic liver diseases: Transformation on the horizon?
回肠胆汁酸转运蛋白（IBAT）抑制剂在儿童胆汁淤积性肝病中的应用：变革即将来临？
Sutton, Harry; Sokol, Ronald J.; Kamath, Binita M.
Hepatology. 82(4):985-995, October 2025.
12
Drug-induced cholestatic liver diseases
药物性胆汁淤积性肝病
Bjornsson, Einar S.; Devarbhavi, Harshad C.
Hepatology. 82(4):996-1015, October 2025.
13
Liver transplantation for cholestatic liver diseases: Timing and disease recurrence
胆汁淤积性肝病的肝移植：时机与疾病复发
Cançado, Guilherme Grossi Lopes; Deeb, Maya; Gulamhusein, Aliya F.
Hepatology. 82(4):1016-1035, October 2025.
Hepatology[Jour] AND 82[volume] AND 5[issue]
肝脏病学 82卷5期
https://journals-lww-com.libproxy1.nus.edu.sg/hep/pages/currenttoc.aspx
Hepatology Highlights（肝病学亮点）
1
When “remission” isn’t enough: The unseen burden of autoimmune hepatitis
当“缓解”尚不足够：自身免疫性肝炎未被察觉的负担
Sidhu, Guneet
Hepatology. 82(5):1037-1038, November 2025.
2
Surgical resection for hepatocellular carcinoma: Leave no TACE?
肝细胞癌的手术切除：是否不再需要经导管动脉化疗栓塞术（TACE）？
Khalid, Mian B.; Ilyas, Sumera I.
Hepatology. 82(5):1039-1040, November 2025.
3
Bundle it up—Care bundles for spontaneous bacterial peritonitis
打包处理——自发性细菌性腹膜炎的护理方案组合
Kanagalingam, Gowthami; Arab, Juan Pablo
Hepatology. 82(5):1041-1042, November 2025.
4
Who improves, who doesn’t and why? Defining improvement and drivers of outcomes in pediatric MASLD
哪些患者病情会改善，哪些不会，原因何在？儿童代谢相关脂肪性肝病（MASLD）中病情改善的定义及预后驱动因素
Harris, Kevin B.; Ilyas, Sumera I.
Hepatology. 82(5):1043-1044, November 2025.
Commentary（述评）
5
Building hepatitis B virus gene transcription from the bottom up
自下而上构建乙型肝炎病毒基因转录
Gómez-Moreno, Andoni; Bradley, Daniel; Ploss, Alexander
Hepatology. 82(5):1045-1047, November 2025.
Editorials（社论）
6
The impact of LRP4 mutations on HCC recurrence and immunotherapy response
LRP4突变对肝细胞癌复发和免疫治疗反应的影响
Lu, Zhen; Wong, Chun-Ming
Hepatology. 82(5):1048-1050, November 2025.
7
Check(point)s and balances: ‘Know thy enemy’
（免疫）检查点与平衡：“知己知彼”
Watt, Kymberly D.
Hepatology. 82(5):1051-1052, November 2025.
8
Identifying the sweet spot in portal pressure reduction with TIPS
利用经颈静脉肝内门体分流术（TIPS）降低门静脉压力的“最佳点”识别
China, Louise; Patch, David
Hepatology. 82(5):1053-1055, November 2025.
9
Divergent trends in cirrhosis and liver cancer highlight the ongoing efforts required for hepatitis elimination
肝硬化和肝癌的分化趋势凸显了消除肝炎所需的持续努力
Wong, Grace Lai-Hung; Chan, Henry Lik-Yuen
Hepatology. 82(5):1056-1057, November 2025.
Original Articles（论著）
Immune-Mediated Diseases, DILI, and Biliary Tract Disease（免疫介导性疾病、药物性肝损伤和胆道疾病）
10
Health-related quality of life is impaired in people with autoimmune hepatitis: Results of a multicentre cross-sectional study within the European Reference Network
自身免疫性肝炎患者健康相关生活质量受损：欧洲参考网络内一项多中心横断面研究的结果
Snijders, Romée J.A.L.M.; Janik, Maciej K.; Mund, Meike; More
Hepatology. 82(5):1058-1072, November 2025.
Liver Cancer（肝癌）
11
LRP4 mutations promote tumor progression and resistance to anti-PD-1 therapy in recurrent hepatocellular carcinoma
LRP4突变促进复发性肝细胞癌的肿瘤进展及抗PD-1治疗耐药性
Sun, Rongqi; Liu, Kaixuan; Pan, Siyuan; More
Hepatology. 82(5):1073-1089, November 2025.
12
Aptamer-directed, nanovesicle-mediated targeting of undruggable molecules in preclinical cholangiocarcinoma models
在临床前胆管癌模型中，利用适配体引导纳米囊泡靶向不可成药分子
Yu, Mincheng; Sample, Jack W.; Yan, Irene K.; More
Hepatology. 82(5):1090-1111, November 2025.
13
Adjuvant transarterial chemoembolization for hepatocellular carcinoma following curative resection: A randomized, open-label, phase 3 trial
肝细胞癌根治性切除术后辅助经导管动脉化疗栓塞术：一项随机、开放标签、3期试验
Ma, Tao; Bai, Xueli; Zhang, Qi; More
Hepatology. 82(5):1112-1121, November 2025.
14
Determining safe washout period for immune checkpoint inhibitors prior to liver transplantation: An international retrospective cohort study
肝移植前免疫检查点抑制剂的安全停药期确定：一项国际回顾性队列研究
Moeckli, Beat; Wassmer, Charles-Henri; El Hajji, Sofia; More
Hepatology. 82(5):1122-1137, November 2025.
Liver Pathobiology（肝脏病理生物学）
15
Repression of the ERRγ-CYP2E1 pathway by FGF4 mitigates alcohol-associated liver injury
成纤维细胞生长因子4（FGF4）抑制ERRγ-CYP2E1通路可减轻酒精相关性肝损伤
Wang, Luyao; Dong, Wenliya; Fan, Lei; More
Hepatology. 82(5):1138-1154, November 2025.
Liver Failure/Cirrhosis/Portal Hypertension（肝衰竭/肝硬化/门静脉高压）
16
End-procedural adherence to recommended hemodynamic targets does not improve the outcome of elective TIPS in patients with cirrhosis
肝硬化患者选择性经颈静脉肝内门体分流术（TIPS）中，手术结束时遵循推荐血流动力学目标并未改善预后
Roccarina, Davide; Saltini, Dario; Adotti, Valentina; More
Hepatology. 82(5):1155-1171, November 2025.
17
Identification of optimal portal pressure decrease to control ascites while minimizing HE after TIPS: A multicenter study
确定TIPS术后控制腹水同时使肝性脑病（HE）最小化的最佳门静脉压力下降值：一项多中心研究
Kabelitz, Martin A.; Hartl, Lukas; Schaub, Golda; More
Hepatology. 82(5):1172-1186, November 2025.
18
Clinical outcomes and care for spontaneous bacterial peritonitis: A national cohort study
自发性细菌性腹膜炎的临床预后和护理：一项全国队列研究
Serper, Marina; Tang, Helen; Zhang, Siqi; More
Hepatology. 82(5):1187-1197, November 2025.
Pediatrics（儿科）
19
Longitudinal response to standard of care in pediatric metabolic dysfunction–associated steatotic liver disease: Rates of improvement and worsening, and factors associated with outcomes
儿童代谢相关脂肪性肝病对标准治疗的纵向反应：改善和恶化的比率以及与预后相关的因素
Newton, Kimberly P.; Jayasekera, Dulshan; Blackford, Amanda L.; More
Hepatology. 82(5):1198-1210, November 2025.
Steatohepatitis（脂肪性肝炎）
20
CD44 in myeloid cells is a major driver of liver inflammation and injury in alcohol-associated liver disease
髓系细胞中的CD44是酒精相关性肝病中肝脏炎症和损伤的主要驱动因素
Rousseau, Déborah; Bonnafous, Stéphanie; Soysouvanh, Frédéric; More
Hepatology. 82(5):1211-1228, November 2025.
21
Prevalence and predictors of cirrhosis and portal hypertension in the United States
美国肝硬化和门静脉高压的患病率及预测因素
Younossi, Zobair M.; de Avila, Leyla; Racila, Andrei; More
Hepatology. 82(5):1229-1240, November 2025.
22
Corticosteroids in severe alcohol-associated hepatitis. Not so fast: A systematic review of randomized controlled trials
糖皮质激素治疗重症酒精相关性肝炎：且慢！一项随机对照试验的系统综述
Shi, Michael A.; Pungwe, Prisca; Comer, Lauren L.M.; More
Hepatology. 82(5):1241-1255, November 2025.
23
Prevalence of metabolic dysfunction–associated steatotic liver disease and fibrosis defined by liver elastography in the United States using National Health and Nutrition Examination Survey 2017-March 2020 and August 2021-August 2023 data
利用2017年-2020年3月及2021年8月-2023年8月美国国家健康与营养检查调查数据，分析美国代谢相关脂肪性肝病和肝纤维化的患病率
Unalp-Arida, Aynur; Ruhl, Constance E.
Hepatology. 82(5):1256-1273, November 2025.
Viral Hepatitis（病毒性肝炎）
24
Global burden of HBV-related liver disease: Primary liver cancer due to chronic HBV infection increased in over one-third of countries globally from 2000 to 2021
全球乙型肝炎病毒（HBV）相关肝病的负担：2000年至2021年，全球超过三分之一的国家因慢性HBV感染导致的原发性肝癌病例增加
Danpanichkul, Pojsakorn; Duangsonk, Kwanjit; Chen, Vincent L.; More
Hepatology. 82(5):1274-1286, November 2025.
Reviews（综述）
25
Neoadjuvant and adjuvant therapy for biliary tract cancer: Advances and limitations
胆道癌的新辅助治疗和辅助治疗：进展与局限
Wilbur, H. Catherine; Soares, Heloisa P.; Azad, Nilofer S.
Hepatology. 82(5):1287-1302, November 2025.
26
Molecular mechanisms in MASLD/MASH-related HCC
代谢相关脂肪性肝病/代谢相关脂肪性肝炎相关肝细胞癌的分子机制
Wang, Xiaobo; Zhang, Liang; Dong, Bingning
Hepatology. 82(5):1303-1324, November 2025.
27
MASH clinical trials and drugs pipeline: An impending tsunami
MASH临床试验及药物研发管线：一场即将到来的海啸
Noureddin, Mazen
Hepatology. 82(5):1325-1340, November 2025.
Special Articles（专题论著）
28
Call to action—Pediatric MASLD requires immediate attention to curb health crisis
行动呼吁——儿童代谢相关脂肪性肝病需立即关注以遏制健康危机
Hartmann, Phillipp; Mouzaki, Marialena; Hassan, Sara; More
Hepatology. 82(5):1341-1351, November 2025.
29
AASLD Practice Statement on the evaluation and management of metabolic dysfunction–associated steatotic liver disease in children
美国肝病研究协会（AASLD）关于儿童代谢相关脂肪性肝病评估和管理的实践声明
Xanthakos, Stavra A.; Ibrahim, Samar H.; Adams, Kathryn; More
Hepatology. 82(5):1352-1394, November 2025.
Fellows' Corner（研究员园地）
30
Fellows’ Corner
研究员园地
Deeb, Maya
Hepatology. 82(5):E115-E116, November 2025.
Visual Brief（速览）
31
Diagnosis and Management of Hepatocellular Carcinoma
肝细胞癌的诊断与治疗
Hepatology. 82(5):E117-E120, November 2025.
Correspondence（读者来信）
32
Letter to the Editor: The divergences in the efficacy of adjuvant transarterial chemoembolization for HCC—In-depth analysis and enlightenments
致编辑的信：肝细胞癌辅助经导管动脉化疗栓塞术疗效的差异——深入分析与启示
Chen, Shuanggang; Shen, Lujun; Fan, Weijun
Hepatology. 82(5):E121-E122, November 2025.
33
Letter to the Editor: Redefining post-resection care: Critical analysis of adjuvant TACE in curative HCC management
致编辑的信：重新定义术后护理：对根治性肝细胞癌治疗中辅助经导管动脉化疗栓塞术的批判性分析
Zhang, Qianqian; Song, Quanmao; Liu, Yanna; More
Hepatology. 82(5):E123, November 2025.
34
Letter to the Editor: Post-TIPS hemodynamic target adherence fails to improve outcomes in cirrhotic patients
致编辑的信：肝硬化患者术后经颈静脉肝内门体分流术（TIPS）血流动力学目标达标未能改善预后
Tantai, Xinxing; Li, Lu; Dai, Shejiao
Hepatology. 82(5):E124-E125, November 2025.
35
Reply: Post-TIPS hemodynamic target adherence fails to improve outcomes in cirrhotic patients
回复：肝硬化患者术后经颈静脉肝内门体分流术（TIPS）血流动力学目标达标未能改善预后
Roccarina, Davide; Saltini, Dario; Senzolo, Marco; More
Hepatology. 82(5):E126-E127, November 2025.
36
Letter to the Editor: Antibody-mediated rejection in liver transplantation following immune checkpoint inhibitors treatment
致编辑的信：免疫检查点抑制剂治疗后肝移植中的抗体介导的排斥反应
Wang, Pusen; Zhong, Lin
Hepatology. 82(5):E128-E129, November 2025.
37
Reply: Antibody-mediated rejection in liver transplantation following immune checkpoint inhibitors treatment
回复：免疫检查点抑制剂治疗后肝移植中的抗体介导的排斥反应
Moeckli, Beat; Lanz, Loyse; Rodríguez-Perálvarez, Manuel; More
Hepatology. 82(5):E130-E131, November 2025.
38
Letter to Editor: Considerations on the specific role of LHX2 in the process of hepatic stellate cells regulating hepatocyte function
致编辑的信：关于肝星状细胞调节肝细胞功能过程中LHX2特定作用的思考
Ni, Jiaping; Zhai, Dongqing; Li, Jintong; More
Hepatology. 82(5):E132-E133, November 2025.
39
Reply: Considerations on the specific role of LHX2 in the process of hepatic stellate cells regulating hepatocyte function
回复：关于肝星状细胞调节肝细胞功能过程中LHX2特定作用的思考
Tao, Jiawang; Wang, Jie
Hepatology. 82(5):E134-E135, November 2025.
40
Letter to the Editor: Clarifying the impact of response criteria and locoregional therapy on complete response outcomes in patients with hepatocellular carcinoma following immunotherapy
致编辑的信：澄清免疫治疗后肝细胞癌患者中疗效标准及局部区域治疗对完全缓解预后的影响
Liu, Tsung-Hao; Yang, Hung-Chih
Hepatology. 82(5):E136-E137, November 2025.
41
Reply: Clarifying the impact of response criteria and locoregional therapy on complete response outcomes in patients with hepatocellular carcinoma following immunotherapy
回复：澄清免疫治疗后肝细胞癌患者中疗效标准及局部区域治疗对完全缓解预后的影响
Scheiner, Bernhard; Pinter, Matthias
Hepatology. 82(5):E138-E139, November 2025.
临床研究
2025-10-28
截至目前，哮喘仍是世界公认的医学难题，被世界卫生组织列为疾病中的四大顽症之一，是仅次于癌症的世界第二大致死和致残疾病。全球约有3.5亿人患有哮喘，其中约有5%-10%的哮喘患者经小分子药物吸入治疗后仍无法有效控制症状，存在巨大的临床未满足需求。根据GINA指南建议，抗体类药物适用于重度患者添加控制治疗，为现有用药基础的叠加控制药物，需要长期用药。然后由于单克隆抗体分子量较大（约150 kDa），稳定性差等原因，现有的技术无法满足大分子进行吸入式给药，只能通过静脉或皮下给药途径进行治疗。
与静脉或皮下给药的全身给药相比，吸入给药具有依从性好、起效快、剂量低、全身暴露少、潜在不良事件更少等优点，适用于更广泛的哮喘患者。然而，迄今为止，暂无吸入式大分子哮喘药物获批上市。
尊敬的患者及家属：
目前国内正在开展“评价 LQ036 单域抗体雾化液在控制不佳哮喘患者中安全性和有效性的随机、双盲、安慰剂对照、多中心IIb期临床研究"，符合入组免费治疗，扫描文末二维码咨询报名！
01
项目名称
评价 LQ036 单域抗体雾化液在控制不佳哮喘患者中安全性和有效性的随机、双盲、安慰剂对照、多中心IIb期临床研究
02
适应患者
缺血性脑卒中
03
研究用药
实验药：LQ036单域抗体雾化液
对照组：安慰剂
药物优势：LQ036 是一种靶向 IL-4Rα 的吸入式单域抗体（纳米抗体）药物，通过雾化吸入方式直接作用于肺部，阻断 IL-4 和 IL-13 的信号通路，从而抑制哮喘的关键炎症反应。
04
完整入排
1 门诊患者，年龄 12~75 周岁（包含临界值），性别不限，体质指数（Body Mass Index，BMI）在 18~30 kg/m2 之间（包括临界值），其中 12-17 岁患者体重须≥30 kg
2 筛选前，根据2025年全球哮喘防治创议（GINA）指南诊断为支气管哮喘，哮喘病史≥12个月者
3 筛选前，至少连续3个月使用吸入糖皮质激素（ICS）并联合至少1种控制药物，且至少连续1个月维持固定的治疗方案和剂量（ICS的维持低、中、高剂量定义根据2025年GINA指南，若使用多次雾化吸入或混合给药方式，合并剂量计算）
4 筛选时，使用支气管舒张剂前FEV1测定值占预计值百分比≥40%且＜80% （对于使用低剂量ICS患者，要求使用支气管舒张剂前FEV1测定值占预计值百分比≥40%且＜85%）
5 筛选时，ACQ-5评分≥1.5
6 筛选时，支气管舒张试验阳性，即吸入400 μg沙丁胺醇15～30分钟后FEV1增加≥12%，且FEV1绝对值增加≥200 mL（如果支气管舒张试验结果未达到阳性阈值，允许在该检查后7天内（不含检查当天）再进行一次支气管舒张试验）；或筛选前12个月内有支气管舒张试验阳性证据
7 筛选时，血EOS计数≥150 cells/μL且FeNO≥25 ppb
8 筛选前12个月内经历≥1次重度急性发作（对于使用低剂量ICS患者不作要求）
9 参与者充分了解试验目的、性质、方法以及可能发生的不良反应，自愿参加本试验，并在试验开始前签署知情同意书
05
完整排除
1 危及生命的哮喘，定义为筛选访视前 1 年或导入期内出现需要气管插管的哮喘发作，和/或伴有高碳酸血症、呼吸骤停或低氧惊厥、哮喘相关的晕厥发作等病史；
2 筛选前1个月内经历哮喘重度急性发作者
3 存在生物制剂过敏史，或已知对试验用药品及其任何组分过敏
4 筛选前8周或5个半衰期（以较长者为准）内曾使用过生物制剂（包括但不限于抗免疫球蛋白E（IgE）单克隆抗体、抗白介素-5（IL-5）单克隆抗体、抗IL-5受体、抗白介素-4/13（IL-4/13）受体单克隆抗体和抗胸腺基质淋巴细胞生成素（TSLP）单克隆抗体等）和/或全身性免疫抑制剂（包括但不限于甲氨蝶呤、环孢素、麦考酚酸酯、他克莫司、青霉胺、柳氮磺胺吡啶、羟氯喹、硫唑嘌呤、环磷酰胺）治疗炎症性疾病
5 筛选前3个月内进行静脉注射用免疫球蛋白（IVIG）或过敏原特异性免疫疗法（SIT） 6 筛选前1个月内或导入期接受全身性糖皮质激素（外用、眼科、鼻内使用糖皮质激素者除外），抗生素，抗真菌、抗病毒、抗寄生虫药物，非选择性β受体阻滞剂，使用具有平喘作用的中草药治疗者
7 筛选前3个月内接种活疫苗或减毒活疫苗，或计划研究期间接种活疫苗或减毒活疫苗
8 筛选前12个月内接受过支气管热成形术
9 筛选前8周内进行过大手术或计划在研究期间进行需要全身麻醉或住院治疗＞1天的手术
10 经研究者判断，合并哮喘之外的呼吸系统疾病，包括但不限于慢性阻塞性肺病（COPD），哮喘-COPD重叠综合征（ACOS）或任何其他重大肺部疾病（如活动性肺炎、特发性肺纤维化、气胸、肺不张、肺纤维化、支气管发育不良、支气管扩张症等），可能会使参与者处于不适当风险或影响试验结果判断
11 患有活动性结核病或非结核性分枝杆菌感染、潜伏的未治疗结核病或不完全治疗的结核病史患者
12 患有活动性自身免疫性疾病或者需要使用免疫抑制治疗的自身免疫性疾病患者，例如，类风湿性关节炎、炎症性肠病、原发性胆汁性肝硬化、系统性红斑狼疮、多发性硬化等
13 筛选期血EOS>1500 cells/μL，或患有其他可导致外周血EOS计数升高的全身性疾病，例如，嗜酸性粒细胞增多综合征、嗜酸性肉芽肿合并多血管炎、嗜酸性食管炎等经研究者判断可能会影响药物评价的情况
14 已知或疑似免疫缺陷：包括感染已经痊愈的侵袭性机会性感染病史（如组织胞浆菌病、李斯特菌病、球孢子菌病、肺孢子虫病和曲霉病）；或者存在不寻常的频发性、复发性或长期感染提示免疫功能受损状态
15 已知的寄生虫感染，或经研究者判断怀疑或高危寄生虫感染者
16 筛选前1个月内或导入期出现活动性感染（如上呼吸道感染），或急性感染需要全身性抗感染治疗
17 淋巴增生疾病病史、恶性肿瘤病史（患有基底细胞癌、皮肤局限性鳞状细胞癌或宫颈原位癌的参与者，如果在签署知情前已经治愈至少12个月，则可以进入本研究），或其他经研究者判断可能会影响药物评价的病史
18 存在其他任何重度和/或未能控制的疾病或治疗，且经研究者判断可能会影响药物评价的情况，包括但不局限于：严重的神经系统疾病、严重的精神障碍、未控制的糖尿病、未控制的高血压、重大心脑血管疾病、患有QT间期延长（男性>450 ms，女性>470 ms，使用Fridericia公式校正）或持续性心律失常等
19 当前吸烟或戒烟时长＜6个月者；或既往有长期吸烟史（≥10包年[包年=每日吸烟量（包）×吸烟时间（年），1包=20支]）者
20 筛选期乙型肝炎病毒表面抗原（HBsAg）、丙型肝炎病毒（HCV）抗体、人类免疫缺陷病毒抗体或梅毒螺旋体特异性抗体检查阳性者（HBsAg阳性但乙型肝炎病毒脱氧核糖核酸(HBV-DNA)低于检测下限者、HCV抗体阳性但丙型肝炎病毒核糖核酸（HCV-RNA）低于检测下限者可入组）
21 伴有严重肝肾功能异常的参与者，如天门冬氨酸氨基转移酶（AST）或丙氨酸氨基转移酶（ALT）>3倍正常值上限，或者血清肌酐>1.5倍正常值上限
22 妊娠期、哺乳期，或计划在试验期间或试验结束3个月内妊娠的女性；根据研究者的判断，不能在签署知情同意至研究末次给药后3月内采取医学上认可的可靠避孕方法避孕的育龄期女性和男性参与者；育龄期女性筛选期和随机入组前妊娠检查结果为阳性
23 签署知情同意书前3个月内参加了其它药物/器械临床研究并使用了试验药物/器械者；或签署知情时仍在其它临床研究的随访期内或试验药物的5个半衰期内（以较长者为准）
24 筛选前3个月内献血/大量失血史，接受输血或使用血制品
25 已知或可疑不服从，吸毒，药物滥用，酗酒者（男性日均纯酒精摄入量超过40g[约2两白酒/2瓶啤酒],女性日均纯酒精摄入量超过20g[约1两白酒/1瓶啤酒]）
26 研究者认为不适合参与本项临床试验的情况
06
报名材料
1 诊断哮喘的病例、既往舒张试验情况
2 处方： 连续3个月的用药处方，使用剂量、频率
3 发作记录：（低剂量组不要求） 因哮喘急性发作使用全身性糖皮质激素 ≥3天 因哮喘急性发作需要住院或急诊治疗（<24小时），且需全身性糖皮质激素治疗 因哮喘急性发作住院（≥24小时）
4 最近一次肺功能报告
5 FeNO报告，如有
6 血液学检查： 近一个月检测报告，如有
7 胸部影像： 近3个月内的胸部CT，如有
07
研究中心
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报名方式
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临床2期临床结果
100 项与 青霉胺 相关的药物交易
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研发状态
10 条最早获批的记录, 后查看更多信息
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| 适应症 | 国家/地区 | 公司 | 日期 |
|---|---|---|---|
| 铅中毒 | 中国 | 1981-01-01 | |
| 重金属中毒 | 日本 | 1976-12-06 | |
| 胱氨酸尿症 | 美国 | 1970-12-04 | |
| 肝豆状核变性 | 美国 | 1970-12-04 | |
| 类风湿关节炎 | 美国 | 1970-12-04 |
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临床结果
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| 研究 | 分期 | 人群特征 | 评价人数 | 分组 | 结果 | 评价 | 发布日期 |
|---|
N/A | 85 | 糧壓憲鬱鏇鏇衊淵網憲(膚願膚窪鏇願糧膚壓糧) = 獵網願顧積繭餘築鹽餘 鹹糧餘繭鹹觸窪膚鹹遞 (遞廠鏇構鏇窪網淵餘夢 ) 更多 | 不佳 | 2024-09-27 | |||
壓糧鬱襯顧鬱獵獵膚願(鬱淵鬱鹹構鏇憲網築鹽) = 艱積夢襯窪構鹹醖構鹽 艱糧範製鬱襯築蓋選憲 (鹽獵淵襯鹽廠獵艱鹽鑰 ) | |||||||
临床3期 | 肝豆状核变性 维持 | 76 | 壓鏇齋範窪醖齋憲壓齋(願鹽構襯衊獵鹹艱積網) = 襯艱鏇壓壓構淵蓋網衊 鹹簾簾糧鬱獵願選夢艱 (鬱獵願繭膚壓襯鬱簾壓 ) 更多 | 不佳 | 2024-08-01 | ||
临床3期 | 维持 24-h urinary copper excretion | alanine aminotransferase | 76 | 鏇鹽積衊齋鬱鬱獵餘簾(簾廠鏇襯齋齋餘製獵網) = 選鬱淵窪鹽鏇艱鑰齋製 鏇鬱顧醖鏇鬱蓋繭積窪 (齋鹽觸鑰淵構膚顧觸鑰 ) | 积极 | 2022-06-24 | ||
鏇鹽積衊齋鬱鬱獵餘簾(簾廠鏇襯齋齋餘製獵網) = 壓鹽夢淵鹽憲醖願淵鹽 鏇鬱顧醖鏇鬱蓋繭積窪 (齋鹽觸鑰淵構膚顧觸鑰 ) |
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