This phase III trial compares a smartphone application with or without nicotine replacement therapy in improving smoking cessation among Hispanic adults who would like to quit smoking. The iCanQuit smartphone application focuses on skills for managing urges, motivation, and relapse prevention with personalized quit plans. Nicotine replacement therapy works by giving small, steady doses of nicotine to help stop cravings and relieve symptoms that occur when a person is trying to quit smoking without any of the other harmful chemicals found in tobacco products.

开始日期2025-11-01

申办/合作机构

Fred Hutchinson Cancer Research Center

[+1]

NCT07089901

/ Not yet recruiting临床4期IIT

Project DEDUCE: Digital Envirotyping to Develop Understanding of Cigarette Smoking and the Environment

Tobacco use is a chronic relapsing condition. That is, even with state-of-the-art treatment, >70% of smoking cessation attempts end in a return to regular smoking. Research demonstrates that everyday environments associated with smoking trigger craving for cigarettes, provoke smoking, and lead to relapse. However, despite this knowledge, understanding of environmental correlates of smoking has been limited by a reliance on self-report, leading to imprecise information about the physical environments in which people live. To overcome this challenge, the research team has pioneered the development of digital envirotyping, which uses digital tools (e.g., sensors, cameras, artificial intelligence) to efficiently and accurately characterize and categorize environments with the goal of identifying environmental markers of behavior and health. Foundational to the digital envirotyping research is computer vision (CV), a type of artificial intelligence (AI) that enables computer systems to recognize objects and scenes in digital images, mimicking how humans perceive and understand visual information. With CV researchers can extract detailed and accurate information (i.e., objects and location types) about the everyday environments of people who smoke (PWS) and relate that information to smoking behavior. After validating the use of CV, the researchers used CV to develop enviromarkers of relapse risk. Importantly, they identified a novel enviromarker in which people at greater risk for relapse when they quit are exposed to a more consistent level of environment-related smoking risk as they move between their smoking and nonsmoking environments.
Research is now needed to advance digital envirotyping and enviromarker development in the field of tobacco addiction. The study will recruit a diverse, national sample of n=500 adults who are interested in quitting smoking. For two weeks prior to quitting, they will undergo photoEMA in which they will take two pictures of their current environment when they smoke, and randomly 10 times per day resulting in >300,000 images total. Cessation will be supported by nicotine replacement therapy (i.e., nicotine patch). The primary clinical outcome will be days to relapse. Specific aims are to (1) further develop, refine, and validate methods for efficient digital envirotyping at scale, (2) leverage CV and AI approaches to develop enviromarkers of smoking relapse, and (3) conduct analyses to increase understanding of environmental smoking risk in women and individuals with low socioeconomic status.

开始日期2025-11-01

申办/合作机构

Duke University

[+1]

NCT07099638

/ Not yet recruiting临床2期IIT

Randomized Factorial Trial of Varenicline With Nicotine Lozenges and a Smartphone Medication Adherence Intervention to Promote Smoking Cessation

Although the prevalence of smoking has declined among U.S. adults, smoking remains the leading preventable cause of cancer incidence and mortality. Quitting smoking increases life expectancy, and quitting at an earlier age is associated with more years of life gained. Effective pharmacotherapies to aid cessation are available, and the combination of behavioral support with pharmacotherapy optimizes cessation outcomes. Varenicline is an effective, first-line smoking cessation treatment, and recent research has investigated combination pharmacotherapy to improve the modest quit rates observed with monotherapy. The findings of two meta-analyses have indicated that varenicline combined with the nicotine patch was more effective than varenicline alone for smoking cessation However, no published studies to date have evaluated the combined impact of varenicline and oral nicotine replacement therapy (NRT) on smoking cessation in a randomized trial. Oral NRT, such as nicotine lozenges, can provide acute relief from cravings/withdrawal, and offers individuals the flexibility to deliver nicotine quickly, in contrast with the continuous, passive, and slow-acting delivery of the nicotine patch. Nevertheless, in clinical trials of other combination pharmacotherapies, participants' adherence to of oral NRT has been suboptimal, making it difficult to determine whether there is an added benefit. Given the near-ubiquity of smartphone ownership (85% of U.S. adults), it is plausible that smartphone-based medication adherence interventions could have a positive influence on pharmacotherapy adherence and smoking cessation. This investigative team has demonstrated the feasibility and potential efficacy of using combination varenicline plus oral NRT treatment to promote smoking cessation in a pilot factorial randomized trial. Likewise, pilot findings showed that medication adherence and smoking cessation rates were higher among those who received smartphone-based medication reminders than those who did not. The proposed study will enroll 496 adults who smoke cigarettes daily. The study will employ a 2x2 factorial design in which participants will be randomized to one of four combinations of two treatment factors: 1) pharmacological treatment (varenicline + nicotine lozenges vs. varenicline alone) and 2) smartphone medication adherence intervention (smartphone-based smoking cessation app with vs. without adherence components). The primary study outcomes will be biochemically-confirmed 7-day point prevalence abstinence at 26 weeks after a scheduled quit date, and medication adherence over the 13-week treatment period. Smartphone-based daily diaries will be employed to assess daily smoking and medication adherence. Notably, the proposed study will employ entirely remote assessment and treatment delivery strategies. Exploratory analyses will evaluate the potential interaction between medication type and the smartphone adherence intervention, and compare the influences of pharmacological treatment type and the medication adherence intervention on weekly physical symptoms (e.g., withdrawal, medication side effects). The overarching goal of the proposed research is to improve smoking cessation treatment and decrease cancer risk.

开始日期2025-10-01

申办/合作机构

University of Oklahoma

[+5]

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2025-12-31·AUSTRALIAN JOURNAL OF PSYCHOLOGY

The relationship between work addiction and addictions to social media, shopping, food, caffeine, and nicotine

Article

作者: Onay, Ömer Alperen ; Griffiths, Mark D. ; Tınmaz Karaçay, Gülay ; Özsoy, Emrah ; Yılmaz, Canan ; Balaban, Özlem

Purpose:

Work addiction is a relatively underexplored behaviour compared to other forms of addiction. Existing research predominantly focuses on the antecedents and consequences of work addiction. However, studies examining its relationship with other types of addiction are notably limited. Therefore the present study investigated the relationships between work addiction and five other types of addiction (i.e. social media addiction, shopping addiction, food addiction, caffeine addiction, and nicotine addiction).

Method:

The research was conducted with 693 employees working in both public and private sectors. Data were collected through an online survey comprising validated scales for assessing the specific types of addiction and demographic questions. Descriptive statistics, internal consistency tests and Pearson correlation analysis were employed for data analysis.

Results:

Correlation analysis showed significant (albeit weak) positive relationships between work addiction and food addiction (r = .14), shopping addiction (r = .12), and caffeine addiction (r = .16). However, no significant relationships were found between work addiction and social media addiction or nicotine addiction. Comorbidity among individuals classified as high-risk for more than one addiction was only observed between two substance-based addictions (caffeine and nicotine), and between one substance-based addiction (caffeine) and one behavioural addiction (social media).

Conclusions:

These findings suggest that although multiple behavioural addictions may be associated, the observed comorbidity patterns primarily occur between two substance-based addictions or between a substance-based and a behavioural addiction, rather than between two behavioural addictions.

2025-12-01·IBRO Neuroscience Reports

Evaluation of the role of omega-3 fatty acids in nicotine-induced neurotoxicity in pregnant Wistar rats and their pups

Article

作者: Aturamu, Ayodeji ; Elemile, Mayowa Grace ; Samuel, Tokunbo Olorunfemi ; Omotosho, Gbenga Olatunde ; Alabi, Quadri Kunle ; Ibiye, Orji Eunice ; Ayoka, Oladele Abiodun ; Ige, Samson Mokolade ; Olamilosoye, Peace Kehinde ; Omole, Joseph Gbenga ; Adefisayo, Modinat Adebukola ; Ogunleye, Fisayo Nathaniel

This study investigated maternal and their pup neurobehaviour following nicotine exposure during gestational and postnatal periods and neuroprotective effect of Omega-3 fatty acids. Thus, the study used thirty pregnant female Wistar rats for this study. Groups I and II (nonpregnant and pregnant) were treated with 1 ml/kg/day of normal saline for 42 days; III was treated with 4 mg/kg/day of nicotine for 42 days; IV-VI were co-administered nicotine 4 mg/kg and 100, 300, 600 mg/kg/day of Omega-3 fatty acids respectively for 42 days. Results: The beam walk time of the mother rats in groups III and IV were significantly higher when compared with other groups. Similarly, the beam walks time of the pups of groups III and IV were significantly higher when compared with the pups of the mother rats in other groups. The brain dopamine and serotonin levels of mother rats in groups III, IV and V were significantly higher when compared with other groups. Also, the brain dopamine and serotonin levels of the pups in groups III and IV were significantly higher when compared with the pups in other groups. The reduced glutathione and catalase of mother and pup rats in groups III and IV were significantly lower when compared with other groups. Photomicrographs of cerebellum and hippocampus of the rats treated with nicotine showed scattered arrangement of pyramidal cells with vacuolated neurons. These alterations were significantly reversed with Omega-3 fatty acids following nicotine exposure. Conclusions. Omega-3 fatty acids at 300 and 600 mg/kg ameliorated nicotine-induced neurotoxicity in mother rats and their pups.

2025-12-01·Toxicology reports

Analysing the acute toxicity of e-cigarette liquids and their vapour on human lung epithelial (A549) cells in vitro

Article

作者: Donnellan, Samantha ; Findlay-Greene, Fern ; Vass, Sharron

The use of alternative tobacco products such as vaping devices has significantly increased over the last 5-years, with the largest increase being amongst 18-25-year-olds. While the quantity of nicotine is tightly regulated, the composition of e-liquid flavourings is largely unregulated, and often absent from product labels. Herein, we compare the toxicity of carrier liquids propylene glycol (PG) & vegetable glycerine (VG) with five popular flavour concentrates: menthol, cherry, butterscotch, vanilla bourbon and tobacco on human alveolar type II cell-like A549 cells. The flavourings were tested in both liquid and vapour form and a vapour assay was developed to assess cytotoxicity of the flavourings. Our results conclude that menthol liquid was the most cytotoxic (LD₅₀ = <0.5 % over a <4 h exposure). Followed by cherry and vanilla bourbon which elicited a similar response at 4 % over 8 h exposure. Tobacco only reached 50 % toxicity at a concentration > 4 % over 24 h exposure. Butterscotch displayed similar toxicity profiles to PG and VG where cytotoxicity exceeded 20 % at 8 % concentration at all time points. The cytotoxicity of menthol was further evaluated as a vapour, with a significant reduction in viable cells and a 5-fold increase in the number of necrotic cells with only 11 % of cells remaining viable after 5 vaping episodes. Analysis revealed the presence of toxic chemicals and heavy metals in the fluids therefore further research is required to fully elucidate the long-term usage of flavourings with vaping devices and the impact this may have on human lung health.

359

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2025-08-25

·CPHI制药在线

54亿美元归0！辉瑞镰状细胞药折戟

关注并星标CPHI制药在线 *展会预登记火热进行中，👆扫描二维码免费领票！ 2025年8月15日，辉瑞（PFE）的股价在盘前交易中悄然爬升2%，资本市场的微笑却掩盖着一个残酷事实：就在同一天，该公司宣布其镰状细胞病（SCD）关键药物inclacumab三期临床THRIVE-131研究彻底失败。241名患者的血管阻塞危象数据，成为压垮骆驼的最后一根稻草。这已是辉瑞在SCD战场遭遇的 "三连败"： 9个月前，拳头产品Oxbryta因"死亡人数异常增加"遭全球撤市，欧洲药管局报告显示用药组死亡率超安慰剂组3倍 5个月前，被寄予厚望的下一代口服药GBT601遭FDA全面叫停试验！此刻，最后一款主力在研药物倒在临床终点线前时间回溯至2022年8月，辉瑞以54亿美元高价收购专注于SCD治疗的生物技术公司GBT，这笔交易被寄予厚望。如今，54亿美元押注化为泡影，成为本年度最惨痛的药物研发失败案例之一。药物研发的高风险游戏，从未停止上演. 一场昂贵的赌注：54亿美元收购的初心与幻灭 2022年，辉瑞以54亿美元高价收购Global Blood Therapeutics（GBT）时，目标非常明确:打造SCD领域"小分子药物+基因疗法"的双轨制未来。彼时，SVB证券分析师曾乐观预测，GBT的管线资产尤其是GBT601作为"功能性治愈"疗法的潜力，足以为这一收购价格提供充分支撑。通过整合Oxbryta及两款在研药物，辉瑞有望在SCD领域实现年销售额超过30亿美元的业绩。收购让辉瑞一举获得了三款核心资产：已上市药物Oxbryta（voxelotor）临床后期候选药物inclacumab 下一代血红蛋白聚合抑制剂GBT601 在收购GBT时，辉瑞血液学研发重点本就聚焦于SCD和血友病领域，与GBT的专长高度契合。然而现实残酷：2023年Oxbryta全球销售额仅3.28亿美元，2024年第二季度更降至9200万美元，远不及预期。更令辉瑞陷入被动的是，inclacumab曾被视为解决SCD治疗痛点的潜力产品。作为一种靶向P-选择素的全人源单抗，该药最大优势在于每季度给药一次的便利性，显著优于当时需每月输注的竞品。 2022年6月，该药凭借"同类最佳"潜力获得FDA的孤儿药和罕见儿科疾病认定。然而，患者招募困难已初显端倪：2024年3月，辉瑞因患者招募缓慢（仅完成280名计划中的78名）终止了一项inclacumab的III期研究。如今54亿美元换来的，只有冰冷的临床数据与破碎的30亿美元年销售幻梦。镰状细胞病：科学与商业的双重困境镰状细胞病作为一种遗传性血液疾病，其病理机制已相对明确：患者血红蛋白β链基因突变导致血红蛋白S（HbS）异常聚合，进而使红细胞变形为镰刀状。这些异常细胞不仅携氧能力低下，还会阻塞微血管，引发血管闭塞危象（VOC）等一系列严重临床表现。全球每年约有500万人死于该疾病，在非洲,中东,印度等地肆虐。值得注意的是，随着全球人口流动，SCD在欧美国家的发病率持续上升：美国疾病控制与预防中心（CDC）数据显示，SCD在美国人群中的发病率已达1/3300，患者超过10万人，主要为非裔美国人；在法国，SCD甚至以1/2415的新生儿发病率超越其他遗传病，成为该国最常见的遗传病长期以来，SCD治疗领域面临选择有限,副作用大,疗效欠佳的困境：羟基脲（Hydroxyurea）：最早获批的SCD治疗药物，但骨髓抑制等严重副作用限制了广泛应用 Endari（L-谷氨酰胺）：2017年获FDA批准，成为20年来首个SCD新药，但临床效果有限 Adakveo（crizanlizumab）：诺华2019年推出的P-选择素抑制剂，2023年1月在III期研究中未能降低VOC发生率 Oxbryta（voxelotor）：由GBT研发，2019年获FDA加速批准，2023年全球销售额3.28亿美元，但安全性问题最终导致撤市这些传统药物共同面临的核心挑战在于：仅能部分缓解症状，无法解决疾病根本病因，且长期使用可能带来难以预料的安全性问题。辉瑞从GBT获得的药物管线，其科学基础主要围绕两个作用机制：血红蛋白S聚合抑制（Oxbryta和GBT601）：通过提高HbS与氧的亲和力，防止红细胞镰状 P-选择素阻断（inclacumab）：通过抑制介导细胞黏附的P-选择素，减少血管炎症和VOC发生然而，THRIVE-131研究的失败揭示了这些机制的局限性。inclacumab虽然在II期研究中显示出减少VOC的潜力，但在更严格的III期随机对照试验中，这一效果未能转化为统计学显著获益。同样值得注意的是，GBT601在2023年美国血液学会（ASH）年会上公布的II/III期初步数据显示能显著提高血红蛋白水平，但血红蛋白水平升高这一替代终点是否真能转化为VOC减少的临床终点，辉瑞最近的挫折似乎给出了否定答案。 SCD药物开发还有另一重困境：商业回报与患者分布的错位。该疾病主要影响撒哈拉以南非洲地区人群，而这些地区的支付能力极为有限。即使在发达国家，SCD患者也多为社会经济地位较低的少数族裔。这种分布特点导致制药公司在定价与市场预期间陷入两难：GlobalData曾预测，到2030年美国镰状细胞疗法市场规模约48亿美元;Fortune Business Insights估计全球市场可达98.4亿美元然而现实是，即使是已上市的创新药物，也面临市场渗透不足的挑战。Oxbryta在2023年全球销售额仅3.28亿美元，远低于预期。而基因疗法的天价定价（220万-310万美元）更是将绝大多数患者拒之门外。辉瑞54亿美元押注的连续失败，不仅是一家公司的挫折，更凸显了整个SCD小分子药物开发领域面临的科学不确定性与商业可持续性挑战。辉瑞的困境与转型在传统小分子药物屡遭挫折之际，基因疗法为镰状细胞病治疗带来了革命性突破。 2023年12月8日，美国FDA同时批准了两款治疗SCD的基因疗法--Vertex/CRISPR Therapeutics的Casgevy（exagamglogene autotemcel）和蓝鸟生物的Lyfgenia（lovotibeglogene autotemcel），标志着基于基因编辑的SCD治疗正式进入临床应用阶段。这两款基因疗法虽然针对相同适应症（12岁及以上复发性VOC的SCD患者），但采用了截然不同的技术路径： Casgevy：基于CRISPR/Cas9基因编辑技术，通过在患者自体造血干细胞中编辑BCL11A基因，重新激活γ-珠蛋白表达，增加具有抗镰状化能力的胎儿血红蛋白（HbF）。在关键临床试验中，Casgevy展现出卓越疗效--超过90%的患者在18个月内未经历VOC Lyfgenia：采用慢病毒载体技术，将经过工程改造、编码具有抗聚合特性血红蛋白的基因导入患者造血干细胞，使红细胞产生HbAT87Q--一种能够抑制镰状血红蛋白聚合的功能性血红蛋白这两款疗法的获批不仅为SCD患者提供了潜在治愈性选择，更代表了医学史上的里程碑: Casgevy成为全球首个基于CRISPR技术的基因编辑疗法，开启了精准基因治疗新时代。然而，尽管疗效显著，基因疗法的临床应用却进展缓慢：价格高昂：Casgevy定价220万美元，Lyfgenia更高达310万美元。如此高昂的价格远超常规药物，即使在美国医疗保障体系中也面临支付障碍流程复杂：需要采集患者自体造血干细胞，在专业GMP设施中进行基因修饰，再回输给经过清髓预处理的患者。整个过程耗时数月，且清髓化疗伴随感染、不孕甚至继发癌症等风险可及性有限：目前全球仅有少数医疗中心具备实施基因治疗的能力，导致患者地理可及性严重受限据悉，两款基因疗法获批后数月内，仅有几十名患者接受了治疗。这种缓慢的商业化进程反映了超高值基因疗法在现实世界中面临的困境,即使科学成功，商业转化仍障碍重重。为突破当前基因疗法的局限，全球研究团队正积极探索下一代技术，如体内基因编辑（in vivo gene editing），旨在避免复杂的干细胞移植过程，通过直接体内给药实现基因治疗，有望大幅降低成本并提高可及性。辉瑞在SCD领域的挫败并非孤例，而是该公司近年来面临的多重挑战的一个缩影。减肥药领域的连续失利：在不到两年的时间里，辉瑞连续放弃三款口服GLP-1药物： 2023年，首个每日一次口服lotiglipron项目因安全性问题被迫搁置 2024年，每日两次口服的danuglipron因缺乏竞争力且耐受性差再遭放弃 2025年4月，每日一次口服danuglipron（缓释剂型）因一名受试者出现可能由药物引起的肝损伤而终止开发 2025年8月，辉瑞宣布终止仅剩的口服GLP-1减肥药PF-06954522研发，彻底退出口服GLP-1减肥药市场专利悬崖的严峻挑战：辉瑞正面临类似2010年代初的重大专利悬崖，到2028年将失去多款重磅药物的专利保护： Eliquis（抗凝药）：2024年销售额74亿美元，专利2027年到期 Ibrance（乳腺癌治疗）：专利2027年到期 Xtandi（前列腺癌治疗）：专利2027年到期 Prevnar 13（肺炎球菌疫苗）：专利2026年到期行业估计表明，到2030年，全球价值超过2360亿美元的品牌药销售额将面临仿制药和生物类似药的竞争。 2025年第一季度，辉瑞营收同比下降8%至137.2亿美元，净利润降至29.7亿美元。公司预计2025年全年销售额在610亿美元至640亿美元之间，调整后每股收益预期为2.80美元至3.00美元。面对这些挑战，辉瑞正在推进一系列战略调整：成本削减计划：2024年宣布35亿美元成本减少;新增目标到2027年底再节省约12亿美元，主要来自销售、信息和行政费用;预计到2026年底，通过研究和机构重组可节省约5亿美元中国市场战略调整：2025年8月11日，辉瑞中国宣布对肿瘤及罕见病事业部进行组织架构优化;血液与罕见病治疗领域划分为两个关键业务单元;BG&H Franchise：整合血液肿瘤与乳腺/泌尿肿瘤业务;RD Franchise：整合血友病与ATTR团队，专注罕见病治疗;肺癌治疗领域业务围绕华北、华南、华东三大片区优化区域布局;在中国杭州下沙设立全球生物技术中心，打造集研发与生产于一体的本土化生物药综合基地研发策略转变：在第二季度财报电话会议上，辉瑞CEO阿尔伯特·博拉强调，未来将通过多笔小型交易而非大型并购来完善管线，且在肥胖症领域的并购会非常谨慎。他还透露，公司正在积极探索从中国引入资产的可能性。启示录：高风险游戏中的生存法则辉瑞54亿美元押注的失败，为整个制药行业提供了深刻的启示：罕见病药物开发的高风险性：辉瑞在SCD领域的困局揭示了罕见病药物开发中高风险与高回报并存的残酷现实。当传统药物开发路径遭遇瓶颈，基因疗法的崛起正在重塑整个治疗格局。替代终点的局限性：GBT601和inclacumab的失败凸显了依赖替代终点的风险。提高血红蛋白水平或减少生物标志物的能力，并不总能转化为临床终点的实质性改善，如减少血管阻塞危象或提高生存率。基因疗法时代的战略思考：随着基因疗法的崛起，传统制药企业需要重新评估在遗传疾病领域的战略定位。一次性治愈疗法的出现，正在改变慢性病管理的商业模式，迫使企业重新思考长期治疗药物的市场潜力。平衡创新与财务可持续性：在面临专利悬崖和研发挫折的双重压力下，大型制药公司需要在激进创新与财务审慎之间找到平衡。辉瑞转向小型交易和中国资产引入的策略，可能成为行业应对不确定性的新范式。辉瑞54亿美元的教训，再次印证了药物研发的本质:它是一场高风险与高回报并存的豪赌。在科学探索与商业回报的平衡木上，即使是最资深的玩家，也可能因一次失败而付出沉重代价。随着基因编辑技术的飞速发展和治疗范式的根本转变，制药巨头们面临的挑战不仅是科学上的突破，更是商业模式的重构。在这个剧变的时代，唯一不变的，是满足患者需求的初心,无论是通过一粒药丸，还是一次性治愈参考文献： 1. GlobalData、Fortune Business Insights对镰状细胞病市场规模的预测（见搜狐、网易2025-08-17报道） 2. 辉瑞2023-2025年财报及成本削减计划（来源：辉瑞官网） END 智药研习社近期直播预告来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

临床3期并购基因疗法孤儿药

2025-08-22

·米内网

【科普】别让“糖网”偷走光明，早期干预的关键策略

精彩内容糖尿病视网膜病变（DR）被称为“沉默的视力小偷”——它悄悄侵蚀视网膜，早期几乎无症状，却可能在不知不觉中夺走视力。国际糖尿病联盟（IDF）2025年发布的《全球糖尿病地图》显示，2024年全球每11个成年人中就有1人患糖尿病（约5.89亿），其中中国患者达1.48亿，预计2050年将增至1.68亿。更令人警惕的是，约1/3的糖尿病患者会进展为DR，而多数人直到视力明显下降时才察觉，此时往往已错过最佳干预时机。早期干预：与时间赛跑的“视力保卫战” DR的可怕之处在于其隐匿性：早期视网膜微血管已开始受损，但患者可能毫无察觉。此时若不干预，血管渗漏、出血会逐渐加重，晚期新生血管疯狂生长，最终导致视力骤降甚至失明。早期干预不仅对保护视力至关重要，还能够显著提升患者的生活质量，减轻长期医疗负担，具有重要意义。实施强化血糖控制、优化血压与血脂管理，内科治疗改善微循环，以及倡导健康生活方式，能够显著延缓疾病进程，减少视力损害的风险。控好“三高”：筑牢防线的基石血糖、血压、血脂的波动是DR进展的“加速器”，三者协同管理才能筑牢防线：血糖管理：避免大幅波动是关键。医生会根据年龄、并发症制定个体化目标（如年轻患者空腹血糖建议4.4-7.0mmol/L），口服药或胰岛素需规律使用，切忌擅自停药。血压控制：目标值建议低于130/80mmHg。血脂调节：高甘油三酯会加速视网膜血管损伤。他汀类药物是治疗糖尿病患者血脂异常的基础。内科治疗：精准打击早期病变 2024年《中国糖尿病防治指南》明确推荐，轻中度非增殖性DR（NPDR）患者在控好“三高”的基础上，联合针对性药物可显著获益。其中，复方丹参滴丸因明确的DR 适应症（2型糖尿病引起的I、II期NPDR）成为重要选择，一项关于复方丹参滴丸预防早期DR机制的研究结果显示，复方丹参滴丸显著改善了细胞排列失调，降低血管通透性和振荡电位的振幅，并恢复视神经纤维层厚度、降低了视网膜和血清中炎症因子的表达水平，可以通过血管和神经保护作用来预防早期DR。近年来得到了多部指南和共识的广泛推荐。定期筛查：给眼睛做“体检” DR早期诊断的唯一可靠方式是专业检查，就像用显微镜找细微裂缝：基础检查：每年一次眼底镜检查，可直观发现微血管瘤、出血点等早期病变。精准评估：荧光素眼底血管造影能清晰显示血管渗漏部位，光学相干断层成像（OCT）可检测毫米级的黄斑水肿，为治疗决策提供依据。筛查频率：无DR且血糖控制良好的患者，至少每1~2年筛查1次；轻度非增殖型糖尿病视网膜病变（NPDR）患者每6~12个月筛查1次，中度NPDR患者每3~6个月筛查1次，重度NPDR患者每3个月筛查1次。生活方式：慢性病管理的“隐形处方” 健康的生活习惯是DR长期管理的“免费良药”：饮食：增加蔬菜、水果及全谷物摄入，减少加工食品与高糖食物，维持血糖稳定。运动：每周150分钟中等强度运动，每次30分钟以上，既能控血糖，又能改善眼部微循环。戒烟限酒：烟草中的尼古丁会直接损伤视网膜血管，酒精则可能升高血压，两者均需严格控制。体重管理：BMI维持在18.5-23.9之间，腰围男性＜90cm、女性＜85cm，可减轻代谢负担。 DR的防治就像一场持久战，早期干预是赢得胜利的关键。通过“控三高+药物干预+ 定期筛查+健康生活”的综合策略，多数患者能有效延缓病变进展，守护清晰视野。记住：糖尿病患者的眼睛更需要“精心呵护”，早一分重视，就多一分光明的可能。声明：本文谨供行业人士参考，消费者请参照药品说明书或遵医嘱购买，内容的合法合规性由作者或委托发布方承担。免责声明：本文仅作医药信息传播分享，并不构成投资或决策建议。投稿及报料请发邮件到872470254@qq.com稿件要求详询米内微信首页菜单栏商务及内容合作可联系QQ：412539092 【分享、点赞、在看】点一点不失联哦

2025-08-21

·药事纵横

辉瑞54亿美元收购项目再受挫

8月15日，辉瑞宣布其治疗镰状细胞病（SCD）的关键药物inclacumab（PF-07940370）在III期临床试验THRIVE-131研究中未达到主要终点。该研究旨在评估inclacumab能否显著降低患者血管闭塞危象（VOCs）发生率，但结果显示，与安慰剂组相比，用药组在48周治疗期内VOC发生率无统计学显著差异。安全性方面，药物耐受性良好，常见不良事件包括贫血、关节痛和背痛。 THRIVE-131研究采用全球多中心、随机、双盲、安慰剂对照设计，共纳入241名16岁及以上SCD患者。所有患者在入组前一年均经历2-10次VOC发作，随机分配后每12周接受一次静脉注射inclacumab（30mg/kg）或安慰剂。主要终点设定为48周内VOC发生率降低，但未达到预期目标。 Inclacumab是一种靶向P-选择素的全人源单克隆抗体，其作用机制是通过抑制P-选择素（一种介导细胞黏附的蛋白）来减少血管阻塞和炎症反应。此前II期研究曾显示其降低VOC的潜力，但III期失败揭示了该靶点在临床应用中的局限性。 54亿美元收购项目连遭重创，辉瑞SCD战略受挫 Inclacumab的失败是辉瑞镰状细胞病药物管线的第三次重大挫折，也是其2022年54亿美元收购Global Blood Therapeutics（GBT）后核心资产的再度折戟： 1、Oxbryta（voxelotor）：2019年获批的首个血红蛋白S聚合抑制剂，因上市后研究显示VOC及死亡风险增加，于2024年9月全球撤市。 2、Osivelotor（GBT601）：下一代血红蛋白修饰剂，2024年12月遭FDA部分临床暂停，2025年5月被全面叫停III期研究。 3、Inclacumab：此次III期失败后，辉瑞从GBT收购的三款核心药物全部陷入困境。关于镰状细胞病镰状细胞病是一种遗传性血液疾病，全球每年约50万新生儿患病，美国患者达9万-10万，以非洲裔人群为主。其病理机制为血红蛋白β链基因突变导致红细胞镰状变形，引发血管阻塞、器官损伤及剧烈疼痛。当前治疗选择有限且挑战重重：羟基脲：可诱导胎儿血红蛋白表达，但存在骨髓抑制等严重副作用。已撤市药物：Oxbryta和诺华的Adakveo（同为P-选择素抑制剂）均因疗效或安全性问题退出市场。基因疗法突破：2023年12月，FDA批准两款基因疗法——Vertex/CRISPR的Casgevy（全球首款CRISPR疗法）和蓝鸟生物的Lyfgenia。Casgevy在关键试验中使＞90%患者18个月内无VOC发作，但定价高达220万-310万美元，且治疗流程复杂。辉瑞表示将继续推进SCD领域其他项目：一是完成Oxbryta的全面数据分析，并于2025年内发布结果；二是THRIVE-131研究的参与者可转入开放标签扩展研究（THRIVE-133），以评估inclacumab的长期安全性。立即扫码加入药事纵横交流群

临床3期并购基因疗法

100 项与尼古丁相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D03365	尼古丁	N07BA01	DB00184

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
烟草依赖	澳大利亚	Johnson & Johnson Pacific Pty Ltd.	2001-11-27
尼古丁依赖	美国	Haleon US Capital LLC	1984-01-13

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
肢端雀斑恶性黑色素瘤	临床3期	美国	McNeil AB	2011-03-01
尼古丁成瘾	临床3期	捷克	McNeil AB	1999-02-01
药物性运动障碍	临床2期	美国	Neuraltus Pharmaceuticals, Inc.	2009-10-01
帕金森病	临床2期	美国	Neuraltus Pharmaceuticals, Inc.	2009-10-01
肺癌	临床1期	美国	Pfizer Inc.	2017-06-16
衰老	临床前	中国	深圳先进技术研究院	2023-02-07

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临床结果

适应症

分期

评价

查看全部结果

研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04590404 (CTgov)	临床3期	吸烟	606	Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)+Nicotine Replacement Therapy+Varenicline	淵製觸製願築範醖夢蓋 = 衊廠選鏇淵顧範鏇壓鑰選蓋鹽選獵範齋鏇膚膚 (築構選窪鏇膚顧顧膚願, 餘蓋鏇壓繭遞製鹹範繭 ~ 製醖膚範鹹獵選鬱艱觸) 更多	-	2025-06-05
NCT05030766 (CTgov)	临床4期	尼古丁成瘾 \| HIV感染 \| 吸烟	95	Nicotine replacement patches (Mindfulness Training (MT) and NRT (Phase 1))	繭壓淵簾齋鹽鏇製網蓋 = 範壓製淵鬱膚願夢糧鬱壓範鏇壓遞簾顧獵壓願 (繭鑰繭醖鹽鑰觸鏇簾淵, 廠願廠選醖構醖簾範繭 ~ 製獵網襯積構襯餘選鹹) 更多	-	2025-06-04
				Nicotine replacement patches+NRT (Contingency Management (CM) and NRT (Phase 1))	繭壓淵簾齋鹽鏇製網蓋 = 衊構糧構餘鏇繭構憲網壓範鏇壓遞簾顧獵壓願 (繭鑰繭醖鹽鑰觸鏇簾淵, 膚淵積鏇網願夢鹹簾範 ~ 選蓋願憲夢齋範範窪願) 更多
NCT04946825 (CTgov)	临床2期	尼古丁成瘾 \| 尼古丁依赖	396	Nicotine replacement therapy patch+Continue electronic cigarettes (Quit Cigarettes, But Continue Using E-cigarettes, With Nicotine Replacement Therapy and Text Support)	顧簾製簾繭蓋構夢繭鹽 = 鑰願艱糧鏇窪鬱衊網鏇蓋餘艱構襯願艱築醖簾 (衊獵構鏇選廠網鏇製積, 網膚艱網範淵簾壓積蓋 ~ 壓憲齋構鏇鑰選廠齋夢) 更多	-	2025-05-22
				Nicotine replacement therapy patch+Quit electronic cigarettes (Quit Cigarettes and Quit E-cigarettes With Nicotine Replacement Therapy and Text Support.)	顧簾製簾繭蓋構夢繭鹽 = 夢鹹鏇襯夢鹹齋憲襯網蓋餘艱構襯願艱築醖簾 (衊獵構鏇選廠網鏇製積, 構願夢蓋簾蓋蓋範壓憲 ~ 鑰簾築鏇夢夢鏇衊選鏇) 更多
NCT02265874 (CTgov)	临床1/2期	肺结节病	50	Habitrol (Treatment)	獵繭壓廠鏇膚夢選願選(夢範衊衊襯願築獵壓夢) = 網醖鏇網顧餘製衊襯鑰選衊醖積衊壓鏇觸構網 (顧襯積獵積獵選艱齋襯, 0.22) 更多	-	2025-04-24
				Placebo to Habitrol (Control)	獵繭壓廠鏇膚夢選願選(夢範衊衊襯願築獵壓夢) = 蓋網餘網鹽網窪築醖廠選衊醖積衊壓鏇觸構網 (顧襯積獵積獵選艱齋襯, 0.04) 更多
NCT04994444 (CTgov)	临床2/3期	尼古丁成瘾	49	Nicoderm CQ (Preloading)	製願鹽窪鑰構醖蓋蓋範(憲餘獵網餘蓋製獵範獵) = 鏇積構窪憲網製衊艱鏇鏇窪餘鬱壓餘鏇繭積艱 (鏇窪淵繭醖衊壓顧齋鹹, 13.2) 更多	-	2025-04-06
				Nicoderm CQ (Standard Treatment)	製願鹽窪鑰構醖蓋蓋範(憲餘獵網餘蓋製獵範獵) = 壓衊繭淵窪鑰窪遞觸獵鏇窪餘鬱壓餘鏇繭積艱 (鏇窪淵繭醖衊壓顧齋鹹, 21.8) 更多
NCT04433767 (Pubmed)	临床2期	抑郁症 nicotine metabolite concentrations	29	Transdermal nicotine patches	窪醖艱構築夢齋簾醖網(鹽醖遞顧構繭糧鏇觸鹹) = improvement in self-reported affective symptoms (apathy, insomnia, rumination, and generalized anxiety symptoms), negativity bias, and disability 壓築糧廠衊築襯窪壓艱 (餘餘願鹹淵範鑰窪鬱獵 ) 更多	积极	2024-10-01
NCT05253573 (SurvLaos, CTgov)	临床2期	肿瘤 \| 吸烟	80	Self-help materials (to support smoking cessation)+Nicotine patch (Automated Treatment)	製選網淵膚糧襯衊鏇鬱 = 鏇蓋糧築壓鏇鹹獵餘窪襯鏇鑰鏇獵獵積顧構簾 (簾廠鬱鏇鹽醖積鑰淵範, 簾壓築築繭膚艱鏇夢鬱 ~ 鬱淵築齋製鏇壓繭膚廠) 更多	-	2024-08-28
				Self-help materials (to support smoking cessation)+Nicotine patch (Standard Care)	製選網淵膚糧襯衊鏇鬱 = 遞鬱範顧網積鬱觸鏇製襯鏇鑰鏇獵獵積顧構簾 (簾廠鬱鏇鹽醖積鑰淵範, 積網膚衊構鬱鏇構艱繭 ~ 築艱簾獵鏇選築遞築遞) 更多
NCT03272685 (CTgov)	临床3期	尼古丁依赖	799	Very Low Nicotine Content Cigarettes (Very Low Nicotine Content Cigarettes)	範網範膚壓鏇網遞鬱願(積遞鑰鏇網鑰鬱鹽製餘) = 膚網壓蓋構窪壓鏇積淵鏇觸壓顧獵衊衊窪選獵 (壓繭窪衊鏇網簾構選顧, 7.88) 更多	-	2024-08-20
				Normal Nicotine Content Cigarettes (Normal Nicotine Content Cigarettes)	範網範膚壓鏇網遞鬱願(積遞鑰鏇網鑰鬱鹽製餘) = 鏇淵構襯遞廠簾鹹鹹範鏇觸壓顧獵衊衊窪選獵 (壓繭窪衊鏇網簾構選顧, 9.07) 更多
NCT03612960 (CTgov)	N/A	肢端雀斑恶性黑色素瘤	34	Very low nicotine content cigarettes (Very Low Nicotine Content Cigarettes)	淵選範鏇網觸憲繭夢積(襯獵蓋窪襯廠憲築壓醖) = 醖選鏇網範艱襯壓夢築願築糧鑰鑰膚鹽簾淵廠 (艱襯鏇鹽餘衊願鹽淵範, 0.18) 更多	-	2024-08-20
				Normal nicotine content cigarettes (Normal Nicotine Content Cigarettes)	淵選範鏇網觸憲繭夢積(襯獵蓋窪襯廠憲築壓醖) = 網夢簾壓淵鬱顧觸窪遞願築糧鑰鑰膚鹽簾淵廠 (艱襯鏇鹽餘衊願鹽淵範, 0.18) 更多
NCT03634839 (CTgov)	临床1期	烟草依赖	42	Flavoring Agents+Nicotine (Sweet Non-menthol, Nicotine 36mg/ml)	醖鏇獵鹽餘夢築醖膚鹽(鬱鬱簾夢鹽鹽衊鏇鹽鏇) = 範鑰鬱製襯窪願選鹹觸憲鏇積鏇夢範醖網簾範 (鹽襯壓廠範糧網獵構鬱, 3.158) 更多	-	2024-08-09
				Flavoring Agents+Nicotine (Sweet Menthol, Nicotine 36mg/ml)	醖鏇獵鹽餘夢築醖膚鹽(鬱鬱簾夢鹽鹽衊鏇鹽鏇) = 鹹鹽淵顧艱齋淵鑰積網憲鏇積鏇夢範醖網簾範 (鹽襯壓廠範糧網獵構鬱, 3.158) 更多