Hydrocephalus affects up to 2 out of every 500 births and results in long-term disability in up to 78% of those affected. The standard treatment of hydrocephalus is cerebrospinal fluid (CSF) diversion via placement of an invasive ventricular shunt to relieve elevated intracranial pressure (ICP). The clinical decision for CSF diversion is based on the ventricular size and clinical symptoms which are not robust indicators of brain health in neonatal hydrocephalus. The purpose of this study is to assess the safety and feasibility of performing brain contrast-enhanced ultrasound (CEUS) in neonates and infants with diagnosed and/or suspected hydrocephalus.

开始日期2025-01-21

申办/合作机构

The Children's Hospital of Philadelphia

NCT06677554

/ Not yet recruiting临床3期IIT

COVARIAN - Contribution of Contrast Enhanced Ultrasound for Diagnosis of Adnexal Torsion: a Randomized Controlled Trial

Adnexal torsion is the rotation of the ovary around its vascular axis resulting, in the absence of treatment, ischemia that can lead to peritonitis by necrosis or impaired fertility. It is a gynecological emergency affecting 3% of women of childbearing age, including from adolescence, and requires surgical treatment as soon as possible, classically within 6 hours.
The symptomatology of adnexal torsion is dominated by pelvic pain of sudden onset and variable intensity, an aspecific sign that does not allow a diagnosis of certainty. There are no biological markers and, in the context of the emergency, the only imaging examination available is pelvic ultrasound associated with a Doppler flow analysis but with a low and variable diagnostic performance depending on the studies (sensitivity variable from 46 to 73%).
There are currently no tests that can provide a diagnosis of certainty. Only surgical exploration, carried out at the discretion of the practitioner on the basis of a bundle of arguments, can confirm or refute the diagnosis. However, this management strategy leads to the realization of emergency surgical interventions wrongly since 3 out of 10 women will finally not have an adnexal torsion (PMSI data from participating centers: 30 to 45% false positives).
Contrast ultrasound is a technique that uses a strict intravascular product to assess the vascularization of the ovary and offers a high diagnostic performance in the context of adnexal torsion. Indeed, a retrospective study, published in 2021, reports a sensitivity of 94% and a specificity of 100%. The preliminary results of our pilot study (AGATA APJC 2019, Dr Bertholdt, NCT04522219) also go in this direction with a sensitivity of 100%, a specificity of 86% and a negative predictive value of 100% (data being published).
The COVARIAN project, second stage of the AGATA project, aims to demonstrate that the addition of a contrast evaluation to standard ultrasound in the diagnostic strategy in case of suspicion of adnexal torsion improves the health of women by reducing the rate of wrongly surgery, that is, without proven torsion.
COVARIAN will be the first prospective multicenter randomized study evaluating the direct benefit for women of using ultrasound contrast evaluation in the management strategy in case of suspicion of adnexal torsion.

开始日期2025-01-01

申办/合作机构

Centre Hospitalier Regional de Nancy

NCT06600880

/ Not yet recruiting临床1期IIT

Neuronavigation-guided Focused Ultrasound-induced Blood-brain Barrier Opening in Alzheimer's Disease Patients and Its Effects on Brain Amyloid and Tau

The primary purpose of this phase 1b study is to further assess the safety and reversibility of focused ultrasound induced blood-brain barrier opening (FUS-BBBO) in participants with Alzheimer´s Disease (AD) using a single-element transducer with neuronavigation guidance. Preliminary results from our phase 1a study demonstrate that our neuronavigation-guided FUS system was capable of safely and transiently open the BBB in participants with AD. The information collected in this new study may be used to design future clinical trials to ultimately provide a viable alternative for treatment of AD in a safe and noninvasive manner.
Our secondary objective includes the assessment of the therapeutic efficacy of FUS-BBBO in reducing amyloid beta and neurofibrillary tangles, the main hallmark pathologies of AD, using PET tracers. Based on our preclinical studies in AD transgenic mouse models, FUS-BBBO alone was able to reduce both the amyloid beta and tau protein load, resulting in improvements in behavioral tasks assessing memory. Therefore, in this new study, the effect of FUS-BBBO on the amyloid beta and tau protein load in patients with AD will be assessed through the use of PET tracers.

开始日期2024-10-01

申办/合作机构

The Trustees of Columbia University in The City of New York

100 项与六氟化硫相关的临床结果

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100 项与六氟化硫相关的转化医学

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100 项与六氟化硫相关的专利（医药）

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1,506

项与六氟化硫相关的文献（医药）

2025-02-01·ULTRASOUND IN MEDICINE AND BIOLOGY

Effects of Different Gas Cores on the Ambient Pressure Sensitivity of the Subharmonic Response of SonoVue

Article

作者: Forsberg, Flemming ; Eisenbrey, John R. ; Halder, Saikat ; Yapar, Mehmet ; Eisenbrey, John R ; Azami, Roozbeh H. ; Sarkar, Kausik ; Azami, Roozbeh H

OBJECTIVE:

Subharmonic Aided Pressure Estimation (SHAPE) is a noninvasive technique for estimating organ-level blood pressure using the strong correlation between the subharmonic signal and ambient pressure. The compressible gas core of microbubbles enables them to generate linear and nonlinear acoustic responses when exposed to ultrasound. Here, the sulfur hexafluoride (SF₆) gas core of SonoVue (known as Lumason in the United States), a clinical contrast agent, was exchanged with a perfluorobutane (PFB) core to investigate its effect on the SHAPE response.

METHODS:

Excitations of 25-700 kPa peak negative pressure (PNP) and 3 MHz transmission frequency were used to study in vitro the effects of overpressure changes ranging from 5 to 25 kPa (37-186 mm Hg).

RESULTS:

Unlike SonoVue with SF₆, at low PNPs (<400 kPa), SonoVue with a PFB gas core exhibited no subharmonic at the atmospheric pressure, but during pressurization, a stable subharmonic response (maximum of 25 dB at 100 kPa PNP and 20 kPa Overpressure) appeared. SonoVue with a PFB gas core showed an increase in subharmonics with overpressure at high PNPs (>400 kPa), which was not observed before in normal SonoVue or other lipid microbubbles. With negligible size distribution difference between these two microbubbles, these effects on subharmonic generation are likely due to the gas core, casting new light on the mechanism by which ambient overpressure affects subharmonic.

CONCLUSION:

This study may inform future SHAPE technique developments.

2025-02-01·CORNEA

Principal Component Analysis of a Real-World Cohort of Descemet Stripping Automated Endothelial Keratoplasty and Descemet Membrane Endothelial Keratoplasty Cases: Demonstration of a Powerful Data-Mining Technique for Identifying Areas of Research

Article

作者: Derumigny, Alexis ; Zevering, Yinka ; Goetz, Christophe ; Perone, Jean-Marc

Purpose::

Principal component analysis (PCA) is a descriptive exploratory statistical technique that is widely used in complex fields for data mining. However, it is rarely used in ophthalmology. We explored its research potential with a large series of eyes that underwent 3 keratoplasty techniques: Descemet membrane endothelial keratoplasty (DMEK), conventional Descemet stripping automated endothelial keratoplasty (ConDSAEK), or ultrathin-DSAEK (UT-DSAEK).

Methods::

All consecutive DMEK/DSAEK cases conducted in 2016 to 2022 that had ≥24 months of follow-up were included. ConDSAEK and UT-DSAEK were defined as preoperative central graft thickness ≥130 and <130 μm, respectively. Seventy-six patient, disease, surgical practice, and temporal outcome variables were subjected to PCA, including preoperative anterior keratometry, the use of sulfur hexafluoride gas (SF6) versus air for primary tamponade, and postoperative best corrected visual acuity and endothelial cell density. Associations of interest that were revealed by PCA were assessed with the Welch t test or Pearson test.

Results::

A total of 331 eyes were treated with DMEK (n = 165), ConDSAEK (n = 95), or UT-DSAEK (n = 71). PCA showed that ConDSAEK and UT-DSAEK clustered closely, including regarding postoperative best corrected visual acuity, and were clearly distinct from DMEK. PCA and follow-up univariate analyses suggested that in DMEK, 1) flatter preoperative anterior keratometry (average, K1, and K2) associated with more rebubbling (P = 0.004–0.089) and graft detachment (P = 0.007–0.022); 2) graft marking did not affect postoperative endothelial cell density; and 3) lower postoperative endothelial cell density associated with SF6 use (all P > 0.001) and longer surgery (P = 0.005–0.091). All associations are currently under additional investigation in our hospital.

Conclusions::

PCA is a powerful technique that can rapidly reveal clinically relevant associations in complex ophthalmological datasets.

2025-02-01·AMERICAN JOURNAL OF CARDIOLOGY

Comparative Safety of Ultrasound Enhancing Agents: A Systematic Review and Bayesian Network Meta-Analysis

Article

作者: Cabra, Arturo ; Gueco, Myra ; Gonzalez, Ricardo De La Fuente ; Naslazi, Emi ; Liu, Daphne ; Fu, Shuai ; Dunham, Dustin M ; Hummel, Noemi ; Maliszewska, Zuzanna

Ultrasound enhancing agents (UEAs), including Optison, DEFINITY, and LUMASON, enhance the diagnostic performance of echocardiography, particularly, in patients with suboptimal acoustic windows. However, there remains a paucity of comparative safety assessments among the Food and Drug Administration-approved UEAs. A Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic literature review performed in August 2023 searched Medline, Embase, Cochrane Library, and gray literature. Randomized and nonrandomized comparative evidence on safety of contrast-enhanced procedures were included. A feasibility assessment ensured homogeneity across studies by comparing patient characteristics and outcomes. Bayesian hierarchical network meta-regression was used to indirectly compare published safety outcomes across different UEAs. In addition, adverse events (AEs) between 2019 and 2023 for each UEA were retrieved from the Food and Drug Administration Adverse Events Reporting System (FAERS), and comparative safety outcomes were derived using annual UEA administration in the United States. The screening of 4,146 records rendered 19 studies for inclusion in the indirect comparison analysis after feasibility assessment. Optison demonstrated favorable safety in direct comparisons with DEFINITY and LUMASON across the majority of investigated AEs. Network meta-regression results on serious AEs within 30 minutes revealed odds ratios (ORs) of 0.59 (95% confidence interval 0.27 to 1.23) and 0.63 (0.29 to 1.33) for Optison versus LUMASON and DEFINITY, respectively, indicating a decreased risk of serious AEs for Optison versus LUMASON and DEFINITY, further supported by statistically significant ORs within FAERS: 0.01 (0 to 0.02), p <0.001 and 0.15 (0.05 to 0.48), p = 0.001 for Optison versus LUMASON and DEFINITY, respectively. In conclusion, our results restate the favorable comparative safety profile of Optison, providing new evidence to inform clinical decision-making.

项与六氟化硫相关的新闻（医药）

2024-10-21

·米内网

集采冲击，造影剂明星药跌出TOP10！3大产品涨超10%，恒瑞、扬子江、南京正大天晴“突围”

精彩内容近期，造影剂市场波澜再起。北京北陆药业的钆喷酸葡胺注射液2个受理号过评；钆特酸葡胺注射液现身第十批集采网传报量名单。此前，海南倍特药业的钆特醇注射液、扬子江广州海瑞药业的钆布醇注射液等3个产品同日获批，原子高科的氟[18F]化钠注射液拿下首仿。米内网数据显示，2024年上半年中国公立医疗机构终端造影剂销售额同比增长1.65%，明星药跌出TOP10，3大产品涨超10%，恒瑞、扬子江、南京正大天晴4个国产品牌上榜。截至目前，造影剂有14个品种（近60个受理号）报产在审。造影剂首仿诞生，倍特、北陆药业领跑过评榜 10月18日，国家药监局官网显示，北京北陆药业的钆喷酸葡胺注射液2个受理号一致性评价补充申请获批。此前，海南倍特药业的钆特醇注射液、扬子江广州海瑞药业的钆布醇注射液等3个产品同日获批，成都克莱蒙医药的碘美普尔注射液成国产第2家，原子高科的氟[18F]化钠注射液拿下首仿。来源：米内网一键检索氟[18F]化钠注射液主要用于正电子发射断层显像（PET），在骨显像中确定成骨活性改变的区域，对诊断癌症骨转移、隐匿性骨折、冠状动脉斑块等病变具有重要的临床价值。目前，氟[18F]化钠注射液仅有原子高科拥有生产批文，南京江原安迪科正电子以仿制3类报产在审。原子高科表示，公司研制的氟[18F]化钠注射液是国内首个获批用于骨显像的PET显像剂，可实现早期、精准、无创的骨转移诊断，填补了我国在骨显像领域PET诊断显像剂的市场空白。今年以来造影剂报产获批、过评情况来源：米内网中国申报进度（MED）数据库今年以来，造影剂新品不断，已有12个品种（39个受理号）获批上市，无论是品种数还是受理号数，均已超过2023年全年（6个品种、10个受理号）。截至目前，造影剂已有14个品种（112个品规）过评，5个品种过评企业数量5家及以上，其中，碘克沙醇注射液过评企业最多，达9家。此外，江苏恒瑞医药的罂粟乙碘油注射液、原子高科的氟[18F]化钠注射液为独家过评。从企业过评品种数量来看，倍特药业最多，有8个品种过评，其次是北陆药业有7个，上海司太立制药有6个，恒瑞医药和正大制药各有5个。集采冲击，明星药跌出TOP10！恒瑞、扬子江、南京正大天晴“突围” 米内网数据显示，造影剂在2024年上半年中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院（简称中国公立医疗机构）终端销售额同比增长1.65%。从集团TOP10格局来看，恒瑞医药、通用电气、拜耳、博莱科、扬子江药业位居前五；康臣药业增速最快，其次是上海司太立制药、博莱科、通用电气均超过10%。 2024年上半年中国公立医疗机构终端造影剂产品TOP10来源：米内网中国公立医疗机构药品终端竞争格局 2024年上半年有16个造影剂销售额超过1亿元，碘佛醇注射液、碘克沙醇注射液、碘海醇注射液位居前三。产品TOP10中，注射用六氟化硫微泡、碘美普尔注射液和碘海醇注射液增速均超过10%。 3个集采品种近年中国公立医院终端市场份额情况来源：米内网中国公立医疗机构药品终端竞争格局目前，造影剂有3个产品被纳入集采，第五批集采品种碘克沙醇注射液和碘海醇注射液市场份额均有所回升，分别排第二、三位；而第七批集采品种碘帕醇注射液在2023年销售额“腰斩”，2024年上半年已跌出造影剂TOP10产品之列。钆特酸葡胺注射液批文情况来源：米内网中国上市药品（MID）数据库近日，钆特酸葡胺注射液现身第十批集采网传报量名单，该产品在2024年上半年中国公立医疗机构终端是造影剂TOP8产品。目前有7家企业拥有生产批文，6家过评，山东新时代药业、华润双鹤药业3家报产在审。未来市场格局将会有何变化？米内网将持续关注。 2024年上半年中国公立医疗机构终端造影剂品牌TOP10来源：米内网中国公立医疗机构药品终端竞争格局品牌TOP10中，恒瑞医药的碘佛醇注射液和钆特酸葡胺注射液、扬子江药业集团的碘克沙醇注射液、南京正大天晴制药的碘克沙醇注射液4个国产品牌上榜。从数量来看，通用电气和博莱科各有3个，恒瑞医药和博莱科有2个上榜。 5个品牌增速亮眼，通用电气的碘海醇注射液和博莱科的注射用六氟化硫微泡均超过20%，博莱科的碘美普尔注射液、通用电气的碘克沙醇注射液、南京正大天晴制药的碘克沙醇注射液均超过10%。新品蜂拥而至，重庆药友制药、葫芦娃……发起冲击今年以来造影剂报产在审产品来源：米内网中国申报进度（MED）数据库近日，海南普利制药的钆布醇注射液有4个受理号以仿制4类报产在审。今年以来，造影剂已有24个受理号报产在审，涉及10个品种，其中，倍特药业的碘比醇注射液冲击首仿，海南葫芦娃药业集团的钆布醇注射液有望成为公司首款造影剂产品。截至目前，造影剂有近60个受理号报产在审，涉及14个品种。钆布醇注射液最为火热，有7家；碘普罗胺注射液，有5家，碘佛醇注射液和碘美普尔注射液均有4家。从企业报产在审品种数量来看，倍特药业最多（4个），其次是重庆圣华曦药业（3个）。资料来源：国家药监局官网、米内网数据库等注：米内网《中国公立医疗机构药品终端竞争格局》，统计范围是：中国城市公立医院、县级公立医院、城市社区中心以及乡镇卫生院，不含民营医院、私人诊所、村卫生室；上述销售额以产品在终端的平均零售价计算。如有疏漏，欢迎指正！本文为原创稿件，转载请注明来源和作者，否则将追究侵权责任。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

一致性评价上市批准带量采购医药出海

2024-06-15

·医药地理

【好文推荐】微泡超声造影剂的研究与应用概况

未经授权，不得转载微泡超声造影剂的研究与应用概况 Research and Application of Microbubble Ultrasound Contrast Agents 闫梦1，何朝星1，李凤2，王岳恒3，向柏1*，邵娟4* (1. 河北医科大学药学院药剂学教研室，河北石家庄 050017；2. 河北医科大学第二医院腹部超声科，河北石家庄 050017；3. 河北医科大学第二医院心脏超声科，河北石家庄 050017；4. 河北医科大学第三医院老年病科，河北石家庄 050017) 摘要由于超声成像具有非侵入性、相对简便、无电离辐射等特点，已被广泛用于各个领域。超声造影剂在超声成像中发挥着重要作用，通常由软壳或硬壳材料组成，尺寸从纳米到微米不等，功能从最初的成像诊断发展成诊断、治疗一体化模式。部分上市的超声造影剂( 例如Levovist®、Optison®、Definity® 和Sonovue®) 已在欧洲、亚洲等地区用于临床超声检查。该综述重点介绍了微泡超声造影剂的研究进展及其临床应用，以期为新型超声造影剂的开发提供参考。关键词超声成像；超声造影剂；微泡；临床应用以下为文章节选超声成像作为一种无创、较为方便、无辐射伤害的诊疗方法，具有成像速度快、可实时成像等优点，已在妇产科、心血管、眼科、消化系统等领域中被广泛应用[1]。该技术通过传感器收集在组织中传播、反射、吸收后的超声波，并生成相应图像[2]。然而，在人体内环境中，病变部位与器官或组织之间的密度差并不足以产生清晰的超声图像，需要给患者静脉或局部注射高阻抗物质，即超声造影剂(ultrasound contrast agent，UCA)，用于改善器官成像[3]。目前，超声造影剂通常是直径为1 ～ 10 μm 的微气泡(microbubbles，MBs)[4]，由不同的外壳封装得到；外壳可增加MBs 的循环时间和耐久性，同时降低气核的释放速率。随着分子材料学的发展，近年来涌现了众多针对MBs 外壳材料的研究[5]。本综述基于造影剂的发展，介绍微泡超声造影剂的研究进展以及临床应用。 ↑长按二维码阅读全文基金项目：国家自然科学基金资助项目(81973251)、河北省自然科学基金资助项目(H2019206445)、河北省2021 年度医学科学研究课题(20211108) 作者简介：闫梦(1999—)，女，硕士研究生，专业方向：新型纳米药物递送系统。通信作者：向柏(1978—)，男，博士，教授，从事新型纳米载体在疾病诊疗中的应用研究。 E-mail：baixiang@hebmu.edu.cn 邵娟(1981—)，女，硕士，副主任医师，从事糖尿病、内分泌疾病等研究。 E-mail：sjyx1981@163.com 文章详情欢迎登录《中国医药工业杂志》官网查看。 END 如需获取更多数据洞察信息或公众号内容合作，请联系医药地理小助手微信号：pharmadl001

临床研究疫苗诊断试剂

2024-06-01

·医药观澜

治疗实体瘤，这6款细胞疗法入选ASCO口头报告，来自西比曼/阿斯利康、科济药业等公司！

▎药明康德内容团队报道2024年美国临床肿瘤学会（ASCO）年会已于今日（当地时间5月31日）在美国芝加哥正式开幕。根据ASCO官网摘要信息，今年共有5800+项研究入选本届大会，其中有426项研究入选了“口头报告环节（Oral Abstract Session）”和“快速口头报告（Rapid Oral Abstract Session）环节”。梳理这些口头报告研究，我们发现有近20项细胞疗法相关研究入选，包括了CAR-T细胞疗法、TCR-T细胞疗法、TIL疗法、基于细胞的现货型免疫疗法等等。在这其中，多家中国公司的细胞疗法也入选了ASCO大会口头报告，如科济药业Claudin18.2靶向CAR-T、艺妙神州靶向GUCY2C的CAR-T、博生吉CD7靶向CAR-T产品等。我们注意到，入选本次ASCO大会口头报告的细胞疗法中，有至少6项研究针对的适应症为实体瘤，涵盖胃肠道肿瘤、滑膜肉瘤、肝癌、乳腺癌、黑色素瘤等。在细胞治疗领域，实体瘤曾经是一座难以逾越的高峰，而近年来越来越多的新疗法、新技术正在解决这一挑战，并取得临床突破。本文中我们将一起看看针对实体瘤适应症的细胞疗法，看看它们的临床表现如何？注：本表由《医药观澜》根据ASCO官网摘要整理，如有遗漏，欢迎补充。西比曼生物/阿斯利康：C-CAR031作用机制：自体抗GPC3 CAR-T疗法适应症：肝细胞癌C-CAR031是一种针对肝细胞癌的自体抗GPC3的CAR-T疗法。本次入选口头报告的是该产品治疗晚期肝细胞癌（HCC）患者的1期研究结果。GPC3是HCC中过表达的表面抗原，在健康组织中几乎不存在。截至2024年1月5日，共有24例患者接受了4个剂量水平（DLs）的C-CAR031输注。所有患者均可进行安全性评估。未观察到剂量限制性毒性和免疫效应细胞相关神经毒性综合征（ICANS）。22个患者可评估疗效。90.9%的患者肿瘤缩小，肝内病变和肝外病变患者的中位肿瘤缩小率为44.0%（范围为3.4%~94.4%）。所有患者疾病控制率（DCR）为90.9%，客观缓解率（ORR）为50.0%，DL4的ORR为57.1%。该研究显示C-CAR031在接受过重度治疗的晚期HCC患者中具有可控的安全性和增强的抗肿瘤活性。艺妙神州：IM96作用机制：靶向GUCY2C的CAR-T疗法适应症：结直肠癌IM96是一款靶向鸟苷酸环化酶2C（GUCY2C）的CAR-T疗法，本次入选口头报告的是该产品治疗转移性结直肠癌患者的1期研究结果。GUCY2C在结直肠癌的所有阶段均异位表达。截至2023年12月，20名患者入组并注射了IM96，所有患者随访时间为7~19个月。安全性数据显示，只有5%的患者表现出神经毒性和3级细胞因子释放综合征（CRS），研究没有达到剂量限制毒性和最大耐受剂量。19例可评估患者中，DCR为73.7%，ORR为26.3%。DL3组（12×108）患者的ORR为40.0%，与肝转移与否无关。DL3组中位无进展生存期为7个月，中位缓解持续时间为10个月。在所有患者中，肿瘤应答与癌胚抗原水平的显著降低相关。本研究表明，IM96在错配修复完整（pMMR）mCRC患者中具有持久的疗效和可接受的安全性，特别是在肝转移患者中显示出较高的治疗潜力。科济药业：CT041作用机制：靶向Claudin18.2自体CAR-T细胞候选产品适应症：胃肠道肿瘤CT041是一种靶向Claudin18.2蛋白的自体CAR-T细胞候选产品，正在针对晚期胃癌/食管胃结合部腺癌的确证性2期临床试验。本次入选口头报告的是一项治疗胃肠道肿瘤患者的1期临床研究数据。疗效数据显示，所有患者的ORR和DCR分别达到37.8%和75.5%。所有患者的中位无进展生存期（PFS）和中位总生存期（OS）分别为4.4个月和8.4个月。在接受CT041单药治疗的可评估疗效的胃癌患者中，有可测量疾病（n=47）的ORR和DCR分别达到57.4%和83.0%，所有可评估疗效的胃癌患者（n=55）的中位PFS和中位OS分别为5.8个月和9.7个月。研究人员认为，CT041在大量预处理的Claudin18.2阳性晚期GI癌症患者中显示出有希望的安全性和高度令人鼓舞的疗效。Adaptimmune：letetresgene autoleucel（lete-cel）作用机制：靶向NY-ESO-1抗原的TCR-T疗法适应症：滑膜肉瘤或粘液样/圆形细胞脂肪肉瘤Lete-cel为一种靶向NY-ESO-1实体瘤抗原的工程化T细胞受体（TCR）-T细胞疗法。NY-ESO-1通过在HLA-A*02于滑膜肉瘤和黏液样/圆细胞脂肪肉瘤（MRCLS）中高度表达。本次入选口头报告的是一项2期临床研究结果。研究纳入98名滑膜肉瘤和MRCLS患者，45名患者可评估疗效。结果显示，总体ORR为40%（包括2例CR，16例PR），其中滑膜肉瘤和MRCLS患者的ORR分别为39%和41%。中位反应持续时间为10.6个月。在该研究中，不良事件与先前观察到的一致。研究人员认为，该研究进一步支持了Lete-cel作为晚期滑膜肉瘤和MRCLS疗法的潜力。Obsidian Therapeutics：OBX-115作用机制：靶向IL-15的TIL疗法适应症：黑色素瘤OBX-115是一款保留白细胞介素2（IL2）的工程化肿瘤浸润淋巴细胞（TIL）疗法，该产品使用经FDA批准的小分子药物乙酰唑胺（ACZ）调节膜结合IL15的表达，为TIL的扩增和存续提供细胞因子支持，因此患者在接受该疗法治疗时不需要同时接受高剂量IL2。该产品目前正处于1/2期多中心研究阶段。入选口头报告的是一项1期研究结果，评估了OBX-115方案在ICI耐药、不可切除/转移性黑色素瘤患者中的疗效和安全性。截至2024年1月2日，9名黑色素瘤患者接受了OBX-115输注，他们既往治疗的中位线为3。在至少12周随访的患者中（n=6），按RECIST v1.1计算的ORR为50%（2例CR，1例PR，3例SD）；所有反应都发生在第6~18周之间，最长反应持续时间>12个月。研究人员认为，OBX-115治疗耐受性良好，产生持续加深和持久的反应，表明其可能介导无大剂量IL2的ICI耐药转移性黑色素瘤的完全缓解和持久的临床益处。BriaCell公司：Bria-IMT（SV-BR-1-GM）作用机制：基于细胞的靶向免疫疗法适应症：乳腺癌Bria-IMT方案是一种基于异体全细胞免疫疗法，可刺激患者的免疫系统诱导靶向杀死癌细胞。根据ASCO官网介绍，经皮内照射Bria-IMT的乳腺癌细胞会分泌GM-CSF，并在HLA-I和II分子上呈递肿瘤相关抗原（TAAs），直接刺激抗肿瘤免疫。PD-1免疫检查点抑制剂（CPI）进一步刺激T细胞并与SV-BR-1-GM协同作用。入选口头报告的是评估该产品结合CPI，治疗既往经过多次治疗（包括ADC和CPI治疗失败）的晚期/转移性乳腺癌的疗效和安全性。共有54例患者接受治疗，结果显示Bria-IMT方案耐受性良好，仅9%因AE退出。在接受SV-BR-1-GM III期制剂治疗的患者中（n=23，结果可评估），ORR为13%，DCR为61%，中位PFS和OS分别为4.1个月和13.3个月。研究结果显示，BRIA-IMT已显示出良好的安全性，同时为重度治疗的晚期/转移性乳腺癌患者提供益处。这项2期研究也为正在进行的3期临床研究提供了依据。值得一提的是，今年1月，BriaCell公司宣布Bria-IMT在伴有中枢神经系统（CNS）转移的晚期乳腺癌患者中达成71%的颅内客观缓解率（iORR）。目前该疗法的的关键3期试验正在进行中。除了上述产品，还有一些其它的细胞疗法入选了本届ASCO大会口头报告，用于治疗不同类型的血液肿瘤（见下表），限于篇幅，此处不再一一介绍。如欲获取本届ASCO大会口头报告的细胞疗法管线和临床试验数据，请扫描下方二维码下载表格查看。相关阅读：2024年ASCO口头报告ADC研发管线一览参考资料：[1]ASCO大会官网. From https://conferences.asco.org/am/abstracts[2]各公司公开资料及官方新闻稿本文来自药明康德内容团队，欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「医药观澜」微信公众号留言联系我们。其他合作需求，请联系wuxi_media@wuxiapptec.com。免责声明：药明康德内容团队专注介绍全球生物医药健康研究进展。本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

细胞疗法免疫疗法ASCO会议临床1期临床结果

100 项与六氟化硫相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	六氟化硫	V08DA05	DB11104

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
膀胱输尿管返流	美国	Bracco Diagnostics, Inc.	2016-12-22
脑血管疾病	中国	Bracco SpA	2014-11-18
肝病	美国	Bracco Diagnostics, Inc.	2014-10-10
心血管疾病	欧盟	Bracco International BV	2001-03-26
心血管疾病	冰岛	Bracco International BV	2001-03-26
心血管疾病	列支敦士登	Bracco International BV	2001-03-26
心血管疾病	挪威	Bracco International BV	2001-03-26
造影剂	欧盟	Bracco International BV	2001-03-26
造影剂	冰岛	Bracco International BV	2001-03-26
造影剂	列支敦士登	Bracco International BV	2001-03-26
造影剂	挪威	Bracco International BV	2001-03-26

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
缺氧缺血性脑病	临床3期	美国	Bracco Diagnostics, Inc.	2020-12-01
缺血性结肠炎	临床3期	美国	Bracco Diagnostics, Inc.	2020-11-04
坏死性小肠结肠炎	临床3期	美国	Bracco Diagnostics, Inc.	2020-11-04
心脏病	临床3期	美国	Bracco Diagnostics, Inc.	2015-10-01
冠心病	临床3期	美国	Bracco Diagnostics, Inc.	2015-09-24
冠心病	临床3期	加拿大	Bracco Diagnostics, Inc.	2015-09-24
冠心病	临床3期	德国	Bracco Diagnostics, Inc.	2015-09-24
冠心病	临床3期	意大利	Bracco Diagnostics, Inc.	2015-09-24
肝癌	临床3期	美国	Bracco Diagnostics, Inc.	2009-09-01
可见病灶	临床3期	美国	Bracco Diagnostics, Inc.	2009-09-01

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临床结果

适应症

分期

评价

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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


NCT03821376 (CTgov)	临床4期	肾肿瘤	12	Lumason	鑰蓋選夢糧夢膚積壓範(齋夢衊窪夢鏇餘鬱獵鑰) = 衊壓膚憲鹹艱淵選淵鏇選鹽廠積築獵淵窪窪鏇 (膚選鏇艱鹹齋衊網範鏇, 襯網製範膚衊艱齋蓋鑰 ~ 蓋觸繭鹹餘艱鹹鹹顧憲) 更多	-	2024-10-10
EURETINA2024	N/A	脉络膜新生血管 \| 创伤性失血	-	Intravitreal recombinant tissue plasminogen activator (r-TPA)	窪積蓋繭蓋襯衊鹹遞觸(窪壓製簾襯憲顧製壓鹹) = Intravitreal anti-VEGF therapy was performed, which led to the improvement of BCVA, 0.4 LogMAR OD, and the reduction of CNV size, as the OCTA report shows 鬱憲夢繭醖簾壓觸膚繭 (製鹹醖窪網遞糧夢廠製 ) 更多	-	2024-09-19
				Intravitreal anti-VEGF therapy
NCT04569799 (TACE, CTgov)	临床4期	肝细胞癌	26	Lumason	鏇廠獵選遞衊鑰齋糧顧(淵願膚醖廠選廠觸製膚) = 鬱憲衊獵醖鑰鹹製蓋觸衊遞範積糧遞壓繭夢願 (獵窪窪簾廠遞淵遞選醖, 齋鏇獵壓餘鹽顧膚壓製 ~ 願鑰憲艱鹽積蓋顧淵蓋) 更多	-	2023-11-02
NCT03687502 (CTgov)	临床2期	阑尾炎	37	Sulfur hexafluoride lipid-type A microspheres	遞顧鹹鹹繭齋鑰餘願構(夢願積簾顧艱蓋鑰鏇範) = 廠鏇餘遞醖淵網淵窪膚積選夢淵醖鬱夢蓋衊積 (鹽艱築獵鬱顧艱襯襯觸, 淵衊獵選鑰顧簾鏇製艱 ~ 簾製窪衊鏇艱範積鑰糧) 更多	-	2022-12-01
NCT03235180 (CTgov)	临床4期	克罗恩病	9	Magnetic Resonance Enterography (MRE)+Sulfur Hexafluoride	簾襯範艱壓膚醖憲醖壓(窪膚鹽齋夢獵範窪鏇鹹) = 襯獵鑰憲遞顧鹹構襯構網選蓋餘鑰壓構鹹網淵 (簾願餘膚網繭繭選積網, 鏇鬱鏇艱繭蓋夢憲夢廠 ~ 鹹憲鬱淵鬱齋窪構淵鏇) 更多	-	2021-11-10
PROSPECTIVE INTRA-INDIVIDUAL COMPARISON (ILCA2020)	N/A	-	-	SULFUR HEXAFLUORIDE (Perfluorobutane (C4F10))	願廠鹽遞襯膚製衊築蓋(範範鹽顧鑰襯選餘範觸) = 鑰憲憲鏇積鏇繭觸顧淵糧繭積衊醖獵憲膚壓簾 (網範襯鏇憲夢製齋憲淵 ) 更多	积极	2020-09-11
ESC2020	N/A	-	100	Perfluoropropane contrast	夢糧窪艱齋顧蓋廠觸簾(顧願鹽顧鹹繭醖鏇築鏇) = 繭蓋糧獵衊廠遞蓋築餘網憲築壓膚壓淵觸糧積 (築醖憲鏇鹹製範膚醖餘 ) 更多	-	2020-08-29
				Sulphur hexafluoride contrast	夢糧窪艱齋顧蓋廠觸簾(顧願鹽顧鹹繭醖鏇築鏇) = 製積夢憲鏇遞積鏇繭憲網憲築壓膚壓淵觸糧積 (築醖憲鏇鹹製範膚醖餘 ) 更多
ERS2019	N/A	哮喘	-	SF6	範繭簾遞衊糧壓觸憲醖(廠積鹹鬱齋積遞衊艱範) = 觸築繭鹹醖醖觸遞鹹願網窪構廠壓鏇窪繭積憲 (網鑰艱積襯壓鑰艱積夢 )	积极	2019-09-28
				SF6	範繭簾遞衊糧壓觸憲醖(廠積鹹鬱齋積遞衊艱範) = 蓋鏇遞艱願構繭糧廠糧網窪構廠壓鏇窪繭積憲 (網鑰艱積襯壓鑰艱積夢 )
NCT03040323 (CTgov)	临床4期	肝病	83	Lumason 60.7Mg Powder for Injection (Biopsy With Lumason)	築醖夢構餘製鏇憲願網(壓廠衊蓋襯淵積顧壓構) = 醖壓鬱製願夢築鏇鏇襯積齋襯鬱衊積網蓋壓壓 (簾顧壓遞衊糧襯製遞憲, 膚簾構窪窪獵膚鹽淵觸 ~ 膚遞憲衊積餘衊顧鹹襯) 更多	-	2019-07-24
				Placebos (Biopsy With Placebos)	築醖夢構餘製鏇憲願網(壓廠衊蓋襯淵積顧壓構) = 夢鏇顧壓觸鏇餘範窪遞積齋襯鬱衊積網蓋壓壓 (簾顧壓遞衊糧襯製遞憲, 糧觸構蓋蓋觸簾餘窪襯 ~ 範鬱鹹淵餘鏇淵膚壓繭) 更多
2019 ARVO Annual Meeting (ARVO2019)	N/A	-	88	20% sulfur hexafluoride (SF6) gas	鑰鑰範襯鹽鏇製觸蓋廠(蓋襯壓鬱襯醖鏇鹹膚觸) = 願襯製廠壓餘蓋淵觸鏇積繭積積鏇鏇憲襯鏇鑰 (鹽積簾積鹹簾範憲餘範 ) 更多	积极	2019-07-01
				20% sulfur hexafluoride (SF6) gas (Air)	鑰鑰範襯鹽鏇製觸蓋廠(蓋襯壓鬱襯醖鏇鹹膚觸) = 襯選觸窪鬱鬱夢製衊製積繭積積鏇鏇憲襯鏇鑰 (鹽積簾積鹹簾範憲餘範 ) 更多