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今天11月8日周日21 条
  1. STAT · 医学与生命科学新闻

    美国心脏协会科学年会展出三项研究:卒中后及2型糖尿病人群降血压治疗在研究与实践中的挑战

    三项研究周六在美国心脏协会芝加哥科学年会上展出,探讨卒中及2型糖尿病人群的降压策略。其中一项小型但人群多样的试验测试卒中后使用一种常用利尿剂,另一项研究强化治疗以达成低于标准的卒中后血压目标,第三项探索2型糖尿病患者更积极的降压。文中指出高血压升高这些人群严重心血管事件风险、治疗需跨专科协作,新闻稿未给出具体结果数据。

  2. The Lancet · Online

    DAPT-SHOCK-AMI 随机双盲试验:急性心肌梗死合并心源性休克患者中 Cangrelor 与碾碎替格瑞洛比较,30 天主要终点非劣效未成立

    DAPT-SHOCK-AMI 随机双盲试验在急性心肌梗死合并心源性休克(AMI-CS)患者中比较 Cangrelor 与碾碎替格瑞洛两种 P2Y12 抑制策略。结果显示,主要 PCI 结束时 Cangrelor 达到有效血小板抑制的比例更高,但 30 天临床主要终点未证实其相对碾碎替格瑞洛的非劣效。作者称这是该人群首个此类随机试验,结果可为未来 P2Y12 抑制策略研究提供依据。

  3. PubMed · Thrombosis and Haemostasis

    RIETE登记2013–2024:31国住院急性肺栓塞患者初始抗凝的时间趋势与地区差异研究

    一项基于RIETE前瞻性多国登记、覆盖31国273家医院2013–2024年36210例住院急性肺栓塞成人患者的观察性研究发表。83.2%患者初始接受皮下低分子肝素(LMWH),7.1%接受普通肝素(UFH),6.8%接受直接口服抗凝药;LMWH使用从85.8%降至79.2%,UFH从8.9%升至10.4%(未校正),LMWH地区差异为37%–95%。

  4. PubMed · Cardiovascular Research

    动脉粥样硬化斑块成纤维细胞源于外膜与中膜Pdgfra谱系阳性细胞并主要维持成纤维细胞身份(小鼠研究,Cardiovascular Research)

    一项发表于 Cardiovascular Research 的小鼠与人类动脉单细胞 RNA 测序荟萃分析(54 个测序文库,含 Myh11、Cdh5 谱系报告小鼠及 Ldlr-/- 小鼠斑块)显示,斑块成纤维细胞身份由 Pdgfra、Pi16、Cygb、Serpinf1 mRNA 稳定定义。

  5. PubMed · Cardiovascular Research

    Cardiovascular Research发表综述:脂肪酸合酶(FAS)在心血管疾病中的分子机制与治疗靶向(含TVB-2640/denifanstat)

    《Cardiovascular Research》发表一篇综述,系统梳理脂肪酸合酶(FAS)在心血管稳态与疾病中的分子机制及治疗靶向。综述指出循环FAS主要源于肝脏,与脂蛋白结合并促进巨噬细胞泡沫细胞形成,独立于LDL-C浓度,可作为外周动脉疾病的诊断生物标志物;临床前模型中巨噬细胞Fasn缺失使动脉粥样硬化减少20–40%。

  6. PubMed · Cardiovascular Research

    肺栓塞患者血小板脂质组改变与血小板分化为不同亚群相关:合并右心室受累者的观察性研究

    一项纳入48例急性肺栓塞(PE)患者的观察性研究,通过CT肺动脉造影和超声心动图区分有无右心室(RV)受累,采用流式细胞术和HPLC-ESI-QTOF-MS/MS分析血小板亚群与脂质组。合并RV受累者聚集型血小板水平更高(P=0.021)、促凝型血小板更低(P=0.033),胆固醇酯、甘油三酯和脂肪酸显著上调,且脂质与两种血小板亚群水平相关。结果提示血小板脂质组重塑可能与PE中血小板表型分化有关。

  7. PubMed · Journal of Experimental Biology

    衰老增加跑步净代谢成本并伴随踝至髋关节机械功重新分布:18名年轻运动员与18名老年运动员对照研究发表于Journal of Experimental Biology

    一项发表于Journal of Experimental Biology的对照研究纳入18名年轻运动员和18名老年(master)运动员,测量跖屈最大等长力矩、跟腱刚度及2.5和3.0 m s⁻¹跑步时的COTnet、关节功与跟腱应变能。

  8. PubMed · eLife

    秀丽隐杆线虫机制研究:低氧应答经生物胺能与神经肽能神经环路延长寿命

    机制研究显示,秀丽隐杆线虫中遗传激活低氧应答可延长寿命,ADF血清素能神经元的HIF-1信号对此既必要又充分,并经GABA能RIS中间神经元的受体SER-7起作用,酪胺、GABA、神经肽NLP-17及氧/二氧化碳感知神经元亦参与该环路。作者指出哺乳动物特定组织中低氧应答存在负面效应限制转化,该环路为衰老调节靶点提供线索。文章在线发表于eLife(2026-11-06,PMID 42992993)。

  9. PubMed · European Heart Journal

    BioTAK 生物标志物评分用于 Takotsubo 综合征与急性冠脉综合征的早期鉴别:开发与外部验证研究

    研究者基于 3615 例 ACS 或 Takotsubo 综合征(TTS)患者的重叠注册数据,在 1823 例开发队列中以机器学习引导特征选择和 logistic 回归构建五项生物标志物评分 BioTAK(含 NT-proBNP、PAM、sLOX-1、LDL-C 及性别),并在 1792 例独立队列外部验证。

  10. PubMed · Journal of Neuroscience

    密集时间采样DW-MRI研究显示学习可在数分钟内重塑人脑微结构

    该研究在74名参与者中采用密集时间采样的弥散加权MRI(2146幅图像、22个时间点、127分钟)结合任务态fMRI,追踪陈述性学习及后续静息期间的脑微结构变化,并以37名匹配对照验证。学习诱导的平均弥散系数(MD)下降在学习开始后约7分钟出现,最稳定变化定位于左侧枕中回/颞中回,且在功能激活区域持续发展至学习后离线巩固期;对照组无变化。材料仅提供摘要,未见长期随访或重复验证数据。

11月7日周六
  1. ClinicalTrials.gov API v2 · 登记更新

    Axsome Therapeutics登记solriamfetol治疗儿童青少年ADHD的III期开放标签长期安全性研究(NCT07773883)

    Axsome Therapeutics在ClinicalTrials.gov更新登记NCT07773883:一项III期、多中心、开放标签研究,评估solriamfetol在患ADHD(注意缺陷多动障碍)的儿童青少年中的长期安全性。本次材料仅提供方案描述,未报告招募状态、样本量、主要终点或安全性结果,具体状态以登记库后续提交为准。

  2. ClinicalTrials.gov API v2 · 登记更新

    BrainGate2:失语人群皮质内神经接口系统可行性研究(BG-Aphasia-01,NCT07791459)在 ClinicalTrials.gov 登记

    责任方 Leigh R. Hochberg, MD, PhD 在 ClinicalTrials.gov 登记 BrainGate2 皮质内神经接口系统用于失语人群的可行性研究(BG-Aphasia-01,NCT07791459)。研究目的为获得初步器械安全性信息,并以尝试说话的方式验证失语者在计算机屏幕上生成文字及可听见的计算机生成语音的原理可行性。本次为登记摘要,未提供招募状态、分期或结果数据。

  3. ClinicalTrials.gov API v2 · 登记更新

    美国国家老龄研究所登记试验方案:psilocybin强化认知训练对老年轻度认知障碍及早期阿尔茨海默病者脑健康的影响(NCT07721467)

    美国国家老龄研究所(NIA)登记NCT07721467试验方案,拟纳入65岁及以上轻度认知障碍或早期阿尔茨海默病者,亦需认知正常健康老年人,比较认知训练联合psilocybin(裸盖菇素)与单纯认知训练对脑健康的影响。方案写明psilocybin间隔2周口服1粒(第二剂可选)且给药后留院24小时,两组均每日平板脑训练并重复影像与睡眠脑波监测。本记录为方案设计,尚无结果数据。

  4. ClinicalTrials.gov API v2 · 登记更新

    六价OX40激动剂INBRX-106单药或联合帕博利珠单抗治疗局部晚期或转移性实体瘤的1/2期、开放标签、非随机4部分试验(ClinicalTrials.gov登记)

    一项1/2期、开放标签、非随机、4部分试验在局部晚期或转移性实体瘤受试者中评估六价OX40激动剂INBRX-106,单独给药或与抗PD-1检查点抑制剂帕博利珠单抗(Keytruda®)联合。试验目的为确定安全性特征并确定最大耐受剂量(MTD)和/或推荐2期剂量(RP2D)。

  5. ClinicalTrials.gov API v2 · 登记更新

    安特卫普大学登记MYSSELF研究(NCT07902375):自采样甲基化分析寻找妇科肿瘤(表观)遗传标志物

    安特卫普大学在ClinicalTrials.gov登记MYSSELF研究(NCT07902375),拟分析首次尿液与阴道自采样中的(表观)遗传甲基化标志物,寻找其与子宫内膜、卵巢、外阴或阴道(癌前)病变及绝经后出血的关联。研究将以临床采集的宫颈或外阴样本以及血液、组织样本作对照,探索这些标志物未来能否帮助更早、侵入性更小的妇科肿瘤检测。该记录仅提供研究目的,材料中未给出样本量与当前招募状态等细节。

  6. STAT · 医学与生命科学新闻

    诺华pelacarsen III期HORIZON试验详细结果公布:大幅降低Lp(a)但未减少心血管事件

    STAT新闻报道,诺华资助的III期HORIZON试验详细结果在美国心脏协会(AHA)科学年会上公布,并同步发表于《新英格兰医学杂志》。试验中pelacarsen大幅降低脂蛋白(a)——约五分之一人群携带的遗传性心血管风险因素——但近五年随访中,随机分配至药物或安慰剂的参与者在心梗、卒中、紧急冠脉血运重建和死亡方面均无差异。

    关注理由:详细结果坐实此前top-line阴性信号:大幅降低Lp(a)未转化为心血管事件减少,动摇该研发通路的核心假设,可与NEJM同步发表原文对照核实具体数据。

  7. STAT · 医学与生命科学新闻

    诺和诺德ziltivekimab在ZEUS试验中未减少心血管事件,心脏病学家表示仍将探索抗炎治疗

    诺和诺德单克隆抗体ziltivekimab在ZEUS试验中降低了炎症细胞因子IL-6水平,但在病情严重的患者中,相比安慰剂未减少心肌梗死、卒中或死亡;结果在美国心脏协会科学年会公布并同步发表于《新英格兰医学杂志》。因数据监查委员会9月判定不太可能成功,诺和诺德已停止该药另外两项试验HERMES与ATHENA。报道引述心脏病学家观点:尽管该药失败,仍将继续探索抗炎治疗。

  8. EMA · What's New

    心血管医学:Human medicines European public assessment report (EPAR): Rivaroxaban Viatris (previously Rivaroxaban Mylan), rivaroxaban, Date of authorisation: 12/11/2021, Revision: 12, Status: Authorised

    原文摘录:Rivaroxaban Viatris (previously Rivaroxaban Mylan) RSS Authorised This medicine is authorised for use in the European Union rivaroxaban Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Rivaroxaban M … 21 MB - DOCX) First published: 04/06/2025 View This page was last updated on 06/11/2026

11月6日周五
  1. EMA · What's New

    儿科学:Human medicines European public assessment report (EPAR): Yorvipath, palopegteriparatide, Date of authorisation: 17/11/2023, Revision: 6, Status: Authorised

    原文摘录:Yorvipath RSS Authorised This medicine is authorised for use in the European Union palopegteriparatide Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Yorvipath is a hormone replacement medicine fo … 37 KB - PDF) First published: 15/09/2023 View News on Yorvipath Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 11-14 September 2023 15/09/2023 More information on Yorvipath EU/3/20/2350 - orphan designation for treatment of hypoparathyroidism EMA/PE/0000241327 - paediatric investigation plan A Study to Assess the Amount of Palopegteriparatide in Breast Milk of Lactating Females Requiring YORVIPATH® (Palopegteriparatide) - post-authorisation study A Global Pregnancy Registry to Assess Maternal, Fetal, and Infant Outcomes Following Exposure to YORVIPATH® (Palopegteriparatide) During Pregnancy and Breastfeeding - post-authorisation study This page was last updated on 06/11/2026

  2. EMA · What's New

    儿科学:Human medicines European public assessment report (EPAR): Bylvay, odevixibat, Date of authorisation: 16/07/2021, Revision: 13, Status: Authorised

    原文摘录:Bylvay RSS Authorised This medicine is authorised for use in the European Union odevixibat Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Bylvay is a medicine for treating patients from the age of … More information on Bylvay EU/3/12/1028 - orphan designation for treatment of progressive familial intrahepatic cholestasis EU/3/12/1040 - orphan designation for treatment of Alagille syndrome EMEA-002054-PIP01-16-M03 - paediatric investigation plan EMA/PE/0000240317 - paediatric investigation plan Bylvay - withdrawal of application for variation to marketing authorisation Registry to Document Treatment Effectiveness, Safety, Including Prospective Long-term Outcomes in Participants with Progressive Familial Intrahepatic Cholestasis (PFIC) who take Odevixibat (Bylvay) - post-authorisation study Prospective Registry-Based Study Evaluating the Effectiveness and Safety of Odevixibat in Participants With Alagille Syndrome (ALGS) - post-authorisation study Prospective Registry-Based Study of the Long-Term Safety of Odevixibat in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC) - post-authorisation study This page was last updated on 06/11/2026

  3. EMA · What's New

    感染病学:Human medicines European public assessment report (EPAR): Comirnaty, COVID-19 mRNA vaccine, Date of authorisation: 21/12/2020, Revision: 64, Status: Authorised

    原文摘录:Comirnaty RSS Authorised This medicine is authorised for use in the European Union COVID-19 mRNA vaccine Medicine Human Authorised Rolling review Application under evaluation CHMP opinion European Commission decision Overview Comirnaty is a vaccine for pr … 5-containing Covid-19 mRNA vaccines in the Nordic countries - post-authorisation study A Non-Interventional Post-Authorization Safety Study (PASS) for Active Safety Surveillance of Recipients of the Pfizer-BioNTech COVID-19 mRNA vaccine in the EU - post-authorisation study Real-world effectiveness of different COVID-19 vaccines in Spain: a cohort study based on public electronic health records (BIFAP) (effectiveness of COVID-19 vaccines in Spain) - post-authorisation study This page was last updated on 06/11/2026

  4. EMA · What's New

    感染病学:Human medicines European public assessment report (EPAR): Entyvio, vedolizumab, Date of authorisation: 22/05/2014, Revision: 34, Status: Authorised

    原文摘录:Entyvio RSS Authorised This medicine is authorised for use in the European Union vedolizumab Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview Entyvio is a medicine used to treat adult patients with … 73 KB - PDF) First published: 21/03/2014 Last updated: 21/03/2014 View News on Entyvio Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 December 2021 17/12/2021 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24-27 February 2020 28/02/2020 European Medicines Agency recommends 39 medicines for human use for marketing authorisation in first half of 2014 10/07/2014 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 March 2014 21/03/2014 European Medicines Agency recommends approval of a locally targeted treatment for ulcerative colitis and Crohn's disease 21/03/2014 More information on Entyvio EMEA-000645-PIP03-18 - paediatric investigation plan EMEA-000645-PIP01-09-M09 - paediatric investigation plan EMEA-000645-PIP04-20-M02 - paediatric investigation plan Vedolizumab-4081: Infection Outcomes among Advanced Therapy-naive Older Adult US Patients With UC/CD Initiating ENTYVIO, TNF-alpha Inhibitors, or Ustekinumab: A Retrospective Observational Matched-Cohort Study Using Medicare Claims Data, 2016-2025 - post-authorisation study Vedolizumab-5001: Organization of Teratology Information Specialists (OTIS) Vedolizumab Pregnancy Exposure Registry - post-authorisation study Vedolizumab-5056: Clinical Effectiveness of Vedolizumab Used in Frames of Drug Program for Crohn’s Disease Treatment in Poland – Prospective, Observational Study Considering Fatigue and Other Patient-reported-outcomes (PROs) (POLONEZ II) - post-authorisation study Comparative Effectiveness of Tofacitinib Versus Ustekinumab and Vedolizumab among Ulcerative Colitis Patients With Prior Anti- Tumor Necrosis Factor (TNF) Failure - post-authorisation study Topics Medicines This page was last updated on 06/11/2026

  5. EMA · What's New

    急诊与重症医学:Human medicines European public assessment report (EPAR): Elaprase, idursulfase, Date of authorisation: 08/01/2007, Revision: 29, Status: Authorised

    原文摘录:Elaprase RSS Authorised This medicine is authorised for use in the European Union idursulfase Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision Overview This is a summary of the European public assessment rep … This page was last updated on 06/11/2026

  6. EMA · News and Safety Reviews

    肿瘤学:Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 November 2026

    原文摘录:Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 3-5 November 2026 6 November 2026 Outcomes of the Committee for Veterinary Medicinal Products (CVMP) meeting News Veterinary Medicines CVMP opinions on veterinary medicinal pro … Related content Committee for Medicinal Products for Veterinary Use (CVMP): 3-5 November 2026 Committee for Veterinary Medicinal Products (CVMP) Related medicine information Credelio Quattro Credelio Nobivac PLUS DHPPi / Leptos Laverdia Scovella