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  1. 1DAPT-SHOCK-AMI试验:坎格瑞洛对碾碎替格瑞洛非劣效未成立7 热度
  2. 2BIO等起诉请求叫停Medicare GLOBE药价参照试点7 热度
  3. 3中国疾控中心主任会见WHO非洲区域主任6 热度
  4. 4诺华pelacarsen降Lp(a)未减少心血管事件6 热度
  5. 5ziltivekimab ZEUS试验阴性,另两项试验终止6 热度
  1. 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。

  2. EMA · What's New

    EMA 授权 rilzabrutinib(Wayrilz)用于既往治疗无效的成人免疫性血小板减少症

    EMA 于 2025 年 12 月 22 日授予 Sanofi 的 rilzabrutinib(Wayrilz)欧盟上市授权,用于既往治疗无效的成人免疫性血小板减少症(ITP),并发布 Revision 1 的 EPAR。

    关注理由:EMA 发布 rilzabrutinib(Wayrilz)欧盟上市授权 EPAR,含 202 名成人 ITP 随机对照试验数据及 12 周无效停药规则,可用于孤儿药治疗路径跟踪。

  3. EMA · What's New

    EMA将多发性骨髓瘤药teclistamab(Tecvayli)的条件性上市许可转为标准许可(EPAR第11版)

    EMA更新teclistamab(Tecvayli)的EPAR:该药用于复发或难治性多发性骨髓瘤成人患者,2022年8月23日获欧盟条件性上市许可,2026年8月20日因公司提交额外数据转为标准上市许可。

    关注理由:该EPAR第11版记录teclistamab由条件性上市许可转为标准许可这一监管证据升级,并汇总其单药及联合daratumumab研究的疗效与安全性数据,便于跟踪多发性骨髓瘤后续监管动作。

  4. EMA · What's New

    EMA通报止吐药Emend(aprepitant)欧盟/EEA供应短缺,Merck Sharp & Dohme B.V.因商业原因计划2028年5月前永久停市

    EMA通报Merck Sharp & Dohme B.V.因商业原因永久停市止吐药Emend(aprepitant,80 mg与125 mg规格),欧盟/EEA短缺持续,预计2028年5月前在所有国家停市,停市与产品质量缺陷或安全问题无关。

    关注理由:该通告确认aprepitant停市源于商业原因而非质量或安全问题,6月龄及以上儿童所需口服混悬剂型无替代品,是化疗支持用药供应需持续跟踪的关键缺口。

  1. ClinicalTrials.gov API v2 · 登记更新

    肿瘤学:Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma

    原文摘录:This phase I/II trial studies the side effects and the best dose of selumetinib and how well it works in treating or re-treating young patients with low grade glioma that has come back (recurrent) or does not respond to treatment (refractory).

    关注理由:这条肿瘤学内容涉及相关临床或研究问题,建议查看原文中的方法与适用范围。

  1. PubMed · JNCI Journal of the National Cancer Institute

    肿瘤学:Treatment-related neutropenia as predictor of response to adjuvant palbociclib in the PALLAS trial (ABCSG-42/AFT-05/BIG-14-13/PrE0109).

    原文摘录:BACKGROUND: Prior analyses of PALLAS (NCT02513394), a phase III trial that randomized patients with stage II-III hormone receptor-positive breast cancer to receive adjuvant palbociclib plus endocrine therapy (ET) or ET alone, did not show benefit of the c … gov, NCT02513394

    关注理由:这条肿瘤学内容涉及随机对照研究,建议同时核对纳入人群、主要终点与报告结果。

  2. PubMed · British Journal of Cancer

    肿瘤学:Which is more effective at improving uptake of bowel cancer screening: text message reminders or patient navigation? Results from a three-arm RCT.

    原文摘录:BACKGROUND: Text message reminders (TMRs) and patient navigation (PN) increase bowel cancer screening uptake. To date, no studies have directly compared these interventions with one another. … TRIAL REGISTRATION: ISRCTN17245519

    关注理由:关注肿瘤学时,这项随机对照研究可提供直接比较的证据,主要终点和研究局限需要一起阅读。

  3. PubMed · Ophthalmology

    儿科学:Three-Year Outcomes of Trabeculotomy vs Combined Trabeculotomy-Trabeculectomy for Primary Congenital Glaucoma.

    原文摘录:PURPOSE: To determine whether trabeculotomy is noninferior to combined trabeculotomy-trabeculectomy (CTT) for primary congenital glaucoma (PCG) with a horizontal corneal diameter (HCD) of 12-14 mm. … 0%) in the CTT

    关注理由:这条儿科学内容涉及随机对照研究,值得重点看研究分组、主要终点和实际结果。

  4. PubMed · Experimental Cell Research

    心血管医学:Single-cell Bioinformatics Analysis and In Vitro Validation Explore Core Genes and Signaling Pathways of Iron Metabolism in Fetal Left Heart Function Injury in Gestational Diabetes Mellitus.

    原文摘录:BACKGROUND: Gestational diabetes mellitus (GDM) is a common metabolic disorder during pregnancy that significantly affects fetal cardiac development.

    关注理由:这篇心血管医学资料有原始研究可供追溯,临床意义还需结合研究人群和结局指标判断。

  5. PubMed · The Annals of Thoracic Surgery

    外科与麻醉:Pharmacological Prevention of Cardiac Surgery-Associated Acute Kidney Injury: Why Trials Failed and a Reimagined Endpoint Framework.

    原文摘录:BACKGROUND: Cardiac surgery-associated acute kidney injury affects approximately one in four adults and is independently associated with perioperative mortality and progression to chronic kidney disease. … Platform designs with biomarker-enriched enrollment could convert the next generation of trials into interpretable tests of kidney protection

    关注理由:这条外科与麻醉内容涉及随机对照研究,值得重点看研究分组、主要终点和实际结果。

  6. PubMed · Blood

    感染病学:The Pathogen Recognition Receptor RIG-I is Functional in Platelets and Limits Thrombotic Responses.

    原文摘录:Influenza is associated with increased thrombotic risk, and its viral RNA (vRNA) can be sensed by pattern-recognition receptor RIG-I, but the function of RIG-I in platelets remains unknown. … Our study is the first to demonstrate that platelets have a functionally active vRNA-sensing RIG-I receptor that finely tunes thrombotic risk and facilitates appropriate leukocyte transmigration during infection, through non-classical platelet activation

    关注理由:这篇感染病学资料可用于了解领域进展,研究设计、结果和局限性值得一起阅读。

  7. PubMed · Kidney International

    医学研究:Systematic overestimation using in silico-driven curation in a population database caused reevaluation of the genetic prevalence of Alport Syndrome.

    原文摘录:INTRODUCTION: A landmark study by Gibson and coworkers in 2021 estimated that one in 106 individuals carry a predicted pathogenic COL4A3 or COL4A4 variant, suggesting autosomal dominant Alport syndrome is massively underdiagnosed. … These findings argu

    关注理由:如果关注医学研究,这项队列研究可以提供观察性证据,阅读时别忘了混杂因素和随访情况。

  8. PubMed · CHEST Journal

    呼吸病学:The impact of removing prior authorization for guideline-concordant maintenance inhaled medications for COPD: a population-based cohort study.

    原文摘录:BACKGROUND: Most patients with chronic obstructive pulmonary disease (COPD) do not receive maintenance inhaled therapies in concordance with evidence-based clinical guidelines. … 6), respectively

    关注理由:这篇呼吸病学队列研究资料适合了解长期变化,研究对象、随访方式和结局指标建议一起查看。

  9. PubMed · The Annals of Thoracic Surgery

    医学研究:A Meta-Analysis of the Role of Esophagectomy in Stage 4 Esophageal Cancer.

    原文摘录:BACKGROUND: Nearly 40% of new cases of esophageal cancer are diagnosed at stage 4. Esophagectomy may offer a survival benefit in highly selected patients with stage 4 esophageal cancer. … Prospective studies are required to define its role

    关注理由:如果希望快速了解医学研究证据全貌,这篇系统综述或荟萃分析有参考价值,异质性和纳入研究质量不能跳过。

  10. PubMed · Critical Care Medicine

    感染病学:Long-Term Mortality in Sepsis Survivors: A Population-Based Study During 15 Years.

    原文摘录:OBJECTIVES: To evaluate long-term mortality among sepsis survivors in Catalonia over a 15-year period and to identify factors associated with increased mortality within 2 years after hospital discharge. DESIGN: Retrospective population-based cohort study.

    关注理由:这篇感染病学队列研究资料适合了解长期变化,研究对象、随访方式和结局指标建议一起查看。

  11. PubMed · The Lancet Oncology

    肿瘤学:Activity and safety of first-line pumitamig plus nab-paclitaxel in triple-negative breast cancer: a single-arm, phase 1b/2 trial.

    原文摘录:BACKGROUND: Pumitamig, an investigational bispecific antibody targeting programmed death ligand-1 and vascular endothelial growth factor A, has shown preliminary efficacy across several tumour types.

    关注理由:这篇肿瘤学资料涉及临床试验,登记状态、研究阶段和受试人群值得进一步核对。

  12. PubMed · Anesthesiology

    外科与麻醉:Frequency of Adherence to Obstetric Anesthesia Best Practices for Cesarean Delivery: A Multicenter Retrospective Cohort Analysis.

    原文摘录:BACKGROUND: Increasingly, protocols have been developed to optimize obstetric anesthesia care. However, there is a paucity of data on adherence to these guidelines.

    关注理由:这篇外科与麻醉队列研究资料适合了解长期变化,研究对象、随访方式和结局指标建议一起查看。

  13. PubMed · Diabetes Care

    内分泌与代谢:Common Genetic Variants Near SLC2A2 and Glycemic Response to Glimepiride in the GRADE Comparative Effectiveness Clinical Trial.

    原文摘录:OBJECTIVE: Optimizing second-line therapy for type 2 diabetes remains challenging because of interindividual variability in response. Current treatment selection does not consider personal genetic profiles.

    关注理由:这条内分泌与代谢内容涉及随机对照研究,除了结论,还应看看样本量、主要终点和不良事件报告。