对于产后出血的特兰克萨姆酸:随机对照试验的系统审查和个体患者数据的元分析
Katharine Ker1, Loïc Sentilhes2, Haleema Shakur-Still1
1Clinical Trials Unit, London School of Hygiene & Tropical Medicine, London, UK.
Lancet (London, England)
|October 26, 2024
概括
特兰克萨姆酸显著降低了女性危及生命的分娩后出血的风险. 这项研究没有发现血栓形成的风险增加,建议在严重出血发生之前在高风险人群中使用.
科学领域:
- 产科和妇科
- 药理学
- 临床试验
背景情况:
- 产后出血 (PPH) 是导致产妇死亡的主要原因.
- 推用于治疗PPH,但其预防作用尚不确定.
- 有限的证据表明,特兰克萨姆酸在预防分娩期间的严重出血是有限的.
研究的目的:
- 系统地审查和执行随机对照试验 (RCT) 的个人患者数据 (IPD) 分析.
- 评估特兰克萨姆酸在孕产妇中预防危及生命的出血和血栓塞栓事件的影响.
- 根据患者的风险因素和施用时间,探索特兰克萨姆酸作用的潜在变化.
主要方法:
- 通过世卫组织国际临床试验注册平台确定RCT的系统审查和IPD元分析.
- 纳入标准:前性注册,安慰剂控制,超过500名女性,偏差风险低.
- 主要结局:危及生命的出血和血栓塞栓事件. 使用单阶段模型进行分析.
主要成果:
- 分析了54,404名妇女的数据 (IPD来自43,409).
- 特兰克萨姆酸减少了危及生命的出血 (0. 65%对0. 85%;或0. 77;p=0. 008).
- 血栓塞栓事件没有显著差异 (0. 2% 与 0. 2%; OR 0. 96; p=0. 82). 根据风险,出生类型,贫血或时间,效果没有变化.
结论:
- 它有效地降低了危及生命的产后出血的风险.
- 没有证据表明松酸会增加血栓形成的风险.
- 在高风险妇女诊断PPH之前,请考虑使用tranexamic acid,但并非所有分娩都建议使用.
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