在产后使用西尔德纳菲尔改善产周结果:随机临床试验
Sailesh Kumar1,2,3, William Tarnow-Mordi4, Ben W Mol5
1Mater Mothers' Hospital and Mater Research Institute-University of Queensland, Brisbane, Queensland, Australia.
JAMA
|June 9, 2025
概括
母亲口服的西尔德纳菲尔酸盐没有减少与产期缺氧相关的周围不良结果. 这项研究没有发现西尔德纳菲尔在分娩期间改善婴儿的结果.
科学领域:
- 产科和妇科
- 新生儿医学
- 药理学
背景情况:
- 西尔德纳菲尔酸盐可能增加子宫胎盘血流,这表明它可能有助于减少围产期并发症.
- 然而,它在减轻与产后胎儿缺氧相关的不良结果方面的有效性仍然不确定.
研究的目的:
- 评估与安慰剂相比,产后口服西尔德纳菲尔酸盐对可能与产后缺氧相关的围产期结果的疗效.
主要方法:
- 一个实用,多中心,随机的临床试验涉及13个澳大利亚医院的3257名女性.
- 参与者每8小时服用50毫克西尔德纳菲尔酸盐或相当于安慰剂.
- 主要综合结局包括死产,新生儿死亡,严重的新生儿抑郁症,酸性,缺氧性缺血性脑病以及其他严重的新生儿疾病.
主要成果:
- 主要综合结果发生在西尔德纳菲尔组的5. 1% 和安慰剂组的5. 2% (RR,1. 02;95% CI,0. 75-1. 37),没有显著差异.
- 西尔德纳菲尔酸盐没有显著影响紧急剖腹产或工具分娩的发病率.
- 在小组分析中没有观察到对初级综合结果的任何单个组件的显著影响,也没有证据表明治疗效果异质.
结论:
- 产妇口服西尔德纳菲尔酸盐并没有减少与产妇低氧相关的周围不良结果的发生率.
- 这些研究结果不支持使用西德纳菲尔酸盐改善产期期内缺氧的孕妇或孕妇的产期期内缺氧风险.
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