维护托科利斯与尼菲迪平在威胁过早分娩对围产期结果的影响:一个随机对照试验
Carolien Roos1, Marc E A Spaanderman, Ewoud Schuit
1Department of Obstetrics and Gynecology, Radboud University Nijmegen Medical Centre, Local Postal Code 791, PO Box 9101, 6500 HB, Nijmegen, The Netherlands. c.roos@obgyn.umcn.nl
JAMA
|January 3, 2013
概括
使用尼菲迪平维护托科里斯并没有显著减少威胁到早产的不良周产期结果. 需要进一步的研究来确认尼菲迪平在预防早产并发症方面是否有任何益处.
科学领域:
- 产科和妇科 产科和妇科
- 新生儿医学 新生儿医学
- 临床试验 临床试验
背景情况:
- 过早分娩仍然是新生儿发病率和死亡率的主要原因.
- 维护托科里斯旨在延长怀孕的威胁早产.
- 尼菲迪平是一种常用的毒解剂.
研究的目的:
- 评估与尼菲迪平的维护托克利斯在减少不良周产期结局方面的有效性.
- 为了确定nifedipine维持治疗是否改善初始托科利斯和皮质类固醇治疗后新生儿的结果.
主要方法:
- 一个双盲,安慰剂对照试验 (APOSTEL-II) 在11个荷兰围产病房中进行.
- 威胁过早分娩的妇女 (怀孕26-32周) 接受了48小时的托科利斯和皮质类固醇.
- 符合条件的妇女随机分配给12天的口服尼菲迪平 (80毫克/天) 或安慰剂.
主要成果:
- 总共有406名女性被随机分配 (201名女性接受了尼菲迪平,205名女性接受了安慰剂).
- 随机化时的平均妊娠年龄在两组中均为29.2周.
- 在nifedipine组的11.9%和安慰剂组的13.7%发生了不良周产期结局 (RR 0.87;95% CI,0.53-1.45),不显著的差异.
结论:
- 与安慰剂相比,用尼菲迪平维持托克利斯并没有显著减少不良围产期结局.
- 在安慰剂组观察到的不良结果的低率表明,尼菲迪平的益处不能完全排除.
- 目前的证据不支持常规使用nifedipine维护托科利斯在威胁过早分娩.
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