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阿托西班与安慰剂对于可能出现的早产 (APOSTEL 8):多中心随机对照试验

Larissa I van der Windt¹, Job Klumper¹, Ruben G Duijnhoven²

¹Department of Obstetrics and Gynaecology, Amsterdam UMC location University of Amsterdam, Amsterdam, Netherlands; Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands.

Lancet (London, England)

|March 6, 2025

概括

在怀孕30周至33周之间,阿托西班并没有比安慰剂更好地改善新生儿结局. 这项研究质疑阿托西班的常规使用,旨在完善基于证据的早产治疗方法.

科学领域:

产科和妇科
新生儿医学
临床药理学

背景情况:

推用于威胁过早分娩,而阿托西班是已注册的选择.
然而,对改善新生儿结局的毒解药物的证据仍然有限.
在APOSTEL 8试验中,研究了阿托西班在改善早产新生儿健康方面的有效性.

研究的目的:

评估阿托西班在改善新生儿发病率和死亡率方面是否优于安慰剂.
在怀孕30至33周之间评估阿托西班的有效性.

主要方法:

一个国际性的,多中心的,随机的,双盲的,安慰剂控制的优越性试验.
参与者有755名可能早产的妇女 (怀孕30至33周),接受阿托西班或安慰剂治疗.
主要结局是围产期死亡率和重症新生儿病率的组合,根据治疗意向进行分析.

主要成果:

在阿托西班和安慰剂组之间,主要结果没有显著差异 (8% vs 9%).
在这两组中,产周死亡率低且相似 (0. 7% vs 0. 9%).
在治疗组中,母亲的不良事件和死亡是可比的.

结论:

亚托西班在威胁早产的新生儿结局方面没有表现优于安慰剂.
这些发现挑战了在这个妊娠窗口中使用阿托西班的标准.
结果旨在减少实践的差异,并支持基于证据的临床护理.

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