尼菲迪平与阿托西班治疗可能出现的早产 (APOSTEL III):多中心随机对照试验
Elvira O G van Vliet1, Tobias A J Nijman1, Ewoud Schuit2
1Department of Obstetrics, Wilhelmina Hospital Birth Centre, Division Woman and Baby, University Medical Centre Utrecht, Utrecht, Netherlands.
Lancet (London, England)
|March 6, 2016
概括
尼菲迪平和阿托西班在延迟早产48小时方面具有相似的有效性,并具有相似的周围生育不良结果. 进一步的研究应探索安慰剂对照试验,以获得威胁早产管理的确切结果.
科学领域:
- 产周医学
- 妇产科
- 新生儿学
背景情况:
- 孕妇可能过早分娩时,通常会接受48小时的治疗,以使产前皮质类固醇能够改善新生儿的健康状况.
- 对于产妇和新生儿的最佳毒解药物没有确定的共识.
- 在APOSTEL III试验中,研究了尼菲迪平与阿托西班对威胁早产的作用.
研究的目的:
- 为了比较尼菲迪平和阿托西班的有效性和安全性,在可能出现早产的妇女中.
- 评估这些毒解药物对综合性周产期不良结果的影响.
主要方法:
- 一个多中心的随机对照试验,涉及508名可能过早分娩的妇女 (怀孕25至34周).
- 参与者被随机分配为服用口服尼菲迪平或静脉注射阿托西班,持续48小时.
- 主要结局是围产期不良结果的组合,包括死亡率和新生儿主要发病率.
主要成果:
- 在nifedipine组的14%的婴儿和在atosiban组的15%的婴儿中发生了初级组合周围不良结果 (RR 0. 91,95% CI 0. 61- 1.37).
- 与阿托西班 (2%) 组相比,尼菲迪平组的死亡人数较多,但在统计上并不显著.
- 在两组治疗中,母亲的不良反应相似.
结论:
- 用尼菲迪平或阿托西班治疗48小时后,可能出现早产的妇女也会出现类似的产周结果.
- 未来的研究应优先进行大规模的安慰剂对照试验,以确定围产期结局,以确定最终的治疗指南.
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