针对自发早产的广谱抗生素:ORACLE II随机试验. 甲骨文协作小组合作小组
S L Kenyon1, D J Taylor, W Tarnow-Mordi
1Department of Obstetrics and Gynaecology, Leicester Royal Infirmary, UK. oracle@le.ac.uk
Lancet (London, England)
|April 11, 2001
概括
针对自发早产的常规抗生素不能改善新生儿的结果. 这项大型试验发现,与安慰剂相比,初级复合结局没有减少,尽管母亲感染不那么常见.
科学领域:
- 产科和妇科 产科和妇科
- 新生儿医学 新生儿医学
- 临床药理学 临床药理学
背景情况:
- 自发早产会带来重大风险,包括新生儿死亡率和长期残疾.
- 此前对这种疾病的抗生素试验得出了不确定的结果.
- 进行了一项大规模随机试验,以最终评估抗生素的疗效.
研究的目的:
- 评价抗生素 (乙红,co-amoxiclav,或两者) 的有效性,以改善自发早产妇女的新生儿结果.
- 为了确定抗生素治疗是否能减少新生儿死亡,慢性肺病或主要脑部异常的复合结果.
主要方法:
- 一个多中心的随机试验,涉及6295名女性,她们有自发的早产和完整的膜.
- 参与者接受了10天或直到分娩为止的红色素,co-amoxiclav,两者或安慰剂.
- 主要结局是医院出院前评估的新生儿死亡率和发病率的综合测量.
主要成果:
- 与安慰剂相比,没有抗生素治疗方案显著降低了复合初级结局.
- 综合结局的比率为:红红5.6%,共西克拉夫5.0%,两者5.9%,安慰剂5.0%.
- 抗生素使用与母亲感染的发病率降低有关.
结论:
- 在没有临床感染证据的情况下,不应常规地向经历自发早产的妇女服用抗生素.
- 这些发现表明,需要重新考虑当前的抗生素方案来管理早产.
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