Kenyon S L, Taylor D J, Tarnow-Mordi W
Department of Obstetrics and Gynaecology, Leicester Royal Infirmary, UK.
Lancet. 2001 Mar 31;357(9261):989-94. doi: 10.1016/s0140-6736(00)04234-3.
Preterm birth after spontaneous preterm labour is associated with death, neonatal disease, and long-term disability. Previous small trials of antibiotics for spontaneous preterm labour have reported inconclusive results. We did a randomised multicentre trial to resolve this issue.
6295 women in spontaneous preterm labour with intact membranes and without evidence of clinical infection were randomly assigned 250 mg erythromycin (n=1611), 325 mg co-amoxiclav (250 mg amoxicillin and 125 mg clavulanic acid; n=1550), both (n=1565), or placebo (n=1569) four times daily for 10 days or until delivery, whichever occurred earlier. The primary outcome measure was a composite of neonatal death, chronic lung disease, or major cerebral abnormality on ultrasonography before discharge from hospital. Analysis was by intention to treat.
None of the trial antibiotics was associated with a lower rate of the composite primary outcome than placebo (erythromycin 90 [5.6%], co-amoxiclav 76 [5.0%], both antibiotics 91 [5.9%], vs placebo 78 [5.0%]). However, antibiotic prescription was associated with a lower occurrence of maternal infection.
This trial provides evidence that antibiotics should not be routinely prescribed for women in spontaneous preterm labour without evidence of clinical infection.
自然早产与死亡、新生儿疾病及长期残疾相关。既往针对自然早产使用抗生素的小型试验结果尚无定论。我们开展了一项随机多中心试验以解决这一问题。
6295名自然早产且胎膜完整、无临床感染证据的女性被随机分配，分别接受每日4次、每次250mg的红霉素治疗（n = 1611），每日4次、每次325mg的阿莫西林克拉维酸（250mg阿莫西林和125mg克拉维酸；n = 1550）治疗，两种药物联合治疗（n = 1565），或安慰剂治疗（n = 1569），持续10天或直至分娩，以先发生者为准。主要结局指标为新生儿死亡、慢性肺病或出院前超声检查发现的重大脑异常的复合指标。分析采用意向性分析。
与安慰剂相比，试验中的任何一种抗生素均未使复合主要结局发生率降低（红霉素组90例[5.6%]，阿莫西林克拉维酸组76例[5.0%]，两种抗生素联合组91例[5.9%]，安慰剂组78例[5.0%]）。然而，抗生素处方与产妇感染发生率较低相关。
本试验提供的证据表明，对于无临床感染证据的自然早产女性，不应常规开具抗生素处方。
