Naik Gaunekar Naguesh, Raman Puvaneswary, Bain Emily, Crowther Caroline A
Suite 28, Mater Medical Centre, 76 Willetts Road, Mackay, Queensland, Australia, 4740.
Cochrane Database Syst Rev. 2013 Oct 31;2013(10):CD004071. doi: 10.1002/14651858.CD004071.pub3.
Calcium channel blocker maintenance therapy is one of the types of tocolytic therapy that may be used after an episode of threatened preterm labour (and usually an initial dose of tocolytic therapy) in an attempt to prevent the onset of further preterm contractions.
To assess the effects of calcium channel blockers as maintenance therapy on preventing preterm birth after threatened preterm labour.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2013) and reference lists of retrieved studies.
Randomised controlled trials of calcium channel blockers used as maintenance therapy to prevent preterm birth after threatened preterm labour, compared with placebo or no treatment.
Two review authors independently assessed study eligibility, extracted data and assessed the risk of bias of included studies.
We included six trials that enrolled 794 women and their babies and all assessed nifedipine as calcium channel blocker maintenance therapy. The six trials were judged to be at a moderate risk of bias overall. No differences in the incidence of preterm birth (risk ratio (RR) 0.97; 95% confidence interval (CI) 0.87 to 1.09; five trials, 681 women), birth within 48 hours of treatment (RR 0.46; 95% CI 0.07 to 3.00; two trials, 128 women) or neonatal mortality (average RR 0.75; 95% CI 0.05 to 11.76; two trials, 133 infants) were seen when nifedipine maintenance therapy was compared with placebo or no treatment. No stillbirths were reported in the one trial that provided data for this outcome. No trials reported on longer-term follow-up of infants.Women receiving nifedipine maintenance therapy were significantly more likely to have their pregnancy prolonged (mean difference (MD) 5.35 days; 95% CI 0.49 to 10.21; four trials, 275 women); however, no differences between groups were shown for birth at less than 34 weeks' gestation, birth at less than 28 weeks' gestation, birth within seven days of treatment, or gestational age at birth. No significant differences were shown between the nifedipine and control groups for any of the secondary neonatal morbidities reported. Similarly, no significant differences were seen for the outcomes relating to the use of health services, except for in one trial, where infants whose mothers received nifedipine were significantly more likely to have a longer length of hospital stay as compared with infants born to mothers who received a placebo (MD 14.00 days; 95% CI 4.21 to 23.79; 60 infants).
AUTHORS' CONCLUSIONS: Based on the current available evidence, maintenance treatment with a calcium channel blocker after threatened preterm labour does not prevent preterm birth or improve maternal or infant outcomes.
钙通道阻滞剂维持疗法是一种可在先兆早产(通常为先兆早产发作后给予初始剂量的宫缩抑制疗法)后使用的宫缩抑制疗法,旨在预防进一步早产宫缩的发作。
评估钙通道阻滞剂作为维持疗法对预防先兆早产后宫缩的效果。
我们检索了Cochrane妊娠与分娩组试验注册库(2013年5月31日)以及检索到的研究的参考文献列表。
将钙通道阻滞剂用作维持疗法以预防先兆早产后宫缩的随机对照试验,与安慰剂或不治疗进行比较。
两位综述作者独立评估研究的合格性,提取数据并评估纳入研究的偏倚风险。
我们纳入了6项试验,共794名妇女及其婴儿,所有试验均评估硝苯地平作为钙通道阻滞剂维持疗法。这6项试验总体被判定为存在中度偏倚风险。与安慰剂或不治疗相比,在早产发生率(风险比(RR)0.97;95%置信区间(CI)0.87至1.09;5项试验,681名妇女)、治疗后48小时内分娩(RR 0.46;95% CI 0.07至3.00;2项试验,128名妇女)或新生儿死亡率(平均RR 0.75;95% CI 0.05至11.76;2项试验,133名婴儿)方面未发现差异。在提供该结果数据的1项试验中未报告死产情况。没有试验报告对婴儿的长期随访情况。接受硝苯地平维持疗法的妇女妊娠延长的可能性显著更高(平均差(MD)5.35天;95% CI 0.49至10.21;4项试验,275名妇女);然而,在妊娠不足34周分娩、妊娠不足28周分娩、治疗后7天内分娩或出生时的孕周方面,两组之间未显示出差异。在报告的任何次要新生儿发病情况方面,硝苯地平组和对照组之间均未显示出显著差异。同样,在与使用卫生服务相关的结果方面,除了1项试验外,未发现显著差异,在该试验中,母亲接受硝苯地平治疗的婴儿与接受安慰剂治疗的母亲所生婴儿相比,住院时间显著更长(MD 14.00天;95% CI 4.21至23.79;60名婴儿)。
基于目前可得的证据,先兆早产后宫缩使用钙通道阻滞剂维持治疗并不能预防早产,也不能改善母婴结局。