Neilson James P, West Helen M, Dowswell Therese
Department of Women's and Children's Health, The University of Liverpool, First Floor, Liverpool Women's NHS Foundation Trust, Crown Street, Liverpool, UK, L8 7SS.
Cochrane Database Syst Rev. 2014 Feb 5;2014(2):CD004352. doi: 10.1002/14651858.CD004352.pub3.
Preterm birth is a major contributor to perinatal mortality and morbidity worldwide. Tocolytic agents are drugs used to inhibit uterine contractions. Betamimetics are tocolytic agents that have been widely used, especially in resource-poor countries.
To assess the effects of betamimetics given to women with preterm labour.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 December 2013) and reference lists of retrieved studies.
Randomised controlled trials of betamimetics, administered by any route or any dose, in the treatment of women in preterm labour where betamimetics were compared with other betamimetics, placebo or no treatment.
Two review authors assessed risk of bias and extracted the data independently.
Twenty-eight trials were assessed as eligible for inclusion in the review, but eight did not report any outcome data relevant to the review. Results are based on the 20 trials that contributed data.Twelve trials, involving 1367 women, compared betamimetics with placebo. Betamimetics decreased the number of women in preterm labour giving birth within 48 hours (average risk ratio (RR) 0.68, 95% confidence interval (CI) 0.53 to 0.88, 10 trials, 1209 women). There was a decrease in the number of births within seven days (average RR 0.80; 95% CI 0.65 to 0.98, five trials, 911 women) but there was no evidence of a reduction in preterm birth (before 37 weeks' gestation) (RR 0.95; 95% CI 0.88 to 1.03, 10 trials, 1212 women). No benefit was demonstrated for betamimetics for perinatal death (RR 0.84; 95% CI 0.46 to 1.55, 11 trials, 1332 infants), or neonatal death (RR 0.90; 95% CI 0.27 to 3.00, six trials, 1174 infants). No significant effect was demonstrated for respiratory distress syndrome (RR 0.87; 95% CI 0.71 to 1.08, eight trials, 1239 infants). A few trials reported on cerebral palsy, infant death and necrotising enterocolitis; no significant differences between groups were identified for any of these outcomes. Betamimetics were significantly associated with the following outcomes: withdrawal from treatment due to adverse effects; maternal chest pain; dyspnoea; palpitation; tremor; headaches; hypokalaemia; hyperglycaemia; nausea or vomiting; nasal stuffiness; and fetal tachycardia.Nine trials compared different types of betamimetics. Other betamimetics were compared with ritodrine in five trials (n = 948). Other comparisons were examined in single trials: hexoprenaline compared with salbutamol (n = 140), slow versus moderate release salbutamol (n = 52) and salbutamol compared with terbutaline (n = 200). Trials were small, varied, and of insufficient quality to delineate any consistent patterns of effect.
AUTHORS' CONCLUSIONS: Betamimetics help to delay birth, which may give time to allow women to be transferred to tertiary care or to complete a course of antenatal corticosteroids. However, multiple adverse effects must be considered. The data are too few to support the use of any particular betamimetic.
早产是全球围产期死亡率和发病率的主要原因。宫缩抑制剂是用于抑制子宫收缩的药物。β-拟交感神经药是已被广泛使用的宫缩抑制剂,尤其是在资源匮乏的国家。
评估β-拟交感神经药用于早产妇女的效果。
我们检索了Cochrane妊娠与分娩组试验注册库(2013年12月31日)以及检索到的研究的参考文献列表。
β-拟交感神经药通过任何途径或任何剂量给药,用于治疗早产妇女的随机对照试验,其中β-拟交感神经药与其他β-拟交感神经药、安慰剂或不治疗进行比较。
两位综述作者独立评估偏倚风险并提取数据。
28项试验被评估为符合纳入综述的条件,但8项试验未报告与综述相关的任何结局数据。结果基于提供数据的20项试验。12项试验,涉及1367名妇女,比较了β-拟交感神经药与安慰剂。β-拟交感神经药减少了48小时内早产分娩的妇女人数(平均风险比(RR)0.68,95%置信区间(CI)0.53至0.88,10项试验,1209名妇女)。7天内的出生人数有所减少(平均RR 0.80;95%CI 0.65至0.98,5项试验,911名妇女),但没有证据表明早产(妊娠37周前)有所减少(RR 0.95;95%CI 0.88至1.03,10项试验,1212名妇女)。未证明β-拟交感神经药对围产期死亡(RR 0.84;95%CI 0.46至1.55,11项试验,1332名婴儿)或新生儿死亡(RR 0.90;95%CI 0.27至3.00,6项试验,1174名婴儿)有好处。未证明对呼吸窘迫综合征有显著影响(RR 0.87;95%CI 0.71至1.08,8项试验,1239名婴儿)。少数试验报告了脑瘫、婴儿死亡和坏死性小肠结肠炎;在这些结局中,未发现组间有显著差异。β-拟交感神经药与以下结局显著相关:因不良反应退出治疗;产妇胸痛;呼吸困难;心悸;震颤;头痛;低钾血症;高血糖症;恶心或呕吐;鼻塞;以及胎儿心动过速。9项试验比较了不同类型的β-拟交感神经药。在5项试验(n = 948)中,将其他β-拟交感神经药与利托君进行了比较。在单项试验中研究了其他比较:己丙肾上腺素与沙丁胺醇(n = 140)、缓释沙丁胺醇与中效释放沙丁胺醇(n = 52)以及沙丁胺醇与特布他林(n = 200)。试验规模小、各不相同且质量不足以描绘出任何一致的效应模式。
β-拟交感神经药有助于延迟分娩,这可能为将妇女转移到三级医疗机构或完成一个疗程的产前糖皮质激素治疗争取时间。然而必须考虑多种不良反应。数据太少,无法支持使用任何特定的β-拟交感神经药。