Lede R, Duley L
Obstetrics and Gynecology, University of Buenos Aires, Argentinian Institute for Evidence Based Medicine, Av. Roque Saenz Peña 825, Buenos Aires, Argentina, 1035.
Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD002857. doi: 10.1002/14651858.CD002857.pub2.
Miscarriage is the spontaneous loss of a pregnancy before the fetus is viable. Uterine muscle relaxant drugs have been used for women at risk of miscarriage in the belief they relax uterine muscle, and hence reduce the risk of miscarriage.
To assess the effects for the woman and her baby of uterine muscle relaxant drugs when used for threatened miscarriage.
We searched the Cochrane Pregnancy and Childbirth Group Trials Register (4 May 2004), and the Cochrane Central Register of Controlled Trials (The Cochrane Library, Issue 2, 2004).
Randomised trials were included, and quasi-randomised trials were excluded. The participants were women with a pregnancy of less than 20 weeks' gestation having a threatened miscarriage. The interventions were any uterine muscle relaxing drugs (including tocolytic and antispasmodic agents) compared with either placebo or no drug. Primary outcomes for the review were miscarriage: defined as spontaneous pregnancy loss before fetal viability, baby death (stillbirth or neonatal death) and maternal death.
Both review authors independently assessed studies for eligibility and trial quality, and extracted data.
One poor quality trial (170 women) was included. This compared a beta-agonist with placebo. There was a lower risk of intrauterine death associated with the use of a beta-agonist (relative risk (RR) 0.25, 95% confidence interval (CI) 0.12 to 0.51). Preterm birth was the only other outcome reported (RR 1.67, 95% CI 0.63 to 4.38).
AUTHORS' CONCLUSIONS: There is insufficient evidence to support the use of uterine muscle relaxant drugs for women with threatened miscarriage. Any such use should be restricted to the context of randomised trials.
流产是指胎儿具有存活能力之前的自然妊娠丢失。子宫肌肉松弛药物一直被用于有流产风险的女性,人们认为这些药物可松弛子宫肌肉,从而降低流产风险。
评估子宫肌肉松弛药物用于先兆流产时对女性及其胎儿的影响。
我们检索了Cochrane妊娠与分娩组试验注册库(2004年5月4日)以及Cochrane对照试验中心注册库(《Cochrane图书馆》,2004年第2期)。
纳入随机试验,排除半随机试验。研究对象为妊娠小于20周且有先兆流产的女性。干预措施为任何子宫肌肉松弛药物(包括宫缩抑制剂和解痉剂),与安慰剂或无药物进行比较。本综述的主要结局指标为流产:定义为胎儿具有存活能力之前的自然妊娠丢失、胎儿死亡(死产或新生儿死亡)和孕产妇死亡。
两位综述作者独立评估研究的纳入资格和试验质量,并提取数据。
纳入了一项质量较差的试验(170名女性)。该试验将一种β激动剂与安慰剂进行了比较。使用β激动剂与宫内死亡风险较低相关(相对危险度(RR)0.25,95%置信区间(CI)0.12至0.51)。早产是报告的唯一其他结局(RR 1.67,95% CI 0.63至4.38)。
没有足够的证据支持对有先兆流产的女性使用子宫肌肉松弛药物。任何此类使用都应限于随机试验的背景下。