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米索前列醇用于终止妊娠中期和晚期宫内死胎——一项系统评价

Misoprostol for termination of pregnancy with intrauterine fetal demise in the second and third trimester of pregnancy - a systematic review.

作者信息

Gómez Ponce de León Rodolfo, Wing Deborah A

机构信息

IPAS and School of Public Health, University of North Carolina at Chapel Hill, NC 28516, USA.

出版信息

Contraception. 2009 Apr;79(4):259-71. doi: 10.1016/j.contraception.2008.10.009. Epub 2008 Dec 9.

Abstract

BACKGROUND

A systematic review was conducted to compare with other methods, using the best available evidence, the benefits and risks associated with the administration of misoprostol to terminate pregnancy with fetal demise in the second and third trimesters (defined as gestational age of more than 14 weeks).

STUDY DESIGN

We assessed all published randomized controlled trials identified from the Cochrane Pregnancy and Childbirth Group Trials Register, MEDLINE, POPLINE, LILACS and CINHAL from 1987 to 2008 comparing misoprostol alone (vaginal, oral or sublingual administration) with placebo or no treatment or any other method of uterine evacuation (including cervical ripening with other prostaglandins administered vaginally or extra-amniotically, oxytocin, as well as mechanical methods of evacuation including extra-amniotic Foley catheter or laminaria placement) in women with diagnosis of intrauterine fetal death in the second and third trimester of pregnancy. We also evaluated the use of misoprostol alone with misoprostol plus other adjuncts such as intravenous oxytocin. Meta-analyses were performed using relative risks (RRs) as the measure of effect size for binary outcomes and weighted mean differences for continuous outcome measures. For all data, 95% confidence intervals (CIs) were also computed.

RESULTS

Fourteen studies comparing different interventions were included. The induction regimens varied considerably in the number of applications of medication, dosages and time intervals between doses. The main outcome was uterine evacuation at 48 h. In all studies evaluated, both vaginal and oral misoprostol showed 100% success rate in achieving uterine evacuation at 48 h. We also evaluated the success at achieving uterine evacuation at 24 h. Although the differences were not statistically significant and heterogeneity was observed, vaginal misoprostol was as effective as oral administration, achieving uterine evacuation within 48 h (RR=0.96, 95% CI=0.85 to 1.09). Oral administration was associated with more side effects than vaginal administration. The mean time intervals from induction to delivery were not significantly different between the vaginal and oral treatment groups [-1.97 (95% CI=-3.22 to 0.72)], so that the clinical benefit of oral administration and avoidance of repeated vaginal administration is probably marginal. Vaginal misoprostol alone was less effective in achieving uterine evacuation at 24 h compared with vaginal misoprostol plus oxytocin. However, there was no statistically significant difference (RR=1.00, 95% CI=0.89 to 1.12) in uterine evacuation at 48 h for vaginal misoprostol either with or without oxytocin administration.

CONCLUSIONS

Overall, the body of evidence regarding induction of labor and delivery for second and third trimester of pregnancy is limited and the studies vary in methodology and selected outcome measures, making direct comparisons difficult. Vaginal misoprostol was less effective than oral misoprostol for effecting delivery within 24 h, but not within 48 h.

摘要

背景

进行了一项系统评价,以利用现有最佳证据,比较米索前列醇用于终止妊娠中期和晚期(定义为孕龄超过14周)胎儿死亡的益处和风险与其他方法。

研究设计

我们评估了1987年至2008年从Cochrane妊娠与分娩组试验注册库、医学期刊数据库(MEDLINE)、计划生育与生殖健康文献数据库(POPLINE)、拉丁美洲和加勒比卫生科学数据库(LILACS)以及护理及健康照护领域数据库(CINHAL)中检索到的所有已发表的随机对照试验,这些试验比较了单独使用米索前列醇(经阴道、口服或舌下给药)与安慰剂或不治疗或任何其他子宫排空方法(包括经阴道或羊膜外给予其他前列腺素进行宫颈成熟、缩宫素,以及包括羊膜外放置Foley导管或海藻棒在内的机械排空方法)在妊娠中期和晚期诊断为宫内胎儿死亡的女性中的效果。我们还评估了单独使用米索前列醇与米索前列醇加其他辅助药物(如静脉注射缩宫素)的使用情况。采用相对危险度(RRs)作为二分类结局效应量的衡量指标,采用加权均数差作为连续结局指标进行荟萃分析。对于所有数据,还计算了95%置信区间(CIs)。

结果

纳入了14项比较不同干预措施的研究。引产方案在用药次数、剂量和给药间隔时间上差异很大。主要结局是48小时内子宫排空。在所有评估的研究中,阴道和口服米索前列醇在48小时内实现子宫排空的成功率均为100%。我们还评估了24小时内实现子宫排空的成功率。虽然差异无统计学意义且存在异质性,但阴道米索前列醇与口服给药效果相同,均能在48小时内实现子宫排空(RR = 0.96,95%CI = 0.85至1.09)。口服给药比阴道给药的副作用更多。阴道和口服治疗组从引产到分娩的平均时间间隔无显著差异[-1.97(95%CI = -3.22至0.72)],因此口服给药的临床益处以及避免重复经阴道给药的益处可能微乎其微。与阴道米索前列醇加缩宫素相比,单独使用阴道米索前列醇在24小时内实现子宫排空的效果较差。然而,无论是否给予缩宫素,阴道米索前列醇在48小时内子宫排空情况无统计学显著差异(RR = 1.00,95%CI = 0.89至1.12)。

结论

总体而言,关于妊娠中期和晚期引产和分娩的证据有限,研究在方法学和所选结局指标方面存在差异,难以进行直接比较。阴道米索前列醇在24小时内引产效果不如口服米索前列醇,但在48小时内并非如此。

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