米非司酮用于足月引产的系统综述与荟萃分析
该系统综述与荟萃分析纳入15项随机对照试验,评估米非司酮用于37周及以上单胎妊娠引产的效果。结果显示,米非司酮组剖宫产率为33.1%,对照组为41.9%,剖宫产风险降低33%(OR 0.67,95%CI 0.54–0.82)。米非司酮还与24小时Bishop评分更高、引产至分娩间隔更短及前列腺素和缩宫素使用减少相关。
要点
- 米非司酮引产可降低33%的剖宫产风险(OR 0.67,95%CI 0.54–0.82)。
- 米非司酮可改善宫颈成熟,减少前列腺素和缩宫素的使用。
- 未发现产后出血、NICU入住或低Apgar评分风险增加。
核心结论
- 米非司酮用于足月引产可降低剖宫产风险,并改善宫颈成熟和引产效率。
- 未发现短期母儿安全风险证据,但结局数据有限。
研究设计与样本
- 系统综述与荟萃分析,遵循PRISMA 2020指南,注册于PROSPERO(CRD420251236886)。
- 检索MEDLINE、Embase、ClinicalTrials.gov和Scopus,截至2025年10月。
- 纳入15项随机对照试验,米非司酮组n=1063,对照组n=811。
- 纳入标准为37周及以上单胎妊娠引产,排除终止妊娠、胎儿宫内死亡、早产引产及合并其他促宫颈成熟措施的研究。
- 使用Cochrane Risk of Bias 2工具评估偏倚风险,采用随机效应模型合并数据。
主要发现
- 米非司酮组剖宫产率为33.1%,对照组为41.9%,OR 0.67(95%CI 0.54–0.82)。
- 米非司酮与24小时Bishop评分更高、引产至分娩间隔缩短相关。
- 米非司酮可减少前列腺素和缩宫素的使用。
- 产后出血、NICU入住和5分钟Apgar评分低于7分在两组间无差异。
- 安慰剂对照及高质量试验敏感性分析中剖宫产OR为0.58(95%CI 0.40–0.83)。
关键数值与推荐
- 主要结局为剖宫产率,米非司酮组33.1%,对照组41.9%。
- 剖宫产OR 0.67,95%CI 0.54–0.82。
- 敏感性分析剖宫产OR 0.58,95%CI 0.40–0.83。
- 次要结局包括引产至分娩间隔、分娩发动时间、Bishop评分、前列腺素或缩宫素需求、产后出血、NICU入住和5分钟Apgar评分低于7分。
临床怎么用
- 米非司酮可作为37周及以上单胎妊娠引产的药物选择之一。
- 米非司酮可能减少后续前列腺素和缩宫素的使用需求。
局限性
- 多数研究未报告产后出血、NICU入住和低Apgar评分等安全性结局。
- 纳入的随机对照试验覆盖不同米非司酮剂量方案和对照条件。
以上解读依据论文摘要(全文未开放获取或许可不允许翻译转载)。
原文
OBJECTIVE: To evaluate mifepristone, a progesterone receptor antagonist, for labor induction and cesarean delivery and related measures of maternal and neonatal safety. DATA SOURCES: A systematic review and meta-analysis of randomized controlled trials was conducted in accordance with PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) 2020 guidelines and registered in PROSPERO (CRD420251236886). MEDLINE, Embase, ClinicalTrials.gov, and Scopus were searched through October 2025. METHODS OF STUDY SELECTION: Eligible studies included randomized trials evaluating mifepristone for labor induction in singleton pregnancies at 37 weeks or more of gestation. Studies involving pregnancy termination, intrauterine fetal death, preterm induction, or concomitant cervical ripening interventions in which the effects of mifepristone could not be isolated were excluded. Two reviewers independently screened studies, extracted data, and assessed risk of bias using the Cochrane Risk of Bias 2 tool. The primary outcome was cesarean delivery. Secondary outcomes included induction-to-delivery interval, time to labor onset, Bishop score, need for prostaglandin or oxytocin, postpartum hemorrhage, neonatal intensive care unit (NICU) admission, and 5-minute Apgar score less than 7. Data were pooled with a random-effects model. TABULATION, INTEGRATION, AND RESULTS: The primary analysis included all 15 eligible randomized controlled trials across mifepristone dosing regimens (n=1,063) and control conditions (n=811). Mifepristone was associated with 33% reduced odds of cesarean delivery (33.1% vs 41.9%, odds ratio 0.67, 95% CI, 0.54-0.82) compared with the control method of induction. Mifepristone was associated with higher Bishop scores at 24 hours, shorter induction-to-delivery intervals, and less prostaglandin and oxytocin use compared with control methods. Findings were similar in sensitivity analysis limited to placebo-controlled and high-quality trials (cesarean delivery odds ratio 0.58, 95% CI, 0.40-0.83). No differences were observed in postpartum hemorrhage, NICU admission, or low Apgar score, although most studies did not report these outcomes. CONCLUSION: Use of mifepristone for labor induction was associated with reduced odds of cesarean delivery, as well as improved cervical ripening and labor induction efficiency. No evidence of short-term maternal or neonatal risk was found, although robust data were limited. Findings support the role of progesterone antagonists for labor induction. SYSTEMATIC REVIEW REGISTRATION: PROSPERO, CRD420251236886.
引用
- Pellot, Darché, Pires, et al. Progesterone Receptor Antagonists for Labor Induction: A Systematic Review and Meta-analysis. Obstet Gynecol. 2026. PMID: 42900860. doi:10.1097/AOG.0000000000006450
供执业医师工作参考,不替代临床判断;数值与分级以指南原文为准。