未足月胎膜早破的宫缩抑制治疗：一项系统评价和荟萃分析。
完整摘要 · 中文译文
目的：基于随机对照试验的证据，评估与不使用宫缩抑制剂相比，宫缩抑制剂治疗对未足月胎膜早破（PPROM）孕妇母胎结局的影响。 数据来源：系统检索了MEDLINE、Embase和Cochrane对照试验中心注册库（CENTRAL），检索时间从数据库建库至2024年7月。检索策略包括与PPROM和宫缩抑制剂相关的受控词表术语及自由文本术语。 研究选择：纳入涉及PPROM孕妇、比较任何宫缩抑制剂治疗与不使用宫缩抑制剂或标准护理的随机对照试验。研究由三名评审员独立筛选，意见分歧通过协商一致解决。 数据提取与综合：两名评审员使用标准化表格独立提取数据。使用Cochrane偏倚风险评估工具2（Risk of Bias 2）评估偏倚风险。二分类结局以比值比（OR）及95%置信区间（CI）汇总，采用随机效应模型。异质性通过I²统计量评估。分析使用Review Manager（RevMan）5.4版进行。评估的结局包括新生儿死亡、新生儿重症监护病房入住、坏死性小肠结肠炎、脑室内出血和新生儿败血症。 结果：四项比较研究，共涉及372名受试者，包括两项随机对照试验和两项非随机研究。与不使用宫缩抑制剂或标准护理相比，宫缩抑制剂治疗未与显著的…… 新生儿死亡率降低（OR: 2.02; 95% CI: 0.51-8.01）、新生儿重症监护病房入住（OR: 0.49; 95% CI: 0.02-14.57）、坏死性小肠结肠炎（OR: 1.35; 95% CI: 0.38-4.72）、脑室内出血（OR: 0.96; 95% CI: 0.01-138.63）或败血症（OR: 1.18; 95% CI: 0.25-5.54）。 结论：在PPROM孕妇中，来自随机对照试验的当前证据并未表明与不使用宫缩抑制治疗或标准护理相比，宫缩抑制治疗具有明确的新生儿获益。鉴于证据确定性较低且可用研究数量有限，该人群中常规使用宫缩抑制治疗仍不明确，应在获得进一步高质量随机试验之前进行个体化决策。Prospero注册号：#CRD420251043906。
完整摘要 · 英文原文
OBJECTIVE: To evaluate the effects of tocolytic therapy on maternal and neonatal outcomes in women with preterm prelabor rupture of membranes (PPROM) compared with no tocolysis, based on evidence from randomized controlled trials. DATA SOURCES: A systematic search was performed in MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) from database inception to July 2024. The search strategy included controlled vocabulary terms and free-text terms related to PPROM and tocolysis. STUDY SELECTION: Randomized controlled trials involving women with PPROM that compared any tocolytic therapy with no tocolysis or standard care were eligible for inclusion. Studies were selected independently by three reviewers, and disagreements were resolved by consensus. DATA EXTRACTION AND SYNTHESIS: Two reviewers independently extracted data using a standardized form. Risk of bias was assessed using the Cochrane Risk of Bias 2 tool. Dichotomous outcomes were summarized as odds ratios (ORs) with 95% confidence intervals (CIs) using a random-effects model. Heterogeneity was assessed using the I2 statistic. Analyses were performed using Review Manager (RevMan) version 5.4. The outcomes assessed included neonatal mortality, neonatal intensive care unit admission, necrotizing enterocolitis, intraventricular hemorrhage, and neonatal sepsis. RESULTS: Four comparative studies, involving 372 participants including two randomized controlled trials and two non-randomized studies. Compared with no tocolysis or standard care, tocolytic therapy was not associated with a significant reduction in neonatal mortality (OR: 2.02; 95% CI: 0.51-8.01), neonatal intensive care unit admission (OR: 0.49; 95% CI: 0.02-14.57), necrotizing enterocolitis (OR: 1.35; 95% CI: 0.38-4.72), intraventricular hemorrhage (OR: 0.96; 95% CI: 0.01-138.63), or sepsis (OR: 1.18; 95% CI: 0.25-5.54). CONCLUSION: In women with PPROM, current evidence from randomized controlled trials does not demonstrate a clear neonatal benefit associated with tocolytic therapy compared with no tocolysis or standard care. Given the low certainty of evidence and the limited number of available studies, the routine use of tocolysis in this population remains uncertain and should be individualized until further high-quality randomized trials are available.Prospero registry: #CRD420251043906.