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优化剖宫产结局的循证医学程序:系统评价概述

Evidence-based medical procedures to optimise caesarean outcomes: an overview of systematic reviews.

作者信息

Diaz Virginia, Gialdini Celina, Chamillard Mónica, Pasquale Julia, Carroli Guillermo, Torloni Maria Regina, Betran Ana Pilar

机构信息

Centro Rosarino de Estudios Perinatales (CREP), Rosario, Argentina.

Facultat de Ciències de la Salut Blanquerna, Universitat Ramon Llull, Barcelona, Spain.

出版信息

EClinicalMedicine. 2025 Apr 30;83:103212. doi: 10.1016/j.eclinm.2025.103212. eCollection 2025 May.

DOI:10.1016/j.eclinm.2025.103212
PMID:40370583
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12076788/
Abstract

BACKGROUND

The use of caesarean sections (CS) is increasing to unprecedented levels worldwide. As with any surgery, it has risks, and understanding the evidence base for interventions involved in a CS is essential to optimise outcomes and inform recommendations. We conducted an overview of systematic reviews (SRs) of randomised controlled trials (RCTs) to summarise the evidence on medical procedures used in CS.

METHODS

Searches were conducted in Cochrane Database of Systematic Reviews, PubMed, EMBASE, LILACSs and CINAHL without date or language restrictions from database inception to January 31, 2024, with an updated search performed on January 24, 2025. We included SRs of RCTs that examined the effectiveness and safety of medical procedures used in CS. AMSTAR 2 and GRADE were used to assess the methodological quality of the SRs and the certainty of evidence at outcome level, respectively. We classified each procedure-outcome pair into one of eight categories according to effect estimates and certainty of evidence. The overview was registered at PROSPERO (CRD 42023208306).

FINDINGS

We identified 29 SRs (15 Cochrane and 14 non-Cochrane) published between 2002 and 2024 involving 408 unique RCTs including over 116,000 participants. Most reviews included trials from low- and middle-income countries (n = 21, 72.4%), combined both elective and emergency CS (n = 19, 65.5%), and were of high quality (n = 18, 62%), while 24.3% (n = 7) were of low and 13.7% (n = 4) were of critically low quality. The SRs presented 512 procedure-outcome comparisons (271 procedure versus procedure, 241 procedure versus no treatment/placebo). There was insufficient or inconclusive evidence for 350 comparisons (68.4%), clear evidence of benefit for 97 (18.9%), possible benefit for 48 (9.3%), clear or possible no difference of effect for 9 (1.8%), clear evidence of harm for 4 (0.8%) and possible harm for 4 (0.8%). We found no SRs for 13 pre-specified procedures. Indwelling bladder catheter and its immediate removal, vaginal preparation with antiseptic solution, antibiotic prophylaxis, early oral intake, and abdominal binders are associated with benefits for some outcomes. There are no SRs on post-CS wound care, stitch removal, or time to resume sexual or physical activity, among others.

INTERPRETATION

There are numerous gaps in the available evidence on medical procedures used in CS that require additional research. There is an urgent need for international recommendations to guide healthcare providers and policymakers in ensuring safer, evidence-based, care for women undergoing CS.

FUNDING

UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), a cosponsored programme executed by the World Health Organization (WHO).

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd15/12076788/7f40590dce75/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd15/12076788/7f40590dce75/gr1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fd15/12076788/7f40590dce75/gr1.jpg
摘要

背景

剖宫产(CS)的使用在全球范围内正升至前所未有的水平。与任何手术一样,剖宫产有风险,了解剖宫产相关干预措施的证据基础对于优化结局并为建议提供依据至关重要。我们对随机对照试验(RCT)的系统评价(SR)进行了概述,以总结剖宫产中所用医疗程序的证据。

方法

在Cochrane系统评价数据库、PubMed、EMBASE、LILACS和CINAHL中进行检索,检索时间从数据库建库至2024年1月31日,无日期或语言限制,并于2025年1月24日进行了更新检索。我们纳入了考察剖宫产中所用医疗程序有效性和安全性的RCT的SR。分别使用AMSTAR 2和GRADE评估SR的方法学质量以及结局水平证据的确定性。我们根据效应估计和证据确定性将每个程序-结局对分为八类之一。该概述已在PROSPERO注册(CRD 42023208306)。

结果

我们识别出2002年至2024年间发表的29篇SR(15篇Cochrane系统评价和14篇非Cochrane系统评价),涉及408项独特的RCT,包括超过116,­000名参与者。大多数评价纳入了来自低收入和中等收入国家的试验(n = 21,72.4%),涵盖择期和急诊剖宫产(n = 19,65.5%),且质量较高(n = 18,62%),而24.3%(n = 7)质量较低,13.7%(n = 4)质量极低。这些SR呈现了512项程序-结局比较(271项程序与程序比较,241项程序与未治疗/安慰剂比较)。350项比较(68.4%)证据不足或不明确,97项(18.9%)有明显获益证据,48项(9.3%)可能获益,9项(1.8%)有明显或可能无效应差异,4项(0.8%)有明显危害证据,4项(0.8%)可能有危害。我们未找到13项预先指定程序的SR。留置膀胱导管及其即时拔除、用抗菌溶液进行阴道准备、抗生素预防、早期口服摄入和腹部束缚带对某些结局有获益。关于剖宫产术后伤口护理、缝线拆除或恢复性活动或体力活动时间等方面没有SR。

解读

剖宫产所用医疗程序的现有证据存在众多空白,需要更多研究。迫切需要国际建议,以指导医疗服务提供者和政策制定者确保为接受剖宫产的女性提供更安全、基于证据的护理。

资助

联合国开发计划署-联合国人口基金-联合国儿童基金会-世界卫生组织-世界银行人类生殖特别研究、发展和研究培训计划(HRP),由世界卫生组织(WHO)共同资助实施的项目

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本文引用的文献

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Early hospital discharge after cesarean delivery: a systematic review and meta-analysis of randomized controlled trials.剖宫产术后早期出院:一项随机对照试验的系统评价和荟萃分析
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优化剖宫产结局的循证外科手术:系统评价概述
EClinicalMedicine. 2024 May 19;72:102632. doi: 10.1016/j.eclinm.2024.102632. eCollection 2024 Jun.
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