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术前米索前列醇减少腹部子宫切除术的失血及相关并发症:10 项随机安慰剂对照试验的系统评价和荟萃分析。

Preoperative Misoprostol to Reduce Blood Loss and Related Morbidities During Abdominal Hysterectomy: a Systematic Review and Meta-analysis of 10 Randomized Placebo-Controlled Trials.

机构信息

Department of Obstetrics and Gynecology, College of Medicine, Alfaisal University, Riyadh, Saudi Arabia.

Department of Pharmacology, College of Graduate Health Sciences, University of Tennessee Health Science Center, Memphis, TN, 38163, USA.

出版信息

Reprod Sci. 2023 May;30(5):1470-1481. doi: 10.1007/s43032-022-01121-8. Epub 2022 Nov 14.

Abstract

The objective of this study is to perform a meta-analysis of all randomized controlled trials (RCTs) that surveyed the efficacy and safety of preoperative misoprostol versus placebo during abdominal hysterectomy. Six databases were screened from inception until 3 August 2022. The eligible studies were assessed for risk of bias. The outcomes were summarized as mean difference (MD) and risk ratio (RR) with 95% confidence intervals (CI) in a random-effects model. Ten RCTs with 1076 patients (misoprostol = 537, placebo = 539 patients) were analyzed. Six and four RCTs had an overall low and high risk of bias (single-blinded), respectively. The mean intraoperative blood loss (n = 10 RCTs, MD =  - 78.97 ml, 95% [- 130.89, - 27.06], p = 0.003), mean difference in hemoglobin drop (n = 10 RCTs, MD =  - 0.42 g/dl, 95% CI [- 0.69, - 0.14], p = 0.003), and mean length of hospital stay (n = 5 RCTs, MD =  - 0.2 d, 95% CI [- 0.24, - 0.16], p < 0.001) were significantly reduced in favor of the misoprostol group compared with the placebo group. However, there were no significant differences between both groups regarding the mean operative time (n = 8 RCTs, MD =  - 0.63 min, 95% CI [- 5.07, 3.81], p = 0.78), rate of perioperative blood transfusion (n = 7 RCTs, RR = 0.83, 95% CI [0.53, 1.3], p = 0.42), and rate of drug-related adverse events (i.e., nausea, vomiting, diarrhea, headache, chills, and fever). Leave-one-out sensitivity analyses revealed stability for all endpoints, except hospitalization stay. There was no publication bias for all endpoints, except perioperative blood transfusion. Among patients undergoing abdominal hysterectomy, preoperative administration of misoprostol was largely safe and linked to substantial decrease in blood loss-related morbidities.

摘要

本研究旨在对所有调查术前米索前列醇与安慰剂在腹部子宫切除术时疗效和安全性的随机对照试验(RCT)进行荟萃分析。从成立到 2022 年 8 月 3 日,共筛选了 6 个数据库。对合格的研究进行了偏倚风险评估。采用随机效应模型,将结局汇总为均数差(MD)和风险比(RR)及其 95%置信区间(CI)。共纳入 10 项 RCT,涉及 1076 例患者(米索前列醇组=537 例,安慰剂组=539 例)。6 项 RCT 总体偏倚风险较低(单盲),4 项 RCT 偏倚风险较高(单盲)。10 项 RCT 的术中失血量(n=10 RCT,MD=-78.97ml,95%CI[-130.89,-27.06],p=0.003)、血红蛋白下降差值(n=10 RCT,MD=-0.42g/dl,95%CI[-0.69,-0.14],p=0.003)和住院时间(n=5 RCT,MD=-0.2d,95%CI[-0.24,-0.16],p<0.001)差异均有统计学意义,米索前列醇组优于安慰剂组。然而,两组之间的平均手术时间(n=8 RCT,MD=-0.63 分钟,95%CI[-5.07,3.81],p=0.78)、围手术期输血率(n=7 RCT,RR=0.83,95%CI[0.53,1.3],p=0.42)和药物相关不良事件发生率(即恶心、呕吐、腹泻、头痛、寒战和发热)差异均无统计学意义。逐一剔除敏感性分析显示,除住院时间外,所有终点均稳定。除围手术期输血外,所有终点均无发表偏倚。在接受腹部子宫切除术的患者中,术前应用米索前列醇基本安全,并与降低与失血相关的发病率密切相关。

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