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随机对照试验的荟萃分析:昂丹司琼预防麻醉后寒战的疗效和安全性。

Meta-analysis of randomized controlled trials on the efficacy and safety of ondansetron in preventing postanesthesia shivering.

机构信息

Department of Neurology, The Second Affiliated Hospital of Nanchang University, Nanchang, 330006, People's Republic of China.

Department of Anaesthesiology, The Second Affiliated Hospital of Nanchang University, Nanchang, 330006, People's Republic of China.

出版信息

Int J Surg. 2016 Nov;35:34-43. doi: 10.1016/j.ijsu.2016.09.009. Epub 2016 Sep 12.

DOI:10.1016/j.ijsu.2016.09.009
PMID:27632391
Abstract

OBJECTIVES

Considerable controversy exists regarding the efficacy of ondansetron in preventing postanesthesia shivering (PAS). We performed a meta-analysis of randomized controlled trials to examine the controversy.

MATERIALS AND METHODS

Randomized controlled trials assessing the effect of ondansetron on the prevention of PAS were identified from electronic databases (PubMed and EMBASE). The meta-analysis was performed with the fixed-effect model or random-effect model according to heterogeneity.

RESULTS

Twelve trials randomized clinical trials met the inclusion criteria including 1205 subjects. Compared with placebo (saline), ondansetron was associated with a significant reduction of PAS (relative risk 0.33; 95% confidence interval, 0.21-0.51), Substantial heterogeneity was observed between trials (P = 0.0002; I = 71%). Trial sequential analysis showed that the cumulative Z-curve crossed the trial sequential monitoring boundary for benefit establishing sufficient and conclusive evidence. Meta-analysis with all five studies using a fixed-effects model suggested that ondansetron and meperidine have similar effects on the prevention of PAS (relative risk, 0.86; 95% confidence interval, 0.66-1.11), the heterogeneity was not significant (P = 0.34; I = 11%). No significant association of ondansetron with bradycardia was found both comparison with placebo and meperidine.

CONCLUSIONS

Treat with ondansetron is safe, and may reduce PAS. This finding encourages the use of ondansetron to prevent PAS, but, more high quality randomized clinical trials are still warranted to confirm the effects of different doses of ondansetron on PAS.

摘要

目的

昂丹司琼预防麻醉后寒战(PAS)的疗效存在较大争议。我们对随机对照试验进行了荟萃分析,以检验这一争议。

材料和方法

从电子数据库(PubMed 和 EMBASE)中确定了评估昂丹司琼预防 PAS 效果的随机对照试验。根据异质性,采用固定效应模型或随机效应模型进行荟萃分析。

结果

12 项随机临床试验符合纳入标准,共纳入 1205 例患者。与安慰剂(生理盐水)相比,昂丹司琼可显著降低 PAS 的发生率(相对风险 0.33;95%置信区间,0.21-0.51)。各试验间存在显著异质性(P=0.0002;I²=71%)。试验序贯分析表明,累积 Z 曲线跨越了获益的试验序贯监测界值,确立了充分和确凿的证据。使用固定效应模型对五项研究进行荟萃分析表明,昂丹司琼和哌替啶预防 PAS 的效果相似(相对风险 0.86;95%置信区间,0.66-1.11),异质性不显著(P=0.34;I²=11%)。与安慰剂和哌替啶相比,昂丹司琼与心动过缓均无显著相关性。

结论

使用昂丹司琼治疗安全,可能降低 PAS 的发生率。这一发现鼓励使用昂丹司琼预防 PAS,但仍需要更多高质量的随机临床试验来证实不同剂量昂丹司琼对 PAS 的影响。

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引用本文的文献

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Postanaesthetic shivering - from pathophysiology to prevention.麻醉后寒战——从病理生理学到预防
Rom J Anaesth Intensive Care. 2018 Apr;25(1):73-81. doi: 10.21454/rjaic.7518.251.xum.