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地塞米松与倍他米松治疗早产:系统评价和网络荟萃分析。

Dexamethasone versus betamethasone for preterm birth: a systematic review and network meta-analysis.

机构信息

Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina.

Instituto de Efectividad Clínica y Sanitaria, Buenos Aires, Argentina.

出版信息

Am J Obstet Gynecol MFM. 2021 May;3(3):100312. doi: 10.1016/j.ajogmf.2021.100312. Epub 2021 Jan 20.

Abstract

OBJECTIVE

This study aimed to evaluate the comparative clinical effectiveness and safety of dexamethasone vs betamethasone for preterm birth.

DATA SOURCES

The sources searched were MEDLINE, EMBASE, Cochrane Library, LILACS, ClinicalTrials.gov, and International Clinical Trials Registry Platform without language restrictions until October 2019 in addition to the reference lists of included studies. Field experts were also contacted.

STUDY ELIGIBILITY CRITERIA

Randomized or quasi-randomized controlled trials comparing any corticosteroids against each other or against placebo at any dose for preterm birth were included in the study.

METHODS

Three researchers independently selected and extracted data and assessed the risk of bias of the included studies by using Early Review Organizing Software and Covidence software. Random-effects pairwise meta-analysis and Bayesian network meta-analysis were performed. The primary outcomes were chorioamnionitis, endometritis or puerperal sepsis, neonatal death, respiratory distress syndrome, and neurodevelopmental disability.

RESULTS

A total of 45 trials (11,227 women and 11,878 infants) were included in the study. No clinical or statistical difference was found between dexamethasone and betamethasone in neonatal death (odds ratio, 1.05; 95% confidence interval, 0.62-1.84; moderate-certainty evidence), neurodevelopmental disability (odds ratio, 1.03; 95% confidence interval, 0.80-1.33; moderate-certainty evidence), intraventricular hemorrhage (odds ratio, 1.04; 95% confidence interval, 0.56-1.78); low-certainty evidence), or birthweight (+5.29 g; 95% confidence interval, -49.79 to 58.97; high-certainty evidence). There was no statistically significant difference, but a potentially clinically important effect was found between dexamethasone and betamethasone in chorioamnionitis (odds ratio, 0.70; 95% confidence interval, 0.45-1.06; moderate-certainty evidence), fetal death (odds ratio, 0.81; 95% confidence interval, 0.24-2.41; low-certainty evidence), puerperal sepsis (odds ratio, 2.04; 95% confidence interval, 0.72-6.06; low-certainty evidence), and respiratory distress syndrome (odds ratio, 1.34; 95% confidence interval, 0.96-2.11; moderate-certainty evidence). Meta-regression, subgroup, and sensitivity analyses did not reveal important changes regarding the main analysis.

CONCLUSION

Corticosteroids have proven effective for most neonatal and child-relevant outcomes compared with placebo or no treatment for women at risk of preterm birth. No important difference was found on neonatal death, neurodevelopmental disability, intraventricular hemorrhage, and birthweight between corticosteroids, and there was no statistically significant difference, but a potentially important difference was found in chorioamnionitis, fetal death, endometritis or puerperal sepsis, and respiratory distress syndrome. Further research is warranted to improve the certainty of evidence and inform health policies.

摘要

目的

本研究旨在评估地塞米松与倍他米松治疗早产的临床效果和安全性。

资料来源

除了纳入研究的参考文献外,还在没有语言限制的情况下,于 2019 年 10 月前通过 MEDLINE、EMBASE、Cochrane 图书馆、LILACS、ClinicalTrials.gov 和国际临床试验注册平台对资料进行了检索。还联系了领域专家。

研究入选标准

将任何剂量的地塞米松或倍他米松与安慰剂进行比较的随机或半随机对照试验均纳入本研究。

方法

三位研究人员使用 Early Review Organizing Software 和 Covidence 软件独立选择和提取数据,并评估纳入研究的偏倚风险。采用随机效应成对荟萃分析和贝叶斯网络荟萃分析。主要结局为绒毛膜羊膜炎、子宫内膜炎或产褥期脓毒症、新生儿死亡、呼吸窘迫综合征和神经发育障碍。

结果

共有 45 项试验(11227 名妇女和 11878 名婴儿)纳入本研究。地塞米松和倍他米松在新生儿死亡(比值比,1.05;95%置信区间,0.62-1.84;中等确定性证据)、神经发育障碍(比值比,1.03;95%置信区间,0.80-1.33;中等确定性证据)、脑室周围出血(比值比,1.04;95%置信区间,0.56-1.78;低确定性证据)或出生体重(增加 5.29 g;95%置信区间,-49.79 至 58.97;高确定性证据)方面无临床或统计学差异。地塞米松和倍他米松在绒毛膜羊膜炎(比值比,0.70;95%置信区间,0.45-1.06;中等确定性证据)、胎儿死亡(比值比,0.81;95%置信区间,0.24-2.41;低确定性证据)、产褥期脓毒症(比值比,2.04;95%置信区间,0.72-6.06;低确定性证据)和呼吸窘迫综合征(比值比,1.34;95%置信区间,0.96-2.11;中等确定性证据)方面存在统计学意义,但潜在临床意义上的差异。元回归、亚组和敏感性分析并未对主要分析结果产生重要影响。

结论

与安慰剂或无治疗相比,皮质类固醇对有早产风险的妇女的大多数新生儿和儿童相关结局均有效。在新生儿死亡、神经发育障碍、脑室周围出血和出生体重方面,皮质类固醇之间无重要差异,且无统计学意义,但在绒毛膜羊膜炎、胎儿死亡、子宫内膜炎或产褥期脓毒症和呼吸窘迫综合征方面存在潜在的重要差异。需要进一步的研究来提高证据的确定性,并为卫生政策提供信息。

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