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体外循环下心内直视手术患儿预防性应用皮质激素:随机对照试验的系统评价和荟萃分析。

Prophylactic corticosteroids for infants undergoing cardiac surgery with cardiopulmonary bypass: a systematic review and meta-analysis of randomized controlled trials.

机构信息

Department of Anesthesiology, West China Hospital, Sichuan University, Chengdu, Sichuan, 610041, China.

出版信息

BMC Anesthesiol. 2024 Oct 25;24(1):385. doi: 10.1186/s12871-024-02772-7.

Abstract

BACKGROUND

Prophylactic corticosteroids have been widely used to mitigate the inflammatory response induced by cardiopulmonary bypass (CPB). However, the impact of this treatment on clinically important outcomes in infants remains uncertain.

METHODS

We systematically searched databases (Medline, Embase, and Cochrane Central Register of Controlled Trials), Clinical Trials Registry, and Google Scholar from inception to March 1, 2024. Randomized controlled trials (RCTs) in which infants undergoing on-pump cardiac surgery received prophylactic corticosteroids or placebo were selected. The risk of bias was assessed using the Cochrane Collaboration risk-of-bias tool. Considering clinical heterogeneity between studies, the random-effects model was used for analysis. Subgroup analyses on the neonatal studies and sensitivity analyses by the leave-one-out method were also conducted.

RESULTS

Eight RCTs comprising 1,920 patients were included. Our analysis suggested no significant difference in postoperative mortality (2.1% vs. 3.3%, risk ratio (RR) = 0.71, 95% confidence interval (CI) [0.41, 1.21]). Significantly increased insulin treatment in infants (19.0% vs. 6.5%, RR = 2.78, 95% CI [2.05, 3.77]) and significantly reduced duration of mechanical ventilation in neonates (mean difference = -22.28 h, 95% CI [-42.58, -1.97]) were observed in the corticosteroids group. There were no differences between groups for postoperative acute kidney injury, cardiac arrest, extracorporeal membrane oxygenation support, low cardiac output syndrome, neurologic events, infection, or length of postoperative intensive care unit stay.

CONCLUSIONS

Current evidence does not support the routine prophylactic use of corticosteroids in infants undergoing cardiac surgery with CPB. Further large-scale research is needed to investigate the optimal agent, dosing regimen, and specific impact on various types of cardiac surgery.

TRIAL REGISTRATION

This systematic review and meta-analysis was registered at the International Prospective Register of Systematic Reviews (CRD42023400176).

摘要

背景

预防性皮质类固醇已广泛用于减轻体外循环(CPB)引起的炎症反应。然而,这种治疗方法对婴儿的临床重要结局的影响尚不确定。

方法

我们系统地检索了数据库(Medline、Embase 和 Cochrane 对照试验中心注册库)、临床试验注册处和 Google Scholar,检索时间从成立到 2024 年 3 月 1 日。选择了接受体外循环心脏手术的婴儿接受预防性皮质类固醇或安慰剂的随机对照试验(RCT)。使用 Cochrane 协作风险偏倚工具评估偏倚风险。考虑到研究之间的临床异质性,使用随机效应模型进行分析。还进行了新生儿研究的亚组分析和通过删除一个研究进行的敏感性分析。

结果

纳入了 8 项 RCT,共 1920 名患者。我们的分析表明,术后死亡率无显著差异(2.1% vs. 3.3%,风险比(RR)=0.71,95%置信区间(CI)[0.41,1.21])。皮质类固醇组婴儿胰岛素治疗显著增加(19.0% vs. 6.5%,RR=2.78,95% CI [2.05,3.77]),新生儿机械通气时间显著缩短(平均差异=-22.28 h,95% CI [-42.58,-1.97])。两组间术后急性肾损伤、心脏骤停、体外膜氧合支持、低心输出量综合征、神经系统事件、感染或术后重症监护病房停留时间无差异。

结论

目前的证据不支持常规预防性使用皮质类固醇治疗接受 CPB 心脏手术的婴儿。需要进一步开展大规模研究,以调查最佳药物、剂量方案以及对各种类型心脏手术的具体影响。

试验注册

本系统评价和荟萃分析已在国际前瞻性系统评价登记处(CRD42023400176)注册。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/54b5/11515339/906ebda4a8fa/12871_2024_2772_Fig1_HTML.jpg

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