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西地那非治疗儿童肺动脉高压的安全性和疗效:随机对照试验的荟萃分析。

Safety and effect of sildenafil on treating paediatric pulmonary arterial hypertension: a meta-analysis on the randomised controlled trials.

机构信息

Department of Paediatrics, Peking University First Hospital, Beijing100034, China.

出版信息

Cardiol Young. 2020 Dec;30(12):1882-1889. doi: 10.1017/S104795112000311X. Epub 2020 Oct 20.

DOI:10.1017/S104795112000311X
PMID:33077013
Abstract

BACKGROUND

Efficacy of sildenafil in treating paediatric pulmonary arterial hypertension is controversial. This systematic review aimed to explore the safety and effect of sildenafil on treating paediatric pulmonary arterial hypertension (PAH) through meta-analysis.

METHODS AND RESULTS

In this study, the electronic databases, including the Cochran Library database, EMBASE, and MEDLINE were systemically retrieved to identify the related randomised controlled trials (RCTs). Two reviewers had independently completed study selection, data collection, and assessment of the bias risk. Amongst 938 articles researched according to our retrieval strategy, 15 papers that involved 673 cases had been screened. Relative to control group, the sildenafil group had markedly reduced mortality (RR = 0.25, 95% CI: 0.12-0.51; p < 0.0001), but difference within the mortality was not statistically significant between high- and low-dose sildenafil groups (p = 0.152). Nonetheless, difference of the mean pulmonary arterial pressure between sildenafil as well as control group was of no statistical significance. Differences in the length of hospital stay and the incidences of pulmonary hypertensive crisis between children with PAH and controls were of no statistical significance. However, the summary estimate favoured that sildenafil reduced the duration of mechanical ventilation time, as well as the length of ICU stay and inotropic support.

CONCLUSIONS

Sildenafil therapy reduces the mortality of PAH patients, but its effects on the haemodynamic outcomes and other clinical outcomes are still unclear.

摘要

背景

西地那非治疗小儿肺动脉高压的疗效存在争议。本系统评价旨在通过荟萃分析探讨西地那非治疗小儿肺动脉高压(PAH)的安全性和疗效。

方法和结果

本研究通过系统检索 Cochrane 图书馆数据库、EMBASE 和 MEDLINE 等电子数据库,以确定相关的随机对照试验(RCT)。两名评审员独立完成了研究选择、数据收集和偏倚风险评估。根据我们的检索策略,共检索到 938 篇文章,筛选出 15 篇涉及 673 例的文章。与对照组相比,西地那非组死亡率明显降低(RR=0.25,95%CI:0.12-0.51;p<0.0001),但高、低剂量西地那非组之间的死亡率差异无统计学意义(p=0.152)。然而,西地那非组和对照组之间的平均肺动脉压差异无统计学意义。肺动脉高压患儿与对照组之间的住院时间和高血压危象发生率差异无统计学意义。然而,汇总估计表明,西地那非可缩短机械通气时间、ICU 住院时间和正性肌力支持时间。

结论

西地那非治疗可降低 PAH 患者的死亡率,但对血液动力学结局和其他临床结局的影响仍不清楚。

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