波生坦治疗新生儿持续性肺动脉高压有效性及安全性的Meta分析

Efficacy and safety of bosentan in the treatment of persistent pulmonary hypertension of the newborn: a Meta analysis

摘要:

目的 系统评估波生坦用于新生儿持续性肺动脉高压（persistent pulmonary hypertension of the newborn，PPHN）的有效性及安全性。 方法 计算机全面检索中国期刊全文数据库、维普中文科技期刊数据库、万方数据库、中国生物医学文献数据库、PubMed、Web of Science、Embase、Cochrane Library等数据库中关于波生坦治疗PPHN的文献，检索时间从建库至2021年8月31日。 结果 纳入8篇随机对照试验进行Meta分析。Meta分析结果示：波生坦组治疗失败率比对照组低［相对危险度（relative risk，RR）=0.23，P<0.001］；肺动脉压力下降幅度大于对照组［均数差（mean difference，MD）=-11.79，P<0.001］；氧分压（MD=10.21，P=0.006）及血氧饱和度（MD=8.30，P<0.001）上升幅度均高于对照组；住院时间短于对照组（MD=-1.35，P<0.001）。描述性分析提示波生坦组治疗后三尖瓣反流程度小于对照组；波生坦治疗的主要不良反应包括肝功能异常、贫血和水肿。对治疗方案、研究地域、药物剂量进行分层分析，结果显示与未分层前一致。 结论 波生坦治疗对PPHN是有效的，但使用波生坦治疗时要注意肝功能异常等不良反应。

Abstract:

Objective To systematically evaluate the efficacy and safety of bosentan in the treatment of persistent pulmonary hypertension of the newborn (PPHN). Methods Chinese Journal Full-text Database, Weipu Database, Wanfang Data, China Biology Medicine disc, PubMed, Web of Science, Embase, and Cochrane Library were searched for literature on bosentan in the treatment of PPHN published up to August 31, 2021. Results A total of 8 randomized controlled trials were included for Meta analysis. The results of the Meta analysis showed that compared with the control group, the bosentan treatment group had a significantly lower treatment failure rate (RR=0.23, P<0.001), a significantly greater reduction in pulmonary artery pressure [mean difference (MD)=-11.79, P<0.001)], significantly greater increases in oxygen partial pressure (MD=10.21, P=0.006) and blood oxygen saturation (MD=8.30, P<0.001), and a significantly shorter length of hospital stay (MD=-1.35, P<0.001). The descriptive analysis showed that the bosentan treatment group had a lower degree of tricuspid regurgitation than the control group after treatment. The main adverse reactions of bosentan treatment included abnormal liver function, anemia and edema. The results of subgroup analysis based on treatment regimen, research area, and drug dose were consistent with those before stratification. Conclusions Bosentan is effective in the treatment of PPHN. However, when using bosentan, attention should be paid to adverse reactions such as abnormal liver function.