大剂量西地那非治疗新生儿持续性肺动脉高压疗效和安全性的Meta-分析

目的 系统评价大剂量西地那非治疗新生儿持续肺动脉高压（PPHN）的疗效和安全性，为临床合理用药提供参考。方法 通过检索Cochrane Library、PubMed、Embase、中国生物医学文献数据库（CBM）、中国学术期刊全文数据库（CNKI）、维普中文期刊全文数据库（VIP）和万方数据库，收集大剂量西地那非（>1 mg/kg）对比常规剂量西地那非（1 mg/kg）治疗PPHN的随机对照试验（RCTs），检索时间从建库到2019年12月。提取相关资料并评价研究的方法学质量，使用RevMan 5.3软件进行Meta-分析。结果 共纳入13项RCTs，共计772例患者。Meta-分析结果显示：试验组的肺动脉下降［MD=-4.21，95%CI（-5.72～-2.69）］、血氧饱和度增加［MD=2.79，95%CI（1.53～4.06）］、氧分压增加［MD=3.43，95%CI（2.19～4.67）］、二氧化碳分压下降［MD=-4.53，95%CI（-7.62～-1.44）］显著优于对照组（P<0.01），不良反应发生率与对照组比较无显著差异［OR=1.55，95%CI（0.61～3.95），P>0.05）］。结论 大剂量西地那非（>1 mg/kg）在治疗PPHN方面与常规剂量西地那非相比，临床疗效更优，安全性相当。

Efficacy and safety of high-dose sildenafil in treatment of persistent pulmonary hypertension in newborns (PPHN): A Meta-analysis

Objective To systematically evaluate the efficacy and safety of high-dose sildenafil in the treatment of persistent pulmonary hypertension in newborns (PPHN), and to provide a reference for the rational drug use. Methods Retrieved from the Cochrane Library, PubMed, Embase, CBM, CNKI, VIP and Wanfang Database from the inception to December 2019, randomized controlled trials (RCTs) about of high-dose sildenafil (> 1 mg/kg) compared with conventional-dose sildenafil (1 mg/kg) in the treatment of PPHN was collected. After the data extraction and evaluation of methodological quality of RCTs, meta-analysis was conducted by using RevMan 5.3 software. Results A total of 13 RCTs were included, involving 772 patients. The results of Metaanalysis showed that pulmonary arteries decreased[MD=-4.21, 95%CI (-5.72~-2.69)], blood oxygen saturation increased[MD=2.79, 95%CI (1.53~4.06)], partial oxygen pressure increased[MD=3.43, 95%CI (2.19~4.67)], the partial pressure of carbon dioxide decreases[MD=-4.53, 95%CI (-7.62~-1.44)] of high-dose sildenafil group were significantly superior to those of conventional-dose sildenafil group, with statistical significance (P<0.01). And the rate of ADR[OR=1.55, 95%CI (0.61~3.95)] of high-dose sildenafil group was no difference of that in conventional-dose sildenafil group. Conclusion High-dose sildenafil (> 1 mg/kg) has better clinical efficacy and similar safety compared with conventional-dose of sildenafil in the treatment of PPHN.