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

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

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。

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.