目的:系统评价西地那非治疗新生儿持续性肺动脉高压(PPHN)的临床疗效,为临床提供循证参考。方法:计算机检索Pub Med、Cochrane图书馆、EMBase(Ovid)、中国生物医学文献数据库、中国期刊全文数据库、万方数据库和中文科技期刊数据库,收集西地那非(试验组)对比基础治疗或安慰剂治疗PPHN的随机对照试验(RCT),对符合纳入标准的临床研究进行资料提取,并参考Cochrane系统评价员手册5.1.0进行质量评价,然后采用Rev Man 5.1统计软件进行Meta分析。结果:共纳入6项RCT,合计210例患儿。Meta分析结果显示,与安慰剂比较,西地那非治疗PPHN可以显著降低患儿的病死率[RR=0.16,95%CI(0.05,0.45),P〈0.001]和氧合指数[2 h后:MD=-12.80,95%CI(-20.11,-5.49),P〈0.001;24 h后:MD=-19.41,95%CI(-24.81,-14.00),P〈0.001],差异均有统计学意义;与基础治疗比较,西地那非治疗PPHN可以显著降低患儿肺动脉压[2 h后:MD=-22.36,95%CI(-24.89,-19.83),P〈0.001;24 h后:MD=-29.43,95%CI(-31.12,-27.74),P〈0.001],差异均有统计学意义,但对病死率无显著影响[RR=0.64,95%CI(0.30,1.39),P=0.26]。结论:西地那非治疗PPHN疗效较好,可以显著降低患儿的氧合指数、肺动脉压和病死率。
OBJECTIVE:To systematically review the clinical efficacy of sildenafil in the treatment of persistent pulmonary hypertension in newborns(PPHN),and to provide evidence-based reference in the clinic. METHODS:Retrieved from Pub Med,Cochrane Library,EMBase(Ovid),CBM,CJFD,Wanfang and VIP,randomized controlled trials(RCTs)about sildenafil(test group)versus basic therapy or placebo in the treatment of PPHN were collected. Meta-analysis was performed by using Rev Man 5.1 software after data extraction and quality evaluation by Cochrane 5.1.0. RESULTS:Totally 6 RCTs were enrolled,involving 210 patients. Results of Meta-analysis showed,compared with placebo,sildenafil can significantly reduce the mortality [RR=0.16,95%CI(0.05,0.45),P〈0.001] and the oxygenation index [after 2 h:MD=-12.80,95%CI(-20.11,-5.49),P〈0.001;after 24 h:MD=-19.41,95%CI(-24.81,-14.00),P〈0.001],with statistical significances;compared with basic therapy,sildenafil can significantly reduce pulmonary arterial pressure [after 2 h:MD=-22.36,95%CI(-24.89,-19.83),P〈0.001;after 24 h:MD=-29.43,95%CI(-31.12,-27.74),P〈0.001],with statistical significances,but there was no statistical difference in mortality[RR=0.64,95%CI(0.30,1.39),P=0.26]. CONCLUSIONS:Sildenafil is effective in the treatment of PPHN,it can significantly reduce the oxygenation index,pulmonary arterial pressure and mortality.