Objective To determine the short term efficacy and safety of sildenafil treatment for pre- or post-opertative pulmonary arterial hypertension( PAH ) in children with congenital heart disease( CHD ).Methods The Cochrane Central Register of Controlled Trials.EMBASE.PubMed, Database of ongoing controlled trials, CBMweb.CNKI and VIP were searched from the establishment of the database to March 2011.Additional data were sought from the related academic conferences and reference lists of included trials to obtain randomized controlled trials ( RCTs ) of sildenafil for PAH in children with CHD.The Cochrane Handbook 5.0 was used to evaluate the methodological quality and RevMan 5.0 software, supplied by the Cochrane Collaboration,was used for meta analysis.If suitable data could not he merged, the results of specific trial were described only.Results A total of 130 literatures were searched.three RCTs that met the inclusion criteria were enrolled.The assessment of literature quality showed that one literature with low risk of hias, while the rest with high risk of bias.①There was no significant difference in mortality prior to discharge between sildenafil group and placebo or conventional treatment group( RR = 0.09,95％ CI: 0.01～1.64 ).②The incidence of PAH crisis in sildenafil group was lower than that in the conventional group.There were significant reductions in mean pulmonary arterial pressure ( v.s placebo or conventional treatment group , MD = - 9.1 mmHg , 95％CI : - 11.3 to -6.9 mmHg; v.s prostaglandin E1 group, MD = - 5.1 mmHg,95％ CI: - 7.6 to - 2.7 mmHg ) and systolic pulmonary ratio arterial pressure ( MD = - 11.2mmHg,95％ CI: - 16.5 to - 5.9 mmHg ) in sildenafil group after 40 min treatment.③Although there was no significant difference in duration of hospitalization between sildenafil group and placebo or conventional treatment group, mechanical ventilation duration was significantly shorter in sildenafil group.④Increase in PaO2/FiO2 ratio was greater in sildenafil group than that in plac:ebo or conventional treatment group( MD = 66.0.95％ CI:35.7 to 96.3 ) after 40 min treatment.⑤ There was slight reduction in mean systemic arterial pressure in sildenafil group( MD = - 4.30 mmHg,95％CI: - 7.8 to - 0.8 mmHg ) after 40 min treatment.⑥Two studies reported no adverse effect occurred in sildenafil group.One study reported ten cases of slight side effect occured in sildenafil group: short lived erections.transient nasal stuffiness and gastrointestinal upset.All complications reversed after discontinuation of the drug.Conclusions Sildenafil can he effective in reducing the elevated PAH without any significant adverse effect during short-term follow-up.However.confirmation of efficacy and long-term safety of sildenafil requires larger, high methodologic quality and long-term follow-up studies.%目的 评价西地那非治疗儿童先天性心脏病(CHD)术前或术后合并肺动脉高压(PAH)的近期疗效和安全性.方法 检索Cochrane临床对照试验库(CENTRAL)、EMBASE、PubMed、在研对照试验数据库、中国生物医学文献数据库、中国期刊全文数据库和中文科技期刊全文数据库.检索时间均从建库至2011年3月.并手工检索相关会议论文集并追查纳入文献的参考文献,获得西地那非治疗儿童CHD术前或术后合并PAH的RCT文献.采用Cochrane评价手册5.0推荐的方法评价纳入文献的方法学质量.用RevMan 5.0软件进行Meta分析,对无法合并分析的结果进行描述性分析.结果 共检索到相关文献130篇,其中3篇RCT文献进入系统评价.1篇文献存在低度偏倚风险,2篇文献存在高度偏倚风险.①西地那非组与安慰剂组或常规治疗组出院前病死率差异无统计学意义(RR=0.09,95%CI:0.01～1.64).②西地那非组PAH危象发生率低于常规治疗组;西地那非组治疗40 min后平均肺动脉压显著低于安慰剂组或常规治疗组(MD=-9.1 mmHg,95%CI:-11.3～ -6.9 mmHg)和前列腺素E1组(MD=-5.1 mmHg,95%CI:-7.6～ -2.7 mmHg );肺动脉收缩压显著低于安慰剂组或常规治疗组,MD=-11.2 mmHg,95%CI:-16.5～ -5.9 mmHg;③西地那非组与安慰剂组或常规治疗组住院时间差异无统计学意义,机械通气时间和重症监护时间显著低于安慰剂组.④西地那非组治疗40 min后氧合指数显著高于安慰剂组或常规治疗组,MD=66.0,95%CI:35.7～96.3.⑤西地那非组治疗40 min后平均体循环动脉压稍有下降,MD=-4.3 mmHg,95%CI:-7.8～-0.8 mmHg.⑥2篇文献报道无药物相关死亡及不良反应的发生;1篇文献报道10例患儿发生不良反应,主要为短暂阴茎勃起、暂时性鼻阻塞和胃肠道反应,在停用西地那非后均恢复.结论 西地那非能有效降低CHD术前或术后合并PAH患儿的肺动脉压,且短期使用有较好的安全性.鉴于纳入文献数量较少且质量偏低,对于西地那非确切疗效的评价还需要大样本和高质量的RCT研究进一步证实.
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