Title: Short term efficacy and safety of sildenafil treatment for pre-or post-opertative pulmonary arterial hypertension in children with congenital heart disease:a systematic review
Abstract: 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 be 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 bias,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(vs placebo or conventional treatment group,MD=-9.1 mmHg,95%CI:-11.3 to-6.9 mmHg;vs 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 placebo or conventional treatment group(MD=66.0,95%CI:35.7 to 96.3) after 40 min treatment.⑤There 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 be 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.
Publication Year: 2011
Publication Date: 2011-01-01
Language: en
Type: article
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