Efficacy And Safety Of Sildenafil For Pulmonary Hypertension In Children:A Systematic Review

Objective:To determine the efficacy and safety of sildenafil for pulmonary hypertension(PH) in children. Methods:The Cochrane Central Register of Controlled Trials, EMBASE, PubMed, CNKI, VIP, Digital Journal of Wangfang Data were searched from establishment to May2011. Additional data were sought from the related academic meeting to obtain randomized controlled trials (RCTs) of sildenafil for pulmonary hypertension in children. The Cochrane Handbook5.0was used to evaluate the methodological quality and RevMan5.0software was used for meta-analysis. If suitable data could not be merged, the results of specific trial were described only. Results:Eleven randomized controlled trial involving582patients were included. Three studies correctly described the generation of random sequences,4correctly described the allocation concealment,6described using of blind and the implementation of the blind,7correctly describe the details of dropout and lose of follow-up. Meta analysis showed that:After treatment with sildenafil, the mortality of patients was lower [RR=0.18,95%CI(0.07,0.48)] and the decreasing of systolic pulmonary arterial pressure and mean pulmonary arterial pressure in patients was obviously [MD=-10.92,95%CI(-15.84,-6.01); MD=-9.11,95%CI(-11.29,-6.92)]. Moreover, sildenafil was benefit to reduce the oxygenation index [MD=-12.53,95%CI(-18.60,-6.47)] and improve the PaO2of patients [MD= 12.39,95%CI(6.00,18.77)], and almost had no influence in systemic blood pressure [MD=0.01,95%CI(-6.64,6.67)]. Six studies reported the adverse events during the research, and there were no treatment related death in sildenafil group during the research. All of six studies reported that the safety and tolerability of sildenafil was well. The main adverse events were short penile erectile, temporary nasal obstruction, gastrointestinal bleeding, gastrointestinal reaction and so on. Conclusions:Sildenafil can be effective in reducing the the risk of death and the elevated pulmonary pressure in children with pulmonary hypertension. In addition, sildenafil could reduce the oxygenation index and improve the PaO2of patients. The safety and tolerability of sildenafil is well during short-term using. However, confirmation of efficacy and long-term safety of sildenafil requires larger, high methodologic quality and long-term follow-up studies.