Cardiologie Pédiatrique, Pôle de Pédiatrie, Hôpital de la Timone, Marseille Cedex 05, France.
Intensive Care Med. 2011 Mar;37(3):502-9. doi: 10.1007/s00134-010-2065-4. Epub 2010 Nov 11.
To evaluate the efficacy and safety of intravenous sildenafil for immediate postoperative pulmonary hypertension (PH) in pediatric patients undergoing congenital heart surgery.
A double-blind, multicenter, placebo-controlled, dose-ranging, parallel-group trial was conducted. Patients were randomized to one of three doses of intravenous sildenafil, or placebo, for a minimum of 24 h.
The study was heavily underpowered. Whereas enrollment of 228 patients (57 per treatment arm) was required to achieve the sample size estimate to detect difference between arms, the sponsor terminated the study after 15 months owing to slow patient accrual. Seventeen patients (median age 5 months) experiencing postoperative PH were randomized and treated, five with placebo and four each with low-, medium-, and high-dose sildenafil. In the first 24 h, 40% of placebo and 17% of sildenafil patients required additional therapy (p = 0.330). Median time to extubation (3 versus 8 days, p = 0.023) and intensive care unit stay (6 versus 15 days, p = 0.008) were shorter for sildenafil patients. Mean ± standard deviation systolic pulmonary artery pressure was reduced with sildenafil (46 ± 11 to 35 ± 6 mmHg, p = 0.027 versus placebo). No adverse events or systemic hypotension were attributed to sildenafil.
Intravenous sildenafil reduced pulmonary artery pressure and shortened time to extubation and intensive care unit stay in children with postoperative PH.
评估静脉注射西地那非治疗小儿先天性心脏病术后肺动脉高压（PH）的疗效和安全性。
进行了一项双盲、多中心、安慰剂对照、剂量范围、平行组试验。患者随机分为三组静脉注射西地那非或安慰剂，至少 24 小时。
研究严重缺乏效力。虽然需要招募 228 名患者（每组 57 名）才能达到检测臂之间差异的样本量估计，但由于患者入组缓慢，赞助商在 15 个月后终止了研究。17 名（中位年龄 5 个月）经历术后 PH 的患者被随机分配并接受治疗，5 名接受安慰剂，4 名接受低、中、高剂量西地那非。在头 24 小时内，40%的安慰剂和 17%的西地那非患者需要额外的治疗（p = 0.330）。西地那非患者的拔管时间（3 天与 8 天，p = 0.023）和重症监护病房住院时间（6 天与 15 天，p = 0.008）更短。西地那非治疗后平均收缩压肺动脉压降低（46 ± 11 至 35 ± 6 mmHg，p = 0.027 与安慰剂相比）。没有与西地那非相关的不良事件或全身低血压。
静脉注射西地那非降低了术后 PH 儿童的肺动脉压，并缩短了拔管和重症监护病房停留时间。
