Dodgen Andrew L, Hill Kevin D
Department of Pediatrics, Duke University Medical Center, Durham, NC, USA.
Department of Pediatrics, Duke University Medical Center, Durham, NC, USA ; Duke Clinical Research Institute, Durham, NC, USA.
Drug Healthc Patient Saf. 2015 Dec 15;7:175-83. doi: 10.2147/DHPS.S65571. eCollection 2015.
Sildenafil is a phosphodiesterase type-5 inhibitor approved for treatment of pulmonary arterial hypertension (PAH) in adults. Data from pediatric trials demonstrate a similar acute safety profile to the adult population but have raised concerns regarding the safety of long-term use in children. Interpretation of these trials remains controversial with major regulatory agencies differing in their recommendations - the US Food and Drug Administration recommends against the use of sildenafil for treatment of PAH in children, while the European Medicines Agency supports its use at "low doses". Here, we review the available pediatric data regarding dosing, acute, and long-term safety and efficacy of sildenafil for the treatment of PAH in children.
西地那非是一种5型磷酸二酯酶抑制剂，已被批准用于治疗成人肺动脉高压（PAH）。儿科试验数据显示，其急性安全性与成人相似，但人们对其在儿童中长期使用的安全性表示担忧。这些试验的解读仍存在争议，主要监管机构的建议各不相同——美国食品药品监督管理局建议不要使用西地那非治疗儿童PAH，而欧洲药品管理局支持“低剂量”使用。在此，我们回顾了有关西地那非治疗儿童PAH的剂量、急性和长期安全性及疗效的现有儿科数据。
