伐地那非在肾移植伴勃起功能障碍患者中应用的有效性和安全性研究

Efficacy and Safety of Vardenafil for Kidney Transplant Recipients with Erectile Dysfunction

目的:评估伐地那非在肾移植后伴阴茎勃起功能障碍(ED)患者中应用的有效性和安全性。方法:选取39例血浆肌酐值<2mg/dl的肾移植伴有ED患者进行为期4周随机、双盲的伐地那非研究,实验组20例,安慰剂组19例。应用勃起功能国际指数(IIEF)进行伐地那非有效性的评估;应用血清肌酐值,肌酐清除率和血液中免疫抑制剂环孢素浓度监测值评估伐地那非的安全性。结果:应用伐地那非治疗的ED患者评分从12.6±3.4改善到26.5±2.8(P<0.01)。肾功能和环孢素浓度在伐地那非治疗前后没有改变。有4例伐地那非组患者观察到不良反应,2例出现头痛,1例出现心悸伴颜面潮红,还有1例出现消化不良。结论:本研究证实伐地那非对肾移植伴ED患者勃起功能改善有效而且安全。

Objective： To evaluate the efficacy and safety of vardenafil in kidney transplant recipients with erectile dysfunction. Methods： Thirty-nine kidney transplant recipients with erectile dysfunction （ED） and serum creatinine values 〈 2 mg/dl were enrolled in a 4-week randomized, double blind, placebo-controlled study, 19 treated with placebo and 20 with vardenafil. Vardenafil efficacy was assessed with the IIEF questionnaire after 4 weeks of treatment, and its safety appraised by measuring serum creatinine levels, creatinine clearances and cyclosporine concentrations before and after the treatment. Results： IIEF scores improved from 12.6 ± 3.4 to 26.5 ± 2.8 （P 〈 0.01 ）, but renal function and cyclosporine concentrations remained unchanged in the vardenafil-treated patients. Adverse effects were observed in 4 patients ： headache in 2, palpitation and flush in 1, and dyspepsia in the other. Conclusion ： Oral vardenafil therapy has a high efficacy and a low incidence of adverse events for kidney transplant recipients with ED. Natl J Amdrol, 2008, 14（10） ： 911-913