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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。
PURPOSE: To evaluate the efficacy and safety of vardenafil in the treatment of post-renal transplant patients with erectile dysfunction (ED). Methods: A randomized, double-blind study of vardenafil in 39 renal transplant recipients with plasma creatinine value <2 mg / dl was conducted in 4 weeks, 20 in the experimental group and 19 in the placebo group. The efficacy of vardenafil was assessed using the International Index of Erectile Function (IIEF); the safety of vardenafil was assessed using serum creatinine, creatinine clearance, and the cyclosporine concentration monitoring of immunosuppressive agents in the blood. Results: The score of ED patients treated with vardenafil improved from 12.6 ± 3.4 to 26.5 ± 2.8 (P <0.01). Renal function and cyclosporine concentrations did not change before and after vardenafil treatment. Adverse reactions were observed in 4 patients in the vardenafil group, with headache in 2 patients, palpitation with flushing in 1, and dyspepsia in 1 patient. CONCLUSIONS: This study demonstrates that vardenafil is effective and safe in improving erectile function in renal transplant recipients with ED.