西地那非联合十一酸睾酮治疗糖尿病性勃起功能障碍的安全性有效性多中心研究

A Multicenter Research of Sildenafil Combined with Testosterone Undecanoate for Treatment of Erectile Dysfunction with Diabetes

目的观察西地那非联合十一酸睾酮治疗糖尿病患者阴茎勃起障碍的疗效和安全性.方法2009年1月至2011年12月多中心收集广州市番禺区中心医院、上海交通大学医学院附属仁济医院、上海市中医医院泌尿男科门诊糖尿病性勃起功能障碍患者共100例,患者签署知情同意书后,根据国际勃起功能指数表（IIEF-5）进行自我评分.随机分为两组：A组：50例,控制血糖常规治疗的基础上服用西地那非（50mg prn）加十一酸睾酮（80mg/Bid）;B组：50例,在控制血糖常规治疗的同时给予西地那非治疗,两组均治疗12周.观察两组患者治疗前后的疗效,并记录患者服药后的不良事件以评价其安全性.结果共计82例完成本次研究,其中A组42例、B组40例.两组患者IIEF-5评分在治疗后均显著增加,而A组较B组增加更显著,差异具统计学意义（P〈0.05）.治疗后每周性交频率均显著增加,A组较B组增加更明显,差异具统计学意义（P〈0.05）.其中A组显效率高达59.5%,有效率为88.1%,明显高于B组（显效率30.00%,有效率55.00%）,P〈0.05.A组37例患者性交时阴茎能满意勃起,而B组只有22例患者性交时阴茎能满意勃起;两组均未出现任何不良反应.结论西地那非联合十一酸睾酮治疗糖尿病性勃起功能障碍较单用西地那非可显著改善患者的勃起能力,且安全性好.

Objective To study the effects and safety of sildenafil combined with testosterone undecanoate for treatment of Erectile Dysfunction （ED）with Diabetes. Methods A total of 100 ED patients with diabetes from Panyu Central Hospital of Guangzhou, Renji Hospital, Shanghai Jiao Tong University School of Medicine, and Traditional Chinese Medicine Hospital of Shanghai, were recruited in the study. Informed consent was obtained from each patient. They were evaluated by the International Index of Erectile Function Table（IIEF-5） and randomly assigned to two groups. Patients in Group A received sildenafil combined with testosterone undecanoate （80mg/Bid） （n=50）, while patients in Group B received sildenafil only （n = 50） for 12 weeks. Both treatments were on the basis of glycemic well control. We assessed the differences of efficacy between two treatments, and recorded the adverse events for safety evaluation. Results Total of 82 patients completed the study, including 42 in Group A and 40 in Group B. Both Groups had significant increases in IIEF scale （P〈0.05）. The increase of IIEF scale in Group A was more dramatic than that in Group B （P〈0.05）. The obvious effective rate and effective rate of Group A were 59.52% and 88.10% respectively, higher than that of Group B （30.00% and 55.00%）, with P value lower than 0.05. No adverse events were noted in two groups. Conclusion Compared to sildenafil therapy only, Sildenafil therapy combined with testosterone undecanoate can improve the sexual function of ED patient with diabetes, having a more satisfactory drug safety.