2型糖尿病患者勃起功能障碍患病率及西地那非的疗效和安全性评价

Prevalence of erectile dysfunction in type 2 diabetic men and evaluation of efficacy and safety of sildenafil treatment

目的调查内分泌门诊中糖尿病患者阴茎勃起功能障碍(ED)患病率,并评价西地那非(万艾可)在糖尿病合并ED患者中的疗效和安全性。方法多中心收集2型糖尿病男性患者6193例,入选6178例,患者签署知情同意书后,根据国际勃起功能指数表(IIEF5)患者进行自我评分。对3个月内服用3剂万艾可的患者除要求填写治疗前的IIEF5表评分外,还要求填写治疗后的总体疗效问题回答表,以评价万艾可治疗的疗效,并记录患者服药后的不良事件以评价其安全性。结果国内42家医院内分泌门诊2型糖尿病患者中ED的患病率为75.2%,其中重度、中度和轻度ED分别为9.1%、17.2%、48.9%。该受检人群中ED的知晓率为85.0%,但治疗率仅为9.4%。多因素回归分析显示患者年龄、糖尿病病程、血糖控制不佳(HbA1C>6.5%)与糖尿病患者ED的发生独立相关。共有389例患者服用万艾可治疗,治疗后患者IIEF5总评分和各问题的评分均显著高于治疗前(P<0.01);根据IIEF5评分,治疗后重、中度ED患者例数明显少于治疗前(P<0.01)。根据总体疗效评估问题的回答,给予万艾可治疗后勃起功能改善率达86.4%。对安全性评价显示服用万艾可后出现的与药物有关的不良事件主要是颜面潮红、头痛、心悸和口干等,大多为轻度。结论在2型糖尿病患者中ED是常见的合并症,万艾可治疗糖尿病合并ED疗效确切,并有良好的安全性。

Objective To investigate the prevalence of erectile dysfunction （ED） in diabetic men in the endocrine outpatient clinics of China and to evaluate the efficacy and safety of sildenafil（Viagra） in these patients. Methods A total of 6 178 patients among 6 193 patients in 42 diabetes outpatient clinics were involved in this study. The patients were informed and then signed the informed consent. The International Index of Erectile Function-5 （IIEF-5） was used to determine the status and severity of ED. In the patients who took 3 doses of Viagra in 3 months, efficacy of Viagra was evaluated using the IIEF-5 and a global efficacy question （ GEQ ; “Did treatment improve your erections？” ） ; and the safety was evaluated according to the adverse events recorded in the patient diary. Results According to the total scores of IIEF-5, the prevalence of ED in diabetic patients was 75.2%, and the prevalences of severe, moderate and mild ED were 9.1%, 17.2%, 48.9% respectively. Logistic regression analysis showed that age, HbA1c and the duration of diabetes were independently associated with the occurrence and the severity of ED. Improvements in mean scores of IIEF-5 and each item of IIEF-5 were significant in patients receiving Viagra compared with that of pretreatment （P〈0. 01）. Moreover, the percent of improved erections （ GEQ, 86.4% ） was significantly increased after receiving Viagra. Improvements in sexual function were seen irrespective of the degree of ED severity. Adverse events were generally mild to moderate in severity, with headache, flushing and dyspepsia reported more often in the Viagra treated patients. Conclusions ED is a very common complication in the male diabetic patients, and it is positively associated with age, HbA1c and the duration of diabetes ; Treatment with Viagra for ED is effective, resulting in an improvement of IIEF-5 scores, and is well tolerated among men with diabetes.