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目的观察他达拉非对Ⅱ型糖尿病患者勃起功能障碍的临床疗效和安全性。方法入选合并勃起功能障碍的男性Ⅱ型糖尿病患者112例,随机分为他达拉非组和西地那非组。他达拉非组患者口服20mg,每周口服2次。西地那非组口服50mg,每周口服2次。两组均持续治疗4周。采用勃起功能国际指数(IIEF-5)和勃起质量量表问卷(EQS)对两组患者的勃起功能状况进行评估和比较。结果治疗前两组患者的IIEF-5评分值和EQS评分值差异没有统计学意义(P>0.05)。治疗4周后,两组患者的IIEF-5评分值和EQS评分值均显著高于治疗前(P<0.01),他达拉非组又高于西地那非组(P<0.05)。他达拉非组的总有效率高于西地那非组(85.7%vs73.2%,P<0.05)。治疗过程中两组患者的血糖水平均控制良好,亦未观察到明显的不良反应。结论他达拉非治疗Ⅱ型糖尿病患者勃起功能障碍具有较好的疗效和安全性。
Objective To observe the clinical efficacy and safety of tadalafil in type Ⅱ diabetes patients with erectile dysfunction. Methods A total of 112 male patients with erectile dysfunction who were type II diabetic were randomly divided into two groups: tadalafil group and sildenafil group. Tadalafil group patients oral 20mg, 2 times a week orally. Sildenafil oral 50mg, 2 times a week orally. Both groups continued treatment for 4 weeks. Erectile function (IIEF-5) and erectile dysfunction scale questionnaire (EQS) were used to assess and compare erectile function in both groups. Results There was no significant difference in IIEF-5 score and EQS score between the two groups before treatment (P> 0.05). After 4 weeks of treatment, the IIEF-5 scores and EQS scores of the two groups were significantly higher than those before treatment (P <0.01), those of tadalafil group were higher than that of sildenafil (P <0.05). The overall efficacy of tadalafil group was higher than that of sildenafil (85.7% vs 73.2%, P <0.05). During the course of treatment, blood glucose levels were well controlled in both groups and no significant adverse reactions were observed. Conclusion Tadalafil treatment of type Ⅱ diabetes patients with erectile dysfunction has good efficacy and safety.