健阳胶囊治疗2型糖尿病勃起功能障碍效果分析

目的评价健阳胶囊在糖尿病勃起功能障碍患者中的疗效和安全性。方法选择2007年7月~2013年10月在恩施州中心医院诊断为2型糖尿病勃起功能障碍的患者120例,分成试验组58例和对照组62例。对照组给予常规降糖,运动治疗及安慰剂治疗;试验组在对照组基础上给予健阳胶囊3粒/次,2次/d,两组均治疗3个月。根据国际勃起功能评分问卷(IIEF-5)分别对两组患者进行评分比较,并比较两组治疗后全球疗效问题(GEQ)阳性答复情况,根据勃起硬度分级量表(EHGS)评价两组治疗效果,记录患者服药后的不良事件以评价其安全性。结果①治疗3个月后,试验组IIEF-5评分(19.87±3.84)分]显著高于治疗前(12.40±2.46)分],差异有统计学意义(P<0.05);且试验组治疗后IIEF-5评分明显高于对照组(15.31±3.27)分],差异有统计学意义(P<0.05)。②试验组治疗后GEQ阳性答复率为81.03%(47/58),对照组为48.39%(30/62),两组比较差异有统计学意义(P<0.05)。③参照EHGS评价结果,试验组总有效率为81.03%(47/58),对照组总有效率为40.32%(25/62),两组间差异有高度统计学意义(P<0.01)。结论健阳胶囊对糖尿病勃起功能障碍有较好的疗效,且有较好的安全性。

Investigation on clinical effect of Jianyang Capsules for type 2 diabetes mellitus with erectile dysfunction

Objective To evaluate the efficacy and safety of Jiangyang Capsules on type 2 diabetes mellitus with erectile dysfunction. Methods 120 ED diabetics patients in Central Hospital of Enshi Autonomous Prefecture from July 2007 to October 2013 were selected and divided into the experiment group（n = 58） and control group（n = 62）. The control group was treated with routine blood sugar reducing, exercise therapy and placebo treatment; the experiment group was treated with Jiangyang Capsules（3 pellets/time, 2 times/d） on the bases of control group, all the patients were treated for 3months. The IIEF-5 score between the two groups was compared; GEQ positive reply situation between the two groups was compared; the treatment effect according to the EHGS scale of the two groups were evaluated; adverse drug reaction was recorded and the safety was evaluated. Results ①IIEF-5 scores of experiment group （19.87±3.84） points] 3 months after the treatment were higher than that of before the treatment （12.40±2.46） points], the difference was statistically significant（P 0.05）; IIEF-5 scores of experiment group 3 months after the treatment were higher than that of control group（15.31±3.27） points], the difference was statistically significant（P 0.05）. ②GEQ positive reply rate in experiment group81.03 %（47/58）] was higher than that in control group 48.39 %（30/62）], the difference was statistically significant（P 0.05）. ③According to the EHGS evaluation results, total effective rate in experiment group was 81.03 %（47/58）, total effective rate in control group was 40.32 %（25/62）, the difference was statistically significant（P 0.01）. Conclusion The Jianyang Capsules is effective and safe in improving erectile dysfunction for type 2 diabetes patients with ED.