温肾活血汤药和胰岛素联合治疗糖尿病勃起功能障碍随机对照试验

A randomly controlled trial （RCT） of the erectile function in diabetics and the effect of Wenshen Huoxue decoction combined with insulin treatment

目的评价温。肾活血汤药和胰岛素联合治疗糖尿病勃起功能障碍（Erectile Dysfunction，ED）的临床疗效。方法采用随机、双盲、安慰剂和对照的研究方案，符合入选标准的受试者190例，随机分为试验组和对照组，每组各95例，对药物和安慰剂进行编号，试验组每天应用胰岛素控制血糖，连续应用温肾活血汤药3个月。对照组每天应用胰岛素控制血糖，连续应用与温肾活血汤药外观、颜色、气味和剂量完全相同不含任何有效药物成分的汤剂3个月。双盲方法观察3个月，数据资料收集完成后统一破盲。结果治疗3个月后，试验组和对照组患者用药后IIEF-5评分，显著高于各自用药前，用药前后两者比较差异有统计学意义（P〈0．05），试验组和对照组患者用药后IIEF-5评分比较差异有统计学意义（P〈0．05）。勃起硬度分级量表（EHGS）进行评估，试验组总有效率为79．27％，对照组总有效率为43．75％，两组间差异有统计学意义（P〈0．05）。结论糖尿病ED通过胰岛素和中药汤剂治疗后，糖尿病得到明显改善，比单纯应用胰岛素效果更好，为糖尿病阴茎勃起功能障碍（DMED）治疗提供更为有效的新的治疗方法。

Objective To evaluate the efficacy of the Wenshen Huoxue decoction combined with insulin in the treatment of erectile dysfunction （ED） in diabetics. Methods This was a double-blind, randomized,placebo and control approach. In total 190 ED diabetics were randomly divided into the experimental group and control group, 95 in each, The first group was administered with insulin to control blood sugar and simultaneously with the Wenshen Huoxue decoction daily for 3 months. The second group was administered insulin too to control blood sugar, in addition, they were given a placebo herbal decoction daily for 3 months. After collection of the data the result was revealed.. Results After treatment, the mean scores of I/EF-5 in the experimental group were significantly higher than that before treatment. There was significantly statistical difference between the two periods （P〈0.05）. There was significantly statistical difference between the mean scores of IIEF-5 between the two groups （P〈0.05）. In assessment of the erectile hardness grading scale （EHGS）, the effective rate of the first group was 79.27%, while 43.75% in the second group. There was s significantly statistical difference between the two groups. Conclusion With insulin and the herbal decoction the condition of dibetics improves significantly, better than exclusive administration of insulin,which is a more effective therapy for ED in diabetics.