益肾活血汤联合缬沙坦治疗2型糖尿病合并男性性功能障碍的临床研究

目的 探讨益肾活血汤联合缬沙坦治疗2型糖尿病（type 2 diabetes mellitus，T2DM）合并男性性功能障碍患者的临床疗效及安全性。方法 将T2DM合并男性性功能障碍患者146例，按随机数字表法分为对照组和观察组，每组73例。对照组患者予缬沙坦胶囊口服，观察组患者加服益肾活血汤，4周为1个疗程，连续治疗3个疗程。观察治疗前后两组患者国际勃起功能障碍指数（International index of erectile dysfunction-5，IIEF-5）、阴茎勃起时间、阴茎头、根部平均硬度及血清性激素促卵泡生成素（Follicle stimulating hormone，FSH）、黄体生成素（Luteinizing hormone，LH）、雌二醇（estradiol，E₂）和睾酮（testosterone，T）]水平变化；评估两组患者治疗后性生活满意度和不良反应发生率；比较两组患者治疗后临床总有效率。结果 观察组患者临床总有效率84.93%明显高于对照组的50.68%（P<0.05）；两组患者治疗后IIEF-5、阴茎勃起时间、阴茎头、根部平均硬度及血清T水平均较治疗前明显升高（P<0.05），血清FSH、LH及E₂水平均显著下降（P<0.05），且观察组各项指标的改善明显优于对照组（P<0.05）；观察组患者性生活总满意度91.78%明显高于对照组的68.49%（P<0.05）；两组患者在治疗期间均未出现明显不良反应。结论 益肾活血汤联合缬沙坦治疗T2DM合并男性性功能障碍临床疗效确切，能有效改善患者的阴茎状态和血清性激素水平，改善患者的性生活，安全性高，值得临床推广应用。

Clinical Study on Yishen Huoxue Decoction Combined with Valsartan in the Treatment of Patients with Type 2 Diabetes Mellitus with Male Sexual Dysfunction

Objective To explore the clinical efficacy and safety of Yishen Huoxue Decoction combined with valsartan in the treatment of type 2 diabetes mellitus (T2DM) with male sexual dysfunction. Methods According to the random number table method, 146 cases of T2DM patients with male sexual dysfunction were divided into a control group and an observation group, with 73 cases in each group. The patients in the control group were given valsartan capsules orally, while those in the observation group were given Yishen Huoxue Decoction on the basis of the control group, 4 weeks as a course of treatment, with 3 consecutive courses of treatment. The changes of the international index erectile dysfunction-5 (IIEF-5), erectile time, penile head, root hardness and serum level of sex hormones (follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E₂) and testosterone (T) were observed before and after treatment in the 2 groups; the sexual life satisfaction and incidence of adverse reactions were evaluated after treatment in the 2 groups; the total effective rate of the 2 groups of patients after treatments was compared. Results The total clinical efficiency rate of the observation group was 84.93%, which was significantly higher than 50.68% of the control group (P<0.05). The IIEF-5, penile erectile time, penile head, the average hardness of root and serum T level of the 2 groups after treatment were significantly higher than those before treatment (P<0.05), and the level of serum FSH, LH, and E₂ were significantly lower (P<0.05), and the improvement of each index of observation group was significantly better than that of the control group (P<0.05); the total satisfaction rate of sexual life in the observation group was 91.78%, which was significantly higher than 68.49% in the control group (P<0.05); there were no significant adverse reactions in the 2 groups during the treatment period. Conclusion Yishen Huoxue Decoction combined with valsartan in the treatment of T2DM patients with male sexual dysfunction has significant clinical effects, which can effectively improve the penile state and serum sex hormone level of patients, improve the sexual life of patients with high safety, and it is worthy of clinical application.