复方玄驹胶囊合用伐地那非治疗勃起功能障碍临床研究

Clinical study of compound Xuanju capsule combining vardenafil in the treatment of erectile dysfunction

目的:观察复方玄驹胶囊合用伐地那非治疗勃起功能障碍(ED)与单用伐地那非的疗效区别。方法:84例肾阳虚型勃起功能障碍患者随机平均分为试验组和对照组。试验组服用复方玄驹胶囊3粒/次,3次/d,性生活前30min服用伐地那非10mg,疗程8周。对照组性生活前30min服用伐地那非10mg,疗程8周。对用药前后患者国际勃起功能评分(IIEF-5)及TSS伴侣评分进行对比分析。结果:两组对勃起功能改善的有效率比较,试验组总有效率95.24%,对照组88.10%,两组对比差异无显著性意义(P>0.05)。IIEF-5评分试验组治疗前后分别为(12.19±2.62)分和(21.67±2.83)分,而对照组治疗前后分别为(10.45±5.34)分和(15.05±4.69)分,每组治疗前后对比差异有显著性意义(P<0.05);治疗后两组IIEF-5评分及TSS伴侣评分比较,试验组的效果均比对照组好,且差异具有显著性意义(P<0.05)。结论:复方玄驹胶囊合用伐地那非治疗勃起功能障碍优于单用伐地那非,PDE-5抑制剂联合中药治疗ED值得推广。

Objectives： To observe the curative effect of Compound Xuanju Capsule（ CXC） combining vardenafil and vardenafil alone in the treatment of erectile dysfunction（ ED）. Methods： The patients（ n = 84） with ED（ kidney yang deficiency） were randomly divided into test group and control group with equal number. The former group was treated with oral CXC once 3 capsules tid plus 10 mg vardenafil at 30 min before sexual activity,while the latter group was treated with 10 mg vardenafil at 30 min before sexual activity. After 8 weeks of treatment,the patients＇ scores on IIEF-5 and their partners＇ scores on Treatment Satisfaction Scale（ TSS） between the two groups were compared. Results： The total rate of erectile function improvement was 95. 24% in test group and88. 10% in control group（ P〉0. 05）. The IIEF-5 scores in test group were（ 12. 19 ± 2. 62） and（ 21. 67 ±2. 83） before and after the treatment. The IIEF-5 scores in control group after treatment were（ 10. 45 ± 5. 34） and（ 15. 05 ± 4. 69） before and after treatment（ P〈0. 05）. The IIEF-5 scores of the patients and the TSS scores of their partners after treatment in test group were markedly higher than these in control group（ P〈0. 05）.Conclusion： Compound Xuanju Capsule combining vardenafil is superior to vardenafil alone in treatment of erectile dysfunction. PDE5-inhibitor combining Chinese medicinal for treating ED is worth of being promoted.