二地鳖甲煎治疗勃起功能障碍肾阴虚证临床观察

Erdi Biejia Decoction for erectile dysfunction with kidney-yin deficiency

目的:通过观察二地鳖甲煎配方颗粒治疗勃起功能障碍(ED)的临床疗效,探讨其作用机理,总结滋阴思想在ED中的应用。方法:收集ED肾阴虚证患者60例,并随机分为2组,治疗组30例口服二地鳖甲煎配方颗粒,对照组30例口服安慰剂颗粒,疗程为8周,观察治疗前后国际勃起功能指数-5(IIEF-5)评分、血清性激素(T、E2、LH、FSH、PRL)指标的变化。结果:治疗组临床总有效率63.33%,IIEF-5评分治疗前为(12.01±3.22)分,治疗后为(23.08±1.71)分,较治疗前明显增加(P<0.05),血浆中性激素变化表现为T浓度由治疗前(16.18±3.21)nmol/L升高到治疗后的(20.14±2.99)nmol/L,E2、LH、FSH、PRL浓度分别由治疗前的(1.07±0.25)、(3.32±1.04)、(3.41±0.63)、(0.38±0.08)nmol/L降低到治疗后的(0.79±0.23)、(2.74±1.09)、(2.86±0.58)、(0.29±0.06)nmol/L,较治疗前有显著性差异(P<0.05);对照组临床总有效率36.67%,IIEF-5较治疗前增加(P<0.05),血浆中性激素无明显变化(P>0.05);两组疗效比较:治疗组疗效优于对照组(P<0.05);并且在IIEF-5评分增加、血浆中性激素变化(T浓度升高,E2、LH、FSH、PRL浓度降低)等方面均有显著性差异(P<0.05)。结论:二地鳖甲煎配方颗粒治疗ED肾阴虚证,疗效优于安慰剂,无明显不良反应。

Objective： To observe the clinical efficacy of the Chinese medicine Erdi Biejia Decoction in the treatment of erectile dysfunction （ED） with kidney-fin deficiency, and explore its action mechanism and the nourishing yin doctrine in the treatment of ED. Methods： We equally randomized 60 ED patients with kidney-y/n deficiency into a treatment and a control group, the former treated with oral Erdi Biejia Decoction, and the latter given placebo, for a course of 8 weeks. We compared the IIEF scores and levels of sex hormones T, E2, LH, FSH and PRL between the two groups before and after treatment. Results： Compared with the control group, the treatment group showed a significantly higher total effectiveness rate （36.67% vs 63.33%, P 〈0.05）, IIEF score （ 18.19 ±5.20 vs 23.08 ± 4.71, P 〈 0.05） and plasma T level （ 116.41 ± 3.19 vs 20.14 ± 2.99, P 〈 0. 05 ）, but remarkably lower levels of E2, LH, FSH and PRL （P 〈 0. 05） after medication, all with statistically significant differences from pre-medication （P 〈 0.05 ）. Con- clusion ： Erdi Biejia Decoction is efficacious in the treatment of ED with kidney-fin deficiency, with no obvious adverse effects.