二仙汤治疗肾阴阳两虚型男性迟发性性腺功能减退症临床研究
Clinical Research of Er Xian Decoction in Treating the Both Kidney Yin and Yang Deficiency Type of Late-Onset Hypogonadism in Males
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摘要: 观察二仙汤治疗肾阴阳两虚型男性迟发性性腺功能减退症(LOH)的临床疗效。方法 采用单盲、随机对照临床观察的研究方法,按照纳入及排除标准,选入80例男性迟发性性腺功能减退症受试者,按1∶1随机分为试验组和对照组。试验组口服中药方剂二仙汤,对照组口服十一酸睾酮胶丸治疗,疗程12周。对比治疗前,治疗后4周、8周、12周,中老年男子部分性雄激素缺乏综合征(PADAM)症状评分分值及血清睾酮(TT)、睾酮分泌指数(TSI)的变化情况。结果 治疗后4周、8周、12周,2组患者PADAM症状评分中,体能加血管症状、精神心理症状、性功能减退症状评分均较治疗前降低,差异有统计学意义(P<0.05);2组患者TT、TSI均较治疗前增加,差异有统计学意义(P<0.05),2组比较,治疗后第4周TT、TSI水平有显著性差异(P<0.05);2组治疗后中医证候积分比治疗前降低(P<0.05),2组组间比较,差异无统计学意义(P>0.05);治疗期间2组均未发生不良事件。结论 二仙汤可显著改善肾阴阳两虚型男性迟发性性腺功能减退症患者临床症状,增加TT、TSI水平,疗效同十一酸睾酮相当。Abstract: OBJECTIVE To observe the efficacy of Er Xian Decoction in treating the both kidney yin and yang deficiency type of late-onset hypogonadism in males (LOH). METHODS In accordance with the acceptance and exclusion criteria, 80 LOH patients were randomly divided into trial group and control group by a randomized controlled single-blind clinical trial and treated for 12 weeks. The trial group was treated with Er Xian Decoction, and the control group with testosterone undecanoate capsule. Compare the partial androgen deficiency in aging males(PADAM) scores, the levels of serum total testosterone (TT) and testosterone secretion index (TSI) of the two groups before treatment and after 4, 8 and 12 weeks of treatment. RESULTS The PADAM scores difference of the trial group between before and after 4, 8 and 12 weeks of treatment has significance in statistics (P<0.05). The TT level and TSI difference of the trial group between before and after 4, 8 and 12 weeks of treatment has significance in statistics (P<0.05). The difference was not statistically significant between the two groups in these indicators except after 4 weeks treatment (P>0.05). After the treatment, TCM syndrome scores in two groups decreased significantly compared with pre-treatment (P<0.05), and the difference was not statistically significant between the two groups (P>0.05). CONCLUSION Er Xian Decoction could significantly improve the clinical symptoms of LOH with both kidney yin and yang deficiency and increase the serum TT level and TSI, and equivalent to the effect of testosterone undecanoate.