Objective: To investigate the clinical effects of oral Testosterone Undecanoate Capsules (TUC) combined with Qilin Pills (QLP) on late-onset hypogonadism (LOH) in men.
Methods: Sixty-three LOH patients meeting the inclusion criteria were randomly divided into a control group (aged ［48.4 ± 6.2］ yr, n = 32) and an experimental group (aged ［47.2 ± 5.6］ yr, n = 31) to be treated with oral TUC (80 mg, qd) and TUC + QLP (6g, tid), respectively, both for 3 months. Comparisons were made between the two groups of patients in the IIEF-5 scores, total testosterone (TT) levels, and scores in the Aging Males' Symptoms (AMS) scale before and after treatment.
Results: After treatment, the patients of the experimental group, as compared with the controls, showed a significantly increased IIEF-5 score (21.7 ± 5.8 vs 15.9 ± 4.7, P <0.05) and TT level (［16.7 ± 2.2］ vs ［13.1 ± 2.8］ nmol/L, P <0.05), but a decreased AMS score (20.7 ± 5.7 vs 31.3±6.5, P <0.05).
Conclusions: TUC combined with Qilin Pills has a better effect and a lower rate of adverse reactions than TUC used alone in the treatment of late-onset hypogonadism in males.
目的: 观察口服十一酸睾酮胶丸联合麒麟丸治疗男性迟发性性腺功能减退症( LOH)患者的临床疗效。方法: 符合纳入标准的63 例LOH患者随机分为对照组和试验组，对照组口服十一酸睾酮胶丸，试验组口服十一酸睾酮胶丸和麒麟丸。十一酸睾酮胶丸用法：80 mg /次，1次/d，连续服用3 个月；麒麟丸用法：6 g/次，3 次/d，连续服用3 个月。比较组内和组间治疗前后的 IIEF-5 评分、老年男性症状问卷(AMS)评分及血清总睾酮(TT)水平的变化。结果： 两组间各项数据无明显差异（P>0.05）。但治疗后试验组IIEF-5 评分(21.7±5.8)分和TT值(16.7±2.2) nmol /L均显著高于对照组(15.9±4.7) 分和(13.1±2.8) nmol /L（P<0.05）；且AMS评分(20.7±5.7)分显著低于对照组(31.3±6.5) 分（P<0.05）。结论: 麒麟丸联合十一酸睾酮胶丸治疗LOH的疗效比单用十一酸睾酮胶丸治疗效果更显著，且不增加不良反应发生率，有一定的临床应用前景。.
Keywords: Testosterone Undecanoate Capsules; late-onset hypogonadism; Qilin Pills.