Wu Meng, Hao Bao-Jin, Liang Wei-Ning, Li Yi-Ze, Geng Qiang, Shang Xue-Jun
Department of Urology, Wujin Hospital of Traditional Chinese Medicine, Nanjing University of Chinese Medicine, Changzhou, Jiangsu 213003, China.
Department of Urology, Jinhu County People's Hospital, Jinhu, Jiangsu 211600, China.
Zhonghua Nan Ke Xue. 2020 Apr;26(4):346-350.
To evaluate the efficacy and safety of Jiarong Tablets (JRT) combined with Testosterone Undecanoate Capsules (TUC) in the treatment of late-onset hypogonadism (LOH) in males.
This randomized open multicentered clinical trial included 200 cases of LOH meeting the inclusion, which were equally randomized into a control (aged ［51.09 ± 5.6］ yr) and a trial group (aged ［50.46 ± 5.2］ yr) to be treated with oral TUC (40 mg, bid) and TUC+JRT (0.92 g, tid) respectively for 12 successive weeks. We obtained the Aging Males' Symptoms (AMS) and IIEF-5 scores, serum total testosterone (TT) content, red blood cell (RBC) count, hepatic and renal function indexes and glucose and total PSA levels before and after treatment, and compared them between the two groups of patients.
Totally, 191 of the LOH patients completed the experiment, 95 in the control and 96 in the trial group. After 12 weeks of treatment, the patients in the trial group, compared with the controls, showed significant improvement in the AMS score (20.6 ± 5.7 vs 31.9 ± 6.1, P < 0.05), IIEF-5 score (20.3 ± 3.1 vs 16.3 ± 3.8, P < 0.05) and serum TT level (［16.1 ± 3.9］ vs ［12.7 ± 3.4］ nmol/L, P < 0.05). There were no significant adverse events or abnormalities in the RBC count, hepatic and renal functions, or glucose and total PSA levels in the two groups of patients before and after medication.
JRT combined with TUC is safe and effective and superior to TUC alone in the treatment of LOH in males.
评估加荣片（JRT）联合十一酸睾酮胶囊（TUC）治疗男性迟发性性腺功能减退（LOH）的疗效和安全性。
本随机开放多中心临床试验纳入200例符合纳入标准的LOH患者，将其随机分为对照组（年龄［51.09±5.6］岁）和试验组（年龄［50.46±5.2］岁），分别口服TUC（40mg，每日2次）和TUC+JRT（0.92g，每日3次），连续治疗12周。在治疗前后获取男性衰老症状（AMS）和国际勃起功能指数-5（IIEF-5）评分、血清总睾酮（TT）含量、红细胞（RBC）计数、肝肾功能指标以及血糖和总前列腺特异性抗原（PSA）水平，并在两组患者之间进行比较。
共有191例LOH患者完成实验，对照组95例，试验组96例。治疗12周后，试验组患者与对照组相比，AMS评分（20.6±5.7对31.9±6.1，P<0.05）、IIEF-5评分（20.3±3.1对16.3±3.8，P<0.05）和血清TT水平（［16.1±3.9］对［12.7±3.4］nmol/L，P<0.05）均有显著改善。两组患者用药前后的RBC计数、肝肾功能、血糖和总PSA水平均无显著不良事件或异常。
JRT联合TUC治疗男性LOH安全有效，且优于单用TUC。
