佳蓉片联合十一酸睾酮胶丸治疗迟发性性腺功能减退症的多中心临床疗效观察  

Jiarong Tablets combined with Testosterone Undecanoate Capsules for late-onset hypogonadism in males: A multicentered clinical trial

作　　者：吴猛[1] 郝宝金 梁威宁 李奕泽 耿强[4] 商学军 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;Department of Andrology,The First School of Clinical Medicine,Southern Medical University/General Hospital of Eastern Theater Command,Nanjing,Jiangsu 210002,China;Department of Andrology,The First Affiliated Hospital of Tianjin University of Chinese Medicine,Tianjin 300193,China)

机构地区：[1]南京中医药大学附属武进中医医院泌尿外科,江苏常州213003 [2]金湖县人民医院泌尿外科,江苏淮安211600 [3]南方医科大学第一临床医学院/东部战区总医院男科,江苏南京210002 [4]天津中医药大学第一附属医院男科,天津300193

出　　处：《中华男科学杂志》2020年第4期346-350,共5页National Journal of Andrology

摘　　要：目的:评价佳蓉片联合十一酸睾酮胶丸治疗男性迟发性性腺功能减退(LOH)的安全性和有效性。方法:采用随机、开放、多中心的临床研究方法,选取200例符合纳入标准的LOH患者,按照数字表法随机分为试验组和对照组各100例,对照组给予患者口服十一酸睾酮胶丸,40 mg/次,2次/d;试验组在此基础上加用佳蓉片,4片/次,3次/d,两组均连续服用12周。分别记录基线期及治疗后两组患者AMS评分、IIEF-5评分、血清TT以及安全性指标(红细胞计数、肝功能、肾功能、血糖以及总前列腺特异性抗原)。结果:191例符合纳入标准的LOH患者完成试验,以AMS评分、血清TT以及IIEF-5评分作为疗效评价指标,经过3个月治疗后,试验组在AMS评分(20.6±5.7)、血清TT(16.1±3.9) nmol/L以及IIEF-5评分(20.3±3.1)方面均优于对照组(31.9±6.1)、(12.7±3.4) nmol/L、(16.3±3.8),差异具有统计学意义(P<0.05)。两组患者治疗前后红细胞计数、肝功能、肾功能、血糖以及tPSA均未发现异常,也无明显的不良反应事件。结论:佳蓉片联合十一酸睾酮胶丸治疗LOH优于单一使用十一酸睾酮胶丸,安全有效,值得临床推广应用。Objective: 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. Methods: 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. Results: 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. Conclusion: JRT combined with TUC is safe and effective and superior to TUC alone in the treatment of LOH in males.

关 键 词：迟发性性腺功能减退 佳蓉片 十一酸睾酮胶丸 多中心 临床疗效观察 

分 类 号：R698+.2[医药卫生—泌尿科学]