还少胶囊治疗脾肾两虚型勃起功能障碍的多中心临床疗效观察

Huanshao Capsules for erectile dysfunction with spleen and kidney deficiency: A multicentered clinical trial

目的:观察还少胶囊治疗脾肾两虚型ED患者的安全性和有效性。方法:采用随机、开放、多中心、阳性药物对照的临床研究方法,选取248例脾肾两虚型ED患者,随机数字表法分为治疗组和对照组各124例,治疗组给予患者口服还少胶囊,3粒/次(1粒=0.38g),3次/日;对照组给予口服五子衍宗丸,6g/次,2次/日;治疗4周。分别记录基线期,治疗2、4周后患者IIEF-5评分,中医证候评分以及肝肾功能。结果:240例符合ED诊断标准的患者完成临床观察,以IIEF-5评分作为疗效评判指标,治疗总有效率治疗组优于对照组(76.6%vs67.8%)。以中医证候评分评判,治疗组症候积分减少≥95%的14例(11.7%),减少≥70%的97例(80.8%),减少≥30%的9例(7.5%);对照组症候积分减少≥95%的7例(5.8%),减少≥70%的84例(70.0%),减少≥30%的29例(24.2%),治疗组在中医证候评分改善方面优于对照组。治疗组在基线期、治疗2、4周后IIEF-5评分分别为(13.04±4.02)、(15.95±3.22)、(20.06±2.17)分;中医证候评分分别为(16.64±5.26)、(10.08±4.89)、(3.05±2.18)分,经过4周治疗后,治疗组较对照组在IIEF-5评分及中医证候评分均有显著改善(P<0.05)。两组患者治疗前后尿、血常规以及肝、肾功能检查均未发现异常,也无明显的不良反应事件。结论:还少胶囊能明显提高脾肾两虚型ED患者IIEF-5评分,改善临床症状,安全有效,值得临床推广应用。

Objective:To investigate the clinical efficacy and safety of Huanshao Capsules (HSC) in the treatment of ED with spleen and kidney deficiency.Methods:This randomized open multicentered positive drug controlled clinical trial included 248 cases of ED with spleen and kidney deficiency,which were assigned to a trial and a control group of equal number to be treated with HSC at the dose of 3 capsules tid and Wuziyanzong Pills at 6 g bid,respectively,both for 4 weeks.We recorded and compared the IIEF-5 scores,traditional Chinese medicine (TCM) symptom scores,and hepatic and renal functions between the two groups of patients before and at 2 and 4 weeks after medication.Results:The clinical observation was completed in 240 of the patients.Based on the IIEF- 5 scores of the patients,the total effectiveness rate was significantly higher in the trial than in the control group (76.6% vs 67.8%,P < 0.05).The TCM symptom scores were decreased by ≥95% in 14 cases (11.7%),≥70% in 97 cases (80.8%) and ≥30% in 9 cases (7.5%) in the trial group as compared with ≥95% in 7 cases (5.8%),≥70% in 84 cases (70.0%) and ≥30% in 29 cases (24.2%) in the control,with remarkably better improvement in the former than in the latter group (P < 0.05).Before and at 2 and 4 weeks after medication,the IIEF-5 scores were 13.04 ± 4.02,15.95 ± 3.22 and 20.06 ± 2.17,and the TCM symptom scores were 16.64 ± 5.26,10.08 ± 4.89 and 3.05 ± 2.18 respectively in the trial group,both significantly improved at 4 weeks in comparison with those in the control (P < 0.05).No abnormality was observed in urine and blood tests or hepatic and renal functions before and after treatment,nor obvious adverse events were found in the two groups of patients during the medication.Conclusion: Huanshao Capsules can safely and effectively improve the IIEF-5 scores and clinical symptoms of ED patients with spleen and kidney deficiency,and therefore deserve a wide clinical application.