中文摘要：

目的：探讨前列通窍胶囊治疗前列腺增生症（BPH）的临床疗效。方法：采用随机对照、双盲双模拟及多中心临床研究方法,将符合纳入标准的186例研究对象按1∶1随机分入治疗组和对照组,最终有效病例治疗组87例,对照组88例,治疗组采用前列通窍胶囊＋癃闭舒胶囊模拟剂,对照组采用前列通窍胶囊模拟剂＋癃闭舒胶囊治疗。8周为1个疗程,观察1个疗程。随访观察4周。结果：治疗组总有效率为63.22%,其中显效率为6.90%;对照组总有效率为47.73%,其中显效率为2.28%,两组疗效比较具有显著性差异（P〈0.01）。两组治疗后患者国际前列腺症状评分（I-PSS）、生活质量（Qo L）评分、最大尿流率（Qmax）、膀胱残余尿量、中医证候积分均有明显改善（P〈0.01）,而前列腺体积无明显变化。组间比较显示,治疗组在改善BPH患者I-PSS、Qo L、Qmax、中医证候积分方面优于对照组（P〈0.01）;在减少膀胱残余尿量方面,无显著性差异。结论：前列通窍胶囊可明显改善BPH引起的临床症状,是治疗BPH的一个安全、有效的制剂,具有广阔的开发应用前景。

英文摘要：

Objective： To evaluate the clinical efficacy of Qianlietongqiao Capsule in the treatment of benign prostatic hyperplasia（BPH）. Methods： A randomized control, double-blind, double-simulation and multi-center clinical trial was applied. One hundred and eighty-six eligible patients with BPH were randomly divided into treatment group and control group in ratio of 1∶1. Finally the effective number of cases in treatment group and control group was 87 and 88 respectively. The treatment group was treated with Qianlietongqiao Capsule and Longbishu Capsule simulants, while the control group was treated with Qianlietongqiao Capsule simulants and Longbishu Capsule. A course of treatment last 8 weeks including the one observation course. Then there would be a 4-week follow-up visit. Results： The total effectiveness rate of treatment group was 63.22% with significant efficiency rate of 6.9% and that of control group was 47.73% with significant efficiency rate of 2.28%. There were significant differences in clinical efficacy between the two groups（P0.01）. The I-PSS, Qo L, Qmax, residual urine volume and TCMSS were obviously improved in both groups after treatment（P0.01）, whereas no changes were found in prostate gland volume; Compared with control group, treatment group was better in the improvement of I-PSS, Qo L, Qmax and TCMSS of BPH patients with significant difference（P0.01）, but there was no significant difference in reducing residual volume between the two groups. Conclusion： Qianlietongqiao Capsule can significantly improve clinical syndromes caused by BPH, which is a safe and effective medicine in treating BPH with broad development and application prospects.