补肾导浊颗粒治疗Ⅲ型前列腺炎的多中心随机对照临床试验

[Bushen Daozhuo Granules for type Ⅲ prostatitis: A multicenter randomized controlled clinical trial].

作者信息

Sun Da-Lin, Cai Bin, Jin Bao-Fang, Xia Guo-Shou, Tang Zhi-An, Yang Wen-Tao, Zou Qiang, Song Guo-Hong, Liu Jian-Guo, Zhao Hong-le, Dai Ning, Wang Jia-Hui, Gu Ya-Long, Zhai Ya-Lin

机构信息

Department of Andrology by Integrated Chinese and Western Medicine, Zhongda Hospital, Southeast University, Nanjing, Jiangsu 210009, China.

Department of Andrology, The Third Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing, Jiangsu 210001, China.

出版信息

Zhonghua Nan Ke Xue. 2017 Feb;23(2):164-168.

PMID:29658256

Abstract

OBJECTIVE

To study the safety and efficacy of Bushen Daozhuo Granules (BDG) in the treatment of type Ⅲ prostatitis.

METHODS

This multicenter randomized controlled clinical trial included 478 patients with type Ⅲ prostatitis, 290 in the trial group and 188 as controls, the former treated with BDG at 200 ml bid and the latter with tamsulosin hydrochloride sustainedrelease capsules at 0.2 mg qd, both for 4 weeks. Before treatment, after 4 weeks of medication, and at 4 weeks after drug withdrawal, we obtained the NIH Chronic Prostatitis Symptom Index (NIHCPSI) scores and compared the safety and effectiveness rate between the two groups of patients.

RESULTS

Compared with the baseline, the NIHCPSI score was markedly decreased in the control group after 4 weeks of medication (21.42 ± 4.02 vs 15.67 ± 3.65, P < 0.05) but showed no statistically significant difference from that at 4 weeks after drug withdrawal (19.03 ± 3.86) (P>0.05), while the NIHCPSI score in the trial group was remarkably lower than the baseline both after 4 weeks of medication and at 4 weeks after drug withdrawal (10.92 ± 2.06 and 12.91 ± 2.64 vs 21.58 ± 3.67, P < 0.05). The trial group exhibited both a higher rate of total effectiveness and safety than the control (P < 0.05).

CONCLUSIONS

BDG is safe and effective for the treatment of type Ⅲ prostatitis.

摘要

目的

研究补肾导浊颗粒（BDG）治疗Ⅲ型前列腺炎的安全性和有效性。

方法

本多中心随机对照临床试验纳入478例Ⅲ型前列腺炎患者，试验组290例，对照组188例。试验组给予BDG 200 ml，每日2次；对照组给予盐酸坦索罗辛缓释胶囊0.2 mg，每日1次，疗程均为4周。于治疗前、用药4周后及停药4周后分别记录美国国立卫生研究院慢性前列腺炎症状指数（NIH-CPSI）评分，比较两组患者的安全性及有效率。

结果

对照组用药4周后NIH-CPSI评分较基线显著降低（21.42±4.02比15.67±3.65，P<0.05），但与停药4周后（19.03±3.86）比较差异无统计学意义（P>0.05）；试验组用药4周后及停药4周后NIH-CPSI评分均显著低于基线（10.92±2.06及12.9±2.64比21.58±3.67，P<0.05）。试验组总有效率及安全性均高于对照组（P<0.05）。