Objective: To study the safety and efficacy of Bushen Daozhuo Granules (BDG) in the treatment of type Ⅲ prostatitis.
Methods: This multicenter 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 sustainedrelease 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 (NIHCPSI) scores and compared the safety and effectiveness rate between the two groups of patients.
Results: Compared with the baseline, the NIHCPSI 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 NIHCPSI 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.
目的： 探讨补肾导浊颗粒治疗Ⅲ型前列腺炎的安全性和有效性。 方法： 采用多中心随机对照研究，对照组口服盐酸坦索罗辛缓释胶囊，0.2 mg/次，每天1次；治疗组口服补肾导浊颗粒，每次200 ml，每日2次，两组的治疗期为4周。分别于治疗前、治疗4周、停药4周行慢性前列腺炎症状评分（CPSI），评估两组的安全性和有效性。 结果： 共有478例患者完成本研究，其中对照组188例，治疗组290例。对照组在治疗4周后的CPSI为（15.67±3.65）分，显著低于治疗前（21.42±4.02）分（P < 0.05），停药4周后CPSI为（19.03±3.86）分，与治疗前相比较，无显著差异（P >0.05）。治疗组在治疗4周、停药4周的CPSI分别为（10.92±2.06）分、（12.91±2.64）分，显著低于治疗前（21.58±3.67）分（P < 0.05），与对照组相比较，均有显著差异（P < 0.05）。治疗组的疾病有效率和总有效率均高于对照组（P < 0.05）。治疗组的安全性优于对照组（P < 0.05）。结论： 补肾导浊颗粒治疗Ⅲ型前列腺炎的安全、有效。.
Keywords: Bushen Daozhuo Granules; type Ⅲ prostatitis; NIH Chronic Prostatitis Symptom Index.