前列通爽胶囊治疗良性前列腺增生症的疗效及安全性.

OBJECTIVE: To probe into the efficacy and safety of Qianlietongshuang capsules in treatment of benign prostatic hyperplasia (blood stasis syndrome). METHODS: 433 cases met the criteria of benign prostatic hyperplasia (blood stasis syndrome) were enrolled by a randomized double-blind multi-center, according to the random number table, the patients were divided into observation group (323 cases) and control group (110 cases). The control group were treated with Zeguilongshuang capsules, while the observation group received Qianlietongshuang capsules. The efficacy of two groups were comprehensively evaluated, and the adverse drug reactions were statistically collected. RESULTS: After treatment of 28 d, the international prostate symptom score, traditional Chinese medicine (TCM) syndrome score, the maximum urinary flow rate, residual urine volume and prostate volume of observation group were respectively (11.32 ±6.23) scores, (4.58 ±2.67) scores, (13.60 ±4.00) ml/s, (30.75 ±50.23) ml and (31.76 ±17.75) cm3 , and the control group were (11.17 ±6.33) scores, (4.45 ±2.63) scores, (13.84 ±4.22) ml/s, (27.20 ±45.60) ml and (30.27 ±13.42) cm3, both groups had been improved significantly, the difference was statistically significant (P<0.05). After treatment of 28 d, there was no statistical significance between two groups in the recent control rate, the total efficiency rate and the total effective rate (P>0.05). The incidence of adverse drug reactions was 1.55% (5/323), control group was 0.91% (1/110), without any statistical significance (P >0.05). CONCLUSIONS: Compared with Qianlietongshuang capsules in treatment of benign prostatic hyperplasia is basically the same with Zeguilongshuang capsules in improve disease symptoms, TCM symptom scores and quality of life in patients without any significant adverse drug reactions. [ABSTRACT FROM AUTHOR]