[The clinical efficacy of Naftopidil tablet in the treatment of benign prostatic hyperplasia]

Abstract

Objectives: To evaluate the clinical efficacy and safety of Naftopidil tablet in treating benign prostatic hyperplasia.

Methods: Eighty BPH patients were divided into two groups randomly by double-blind, double-simulated and active control parallel study trials. Forty patients in treatment group were given Naftopidil tablet 25 mg, p.o., qn for 42 days, while 40 patients in control group were given Tamsulosin 0.2 mg, p.o., qn for 42 days. Statistical analysis was given from 77 cases in the groups. Estimation of the efficacy was done by the change of major indexes include international prostate symptom score (IPSS), maximum flowrate (Qmax) and secondary indexes such as quality of life (QOL), residual urine (Ru) and volume of prostate (V).

Results: The changes of IPSS, Qmax, QOL had significant difference between two groups before and after treatment(P < 0.05). The change of Ru had no significant difference between two groups before and after treatment (P > 0.05) while there was significant difference between two groups after six-week treatment(P < 0.05). The change of V had no significant difference (P > 0.05). The adverse reactions in both groups were mild, and there was no significant difference between two groups(P > 0.05).

Conclusions: Naftopidil tablet was safe and effective in treating benign prostatic hyperplasia.