[Clinical study of Eviprostat for the treatment of benign prostatic hyperplasia].

OBJECTIVE

To study the efficacy and safety of Eviprostat for the treatment of benign prostatic hyperplasia (BPH).

METHODS

An open, multicentral clinical trial was conducted in 100 patients with BPH. Patients received a 12-week oral administration of Eviprostat 2 tablets per-time, 3 times a day. The main indexes of efficacy include international prostatic symptom score (IPSS), maximum urinary flow rate (Qmax), residual urine ( Ru) and prostatic volume (V). The additional indexes are quality of life score (QOL) and average urinary flow rate (Qave).

RESULTS

After a 12-week therapy, IPSS, QOL score, Qmax and Qave were significantly improved. IPSS was averagely decreased by 5.67 (P < 0.001); QOL score was averagely decreased by 1.44 (P < 0.001); Qmax was averagely increased by 1.70 ml/s (P <0.001); Qave was averagely increased by 1.15 ml/s (P < 0.001); Ru was averagely decreased by 5.07 ml (P = 0.046) , PSA level was averagely decreased by 0.129 microg/L (P < 0.017). The clinical adverse event rate was 1%.

CONCLUSION

Eviprostat is a kind of safe, effective and preferable drug for treating BPH. It can improve the subjective symptoms and objective measures of the patients.