[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%.


CONCLUSIONS
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.
Song
Yi
Y
Institute of Urology, the First Hospital of Peking University, Beijing 100034, China.
Li
Ning-chen
NC
Wang
Xiao-feng
XF
Ma
Lu-lin
LL
Wan
Ben
B
Hong
Bao-fa
BF
Na
Yan-qun
YQ
D000368:Aged; D000369:Aged, 80 and over; D004338:Drug Combinations; D004979:Ethamsylate / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010936:Plant Extracts / Q000009:adverse effects / Q000627:therapeutic use*; D011470:Prostatic Hyperplasia / Q000188:drug therapy*; D011788:Quality of Life; D016896:Treatment Outcome; D014563:Urodynamics
D004338:Drug Combinations; D010936:Plant Extracts; D004979:Ethamsylate; C010152:eviprostat