Safety and efficacy of China-made sildenafil citrate in the treatment of erectile dysfunction.
- Author:
De-Feng LIU
1
;
Ji-Chuan ZHU
2
;
Hui JIANG
3
;
Kai HONG
3
;
Qing-Quan XU
3
;
Zhan-Ju HE
4
;
Tian-Ming PAN
3
;
Shen-Rong ZHUANG
3
;
Xin GAO
5
;
Bin ZHANG
5
;
Xi-Shuang SONG
6
;
Tao JIANG
6
;
Zhe ZHANG
3
;
Han WU
3
Author Information
1. Department of Reproductive Andrology, Peking University Third Hospital, Beijing 100191, China.
2. >Department of Urology, Peking University People's Hospital, Beijing 100044, China.
3. Department of Urology, Peking University Third Hospital, Beijing 100191, China.
4. Department of Urology, Peking University First Hospital, Beijing 100034, China.
5. Department of Urology, The Third Affiliated Hospital of Sun Yat-sen University, Guangzhou, Guangdong 510630, China.
6. Department of Urology, The Frist Affiliated Hospital of Dalian Medical University, Dalian, Liaoning 510630, China.
- Publication Type:Journal Article
- Keywords:
China-made sildenafil citrate;
International Index of Erectile Function;
efficacy;
erectile dysfunction;
safety
- MeSH:
Aged;
China;
Coitus;
Double-Blind Method;
Drug Compounding;
Erectile Dysfunction;
drug therapy;
etiology;
Humans;
Male;
Phosphodiesterase 5 Inhibitors;
therapeutic use;
Sildenafil Citrate;
therapeutic use;
Smoking;
Treatment Outcome
- From:National Journal of Andrology
2017;23(1):43-48
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To evaluate the safety, efficacy and tolerability of China-made sildenafil citrate (Jinge) in the treatment of ED.
METHODS:We conducted a multi-center, randomized, double-blind and placebo-controlled clinical trial among 222 ED patients in five urological or andrological clinics of China. The patients were randomly assigned to receive sildenafil citrate (SC, n = 111) or placebo (n = 111) for 8 weeks. We obtained and analyzed the demographic and clinical characteristics of the patients, the scores of International Index of Erectile Function (IIEF), the success rate of sexual intercourse, and the incidence of adverse events.
RESULTS:No statistically significant differences were found between the patients of the SC and those of the placebo group in the mean age (［47.2±11.32］ yr vs ［46.67±13.08］ yr, P>0.05), psychological etiology (27.93% vs 23.42%, P>0.05), organic etiology (21.62% vs 29.73%, P>0.05) or mixed etiology (50.45% vs 46.85%, P>0.05), nor in height, weight, nationality, or history of smoking, drinking or allergy. Compared with the placebo controls, the SC-treated patients showed significant increases in the excellence rate of effectiveness (29.91% vs 78.90%, P<0.01), success rate of sexual intercourse (29.16% vs 63.87%, P<0.01), and total effectiveness rate (34.58% vs 77.98%, P<0.01). The effectiveness rates on organic, psychogenic and mixed types ED were remarkably higher in the SC group (64.52%, 83.33%, and 82.14%) than in the placebo control (46.15%, 21.21%, and 25.00%) (P<0.01). Mild or temporary adverse events were observed in 32 cases in the SC group as compared with 13 in the placebo control.
CONCLUSIONS:China-made sildenafil citrate is an effective, safe and well-tolerated drug for ED of different etiologies in the Chinese population.
