[Safety and efficacy of China-made sildenafil citrate in the treatment of erectile dysfunction].

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 (ï¼»47.2±11.32ï¼½ yr vs ï¼»46.67±13.08ï¼½ 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.

[Clinical analysis of yuziwan in the treatment of 30 sterile men with abnormal protamine].

OBJECTIVE: To study the clinical application and effects of Yuziwan in the treatment of male sterility patient with abnormal protamine. METHODS: The changes of protamine, semen and sex hormones of 30 male sterility patients treated by Yuziwan were observed before and after the treatment. RESULTS: After a 3-month course of treatment, 9 cases were cured, 15 obviously improved and 6 failed to respond. The ratio of histone to protamine was decreased from (1.34 +/- 0.52) before the treatment to (0.72 +/- 0.32) after it, with significant difference (P < 0.01), the semen quality obviously improved (P < 0.05), and the LH and T levels markedly raised (P < 0.01). Yuziwan evidently improved the abnormal protamine, sperm quality and endocrine function of the sterility patients. CONCLUSION: Yuziwan has good curative effect on male sterility.

Efficacy and safety of on-demand tadalafil for the treatment of erectile dysfunction in South-East Asian men.

AIM: Tadalafil is an inhibitor of phosphodiesterase type 5 used for the treatment of erectile dysfunction (ED). The efficacy and safety of tadalafil have been evaluated extensively in Western populations. Our aim was to assess the efficacy and safety of on-demand tadalafil for the treatment of ED in South-East Asian men. METHODS: This was a randomized, double-blind, placebo-controlled study of men with mild to severe ED of various etiologies randomized to receive placebo (n = 122), tadalafil 10 mg (n = 120), or tadalafil 20 mg (n = 125), taken as needed (maximum once daily) for 12 weeks. Efficacy assessments included the International Index of Erectile Function (IIEF), the Sexual Encounter Profile (SEP) diary, and a Global Assessment Question (GAQ). RESULTS: Men from China, Singapore, and the Philippines participated in this trial (n = 367). Compared with placebo, tadalafil significantly improved erectile dysfunction on all efficacy outcomes (P < 0.001). Patients receiving tadalafil 10 mg and 20 mg experienced a significant mean improvement of 8.1 and 8.7, respectively, in the IIEF Erectile Function (IIEF-EF) domain score from baseline (vs placebo 2.4, P < 0.001). In patients receiving tadalafil 10 mg and 20 mg, the mean per-patient success rate for intercourse attempts (SEP3) was 62% and 70%, respectively, compared with 32% for the placebo group (P < 0.001). Of patients who received tadalafil 10 mg and 20 mg, 81% and 86% reported improved erections at endpoint (GAQ) compared with 44% in the placebo group (P < 0.001). The most common adverse events reported by patients were headache, back pain, dyspepsia, and dizziness. CONCLUSIONS: Tadalafil was an effective and well-tolerated treatment for South-East Asian men with ED.

[Prevalence of chronic prostatitis and its effects on male infertility].

OBJECTIVE: To investigate the prevalence of chronic prostatitis (CP) in male infertility patients and its effects on male infertility. METHODS: 534 male patients with complaints of male infertility were interviewed for the history of prostatic disease and underwent digital rectal examination of prostate, analysis of semen and express prostatic secretions (EPS). Bacterial culture of urine was done in 40 randomly selected inflammatory CP patients by pre- and post-message method (pre- and post-massage test, PPMT). RESULTS: 209 out of the 534 patients with male infertility were diagnosed as chronic prostatitis with a prevalence rate of 39.1%, among which 46 with CP type II and IIIA with the prevalence rate of 8.6%, 28 with CP type IIIB (5.2%), and 135 with CP type IV (25.3%) respectively. Positive bacterial culture was found in 10 out of the 40 cases of inflammatory chronic prostatitis (25.0%). The bacterial infection rate was 24.2% (8/33) in the cases of CP type IV. The prevalence rate of liquefaction dysfunction was much higher in the patients of male infertility with CP (22.7%) than in those without CP (14.3%, P < 0.05), however, it had little influence on the quality of semen, pH value, sperm density, and sperm motility. CONCLUSION: Quite common in patients with male infertility, CP prolongs the time of liquefaction, but has no other reverse influence on semen.