Safety and efficacy of China-made sildenafil citrate in the treatment of erectile dysfunction / 中华男科学杂志
National Journal of Andrology
;
(12): 43-48, 2017.
Artigo
em Chinês
| WPRIM
| ID: wpr-812812
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.
Texto completo:
DisponíveL
Índice:
WPRIM (Pacífico Ocidental)
Assunto principal:
Fumar
/
China
/
Método Duplo-Cego
/
Resultado do Tratamento
/
Coito
/
Usos Terapêuticos
/
Composição de Medicamentos
/
Tratamento Farmacológico
/
Inibidores da Fosfodiesterase 5
/
Citrato de Sildenafila
Tipo de estudo:
Ensaio Clínico Controlado
Limite:
Idoso
/
Humanos
/
Masculino
País/Região como assunto:
Ásia
Idioma:
Chinês
Revista:
National Journal of Andrology
Ano de publicação:
2017
Tipo de documento:
Artigo
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