摘要
目的 观察枸橼酸西地那非上市后实际临床应用中的安全性和有效性。 方法 采用多中心、开放、非对照的方法 ,在全国 3 6家医院对 2 10 1例因勃起功能障碍口服西地那非治疗的患者进行了观察随访。平均观察期 65d( 6～ 3 10d)。 2 60例患者 ( 12 .4% )观察达 6个月以上。 结果 所观察到的各系统不良事件的特点和类型与说明书中所列及中国Ⅱ期临床试验结果一致。未发现新的不良事件 ,不良事件发生率并不因服药期延长而升高。所有不良事件均为轻度至中度 (以轻度为主 ) ,多数不需处理即可缓解 ,多于服药当天缓解。西地那非治疗勃起功能障碍的总有效率为 82 .3 %。 结论 西地那非治疗勃起功能障碍安全、有效。
Objective To evaluate the safety and efficacy of viagra in the treatment of erectile dysfunction in clinical practice after its marketing. Methods An open,non-control,multicenter study was conducted in 36 hospitals throughout China.A total of 2 101 patients who were already prescriped with viagra were evaluated in this study.The mean study duration was 65 days (range from 6 to 310 days).260 ( 12.4%) of these patients were followed up for at least 6 months. Results The profile and the features of adverse events observed in this study were consistent with those listed in the package insert and consistent with those observed in Chinese phase Ⅱ study.No new,unexpected adverse event was found.All adverse events were mild or moderate in severity (mainly mild).Most of them resolved without any further intervention,and within one day.This study showed the overall effective rate of viagra for erectile dysfunction was 82.3%. Conclusions Viagra is safe and effective in treating erectile dysfunction in clinical practice.
出处
《中华泌尿外科杂志》
CAS
CSCD
北大核心
2003年第2期134-137,共4页
Chinese Journal of Urology
