基于总处方量的不良反应报告分析对盐酸伐地那非安全性评估研究  

ADR Analysis-based Evaluation on the Safety of Vardenafil Hydrochloride

作　　者：陈亮[1,2] 贾金铭[1] 

机构地区：[1]中国中医科学院广安门医院,北京100053 [2]国家安全生产监督管理总局煤炭总医院泌尿外科,北京100028

出　　处：《中国医院用药评价与分析》2010年第10期946-948,共3页Evaluation and Analysis of Drug-use in Hospitals of China

基　　金：国家博士后科学基金资助项目(20100470511);国家自然科学基金资助项目(30901492);煤炭总医院科研基金资助项目(200902;201012)

摘　　要：目的:基于盐酸伐地那非(艾力达)上市以来总处方量的不良反应报告分析,评估其安全性,旨在对临床规范用药提供有益借鉴。方法:查阅WHO药品不良反应数据库,检索并分析比较药品不良反应报告。结果:药品不良反应报告主要集中在心血管等系统。各个系统不良反应表现形式各异,但都比较轻微,基于总处方量来讲,不良反应报告率极低。严重不良反应如心肌梗塞、异常勃起的报告率极少。结论:枸橼酸西地那非治疗勃起功能障碍的安全性比较高;应继续规范药物的临床应用,尽量减少死亡、异常勃起等严重不良反应的发生。OBJECTIVE：To evaluate the safety of vardenafil hydrochloride based on the analysis on the proportion of its ADR（adverse drug reaction） cases in the total prescriptions since its approval to the market for reference of clinical standard medication.METHODS：Vardenafil hydrochloride-induced ADR cases were retrieved from WHO ADR database and which were analyzed statistically.RESULTS：The vardenafil hydrochloride-induced ADR predominantly appeared in cardiovascular system.The clinical manifestation of which varied in different systems,but all were mild.The proportion of ADR prescriptions in the total was extremely low.Serious ADR cases induced by vardenafil hydrochloride such as myocardial infarction and priapism etc were rarely seen.CONCLUSION：Sildenafil is safe for various erectile dysfunction,but the use of this drug should be standardized in an effort to reduce the incidence of serious ADR such as of death and priapism.

关 键 词：盐酸伐地那非 药品不良反应 安全性 

分 类 号：R969.3[医药卫生—药理学]