基于总处方量的不良反应报告分析西地那非用药安全性研究

Safety of Sildenafil Viewed from the Perspective of Sildenafil-induced ADRs Case Reports

目的:基于枸橼酸西地那非(万艾可)上市来总处方的不良反应报告分析,评估其安全性,进一步促进临床规范用药。方法:查阅世界卫生组织药品不良反应数据库,检索并分析和比较枸橼酸西地那非的不良反应报告。结果:枸橼酸西地那非药品不良反应报告主要集中在心血管、神经、消化等系统,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(至少1.7亿)来讲,不良反应报告率极低,严重不良反应少见。结论:枸橼酸西地那非治疗勃起功能障碍的安全性高,该药物对肺动脉高压、神经再生、女性性功能障碍等病症的应用研究应该继续深入。

OBJECTIVE：To evaluate the safety of Sildenafil（Viagra） based on its ADR（adverse drug reaction） case reports since its introduction into market and to promote its clinical standardized clinical utilization.METHODS：The Sildenafil-induced ADR cases collected from WHO ADR database were analyzed and compared.RESULTS：The Sildenafil-induced ADR had a predominant involvement ofcardiovascular system,nervous system and digestive system.The ADRs varied in different system but all were mild.The incidence of ADRs of Sildenafil was quite low and severe ADRs were rare considering the large number of total prescriptions（at least 170 million）.CONCLUSION：It is safe to useSildenafilto treat ejaculatory dysfunction（ED）.Researches on the new use of Sildenafil in the treatment ofpulmonary hypertension,neurogenesis and female sexual dysfunction remain to be done further.