基于总处方量的3种磷酸二酯酶抑制剂的安全性分析

Total Prescription Amount-based Analysis on the Safety of Three Phosphodiesterase Inhibitors

目的:基于总处方量,比较和探讨上市后3种磷酸二酯酶抑制剂(西地那非、伐地那非、他达那非)可疑不良反应发生的特点,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3种药物的不良反应报告。结果:3种药物致不良反应报告主要集中在心血管、神经、消化等系统。每种药物的不良反应各有特点,严重不良反应如异常勃起的报告率逐年下降。结论:应该继续规范3种药物的临床应用,以尽量减少死亡、异常勃起等严重不良反应的发生,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更应该谨慎进行。

OBJECTIVE：To evaluate the characteristics of the suspected adverse drug reaction（ADR） of Sildenafil,Vardenafil and Tadalafil since their introduction into the market for providing benificial references for clinical standard drug use.METHODS：The ADR reports of the three phosphodiesterase inhibitors collected from WHO ADR database were analyzed statistically.RESULTS：The chief ADR-involved systems included cardiovascular system,nervous system and digestive system.The ADRs of Sildenafil,Vardenafil and Tadalafil varied in manifestations.The rate of serious ADR such as priapism was declining year on year.CONCLUSION：It is of utmost importance to standardize the clinical use of Sildenafil,Vardenafil and Tadalafil to reduce the incidences of serious effects such as death,priapism;moreover,the study on application of these drugs for pulmonary hypertension,premature ejaculation,neurogenesis and female sexual dysfunction should be conducted with more caution