欧洲消费者报告的勃起功能障碍药物的副作用。
Side effects reported by European consumers for medications for erectile dysfunction.
作者信息
Aagaard Lise, Hansen Ebba Holme
机构信息
Clinical Pharmacology, Institute of Public Health, University of Southern Denmark, Copenhagen, Denmark ; Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark.
Section for Clinical and Social Pharmacy, Department of Pharmacy, University of Copenhagen, Copenhagen, Denmark ; Danish Pharmacovigilance Research Project (DANPREP), Copenhagen, Denmark.
出版信息
J Res Pharm Pract. 2013 Apr;2(2):93-5. doi: 10.4103/2279-042X.117390.
OBJECTIVE
To characterise consumer adverse drug reaction (ADR) reports for phosphodiesterase type 5 (PDE5) inhibitors.
METHODS
We included ADR reports submitted by adults to the European ADR database (EudraVigialnce) from 2007 to 2011. ADRs were classified according to type, seriousness and age and sex of consumers. The unit of analysis was one ADR.
FINDINGS
Totally, 328 ADRs were reported for sildenafil and vardenafil, and only 5% of these were serious. The largest number of reported ADRs was found for sildenafil, i.e., "lack of efficacy" and/or "drug efficacy decreased" (n = 134) and "headache" (n = 21).
CONCLUSION
ADRs reported by consumers for PDE5 inhibitors were relatively low, and only few ADRs were serious.
目的
对5型磷酸二酯酶（PDE5）抑制剂的消费者药物不良反应（ADR）报告进行特征分析。
方法
我们纳入了2007年至2011年成年人向欧洲药物不良反应数据库（EudraVigilance）提交的ADR报告。ADR根据类型、严重程度以及消费者的年龄和性别进行分类。分析单位为一例ADR。
结果
西地那非和伐地那非共报告了328例ADR，其中只有5%为严重ADR。西地那非报告的ADR数量最多，即“疗效不佳”和/或“药物疗效降低”（n = 134）以及“头痛”（n = 21）。
结论
消费者报告的PDE5抑制剂ADR相对较少，且严重ADR仅有少数几例。
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