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β受体阻滞剂暴露后发生银屑病的风险:药物警戒信号描述。

Psoriasis risk after beta-blocker exposure: Description of a pharmacovigilance signal.

机构信息

Regional Centre of Pharmacovigilance and Pharmacoepidemiology, Reims University Hospital, Reims, France.

EA 3797 Vieillissement, Fragilité, Faculty of Medicine, University of Reims Champagne-Ardenne, Reims, France.

出版信息

Br J Clin Pharmacol. 2022 Aug;88(8):3813-3818. doi: 10.1111/bcp.15330. Epub 2022 Apr 6.

Abstract

AIM

We aimed to investigate French pharmacovigilance data. The objective was to characterize psoriatic conditions that occurred after beta-blocker (BB) exposure and bring to light a possible pharmacovigilance signal.

METHODS

Spontaneous reports of psoriatic conditions recorded in the French National Pharmacovigilance Database (FPVD) between 1985 and 2019 were extracted. We performed a retrospective, descriptive analysis of reports linked to BB exposure. Association between psoriasis risk and BB exposure was assessed using a case/noncase study.

RESULTS

Two hundred and twenty-five reports of psoriatic conditions after BB exposure were recorded in the FPVD during the study period. Both cardioselective and noncardioselective, topical and systemic BBs are involved. Therapeutic indication of BB was mainly hypertension. Mean time to onset was 5 months and outcome was favourable in 68% after BB discontinuation. These features were concordant with those of literature reports. The reporting odds ratio (ROR) was 8.95 (95% confidence interval 7.75-10.33).

CONCLUSION

We highlighted a statistically significant disproportionality which constitutes a pharmacovigilance signal. Psoriasis risk with BBs is a class effect. Increasing surveillance during the first year of BB exposure is needed.

摘要

目的

我们旨在研究法国药物警戒数据。目的是描述β受体阻滞剂(BB)暴露后出现的银屑病情况,并揭示可能的药物警戒信号。

方法

从 1985 年至 2019 年期间,从法国国家药物警戒数据库(FPVD)中提取了记录的银屑病情况的自发报告。我们对与 BB 暴露相关的报告进行了回顾性、描述性分析。使用病例/非病例研究评估了银屑病风险与 BB 暴露之间的关联。

结果

在研究期间,FPVD 中记录了 225 例 BB 暴露后出现的银屑病情况报告。涉及到选择性和非选择性、局部和全身 BB。BB 的治疗适应症主要是高血压。发病的平均时间为 5 个月,68%的患者在 BB 停药后病情好转。这些特征与文献报告一致。报告比值比(ROR)为 8.95(95%置信区间 7.75-10.33)。

结论

我们强调了一个具有统计学意义的不成比例性,这构成了一个药物警戒信号。BB 类药物与银屑病风险有关,这是一种类效应。需要在 BB 暴露的第一年增加监测。

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