氟喹诺酮类药物诱导的光敏感性：VigiBase 中的病例/非病例研究的基于化学片段的方法。

Fluoroquinolone-Induced Photosensitivity: A Chemical Fragment-Based Approach by a Case/Non-case Study in VigiBase.

机构信息

Service de Pharmacologie Médicale et Clinique, Centre Régional de Pharmacovigilance, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.

Centre d'Investigation Clinique 1436, Centre Hospitalier Universitaire de Toulouse, Toulouse, France.

出版信息

Drug Saf. 2020 Jun;43(6):561-566. doi: 10.1007/s40264-020-00917-4.

DOI:10.1007/s40264-020-00917-4

PMID:32146702

Abstract

INTRODUCTION

Fluoroquinolones are widely used to treat bacterial infections. Many in vitro and in vivo studies have established a chemical relationship between fluoroquinolones' particular chemical structure and photosensitivity. The aim of this study was to establish a relationship between the chemical structure of fluoroquinolones and the risk of photosensitivity adverse effects from real-world data.

METHODS

All the Individual Case Safety Reports (ICSRs) related to fluoroquinolones and registered in the World Health Organization global database (VigiBase) up to December 31, 2017 were collected. A disproportionality analysis was performed in order to quantify the photosensitivity risk for each fluoroquinolone by calculating their reporting odds ratio (ROR).

RESULTS

Up to December 31, 2017, 282,805 ICSRs related to fluoroquinolones were selected, of which 1647 were photosensitivity adverse event cases. Sparfloxacin had the highest adjusted ROR of 161.10 (95% confidence interval [CI] 133.66-194.02) followed by grepafloxacin (40.30 [26.30-59.60]) closely followed by lomefloxacin (32.61 [28.61-37.07]), then enoxacin (11.04 [8.33-14.32]) and fleroxacin (8.22 [5.06-12.56]).

CONCLUSION

This study confirms the high reporting rate of photosensitivity adverse effects for sparfloxacin from real-world data. Moreover, our data suggest more photosensitivity adverse effects reporting for fluoroquinolones with a halogen at their 8th position.

摘要

简介

氟喹诺酮类药物被广泛用于治疗细菌感染。许多体外和体内研究已经建立了氟喹诺酮类药物特定化学结构与光敏感性之间的化学关系。本研究旨在从真实世界数据中建立氟喹诺酮类药物的化学结构与光敏性不良反应风险之间的关系。

方法

收集截至 2017 年 12 月 31 日在世界卫生组织全球数据库（VigiBase）中注册的与氟喹诺酮类药物相关的所有个体病例安全报告（ICSR）。通过计算每个氟喹诺酮类药物的报告比值比（ROR），进行了比例失调分析，以量化每种氟喹诺酮类药物的光敏性风险。

结果

截至 2017 年 12 月 31 日，共选择了 282805 例与氟喹诺酮类药物相关的 ICSR，其中 1647 例为光敏性不良反应病例。司帕沙星的调整后 ROR 最高，为 161.10（95%置信区间[CI]为 133.66-194.02），其次是格帕沙星（40.30 [26.30-59.60]），紧随其后的是洛美沙星（32.61 [28.61-37.07]），然后是依诺沙星（11.04 [8.33-14.32]）和氟罗沙星（8.22 [5.06-12.56]）。