基于JADER数据库的奈玛特韦/利托那韦不良事件信号检测与分析

doi:10.19803/j.1672-8629.20230091

摘要/Abstract

摘要： 目的基于日本药品不良事件报告（JADER）数据库,对奈玛特韦/利托那韦潜在药品不良事件（ADE）信号进行检测和分析,为其临床安全使用提供参考。方法采用报告比值比（ROR）法和综合标准（MHRA）法对JADER数据库（202212版）中,包含了日本独立行政法人医药品医疗器械综合机构（PMDA）在发布数据库前 4 个月从制药公司或医疗机构收到的ADE报告（2004年4月至2022年8月）的奈玛特韦/利托那韦相关ADE报告进行数据挖掘。结果共筛选得到奈玛特韦/利托那韦ADE 报告 92 份,检测出比例失衡信号34个,涉及11个系统-器官分类（SOC）,主要集中在各类检查、胃肠系统疾病、全身性疾病及给药部位各种反应和肾脏及泌尿系统疾病等。其中未在我国现有药品说明书中记载的ADE信号27个,主要包括肾功能损害、血尿素升高、超说明书使用、C反应蛋白升高和皮疹等。结论本研究检测出的新ADE信号对药品说明书中现有的安全性信息提供了补充。临床用药过程中应加强对相关ADE的监测,保障患者用药安全。

关键词: 奈玛特韦, 利托那韦, 药品不良事件, 日本药品不良事件报告, 肾功能损害, 血尿素升高, 超说明书使用, C反应蛋白升高

Abstract: Objective To detect and analyze the potential adverse event signals related to nirmatrelvir/ritonavir based on Japanese Adverse Drug Event Report (JADER) database in order to provide reference for safe clinical use of nirmatrelvir/ritonavir. Methods The reporting odds ratio (ROR) method and the MHRA method were used to search the JADER database (version 202212) for ADE reports related to nirmatrevir/ritonavir from pharmaceutical companies or healthcare institutions between April 2004 and August 2022. Results A total of 92 reports of ADE related to nirmatrelvir/ritonavir were retrieved. Thirty-four disproportional signals related to 11 system organs classes (SOC) were detected. ADE signals were mostly distributed in various examinations, gastrointestinal disorders, general disorders, manifestations of administration sites and renal and urinary disorders. Among them, there were 27 new ADE signals, such as renal impairment, increases of blood urea, off-label use and c-reactive protein elevation. Conclusion The new ADE signals detected in this study can add to the information about safety specified in the instructions. In the process of medication, related ADE should be monitored to ensure the safety of patients.

Key words: nirmatrelvir, ritonavir, adverse drug event, JADER, renal impairment, increases of blood urea, off-label, C-reactive protein elevation

中图分类号:

R978
R994.11

钱佩佩, 曹凯, 徐炳欣, 应亚宾, 赵宁珂, 赵亮. 基于JADER数据库的奈玛特韦/利托那韦不良事件信号检测与分析[J]. 中国药物警戒, 2023, 20(10): 1154-1158.

QIAN Peipei, CAO Kai, XU Bingxin, YING Yabin, ZHAO Ningke, ZHAO Liang. Signal detection and analysis of adverse events related to nirmatrelvir/ritonavir based on JADER database[J]. Chinese Journal of Pharmacovigilance, 2023, 20(10): 1154-1158.

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