基于美国FAERS数据库索磷布韦/维帕他韦和来迪派韦/索磷布韦不良反应信号分析

doi:10.19803/j.1672-8629.20230248

中国药物警戒 ›› 2024, Vol. 21 ›› Issue (4): 440-446.
DOI: 10.19803/j.1672-8629.20230248

基于美国FAERS数据库索磷布韦/维帕他韦和来迪派韦/索磷布韦不良反应信号分析

韩丽^1,2, 陈力^1,*, 陈乾³, 肖洪涛²

¹四川大学华西第二医院药学部,四川大学循证药学中心,四川成都 610041;
²四川省肿瘤临床医学研究中心,四川省肿瘤医院·研究所,四川省癌症防治中心,电子科技大学附属肿瘤医院药学部,四川成都 610041;
³四川省宜宾市第一人民医院药学部,四川宜宾 644000

收稿日期:2023-04-22 出版日期:2024-04-15 发布日期:2024-04-18
通讯作者: ^*陈力,男,硕士,主任药师,临床药学与合理用药。E-mail:13674852@qq.com
作者简介:韩丽,女,博士,主管药师,临床药学与医院药物管理
基金资助:
四川省科技厅项目（2019JDR0163）

Signal detection of adverse reaction of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir based on FAERS database

HAN Li^1,2, CHEN Li^1,*, CHEN Qian³, XIAO Hongtao²

¹Department of Pharmacy/Evidence-Based Pharmacy Center, West China Second University Hospital, Sichuan University, Chengdu Sichuan 610041, China;
²Department of Pharmacy, Sichuan Clinical Research Center for Cancer, Sichuan Cancer Hospital & Institute, Sichuan Cancer Center, Affiliated Cancer Hospital of University of Electronic Science and Technology of China, Chendu Sichuan 610041, China;
³Department of Pharmacy, the First People's Hospital of Yibin City, Yibin Sichuan 644000, China

Received:2023-04-22 Online:2024-04-15 Published:2024-04-18

摘要/Abstract

摘要： 目的挖掘和分析索磷布韦/维帕他韦（SOF/VEL）和来迪派韦/索磷布韦（LED/SOF）上市后的不良反应（ADR）信号,为两药临床安全合理使用提供参考。方法采用报告比值比（ROR）法和信息成分（IC）法对美国食品药品监督管理局不良事件报告系统（FAERS）数据库 2017年1月1日至2021年9月30日接收的不良事件（ADE）报告进行数据挖掘,使用《监管活动医学词典》（MedDRA）术语对报告中ADE描述用语进行标准化,筛选出有信号的ADR进行对比分析。结果最终得到SOF/VEL信号16个,LED/SOF 信号18个。两者ADE重叠信号7个,主要为全身、胃肠、肝胆、神经及精神系统损害,且均有HBV再激活风险。SOF/VEL较为特异的ADR有食欲增加、酒精滥用和月经出血过多;LED/SOF较为特异的ADR有非急性卟啉病、胆管上皮细胞癌和冷球蛋白血症。结论该研究有效利用ROR法和IC法挖掘出SOF/VEL和LED/SOF的ADR风险信号,为两药临床安全合理使用提供了新的证据支持。

关键词: 索磷布韦/维帕他韦, 来迪派韦/索磷布韦, 信号, 数据挖掘, 报告比值比法, 信息成分法, 美国食品药品监督管理局不良事件报告系统

Abstract: Objective To provide reference for safe and rational use of sofosbuvir/velpatasvir（SOF/VEL） and ledipasvir/sofosbuvi（LED/SOF） by analyzing signals of post-marketing adverse drug reactions (ADR) of the two drugs. Methods Data on adverse events reported by the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) between January 1, 2017 and September 30, 2021 was mined by adopting the reporting odds ratio (ROR) method and the information component (IC) method. Description terms of ADR in the reports were standardized using the medical dictionory for regulatory activities(MedDRA) terminology. ADR with signals were screened out and compared. Results A total of 16 signals of SOF/VEL and 18 signals of LED/SOF were finally obtained, including 7 overlapping signals which mainly involved systemic, gastrointestinal, hepatobiliary, neurological and mental system damage, and the risk of HBV reactivation. The specific ADR of SOF/VEL were increased appetite, alcohol use and heavy menstrual bleeding while those of LED/SOF were nonacute porphyria, cholangiocarcinoma and cryoglobulinaemia. Conclusion In this study, ROR and IC methods have been used to dig out the ADR risk signals of SOF/VEL and LED/SOF, which provides new evidence for their safe and rational use.

Key words: sofosbuvir/velpatasvir, ledipasvir/sofosbuvir, signals, data mining, reporting odds ratio, information component, FAERS

中图分类号:

R978
R994.11

韩丽, 陈力, 陈乾, 肖洪涛. 基于美国FAERS数据库索磷布韦/维帕他韦和来迪派韦/索磷布韦不良反应信号分析[J]. 中国药物警戒, 2024, 21(4): 440-446.

HAN Li, CHEN Li, CHEN Qian, XIAO Hongtao. Signal detection of adverse reaction of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir based on FAERS database[J]. Chinese Journal of Pharmacovigilance, 2024, 21(4): 440-446.

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基于美国FAERS数据库索磷布韦/维帕他韦和来迪派韦/索磷布韦不良反应信号分析

Signal detection of adverse reaction of sofosbuvir/velpatasvir and ledipasvir/sofosbuvir based on FAERS database

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