Mining and Analysis of Adverse Drug Reaction Signals Caused by Tacrolimus Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database

CHENG Yi; CHEN Chen; YU Chunfei; CHEN Qian; CHEN Li

doi:10.14009/j.issn.1672-2124.2020.05.029

您当前的位置：

首页 >

文章列表页 >

Mining and Analysis of Adverse Drug Reaction Signals Caused by Tacrolimus Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database

更新时间：2022-10-08

- Mining and Analysis of Adverse Drug Reaction Signals Caused by Tacrolimus Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database
- Vol. 20, Issue 5, Pages: 620-624(2020)
- 作者机构：
  
  1. 四川大学华西第二医院药学部/循证药学中心
  2. 出生缺陷与相关妇儿疾病教育部重点实验室
  3. 重庆医科大学附属儿童医院药学部/儿童发育疾病研究教育部重点实验室
  4. 四川大学华西药学院
  5. 宜宾市第一人民医院药学部
- 作者简介：
- 基金信息：
- DOI：10.14009/j.issn.1672-2124.2020.05.029
  CLC： R95
- Published：2020，
扫描看全文
[1]程艺,陈晨,余春飞,陈乾,陈力.基于美国食品药品监督管理局不良事件报告系统数据库的他克莫司致药品不良反应信号挖掘与分析[J].中国医院用药评价与分析,2020,20(05):620-624.

CHENG Yi, CHEN Chen, YU Chunfei, et al. Mining and Analysis of Adverse Drug Reaction Signals Caused by Tacrolimus Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database. [J]. 20(5):620-624(2020)
[1]程艺,陈晨,余春飞,陈乾,陈力.基于美国食品药品监督管理局不良事件报告系统数据库的他克莫司致药品不良反应信号挖掘与分析[J].中国医院用药评价与分析,2020,20(05):620-624. DOI： 10.14009/j.issn.1672-2124.2020.05.029.

CHENG Yi, CHEN Chen, YU Chunfei, et al. Mining and Analysis of Adverse Drug Reaction Signals Caused by Tacrolimus Based on the U.S.Food and Drug Administration Adverse Event Reporting System Database. [J]. 20(5):620-624(2020) DOI： 10.14009/j.issn.1672-2124.2020.05.029.

摘要

目的:利用美国食品药品监督管理局（food and drug administration

FDA）不良事件报告系统（FDA adverse event reporting system

FAERS）

挖掘与分析免疫抑制剂他克莫司致药品不良反应信号

为临床安全用药提供参考。方法:采用回顾性研究方法

利用报告比值比（reporting odds ratio

ROR）法和比例报告比值（proportional reporting ratio

PRR）法

对FEARS数据库中2009年第1季度至2019年第1季度共41个季度的他克莫司致不良事件报告进行数据挖掘与分析。结果:使用ROR法得到他克莫司致药品不良反应信号共1 365个

将其信号强度按照降序排列得到排序居前50位的信号

其中原研药说明书中未提及的不良反应共14个

按世界卫生组织术语集分类累及2个新的系统;新的不良反应主要集中在泌尿系统损害、全身性损害、免疫功能紊乱、呼吸系统损害、代谢和营养障碍以及中枢和外周神经系统损害。结论:他克莫司药品说明书未收录的不良反应较多且累及器官和（或）系统分布广泛

建议临床用药时需谨慎。

Abstract

OBJECTIVE: To mine and analyze the adverse drug reaction signals caused by the immunosuppressive agent tacrolimus according to the U. S. Food and Drug Administration（FDA） Adverse Event Reporting System（FAERS） database

so as to provide references for the application safety of drug use in clinic. METHODS: The method of retrospective analysis method

reporting odds ratio（ROR） method and proportional report ratio（PRR）method

data mining and analysis were conducted on tacrolimus-induced adverse event reports of 41 quarters from the1 st quarter of 2009 to the 1 st quarter of 2019 in the FEARS database. RESULTS: A total of 1 365 adverse drug reaction signals caused by tacrolimus were obtained by using ROR method. The signal strength was ranked in descending order to obtain the top 50 signals

among which there were 14 adverse drug reactions not mentioned in the original drug specification

and 2 new systems were involved according to the World Health Organization Terminology Set. New adverse drug reactions mainly focused on urinary system damage

systemic damage

immune dysfunction

respiratory system damage

metabolic and nutritional disorders

and central and peripheral nervous system damage.CONCLUSIONS: There are many adverse drug reactions with wide range of organs and/or systems involved that are not included in the instructions of tacrolimus. It is recommended to be cautious in clinical administration.

关键词

他克莫司不良反应信号比例失衡法

Keywords

TacrolimusAdverse drug reaction signalsRatio imbalance method

references

查看原文

Views

222

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Correlation Between CYP3A5 Gene Polymorphism and Tacrolimus Concentration/Dose Ratio in the Early Postoperative Period After Liver Transplantation

Expert Consensus on Individual Treatment of Tacrolimusin Solid Organ Transplantation

Systematic Review of Effects of Wuzhi Capsules on Tacrolimus Treatment After Liver and Kidney Transplantation

Literature Analysis of Hyperkalemia Induced by Tacrolimus

Literature Analysis of Adverse Drug Reactions and Drug Interaction of Tacrolimus

Related Author

LIU Lihong

AI Chao

QIU Kui

WANG Huaguang

WANG Xin

HUANG Jie

ZHANG Xianglin

WANG Xuebin

Related Institution

School of Pharmaceutical Sciences,Capital Medical University

Dept.of Pharmacy, Beijing Tsinghua Changgung Hospital,School of Clinical Medicine,Tsinghua University

Dept.of Pharmacy, Beijing Chaoyang Hospital, Capital Medical University

Dept. of Pharmacy, China-Japan Friendship Hospital

Chinese Pharmacological Society

⁰