基于美国FDA不良事件报告系统的硫唑嘌呤相关死亡事件数据挖掘研究
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篇名: 基于美国FDA不良事件报告系统的硫唑嘌呤相关死亡事件数据挖掘研究
TITLE:
摘要: 目的:基于美国FDA不良事件报告系统(FAERS),对硫唑嘌呤相关死亡事件进行数据挖掘,为临床安全使用硫唑嘌呤提供参考。方法:下载2004年第一季度至2018年第四季度共60个季度的FAERS数据,经过Medex_UIMA_1.3.7系统进行药品名称标准化、《ICH国际医学用语词典》不良事件系统分类等数据清洗后,提取硫唑嘌呤相关死亡事件,采用报告比值比法(ROR)和比例报告比值法(PRR)进行信号检测。对硫唑嘌呤相关死亡事件患者的基本信息、报告者信息、报告的时间分布和国家分布、信号检测结果、直接/间接死亡患者用药剂量和合并用药,以及间接死亡患者报告频率进行分析。结果:共提取到硫唑嘌呤不良事件报告记录39 695条,其中直接死亡事件报告707条,间接死亡事件报告3 219条;死亡者中位年龄55岁;医师和其他卫生专业人员报告共占77.38%;硫唑嘌呤口服给药报告占已知给药途径报告例数的90.40%(647/715)。“胎儿死亡”(ROR=4.16,PRR=4.16)和“新生儿死亡”(ROR=4.99,PRR=4.99)检测出信号。在死亡病例中,老年患者约占30%;存在硫唑嘌呤超禁忌症、超剂量使用情况;在合并用药中,免疫抑制类药物使用频率最高;在间接死亡病例中,感染事件报告频率最高(3 122例次)。结论:应重视硫唑嘌呤潜在的致死风险,严格把握硫唑嘌呤禁忌症和剂量,关注老人、儿童特殊人群用药;建议硫唑嘌呤使用前完善基因检测,以精准用药。
ABSTRACT: OBJECTIVE: To mine the data of azathioprine related death events based on FDA Adverse Event Report System (FAERS), and to provide reference safe use of azathioprine in clinic. METHODS: Totally 60 quarters of FARES data were downloaded from 2004Q1 to 2018Q4. After drug names standardized by Medex_UIMA_1.3.7 and adverse events classified by MedDRA, death events related to azathioprine were extracted. The safety signals were detected by using ROR and PRR methods. The death events related to azathioprine were analyzed in respects of patient’s general information, reporter’s information, time and country distribution of reports, signal detection results, dose and drug combination of direct and indirect death, reported frequency of indirect deaths. RESULTS: A total of 39 695 azathioprine related death events were gathered, including 707 direct death reports and 3 219 indirect death reports. The media age was 55 years in dead. Physicians and other health professionals reports took up 77.38%. Azathioprine administered orally took up 90.40% (647/715) in reported cases of known route of adiministration. “Fetal death” (ROR=4.16, PRR=4.16) and “neonatal death” (ROR=4.99, PRR=4.99) were detected as signal. About 30 percent of the death reports were the old patients. There were cases using azathioprine beyond contraindications or maximum dosage. Among drug combination, immunosuppressive drugs were used most frequently. Infection events were reported most frequently in indirect deaths (3 122 reports). CONCLUSIONS: The potential death risk of azathioprine should be paid attention to, and the contraindications and dosage of azathioprine should be strictly controlled. Great importance should be paid attention to medication for special population of the elderly and children. It is suggested that genetic testing and precise drug use should be perfected before using azathioprine.
期刊: 2019年第30卷第21期
作者: 吴斌,吴逢波,何治尧,徐珽
AUTHORS: WU Bin,WU Fengbo,HE Zhiyao,XU Ting
关键字: 硫唑嘌呤;不良事件报告系统;死亡;数据挖掘
KEYWORDS: Azathioprine; Adverse event reporting system; Death; Data mining
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