基于FAERS数据库的双膦酸盐类药物不良事件信号挖掘研究

Research on Signal Mining of Adverse Drug Events of Bisphosphonate Based on FAERS

关键词:  双膦酸盐类药物  FDA不良事件报告系统  不良事件信号挖掘  比值比法  比例报告比值法

Key words:  bisphosphonate  FDA adverse event reporting system  adverse event signal mining  reporting odds ratio method  proportional ratio report ratio method

摘要:

目的 基于FDA不良事件报告系统(FDA adverse event reporting system，FAERS)数据库对双膦酸盐类药物(bisphosphonate，BPS)的不良事件信息进行分析对比，挖掘其潜在的药品不良反应(adverse drug reaction，ADR)信号，以期优化患者治疗方案，为临床安全合理用药提供参考。方法 从FAERS提取2004年第1季度—2020年第4季度的不良事件报告数据，利用比值比(report odds ratio，ROR)法和比例报告比值(proportional report ratio，PRR)法对BPS的报告进行数据挖掘。得到有效信号后，利用国际医学用语词典术语集进行汉化及系统、器官归类。结果 经过筛选后，结果显示：阿仑膦酸钠累及19个系统，共1 072种信号；唑来膦酸共累及20个系统，共709种信号；利塞膦酸累及20个系统，共638种信号；帕米膦酸累及18个系统，共456种信号；伊班膦酸累及19个系统，共361种信号。结论 该研究有效利用ROR法和PRR法挖掘出5种BPS的ADR信号，5种BPS之间ADR具有一定的差异性，可为临床用药提供一定的参考，有利于促进临床合理用药。

Abstract:

OBJECTIVE To analyze and compare the adverse event information of bisphosphonate(BPS) based on the FDA adverse event reporting system(FAERS) database, and to explore potential adverse drug reaction(ADR) signals, in order to optimize the treatment plan for patients and provide a basis for clinical safe and rational drug use. METHODS Adverse event reports were extracted from FAERS from the first quarter of 2004 to the fourth quarter of 2020, and the BPS reports were mined using report odds ratio(ROR) method and proportional report report ratio(PRR) method. After obtaining effective signals, the Medical Dictionary for Regulatory Activities(MedDRA) term set was used for Chinese system and organ classification. RESULTS After screening, the results showed that alendronate sodium involved 19 systems, a total of 1 072 signals. Zoledronic acid involved 20 systems with 709 kinds of signals. Risedronic acid involved 20 systems with a total of 638 signals. Pamidronic acid involved 18 systems with a total of 456 signals. Ibandronic acid involved 19 systems with a total of 361 signals. CONCLUSION In this study, ROR and PRR methods are effectively used to mine ADR signals of 5 BPS. There are certain differences in ADR among the 5 BPS, which can provide certain reference for clinical drug use and promote rational clinical drug use.