基于真实世界坎格列净上市后不良反应信号的挖掘与分析

Mining and Analysis of the Adverse Drug Reaction Signals Induced by Canagliflozin in Post-marketing Experience Based on Real World Research

关键词:  坎格列净  信号  数据挖掘  真实世界研究  美国食品药品监督管理局

Key words:  canagliflozin  signal  data mining  real world research  FDA

摘要:

目的 挖掘和分析坎格列净上市后的不良反应信号，为临床合理用药提供参考。方法 利用报告比值比法和多项伽玛泊松分布缩减法对美国食品药品监督管理局不良事件报告系统进行坎格列净的不良反应信号挖掘，统计分析纳入研究信号的相关用药信息。结果 纳入2013年第1季度—2018年第4季度的不良反应报告20 961 611份，其中首要怀疑药物为坎格列净的报告28 474份，2种方法挖掘出相同信号231个，其中外科和医疗操作不良反应信号16个。在发生外科和医疗操作不良反应的患者中，男性多于女性；年龄集中在41~65岁；用药剂量多为100 mg·d^-1和300 mg·d^-1；上报数随着用药时间的延长而增多。结论 坎格列净有致患者发生截肢等医疗操作的风险，临床用药时应注意监测，避免这类严重不良反应的发生。

Abstract:

OBJECTIVE To provide reference for rational drug use in clinic by mining and analysis the adverse drug reaction(ADR) signals induced by canagliflozin in post-marketing experience. METHODS Reporting odd ratio method and multi-item gamma possion shrinke method were used to mine the adverse reaction signals induced by canagliflozin from the U.S. Food & Drug Administration adverse event reporting system, the medication information of signal included in the study was counted and analyzed. RESULTS Totally 20 961 611 ADR reports from the first quarter of 2013 to the fourth quarter of 2018 were included in the analysis, among which 28 474 were mainly induced by canagliflozin. A total of 231 ADR signals related to canagliflozin were mined in two ways, with 16 surgical and medical procedure ADR signals. Among the patients with surgical and medical procedure adverse reactions, males were more than females, the patients aged 41-65 years old, daily dose of 100 mg·d^-1 and 300 mg·d^-1 were the most, the number of ADRs were increased along with the long time use of canagliflozin. CONCLUSION Cangliflozin can lead to the risk of medical procedure such as amputation in patients, it shall be monitored during clinical medication to avoid these serious ADRs.