比值失衡测量法在甲氨蝶呤不良反应信号挖掘中的应用与分析

摘要

Objective This study provides a reference for rational and safe clinical medication through the signal mining analysis on the adverse reactions of methotrexate. Methods We used the reporting odds ratio (ROR) and the proportional reporting ratio (PRR) to analyze the data of methotrexate from the united states FDA adverse event reporting ssystem (FAERS),and a total of 20 quarterly reports were used for data mining from the first quarter of 2012 to the fourth quarter of 2016. Results Calculated by the ROR and PRR methods, 1364 sig-nals were obtained, and the signals were completely coincident. 66 cases were obtained by twice-screen on the signal preferred terms (PT), of which 31 cases were new adverse reactions. Conclusion Strong signal of Methotrexate was found and new adverse reaction signals were observed including the influence of drugs treatment (increased chemotherapeutic drugs, decreased drug clearance), skeletal muscle systems, and skin effects (seborrheic eczema, lichenoid keratosis). It provides reference for the clinical medication supervision of medical staff and takes the corresponding risk precautionary measures.%目的 通过对甲氨蝶呤不良反应的信号挖掘分析,为临床合理安全用药提供参考.方法 利用报告比值比法(ROR)和比例报告比值法(PRR)对美国FDA不良事件报告系统(FAERS)甲氨蝶呤2012年第一季度~2016年第四季度共20个季度的报告进行数据挖掘.结果 采用ROR法和PRR法进行计算,均得到1364个信号,且信号完全重合;将有信号的甲氨蝶呤不良反应(PT)进行二次筛选,获得66例,其中新的不良反应31例.结论 挖掘出与甲氨蝶呤药物较强相关的新的不良反应信号包括治疗药物影响(化疗药物水平增加、药物清除率下降)、骨骼肌肉系统、皮肤影响(皮脂性湿疹、苔藓样角化病),为医护人员临床用药监护提供参考,并采取相应风险防范措施.