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目的运用数据挖掘的方法检测达比加群酯的不良反应信号,为临床安全合理地使用该药提供依据。方法采用比例报告比值比(PRR)和报告比值比(ROR)对美国食品和药物管理局(FDA)的不良事件报告系统(FAERS)2008-2014年的数据进行信号检测。结果结合PRR(>10)和ROR(>10)共检测出达比加群酯的不良反应信号46个,存在药品说明书未涵盖的新不良反应。在出血不良反应中,肠系膜出血信号强度最高[PRR=97.52,95%CI(95.13,99.91);ROR=97.53,95%CI(95.26,99.80)]。结论通过数据挖掘的信号检测方法,发现达比加群酯肠系膜出血信号强烈及说明书未涉及的新不良反应,应引起临床重视。
Objective To detect the adverse reaction signal of dabigatran etexilate by data mining method and provide the basis for safe and rational use of this drug in clinic. Methods Signals from the FDA Food and Drug Administration (FAERS) 2008-2014 data were analyzed using the ratio of reported odds ratio (PRR) to the reported odds ratio (ROR). Results 46 adverse reactions of dabigatran etexilate were detected with PRR (> 10) and ROR (> 10). There were new adverse reactions not covered by the drug specification. Mesenteric hemorrhage signal intensity was highest in adverse reactions of bleeding [PRR = 97.52, 95% CI (95.13, 99.91); ROR = 97.53, 95% CI (95.26, 99.80)]. Conclusions The signal detection method of data mining has found that dabigatran etexilate mesenteric hemorrhage signal is strong and new adverse reactions that are not covered by this manual should be given clinical attention.