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目的研究以触发器作为筛查药物不良事件(ADEs)信号的可行性。方法选择浙江省3家三级医院的2015年住院患者作为研究对象,设计潜在过度抗凝触发器(使用华法林且国际标准化比值≥6)、潜在阿片类药物过度使用触发器(纳洛酮作为阿片类药物导致过度镇静的信号),删除重复和假阳性ADEs,并与医院不良事件呈报数据进行比对。结果过度抗凝触发器和过度镇静触发器分别触发39例次和11例次潜在的ADEs,通过手工检索确认过度抗凝触发器触发了9例次ADEs[阳性预测值(positive predictive value,PPV)23.1%],而过度镇静触发器触发了4例次ADEs(PPV 36.4%)。未发现严重的华法林导致的过度抗凝或阿片类药物导致的过度镇静ADEs没有上报,但几乎所有的ADEs(12/13)未通过医院的自发系统上报。结论通过设计用药事件触发器有助于有效改善ADEs漏报。
Objective To investigate the feasibility of using triggers as a screening signal for adverse drug events (ADEs). Methods In-hospital patients from 3 tertiary hospitals in Zhejiang Province were selected as the research object to design potential over-anticoagulation triggers (with warfarin and international standardization ratio≥6), potential opioid overuse triggers (naloxone As a signal of opioids leading to over-sedation), remove duplicates and false-positive ADEs and compare them with hospital adverse event reporting data. Results The over-anticoagulant trigger and the over-sedation trigger triggered 39 cases and 11 cases of potential ADEs, respectively, and 9 cases of positive predictive value (PPV) of ADEs were triggered by manual retrieval of over-anticoagulation triggers 23.1%], while over-sedation triggers triggered 4 episodes of ADEs (PPV 36.4%). No serious warfarin-induced over-sedation or opioid-induced over-sedation ADEs were not reported, but almost all ADEs (12/13) were not reported through hospital spontaneous systems. Conclusion Designing event triggers helps to improve the false negatives of ADEs.