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目的:开展重点品种重点事件的多中心主动监测研究,探讨军队医院开展ADE主动监测、自动警示与评估工作的特点、规律和相关因素,深化药品安全监测技术。方法:由经过集中培训的高年资临床药师,收集2014年1–6月期间5所扩大试点医院运行“住院患者药品不良事件主动监测与评估警示系统”的预警数据,逐例分析确定ADE阳性案例,统一汇总并分类统计。结果:四种ADE(肝功能异常、肾功能异常、贫血、血小板减少)自动监测结果的阳性预测值分别为(78.93±24.97)%、(46.45±32.81)%、(46.00±36.47)%、(41.27±31.14)%。由于案例排除率过高,未涵盖多数用药患者,相应的ADE发生率也高。研究者主动试行了22对拓展品种监测,主要为多个品种对1个ADE、也有1个品种对多个ADE,拓展品种的阳性预测值普遍高于常规品种。结论:该系统实现了“实时监测”和“预防为主”的药品风险控制模式;为大数据时代有效防范临床用药风险、减少ADE损害提供新的思路;为临床药师针对性开展重点品种主动监测提供高效实用的技术支撑工具。
OBJECTIVE: To carry out multi-center active surveillance of key species and key events, and to explore the characteristics, laws and related factors of active surveillance, automatic warning and assessment of ADEs in military hospitals, and to deepen the drug safety monitoring technology. Methods: The senior pharmacist with intensive training collected from January to June, 2014 collected early warning data of 5 large-scale pilot hospitals in operation and the “In-patient Patient Adverse Event Active Monitoring and Evaluation Warning System”, and analyzed case by case ADE positive cases, a unified summary and classification statistics. Results: The positive predictive value of ADE (automatic dysfunction of liver, abnormal renal function, anemia and thrombocytopenia) were (78.93 ± 24.97)%, (46.45 ± 32.81)%, (46.00 ± 36.47)%, 41.27 ± 31.14)%. Due to the high rate of case exclusions, the majority of patients who are not covered by the drug, the corresponding incidence of ADE is also high. The researchers actively piloted 22 pairs of extended variety monitoring, mainly for a variety of varieties of an ADE, there are also a variety of multiple ADE, expand the varieties of positive predictive value is generally higher than the conventional varieties. Conclusion: This system realizes the drug risk control mode of “real-time monitoring ” and “prevention-based ”; provides new ideas for effectively preventing clinical drug risks and reducing ADE damage in the era of big data; Active monitoring of key species to provide efficient and practical technical support tools.