替加环素药源性肝损伤与胰腺炎的主动监测研究

发布时间：2018-02-10 07:10

本文关键词： 替加环素药品不良反应自动监测药源性肝损伤药源性胰腺炎　出处：《中华医院感染学杂志》2017年20期 　论文类型：期刊论文

【摘要】：目的探讨住院患者应用注射用替加环素相关的药源性肝损伤和药源性胰腺炎的发生情况。方法采用回顾性研究方法、借助"医疗机构药品不良事件(ADE)主动监测与智能评估警示系统"监测医院信息系统(HIS)历史库中,选择2012年3月-2017年3月期间使用过注射用替加环素的所有住院患者499例,并人工逐一甄别系统报警的疑似药源性肝损伤和药源性胰腺炎病例。结果药源性肝损伤(DILI)和药源性胰腺炎(DIP)的实际筛查病例分别为487例占97.60%和424例占84.97%。经人工评价具关联性的药源性肝损伤阳性病例为8例占1.60%,未发现药源性胰腺炎阳性病例。8例药源性肝损伤患者平均(69.75±20.49)岁,平均发生时间为用药后(5.25±4.06)天,轻度和重度肝损伤各4例;肝细胞损伤型为3例占37.50%,胆汁淤积型为5例占62.50%;采取停药及对症治疗后治愈3例、好转2例、持续3例。结论 499例替加环素住院患者中药源性肝损伤较为常见,略高于说明书,药源性胰腺炎0例,有待后续扩大监测样本。利用专项软件实施自动监测,能高效快捷的获取优质的真实世界用药风险数据,协助临床及时识别并规避用药风险。
[Abstract]:Objective to investigate the incidence of drug-induced liver injury and drug-induced pancreatitis in inpatients with tegacycline for injection. In the history database of "ADE" active Monitoring and Intelligent Evaluation warning system for Monitoring Hospital Information system (HIS), 499 patients who had used tegacycline for injection between March 2012 and March 2017 were selected. Results the actual screening cases of drug-induced liver injury (DILI) and drug-induced pancreatitis (DIP) were 97.60% cases (97.60% cases) and 84.97 cases (44.97 cases) respectively. The positive rate of drug-induced liver injury was 1.60 years (8 / 8). The average age of the patients with drug-induced liver injury was 69.75 卤20.49 years old. The average time of occurrence was 5.25 卤4.06 days after treatment, 4 cases were mild and 4 severe liver injury, 3 cases were hepatocyte injury type (37.50 cases), 5 cases were cholestasis type (62.50%), 3 cases were cured and 2 cases were improved after drug withdrawal and symptomatic treatment. Conclusion liver injury caused by traditional Chinese medicine is more common in 499 patients with tegacycline, which is slightly higher than the specification. There are 0 cases of drug-induced pancreatitis. High-efficient and fast access to real world drug risk data, to help clinical timely identification and avoid drug risks.
【作者单位】：解放军总医院药品供应中心;重庆医科大学药学院;
【基金】：2014年全军后勤科研重点基金资助项目(BWS14R039)
【分类号】：R595.3

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