优化后的触发器在心血管疾病患者不良事件监测中的适用性分析  

Applicability of optimized triggers in monitoring adverse events in patients with cardiovascular diseases

作　　者：林晓霞 李佳[3] 杨亚军[1] LIN Xiao-xia;LI Jia;YANG Ya-jun(School of Pharmacy,Guangdong Medical University,Zhanjiang Guangdong 524023;Department of Pharmacy,People’s Hospital of Maoming,Maoming Guangdong 525000;Department of Pharmacy,The First Affiliated Hospital of Sun Yat-sen University,Guangzhou 510080)

机构地区：[1]广东医科大学药学院,广东湛江524023 [2]茂名市人民医院药学部,广东茂名525000 [3]中山大学附属第一医院药学部,广州510080

出　　处：《中南药学》2024年第6期1652-1657,共6页Central South Pharmacy

基　　金：临床重点药品的使用监测和评价研究专项基金(No.Y2022FH-YWPJ01-203);茂名市科技计划项目(No.2023347)。

摘　　要：目的 验证优化后触发器对心血管疾病患者药品不良事件(ADE)监测的适用性。方法 采用德尔菲法征集专家的意见优化触发器,根据纳入/排除标准对2022年某三级甲等医院心血管内科出院患者进行病历审查,评价触发器在提高ADE检出率的优势。结果 240份病历中,经触发器检出阳性条目及例次分别为206条、169例患者,判定为ADE条目及例次分别为107条、74例患者,总体触发器阳性预测值为51.94%(107/206)。ADE严重程度分级最多的是E级损伤,占89.19%;共累及9个系统-器官,受损伤系统最多的是胃肠系统损伤,共55例次;代谢和营养障碍次之,共18例次。主动监测检出率为30.83%(74/240),该医疗机构同期自主上报率为0.28%(6/2166),两者差异有统计学意义(P<0.05)。结论 相比于自发上报系统,优化后的心血管药物触发器设计合理,可提高ADE的检出率。Objective To verify the applicability of optimized triggers in monitoring adverse drug events(ADE)in patients with cardiovascular diseases.Methods Delphi method was used to collect experts’opinions to optimize the triggers.According to the inclusion/exclusion criteria,medical records of discharged patients from the Department of Cardiovascular Medicine of a TierⅢGrade A hospital in 2022 were reviewed to evaluate the advantages of triggers in improving the detection rate of ADE.Results Among 240 cases,206 positive items and 169 patients were detected by the trigger,and 107 items and 74 patients were determined with ADE,with an overall positive predictive value(PPV)of 51.94%(107/206).The most severe ADE severity was grade E damage,accounting for 89.19%.Totally 9 systems-organs were involved,and the most damaged was the gastrointestinal system damage(55 cases),followed by metabolic and nutritional disorders(18 cases).The detection rate of active monitoring was 30.83%(74/240),and the independent reporting rate of the medical institution was 0.28%(6/2166)in the same period,with a significant difference(P<0.05).Conclusion Compared with autonomous reporting system,optimized cardiovascular drug triggers are reasonably designed and effectively improve the detection rate of ADE.

关 键 词：全面触发工具 德尔菲法 药品不良事件 主动监测 心血管系统药物 

分 类 号：R969.3[医药卫生—药理学]