药品不良事件触发器在挖掘唑来膦酸注射液有关不良事件的应用效果分析  

Analysis of Application Effect of Adverse Drug Event Triggers in Monitoring of Adverse Event Related to Zoledronic Acid Injection

作　　者：徐思恩 吕杏放[2] 饶智明 张映娜 Xu Sien;Lyu Xingfang;Rao Zhiming;Zhang Yingna(Zhaoqing Hospital of Traditional Chinese Medicine,Zhaoqing 526020,Guangdong Province,China;Zhaoqing Third People's Hospital,Zhaoqing 526020,Guangdong Province,China)

机构地区：[1]肇庆市中医院,广东肇庆526020 [2]肇庆市第三人民医院,广东肇庆526020

出　　处：《中国社区医师》2023年第13期14-16,共3页Chinese Community Doctors

基　　金：2021年度广东省医学科研基金立项项目(编号:B2021154)。

摘　　要：目的:探讨药品不良事件(ADE)触发器在挖掘唑来膦酸注射液有关不良事件的应用效果。方法:选取2021年1—12月于肇庆市中医院使用唑来膦酸注射液治疗骨质疏松症的252例住院患者作为研究对象,从医院电子信息系统调取病历资料,由ADE触发工具进行检测,统计检测结果。结果:252例患者经过检测获得16项和唑来膦酸注射液可能有关的触发器,其中阳性374例次,ADE触发器阳性66例次,阳性预测值为17.65%;16项ADE触发器中9项为阳性,占56.25%,其中阳性例次以发热占比最高,占34.68%;其次是腹痛,占21.74%;第3位是流感样症状,占13.51%。252例患者经检测ADE累及器官和系统,其中全身反应最多,有49例次,占74.24%;其次为胃肠系统,有11例次,占16.67%。ADE触发器检出率高于自愿呈报率,差异有统计学意义(P=0.001)。59例ADE触发器阳性患者中,均为E级,占100%;未观察到F级、G级、H级和I级ADE发生。结论:选择ADE触发器挖掘唑来膦酸注射液有关不良事件具备一定可行性,但还需进一步完善。Objective:To explore the application effect of adverse drug event(ADE)triggers on the monitoring of adverse events related to zoledronic acid injection.Methods:A total of 252 inpatients who were treated with zoledronic acid injection for osteoporosis in Zhaoqing Hospital of Traditional Chinese Medicine from January 2021 to December 2021 were selected as the study subjects.Their medical records were extracted from the hospital electronic information system and detected using ADE triggers.The detection results were counted.Results:The 252 patients were tested to obtain 16 triggers that were possibly related to zoledronic acid injection,including 374 positive cases and 66 ADE trigger positive cases,with a positive predictive value of 17.65%;Among the 16 ADE triggers,9 were positive,accounting for 56.25%,of which fever accounted for the highest proportion of positive cases(34.68%);followed by abdominal pain(21.74%);and influenza like symptoms(13.51%).Among 252 patients,ADE was detected to involve organs and systems,among which systemic reactions accounted for the highest proportion,involving 49 cases(74.24%);followed by the gastrointestinal system,involving 11 cases(16.67%).The detection rate of ADE trigger was higher than that of voluntary reporting,and the difference was statistically significant(P=0.001).Among the 59 ADE trigger positive patients,all cases were grade E,accounting for 100%;no ADE of grade F,G,H,and I was observed.Conclusion:It is feasible to use ADE triggers in the monitoring of adverse events related to zoledronic acid injection,but it needs further improvement.

关 键 词：唑来膦酸注射液 药品不良事件 触发器 

分 类 号：R95[医药卫生—药学]