全面触发工具在肾移植受者免疫抑制药品不良事件监测中的运用

doi:10.19803/j.1672-8629.2021.03.12

中国药物警戒 ›› 2021, Vol. 18 ›› Issue (3): 265-270.
DOI: 10.19803/j.1672-8629.2021.03.12

全面触发工具在肾移植受者免疫抑制药品不良事件监测中的运用

韩忠灵^1,3, 夏菊梅⁴, 王轶睿², 杨立³, 滕亮^2,*

¹新疆医科大学药学院,新疆乌鲁木齐 830011;
²新疆医科大学第一附属医院药学部,新疆乌鲁木齐 830054;
³新疆军区总医院药剂科,新疆乌鲁木齐 830000;
⁴广州市增城区人民医院肾内科,广东广州 510000

出版日期:2021-03-15 发布日期:2021-04-06
通讯作者: ^*滕亮,男,主任药师·硕导,医院药学。E-mail:tl750212@126.com
作者简介:韩忠灵,女,在读硕士,主管药师,临床药学。
基金资助:
新疆军区总医院青年培育科研项目（2020jzbj1010）

Application of Global Trigger Tool in Monitoring Adverse Drug Events of Immunosuppressive Drugs in Kidney Transplant Recipients

HAN Zhongling^1,3, XIA Jumei⁴, WANG Yirui², YANG Li³, TENG Liang^2,*

¹Pharmacy College of Xinjiang Medical University, Urumqi Xinjiang 830011, China;
²Department of Pharmacy, the First Affiliated Hospital of Xinjiang Medical University, Urmuqi Xinjiang 830054, China;
³Department of Pharmacy, General Hospital of Xinjiang Military Region, Urumqi Xinjiang 830000, China;
⁴Department of Nephrology, Guangzhou Zengcheng District People's Hospital, Guangzhou Guangdong 510000, China

Online:2021-03-15 Published:2021-04-06

摘要/Abstract

摘要： 目的运用全面触发工具（global trigger tool, GTT）初步建立新疆某医院肾移植受者免疫抑制药品不良事件（adverse drug events, ADE）的主动监测模型。方法采用触发器进行回顾性审查病例324份,对病例中ADE及其分类、分级进行判定,并采用Logistic分析探讨与ADE发生可能相关的因素,初步建立ADE主动监测模型。结果 39项触发器全部触发,总体阳性预测值（PPV%）为27.74%,触发器阳性触发率97.22%。判定出564个ADE,触发器ADE检出率68.52%（222/324）,ADE/100例患者为174.07,ADE/1 000患者天是32.03。ADE累及系统-器官13类,主要是代谢和营养障碍（30.67%）、血液系统（17.2%）、机会性感染（15.07%）。二分类Logistic分析显示7个因素是肾移植受者发生ADE的独立危险因素。在此基础上建立了免疫抑制剂ADE个体化列线图模型,方法学考察表明该模型具有很好的预测价值（AUC为0.863）。结论全面触发工具可用于肾移植受者免疫抑制ADE的监测,但需进一步完善触发器并进行验证研究。

关键词: 药品不良事件, 全面触发工具, 免疫抑制剂

Abstract: ：Objective To establish an active monitoring model of immunosuppressive drug adverse events (ADE) in renal transplant recipients in a hospital in Xinjiang by using the Global Trigger Tool (GTT). Methods A retrospective analysis of 324 cases of renal transplant recipients was conducted using the GTT. ADE in these cases were classified and graded. Logistic analysis was used to explore the possible factors related to ADE, and a monitoring model of ADE was established. Results All the 39 triggers were positive, the total PPV% was 27.74%, and the positive trigger rate was 97.22%. The detection rate of ADE by the GTT was 68.52% (222/324), the number of ADE detected among every 100 patients was 174.07, compared with 32.03 for every 1 000 patient days. The ADE were divided into 13 categories, the main ones of which were metabolic and nutritional disorders (30.67%), damage to the blood system (17.2%), and opportunistic infections (15.07%). According to the results of binomial logistic analysis, 7 factors were independent risk factors for ADE in renal transplant recipients. The results of methodological study showed that the model was of good predictive value (AUC 0.863). Conclusion The GTT can be used to monitor adverse events of immunosuppressive drugs in renal transplant recipients, but this approach needs to be improved and verified.

Key words: adverse drug events, global trigger tool, immunosuppressant

中图分类号:

R994.11

韩忠灵, 夏菊梅, 王轶睿, 杨立, 滕亮. 全面触发工具在肾移植受者免疫抑制药品不良事件监测中的运用[J]. 中国药物警戒, 2021, 18(3): 265-270.

HAN Zhongling, XIA Jumei, WANG Yirui, YANG Li, TENG Liang. Application of Global Trigger Tool in Monitoring Adverse Drug Events of Immunosuppressive Drugs in Kidney Transplant Recipients[J]. Chinese Journal of Pharmacovigilance, 2021, 18(3): 265-270.

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全面触发工具在肾移植受者免疫抑制药品不良事件监测中的运用

Application of Global Trigger Tool in Monitoring Adverse Drug Events of Immunosuppressive Drugs in Kidney Transplant Recipients

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