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

doi:10.19803/j.1672-8629.2021.03.12

Abstract

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

CLC Number:

R994.11

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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