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

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/1000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。

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 1000 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.