摘要
目的验证全面触发工具(global trigger tool,GTT)在老年住院患者药品不良事件(adverse drug event,ADE)监测中的可行性。方法根据《IHI global trigger tool for measuring adverse events》中推荐的触发器和国内其他研究使用的触发器,并结合该院生化指标范围、药品目录和该院老年患者处方习惯,对触发器进行调整,最终制定出31项触发器。随机抽取本院2015年12月26日至2016年12月25日老年病科65岁以上出院病历360份,使用GTT审查病历,再通过Naranjo评定法判定ADE,将确定的ADE进行严重程度分级、造成ADE的药物类别和累及系统-器官分析。应用SPSS 21.0软件进行统计分析,检验水准为α=0.05(双侧)。结果审查的360份病历中,触发器检出阳性的患者169例,阳性率为46.94%。31项触发器中,19项触发器检出阳性。75例患者发生98例次ADE,ADE发生率为20.83%(75/360)。98例次ADE中,E级伤害97例次,F级伤害1例次。ADE共涉及9类药物,其中心血管系统药物导致ADE发生的占比最高,达58.16%;共累及系统-器官11个,其中代谢及营养障碍占比最高,达42.86%。GTT的真实性指标:灵敏度为100.00%,特异度67.02%,正确指数0.67。可靠性指标:符合率73.89%,Kappa值0.46。阳性预测值(positive predictive value,PPV)为44.38%。经Logistic回归分析发现,年龄、住院天数、用药品规数、触发器检出阳性数和基础疾病数对老年住院患者ADE发生有显著影响。结论GTT用于监测老年住院患者ADE的真实性、可靠性较好,PPV较高,但部分触发器需继续改进。
Objective To evaluate the feasibility of global trigger tool(GTT)in monitoring adverse drug events in elderly patients.Methods Based on the triggers recommended by IHI Global Trigger Tool for Measuring Adverse Events and those used in domestic studies,and considering the scope of biochemical indexes,drug catalogues and prescription habits in the hospital,some triggers were adjusted.A total of 31 triggers were finally developed.The clinical records of 360 patients aged above 65 years and discharged from the Department of Geriatrics from December 26,2015 to December 25,2016 were randomly selected.These records were reviewed by GTT and related ADE were determined using the Naranjo method.All the ADE were evaluated for severity classification,drug classification and involved system-organs.Statistical analysis was conducted with SPSS software,version 21.0,for window.Results Among the 360 elderly patients,169 records were positive according to the GTT method,so the positive rate was 46.94%.Nineteen of the 31 triggers were positive.There were 98 ADE identified that involved 75 patients.The incidence of ADE was 20.83%.Ninety-seven cases were category E and one case was category F.A total of 9 classes of drugs were involved in ADE.The incidence of ADE induced by cardiovascular drugs was the highest(58.16%).Eleven system-organs were involved.The percentage of ADE related to metabolism and nutrition was 42.86%.Authenticity indexes of GTT included a sensitivity of 100.00%,a specificity of 67.02%,and a Youden’s index of 0.67.As for reliability indexes,the consistency rate was 73.89%,Kappa value was 0.46 and PPV was 44.38%.Logistic regression analysis found that age,length of hospital stay,the number of medications,the number of positive triggers and the number of preexisting diseases were significantly correlated with ADE among the elderly patients.Conclusion The validity and reliability of GTT for monitoring ADE in elderly patients are good,and PPV is high,but some triggers need to be improved.
作者
张伟威
王娜
ZHANG Weiwei;WANG Na(Hebei Medical University,Shijiazhuang Hebei 050000,China;First Hospital of Qinhuangdao,Qinhuangdao Hebei 066000,China)
出处
《中国药物警戒》
2021年第1期56-63,共8页
Chinese Journal of Pharmacovigilance
