目的采用全面触发工具(GTT)建立儿童住院患者药品不良事件(ADE)的主动监测方法,评价住院患儿的ADE发生情况。方法用专家咨询法建立儿童ADE触发器,采用等距随机抽样方法抽取本院2014年10月至2015年9月住院患儿归档病历600份,按GTT法进行回顾性病历审查。对触发器阳性所涉及情况进一步审查以确定或排除ADE,审查中发现的无触发器阳性但确定发生的ADE一并记录。所有ADE进行严重程度分级、类型分布及相关药物分析,计算ADE检出率及触发器阳性预测值(PPV)等。结果最终纳入587例病历,共检出119例患儿共计159例次ADE。GTT检出105例患儿共计120例次ADE,检出率17.9%(105/587),无触发器阳性但确定为ADE的39例次。建立的36项触发器,实际应用中有26项呈阳性(72%);触发器总阳性频次905次,检出ADE的有143次,触发器PPV 15.8%(143/905)。159例次ADE中暂时性伤害占98.7%(E级77.4%、F级20.8%),最常累及胃肠系统,相关药物以抗菌药物为主(36.9%)。结论 GTT对儿童ADE的监测及评价具有积极作用,但尚需进一步改进。 Objective To establish an active monitoring method for adverse drug events (ADEs) in hospitalized children with GTT to evaluate the incidence of ADE in hospitalized children. Methods The ADE triggers for children were established by using expert consultation method. Six hundred hospitalized cases were collected by the hospital from October 2014 to September 2015 using the equidistant random sampling method. The retrospective medical records were reviewed according to the GTT method. Further review of trigger-positive conditions to identify or exclude ADEs was also reported for trigger-positive ADEs identified at review. All ADEs were graded for severity, type distribution and related drug analyzes, and ADE detection rates and triggers positive predictive value (PPV) were calculated. Results The final inclusion of 587 cases of medical records, a total of 119 cases were detected in a total of 159 cases of ADE. A total of 120 ADEs were detected in 105 children with GTT, the detection rate was 17.9% (105/587). There were 39 triggers without trigger but with ADE. Thirty-six triggers were established, of which 26 were positive (72%). The total number of triggers was 905, ADE was detected 143 and trigger PPV 15.8% (143/905). 159 cases of ADE temporary injury accounted for 98.7% (E grade 77.4%, F grade 20.8%), most commonly involving the gastrointestinal system, the main drug-related drugs (36.9%). Conclusion GTT has a positive effect on the monitoring and evaluation of ADE in children, but it needs further improvement.