自行建立的33项儿童药物不良事件触发器的临床应用效果评价

Clinical application effect evaluation of self-established 33 triggers for drug adverse events in children

目的评价自行建立的33项触发器在儿童药物不良事件(ADE)监测中的效能,并探讨可能与ADE相关的患儿特异性因素。方法采用美国健康促进研究所全面触发工具白皮书推荐的抽样方法,从四川省人民医院2017年1月1日至9月30日出院患儿病历中抽取200份病历,以自行建立的33项儿童ADE触发器对病历进行检测,对检出触发器阳性触发的病历进一步分析患儿是否发生ADE,进行ADE分类、分级及因果关系判定,并分析致儿童ADE的常见药物种类以及患儿特异性因素与ADE的相关性。结果200份病历涉及200例患儿,其中男性128例,女性72例;平均年龄6岁,范围出生后38 min^18岁;住院时间2~43 d,平均10 d。200份病历中至少检测到1次触发器阳性触发的病历为128份,触发器阳性触发率为64.0%(95%CI: 57.0%~71.0%)。33项触发器中有29项(87.9%)检测到394例次阳性触发,判定发生ADE 98例次,涉及41例患儿,触发器ADE检出率为20.5%(41/200),触发器检测ADE的阳性预测值为24.9%(95%CI: 20.1%~28.0%)。98例次ADE可归为12大类,较常见者为白细胞数量异常(21.4%,21例次)、皮肤损害(11.2%,11例次)和血小板数量异常(10.2%,10例次);1、2、3级ADE分别占39.8%(39例次)、56.1%(55例次)和4.1%(4例次);因果关系判定为肯定相关、很可能相关、可能相关、待评价和无法评价者分别为4例次(4.1%)、73例次(74.5%)、19例次(19.4%)、1例次(1.0%)和1例次(1.0%)。98例次ADE涉及18类52种药物,药物出现频次为1~16次,共143次,其中以抗肿瘤药物出现频次最多(44.1%,63次),其次为抗菌药物(23.8%,34次)。Logistic回归分析结果显示,住院天数和诊断病症为白血病与发生ADE的可能性呈正相关。结论自行建立的33项触发器可有效监测儿童ADE,但还需进一步完善。可能与ADE相关的患儿特异性因素为住院天数多和罹患白血病。

Objective To evaluate the effectiveness of self-established 33 triggers in detecting drug adverse events (ADE) in children and explore child-individual factors possibly associated with ADE. Methods Two hundred medical records of inpatient in Sichuan Provincial People′s Hospital, who discharged from January 1, 2017 to September 30, 2017, were sampled using the sampling method recommended by the global trigger tool white paper of U. S. Institute for Healthcare Improvement. The medical records were detected using the self-established 33 ADE triggers. If there were positive triggers, whether the children developed ADE, the classification, grading, and causal judgement of ADE, types of common drugs causing ADE in children, and the association between the individual factors in children and ADE were further analyzed. Results In the 200 medical records, 200 children were involved, including 128 males and 72 females, aged from 38 minutes after birth to 18 years with the average age of 6 years. The time of hospital stay was 2 to 43 days with the average time of 10 days. Of the 200 medical records, 128 had at least 1 positive trigger, and the positive trigger rate was 64.0%(95%CI: 57%-71%). Of the 33 triggers, 29 were triggered a total of 394 times, and 98 ADE were detected, involving 41 children. Thus the detectable rate of the triggers was 20.5%(41/200), and the positive predictive value (PPV) of the triggers in detecting ADE was 24.9%(95%CI: 20.1%-28.0%). Ninety eight ADE could be classified into 12 categories, and ADE such as abnormal white blood cell count (21.4%, 21 times), skin lesions (11.2%, 11 times), and abnormal platelet count (10.2%, 10 times) were more common. The proportion of ADE that were grading as grade 1, grade 2, and grade 3 were 39.8%(39 times), 56.1%(55 times), and 4.1%(4 times), respectively. In the causality determination, 4 (4.1%), 73 (74.5%), 19 (19.4%), 1(1.0%), and 1 (1.0%) ADE were determined as certain, probable, possible, conditional, and unassessable. Ninety eight ADE involved 18 classes (including 52 kinds) of drugs, and the frequency of drug occurrence ranged from 1 to 16 times, with a total of 143 times. Anti-tumor drugs (44.1%, 63 times) appeared most frequently, and followed by antibacterial agents (23.8%, 34 times). Logistic regression analysis showed that hospital stay and diagnosis of leukemia were positively correlated with the likelihood of ADE occurrence. Conclusions The self-established 33 triggers could effectively monitor ADE in children, despite that further improvements were necessary. The individual factors in children that might be associated with ADE were more hospitalization days and suffering from leukemia.