儿童使用奥卡西平致皮肤不良反应数据分析方法的探索

Exploration on data analysis of oxcarbazepine induced skin ADR in children

目的:探索美国不良事件报告系统(AERS)中儿童使用奥卡西平致皮肤不良反应(ADR)数据分析方法,为临床用药提供参考。方法:对2007年第一季度到2014年第二季度AERS数据库中儿童使用奥卡西平致皮肤ADR的数据进行提取、验证及统计分析。结果:从AERS数据库中共挖掘出279个可疑的ADR报告,其中皮肤ADR信号13个,涉及患儿40例。通过统计学分析发现皮肤ADR相对于其他ADR,在年龄(P=0.065)、性别(P=0.213)、人种(P=0.054)、给药剂量(P=0.225)中的分布差异均无统计学意义。医疗机构是皮肤ADR报告的主要来源,医师上报数目最多,并以快速上报为主(P<0.05),其结局造成住院或住院时间延长的病例较多(52.5%)。结论:奥卡西平皮肤ADR虽然少见,但是往往会造成儿童住院治疗或住院时间加长,我们应对不同性别、不同年龄段和不同给药剂量的患者予以相同的重视,加强对奥卡西平皮肤ADR的监测。

OBJECTIVE To explore the method of data extraction and analysis on oxcarbazepine induced skin adverse drug reaction（ ADR） in children from Adverse Event Reporting System（ AERS）,provide a reference for clinical medication. METHODS Data of oxcarbazepine induced skin ADR in children from the first quarter of 2007 to the second quarter of 2014 in AERS were extracted,validated and statistically analyzed. RESULTS A total of 279 suspected ADR reports were excavated from AERS database,in which13 skin ADR signals were found involving 40 cases. Statistical analysis showed that compared to other adverse reactions,no statistically significant difference were observed in age（ P = 0. 065）,gender（ P = 0. 213）,race（ P = 0. 054） or dose（ P = 0. 225） in skin ADRs.Medical institutions were the main sources of skin ADR reports,most were came from physicians and expedited reports（ P〈0. 05）,and primary outcomes of patients were hospitalization-initial or prolonged（ 52. 5%）. CONCLUSION Oxcarbazepine induced skin ADR is rare,but often causes children hospitalization or prolong of hospitalization. We should pay equal attentions on patients with different genders,ages and different drug doses,to strengthen monitoring of oxcarbazepine induced skin ADRs.