基于AERS的丙戊酸不良反应信号挖掘与数据分析

Data analysis and signal excavation of valproic acid induced ADR based on the AERS

目的:检测美国不良事件报告系统(AERS)中丙戊酸致各系统不良反应(ADR)的信号并分析其影响因素,为临床合理用药提供参考。方法:采用报告比值比法(ROR)对AERS数据库中2017年第1季度-2017年第4季度收集的报告进行提取分析,挖掘丙戊酸致血液、代谢、消化、皮肤系统不良反应的相关信号,并使用SPSS20.0分析年龄、性别、用药剂量及联合用药对血液系统不良反应的影响。结果:纳入以丙戊酸为首要怀疑药物的不良反应报告110份,其中血液系统不良反应报告数和信号数均为最多。统计学分析显示血液系统ADR相对于其他系统ADR,在年龄(P=0.002)、性别(P=0.003)中分布有统计学意义,在用药剂量(P=0.778)、联合用药(P=0.847)中分布无统计学意义。儿童特别是女性患者对血液系统不良反应较敏感。结论:通过对丙戊酸安全信号和影响因素的检测和分析发现,应重视年龄和性别对血液系统不良反应的影响,并有必要进行进一步信号评价和验证,为临床安全用药提供依据。

OBJECTIVE To detect the adverse drug reactions(ADR) signals of valproic acid in American Adverse Event Reporting System(AERS) and analyze the influencing factors of adverse reactions, so as to provide references for clinical rational drug use.METHODS The reports collected from the first quarter of 2017 to the fourth quarter of 2017 in AERS database were extracted and analyzed by reporting odds ratio(ROR). The related signals of adverse reactions of blood, metabolism, digestion and skin system induced by valproic acid were excavated.RESULTS 110 reports of adverse drug reactions were reported, among which the number of reports and signals of hematological adverse drug reactions were the most. Statistical analysis showed a statistically significant distribution of hematological ADRs relative to other systemic ADRs in age(P=0.002) and gender(P=0.003), and no statistically significant distribution was detected in dose of medication(P=0.778) and combination(P=0.847). Children, especially female patients, were more sensitive to hematological adverse reactions.CONCLUSION The detection and analysis of safety signals and influencing factors of valproic acid indicate that attention should be paid to the influence of age and gender on hematological adverse reactions, and it is necessary to carry out further signal evaluation and verification, so as to provide the basis for clinical safe medication.