基于FAERS数据库的儿童使用氯雷他定不良事件信号挖掘与分析

Data mining and analysis of adverse drug events signals for Loratadine in children based on FAERS database

目的挖掘真实世界数据中儿童使用氯雷他定的不良事件(ADE)信号,发现其潜在的ADE类型,为合理用药提供依据。方法提取美国食品药品管理局不良事件报告系统(FAERS)数据库中2013年第1季度至2021年第2季度的ADE报告并筛选出儿童使用氯雷他定的报告,采用比例报告比值(PRR)法和报告比值比(ROR)法进行信号挖掘,使用《国际医学用语词典》(MedDRA)对ADE信号挖掘结果进行系统分类。结果经筛选后共纳入19237份报告,1738种ADE,信号186个,涉及系统/器官分类24个(各类损伤、中毒及操作并发症占22.49%),标准化MedDRA分析查询(SMQ)层级38个(用药错误占15.74%),药品说明书未收载的ADE较强信号包括眼睑松垂和广场恐怖症等。结论经PRR法和ROR法分析发现虽然儿童使用氯雷他定具有良好的安全性,但存在一定的用药错误,建议在临床用药中加强监护,严格按照药品说明书规定使用,提高药学服务质量,保障患儿用药安全、有效。

Objective By mining the adverse event(ADE)signals for loratadine in children from real-world data,to find the potential ADE types,and to provide evidence for rational administration of drug.Methods ADE reports from the U.S.Food and Drug Administration Adverse Event Reporting System(FAERS)database from the first quarter of 2013 to the second quarter of 2021 were extracted,and the cases under 18 years old who used loratadine were screened out.Proportional reporting ratio(PRR)method and reporting odds ratio(ROR)method were used for data mining,and the Medical Dictionary for Regulatory Activities(MedDRA)was used to systematically classify the ADE signals.Results A total of 19237 reports were included after screening,including 1738 ADE and 186 signals,involving 24 system/organ classifications(injury,poisoning and procedural complications:22.49%)and 38 standardised MedDRA queries(medication error:15.74%).Blepharochalasis and agoraphobia with strong signal were not recorded in the drug instructions.Conclusion It is found after analysis by PRR and ROR methods that although the use of loratadine in children has good safety,there are certain medication errors.It is suggested to strengthen monitoring in clinical medication,use in strict accordance with the provisions of the drug labels,improve the quality of pharmaceutical services,and ensure the safe and effective medication for children.