目的 通过挖掘真实世界中与普瑞巴林关联的药物不良事件信号,为其临床安全合理用药提供参考。方法 调取美国食品药品监督管理局(FDA)不良事件报告系统(FAERS)中普瑞巴林2015年1月1日—2023年1月31日的数据,运用报告比值比法和贝叶斯可信区间递进神经网络法进行信号挖掘,分析其药物不良反应发生情况。结果 共得到药物不良事件信号288个,其中发生频次排在前5位的药物不良事件是全身性疾病及给药部位各种反应,精神疾病类,各类神经系统疾病,各类损伤、中毒及操作并发症,各种肌肉骨骼,以及结缔组织疾病;挖掘到9个未收录于说明书中的新发现可疑不良反应,尿尿素增高、颏麻木综合征、幻肢综合征、身高降低等。结论 普瑞巴林在真实世界中发生的常见不良反应应与说明书保持一致性,对于临床上部分新出现可疑的不良反应,在用药时应重点关注。

Objective To explore the adverse drug event signals related to pregabalin in the real world, and to provide reference for its rational and safe use in clinical practice.Methods The data of pregabalin from January 1, 2015 to October 31, 2022 were retrieved from the US Food and Drug Administration Adverse Event Reporting System(FAERS). The reported odds ratio method and Bayesian confidence interval progressive neural network method were used for signal mining, and the occurrence of adverse drug reactions was analyzed.Results A total of 288 signals of adverse drug event were obtained, among which the high frequency of adverse drug event were mainly concentrated in systemic diseases and various reactions at the drug administration site, various injuries, poisoning and operation complications, psychiatric disorders, various nervous system diseases, various musculoskeletal and connective tissue diseases, etc. Nine new suspected adverse drug reaction that were not included in the instructions were found, such as increased urine urea, Numb chin syndrome, phantom limb syndrome, and decreased height.Conclusion The common adverse drug reaction of pregabalin in the real world are consistent with the instructions, but there are some new suspected adverse reactions, which should be paid attention to in clinical medication.

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