目的 通過挖掘真實世界中與普瑞巴林關聯(lián)的藥物不良事件信號,為其臨床安全合理用藥提供參考。方法 調(diào)取美國食品藥品監(jiān)督管理局(FDA)不良事件報告系統(tǒng)(FAERS)中普瑞巴林2015年1月1日—2023年1月31日的數(shù)據(jù),運用報告比值比法和貝葉斯可信區(qū)間遞進神經(jīng)網(wǎng)絡法進行信號挖掘,分析其藥物不良反應發(fā)生情況。結(jié)果 共得到藥物不良事件信號288個,其中發(fā)生頻次排在前5位的藥物不良事件是全身性疾病及給藥部位各種反應,精神疾病類,各類神經(jīng)系統(tǒng)疾病,各類損傷、中毒及操作并發(fā)癥,各種肌肉骨骼,以及結(jié)締組織疾病;挖掘到9個未收錄于說明書中的新發(fā)現(xiàn)可疑不良反應,尿尿素增高、頦麻木綜合征、幻肢綜合征、身高降低等。結(jié)論 普瑞巴林在真實世界中發(fā)生的常見不良反應應與說明書保持一致性,對于臨床上部分新出現(xiàn)可疑的不良反應,在用藥時應重點關注。

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.

R971