来源：风湿病与关节炎,2023,12（9）:17-21.30.

基于FAERS数据库的聚乙二醇重组尿酸酶注射液不良事件信号挖掘研究（临床研究）

龚中洁¹，于　佳²，卢　云²，余　谦²，杨　静²，梁　江^1,2

　　【摘　要】目的：基于美国食品药品监督管理局不良反应事件报告系统（FAERS）数据库，检索并分析治疗痛风药物聚乙二醇重组尿酸酶注射液（普瑞凯希，peglolicase）的不良事件信号，为临床安全用药提供参考。方法：以“peglolicase”为关键词，检索数据库内2018年第1季度至2022年第2季度该药的不良事件报告，删除重复项，用比例失衡法中的报告比值比法和比例报告比值法计算、评估并确立不良事件预警信号。结果：获得以聚乙二醇重组尿酸酶为目标药物的不良事件有效报告数988起（来自569例患者），检测筛选获得有效信号119个，主要涉及13个系统器官分类，其中报告数位于前3位的为痛风性关节炎再发（87起，8.81%），血尿酸升高（66起，6.68%），痛风治疗反应下降（66起，6.68%）。结论：聚乙二醇重组尿酸酶的不良事件主要集中在原发疾病症状及化验值、各类检查，建议临床用药时应注意监测患者痛风性关节炎再发、肾功能异常等不良反应，及时采取相应措施。

　　【关键词】　痛风；聚乙二醇重组尿酸酶；尿酸；报告比值比法；比例失衡法；不良事件报告信号

Research on Signal Mining of Adverse Event Caused by Polyethylene Glycol Recombinant Uricase Injection Based on FAERS Database

GONG Zhong-jie,YU Jia,LU Yun,YU Qian,YANG Jing,LIANG Jiang

　　【ABSTRACT】Objective:Based on FAERS database,to search and analyze the adverse event signals of the gout treatment drug polyethylene glycol recombinant uratase injection,and to provide reference for clinical safe medication.Methods:Using "peglycase" as the keyword,search for adverse event reports of the drug from the first quarter of 2018 to the second quarter of 2022 in the database,and delete duplicates.Calculate,evaluate,and establish adverse event warning signals using the reporting odds ratio and the proportional reporting ratio in the proportional imbalance method.Results:A total of 988 effective reports of adverse events were obtained with polyethylene glycol recombinant uratase as the target drug（from 569 patients）,and 119 effective signals were detected and screened,mainly involving 13 system organ classifications.Among them,the top three reported cases were recurrent gout（87 cases,8.81%）,elevated blood uric acid（66 cases,6.68%）,and poor therapeutic response of gout（66 cases,6.68%）.Conclusion:The adverse events of polyethylene glycol recombinant uratase mainly focus on the symptoms and laboratory values of the primary disease,as well as various examinations.It is recommended to pay attention to monitoring the recurrence of gouty arthritis and abnormal renal function in patients during clinical medication,and take corresponding measures in a timely manner.

　　【Keywords】 gout;polyethylene glycol recombinant uratase;uric acid;reporting odds ratio;proportional imbalance;reporting signal of adverse event