基于美国FAERS数据库的卡格列净不良反应信号挖掘

目的：利用大样本数据对卡格列净的不良反应（adverse drug reactions，ADR）信号进行挖掘分析，为临床合理安全用药提供参考。方法：收集美国FDA不良事件报告系统中2015年第一季度至2021年第二季度共26季度的卡格列净的ADR报告，采用报告比值比（reporting odds ratio，ROR）法和比例报告（proportional reporting ratio，PRR）法对其进行数据挖掘。利用国际医学用语词典（Medical Dictionary for Drug Regulatory Activities，MedDRA）分析药物不良事件安全信号。结果：共提取到卡格列净相关ADR报告14 039份，除去信息未知的情况，其中女性5 439例（38.7%），男性5 824例（41.5%）；年龄主要分布在45~64岁（3 779例，占26.92%）。挖掘到该药相关ADR信号主要表现为截肢、酮症酸中毒、泌尿生殖系统感染等事件，且截肢好发于男性及高龄患者；泌尿生殖系统感染好发于女性。将信号进行规整比对，还挖掘出骨髓炎、特发性阴囊坏死、胰腺炎、排尿障碍等药品说明书中尚未提及的ADR。结论：利用FAERS数据库可较全面深入地分析卡格列净的ADR，为临床安全合理用药提供参考。

Data mining for adverse drug reactions of canagliflozin based on FAERS database

OBJECTIVE To provide reference for rational and safe drug use in clinic, large sample data were used to analyze the adverse drug reaction (ADR) signals of canagliflozin.METHODS The 26 quarterly ADR reports from the first quarter of 2015 to the second quarter of 2021 were collected from the FDA adverse event reporting system. The data were mined by using the reporting ratio (ROR) and the proportional reporting ratio (PRR) methods. The safety signals of adverse drug events were analyzed by using Medical Dictionary for Drug Regulatory Activities (MedDRA).RESULTS A total of 14 039 ADR reports related to canagliflozin were collected. After excluding unknown information, the reports included 5 439 (38.7%) females and 5 824 (41.5%) males, and most of the patients were 45-64 years old (3 779 cases, 26.92%). The ADR signals related to the drug were mainly manifested as amputation, ketoacidosis, urinary and reproductive system infection and other events, and amputation was more common in males and elderly patients, and genitourinary infections were more common in women. The signals were compared regularly and the ADRs not mentioned in the drug instruction were dig out, such as osteomyelitis, Fournier's gangrene, pancreatitis and dysuria.CONCLUSION The data of FAERS can be used to analyze the side effects of canagliflozin and provide reference for clinically safe and rational drug use.