中国医院用药评价与分析2024，Vol.24Issue(6)：756-760,5.DOI:10.14009/j.issn.1672-2124.2024.06.026
原研门冬胰岛素30注射液的药品不良反应/药品不良事件风险信号挖掘与用药启示
Risk Signal Mining of Adverse Drug Reactions/Adverse Drug Events of Original Insulin Aspart 30 Injection and Medication Enlightenment
摘要
Abstract
OBJECTIVE:To explore the the risk signals of adverse drug reactions/adverse drug events(ADR/ADE)of original insulin aspart 30 injection,so as to provide reference for the clinical safety application of generic medicine in China.METHODS:Reporting odds ratio(ROR),proportional reporting ratio(PRR)and medicines and healthcare products regulatory agency method(MHRA)method were used to mine the risk signals of insulin aspart 30 injection in the US Food and Drug Administration Adverse Event Reporting System(FAERS)database from the first quarter of 2004 to the fourth quarter of 2022.RESULTS:A total of 2344 ADR/ADE reports of insulin aspartate 30 injection were collected in the FAERS database.Three methods were used to detect 137 signals at the preferred terminology(PT)level,including 21 system organ classification(SOC),and 24 risk signals at the standard Med DRA analysis query(SMQ)level.According to the number of SOC reports,signal strength of PT,number of SMQ reports and signal strength ranking,hypoglycemia and various clinical manifestations induced by hypoglycemia were the most common ADR/ADE.Elevated blood glucose,weight gain,insulin autoimmune syndrome and various neonatal disorders were obtained as ADR/ADE that were not mentioned in the drug instructions,and the significance of the above signals for clinical guidance was analyzed.CONCLUSIONS:Extra attention should be paid to hyperglycemia,weight gain,and insulin autoimmune syndrome that are not documented in the drug instructions of insulin aspart 30 injection.Insulin aspart 30 injection is not recommended for glycemic control during pregnancy.关键词
门冬胰岛素30注射液/不良事件/美国食品药品监督管理局不良事件报告系统/信号挖掘Key words
Insulin apart 30 injection/Aadverse events/FAERS/Signal mining分类
医药卫生引用本文复制引用
刘宁,范宝霞,张红艳,彭婷婷..原研门冬胰岛素30注射液的药品不良反应/药品不良事件风险信号挖掘与用药启示[J].中国医院用药评价与分析,2024,24(6):756-760,5.基金项目
山东省第二批药品临床综合评价项目(No.2022YZ004) （No.2022YZ004）
