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

目的:挖掘门冬胰岛素30注射液原研品种的药品不良反应/药品不良事件(ADR/ADE)风险信号,为我国仿制品种的临床安全应用提供参考。方法:运用报告比值比法(ROR)、比例报告比法(PRR)和综合标准法(MHRA),对2004年第1季度至2022年第4季度美国食品药品监督管理局不良事件报告系统(FAERS)数据库中门冬胰岛素30注射液的ADR/ADE报告进行风险信号挖掘。结果:在FAERS数据库中收集到门冬胰岛素30注射液的ADR/ADE报告2 344例。运用3种方法检测出首选术语(PT)层级信号137个,累及21个系统器官分类(SOC),在标准Med DRA分析查询(SMQ)层级检测出风险信号24个。分别按照SOC报告数、PT的信号强度、SMQ的报告数和信号强度排序,低血糖及低血糖导致的各种临床表现为最常见的ADR/ADE。挖掘出血糖升高、体重增加、胰岛素自身免疫综合征和各种新生儿疾病是药品说明书中未提及的ADR/ADE,对以上信号的临床指导意义进行了分析。结论:门冬胰岛素30注射液的药品说明书中未记载的血糖升高、体重增加、胰岛素自身免疫性综合征等ADR/ADE,需在用药过程中格外注意;一般妊娠期不建议使用门冬胰岛素30注射液控制血糖。

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.