摘要
目的对度拉糖肽上市后安全性进行再评价,为临床安全合理用药提供依据。方法采用ROR和BCPNN 2种方法对FAERS数据库中2014年第1季度至2021年第2季度收集的报告进行信号挖掘及分析。利用SPSS 23.0分析性别、年龄及给药剂量对主要累及系统ADR的影响。结果共纳入5729311份报告,首要怀疑度拉糖肽的报告有25523份;ROR和BCPNN法同时挖掘出95个度拉糖肽的安全警戒信号,其中说明书中未提及的可疑ADR信号有26个。累及11个系统,胃肠系统ADR最多。与其他系统ADR比较,患者性别、年龄和给药剂量对胃肠系统ADR的影响均有统计学意义(P<0.05),女性多于男性,年龄以60岁以上居多,给药剂量多为0.75 mg/周。度拉糖肽致严重ADR报告共计2065例,占比为8.09%。结论对度拉糖肽安全警戒信号进行挖掘与评价,提示临床采取相应的措施,关注高风险人群,可预防ADR发生,降低用药风险。
Objective To re-evaluate the safety of dulaglutide after listing,so as to provide evidence for clinical safe and rational drug use.Methods ROR and BCPNN were used to mine and analyze the reports collected in FAERS database from the first quarter of 2014 to the second quarter of 2021.SPSS 23.0 was used to analyze the effects of gender,age and dosage on ADR of the main involved systems.Results A total of 5729311 reports were included,of which 25523 were suspected of dulaglutide;ROR and BCPNN methods simultaneously mined 95 safety warning signals of dulaglutide,including 26 suspicious ADR signals not mentioned in the specification,involving 11 systems,and the gastrointestinal system had the most ADR.Compared with other ADR systems,the effects of gender,age and dosage on gastrointestinal ADR were statistically significant(P<0.05).Women were more than men,most of them were over 60 years old,and the dosage was 0.75 mg a week.There were 2065 cases of severe ADR caused by dulaglutide,and the proportion of severe ADR was 8.09%.Conclusion Mining and evaluating the safety warning signal of dulaglutide suggests that the clinical doctors should take corresponding measures and pay attention to the high-risk population,which can prevent the occurrence of ADR and reduce the risk of medication.
作者
吴遵平
吴利利
WU Zun-ping;WU Li-li(Department of Pharmacy,the Third Affiliated Hospital of Zunyi Medical University/Zunyi First People′s Hospital,Zunyi 563099,China;Department of Pharmacy,Affiliated Hospital of Zunyi Medical University,Zunyi 563003,China)
出处
《实用药物与临床》
CAS
2022年第9期777-781,共5页
Practical Pharmacy and Clinical Remedies
基金
贵州省遵义市科技合作计划(遵市科合社字[2018]60号)。
关键词
度拉糖肽
报告比值法
贝叶斯置信传播神经网络法
药物警戒
信号挖掘
Dulaglutide
Reporting odds ratio
Bayesian confidence propagation neural network
Pharmacovigilance
Signal mining
