基于openFDA对曲妥珠单抗和帕妥珠单抗不良反应的比较分析

Comparative Analysis of Adverse Drug Reactions of Trastuzumab and Pertuzumab Based on OpenFDA

目的:研究分析美国食品药品管理局公共数据开放项目(openFDA)数据库中曲妥珠单抗和帕妥珠单抗药品不良反应(ADR)的上报情况,为临床合理用药提供有效参考。方法:通过访问openFDA数据库ADR交互式图表板块提供的应用程序编程接口(API),对2004年1月1日~2021年6月30日曲妥珠单抗和帕妥珠单抗ADR报告数据进行检索,多角度分析所得数据及图表。结果:曲妥珠单抗和帕妥珠单抗ADR报告分别为15 457份和5 551份;主要由医师和其他卫生专业人员上报;上报国家以欧美发达国家为主;两药适应证均以治疗人表皮生长因子受体-2(HER-2)阳性转移性乳腺癌为主;两药ADR类型大多为严重的ADR;曲妥珠单抗的转归情况多数未知,而帕妥珠单抗的转归情况以已恢复/已解决为主。结论:利用openFDA数据库可对两药ADR信息进行全面分析总结,临床使用曲妥珠单抗和帕妥珠单抗时,应密切关注适应证及不良反应,提高对药物心脏毒性等不良反应的警惕性,促进药物的合理使用。

Objective:To study and analyze adverse drug reactions(ADR) of trastuzumab and pertuzumab in the database of the U.S.Food and Drug Administration public data open project(openFDA),so as to provide an effective reference for the clinical rational usage of drugs.Methods:By accessing the application programming interface(API) in the ADR interactive chart section of the openFDA database,the ADR reported data of trastuzumab and pertuzumab from January 1 st,2004 to June 30 th,2021 were detailed retrieved.The obtained data and charts were analyzed from multi-angle.Results:The ADR reports of trastuzumab and pertuzumab were 15 457 and 5 551,respectively.ADR reports mostly came from physicians and other health professionals.The developed countries in Europe and America were the main countries on ADR.The main indication for the two drugs was human epidermal growth factor receptor-2(HER-2) positive metastatic breast cancer.Most of the ADR types of two drugs were serious adverse reactions.The outcomes of trastuzumab were mostly unknown,while the outcomes of patuzumab were mainly recovered/resolved.Conclusion:The openFDA database can be used to comprehensively analyze and summarize the ADR related information of the two drugs.During the clinical use of trastuzumab and pertuzumab,close attention should be paid to indications and adverse reactions,so as to improve the vigilance of adverse reactions such as drug cardiotoxicity and promote the rational use of drugs.