摘要
目的基于FAERS数据库对三种铂类药物(顺铂、卡铂、奥沙利铂)进行不良事件信号挖掘,探索不良反应(ADR)发生的特点及其与药物的关联强度,以期为临床用药提供一定的参考。方法提取FAERS数据库2015年第一季度至2019年第四季度共20个季度的不良事件报告数据,利用报告比值比法(ROR)和比例报告比值法(PRR)对三种铂类药物的相关报告进行数据挖掘。得到有效信号后,再利用MedDRA术语集进行汉化及系统归类。结果采用ROR法和PRR法进行计算后,二次筛选并合并相同不良事件信号,三种铂类药物共得到227个信号,信号累及24个不同的系统器官(SOC),其中顺铂主要集中于血液及淋巴系统疾病(累计不良事件1828例)、胃肠系统疾病(1415例);卡铂主要集中于血液及淋巴系统疾病(3816例)、胃肠系统疾病(2613例);奥沙利铂主要集中于胃肠系统疾病(2510例)、全身性疾病及给药部位各种反应(2249例)和各类神经系统疾病(1813例)。顺铂、奥沙利铂与胃肠道反应关联性更强,肾毒性则以顺铂为主,而骨髓抑制以顺铂、卡铂为主,周围神经疾病与奥沙利铂关联最强,卡铂和奥沙利铂与过敏反应具有较强的关联性。结论本研究获得的常见ADR信号及其累及系统与说明书具有一致性,证实了本研究方法的可靠性。顺铂、卡铂、奥沙利铂发生ADR累及的主要系统具有差异性,可为临床用药提供一定的参考,有利于促进临床合理用药。
Objective To provide a reference for clinical administration of platinum drugs,we mine the adverse event signals of three platinum drugs(cisplatin,carboplatin,oxaliplatin)based on the FAERS database and explore the characteristics of ADE occurrence and the correlation strength between ADE and drugs.Methods We use reporting odds ratio(ROR)and proportional reporting ratio(PRR)methods to mine the adverse reaction signals of three platinum drugs based on the adverse reaction report data of 20 quarters from the first quarter of 2015 to the fourth quarter of 2019 extracted from the FAERS database.After valid signals were obtained,the MedDRA was used for translation and system organ classification.Results After ROR and PRR calculation,secondary screening and combining the same adverse reaction signals,a total of 227 signals were detected for the three platinum drugs,which involved 24 different system organ classes(SOCs).Cisplatin mainly focused on blood and lymphatic system disorders(the number of adverse events,n=1828),and gastrointestinal disorders(n=1415).Carboplatin mainly focused on blood and lymphatic system disorders(n=3816),and gastrointestinal disorders(n=2613).Oxaliplatin mainly focused on gastrointestinal disorders(n=2510),general disorders and reactions at administration site(n=2249),and nervous system disorders(n=1813).Cisplatin and oxaliplatin were more closely related to the gastrointestinal response.The nephrotoxicity was mainly caused by cisplatin,while the marrow inhibition was mainly caused by cisplatin and carboplatin.Peripheral neuropathy was the most strongly associated with oxaliplatin.Carboplatin and oxaliplatin has a strong correlation with allergic reactions.Conclusion The common ADR signals and ADR involved systems obtained in this study are consistent with the instructions,confirming the reliability of the research method.The major systems involved in ADR involving cisplatin,carboplatin,and oxaliplatin are different,which can provide a reference for clinical drug use and promote rational drug
作者
胡晓雯
刘璐
冉怡雯
赵尹瑜
张臣宇
马洪波
陈力
HU Xiaowen;LIU Lu;RAN Yiwen;ZHAO Yinyu;ZHANG Chenyu;MA Hongbo;CHEN Li(Department of Pharmacy/Evidence-Based Pharmacy Center,West China Second University Hospital,Sichuan University,Chengdu,Sichuan,610041,China;Key Laboratory of Birth Defects and Related Diseases of Women and Children,Ministry of Education,Chengdu,Sichuan,610041,China;West China School of Pharmacy,Sichuan University,Chengdu,Sichuan,610041,China)
出处
《肿瘤药学》
CAS
2020年第5期608-616,共9页
Anti-Tumor Pharmacy
基金
四川省科技厅项目(2019JDR0163)。
关键词
铂类药物
FAERS
不良反应信号挖掘
报告比值比法
比例报告比值法
Platinum drugs
FAERS
Adverse reaction signal mining
Reporting odds ratio method
Proportional reporting ratio method
