中国药房2018，Vol.29Issue(20)：2840-2844,5.DOI:10.6039/j.issn.1001-0408.2018.20.23
达沙替尼和伊马替尼的不良反应信号检测研究
Study on ADR Signal Detection of Dasatinib and Imatinib
摘要
Abstract
OBJECTIVE:To mine the ADR signals of dasatinib and imatinib,and to provide reference for safe use of two drugs in clinic. METHODS:ROR and PRR method of disproportionality measures were used to mine the data in the reports about dasatinib and imatinib of 17 quarters from FDA ADE Reporting System during the fourth quarter of 2012-the fourth quarter of 2016. ADR description terms in reports were standardized with international medical terms dictionary. ADR with signal detected by both methods were screened again. RESULTS & CONCLUSIONS:Totally 505 ADR signals for dasatinib and 929 ADR signals for imatinib had been found by ROR and PRR. After re-screening,there were 351 ADR signals for dasatinib and 649 ADR signals for imatinib,including 153 ADR signals for both dasatinib and imatinib. ADR signals for both dasatinib and imatinib obtained in this study were in agreement with known safety information. ADR mainly occurred in gastrointestinal tract,blood and lymphatics,kidney and urinary system,cardiovascular and musculoskeletal tissue,etc. However,incomplete information in the instructions was also found,such as possible urinary system-related ADR signals caused by dasatinib were detected in this study is not mentioned in drug instruction;imatinib could cause ADR signals of left atrium and right atrium dilation,which were not included in their instructions. Common ADRs,such as headaches,metioned in drug instructions of imatinib,did not appear in the top 50 signal intensities in this study. In addition,the ADR of the two drugs also varied,such as 7 ADR signals as periorbital edema and ocular edoma of forimatinib were much stronger than dasatinib;5 ADR signals of dasatinib,such as pericardial effusion and pleural effusion were much stronger than imatinib,indicating clinical drug selection should be based on individual situation of patients.关键词
达沙替尼/伊马替尼/不良反应信号/比例失衡法/报告比值比法/比例报告比值法Key words
Dasatinib/Imatinib/ADR signals/Measures of disproportionality/ROR/PRR分类
医药卫生引用本文复制引用
吴邦华,闫康,陈力..达沙替尼和伊马替尼的不良反应信号检测研究[J].中国药房,2018,29(20):2840-2844,5.基金项目
四川省科技厅基金资助项目(No.2015ZR0149) （No.2015ZR0149）
