达沙替尼和伊马替尼的不良反应信号检测研究 点击下载
| 论文标题： | 达沙替尼和伊马替尼的不良反应信号检测研究 |
| 英文标题： | |
| 中文摘要： | 目的：挖掘达沙替尼和伊马替尼的不良反应（ADR）信号，为两药的临床安全使用提供参考。方法：采用关于达沙替尼和伊马替尼的报告比值比法（ROR）和比例报告比值法（PRR），对美国FDA不良事件报告系统2012年第4季度－2016年第4季度共17个季度的比例失衡法中的报告进行数据挖掘，使用国际医学用语字典对报告中的ADR描述用语进行标准化，并对经两种方法检测同时有信号的ADR进行二次筛选。结果与结论：共得到达沙替尼ADR信号505个，伊马替尼ADR信号929个；经二次筛选后得到达沙替尼ADR信号351个，伊马替尼ADR信号649个，其中有153个信号为达沙替尼和伊马替尼的重叠信号。本研究所得到的达沙替尼和伊马替尼的ADR信号与已知的相关安全性信息基本一致，其ADR主要累及胃肠系统、血液及淋巴管、肾脏及泌尿系统、心血管和肌肉骨骼等方面。但也发现药品说明书有收录不全之处，如检测到的达沙替尼可能引起泌尿系统相关ADR的信号在其药品说明书中尚未提及，且伊马替尼可引起左心房与右心房扩张的ADR信号也均未收录于其说明书中；而伊马替尼说明书提到的常见ADR如头痛等，却未在本研究信号强度前50位出现。此外，两药的ADR也各有不同之处，如眶周水肿、眼部水肿等7个ADR信号中，伊马替尼远远强于达沙替尼；而心包积液、胸腔积液等5个ADR信号中，达沙替尼远远强于伊马替尼。这提示临床应注意根据患者个体情况选择用药。 |
| 英文摘要： | 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. |
| 期刊： | 2018年第29卷第20期 |
| 作者： | 吴邦华，闫康，陈力 |
| 英文作者： | WU Banghua，YAN Kang，CHEN Li |
| 关键字： | 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 |
| KEYWORDS： | Dasatinib； Imatinib； ADR signals； Measures of disproportionality； ROR； PRR |
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