达沙替尼上市后呼吸系统不良反应信号的检测与分析  

Detection and evaluation of dasatinib-induced respiratory system ADR signals in post-marketing experience

作　　者：田雅兰[1,2] 边桂芝 曹培 张志勇[2] 

机构地区：[1]四川大学华西药学院,成都610041 [2]四川大学华西医院药剂科,成都610041 [3]四川大学华西临床医学院,成都610041

出　　处：《中国新药杂志》2018年第2期236-241,共6页Chinese Journal of New Drugs

摘　　要：目的:检测和分析达沙替尼上市后的不良反应信号,为临床合理用药提供参考。方法:采用报告比值比法(ROR)对美国食品药品监督管理局(FDA)不良事件呈报系统(AERS)进行不良反应信号检测,并利用SPSS 19.0分析性别、年龄、剂量及用药时长对不良反应的影响。结果:在纳入分析的76 982 127份不良反应报告中,以达沙替尼为首要怀疑药物的报告11 461份,经ROR法检测,共得到343个达沙替尼不良反应信号,其中呼吸系统、胸及纵隔疾病信号26个。相比其他系统不良反应,呼吸系统、胸及纵隔疾病不良反应在性别(P=0.003)、年龄(P=0.000)和用药时长(P=0.000)方面均有统计学差异;给药剂量(P=0.911)分布无统计学差异。结论:达沙替尼具有呼吸系统、胸及纵隔病症的安全风险,临床应用时应注意防范。Objective： To detect and analyze the ADR signals of dasatinib in post-marketing experience, and provide references for clinic. Methods： Reporting odd ratio （ROR） algorithm was used to investigate the ADR signals from AERS submitted to the U.S. FDA, and the effects of gender, age, medication duration and dosage were analyzed by SPSS 19.0. Results： A total of 76 982 127 reports were found for all drugs, among which 11 461 reports suspected that dasatinib was the primary drug causing the ADR. After detection, 343 signals related to dasatinib were identified, including 26 signals relevant to respiratory, thoracic and mediastinal disorders. There existed significant difference in the gender （P = 0. 003 ）, age （P =0. 000） and medication duration （P = 0. 000）, but not in the dosage （P=0. 911 ） of the 26 signals compared with other ADRs. Conclusion： There exist risks of respiratory, thoracic and mediastinal disorders when taking dasatinib, so corresponding preventive measures should be taken in clinical application.

关 键 词：达沙替尼 药物不良反应 信号检测 合理用药 

分 类 号：R979.1[医药卫生—药品]