摘要
目的:检测和分析替格瑞洛上市后不良反应信号,为临床合理用药提供参考。方法:采用数据挖掘方法对美国FDA不良事件报告系统数据库进行替格瑞洛不良反应信号检测,并利用SPSS 17.0分析性别、年龄、用药时长对目标信号的影响。结果:在纳入分析的8 417 145例报告中,共检测到193个替格瑞洛不良反应信号,其中在心脏系统、呼吸系统、胸及纵膈疾病分布最多。经统计学分析,相比其他系统不良反应,呼吸系统、胸及纵膈疾病在性别和年龄分布中差异无统计学意义;维持剂量时,在用药时长(P=0.019)分布中差异有统计学意义。结论:呼吸系统、胸及纵膈疾病不良反应大多发生在用药前3个月,临床医生、药师应了解替格瑞洛所致不良反应的分布及危险因素,加强其用药监护,以减少不良反应的发生。
Objective： To detect the signals of ticagrelor-induced drug adverse reactions（ ADRs）,and analyze its post-marketing ADR for providing references in clinic. Methods： A form of data mining was used to detect the ADR signals in the FAERS. The influence factors,i. e. gender,age,and medication duration were analyzed by SPSS 17. 0. Results： A total of 8 417 145 reports were found,in which 193 signals related to ticagrelor were identified. Cardiac, respiratory, thoracic and mediastinal disorders contained the most ADR signals.Compared these disorders with other ADRs,a significant difference exited in medication duration（ P = 0. 019）,but not in the age and the gender. Conclusion： Medication duration in initial 3 months was the risk factor of respiratory,thoracic and mediastinal disorders. Clinicians and pharmacists should familiarize the distribution and characteristics of the ADRs,and enhance pharmaceutical care of ticagrelor to decrease these avoidable ADRs.
作者
边桂芝
钟燕
田雅兰
张志勇
BIAN Gui-zhi ZHONG Yan TIAN Ya-lan ZHANG Zhi-yong(West China School of Pharmacy Department of Pharmacy, West China Hospital, Sichuan University, Chengdu 610041 , China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2016年第20期2390-2394,共5页
Chinese Journal of New Drugs
关键词
替格瑞洛
不良反应
信号检测
合理用药
ticagrelor
adverse drug reactions（ADRs）
signal detection
reasonable administration
