目的 统计分析北京地区近10年来利伐沙班的不良反应(adverse drug reaction,ADR)报告,为利伐沙班的安全合理应用提供用药依据。方法 收集2009年7月至2018年 12月北京市药品ADR监测中心数据库中利伐沙班ADR报告,并对 359 例ADR统计分析,ADR报告类型、ADR发生时间、患者年龄、性别和民族分布、严重ADR、过敏史、给药途径、剂型、用量、用药原因、患者既往ADR史、ADR累及器官／系统及表现、ADR关联性评价结果、ADR处理及预后。结果 利伐沙班致ADR在65岁以上发生率较高,比例为62.95%。14.21％的ADR发生于用药后24 h内,临床表现复杂多样,涉及机体多个器官或系统,主要的严重ADR是出血、中枢神经系统损害、胃肠道系统损害和皮肤及其附件损害。结论 利伐沙班的安全性是临床应关注的问题,应在合理使用的基础上,监测并及时处理其ADR。
Abstract
OBJECTIVE To analyze the reports of rivaroxaban-induced adverse drug reaction (ADR) in Beijing area in the recent 10 years, and to provide reference for rational use of rivaroxaban. METHODS Three hundred and fifty nine reports of ADR from July 2009 to December 2018 induced by rivaroxaban received by Beijing Drug Adverse Reaction monitoring center were collected. The type and time of ADR, the age of patients, the gender and nation of patients, serious adverse reactions, allergy history, administration, dosage, preparation, the indication, ADR history, ADR involved organ and system, the causal relationship, treatments and prognosis were retrospectively analyzed. RESULTS The ADR induced by rivaroxaban were more often occurred in patients aged higher than 65 years, the percentage was 62.95%.With 14.21％ appearing within 24 h after drug use. The clinical presentation was complex and diverse, which involved different systems and organs, predominantly the lesion of the vascular diseases, central nervous system, gastrointestinal system and skin and its accessories. CONCLUSION Safety to use with rivaroxaban is worth paying attention by clinicans, who should detect and deal with ADR of rivaroxaban in time on basis of rational use.
关键词
利伐沙班 /
药品不良反应 /
分析
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Key words
rivaroxaban /
adverse drug reaction /
analysis
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中图分类号：
R969.3
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参考文献
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脚注
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基金
中国医学科学院医学与健康科技创新工程经费项目资助(2016-I2M-4-003)
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