1632例老年患者使用氨甲环酸注射剂的不良反应报告分析

Analysis of 1632 cases of adverse drug reaction reports in elderly patients using tranexamic acid injection

目的:探讨老年患者氨甲环酸注射剂所致ADR的特点和临床表现,以期为老年患者安全用药提供参考。方法:收集2013年1月–2020年5月四川省药品不良反应监测中心数据库中65岁及以上老年患者使用氨甲环酸注射剂致药品不良反应(ADR)的报告,对其进行统计分析。结果:共收集到氨甲环酸注射剂ADR报告1632份,其中氨甲环酸氯化钠注射液相关ADR报告数远多于氨甲环酸注射液和注射用氨甲环酸(1268份vs 317份vs 47份)。氨甲环酸注射剂所致ADR累及系统/器官主要为胃肠道系统、中枢及外周神经系统以及交感副交感神经系统。新的ADR报告315份(19.30%),其中新的一般ADR报告291份,主要为胃肠道系统、交感副交感神经系统和全身性损害;新的严重ADR报告35份,主要为中枢及外周神经系统损害。结论:氨甲环酸注射剂可致老年患者多个系统/器官损害,可能发生新的ADR,提示临床在应用时需注意用药安全。

Objective:To explore the characteristics and clinical manifestations of adverse drug reaction(ADR)caused by tranexamic acid injection in elderly patients,in order to provide references for safe drug use in them.Methods:The ADR reports of tranexamic acid injection in the patients aged 65 years old and over in the database of Sichuan adverse drug reaction monitoring center from January 2013 to May 2020 were collected and statistically analyzed.Results:A total of 1632 ADR reports related to tranexamic acid injection preparations were collected,of which the number of ADR reports associated with tranexamic acid sodium chloride injection was much more than that of tranexamic acid injection and tranexamic acid for injection(1268 parts vs 317 parts vs 47 parts).Systems/organs involed in ADR caused by tranexamic acid injection were mainly gastrointestinal system,the central and peripheral nervous system and the sympathetic and parasympathetic nervous system.There were 315 new ADR reports(19.30%)in which 291 reports were the new general ADR with the top 3 involved systems as gastrointestinal system,sympathetic and parasympathetic nervous system,and systemic damage.There were 35 new severe ADR reports,mainly central and peripheral nervous system damage.Conclusion:Tranexamic acid injection can cause damage to multiple organs and systems in elderly patients and may cause new ADRs,which indicated that more attentions should be paid to its safety use in clinic.