369例中药注射剂不良反应/不良事件分析

Analysis of 369 Cases of ADR/ADE Induced by Traditional Chinese Medicine Injections

目的:了解中药注射剂不良反应/不良事件(ADR/ADE)发生情况及相关影响因素,为临床合理用药提供参考。方法:对2010~2016年我院ADR监测中心收集到的369例中药注射剂ADR/ADE报表进行汇总分析,统计患者性别、年龄、过敏史,可疑药物品种,ADR/ADE临床表现、类型、关联性评价与转归,评价ADR/ADE病例中中药注射剂用药适宜性。结果:369例中药注射剂ADR/ADE中,≥61岁老年人发生212例(占57.45%),有药物过敏史31例,涉及中药注射剂品种33种,发生ADR/ADE的中药注射剂以华蟾素注射液最多。中药注射剂ADR/ADE累及系统-器官的主要表现以皮肤及附件损害(23.9%)、用药部位损害(21.7%)、神经系统损害(12.0%)为主。369例中药注射剂ADR/ADE报告中,超适应证用药38例,超剂量用药11例。结论:中药注射剂ADR/ADE主要由药物因素、患者自身因素以及临床使用不当等原因造成,应规范中药注射剂临床合理使用,保障患者安全使用中药注射剂。

Objective： To assess relevant factors of ADR/ADE of Traditional Chinese Medicine Injections through ADR/ADE reports and promote rational drug use. Methods： 369 ADR/ADE cases induced by traditional Chinese medicine injections collected by the ADR drugs monitoring center in our hospital from 2010 to 2016 were analyzed. The patients＇ sex,age,allergic history,suspected drugs,clinical manifestation,type,relevance evaluation and outcome were recorded,the suitability of traditional Chinese medicine injections in the ADR/ADE cases were evaluated. Results： In the total 369 ADR/ADE cases,patients over the age of 61 years were prone to have ADR/ADE,accounting for 57. 45%. There were 31 cases with history of drug allergy. The 369 ADR/ADE cases were related to 33 kinds of traditional Chinese medicine injections. Of them,the drug caused most ADR/ADE was Huachansu injection. The main consequences of these ADR/ADE cases involved following damages： skin and its accessories damage（ 23. 9%）,medical site damage（ 21. 7%） and nervous system damage（ 12. 0%）. In all cases,there were 38 patients with no existing reasonable drug application with the indication and 11 patient with overdose. Conclusion： The contributing factors of the ADR/ADE included patients individual differences,medicines themselves and clinical application. Only through standarding the clinical rational drug use and clinical rational drug use could patient＇s safe medication be ensured.