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目的:分析医院2013年—2015年度中药注射剂致不良反应(ADRs)的发生情况及特点,为指导临床安全合理使用中药注射剂提供参考。方法:采用回顾性分析方法,分析医院2013年—2015年度上报国家药物不良反应监测中心的ADRs报告中116例中药注射剂致ADRs报告的相关因素。结果:116例中药注射剂致ADRs涉及22个中药制剂品种,其中银杏达莫注射液引起ADRs为最多占16.38%;60岁以上患者38例占32.76%;注射后30 min以内发生ADRs占46.55%;累及系统-器官的主要表现以皮肤及附件损害(34.76%)为主;严重的ADRs较少占5.17%。结论:应重视并加强中药注射剂致不良反应的监测,促进合理用药,确保用药安全。
OBJECTIVE: To analyze the occurrence and characteristics of ADRs in hospitals from 2013 to 2015, and provide references for guiding the clinical use of Chinese traditional medicine injection safely and reasonably. Methods: A retrospective analysis was used to analyze the factors associated with ADRs reported by 116 TCM injections in the ADRs reported by the National Center for Adverse Drug Reactions from 2013 to 2015 in the hospital. Results: The ADRs of 116 Chinese herbal injection injections involved 22 varieties of traditional Chinese medicine. The ADRs accounted for 16.38% of the total, while 38 cases of patients over 60 accounted for 32.76%. ADRs accounted for 46.55% within 30 minutes after injection. Mainly involved in the system - organ damage mainly to skin and appendages (34.76%); severe ADRs accounted for less than 5.17%. Conclusion: We should pay attention to and strengthen the monitoring of side effects caused by traditional Chinese medicine injections, promote the rational use of drugs and ensure the safety of medication.