注射用血塞通不良反应药学干预研究

Research on pharmacological intervention of adverse reaction of Xuesaitong Injection

目的:研究分析注射用血塞通所致不良反应的一般规律及特点,并比较药学干预在减少不良反应事件发生中的效果和作用,制定合理使用中药注射剂的规范,促进临床合理使用中药注射剂。方法:本课题采用调查统计和对比分析的方法,按WHO药品不良反应监测中心规定的不良反应进行分类[1],统计分析本院2014年1月-2017年12月注射用血塞通不良反应发生的年龄、性别、原患疾病、过敏史、用药情况(给药剂量、药物配伍情况)、ADR出现时间、ADR临床表现及愈后情况,并对实施药学干预前后注射用血塞通发生不良反应的情况进行对比分析。结果:注射用血塞通不良反应事件的发生与患者的年龄,给药剂量,药物配伍情况以及超适应证用药有关,药学干预之后注射用血塞通不良反应事件数量显著下降,中药注射剂的临床使用更加规范。结论:药学干预在注射用血塞通临床运用方面具有显著效果,能够显著降低不良反应发生的频率,值得将其作为中药注射剂临床合理使用规范中的重要一环。

Objective:To find the general rules and characteristics of adverse reactions caused by Xuesaitong(血塞通)injection,and compare the effects of pharmaceutical intervention in reducing the occurrence of adverse events,to formulate guidelines for the rational use of traditional Chinese medicine injections and to promote the rational use of Chinese medicine in clinical practice.Methods:This study used the methods of survey statistics and comparative analysis to classify the adverse reactions as defined by the WHO Adverse Drug Reaction Monitoring Center[1],and statistically analyzed the occurrence of adverse reactions of Xuesaitong(血塞通)for injection from January 2014 to December 2017 including the age,sex,pre-existing disease,allergies,medications(administration dose,drug compatibility),ADR appearance time,clinical manifestations of ADR,and the adverse reactions of Xuesaitong(血塞通)injection before and after the implementation of pharmaceutical intervention were compared.Results:The incidence of adverse events of injection of Xuesaitong(血塞通)was related to the patient’s age,dose,drug compatibility and over-indication drug use.After drug intervention,the number of adverse events of Xuesaitong(血塞通)for injection decreased significantly.Clinical use of TCM injections were more standardized.Conclusion:Pharmacological intervention had significant effect on the clinical application of Xuesaitong(血塞通)injection.It could significantly reduce the frequency of adverse reactions,which was worth being used as an important step in the clinical rational use of traditional Chinese medicine injections.