我院近3年中药注射剂不良反应/事件报告分析

目的了解我院中药注射剂不良反应/事件(ADR/E)的特点和规律,确保中药注射剂临床用药安全有效,减少药品不良反应的发生。方法采用回顾性研究方法 ,对我院2009-2011年收集的中药注射剂ADR/E报告表进行统计分析。结果 90例ADR/E报告中,60岁以上者占60.00%,男女比例持平;以静脉使用治疗心脑血管疾病的中药注射剂引起的ADR/E最为多见;ADR发生部位以皮肤及其附件损害最多;导致出现ADR/E的原因主要与中药注射剂本身特点有关,亦与临床不合理使用有关。结论应加强对中药注射剂ADR/E的监测和相关研究,重视中药注射剂的安全性和质量再评价。

Analysis of traditional Chinese medicine injection adverse drug reaction/event of our hospital in recent three years

Objective To understand the character and regular pattern of traditional Chinese medicine injection adverse drug reaction/event（ADR/E）in our hospital in order to strengthen the management of the clinical application,ensure its effect,and reduce the occurrence of ADR/E.Methods Using retrospective study method,90 cases of ADR/E collected from 2009 to 2011 in our hospital were classified,analyzed and evaluated.Results Among the 90 cases,male to female ratio was flat,60% of the patients were more than 60 years old.The intravenous medication used in cardiovascular and cerebrovascular diseases was the main route resulting in ADR/E.The main types of ADR/E were reflected in the skin and its appendages.The main reasons led to the ADR/E were related to the characteristics of traditional Chinese medicine injection itself and clinical unreasonable use.Conclusion We should strengthen the monitoring and research on traditional Chinese medicine injection of ADR/E and pay attention to its safety and re-evaluation of quality.