中药注射液引起过敏的机制及评价方法

Mechanism and Evaluation Methods of Allergy Caused by Traditional Chinese Medicine Injection

目的:总结中药注射液(TCMI)引起过敏的机制,为完善TCMI的药品非临床研究质量管理规范(GLP)提供参考。方法:回顾性研究国内外数据库中有关TCMI与过敏的文献,参考目前有关研究过敏的实验方法,对以后研究进行展望。结果:TCMI引起过敏的机制大部分为抗原抗体反应,也有类过敏反应。目前评价TCMI引起过敏的方法仅为动物实验,但经该方法评价后临床上仍有较多TCMI引起过敏反应的报道。现有过敏的实验研究提示,可以通过炎症介质的检测或流式细胞技术来完善TCMI的安全性评价。结论:TCMI引起过敏的机制较复杂,需要加强对其评价方法的研究,采用体内、外多个试验相结合综合评价法,可能是一个有效的途径。

Objective： To summarize the allergic mechanism caused by traditional Chinese medicine injection （TCMI） to provide some references for perfecting Good Laboratory Practice （GLP） of TCMI. Method： The related iteratures in data bases at home and abroad were reviewed, and the present experimental research methods about allergies were referred to to have a view of future studies. Result： The allergic mechanism of TCMI was mostly antigen-antibody reaction, part of which was anaphylactoid reaction. The method of the evaluation of allergy caused by TCMI only was animal experiments, but there were still some allergies caused by TCMI after the evaluation with this method. The present experimental research methods indicated that the detection of mediators of inflammation and FCM （Flow Cytometry） could be used to evaluate the allergies caused by TCMI. Conclusion： More attention should be paid to allergies caused by TCMI for its complicated mechanism and frequent occurrences in clinic. It may be an effective way to evaluate the allergies caused by TCMI with several methods including in vivo and in vitro.