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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 mechanism of TCM-induced allergy (TCMI) and provide reference for improving TCMI’s non-clinical research quality management standard (GLP). Methods: The literature about TCMI and allergy in domestic and foreign databases was retrospectively reviewed. With reference to the current experimental methods for studying allergy, the future research was prospected. Results: Most of the mechanisms of TCMI-induced allergy were antigen-antibody reaction and allergic reaction. The current evaluation of TCMI allergy caused by only animal experiments, but after the evaluation of the method there are still more clinical reports of allergic reactions caused by TCMI. Experimental studies of existing allergies suggest that the safety assessment of TCMI may be refined by the detection of inflammatory mediators or by flow cytometry. CONCLUSION: The mechanism of TCMI causing allergy is complicated, so it is necessary to strengthen the research on its evaluation method. Combined with comprehensive evaluation method of multiple experiments in vivo and in vitro, it may be an effective way.