药物类过敏反应发生机制及临床前评价方法研究进展

Progress in research of the mechanism and preclinical evaluation of drug pseudoallergy

药物类过敏反应是临床常见不良反应,中药注射剂、造影剂(RCM)、脂质体药物(如阿霉素,两性霉素,柔红霉素等)、两亲脂性胶束溶剂(如聚氧乙烯蓖麻油,紫杉醇载体等)、麻醉药、抗生素、镇痛药和止血剂等均可引起类过敏反应。然而,目前对类过敏反应产生的机制尚不完全清楚,现有的方法对预测药物类过敏反应仍存在不同程度的局限性。迄今为止,国内外均未建立类过敏反应的检测模型,亦缺少有关类过敏反应评价的技术指导原则,药物类过敏反应的评价受到了很大限制。因此,寻找评价类过敏反应的试验模型及其评价指标,合理有效地评价类过敏反应,从而实现对药物质量的控制,是目前急需解决的问题。本文从类过敏的发生机制、体内外评价模型及评价指标等方面对类过敏反应的研究进展作一综述,为其进一步研究提供参考。

Drug pseudoallergy is one of the common clinical adverse reactions. Drugs and agents causing pseudoallergy include traditional Chinese medicine injections,radiocontrast media（RCM）,liposomal drugs（e. g.Doxil,Ambisome and Dauno Xome）,micellar solvents containing amphiphilic lipids（e. g. Cremophor EL,the vehicle of Taxol）,anesthetics,antibiotics,analgesics,hemostatic agents,and so on. However,the mechanism of the pseudoallergic reactions has not yet been known clearly,and the existing methods for predicting pseudoallergic reactions still have different kinds of limitations. So far,the model for the detection of pseudoallergy has not been established either at home or abroad. Furthermore,there also have no technical guidelines for the evaluation of drug pseudoallergy. As a result,the safety evaluation of drug pseudoallergy is limited. So,it is an urgent need to search for the evaluation models and evaluation indexes of pseudoallergy,so as to evaluate drug pseudoallergy reasonably and effectively. Thus,the quality of medicines and drugs can be better controlled. In this paper,we summarize the research progress of the mechanisms,in vivo and in vitro evaluation models and evaluation indexes of drug pseudoallergy,aiming to provide reference for the further studies.