| 药物过敏和类过敏的临床前评价要求概述 |
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| 引用本文： | 韩佳寅,易艳,梁爱华,张宇实,李春英,赵雍,王连嵋,卢禹婷,李桂琴.药物过敏和类过敏的临床前评价要求概述[J].中国中药杂志,2015,40(14):2685-2689. |
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| 作者姓名： | 韩佳寅 易艳 梁爱华 张宇实 李春英 赵雍 王连嵋 卢禹婷 李桂琴 |
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| 作者单位： | 中国中医科学院 中药研究所, 中药鉴定与安全性检测评估北京市重点实验室, 北京 100700,中国中医科学院 中药研究所, 中药鉴定与安全性检测评估北京市重点实验室, 北京 100700,中国中医科学院 中药研究所, 中药鉴定与安全性检测评估北京市重点实验室, 北京 100700,中国中医科学院 中药研究所, 中药鉴定与安全性检测评估北京市重点实验室, 北京 100700,中国中医科学院 中药研究所, 中药鉴定与安全性检测评估北京市重点实验室, 北京 100700,中国中医科学院 中药研究所, 中药鉴定与安全性检测评估北京市重点实验室, 北京 100700,中国中医科学院 中药研究所, 中药鉴定与安全性检测评估北京市重点实验室, 北京 100700,中国中医科学院 中药研究所, 中药鉴定与安全性检测评估北京市重点实验室, 北京 100700,中国中医科学院 中药研究所, 中药鉴定与安全性检测评估北京市重点实验室, 北京 100700 |
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| 基金项目： | 国家"重大新药创制"科技重大专项(2015ZX09501004-003);国家自然科学基金项目(81202993, 81374057);中国中医科学院中药所基本科研业务费自主选题项目(ZZ2014023);中国中医科学院博士研究生创新人才培养基金项目 |
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| 摘 要： | 药物过敏和类过敏反应是主要的不可预测药物不良反应。过敏反应一般由药物、药物代谢产物或药物添加剂的免疫原性引起;类过敏反应可能是由药物刺激或激活炎症介质的释放而引起的。药物过敏和类过敏反应的临床前评价属于免疫毒性评价的范畴。由于不同类型过敏和类过敏反应的发生机制不同,目前没有任何一种体内或体外方法可以预测所有类型的反应。近年来FDA,SFDA,OECD,ICH,WHO等颁布了一系列针对药物免疫毒性临床前评价的指导原则,但目前关于新药临床前过敏和类过敏反应评价的要求和方法尚未完全统一。该文主要就药物过敏和类过敏的临床前评价要求进行综述。
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| 关 键 词： | 药物致敏性评价 药物过敏 药物类过敏 免疫毒性指导原则 |
| 收稿时间： | 2015/3/21 0:00:00 |
Review on requirements of drug allergy or pseudoallergic reactions in pre-clinical evaluation |
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| HAN Jia-yin,YI Yan,LIANG Ai-hu,ZHANG Yu-shi,LI Chun-ying,ZHAO Yong,WANG Lian-mei,LU Yu-ting and LI Gui-qin.Review on requirements of drug allergy or pseudoallergic reactions in pre-clinical evaluation[J].China Journal of Chinese Materia Medica,2015,40(14):2685-2689. |
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| Authors: | HAN Jia-yin YI Yan LIANG Ai-hu ZHANG Yu-shi LI Chun-ying ZHAO Yong WANG Lian-mei LU Yu-ting and LI Gui-qin |
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| Institution: | Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China,Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China,Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China,Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China,Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China,Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China,Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China,Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China and Key Laboratory of Beijing for Identification and Safety Evaluation of Chinese Medicine, Institute of Chinese Materia Medica, China Academy of Chinese Medical Sciences, Beijing 100700, China |
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| Abstract: | Drug allergy and pseudoallergic reactions are main adverse drug reactions. Allergy is mainly induced by the immunogenicity of drug, drug metabolic products or drug additive. Pseudoallergic reactions may result from the irritation or activation of inflammatory material release. Pre-clinical evaluation of drug allergy and pseudoallergic reactions is included in immunotoxicity evaluation. Now there is no in vivo or in vitro method that could predict all kinds of allergy or pseudoallergic reactions due to the different mechanisms. In the past few years, FDA, SFDA OECD, ICH and WHO have published several guidelines on per-clinical immunotoxicity evaluation, however, no agreement has been reached on allergy and pseudoallergic reactions evaluation. This article reviews the requirements of allergy and pseudoallergic reactions in pre-clinical evaluation. |
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| Keywords: | drug sensitization evaluation drug allergy drug pseudoallergic reactions immunotoxicity guideline |
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