多组分生化药致敏性评价策略研究进展

多组分生化药因来源复杂、物质基础不明,部分品种临床应用中不良反应率较高而被录入国家重点监控药品目录.虽然其不良反应多涉及过敏样反应,但是目前对多组分生化药的过敏性研究甚少,尚未形成完善的过敏性研究评估体系.故本文通过对多组分生化药的特点及近年来国内外复杂机制类药物过敏性研究相关文献进行分析,阐述了适用于多组分生化药的过...

Advances in the Evaluation Strategy of Allergenicity of Multi-component Biochemical Drugs

The multi-component biochemical drugs are listed in the national key monitoring drugs catalogue because of their complex sources, unknown material basis and high adverse reactions in clinical application of some varieties.Although the adverse reactions are mostly related to anaphylactic reactions, at present, there are few studies on the anaphylaxis of multi- component biochemical drugs, and a complete evaluation system of anaphylactic research has not been formed.Therefore, based on the analysis of the characteristics of multi-component biochemical drugs and the related literature on the allergy research of complex mechanism drugs at home and abroad in recent years, this paper expounds the allergy and pseudoallergy evaluation strategies applicable to multi-component biochemical drugs, and analyzes and summarizes the means and technical methods of allergy research from both in vivo and in vitro, with a view to the clinical application and safety of multi-component biochemical drugs research and production process optimization to provide reference and basis.