重组结核分枝杆菌变态反应原皮肤试验用制剂命名探讨

doi:10.19982/j.issn.1000-6621.20220486

中国防痨杂志 ›› 2023, Vol. 45 ›› Issue (4): 333-335.doi: 10.19982/j.issn.1000-6621.20220486

重组结核分枝杆菌变态反应原皮肤试验用制剂命名探讨

赵爱华, 都伟欣, 王国治, 徐苗()

中国食品药品检定研究院结核病疫苗和过敏原产品室,北京 102629

收稿日期:2022-12-02 出版日期:2023-04-10 发布日期:2023-03-31
通信作者: 徐苗 E-mail:xumiaobeijing@126.com

Discussion on the nomenclature of recombinant Mycobacterium tuberculosis allergen skin test

Zhao Aihua, Du Weixin, Wang Guozhi, Xu Miao()

Division of Tuberculosis Vaccine and Allergen Products, National Institutes for Food and Drug Control, Beijing 102629, China

Received:2022-12-02 Online:2023-04-10 Published:2023-03-31
Contact: Xu Miao E-mail:xumiaobeijing@126.com

摘要/Abstract

摘要：

针对世界卫生组织于2022年推荐的结核感染检测新方法,基于结核分枝杆菌抗原检测结核分枝杆菌感染的皮肤试验检测技术(MTB antigen-based skin tests,TBST),作者对已上市与在研同类新品种的命名情况进行梳理,参考中国生物制品命名相关原则,对该类产品命名进行探讨,供研发、使用和监管部门的专家讨论参考。

关键词: 分枝杆菌,结核, 分枝杆菌感染, 变态反应和免疫学, 命名

Abstract:

In view of the new tuberculosis infection test recommended by WHO in 2022, the MTB antigen-based skin tests (TBST) for the diagnosis of tuberculosis infection, the authors sorted out the name of new varieties of the same kind that have been listed and are under research, discussed the nomenclature of such products with reference to the principles related to nomenclature of biological products in China, expected to provide discussion and reference for experts from research and development, use and regulatory departments.

Key words: Mycobacterium tuberculosis, Mycobacterium infection, Allergy and immunology, Nomenclature

中图分类号:

赵爱华, 都伟欣, 王国治, 徐苗. 重组结核分枝杆菌变态反应原皮肤试验用制剂命名探讨[J]. 中国防痨杂志, 2023, 45(4): 333-335. doi: 10.19982/j.issn.1000-6621.20220486

Zhao Aihua, Du Weixin, Wang Guozhi, Xu Miao. Discussion on the nomenclature of recombinant Mycobacterium tuberculosis allergen skin test[J]. Chinese Journal of Antituberculosis, 2023, 45(4): 333-335. doi: 10.19982/j.issn.1000-6621.20220486

图/表 1

参考文献 15

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制剂名称	结核分枝杆菌蛋白	结构
重组结核杆菌变态反应原11kDa	ESAT6	11kDa蛋白
注射用结核病变态反应原RP22	ESAT6 和 CFP10	C-E
重组结核杆菌蛋白(D-EC)	ESAT6 和 CFP10	E-E-C-C
重组结核杆菌蛋白(EEC)	ESAT6 和 CFP10	E-E-C
重组结核杆菌蛋白(EM)	ESAT6 和 MBP64	E-M

重组结核分枝杆菌变态反应原皮肤试验用制剂命名探讨

Discussion on the nomenclature of recombinant Mycobacterium tuberculosis allergen skin test

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