中国结核分枝杆菌微量肉汤稀释法药物敏感性试验标准化专家共识

doi:10.19982/j.issn.1000-6621.20250070

摘要/Abstract

摘要：

耐药结核病长期以来一直是全球公共卫生领域的严峻挑战,目前仅依赖二分类表型药物敏感性试验(简称“表型药敏试验”)和基因型药敏试验难以为患者提供精准有效的治疗方案。基于微孔板的微量肉汤稀释法药敏试验不仅能够一次性涵盖多种药物和多个浓度,还可以为临床提供量化的耐药信息,因此,受到越来越多的关注。为了合理、科学、规范地使用微量肉汤稀释法药敏试验,中国防痨协会结核病基础专业分会组织多位相关领域专家,针对该药敏方法的技术特点、应用价值、标准化操作、结果解读,以及实际操作中的注意事项等问题制定了本共识,并提出了12条推荐意见,旨在为结核病防治相关临床及实验室工作人员提供统一的指导原则。

关键词: 分枝杆菌,结核, 微生物敏感性试验, 微量肉汤稀释法, 总结性报告(主题)

Abstract:

Drug resistant tuberculosis has long been a serious challenge in the field of global public health. At present, it is difficult to provide accurate and effective treatment plans for patients based solely on binary phenotypic drug sensitivity and genotypic drug sensitivity tests. The microbroth dilution drug sensitivity test based on the microplate not only covers a variety of drugs and multiple concentrations at one time, but also provides quantitative drug resistance information for the clinic, so it is receiving more and more attention. In order to use the microbroth dilution drug sensitivity test in a reasonable, scientific, and standardized manner, the Tuberculosis Basic Professional Branch of Chinese Antituberculosis Association had organized experts in relevant fields to formulate this consensus on technical characteristics, application value, standardized operation, result interpretation, and precautions in actual operation of this drug sensitivity method, and proposed 12 recommendations, aiming to provide unified guiding principles for clinical and laboratory staff who are related to tuberculosis.

Key words: Mycobacterium tuberculosis, Microbial sensitivity tests, Broth microdilution, Consensus development conferences as topic

中图分类号:

R-331
R372

中国防痨协会结核病基础专业分会. 中国结核分枝杆菌微量肉汤稀释法药物敏感性试验标准化专家共识[J]. 中国防痨杂志, 2025, 47(5): 535-545. doi: 10.19982/j.issn.1000-6621.20250070

Tuberculosis Basic Professional Branch, Chinese Antituberculosis Association. Expert consensus on the standardization of broth microdilution method for drug susceptibility testing of Mycobacterium tuberculosis in China[J]. Chinese Journal of Antituberculosis, 2025, 47(5): 535-545. doi: 10.19982/j.issn.1000-6621.20250070

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药物中文名	药物英文名	药物英文缩写	推荐级别	推荐浓度范围(mg/L)
利福平	Rifampicin	RIF	最高	0.016~2
异烟肼	Isoniazid	INH	最高	0.016~2
左氧氟沙星	Levofloxacin	LFX	最高	0.06~8
莫西沙星	Moxifloxacin	MFX	最高^a	-
贝达喹啉	Bedaquiline	BDQ	最高	0.008~1
利奈唑胺	Linezolid	LZD	最高	0.06~4
氯法齐明	Clofazimine	CFZ	最高	0.008~1
德拉马尼	Delamanid	DLM	最高	0.002~0.25
普托马尼	Pretomanid	PMD	最高^b	-
吡嗪酰胺	Pyrazinamide	PZA	最高^c	-
乙胺丁醇	Ethambutol	EMB	较高	0.125~8
D-环丝氨酸	D-cycloserine	DCS	较高	1~64
特立齐酮	Terizidone	TZD	较高^d	-
乙硫异烟胺	Ethionamide	ETO	较高	0.125~16
丙硫异烟胺	Prothionamide	PTO	较高^e	-
卡那霉素	Kanamycin	KAN	一般^f	0.125~16
阿米卡星	Amikacin	AMK	一般^g	-
链霉素	Streptomycin	STR	不推荐	-
卷曲霉素	Capreomycin	CPM	不推荐	-
对氨基水杨酸	Para-aminosalicylic acid	PAS	不推荐^h	-
利福喷丁	Rifapentine	RFT	不推荐ⁱ	-
利福布汀	Rifabutin	RFB	不推荐	-
氧氟沙星	Ofloxacin	OFX	不推荐^j	-

药物名称 (缩写)	WHO推荐ECOFF 值(mg/L)^[5]	CLSI推荐折点 (mg/L)^[26]	EUCAST推荐折点(mg/L)^[27]	CRyPTIC Consortium 推荐ECOFF值 (UKMYC6/5)(mg/L)^[28]	本共识拟临时推荐折点(mg/L)
利福平(RIF)	0.5	0.5	-	0.5	0.5
异烟肼(INH)	0.125	0.12	-	0.1(0.2/0.4为临界MIC)	0.125
左氧氟沙星(LFX)	1	-	-	1	1
莫西沙星(MFX)	-	-	-	1	0.5
贝达喹啉(BDQ)	0.125(或0.25)	-	0.25	0.25	0.25
利奈唑胺(LZD)	1.0(或2.0)	-	-	1	1
氯法齐明(CFZ)	0.25(或0.5)	-	-	0.25	0.25
德拉马尼(DLM)	0.06(或0.125)	-	0.06	0.12	0.125
普托马尼(PTM)	-	-	2	-	2
乙胺丁醇(EMB)	4	≤2.0为敏感,4.0为不确定,≥8.0为耐药	-	4(4为临界MIC)	≤2.0为敏感,4.0为不确定结果,≥8.0为耐药
D-环丝氨酸(DCS)	32(或64)	-	-	-	32
乙硫异烟胺(ETO)	4	-	-	4(4为临界MIC)	4
卡那霉素(KAN)	4	-	-	4	4
阿米卡星(AMK)	-	-	-	1	1
链霉素(STR)	-	-	-	-	2
卷曲霉素(CPM)	-	-	-	-	-
对氨基水杨酸(PAS)	-	-	-	-	2
利福布汀(RFB)	-	-	-	0.12	-
利福喷丁(RFT)	-	-	-	-	-
氧氟沙星(OFX)	-	-	-	-	2

药物名称(缩写)	MIC值质控范围(mg/L)^a
药物名称(缩写)	CLSI-冻干药粉微孔板^[26]	CLSI-冷冻微孔板^[26]	其他研究
利福平(RIF)	≤0.12	0.06~0.25	0.03~0.25^[30]
异烟肼(INH)	≤0.12	0.03~0.12	0.03~0.25^[30]
左氧氟沙星(LFX)	-	0.12~1	0.12~1^[30]
莫西沙星(MFX)	≤0.5	0.06~0.5	0.06~0.5^[30]
贝达喹啉(BDQ)	-	0.015~0.06	0.015~0.06^[31]
利奈唑胺(LZD)	-	0.25~2	0.25~2^[30]
氯法齐明(CFZ)	-	0.03~0.25	0.03~0.25^[30]
德拉马尼(DLM)	-	-	0.002~0.016^[32]
普托马尼(PMD)	-	-	-
乙胺丁醇(EMB)	≤0.5~2	0.25~2	0.25~2^[30]
D-环丝氨酸(DCS)	-	-	4~16^[33-34]
特立齐酮(TZD)	-	-	-
乙硫异烟胺(ETO)	0.6~2.5	-	-
卡那霉素(KAN)	1.2~5	0.25~2	0.25~2^[30]
阿米卡星(AMK)	0.25~1	0.25~2	0.25~2^[30]
链霉素(STR)	0.5~2	-	-
卷曲霉素(CPM)	-	0.5~4	0.5~4^[30]
对氨基水杨酸(PAS)	≤0.5	-	-
利福喷丁(RFT)	-	-	-
利福布汀(RFB)	≤0.12	-	-
氧氟沙星(OFX)	0.5~2	0.25~2	0.25~2^[30]