风湿性疾病患者合并结核分枝杆菌潜伏感染诊治的专家共识

doi:10.19982/j.issn.1000-6621.20220225

中国防痨杂志 ›› 2022, Vol. 44 ›› Issue (9): 869-879.doi: 10.19982/j.issn.1000-6621.20220225

风湿性疾病患者合并结核分枝杆菌潜伏感染诊治的专家共识

国家感染性疾病临床医学研究中心/深圳市第三人民医院, 北京大学深圳医院, 中国医学科学院北京协和医院, 中国防痨协会, 《中国防痨杂志》编辑委员会, 深圳市炎症与免疫性疾病重点实验室

收稿日期:2022-06-09 出版日期:2022-09-10 发布日期:2022-09-05
基金资助:
国家自然科学基金(82070016);国家自然科学基金(81974253);国家自然科学基金(81901641);广东省感染性疾病(结核病)临床医学研究中心(2020B1111170014);广东省自然科学基金面上项目(2019A1515011112);深圳市科技创新委员会重点基础研究项目(JCYJ20200109140203849);深圳市科技创新委员会重点基础研究项目(JCYJ20210324131813036);深圳三名工程项目(SZSM201612009)

Expert consensus on diagnosis and treatment of latent tuberculosis infection in patients with rheumatic diseases

Received:2022-06-09 Online:2022-09-10 Published:2022-09-05
Supported by:
National Natural Science Foundation of China(82070016);National Natural Science Foundation of China(81974253);National Natural Science Foundation of China(81901641);Clinical Research Centre for Infectious Disease (Tuberculosis) of the Guangdong Province, China(2020B1111170014);The General Program of Natural Science Foundation of the Guangdong Province, China(2019A1515011112);Key Basic Research Special Program of Shenzhen Scientific Committee(JCYJ20200109140203849);Key Basic Research Special Program of Shenzhen Scientific Committee(JCYJ20210324131813036);Sanming Project of Medicine in Shenzhen(SZSM201612009)

摘要/Abstract

摘要：

风湿性疾病作为一类常见的自身免疫性疾病,治疗上经常使用糖皮质激素、免疫抑制剂、生物制剂和小分子靶向药物等,这些药物的应用往往会导致患者自身免疫功能异常,致使其具有较高的LTBI发生风险,且发展为活动性结核病的风险也显著增加。因此,在临床工作中,需要对符合筛查条件的风湿性疾病患者进行LTBI筛查。这就要求风湿免疫科医师和结核科医师加强协作,提高意识,针对需要进行LTBI筛查的风湿性疾病患者进行科学评估,制定规范的筛查流程和预防性治疗方案,以防范风湿性疾病患者合并LTBI后发展为活动性结核病。基于此,国家感染性疾病临床医学研究中心/深圳市第三人民医院、北京大学深圳医院、中国医学科学院北京协和医院、中国防痨协会、《中国防痨杂志》编辑委员会和深圳市炎症与免疫性疾病重点实验室共同组织国内结核病和风湿性疾病领域专家撰写了《风湿性疾病患者合并结核分枝杆菌潜伏感染诊治的专家共识》(简称“共识”)。本共识基于我国风湿性疾病患者合并LTBI的流行病学、循证医学证据和临床研究等方面数据,经过多次研讨并达成一致意见,供同道参考借鉴。

关键词: 风湿性疾病, 分枝杆菌,结核, 感染, 诊断, 治疗应用

Abstract:

Rheumatic diseases are autoimmune diseases that occur when an individual’s immune system mistakenly attacks healthy tissues, and are often treated with glucocorticoids, immunosuppressants, biological agents, and small-molecule targeted drugs, etc., which can lead to an increased risk of other autoimmune dysfunctions in patients and the activation of latent tuberculosis infection (LTBI). Therefore, LTBI screening in clinical is essential for patients with rheumatic diseases who meet the screening criteria. This requires greater collaboration and awareness between rheumatologists and tuberculosis physicians, to conduct scientific assessment for patients with rheumatic diseases who need LTBI screening, and to develop preventive treatment guidelines to prevent patients with rheumatic diseases from developing active tuberculosis after LTBI. Therefore, the National Clinical Research Centre for Infectious Disease/The Third People’s Hospital of Shenzhen, Peking University Shenzhen Hospital, Peking Union Medical College Hospital of Chinese Academy of Medical Sciences, Chinese Antituberculosis Association, Editorial Board of Chinese Journal of Antituberculosis and Shenzhen Key Laboratory of Inflammatory and Immune Diseases joint effort in the publication of an expert consensus on the diagnosis and treatment of LTBI in patients with rheumatic diseases. This consensus is based on the epidemiology, evidence-based medicine, and clinical research of rheumatic diseases complicated with LTBI, and has been discussed for many times and reached consensus. It can serve as a reference.

Key words: Rheumatic diseases, Mycobacterium tuberculosis, Infection, Diagnosis, Therapeutic uses

中图分类号:

R593
R52

国家感染性疾病临床医学研究中心/深圳市第三人民医院, 北京大学深圳医院, 中国医学科学院北京协和医院, 中国防痨协会, 《中国防痨杂志》编辑委员会, 深圳市炎症与免疫性疾病重点实验室. 风湿性疾病患者合并结核分枝杆菌潜伏感染诊治的专家共识[J]. 中国防痨杂志, 2022, 44(9): 869-879. doi: 10.19982/j.issn.1000-6621.20220225

National Clinical Research Centre for Infectious Disease/The Third People’s Hospital of Shenzhen, Peking University Shenzhen Hospital, Peking Union Medical College Hospital of Chinese Academy of Medical Sciences, Chinese Antituberculosis Association, Editorial Board of Chinese Journal of Antituberculosis, Shenzhen Key Laboratory of Inflammatory and Immune Diseases. Expert consensus on diagnosis and treatment of latent tuberculosis infection in patients with rheumatic diseases[J]. Chinese Journal of Antituberculosis, 2022, 44(9): 869-879. doi: 10.19982/j.issn.1000-6621.20220225

图/表 6

表1

表2

表3

风湿性疾病患者合并LTBI诊治的专家推荐意见

意见条目	推荐意见	推荐级别及证据级别
1	对拟使用肿瘤坏死因子抑制剂治疗的风湿性疾病患者,建议应常规进行LTBI筛查	1A
2	使用靶向合成改善病情抗风湿药(如托法替布)的患者,建议应常规进行LTBI筛查	1B
3	对拟长期使用中大剂量糖皮质激素者,尤其是系统性红斑狼疮、使用免疫抑制剂、低体质量指数、合并肺间质病变的人群,有条件者建议进行LTBI筛查	1C
4	需长期使用具有结核病活动中高风险的改善病情抗风湿药(如来氟米特、甲氨蝶呤、环孢素、环磷酰胺、吗替麦考酚酯)的风湿性疾病患者,有条件者建议进行LTBI筛查	1D
5	风湿性疾病患者结核菌素皮肤试验硬结平均直径≥10mm的阳性者,或接受免疫抑制治疗时间>1个月、结核菌素皮肤试验硬结平均直径≥5mm的患者,应予以警惕,有条件者建议进一步完善γ-干扰素释放试验检测	2D
6	对风湿性疾病患者而言,γ-干扰素释放试验的准确性优于结核菌素皮肤试验,建议风湿性疾病患者优先应用γ-干扰素释放试验筛查LTBI	1B
7	LTBI目前缺乏诊断的金标准,推荐在有条件时联合应用多种方法进行筛查,比如γ-干扰素释放试验联合结核菌素皮肤试验	2D
8	既往完成规范抗结核治疗5年以内者可不予预防性抗结核治疗,建议此类患者在使用生物制剂的时候首选非肿瘤坏死因子抑制剂	1B
9	若病情允许,建议合并LTBI的风湿性疾病患者在预防性抗结核治疗至少1个月后再启动生物制剂治疗;如病情紧急需要立即启动生物制剂治疗时,建议在充分评估风险后同时启动生物制剂和预防性抗结核治疗	2D
10	异烟肼、利福平单药或联合用药方案原则上均可使用,但建议优先推荐使用3个月异烟肼和利福喷丁(3HP)方案	1A

表3

表4

图1

表5

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证据级别	具体描述	研究类型	表达字母
高级证据	非常确信真实的效应值接近效应估计,未来研究几乎不可能改变现有评价结果的可信度	随机对照试验;质量升高二级的观察性研究	A
中级证据	对效应估计值我们有中等程度的信心:真实值有可能接近估计值,但仍存在二者大小相同的可能性;未来研究可能对现有评估有重要影响,可能改变评价结果的可信度	质量降低一级的随机对照试验;质量升高一级的观察性研究	B
低级证据	我们对效应估计值的确信程度有限:真实值可能与估计值大不相同;未来研究很有可能对现有评估有重要影响,改变评估结果可信度的可能性较大	质量降低二级的随机对照试验;观察性研究	C
极低级证据	我们对效应估计值几乎没有信心:真实值很可能与估计值大不相同;任何评估都很不确定	质量降低三级的随机对照试验;质量降低一级的观察性研究;系列病例观察;个案报道	D

证据质量	推荐强度	具体描述	表达数字
高级证据	支持使用某项干预措施的强推荐	评价者确信干预措施利大于弊	1
中级证据	支持使用某项干预措施的弱推荐	利弊不确定或无论高低质量的证据均显示利弊相当	2
低级证据	反对使用某项干预措施的弱推荐		2
极低级证据	反对使用某项干预措施的强推荐	评价者确信干预措施弊大于利	1

意见条目	专家群体权威系数(0~1)	重要性评价		变异系数 (0~1)
意见条目	专家群体权威系数(0~1)	平均值(0~5)	标准差	变异系数 (0~1)
1	0.92	4.90	0.31	0.06
2	0.89	4.38	0.82	0.19
3	0.84	3.83	0.89	0.23
4	0.81	4.00	0.89	0.22
5	0.86	4.24	0.88	0.20
6	0.88	4.14	0.64	0.15
7	0.88	3.90	0.82	0.21
8	0.82	4.03	0.68	0.17
9	0.87	4.45	0.74	0.17
10	0.83	4.00	0.76	0.19

治疗方案	剂量			用法	疗程
治疗方案	成人	儿童	最大剂量	用法	疗程
异烟肼+利福喷丁每周疗法(3HP)				1次/周	3个月
异烟肼	900mg/次	年龄2~14岁:(1)体质量10~15kg:300mg/次;(2)体质量16~23kg:500mg/次;(3)体质量24~30kg:600mg/次;(4)体质量>31kg:700mg/次年龄>14岁:900mg/次	900mg/次
利福喷丁	900mg/次	年龄2~14岁:(1)体质量10~15kg:300mg/次;(2)体质量16~23kg:450mg/次;(3)体质量24~30kg:600mg/次;(4)体质量>31kg:750mg/次年龄>14岁:900mg/次	900mg/次
利福平单药每日疗法	体质量<50kg:450mg/次;体质量≥50kg:600mg/次	10mg·kg^-1·次^-1	450mg/次	1次/d	4个月
异烟肼+利福平每日疗法				1次/d	3个月
异烟肼	300mg/次	10mg·kg^-1·次^-1	300mg/次
利福平	体质量<50kg:450mg/次;体质量≥50kg:600mg/次	10mg·kg^-1·次^-1	450mg/次
异烟肼单药每日疗法	300mg/次	10mg·kg^-1·次^-1	300mg/次	1次/d	6~9个月

风湿性疾病患者合并结核分枝杆菌潜伏感染诊治的专家共识

Expert consensus on diagnosis and treatment of latent tuberculosis infection in patients with rheumatic diseases

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