中国防痨杂志 ›› 2022, Vol. 44 ›› Issue (1): 9-27.doi: 10.19982/j.issn.1000-6621.20210680
中国人民解放军总医院第八医学中心全军结核病研究所/全军结核病防治重点实验室/结核病诊疗新技术北京市重点实验室, 《中国防痨杂志》编辑委员会, 中国医疗保健国际交流促进会结核病防治分会基础和临床学部
收稿日期:
2021-11-26
出版日期:
2022-01-10
发布日期:
2021-12-29
Tuberculosis Prevention and Control Key Laboratory/Beijing Key Laboratory of New Techniques of Tuberculosis Diagnosis and Treatment/Institute for Tuberculosis Research of the 8th Medical Center of Chinese PLA General Hospital, Editorial Board of Chinese Journal of Antituberculosis , Basic and Clinical Speciality Committees of Tuberculosis Control Branch of China International Exchange and Promotive Association for Medical and Health Care
Received:
2021-11-26
Online:
2022-01-10
Published:
2021-12-29
摘要:
结核病不仅是一种细菌感染性疾病,也是一种免疫性疾病,它的发生、发展及转归与患者的抗结核免疫功能密切相关。结核病患者通常在固有免疫和适应性免疫功能方面存在异常,检测其免疫细胞数量和免疫功能可评价其免疫功能状态,为临床施行免疫干预提供依据。对活动性结核病患者应用免疫制剂进行免疫干预,可增强其免疫功能,从而提高治愈率、缩短疗程,同时,可清除持留菌而降低复发率。尽管目前结核病免疫辅助诊断在临床应用广泛,然而,对结核病的抗结核免疫和免疫异常机制及其在结核病中的作用尚认识不足、缺乏深入的研究;对活动性结核病患者免疫功能状态评估的指征、评估指标的应用及其临床意义尚未达成一致意见;而免疫制剂的应用受到政策的限制,对活动性结核病患者免疫干预与否、免疫治疗的指征、免疫制剂的选择也未达成一致意见,临床应用不规范。为此,中国人民解放军总医院第八医学中心、《中国防痨杂志》编辑委员会、中国医疗保健国际交流促进会结核病防治分会基础和临床学部联合组织专家拟定《活动性结核病患者免疫功能状态评估和免疫治疗专家共识(2021年版)》。本共识概述了抗结核免疫及结核病患者免疫异常机制,介绍了我国临床常用的结核病患者免疫相关检测方法,提出了活动性结核病患者免疫功能状态评估的指征、方法及策略;系统介绍了我国临床可用的免疫治疗制剂,确定了活动性结核病患者免疫治疗的适应证和禁忌证,以帮助临床医师对活动性结核病患者适时、合理地进行免疫治疗。
中图分类号:
中国人民解放军总医院第八医学中心全军结核病研究所/全军结核病防治重点实验室/结核病诊疗新技术北京市重点实验室, 《中国防痨杂志》编辑委员会, 中国医疗保健国际交流促进会结核病防治分会基础和临床学部. 活动性结核病患者免疫功能状态评估和免疫治疗专家共识(2021年版)[J]. 中国防痨杂志, 2022, 44(1): 9-27. doi: 10.19982/j.issn.1000-6621.20210680
Tuberculosis Prevention and Control Key Laboratory/Beijing Key Laboratory of New Techniques of Tuberculosis Diagnosis and Treatment/Institute for Tuberculosis Research of the 8th Medical Center of Chinese PLA General Hospital, Editorial Board of Chinese Journal of Antituberculosis , Basic and Clinical Speciality Committees of Tuberculosis Control Branch of China International Exchange and Promotive Association for Medical and Health Care . Expert consensus on immune function assessment and immunotherapy in patients with active tuberculosis (2021 Edition)[J]. Chinese Journal of Antituberculosis, 2022, 44(1): 9-27. doi: 10.19982/j.issn.1000-6621.20210680
表1
GRADE证据质量分级
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 |
表3
活动性结核病患者免疫功能状态评估方法及意义
检测方法 | 与抗结核免疫功能低下相关的检测指标 | 免疫功能状态评估的意义 |
---|---|---|
血常规 | 淋巴细胞百分比和计数明显低于正常范围 | 适应性免疫应答细胞减少 |
单核细胞计数明显低于正常范围 | 外周血参与固有免疫应答的细胞减少 | |
淋巴细胞亚群分析 | 自然杀伤细胞、自然杀伤T细胞明显低于正常范围 | 固有免疫和适应性免疫应答减弱 |
CD3+、CD4+T细胞百分比和绝对计数明显低于正常范围,CD8+ T细胞绝对计数明显低于正常范围,CD8+T细胞百分比明显高于正常范围,CD4+/CD8+T细胞比值明显降低 | 细胞免疫应答细胞减少,细胞免疫功能低下 | |
B细胞绝对计数明显低于正常范围 | 体液免疫应答细胞减少 | |
CD3+CD28+、CD4+CD28+、CD8+CD28+T细胞明显低于正常范围,或CD3+CD28-、CD4+CD28-、CD8+CD28-T细胞明显高于正常范围 | T细胞激活所需的重要协同刺激分子CD28表达明显减少,T细胞经抗原刺激后不能激活,而不能发挥细胞免疫作用 | |
γ-干扰素释放试验-酶联免疫斑点法(IGRA-ELISPOT) | 植物血凝素非特异性诱导的分泌γ-干扰素的效应T细胞斑点数明显低于参考值 | 非特异性细胞免疫功能降低 |
结核抗原特异性诱导的分泌γ-干扰素的效应T细胞斑点数明显低于参考值,呈阴性反应 | 结核特异性细胞免疫功能降低 | |
γ-干扰素释放试验-酶联免疫吸附试验(IGRA-ELISA) | 植物血凝素刺激孔γ-干扰素和白细胞介素2水平明显低于参考值 | 关键免疫效应分子减少,免疫功能下降 |
结核特异性抗原刺激孔γ-干扰素和白细胞介素2水平明显低于参考值,呈阴性反应 | 抗结核免疫的关键效应分子减少,抗结核免疫功能下降 | |
胶体金或酶联免疫吸附试验或化学发光方法 | 抗结核抗体免疫球蛋白G(IgG)阳性 | Th1/Th2免疫应答失衡 |
抗结核抗体IgG阴性 | 伴有B细胞明显减少,提示体液免疫功能低下 | |
结核菌素皮肤试验 | 结核菌素皮肤试验无反应或皮肤硬结平均直径小于 5mm,呈阴性反应 | 固有免疫和T细胞免疫功能低下或免疫抑制 |
表4
临床常用的活动性结核病免疫治疗制剂主要成分、功效及推荐使用的证据级别
分类 | 药名 | 主要成分 | 功效 | GRADE推荐强度 和证据质量分级 |
---|---|---|---|---|
细胞因子 | 重组人γ-干扰素 | γ-干扰素 | 具有广泛免疫调节作用,可激活巨噬细胞,增强其清除结核分枝杆菌的效力;有助于提高患者Th1免疫保护效应,从而提高结核病的治疗效果 | 1B |
重组人白细胞介 素2 | 白细胞介素2 | 可促进淋巴细胞生长、增殖、分化,提高Th1免疫活性;同时激活巨噬细胞,提升巨噬细胞杀伤结核分枝杆菌的能力,从而提高结核病的治疗效果 | 2C | |
小分子活性肽 | 胸腺肽 | 胸腺组织分泌的具有免疫活性的小分子多肽 | 能促进淋巴细胞成熟,非特异性地调节和增强免疫功能,提高抗结核治疗效果 | 2B |
胸腺五肽 | 人工合成的人体胸腺激素中重要的免疫活性五肽 | 是一种非特异性双向免疫调节药物,具有诱导T细胞分化、发育、成熟并活化的功能,促进Th1型细胞因子的分泌;并能调节T细胞亚群的比例,使其趋于正常,可提高抗结核治疗效果 | 2B | |
胸腺法新 | 人工合成的人体胸腺素组分 5中的一种由28种氨基酸组成的生物活性多肽 | 具有较高的非特异性免疫增强活性,可提高抗结核治疗效果 | 2B | |
治疗性疫苗 | 母牛分枝杆菌 菌苗 | 灭活的母牛分枝杆菌 | 具有双向免疫调节作用,能提高正常小鼠腹腔巨噬细胞产生过氧化氢、一氧化氮水平,促进T细胞增殖反应;对免疫功能低下小鼠淋巴细胞转化、巨噬细胞吞噬功能具有明显增强作用,可提高抗结核治疗效果 | 1A |
分类 | 药名 | 主要成分 | 功效 | GRADE推荐强度 和证据质量分级 |
草分枝杆菌菌苗 | 灭活的草分枝杆菌 | 可刺激T细胞释放多种细胞因子,并可诱导自然杀伤细胞、B细胞活化,增强机体抗结核免疫功能,提高抗结核治疗效果 | 2B | |
卡介苗多糖核酸 注射液 | 提取卡介菌免疫活性较强的菌体多糖、核酸成分 | 可促进单核-巨噬细胞系统增生,增强巨噬细胞吞噬与消化能力,增强细胞免疫和体液免疫功能,提高抗结核治疗效果 | 2C | |
免疫抑制剂 | 糖皮质激素 | 糖皮质激素 | 抑制免疫反应,减少渗出和炎性细胞浸润,稳定溶酶体膜,保护线粒体,减轻充血水肿,减少免疫病理损伤 | 参照《糖皮质激素在结核病治疗中的合理应用专家共识》 |
沙利度胺 | 谷氨酸衍生物 | 具有免疫调节和抗炎作用,用于严重的结核免疫反应或免疫病理损伤患者,或复杂的中枢神经系统结核病患者 | 2C | |
中成药制剂 | 肺泰胶囊 | 苦荬菜、黄芩、北沙参、瓜蒌、太子参、百部、枇杷叶、川贝母和白及 | 调节免疫功能,提高抗结核治疗效果 | 1B |
芪甲利肺胶囊 | 黄芪、鳖甲、地骨皮、蛤蚧、冬虫夏草、白及、珍珠、连翘、夏枯草、乌梢蛇、百部、川贝、黄芩和鱼腥草 | 调节免疫功能,提高抗结核治疗效果 | 1B | |
结核丸 | 龟甲(醋制)、百部(蜜炙)、地黄、熟地黄、阿胶、鳖甲(醋制)、北沙参、白及、牡蛎、川贝母、熟大黄、蜂蜡等16味中药 | 调节免疫功能,提高抗结核治疗效果 | 1B | |
抗痨胶囊或抗 痨丸 | 矮地茶、百部、穿破石、五指毛桃、白及、桑白皮 | 调节免疫功能,提高抗结核治疗效果 | 1B | |
疗肺宁片 | 百部、穿心莲、羊乳根、白及 | 调节免疫功能,提高抗结核治疗效果 | 1B |
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