中国防痨杂志 ›› 2024, Vol. 46 ›› Issue (2): 127-140.doi: 10.19982/j.issn.1000-6621.20230428
国家呼吸内科医疗质量控制中心, 中华医学会结核病学分会, 中国防痨协会结核病控制专业分会, 中日友好医院
收稿日期:
2023-12-02
出版日期:
2024-02-10
发布日期:
2024-01-30
基金资助:
National Center of Medical Quality Control for Respiratory Diseases , Tuberculosis Branch of Chinese Medical Association , Tuberculosis Control Branch of Chinese Antituberculosis Association , China-Japan Friendship Hospital
Received:
2023-12-02
Online:
2024-02-10
Published:
2024-01-30
Supported by:
摘要:
肺结核诊断延迟不仅造成患者个体的疾病进展和治疗困难,而且在群体层面导致结核病的持续传播。作为肺结核患者主要的首诊场所,综合医疗机构肺结核的早期发现对于实现“终止结核病流行”策略目标具有重要意义。国家呼吸内科医疗质量控制中心、中华医学会结核病学分会、中国防痨协会结核病控制专业分会、中日友好医院共同组织专家,在借鉴世界卫生组织相关指南的基础上,补充国内外相关研究证据,结合我国结核病防治实践,制定了《综合医疗机构肺结核早期发现临床实践指南》。本指南系统总结了肺结核诊断技术的特点,提出了在综合医疗机构就诊的不同目标人群的肺结核筛查路径,为全国各级综合医疗机构进一步完善和优化肺结核早期发现提供循证证据和临床实践指引。
中图分类号:
国家呼吸内科医疗质量控制中心, 中华医学会结核病学分会, 中国防痨协会结核病控制专业分会, 中日友好医院. 综合医疗机构肺结核早期发现临床实践指南[J]. 中国防痨杂志, 2024, 46(2): 127-140. doi: 10.19982/j.issn.1000-6621.20230428
National Center of Medical Quality Control for Respiratory Diseases , Tuberculosis Branch of Chinese Medical Association , Tuberculosis Control Branch of Chinese Antituberculosis Association , China-Japan Friendship Hospital . Clinical practice guidelines for early detection of pulmonary tuberculosis in general medical facilities[J]. Chinese Journal of Antituberculosis, 2024, 46(2): 127-140. doi: 10.19982/j.issn.1000-6621.20230428
表1
结核分枝杆菌病原学检测技术
检测技术 | 原理 | 优点 | 缺点 | 敏感度 | 特异度 |
---|---|---|---|---|---|
涂片显微镜检查 | 临床标本涂片染色后显微镜下直接寻找、观察病原菌,是结核病诊断和发现传染源的主要手段 | 对硬件设施要求不高,价格低廉,适合基层开展 | 敏感度较低;不能区分死菌和活菌,无法开展后续的药物敏感性试验;不能区分结核分枝杆菌和非结核分枝杆菌 | 32%~97%[ | 50%~100%[ |
分枝杆菌培养检测 | 在人工培养基上分离菌落,或检测分枝杆菌生长的代谢产物来确定目标病原菌,是结核病诊断的金标准 | 比痰涂片显微镜检查敏感度和特异度高,获得的阳性菌株可以用于后续的菌种鉴定、药物敏感性检测等 | 报告结果时间长、操作复杂,生物安全风险高,对设备和实验室要求较高 | 89%(涂阳培阳)[ | >99%[ |
分子生物学检测a | 通过分子扩增手段检测临床标本中特异性的靶标,从而检测是否存在结核分枝杆菌核酸或耐药基因 | 操作简单、快速、敏感度高、自动化程度高 | 价格较高,对实验室有特殊要求 | GeneXpert MTB/RIF:85%(95%CI:82%~88%)[ | GeneXpert MTB/RIF:98%(95%CI:97%~98%)[ |
表2
结核病免疫学检测技术
检测技术 | 原理 | 优点 | 缺点 | 敏感度 (95%CI) | 特异度 (95%CI) |
---|---|---|---|---|---|
结核菌素皮肤试验 | 一种以结核菌素纯蛋白衍生物作为免疫原的迟发型变态反应的皮肤试验[ | 操作简单,敏感度高,无需实验室与特殊设备辅助,适用于各种环境 | 不能区分活动性结核病、结核分枝杆菌潜伏感染、接种卡介苗引起的致敏反应,以及非结核分枝杆菌感染引起的交叉反应;注射方式及48~72h的判读方式影响便利性 | 82%(72%~ 88%)[ | 93%(90%~ 95%)[ |
结核分枝杆菌特异抗原皮肤试验 | 一种以早期分泌抗原靶6和培养滤液蛋白10等结核分枝杆菌蛋白作为变态反应原用于结核分枝杆菌感染检测的新型皮肤试验[ | 不受卡介苗接种影响,较少受到非结核分枝杆菌感染的影响 | 不能区分活动性结核病和结核分枝杆菌潜伏感染;注射方式及48~72h的判读方式影响便利性;价格较高 | 78%(70%~ 84%)[ | 98%(94%~ 99%)[ |
γ-干扰素释放试验 | 采用结核分枝杆菌蛋白质的多肽抗原刺激效应T淋巴细胞分泌γ-干扰素以检测并定量分析γ-干扰素浓度 | 不受卡介苗接种影响,较少受到非结核分枝杆菌感染的影响,体外检测便利性高 | 不能区分活动性结核病和结核分枝杆菌潜伏感染;价格较高;对实验室有一定要求 | 77%(66%~ 85%)[ | 99%(80%~ 100%)[ |
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