诊疗方案
结核病病原学分子诊断专家共识
中华医学会结核病学分会临床检验专业委员会
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DOI: 10.3760/cma.j.issn.1001-0939.2018.09.008
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摘要

结核病是威胁人类健康的重要公共卫生问题之一,据世界卫生组织(World Health Organization,WHO)估计2016年全球约有1 040万例新发结核病患者,其中167万例死于结核病 [ 1 ] 。特别是2018年以来,伴随着耐多药结核病(multidrug-resistant tuberculosis, MDR)和广泛耐药结核病(extensively drug-resistant tuberculosis, XDR)患者的日益增多,结核病的防控工作面临前所未有的挑战 [ 2 , 3 ] 。我国是全球30个结核病高负担国之一,每年新发结核病患者89.5万例,位居世界第三位;耐多药结核病患者5.8万例,位居世界第二位 [ 1 ] ,因此,结核病成为制约我国社会经济发展的重大公共问题之一 [ 4 ] 。早诊断、早隔离、早治疗是减少肺结核发病和死亡的关键环节,诊断的滞后导致个体化治疗的延误和结核分枝杆菌( Mycobacterium tuberculosis,MTB)的传播 [ 5 , 6 ] 。结核病实验室诊断是发现结核病患者的重要途径,痰涂片检查价格低廉、操作简便,但敏感度不高;痰培养敏感度较高,一直作为结核病实验室诊断的金标准,但因其检测周期过长,不能为临床提供时效性检测结果 [ 7 , 8 , 9 ] 。鉴于现有细菌学检测方法的诸多不足,WHO于2013年修订了结核病的诊断标准 [ 10 ] ,将分子生物学方法检测阳性的患者纳入病原学阳性的范畴。我国也于2017年重新修订了肺结核诊断标准,此标准中将分子生物学诊断阳性作为病原学阳性的诊断依据 [ 11 ] 。虽然分子生物学诊断技术的时效性优于传统方法,但正确、全面地解读结核病分子生物学诊断报告,特别是当分子诊断技术与传统诊断技术结果存在不一致时,如何更好地利用分子生物学诊断报告服务临床诊断是困扰临床工作者的难题。为了更好地理解新版指南的诊断标准,提高结核病诊疗人员对分子生物学诊断技术实验室结果的解读能力,中华医学会结核病学分会临床检验专业委员会组织实验室和临床领域的专家对分子生物学诊断技术领域的重要问题进行讨论,并撰写本共识。

引用本文

中华医学会结核病学分会临床检验专业委员会. 结核病病原学分子诊断专家共识[J]. 中华结核和呼吸杂志,2018,41(9):688-695.

DOI:10.3760/cma.j.issn.1001-0939.2018.09.008

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结核病是威胁人类健康的重要公共卫生问题之一,据世界卫生组织(World Health Organization,WHO)估计2016年全球约有1 040万例新发结核病患者,其中167万例死于结核病 [ 1 ]。特别是2018年以来,伴随着耐多药结核病(multidrug-resistant tuberculosis, MDR)和广泛耐药结核病(extensively drug-resistant tuberculosis, XDR)患者的日益增多,结核病的防控工作面临前所未有的挑战 [ 2 , 3 ]。我国是全球30个结核病高负担国之一,每年新发结核病患者89.5万例,位居世界第三位;耐多药结核病患者5.8万例,位居世界第二位 [ 1 ],因此,结核病成为制约我国社会经济发展的重大公共问题之一 [ 4 ]。早诊断、早隔离、早治疗是减少肺结核发病和死亡的关键环节,诊断的滞后导致个体化治疗的延误和结核分枝杆菌( Mycobacterium tuberculosis,MTB)的传播 [ 5 , 6 ]。结核病实验室诊断是发现结核病患者的重要途径,痰涂片检查价格低廉、操作简便,但敏感度不高;痰培养敏感度较高,一直作为结核病实验室诊断的金标准,但因其检测周期过长,不能为临床提供时效性检测结果 [ 7 , 8 , 9 ]。鉴于现有细菌学检测方法的诸多不足,WHO于2013年修订了结核病的诊断标准 [ 10 ],将分子生物学方法检测阳性的患者纳入病原学阳性的范畴。我国也于2017年重新修订了肺结核诊断标准,此标准中将分子生物学诊断阳性作为病原学阳性的诊断依据 [ 11 ]。虽然分子生物学诊断技术的时效性优于传统方法,但正确、全面地解读结核病分子生物学诊断报告,特别是当分子诊断技术与传统诊断技术结果存在不一致时,如何更好地利用分子生物学诊断报告服务临床诊断是困扰临床工作者的难题。为了更好地理解新版指南的诊断标准,提高结核病诊疗人员对分子生物学诊断技术实验室结果的解读能力,中华医学会结核病学分会临床检验专业委员会组织实验室和临床领域的专家对分子生物学诊断技术领域的重要问题进行讨论,并撰写本共识。
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