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资料背景:淋巴结炎是结核病最常见的肺外表现。常规诊断方法,例如涂片镜检和培养,对于结核性淋巴结炎的诊断都不是非常精确。核酸扩增试验(NAAT)可以提供有益的辅助诊断。目的:通过系统回顾,评价NAAT方法诊断结核性淋巴结炎的实际效果。实验设计:我们进行了文献检索,发现36篇文章中包含了49个NAAT与结核性淋巴结炎参比标准的比较研究。每一个研究估计的灵敏度和特异性均采用树状图和概括性接收器工作特性曲线(SROC)来体现。结果:所有研究的质量大致相当,但很多研究的报告质量较差。各研究估计的NAAT的灵敏度(2%～100%)和特异性(28%～100%)差异很大,可能是由于研究的人群、质量和检测技术不同所致。商业化的NAAT试验应用20μl以上的模板,包含差异分析的报告提供了较高的诊断精确性。双盲、模板体积和差异分析可能解释一些结果不同的原因。结论:检测结核性淋巴结炎的NAAT研究所获得的结果高度可变,而且不一致,不可能成为临床确诊的指标。研究报告未标准化,而且通常包含的信息量不足。由于可能存在假阳性和假阴性结果,因此NAAT方法需与常规的方法联合应用,对临床可疑病例需依具体情况判断。
Background: Lymphadenitis is the most common extrapulmonary manifestation of tuberculosis. Routine diagnostic methods, such as smear microscopy and culture, are not very accurate for the diagnosis of tuberculous lymphadenitis. Nucleic acid amplification assay (NAAT) can provide useful adjuvant diagnosis. Objective: To systematically review and evaluate the actual results of NAAT in the diagnosis of tuberculous lymphadenitis. Experimental Design: We conducted a literature search and found that 36 articles contained 49 comparative studies of NAAT and tuberculous lymphadenitis reference standards. The estimated sensitivity and specificity for each study are based on dendrograms and a generalized receiver operating characteristic curve (SROC). Results: The quality of all studies was roughly the same, but many studies reported poor quality. The sensitivity (2% -100%) and specificity (28% -100%) of the NAAT estimates for each study vary greatly, possibly due to differences in population, quality and detection techniques used. Commercially available NAAT assays using more than 20 μl of template and reports containing differential analysis provide high diagnostic accuracy. Double-blind, template size and variance analysis may explain some of the reasons for the different outcomes. CONCLUSIONS: The results obtained with the NAAT study for the detection of tuberculous lymphadenitis are highly variable and inconsistent and may not be clinically definitive indicators. The study is not standardized and usually contains insufficient information. Because there may be false-positive and false-negative results, the NAAT method should be used in combination with conventional methods, and the clinical suspicion cases should be judged according to the specific conditions.