文献类型：期刊文献

中文题名：分枝杆菌双相罗氏培养基在结核病诊断中的应用研究

英文题名：Evaluation the application of mycobacterial biphasic L-J medium in the diagnosis of tuberculosis

作者：宋媛媛[1];刘二勇[1];陶波山[2];黄费湘[3];肖亚利[4];蓝如束[5];谭云洪[6];李辉[7];叶磊[8];成诗明[9];赵雁林[1]

第一作者：宋媛媛

机构：[1]中国疾病预防控制中心结核病预防控制中心国家结核病参比实验室,北京102206;[2]中国疾病预防控制中心结核病预防控制中心患者关怀部,北京102206;[3]广西壮族自治区北海市结核病防治院检验科;[4]湖南省邵阳市结核病防治医院检验科;[5]河南省南阳市第六人民医院检验科;[6]广西壮族自治区疾病预防控制中心结核病防制所;[7]湖南省结核病防治所检验科;[8]河南省疾病预防控制中心结核病参比实验室;[9]北京联合大学师范学院基础教学部

第一机构：中国疾病预防控制中心结核病预防控制中心国家结核病参比实验室,北京102206

年份：2018

卷号：40

期号：12

起止页码：1325-1329

中文期刊名：中国防痨杂志

外文期刊名：The Journal of The Chinese Antituberculosis Association

收录：CSTPCD

基金：中国防痨协会分枝杆菌双相罗氏培养基（培养法在结核病诊断中的现场应用性评估项目ZGFL-2014-002）

语种：中文

中文关键词：分枝杆菌,结核;培养基;细菌学技术;诊断;对比研究

外文关键词：Mycobacterium tuberculosis;Culture media;Bacteriological techniques;Diagnosis;Comparative study

摘要：目的 评价分枝杆菌双相罗氏培养基在结核病诊断中的价值,探讨其在我国基层实验室应用的可行性。方法采取多中心试验方法,在我国3个省的3个地市级结核病诊疗机构连续纳入2014年10月至2015年10月期间的初诊肺结核可疑症状者2320例,其中15例因分枝杆菌改良罗氏培养基（简称“罗氏培养基”）和分枝杆菌双相罗氏培养基（简称“双相培养基”）中的1种或2种培养污染或结果缺失,对两种培养基培养结果进行比较时不计入分析。每例患者留取3份痰标本（即时痰、夜间痰、晨痰）进行萋-尼染色法涂片镜检（简称“涂片”）,并选取2份性状好的痰标本同时进行罗氏培养基培养、双相培养基培养。使用SPSS 24.0软件,采用配对χ2检验比较两种培养基的阳性检出率,以P〈0.05为差异有统计学意义;分别以罗氏培养基培养结果、临床诊断为标准对双相培养基的检测效能进行评价;采用Wilcoxon秩和检验对罗氏培养基与双相培养基检出时间的差异进行统计学分析,以P〈0.05为差异有统计学意义。结果罗氏培养基和双相培养基两种培养方法阳性检出率分别为19.65%（453/2305）和22.00%（507/2305）,差异有统计学意义（χ2=22.091,P=0.000）;以罗氏培养基培养结果为标准,双相培养基的敏感度为91.39%（414/453）,特异度为94.98%（1759/1852）,一致率为94.27%（2173/2305）;以临床诊断为标准,罗氏培养基和双相培养基的ROC曲线下面积分别为0.694（95%CI：0.672~0.715）、 0.707（95%CI：0.685~0.728）;罗氏培养基报阳时间中位数（四分位数）[M（Q1,Q3）]为28（21,34）d,双相培养基报阳时间M（Q1,Q3）为18（14,24）d,差异有统计学意义（Z=15.114,P=0.000）。结论双相培养基较罗氏培养基具有更高的阳性检出率,诊断价值较高,报阳时间明显缩短,是一种可以作为结核病临床诊断的参考方法,在我国基层实验室有一定推广应用价值。
Objective To evaluate the value of mycobacterial biphasic L-J medium in the diagnosis of tuberculosis, and to explore its feasibility in China. Methods We conducted a multicenter trial to consecutively enroll all patients with suspected TB at 3 prefecture-level TB clinics in 3 provinces of China from October 2014 to October 2015. Of the 2320 suspicious patients enrolled, 15 cases had either one or two of the two cultures （mycobacterial modified L-J medium and mycobacterial biphasic L-J medium） with contamination or missing results, and their comparison of the culture results of the two media is not included in the analysis. 3 sputum specimens collected per patient （immediate sputum, night sputum, morning sputum） for Ziehl-Neelson stain smear microscopy （“smear”）, and 2 sputum specimens with good traits were selected simultaneously for modified L-J medium and biphasic L-J medium culture. The positive detection rate of the two media was compared by paired χ2 test using SPSS 24.0 software, and P〈0.05 was considered statistically significant; The detection efficiency of the biphasic L-J medium was evaluated by the culture results of modified L-J medium and the clinical diagnosis as the standard; The difference between the detection time of modified L-J medium and biphasic L-J medium was statistically analyzed by Wilcoxon rank sum test. P〈0.05 was considered statistically significant. Results The positive detection rates of modified L-J medium and biphasic L-J medium were 19.65% （453/2305） and 22.00% （507/2305）, respectively, and the difference was statistically significant （χ2=22.091, P=0.000）; Based on the culture results of modified L-J medium, the sensitivity of biphasic L-J medium was 91.39% （414/453）, and the specificity was 94.98% （1759/1852）, and the agreement rate was 94.27% （2173/2305）;Based on clinical diagnosis, the area under the ROC curve of modified L-J medium and biphasic L-J medium were 0.694 （95%CI： 0.672-0.715）, 0.707 （95%CI： 0.685-0.728）, respectively; The median （quartile）（M （Q1, Q3）） of days when modified L-J medium reported a positive result was 28 （21, 34）d, while the M （Q1, Q3） of days when biphasic L-J medium reported a positive result was 18 （14, 24）d. The difference was statistically significant （Z=15.114, P=0.000）. Conclusion Biphasic L-J medium has a higher positive detection rate than modified L-J medium. This method has a high diagnostic value, and the time for reporting positive results is significantly shortened. It is a reference method that can be used as a clinical diagnosis for tuberculosis, and has certain application value in grassroots laboratories in China.