天津医药

天津医药 ›› 2018, Vol. 46 ›› Issue (9): 956-959.doi: 10.11958/20180463

• 临床研究 • 上一篇    下一篇

RNA恒温扩增实时荧光检测技术对复治菌阳肺结核患者疗效评价的研究

耿书军，刘建玲，党萍，马清艳，侯莉莉，康冠楠，宋韬   

  1. 1河北省胸科医院结核内科（邮编050041），2呼吸内科
  • 收稿日期:2018-03-28 修回日期:2018-06-25 出版日期:2018-09-15 发布日期:2018-10-10
  • 通讯作者: 耿书军 E-mail:shujungeng@163.com

Study on the efficacy evaluation of real-time fluorescence assay of RNA isothermal amplification in the treatment of patients with positive pulmonary tuberculosis

GENG Shu-jun,LIU Jian-ling,DANG Ping,MA Qing-yan,HOU Li-li,KANG Guan-nan,SONG Tao   

  1. 1 Department of Tuberculosis Medicine, 2 Department of Respiratory Medicine, Hebei Chest Hospital, Hebei 050041, China
  • Received:2018-03-28 Revised:2018-06-25 Published:2018-09-15 Online:2018-10-10

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摘要： 目的 探讨RNA恒温扩增实时荧光检测（SAT）技术在初次复治菌阳肺结核患者化疗效果监测中的价值。方法 选取2015年6月—2016年12月在我科住院，临床诊断为初次复治菌阳肺结核患者62例。患者经标准化的抗结核治疗2个月后，取痰标本分别经彭氏杯抗酸染色、BACTEC MGIT-960培养和菌种鉴定、SAT 检测，以BACTECMGIT-960培养、菌种鉴定为金标准，评价SAT在抗结核治疗药物疗效监测方面的价值。结果 62例患者治疗后结核菌培养阳性49例，其中人型结核分枝杆菌42例，非结核分枝杆菌7例；结核菌培养阴性13例。痰彭氏杯抗酸染色阳性32例，阴性30例。SAT检测阳性41例，阴性21例。SAT与痰培养有较好的一致性（Kappa值=0.964），其敏感度、特异度、阳性预测值、阴性预测值分别为97.62%、100%、100%、95.24%；彭氏杯抗酸染色与MGIT-960培养结果一致性较差（Kappa值=0.086），其敏感度、特异度、阳性预测值、阴性预测值分别为54.76%、55.00%、71.88%、36.67%。结论 SAT技术可用于初次复治菌阳肺结核患者药物疗效的监测，可根据其结果及时调整用药，值得临床推广。

关键词: 核酸扩增技术；结核, 肺；结核分枝杆菌；药物疗效

Abstract: Objective To investigate the value of real-time fluorescence detection technique of RNA (SAT constantamplification in monitoring the effect of chemotherapy on patients with sputum positive pulmonary tuberculosis. Methods Sixty-two patients were selected, who were clinically diagnosed as the first-time retreatment for sputum smear-positive pulmonary tuberculosis and were hospitalized in our department from June 2015 to December 2016. After two-month standard anti-tuberculosis treatment, sputum samples were detected by Peng’s vessel acid-fast staining, BACTEC MGIT-960 culture and strain identification, SAT detection. The BACTEC MGIT-960 culture and strain identification were used as gold standards, the value of SAT during the monitoring the therapeutic effect of the anti-tuberculosis drugs was assessed.Results After the treatment, 49 cases out of 62 showed positive results in mycobacterium tuberculosis culture test, among them 42 patients were diagnosed as human type mycobacterium tuberculosis, 7 patients were diagnosed as nontuberculous mycobacteria infection, and 13 cases showed negative results in mycobacterium tuberculosis culture. Thirty-two cases showed positive results in sputum Peng’s vessel acid-fast staining test, and 30 cases showed negative results. Forty-one cases showed positive results in SAT test and 21 cases showed negative results in SAT. SAT results were well concordant with sputum culture results (Kappa value=0.964), and the sensitivity, the specificity, the positive predictive value and the negative predictive value of SAT were 97.62%, 100%, 100% and 95.24% respectively. Peng’s vessel acid-fast staining results were badly concordant with MGIT-960 culture results (Kappa value=0.086), and the sensitivity, the specificity, the positive predictive value and the negative predictive value of Peng’s vessel acid-fast staining were 54.76%, 55.00%,71.88% and 36.67% respectively. Conclusion SAT results can be used as good indices during the monitoring therapeutic effects of drugs used for the first-time retreatment in patients with sputum smear-positive pulmonary tuberculosis, which is worth promoting.

Key words: nucleic acid amplification technology, tuberculosis, lung, mycobacterium tuberculosis, drug efficacy