RNA恒温实时荧光检测技术对耐多药结核病患者疗效评价的研究OA
A study on the evaluation of efficacy in multidrug-resistant tuberculosis patients by RNA isothermal real-time fluorescence detection technology
目的 评估 RNA 恒温实时荧光检测(SAT)技术在耐多药结核病(MDR-TB)患者二线药物治疗疗效监测中的临床价值.方法 选取2022年1月—2023年1月接收的74例 MDR-TB 患者,采集患者基线及治疗第1、2、3、4、5、6、8、10、12、18、24个月后的痰标本,所有患者均接受涂片抗酸染色、固体培养法、SAT 检测.以临床诊断结果为金标准,分析并比较三种检测方法的结核分枝杆菌(MTB)阳性率变化趋势、敏感性、特异性及与最终诊断的一致性.评价 SAT 在抗结核治疗药物疗效监测方面的价值.结果 ①涂片抗酸染色检测显示:抗酸杆菌阳性率下降速度最快,治疗 2 个月后阳性率降至21.62%.②固体培养法检测显示:治疗2个月后MTB 阳性率降至31.08%,治疗3个月后MTB 阳性率下降趋势与涂片抗酸染色法相近.③SAT 显示:治疗后 MTB 阳性率随着疗程延长逐步下降,治疗 2 个月后 MTB 阳性率降至43.24%,治疗3个月后 MTB 阳性率为23.73%,这两个时间点的阳性率均高于同期涂片抗酸染色与固体培养法的检测结果(P<0.05).④治疗第 6 个月后,三种检测方法对 MDR-TB 患者结核阳性率监测结果对比差异无统计学意义(P>0.05).治疗第12个月后,三种检测方法阳性率均保持 0.⑤治疗 2 个月后,以临床诊断结果为金标准,涂片抗酸染色检测、固体培养法检测、SAT 诊断一致性 Kappa 值分别为 0.473、0.573、0.780;三种检测方法特异度比较差异无统计学意义(P>0.05);SAT 的敏感度最高(87.50%),准确度(89.19%)与固体培养法的(79.73%)比较差异无统计学意义(P>0.05),但高于涂片抗酸染色(75.68%)(P<0.05);涂片抗酸染色法与固体培养法之间的敏感度、准确度比较差异均无统计学意义(P>0.05).结论 SAT 技术通过靶向活菌 RNA,在 MDR-TB 疗效监测中展现出更高的时效性与准确性,其快速转阴的特性有助于指导精准停药,弥补了传统痰涂片与痰培养的不足.
Objective To evaluate the clinical value of RNA isothermal real-time fluorescence detection(SAT)technology in monitoring the efficacy of second-line drug therapy in patients with multidrug-resistant tuberculosis(MDR-TB).Methods A total of 74 MDR-TB patients admitted to hospital from January 2022 to January 2023 were enrolled,and sputum specimens were collected at baseline and at 1,2,3,4,5,6,8,10,12,18,and 24 months of treatment.All patients underwent smear acid fast staining,solid culture method,and SAT testing.Clinical diagnostic results was used as gold standard,the trend,sen-sitivity,specificity,and consistency with the final diagnosis of Mycobacterium tuberculosis(MTB)positive rate of three detec-tion methods were analyzed and compared.In addition,the value of SAT in monitoring the efficacy of anti tuberculosis drugs was evaluated.Results ① Acid-fast smear microscopy showed that the positive rate of acid-fast bacilli declined most rapidly,dropping to 21.62%after 2 months of treatment.② Solid culture demonstrated that the MTB positive rate decreased to 31.08%after 2 months of treatment,and the declining trend of MTB positive rate after 3 months of treatment was similar to that of acid-fast smear microscopy.③ SAT showed that the positive rate of MTB gradually decreased with the prolongation of treatment course.After 2 months of treatment,the positive rate of MTB decreased to 43.24%,and after 3 months of treatment,the posi-tive rate of MTB was 23.73%.The positive rates at these two time points were higher than those of acid fast staining and solid culture method detection results at the same time(P<0.05).④ After 6 months of treatment,there was no statistically signifi-cant difference in the monitoring results of tuberculosis positive rate among MDR-TB patients among the three testing methods(P>0.05).After 12 months of self-treatment,the positive rates of all three testing methods remained at 0.⑤After 2 months of treatment,clinical diagnosis results was used as gold standard,the diagnostic consistency Kappa values for smear acid-fast stai-ning detection,solid culture method detection,and SAT were 0.473,0.573,and 0.780,respectively.There was no statisti-cally significant difference in specificity among the three detection methods(P>0.05).SAT demonstrated the highest sensitivi-ty(87.50%),while its accuracy(89.19%)showed no statistically significant difference compared to the solid culture method(79.73%)(P>0.05),but was higher than that of smear acid-fast staining(75.68%)(P<0.05).There were no statistically significant differences in sensitivity and accuracy between smear acid-fast staining and solid culture methods(P>0.05).Con-clusion SAT technology,by targeting live bacterial RNA,demonstrates greater timeliness and accuracy in monitoring the effi-cacy of MDR-TB treatment.Its characteristic of rapidly converting to negative helps guide precise drug discontinuation,addressing the limitations of traditional sputum smear and sputum culture methods.
眭文娴;黄丽花;罗兰波;胡敏;陈桂彬;周游;杨小兵
广西壮族自治区胸科医院 医学检验科,广西 柳州 545005广西壮族自治区胸科医院 医学检验科,广西 柳州 545005广西壮族自治区胸科医院 医学检验科,广西 柳州 545005广西壮族自治区胸科医院 医学检验科,广西 柳州 545005广西壮族自治区胸科医院 医学检验科,广西 柳州 545005广西壮族自治区胸科医院 科教科,广西 柳州 545005广西壮族自治区胸科医院 科教科,广西 柳州 545005
医药卫生
结核分枝杆菌RNA恒温实时荧光检测耐多药结核病疗效监测
Mycobacterium tuberculosis(MTB)RNAisothermal real-time fluorescence detectionmultidrug-resistant tuberculosis(MDR-TB)efficacy monitoring
《右江医学》 2026 (4)
376-381,6
广西医疗卫生适宜技术开发与推广应用项目(S2021031)
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