熔解曲线法和微量MIC法在结核分枝杆菌耐药性检测中的效果比较  

Comparative analysis of Melting Curve Method and Micro-MIC Method in the Detection of Drug Resistance of Mycobacterium Tuberculosis

作　　者：杨映晖 伍定辉[1] 宋育明[1] 董春萍 姚向阳[1] YANG Yinghui;WU Dinghui;SONG Yuming;DONG Chunping;YAO Xiangyang(Department of Lung,the First Affiliated Hospital of Xiamen University,Xiamen 361022,Fujian,China)

机构地区：[1]厦门大学附属第一医院肺科,福建厦门361022

出　　处：《中国药物滥用防治杂志》2024年第5期831-836,共6页Chinese Journal of Drug Abuse Prevention and Treatment

摘　　要：目的:比较熔解曲线法和微量MIC法在一线、二线抗结核药物耐药性检测中的应用价值以及优劣势。方法:收集2020年1月—2021年1月厦门大学附属第一医院肺科住院和门诊患者共160例的培阳菌株,治疗药物选用异烟肼、链霉素、乙胺丁醇、阿米卡星、卷曲霉素、利福平和氟喹诺酮7种常见抗结核药物。以罗氏比例法为金标准,基于熔解曲线法和微量MIC法检测结核患者对每个药物的耐药敏感度、特异度以及结果可靠性进行分析。结果:以罗氏比例法检测结果为参考标准,熔解曲线法和微量MIC法检测异烟肼耐药敏感度分别检测出异烟肼耐药敏感度为91.5%和100%,特异度为94.7%和96.5%,Kappa值为0.851和0.941;检测出链霉素耐药敏感度分别为82.4%和91.2%,特异度为94.4%和97.6%,Kappa值为0.760和0.888;检测出乙胺丁醇耐药敏感度分别为80%和60%,特异度为95%和99.3%,Kappa值为0.705和0.697;检测出阿米卡星耐药敏感度均为100%,特异度为99.4%和98.1%,Kappa值为0.854和0.658;检测出卷曲霉素耐药敏感度分别为42.9%和71.4%,特异度均为99.3%,Kappa值为0.531和0.760;检测出利福平耐药敏感度分别为94.9%和89.7%,特异度为96.7%和97.5%,Kappa值为0.900和0.880;检测出氟喹诺酮耐药敏感度分别为95.2%和61.2%,特异度为100%和97.8%,Kappa值为0.972和0.665。结论:熔解曲线法对异烟肼、阿米卡星、利福平和氟喹诺酮类药物的耐药性检测效能与金标准具有完全一致性,对链霉素、卷曲霉素和乙胺丁醇的耐药性检测效能与金标准具有中高度一致性;微量MIC法对异烟肼、链霉素和利福平药物的耐药性检测效能与金标准具有完全一致性,对乙胺丁醇、阿米卡星、卷曲霉素和氟喹诺酮的耐药性检测效能与金标准具有中高度一致性;两种方法均具有准确、快速、高效的特点,在临床上可一定程度上替代金标准使用。Objective:To compare the application value,advantages and disadvantages of melting curve method and micro MIC method in the detection of drug resistance of first-line and second-line anti-tuberculosis drugs.Methods:A total of 160 culture-positive strains were collected from inpatients and outpatients in the Department of Pulmonary Medicine of the First Affiliated Hospital of Xiamen University from January 2020 to January 2021.Seven common anti-tuberculosis drugs,isoniazid,streptomycin,ethambutol,amikacin,capreomycin,rifampicin and fluoroquinolone,were selected for treatment.With Roche ratio method as the gold standard,the sensitivity,specificity and reliability of drug resistance of tuberculosis patients to each drug were detected based on melting curve method and micro-MIC method.Results:With the results of Roche proportional method as the reference standard,the sensitivity of isoniazid resistance detected by melting curve method and micro-MIC method was 91.5%and 100%respectively,the specificity was 94.7%and 96.5%,and the Kappa value was 0.851 and 0.941.The sensitivity of streptomycin resistance was 82.4%and 91.2%,the specificity was 94.4%and 97.6%,and the Kappa value was 0.760 and 0.888.The sensitivity of ethambutol resistance was 80%and 60%,the specificity was 95%and 99.3%,and the Kappa value was 0.705 and 0.697.The sensitivity of amikacin resistance was 100%,the specificity was 99.4%and 98.1%,and the Kappa value was 0.854 and 0.658.The sensitivity of capreomycin resistance was 42.9%and 71.4%,the specificity was 99.3%,and the Kappa value was 0.531 and 0.760.The sensitivity of rifampicin resistance was 94.9%and 89.7%,the specificity was 96.7%and 97.5%,and the Kappa value was 0.900 and 0.880.The sensitivity of fluoroquinolone resistance was 95.2%and 61.2%,the specificity was 100%and 97.8%,and the Kappa value was 0.972 and 0.665.Conclusion:The detection efficiency of the melting curve method for the resistance of isoniazid,amikacin,rifampicin and fluoroquinolones was completely consistent with the gold standard,a

关 键 词：熔解曲线法 结核分枝杆菌 微量MIC法 抗结核药物 耐药检测 

分 类 号：R446.5[医药卫生—诊断学]