MGIT 960系统快速检测结核分枝杆菌药物敏感性的应用评价
Application Evaluation on BACTEC MGIT 960 System for Drug Susceptibility Testing of Mycobacterium Tuberculosis
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摘要:
目的 评价液体培养及快速药敏检测技术(BACTEC MGIT 960 系统)检测结核分枝杆菌对一线、二线8 种抗结核药物敏感性的效果。 方法 用BACTEC MGIT 960 系统对结核分枝杆菌临床分离株进行一线、二线8 种抗结核药物的药物敏感性试验, 以传统的L-J 比例法药敏试验作对照, 从结果报告时间和符合率等方面进行评价。统计学分析分别采用配对t 检验和Kappa 检验。 结果 用MGIT 960 法与L-J 比例法同时对202 株结核分枝杆菌临床分离株进行一线药物异烟肼、利福平、链霉素和乙胺丁醇的药物敏感性检测, 该两种方法对此4 种药物的符合率分别为98.0%(198/202)、96.5%(195/202)、94.1%(190/202)和83.7%(169/202);而该两种方法对77 株结核分枝杆菌临床分离株进行二线药物卷曲霉素、卡那霉素、氧氟沙星和乙硫异烟胺的药物敏感性检测符合率, 分别为87.0%(67/77)、93.5%(72/77)、97.4%(75/77)和68.8%(53/77)。MGIT 960 法完成一线、二线药物药敏试验的时间中位数分别为11 d 和8 d, 而比例法规定判读时间为28 d, 二者检测时间差异有统计学意义(P < 0.01)。 结论 与传统比例法相比, BACTEC MGIT 960 系统能够快速、准确地检测结核分枝杆菌对一线、二线抗结核药物的敏感性, 有利于耐药结核病的早期诊断和治疗。 Abstract:Objective To evaluate the reliability of BACTEC MGIT 960 in testing susceptibilities of Mycobacterium tuberculosis to 8 tuberculosis (TB) medicines for first-line and second-line treatment. Methods The susceptibilities of 8 firstline and second-line anti-tuberculosis drugs, including isoniazid (INH), rifampicin (RFP), streptomycin (SM), ethambutol (EMB), capreomycin (CPM), kanamycin (KAN), ofloxacin (OFLX), and ethionamide (ETH), were tested by BACTEC MGIT 960 system, and the results (average time of reporting results and rater agreement) were compared with those obtained by the traditional L-J proportion method. Statistical analysis was performed using paired t test and Kappa test. Results The agreement rates of the 4 first-line drugs, INH, RFP, SM, and EMB, tested by MGIT 960 and L-J proportion method were 98.0% (198/202), 96.5% (195/202), 94.1% (190/202), and 83.7% (169/202), respectively. The agreement rates of the 4 second-line drugs, CPM, KAN, OFLX, and ETH, were 87.0% (67/77), 93.5% (72/77), 97.4% (75/77) and 68.8% (53/77), respectively. The medians of drug susceptibility testing durations using MGIT 960 were 11 days for the first-line drugs and 8 days for the second-line drugs, respectively; while the medians using L-J proportion method were both 28 days for the first-line and the second-line drugs (P < 0.01). Conclusion The BACTEC MGIT 960 system is an accurate and rapid method to test the susceptibilities of Mycobacterium tuberculosis to first-line and the second-line drugs, and applicable to early diagnosis and treatment of drug-resistant TB.
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