中文摘要：

目的运用GenoType MTBDRplus线性探针法鉴定结核分枝杆菌耐药情况，与传统药物敏感试验进行比较，评估其在预测耐药结核患者预后中的作用。方法收集浙江省诸暨市人民医院2011年2月到2012年1月基线痰涂片阳性的肺结核患者标本275份，进行结核分枝杆菌的分离培养及药物敏感试验。同时采用GenoType MTBDRplus线性探针法检测异烟肼及利福平耐药情况。对所有人组结核患者进行随访，包括痰培养和胸部X线片。结果GenoType MTBDRplus线性探针法和传统药物敏感试验均为耐药者有192株。传统药物敏感试验发现14株耐多药菌株，21株异烟肼单耐药株和2株利福平单耐药株，而GenoType MTBDRplus线性探针法分析结果分别为14、18和2株。以传统药物敏感试验作为金标准，线性探针分析利福平耐药性一致；21株耐异烟肼株中，5株未检测出。GenoType MTBDRplus线性探针法检测耐药的患者中，131株敏感菌治疗成功10例，占84．0％；15株异烟肼单耐药、11株多重耐药株中，治疗成功分别有9例和3例。2例单耐利福平，其中1例治愈，1例失败。分子耐药检测对异烟肼单耐药患者治疗失败的预测值为40．0％；对异烟肼敏感患者治疗成功的预测值为83．5％；对利福平单耐药患者治疗失败的预测值为50．0％，对利福平敏感患者治疗成功的预测值为81．5％；对耐多药结核患者治疗失败的预测值为72．7％，对非耐多药患者治疗成功的预测值为81．1％。结论GenoType MTBDRplus线性探针法是检测结核分枝杆菌耐药性的一项快速、可靠的方法，其耐药检测结果可用于临床耐药结核预后的预测。

英文摘要：

Objective To identify drug resistance status of Mycobacterium tuberculosis （MTB） strains by the GenoType MTBDRplus line-probe assay （LPA）, compare its performance with traditional drug susceptibility testing （DST）, and to assess its predictive value for the prognosis of patients with drug resistance tuberculosis. Methods Pulmonary tuberculosis patients who visited Zhuji Peoplers Hospital, Zhejiang Province during February 2011 and January 2012 with a positive result of sputum smear at baseline were all recruited. A total of 275 culture positive specimens were collected, then isolated and cultured for Mycobacterium tuberculosis in the laboratory. DST were performed, meanwhile, GenoType MTBDRplus were also applied to detect resistance to isoniazid （INH） and rifampin （RMP）. All the tuberculosis patients who were recruited were followed, including sputum culture and chest radiography. Results There were 192 strains showing drug resistance both by DST and MTBDRplus LPA. Fourteen multidrug resistant （MDR）, 21 INH mono-resistant and 2 RMP mono resistant strains were detected by DST. As for GenoType MTBDRplus LPA, MDR, INH mono resistant and RMP mono-resistant strains were 14, 18 and 2, respectively. Taken DST as the gold standard, LPA was more accurate in the detection of resistance to RMP, while it failed to detect 23.8% （5/21） of the INH-resistant strains. We analyzed the prognosis of patients with drug resistance by GenoType MTBDRplus LPA, the rates of treatment success were 84% （110/ 131）, 9/15, 3/11 in patients infected with susceptible, INH mono-resistant and MDR strains, respectively. For the 2 cases of RMP mono-resistance, one was cured and the other failed. The predictive value of molecular drug resistance test for treatment failure in INH mono-resistant patients was 40.0%, while that was 83.5% for treatment success in INH susceptible patients. The predictive value for treatment failure in RMP mono-resistant patients was 50.0%, while that was 81.5%0 for treatment success in RMP s