含贝达喹啉及利奈唑胺方案治疗耐多药结核病24周疗效及安全性观察

目的 评价含贝达喹啉联合利奈唑胺方案治疗耐多药结核病(multidrug-resistant tuberculosis,MDR-TB)的早期疗效及安全性.方法 纳入2018年3月至2020年10月成都市公共卫生临床医疗中心门诊及住院部确诊为MDR-TB的患者68例,所有患者均给予贝达喹啉联合利奈唑胺的方案抗痨,动态监测...

An observational study on efficacy and safety of bedaquiline combined with linezolid in the treatment of MDR-TB for 24 weeks

Objective To evaluate the early efficacyand safety of bedaquiline combined with linezolidin the treatment of multidrug-resistant tuberculosis(MDR-TB).Methods A total of 68 patients diagnosed with MDR-TB in the outpatient and inpatient departments of Chengdu Public Health Clinical Medical Center from March 2018 to October 2020 were included.All patients were given an anti-tuberculosis regimen based on bedaquiline combined with linezolid,the changes in sputum Mycobacterium tuberculosis culture,chest imaging,electrocardiogram,hematuria routine,liver and kidney function,and visual acuity were monitored dynamically within 24 weeks of treatment for the evaluation of therapeutic effect and drug safety.Results A total of 68 patients were included in this study,including 10(14.71%)MDR-TB patients,33(48.53%)pre-extensive drug-resistant tuberculosis(Pre-XDR-TB)patients,25(36.76%)extensive drug-resistant tuberculosis(XDR-TB)patients.62(91.18%)cases completed 24-weeks treatment,3(4.41%)cases died,1(1.47%)case dropped out of the group,2(2.94%)cases were lost to follow-up.Of the 62 patients who completed 24 weeks of treatment,59(95.16%,59/62)cases achieved sputum culture negative conversion,the median time of conversion was 4(4,24)weeks,and 59(95.16%,59/62)cases achieved imaging absorption.Almost all patients had adverse events within 24 weeks.There were 29(42.65%)casesof adverse events related tobedaquiline QTc intervalprolongation,with a median time of 4(2,12)weeks,of which,there were 6(8.82%)cases with a QTc interval≥500ms,1(1.47%)case with a QTc interval prolongation>100ms,7(10.29%)cases with bedaquinoline permanently discontinued.There were 24(35.29%)cases of adverse events related to linezolid,including 14(20.59%)cases of hematological toxicity with an average time of 9.5±6.2 weeks,9(13.24%)cases of peripheral neuritis with an average time of 20.3±2.8 weeks,and 1(1.47%)case of optic neuritis with the onset time of 16 weeks.Linezolid was permanently discontinued in 2(2.94%)patients due to adverse events,and 16(23.53%)patients continued to be used after reduction or interruption.Conclusion The regimen containing bedaquiline and linezolid in the treatment of MDR-TB,Pre-XDR-TB,and XDR-TB has a high negative conversion rate of Mycobacterium tuberculosis culture at 24 weeks.Although there are many adverse events,the tolerance of patients was acceptable.