含贝达喹啉方案治疗耐药结核病的疗效和安全性观察

Observation on the efficacy and safety of containing Bedaquiline regimen in the treatment of drug-resistant tuberculosis

目的评价含贝达喹啉方案治疗耐药结核病患者的有效性及安全性。方法以2018年8月-2020年3月在昆明市第三人民医院接受含贝达喹啉耐药方案治疗的36例耐药结核病患者为研究对象,包括RR-TB 2例(5.6%)、MDR-TB 5例(13.9%)、Pre-XDR-TB 20例(55.5%)、XDR-TB 9例(25.0%),观察接受治疗的耐药患者治疗效果及安全性。结果36例患者使用含贝达喹啉方案,其中22例(61.1%)临床治愈,7例(19.4%)完成临床治疗,1例(2.8%)治疗失败,2例(5.6%)死亡,4例(11.1%)失访;发生QT间期延长32例(88.9%);治疗2周、4周、8周、12周、16周、20周、24周期间的QTcF与治疗前(基线)比较,差异具有统计学意义(P<0.01)。结论含贝达喹啉方案治疗耐药结核病的总体治疗效果良好,未发生重大药物不良事件,值得临床推广应用。

Objective To evaluate the efficacy and safety of a regimen containing bedaquinoline in the treatment of drug-resistant tuberculosis.Methods 36 patients with drug-resistant TB who received containing Bedaquinoline-resistant regimen in Kunming Third People s Hospital from August 2018 to March 2020 were studied.There were 2 cases of RR-TB(5.6%),5 cases of MDR-TB(13.9%),20 cases of Pre-XDR-TB(55.5%),and 9 cases of XDR-TB(25.0%).The therapeutic effect and safety of the drug-resistant patients receiving treatment were observed.Results 36 cases treated with containing Bedaquiline regimen,of which 22 cases(61.1%)were cured,7 cases(19.4%)completed clinical treatment,1 case(2.8%)failed treatment,2 cases(5.6%)died,and 4 cases(11.1%)were lost to follow-up.QT interval prolongation occurred in 32 cases(88.9%).The difference of QTcF during 2,4,8,12,16,20 and 24 weeks of treatment was statistically significant compared with that before treatment(baseline)(P<0.01).Conclusions The overall therapeutic effect of the regimen containing Bedaquinoline in the treatment of drug-resistant tuberculosis is good,and no major adverse drug events have occurred,which is worthy of clinical application.