含贝达喹啉方案治疗利福平耐药结核病患者QTc间期>500ms的危险因素分析OA
Risk factors for QTc interval>500 ms in patients with rifampicin-resistant tuberculosis treated with bedaquiline-containing regimens
目的:探讨含贝达喹啉(bedaquiline,Bdq)方案治疗利福平耐药结核病(rifampicin-resistant tubercu-losis,RR-TB)患者发生QTc间期>500ms的危险因素,为临床早期识别高危人群提供依据.方法:采取多中心回顾性队列研究,收集2018年2月至2025年12月首都医科大学附属北京胸科医院和陕西省结核病防治院收治的521例接受含贝达喹啉方案治疗的RR-TB患者的临床资料.以治疗开始首次出现QTc间期>500 ms的时间为时间变量,以单次心电图测量QTc>500 ms为终点事件,采用Cox比例风险模型分析相关影响因素.结果:多因素Cox比例风险模型分析显示,450 ms≤基线QTc<500 ms(aHR=6.640,95%CI:3.540~12.450)、合并心脏病史(aHR=5.840,95%CI:2.600~13.120)、合用氯法齐明(clofazimine,Cfz)(aHR=3.322,95%CI:1.247~8.855)、合用德拉马尼(delamanid,Dlm)(aHR=1.920,95%CI:1.040~3.550)、三药联合使用(Bdq+Cfz+Dlm)(aHR=3.770,95%CI:1.320~10.790)为 QTc>500ms 的独立危险因素.结论:450ms≤基线 QTc<500ms、既往心脏病史、联合使用Cfz或Dlm、三药联合使用(Bdq+Cfz+Dlm)均显著增加RR-TB患者QTc>500 ms的发生风险.建议对上述高危人群加强心电图监测,制定个体化治疗方案.
Objective:To investigate the risk factors for QTc interval>500 ms in patients with rifampicin-resistant tuberculosis(RR-TB)treated with bedaquiline(Bdq)-containing regimens,and to provide evidence for early identification of high-risk populations in clinical practice.Methods:A multicenter retrospective cohort study was conducted.Clinical data of 521 RR-TB patients treated with Bdq-containing regimens admitted to Beijing Chest Hospital Affiliated to Capital Medical University and Shaanxi Provincial Tuberculosis Prevention and Control Hospital from February 2018 to December 2025 was collected.The time from treatment initiation to the first occurrence of QTc interval>500 ms was used as the time variable,and a single electrocardiographic measurement of QTc>500 ms was defined as the endpoint event.Cox proportional hazards model was employed to analyze the relevant influencing factors.Results:Multivariable Cox regression analysis revealed that baseline QTc being 450-500 ms(adjusted hazard ratio(aHR)=6.640,95%confidence interval(CI):3.540-12.450),history of cardiac disease(aHR=5.840,95%CI:2.600-13.120),concurrent use of clofazimine(Cfz)(aHR=3.322,95%CI:1.247-8.855),concurrent use of delamanid(Dlm)(aHR=1.920,95%CI:1.040-3.550),triple-drug combination therapy(Bdq+Cfz+Dlm)(aHR=3.770,95%CI:1.320-10.790)were independent risk factors for QTc>500 ms.Conclusion:Baseline QTc being 450-500 ms,prior history of cardiac disease,concurrent use of Cfz or Dlm,triple-drug combination therapy(Bdq+Cfz+Dlm)all significantly increase the risk of QTc>500 ms in RR-TB patients.Enhanced electrocardiographic monitoring and individualized treatment strategies are recommended for these high-risk populations.
矫晓克;董可鑫;杨新亮;聂文娟
首都医科大学附属北京胸科医院/北京市结核病胸部肿瘤研究所结核一科,北京 101149首都医科大学附属北京胸科医院/北京市结核病胸部肿瘤研究所结核一科,北京 101149陕西省结核病防治院结核科,西安 710105首都医科大学附属北京胸科医院/北京市结核病胸部肿瘤研究所结核一科,北京 101149
医药卫生
贝达喹啉结核抗药性因素分析,统计学
BedaquilineTuberculosisDrug resistanceFactor analysis,statistical
《中国防痨杂志》 2026 (7)
992-999,8
国家重点研发计划项目(2024YFC2311200)北京市卫生健康委员会登峰项目(G202511062)北京市卫健委研究型病房卓越临床研究计划(BRWEP2024W042160100)北京市通州区科技计划项目(WS2025017)广州国家实验室专项结核病短程治疗方案开发(GZNL2024A01030) National Key Research and Development Program of China(2024YFC2311200)Beijing Municipal Health Commission Dengfeng Program(G202511062)Beijing Municipal Health Commission Excellent Clinical Research Program for Research-Oriented Wards(BRWEP2024W042160100)Beijing Tongzhou District Science and Technology Program Project(WS2025017)Guangzhou National Laboratory Special Profect:Development of Short-Course Regimens for Tuberculosis Treatment(GZNL2024A01030)
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