【摘要】 目的 评价含贝达喹啉方案治疗耐多药肺结核患者发生QT间期延长的临床特点及可能的危险因素，为耐多药肺结核患者的安全用药和合理监测提供临床依据。方法 选取2019年3月～2024年4月期间在广州市胸科医院明确诊断为耐多药肺结核的193例患者为研究对象，所有患者均接受含贝达喹啉方案治疗，治疗后第2、4、8、12、16、20、24周进行随访，包括心电图基于Fridericia公式校正心率后的QT间期（QTc F）、血清电解质、合并用药等，分析QTc F变化以及可能相关的影响因素。结果 治疗过程中监测心电图最大QTc F值与基线差值（△QTc F）变化情况：193例患者中有61例（31.61%）△QTc F <30 ms;94例（48.70%）30 ms≤△QTc F <60 ms;38例（19.69%）△QTc F≥60 ms，其中有1例患者因QTc F值超过500 ms（经重复检查心电图证实）而停用贝达喹啉。各监测时间点QTc F均值与基线比较，差异均有统计学意义，所有患者均无心力衰竭发生，无死亡病例。多因素Logistic回归分析结果显示，合用氯法齐明（OR=4.510,95%CI:1.250～16.274,P=0.021）、治疗期间发生低钾血症（OR=28.984,95%CI:2.404～349.434,P=0.008）是使用含贝达喹啉方案治疗耐多药肺结核患者发生QT间期明显延长（△QTc F≥60 ms）的危险因素。结论 QT间期延长在含贝达喹啉方案治疗的耐药结核病患者中较常见，但因此停药及严重心脏不良事件的发生率低，联合使用氯法齐明或治疗过程中出现低钾血症将增加QT间期延长的风险。在使用含贝达喹啉方案时，需密切监测QT间期和相关症状，在严格的临床管理下，其总体风险可控。更多还原

【Abstract】 Objective To evaluate the clinical characteristics and possible risk factors of QT interval prolongation in patients with multidrugresistant tuberculosis(MDR-TB) treated with bedaquiline-containing regimens, and to provide a clinical basis for safe medication and reasonable monitoring of MDR-TB patients. Methods From March 2019 to April 2024, 193 patients with MDR-TB diagnosed in Guangzhou Chest Hospital were treated with bedaquiline-containing regimens, and were followed up at the 2nd, 4th, 8th, 12th, 16th, 20th, and 24th weeks after treatment, including the ECG is based on the QT interval after heart rate correction based on Fridericia’s formula(QTc F), serum electrolytes, and concomitant medications, the changes of QTcF and possible related influencing factors were analyzed. Results The change of the maximum QTcF value from baseline （△ QTc F） on ECG during treatment: 61 of 193 patients(31.61%) were △ QTc F < 30 ms; 94 cases(48.70%) were 30 ms ≤△ QTc F < 60 ms; 38 patients(19.69%) were△QTc F≥60 ms, of which 1 patient discontinued bedaquiline because the QTc F value exceeded 500 ms(confirmed by repeat ECG), The mean of QTc F at each monitoring time point was compared with the baseline, and the differences were statistically significant,and all patients had no heart failure and no death. The Logistic regression analysis indicated that patients combination with clofazimine [odds ratio(OR) = 4.510, 95%CI:1.250 ～ 16.274, P = 0.021)], patients with hypokalemia during treatment(OR = 28.984, 95%CI: 2.404 ～ 349.434, P = 0.008) were risk factors for QT interval prolongation in patients with MDR-TB treated with bedaquinine-containing regimens（△ QTc F ≥ 60 ms）. Conclusion QT interval prolongation is common in patients with drug-resistant tuberculosis treated with bedaquinine-containing regimens, but the incidence of drug discontinuation and serious cardiac adverse events is low, and the risk of QT interval prolongation will be increased by the combination of clofazimine or hypokalemia during treatment. The QT interval and associated symptoms need to be closely monitored for bedaquininecontaining regimens, and the overall risk is manageable under strict clinical management.更多还原