Clinical cohort analysis of the efficacy and safety of extended-course bedaquiline in patients with multidrug-resistant/rifampicin-resistant pulmonary tuberculosis

doi:10.19982/j.issn.1000-6621.20250372

Abstract

Abstract:

Objective: To evaluate the efficacy and safety of extended-course (>6 months) bedaquiline-containing regimens in the treatment of multidrug-resistant/rifampin-resistant pulmonary tuberculosis (MDR/RR-PTB). Methods: Patients with MDR/RR-PTB treated at Beijing Chest Hospital, Capital Medical University, between January 1, 2020 and January 1, 2024 were included in this cohort study. Outcomes were compared between patients receiving a standard course (≤6 months) and those receiving an extended course (>6 months) of bedaquiline-containing combination regimens. The treatment completion rate and the incidence of adverse events were recorded. Multivariable logistic regression was used to analyze factors associated with a Fridericia-corrected QT interval (QTcF) >500 ms. Results: A total of 126 patients were included in the study. Among them, 75 patients (59.5%) were assigned to the standard group, while 51 patients (40.5%) were assigned to the extended group. No serious cardiac adverse events were observed in either the standard-course or extended-course group. There was no statistically significant difference between the two groups in the proportion of favorable treatment outcomes (standard vs. extended: 86.7% (65/75) vs. 88.2% (45/51)), the difference was statistically significant (χ²=0.043, P=0.835). Likewise, the incidences of QTcF 450-500 ms (standard vs. extended: 37.3% (28/75) vs. 43.1% (22/51)) and QTcF >500 ms (standard vs. extended: 10.7% (8/75) vs. 9.8% (5/51)) did not differ significantly between the two groups (χ²=1.851, P=0.173; χ²=0.414, P=0.521). Multivariable analysis showed that a history of cardiac disease (OR=6.50, 95%CI: 1.52-27.80) was risk factor for QTcF prolongation (>500 ms). Conclusion: For patients with multidrug-resistant/rifampicin-resistant pulmonary tuberculosis, extended-course use of bedaquiline demonstrates good overall efficacy and safety, with no observed increase in the risk of serious adverse events.

Key words: Tuberculosis, Bedaquiline, Drug toxicity, Treatment outcomes, Factor analysis, statistical

CLC Number:

R521
R453

Wang Jing, Jing Wei, Li Weiwen, Zhu Qingdong, Pang Yu, Chu Naihui, Nie Wenjuan. Clinical cohort analysis of the efficacy and safety of extended-course bedaquiline in patients with multidrug-resistant/rifampicin-resistant pulmonary tuberculosis[J]. Chinese Journal of Antituberculosis, 2026, 48(3): 313-319. doi: 10.19982/j.issn.1000-6621.20250372

Figures/Tables 5

References 19

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临床特征	标准组(75例)	延长组(51例)	统计检验值	P值
年龄(岁, $\bar{x}±s$)	37.5±15.5	34.5±13.2	t=1.170	0.321
性别[例(构成比,%)]			χ²=0.252	0.616
男性	47(62.7)	30(58.8)
女性	28(37.3)	21(41.2)
既往治疗史[例(构成比,%)]			χ²=0.105	0.746
有	51(68.0)	36(70.6)
无	24(32.0)	15(29.4)
吸烟史[例(构成比,%)]			χ²=0.090	0.764
有	26(34.7)	19(37.3)
无	49(65.3)	32(62.7)
饮酒史[例(构成比,%)]			χ²=0.375	0.540
有	23(30.7)	18(35.3)
无	52(69.3)	33(64.7)
心脏病病史[例(构成比,%)]			χ²=0.028	1.000
有	5(6.7)	3(5.9)
无	70(93.3)	48(94.1)
合并抗结核药物[例(合并治疗率,%)]
德拉马尼	14(18.7)	10(19.6)	χ²=0.016	0.900
氯法齐明	70(93.3)	45(88.2)	χ²=0.744	0.388
莫西沙星	24(32.0)	12(23.5)	χ²=1.115	0.291
左氧氟沙星	30(40.0)	14(27.5)	χ²=2.484	0.115

治疗结局	标准组(75例)	延长组(51例)	χ²值	P值
良好结局	65(86.7)	45(88.2)	0.043	0.835
治愈	55(73.3)	35(68.6)	0.329	0.566
完成治疗	10(13.3)	10(19.6)	0.878	0.349
不良结局	10(13.3)	6(11.8)	0.043	0.835
治疗失败	6(8.0)	4(7.8)	0.001	1.000
失访	3(4.0)	1(2.0)	0.411	0.521
死亡	1(1.3)	1(2.0)	0.014	1.000

不良反应	标准组(75例)	延长组(51例)	χ²值	P值
QTcF>500ms	8(10.7)	5(9.8)	0.414	0.521
QTcF 450~500ms	28(37.3)	22(43.1)	1.851	0.173
肝功能异常	25(33.3)	13(25.5)	1.370	0.243
消化道反应	11(14.7)	7(13.7)	0.001	0.972
周围神经病变	8(10.7)	4(7.8)	0.061	0.807
心肌酶异常	1(1.3)	0(0.0)	0.993	0.411

因素	QTcF>500ms (13例)	QTcF≤500ms (113例)	β值	s $\bar{x}$值	Wald χ²值	OR值	95%CI值	P值
性别[例(构成比,%)]
男性	8(61.5)	69(61.1)	1.00
女性	5(38.5)	44(38.9)	0.03	0.57	0.00	1.03	0.34~3.09	0.956
年龄组[例(构成比,%)]
18~44岁	8(61.5)	80(70.8)	1.00
45~59岁	4(30.8)	23(20.4)	0.53	0.63	0.72	1.70	0.49~5.89	0.397
≥60岁	1(7.7)	10(8.8)	―0.09	1.09	0.01	0.91	0.10~8.53	0.934
治疗史[例(构成比,%)]
初治	2(15.4)	37(32.7)	1.00
复治	11(84.6)	76(67.3)	0.73	0.77	0.90	2.07	0.46~9.29	0.343
心脏病病史[例(构成比,%)]
无	9(69.2)	109(96.5)	1.00
有	4(30.8)	4(3.5)	1.87	0.74	6.41	6.50	1.52~27.80	0.011
应用贝达喹啉时间[例(构成比,%)]
标准组	8(61.5)	67(59.3)	1.00
延长组	5(38.5)	46(40.7)	0.07	0.59	0.01	1.07	0.34~3.32	0.900
合并用药[例(构成比,%)]
德拉马尼
无	12(92.3)	80(70.8)	1.00
有	1(7.7)	33(29.2)	―1.60	1.04	2.39	0.20	0.03~1.52	0.122
左氧氟沙星
无	7(53.8)	75(66.4)	1.00
有	6(46.2)	38(33.6)	0.36	0.60	0.36	1.44	0.44~4.68	0.547
莫西沙星
无	7(53.8)	83(73.5)	1.00
有	6(46.2)	30(26.5)	0.65	0.60	1.17	1.91	0.59~6.15	0.280
氯法齐明
无	1(7.7)	11(9.7)	1.00
有	12(92.3)	102(90.3)	0.25	1.09	0.05	1.29	0.15~10.80	0.820