含贝达喹啉方案治疗南宁市耐多药/利福平耐药肺结核患者成本效果分析:一项回顾性队列研究

doi:10.19982/j.issn.1000-6621.20240553

中国防痨杂志 ›› 2025, Vol. 47 ›› Issue (7): 914-920.doi: 10.19982/j.issn.1000-6621.20240553

含贝达喹啉方案治疗南宁市耐多药/利福平耐药肺结核患者成本效果分析:一项回顾性队列研究

韦柳迎¹, 荆玮², 刘志峰³, 聂文娟², 黄献珍¹, 黄连飘¹, 班凤婷¹, 林艳荣¹, 阳世雄⁴(), 朱庆东¹()

¹ 南宁市第四人民医院结核科,南宁 530023
² 首都医科大学附属北京胸科医院结核一科,北京 101149
³ 首都医科大学附属北京胸科医院急诊科,北京 101149
⁴ 南宁市第四人民医院医院办公室,南宁 530023

收稿日期:2024-12-09 出版日期:2025-07-10 发布日期:2025-07-03
通信作者: 朱庆东,Email:zhuqingdong2003@163.com; 阳世雄,Email:13407719256@163.com
基金资助:
南宁市科学研究与技术开发计划项目(20213025-3);广西壮族自治区卫生健康委员会自然科学项目(Z20211324);北京医管局“青苗人才”项目(QML20231606)

Cost-effectiveness analysis of bedaquiline-containing regimens for the treatment of patients with multidrug/rifampicin-resistant pulmonary tuberculosis in Nanning: a retrospective cohort study

Wei Liuying¹, Jing Wei², Liu Zhifeng³, Nie Wenjuan², Huang Xianzhen¹, Huang Lianpiao¹, Ban Fengting¹, Lin Yanrong¹, Yang Shixiong⁴(), Zhu Qingdong¹()

¹ Department of Tuberculosis, Nanning Fourth People’s Hospital, Nanning 530023, China
² The First Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China
³ Department of Emergency, Beijing Chest Hospital, Capital Medical University, Beijing 101149, China
⁴ Hospital Office, Nanning Fourth People’s Hospital, Nanning 530023, China

Received:2024-12-09 Online:2025-07-10 Published:2025-07-03
Contact: Zhu Qingdong,Email:zhuqingdong2003@163.com; Yang Shixiong,Email:13407719256@163.com
Supported by:
Nanning Science Research and Technology Development Program(20213025-3);Natural Science Project of Guangxi Zhuang Autonomous Region Health Commission(Z20211324);“Young talents” Program of Beijing Hospitals Authority(QML20231606)

摘要/Abstract

摘要：

目的:评估广西壮族自治区南宁市使用含贝达喹啉方案治疗耐多药/利福平耐药肺结核患者的疗效、安全性及成本效果。方法:纳入2019年1月至2024年1月在南宁市第四人民医院收治的成年耐多药/利福平耐药肺结核患者。根据患者的治疗方案分为传统长疗程方案组(传统组)和含贝达喹啉方案组(贝达喹啉组)。收集患者的人口学特征、治疗过程、治疗结果、不良反应和治疗费用等数据,进行统计分析。结果:研究共纳入521例患者,其中贝达喹啉组134例,传统组387例。贝达喹啉组治疗结局良好的比例为82.1%(110/134),明显高于传统组的63.3%(245/387),差异有统计学意义(χ²=16.173,P=0.001)。贝达喹啉组的不良反应发生率为31.3%(42/134),与传统组的35.4%(137/387)相比,差异无统计学意义(χ²=0.726,P=0.394)。贝达喹啉组无死亡患者,传统组有24例患者死亡。传统组失访率为24.0%(93/387),明显高于贝达喹啉组的12.7%(17/134),差异有统计学意义(χ²=7.691,P=0.006)。贝达喹啉组的治疗费用为11.0 (10.2,11.8)万元,明显高于传统组的6.6 (6.1, 7.7)万元,差异有统计学意义(Z=75078.000,P=0.001)。成本效果分析显示,传统组每成功治疗1例患者所需的医疗费用为10.6万元,贝达喹啉组为13.4万元。结论:贝达喹啉治疗成本较高,成本效果高于传统治疗,但是治疗成功率也相对较高,安全性良好,是治疗利福平耐药肺结核患者的新选择。

关键词: 结核, 抗多种药物性, 贝达喹啉, 费用效益分析, 治疗学, 回顾性研究

Abstract:

Objective: To evaluate the efficacy, safety, and cost-effectiveness of bedaquiline-containing regimens for the treatment of multidrug/rifampicin-resistant tuberculosis (TB) patients in Nanning, Guangxi Zhuang Autonomous Region. Methods: Adult multidrug/rifampicin-resistant TB patients admitted to the Fourth People’s Hospital of Nanning from January 2019 to January 2024 were included. Patients were divided into two groups based on their treatment regimens: the conventional long-course regimen group (conventional group) and the bedaquiline-containing regimen group (bedaquiline group). Data on patients’ demographic characteristics, treatment process, treatment outcomes, adverse reactions, and treatment costs were collected and analyzed statistically. Results: A total of 521 patients were included in the study, with 134 in the bedaquiline group and 387 in the conventional group. The proportion of patients with favorable treatment outcomes in the bedaquiline group was 82.1% (110/134), significantly higher than that in the conventional group (63.3%, 245/387), with a statistically significant difference (χ²=16.173, P=0.001). The incidence of adverse reactions in the bedaquiline group was 31.3% (42/134), which was not significantly different from that in the conventional group (35.4%, 137/387)(χ²=0.726, P=0.394). There were no deaths in the bedaquiline group, while 24 patients died in the conventional group. The loss-to-follow-up rate in the conventional group was 24.0% (93/387), significantly higher than that in the bedaquiline group (12.7%, 17/134), with a statistically significant difference (χ²=7.691, P=0.006). The median treatment cost in the bedaquiline group was 11.0 (10.2,11.8) ten thousand yuan, significantly higher than that in the conventional group 6.6 (6.1, 7.7) ten thousand yuan, with a statistically significant difference (Z=75078.000, P=0.001). Cost-effectiveness analysis showed that the medical cost per successfully treated patient was 106000 yuan in the conventional group and 134000 yuan in the bedaquiline group. Conclusion: Although the treatment cost of bedaquiline is relatively high, its success rate is also relatively high, and its safety is good. It can provide more treatment options for rifampicin-resistant TB patients.

Key words: Tuberculosis, multidrug-resistant, Bedaquiline, Cost-benefit analysis, Therapeutics, Retrospective studies

中图分类号:

R521

韦柳迎, 荆玮, 刘志峰, 聂文娟, 黄献珍, 黄连飘, 班凤婷, 林艳荣, 阳世雄, 朱庆东. 含贝达喹啉方案治疗南宁市耐多药/利福平耐药肺结核患者成本效果分析:一项回顾性队列研究[J]. 中国防痨杂志, 2025, 47(7): 914-920. doi: 10.19982/j.issn.1000-6621.20240553

Wei Liuying, Jing Wei, Liu Zhifeng, Nie Wenjuan, Huang Xianzhen, Huang Lianpiao, Ban Fengting, Lin Yanrong, Yang Shixiong, Zhu Qingdong. Cost-effectiveness analysis of bedaquiline-containing regimens for the treatment of patients with multidrug/rifampicin-resistant pulmonary tuberculosis in Nanning: a retrospective cohort study[J]. Chinese Journal of Antituberculosis, 2025, 47(7): 914-920. doi: 10.19982/j.issn.1000-6621.20240553

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特征	传统组(387例)	贝达喹啉组(134例)	统计检验值	P值
性别[例(构成比,%)]			χ²=0.463	0.496
男性	292(75.5)	105(78.4)
女性	95(24.5)	29(21.6)
年龄范围(岁)	14~82	15~72
平均年龄(岁,$\bar{x}±s$)	43.8±15.6	42.4±13.1	t=0.945	0.173
体质量指数范围	12.0~33.0	12.6~27.1
平均体质量指数($\bar{x}±s$)	19.2±4.0	20.6±3.4	t=1.258	0.335
吸烟史[例(发生率,%)]	180(46.5)	58(43.3)	χ²=3.206	0.073
饮酒史[例(发生率,%)]	157(40.6)	49(36.6)	χ²=2.636	0.268
白蛋白范围(g/L)	19.8~51.8	20.2~49.4
平均白蛋白水平(g/L,$\bar{x}±s$)	37.5±4.7	38.4±5.6	t=―1.936	0.053
耐药种类[例(构成比,%)]			χ²=0.722	0.697
利福平耐药	17(4.4)	7(5.2)
耐多药	270(69.8)	97(72.4)
广泛耐药	100(25.8)	30(22.4)
既往治疗史[例(发生率,%)]	309(79.8)	104(77.6)	χ²=0.302	0.583
合并症[例(发生率,%)]
糖尿病	63(16.3)	23(17.2)	χ²=0.190	0.663
乙型肝炎	27(7.0)	9(6.7)	χ²=0.010	0.918
肺部空洞[例(发生率,%)]	279(72.1)	106(79.1)	χ²=2.537	0.111

治疗结局	传统组			贝达喹啉组			χ²值^a	P值^a
治疗结局	小计 (387例)	A组 (217例)	B组 (170例)	小计 (134例)	C组 (75例)	D组 (59例)	χ²值^a	P值^a
良好结局	245(63.3)	129(59.4)	114(67.1)	110(82.1)	61(81.3)	49(83.1)	16.173	0.001
治愈	152(39.3)	79(36.4)	72(42.4)	65(48.5)	36(48.0)	29(49.2)	3.490	0.062
完成治疗	93(24.0)	50(23.0)	42(24.7)	45(33.6)	25(33.3)	20(33.9)	4.663	0.031
不良结局	142(36.7)	88(40.6)	56(32.9)	24(17.9)	14(18.7)	10(16.9)	16.173	0.001
治疗失败	25(6.5)	15(6.9)	12(7.1)	7(5.2)	4(5.3)	3(5.1)	0.264	0.608
死亡	24(6.2)	15(6.9)	9(5.3)	0(0.0)	0(0.0)	0(0.0)	8.711	0.003
失访	93(24.0)	58(26.7)	35(20.6)	17(12.7)	10(13.3)	7(11.9)	7.691	0.006

不良反应	传统组(387例)			贝达喹啉组(134例)			χ²值^a	P值^a
不良反应	例数	发生率(%)	起数	例数	发生率(%)	起数	χ²值^a	P值^a
皮肤变色	57	14.7	57	17	12.7	17	0.341	0.559
肝损伤	36	9.3	57	10	7.5	19	0.418	0.518
高尿酸血症	18	4.7	26	5	3.7	10	0.200	0.655
白细胞减少	10	2.6	20	3	2.2	7	0.049	0.825
胃肠道反应	4	1.0	15	2	1.5	7	0.184	0.668
QT间期延长	5	1.3	16	1	0.7	4	0.260	0.610
精神症状	2	0.5	7	1	0.7	3	0.092	0.762
其他^b	5	1.3	20	3	2.2	9	0.590	0.442
合计	137	35.4	218	42	31.3	76	0.726	0.394

分组	费用合计 [万元, M(Q₁,Q₃)]	药品费用 [万元, M(Q₁,Q₃)]	检验检查费用 [万元, M(Q₁,Q₃)]	不良反应治疗费用[万元, M(Q₁,Q₃)]	良好结局率 (%)	成本/效果 (万元/例)
传统组	6.6(6.1,7.7)	5.2(4.7,5.9)	0.5(0.4,0.6)	0.9(0.8,1.0)	63.3	10.6
A组	6.0(5.9,6.8)	4.6(4.3,5.6)	0.4(0.3,0.5)	0.9(0.7,1.1)	59.3	10.3
B组	7.9(6.2,8.2)	6.5(5.9,6.8)	0.4(0.3,0.5)	0.8(0.6,1.0)	67.3	11.9
贝达喹啉组	11.0(10.2,11.8)	10.3(9.5,11.1)	0.4(0.3,0.4)	0.4(0.3,0.4)	82.1	13.4
C组	10.6(9.8,11.6)	9.9(9.6,11.2)	0.3(0.3,0.5)	0.3(0.2,0.4)	80.3	13.3
D组	11.6(9.9,12.1)	11.1(9.7,11.6)	0.3(0.3,0.4)	0.2(0.2,0.3)	83.9	13.9

含贝达喹啉方案治疗南宁市耐多药/利福平耐药肺结核患者成本效果分析:一项回顾性队列研究

Cost-effectiveness analysis of bedaquiline-containing regimens for the treatment of patients with multidrug/rifampicin-resistant pulmonary tuberculosis in Nanning: a retrospective cohort study

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