B-Pa-L/M方案治疗利福平耐药肺结核的安全性分析

doi:10.19982/j.issn.1000-6621.20260364

中国防痨杂志 ›› 2026, Vol. 48 ›› Issue (10): 1487-1496.doi: 10.19982/j.issn.1000-6621.20260364

B-Pa-L/M方案治疗利福平耐药肺结核的安全性分析

江文欣¹, 张向荣², 唐佩军³, 秦志华⁴, 高春景⁵, 张设⁶, 赵新国⁷, 竺丽梅¹, 刘巧¹()

¹ 江苏省疾病预防控制中心慢性传染病防制所, 南京 210009
² 南京市第二医院汤山分院结核五科, 南京 211113
³ 苏州市第五人民医院肺科, 苏州 215007
⁴ 南通市第六人民医院结核科, 南通 226011
⁵ 徐州市第七人民医院结核一科, 徐州 221004
⁶ 扬州市第三人民医院结核一科, 扬州 225200
⁷ 无锡市第五人民医院肺病科, 无锡 214000

收稿日期:2026-06-23 出版日期:2026-10-10 发布日期:2026-09-30
通信作者: 刘巧,Email:liuqiaonjmu@163.com
基金资助:
国家自然科学基金(82574173);国家自然科学基金(82003516);江苏省自然科学基金面上项目(BK20251958);江苏省“十四五”流行病学重点学科(ZDXK202250)

Safety analysis of the B-Pa-L/M regimen for rifampicin-resistant pulmonary tuberculosis

Jiang Wenxin¹, Zhang Xiangrong², Tang Peijun³, Qin Zhihua⁴, Gao Chunjing⁵, Zhang She⁶, Zhao Xinguo⁷, Zhu Limei¹, Liu Qiao¹()

¹ Department of Chronic Infectious Disease Control, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China
² Department of Tuberculosis V, Tangshan Branch of Nanjing Second Hospital, Nanjing 211113, China
³ Department of Pulmonary Medicine, The Fifth People’s Hospital of Suzhou, Suzhou 215007, China
⁴ Department of Tuberculosis, The Sixth People’s Hospital of Nantong, Nantong 226011, China
⁵ Department of Tuberculosis I, The Seventh People’s Hospital of Xuzhou, Xuzhou 221004, China
⁶ Department of Tuberculosis I, The Third People’s Hospital of Yangzhou, Yangzhou 225200, China
⁷ Department of Pulmonary Medicine, The Fifth People’s Hospital of Wuxi, Wuxi 214000, China

Received:2026-06-23 Online:2026-10-10 Published:2026-09-30
Contact: Liu Qiao, Email: liuqiaonjmu@163.com
Supported by:
National Nature Science Foundation of China(82574173);National Nature Science Foundation of China(82003516);Jiangsu Provincial Natural Science Foundation(BK20251958);Jiangsu Provincial Medical Key Discipline(ZDXK202250)

摘要/Abstract

摘要：

目的: 评价B-Pa-L/M方案(B:贝达喹啉;Pa:普托马尼;L:利奈唑胺;M:莫西沙星)治疗利福平耐药肺结核(rifampicin-resistant pulmonary tuberculosis,RR-PTB)患者的安全性,并结合初步疗效指标分析其在我国真实世界临床实践中的应用效果。方法: 采用多中心真实世界观察性研究方法,纳入2025年4—8月江苏省6家结核病定点医院接受B-Pa-L/M方案治疗的RR-PTB患者。收集患者基线资料及治疗过程中临床症状、实验室检查、心电图及影像学随访资料,采用美国国家癌症研究所《常见不良事件评价标准》(Common Terminology Criteria for Adverse Events,CTCAE)5.0版对不良事件进行分级。分析不良事件发生情况、严重程度及药物调整情况,并描述细菌学阴转情况及治疗结局。结果: 共纳入51例患者,其中1例因胃肠道反应于治疗早期退出,其余患者均按疗程进行治疗。6例(12.0%)发生≥3级不良事件。血液学毒性、Fridericia校正QT间期(Fridericia-corrected QT interval,QTcF)延长和肝功能异常是最常见的不良事件,发生率分别为46.0%(23/50)、34.0%(17/50)和32.0%(16/50)。治疗期间14例(28.0%,14/50)患者因不良反应进行药物调整,其中4例减量、8例暂停用药、1例更换药物,仅1例因严重胃肠道反应退出治疗。治疗期间发生的98例次不良事件中,90.8%(89/98)的不良事件经剂量调整、短暂停药及对症处理后可缓解,仅9.2%(9/98)的不良事件因不良反应导致永久停药或退出治疗。总体治疗成功率为92.0%(46/50);细菌学阴转分析显示,治疗2个月末痰涂片和痰培养阴转率分别为90.6%(29/32)和100.0%(36/36)。结论: B-Pa-L/M方案在RR-PTB患者治疗中表现出较好的临床疗效及可管理的安全性。虽然不良事件发生较为常见,但多数为轻中度反应,经积极监测及个体化处理后患者仍能够维持治疗并获得较高的治疗成功率。

关键词: 结核, 利福平, 抗药性, 药物副反应, 治疗结果

Abstract:

Objective: To evaluate the safety of the B-Pa-L/M regimen in patients with rifampicin-resistant pulmonary tuberculosis (RR-PTB) and to assess its effectiveness in real-world clinical practice in China based on preliminary treatment outcomes. Methods: A multicenter real-world observational study was conducted among patients with RR-PTB who received the B-Pa-L/M regimen at six designated tuberculosis hospitals in Jiangsu Province, between April and August 2025. Baseline characteristics and follow-up data, including clinical manifestations, laboratory findings, electrocardiographic examinations, and radiological assessments, were collected. Adverse events (AEs) were graded according to version 5.0 of the Common Terminology Criteria for Adverse Events (CTCAE) issued by the U.S. National Cancer Institute. The incidence, severity, and management of AEs were analyzed, and bacteriological conversion and treatment outcomes were evaluated. Results: A total of 51 patients were enrolled, of whom one withdrew from treatment during the early treatment phase because of severe gastrointestinal adverse reactions, whereas the remaining patients continued treatment according to the planned regimen. Grade ≥3 AEs occurred in six patients (12.0%). Hematologic toxicity, Fridericia-corrected QT interval (QTcF) prolongation, and liver function abnormalities were the most common AEs, occurring in 46.0% (23/50), 34.0% (17/50), and 32.0% (16/50) of patients, respectively. During treatment, 14 patients (28.0%, 14/50) required treatment modification because of AEs, including dose reduction in four patients, temporary drug interruption in eight, and drug substitution in one; only one patient withdrew from treatment because of severe gastrointestinal toxicity. Among the 98 AE episodes recorded during treatment, 90.8% (89/98) resolved following dose adjustment, temporary drug interruption, or supportive treatment, whereas 9.2% (9/98) resulted in permanent discontinuation of the implicated drug or withdrawal from treatment. The overall treatment success rate was 92.0% (46/50). At the end of month 2, the sputum smear and culture conversion rates were 90.6% (29/32) and 100.0% (36/36), respectively. Conclusion: The B-Pa-L/M regimen demonstrated favorable clinical effectiveness and a manageable safety profile in patients with RR-PTB. Although AEs were common, most were mild to moderate and could be effectively managed through active safety monitoring and individualized interventions, enabling most patients to complete treatment and achieve a high treatment success rate.

Key words: Tuberculosis, Rifampicin, Drug resistance, Adverse drug reaction, Treatment outcome

中图分类号:

R521

江文欣, 张向荣, 唐佩军, 秦志华, 高春景, 张设, 赵新国, 竺丽梅, 刘巧. B-Pa-L/M方案治疗利福平耐药肺结核的安全性分析[J]. 中国防痨杂志, 2026, 48(10): 1487-1496. doi: 10.19982/j.issn.1000-6621.20260364

Jiang Wenxin, Zhang Xiangrong, Tang Peijun, Qin Zhihua, Gao Chunjing, Zhang She, Zhao Xinguo, Zhu Limei, Liu Qiao. Safety analysis of the B-Pa-L/M regimen for rifampicin-resistant pulmonary tuberculosis[J]. Chinese Journal of Antituberculosis, 2026, 48(10): 1487-1496. doi: 10.19982/j.issn.1000-6621.20260364

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特征	例数	构成比(%)
低体质量指数(<18.5kg/m²)^a(%)	13	26.0
性别
男性	39	78.0
女性	11	22.0
吸烟史^a	26	52.0
饮酒史^a	25	50.0
合并糖尿病^a	11	22.0
合并高血压^a	10	20.0
入组方案
B-Pa-L	12	24.0
B-Pa-L-M	38	76.0
耐药类型
RR-PTB	19	38.0
MDR-PTB	19	38.0
pre-XDR-PTB	12	24.0
患者分类
新患者	30	60.0
复发患者	11	22.0
治疗失败患者	9	18.0
基线痰涂片阳性^a	32	64.0
基线痰培养阳性^a	36	72.0

不良事件	合计	1~2级	≥3级
QTcF延长	17(34.0)	16(32.0)	1(2.0)
白细胞减少	11(22.0)	10(20.0)	1(2.0)
贫血	17(34.0)	15(30.0)	2(4.0)
血小板减少	9(18.0)	9(18.0)	0(0.0)
恶心	8(16.0)	8(16.0)	0(0.0)
呕吐	3(6.0)	3(6.0)	0(0.0)
胃痛	3(6.0)	3(6.0)	0(0.0)
头晕	1(2.0)	1(2.0)	0(0.0)
周围神经病变	3(6.0)	3(6.0)	0(0.0)
视物模糊	1(2.0)	1(2.0)	0(0.0)
ALT升高	15(30.0)	13(26.0)	2(4.0)
AST升高	10(20.0)	9(18.0)	1(2.0)

不良事件分类	包含的具体不良事件	例数	发生率 (%)
血液学毒性	贫血、白细胞减少、血小板减少	23	46.0
QTcF延长	QTcF延长	17	34.0
肝功能异常	ALT升高、AST升高	16	32.0
胃肠道反应	恶心、呕吐、胃痛、胃肠道不适	9	18.0
神经系统损伤	周围神经病变、视物模糊、头晕	5	10.0

B-Pa-L/M方案治疗利福平耐药肺结核的安全性分析

Safety analysis of the B-Pa-L/M regimen for rifampicin-resistant pulmonary tuberculosis

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指标	例数	发生率(%)
发生≥3级不良事件	6	12.0
因不良反应进行药物调整	14	28.0
因不良反应药物减量	4	8.0
因不良反应更换药物	1	2.0
因不良反应停用药物	8	16.0
因不良反应退组	1	2.0

不良反应类型	调整药物	调整方式	例数
胃肠道反应	莫西沙星	停药	3
胃肠道反应	未说明	退组	1
胃肠道反应	未说明	自行停药/治疗中断	1
肝功能损伤	莫西沙星	换药 (改用左氧氟沙星)	1
肝功能损伤	莫西沙星	停药	1
头晕	莫西沙星	停药	1
QTcF间期延长	莫西沙星	停药	1
血细胞减少	利奈唑胺	减量	3
血细胞减少	利奈唑胺	停药	1
视物模糊	利奈唑胺	减量	1
双下肢麻木	利奈唑胺	减量	1
脚麻	利奈唑胺	停药	1

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