接受含普托马尼短程方案治疗的利福平耐药肺结核患者抑郁、焦虑及失眠症状评估

doi:10.19982/j.issn.1000-6621.20260460

中国防痨杂志 ›› 2026, Vol. 48 ›› Issue (10): 1531-1537.doi: 10.19982/j.issn.1000-6621.20260460

接受含普托马尼短程方案治疗的利福平耐药肺结核患者抑郁、焦虑及失眠症状评估

项静灵¹, 李嵘², 王芙蓉², 佟冬怡³, 聂文娟¹(), 庞宇⁴()

¹ 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
² 内蒙古自治区第四医院, 呼和浩特010010
³ 中国医科大学附属盛京医院麻醉科, 沈阳 110004
⁴ 北京市红十字血液中心/北京市红十字血液研究所, 北京 100088

收稿日期:2026-08-11 出版日期:2026-10-10 发布日期:2026-09-30
通信作者: 聂文娟,Email:94642975@qq.com;庞宇,Email:hlgyypy@126.com
基金资助:
北京重大呼吸道传染病研究中心课题(BJRID2025-013);北京市卫生健康委员会登峰项目(G202511062);北京市通州区科技计划项目(WS2025017);辽宁省教育厅基本科研项目(JYTMS20230105)

Assessment of depressive, anxious, and insomnia symptoms in patients with rifampicin-resistant pulmonary tuberculosis receiving a pretomanid-containing short-course regimen

Xiang Jingling¹, Li Rong², Wang Furong², Tong Dongyi³, Nie Wenjuan¹(), Pang Yu⁴()

¹ Tuberculosis Department Ⅰ, Beijing Chest Hospital, Capital Medical University, Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing 101149, China
² Inner Mongolia Fourth Hospital, Inner Mongolia Autonomous Region, Hohhot 010010, China
³ Department of Anesthesiology, Shengjing Hospital of China Medical University, Shenyang 110004, China
⁴ Beijing Red Cross Blood Center (Beijing Red Cross Blood Research Institute), Beijing 100088, China

Received:2026-08-11 Online:2026-10-10 Published:2026-09-30
Contact: Nie Wenjuan,Email:94642975@qq.com;Pang Yu, Email: hlgyypy@126.com
Supported by:
Beijing Research Center for Major Respiratory Infectious Diseases Project(BJRID2025-013);Beijing Municipal Health Commission Dengfeng Program(G202511062);Beijing Tongzhou District Science and Technology Program Project(WS2025017);Liaoning Provincial Department of Education Research Fund(JYTMS20230105)

摘要/Abstract

摘要：

目的: 研究接受含普托马尼(pretomanid,Pa)短程方案治疗的利福平耐药肺结核(rifampicin-resistant pulmonary tuberculosis,RR-PTB)患者在治疗期间的抑郁、焦虑及失眠症状的横断面筛查情况,并探索心理评估筛查阳性与治疗期间不良事件的关联。方法: 2025年3月20日至2025年11月20日纳入中国15个研究中心接受B-Pa-L/M(B:贝达喹啉;L:利奈唑胺;M:莫西沙星)方案治疗的34例RR-PTB患者。每例患者在治疗期间的一个非固定时间点接受1次患者健康问卷(patient health questionnaire-9,PHQ-9)、广泛性焦虑障碍量表(generalized anxiety disorder-7,GAD-7)和失眠严重程度指数量表(insomnia severity index,ISI)评估。分别以PHQ-9≥5分、GAD-7≥5分及ISI≥8分作为抑郁、焦虑和失眠症状筛查阳性的界值,任一量表达到上述界值定义为心理评估筛查阳性。采用患者报告和随访的方式收集治疗期间不良事件。发生与未发生不良事件患者心理评估筛查阳性比例的比较采用Fisher确切概率法检验。结果: 34例RR-PTB患者中,PHQ-9、GAD-7和ISI筛查阳性者分别为2例(5.9%)、1例(2.9%)和2例(5.9%);任一心理量表筛查阳性者共2例(5.9%)。治疗期间共有6例(17.6%)患者发生不良事件,包括双足麻木2例、贫血2例、轻度转氨酶升高1例和恶心1例,均未导致整个治疗方案中断。发生不良事件患者的心理评估筛查阳性比例为2/6。结论: 在治疗期间的一次性非固定时间点心理评估筛查中,32例接受含普托马尼短程方案治疗的RR-PTB患者未达到抑郁、焦虑或失眠症状的筛查阳性界值。发生不良事件患者的心理评估筛查阳性比例较高,提示不良事件的发生与心理量表的阳性发生率可能存在一定的关联。

关键词: 结核,肺, 普托马尼, 利福平, 药物耐受性, 抑郁, 焦虑, 失眠

Abstract:

Objective: To describe the prevalence of depressive, anxiety, and insomnia symptoms among patients with rifampicin-resistant pulmonary tuberculosis (RR-PTB) receiving a pretomanid (Pa)-containing short-course regimen and to explore the association between positive psychological symptom screening and treatment-emergent adverse events (AEs). Methods: The prospective, single-arm, multicenter study enrolled 34 RR-PTB patients from 15 centers in China between March 20, 2025 and November 20, 2025. All patients were treated with either the B-Pa-L (bedaquiline-pretomanid-linezolid) or B-Pa-L-M (bedaquiline-pretomanid-linezolid-moxifloxacin) regimen. Each patient underwent a single assessment using the Patient Health Questionnaire-9 (PHQ-9), Generalized Anxiety Disorder-7 (GAD-7), and Insomnia Severity Index (ISI) at a non-fixed time point during treatment. Cut-off values were set at PHQ-9 ≥5 for depression, GAD-7 ≥5 for anxiety, and ISI ≥8 for insomnia; positivity on any scale defined an overall positive psychological screening. AEs were collected via a standardized case report form. Fisher’s exact test was used to compare the positive screening rates between patients with and without AEs. Results: Positive screening rates were 5.9% (2/34) for PHQ-9, 2.9% (1/34) for GAD-7, and 5.9% (2/34) for ISI; only 2 patients (5.9%) screened positive on at least one scale. During treatment, 6 patients (17.6%) experienced AEs, including bilateral foot numbness (2 cases), anemia (2 cases), mild transaminase elevation (1 case), and nausea (1 case). None of these events led to permanent discontinuation of the entire treatment regimen. Among patients who experienced AEs, the positive psychological screening rate was 2/6. Conclusion: In a single, non-fixed time-point screening during therapy, the majority of RR-PTB patients treated with Pa-containing short-course regimens did not meet the threshold for clinically significant depression, anxiety, or insomnia. However, patients with adverse events had a notably higher rate of positive psychological screening, suggesting a possible correlation between psychological distress and treatment-related toxicity.

Key words: Tuberculosis, pulmonary, Pretomanid, Rifampicin, Drug resistant, Depression, Anxiety, Insomnia

中图分类号:

R521

项静灵, 李嵘, 王芙蓉, 佟冬怡, 聂文娟, 庞宇. 接受含普托马尼短程方案治疗的利福平耐药肺结核患者抑郁、焦虑及失眠症状评估[J]. 中国防痨杂志, 2026, 48(10): 1531-1537. doi: 10.19982/j.issn.1000-6621.20260460

Xiang Jingling, Li Rong, Wang Furong, Tong Dongyi, Nie Wenjuan, Pang Yu. Assessment of depressive, anxious, and insomnia symptoms in patients with rifampicin-resistant pulmonary tuberculosis receiving a pretomanid-containing short-course regimen[J]. Chinese Journal of Antituberculosis, 2026, 48(10): 1531-1537. doi: 10.19982/j.issn.1000-6621.20260460

图/表 3

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表3

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临床资料	统计值
人口学特征
男性[例(构成比,%)]	24(70.6)
女性[例(构成比,%)]	10(29.4)
年龄(岁,$\bar{x}±s$)	41.2±12.5
身高(cm,$\bar{x}±s$)	169.2±8.5
体质量(kg,$\bar{x}±s$)	60.5±14.1
BMI(kg/m²,$\bar{x}±s$)	20.8±3.7
BMI分类[例(构成比,%)]
<18.5(偏轻)	4(11.8)
18.5~23.9(正常)	25(73.5)
≥24.0(超重/肥胖)	5(14.7)
实验室检查
基线白蛋白(g/L,$\bar{x}±s$)	39.6±4.4
低白蛋白血症(<35g/L)[例(发生率,%)]	3(8.8)
治疗方案情况
联合使用莫西沙星[例(使用率,%)]	11(32.4)
精神心理状况评分
PHQ-9评分[分,M(Q₁,Q₃)]	1.0(0.0,2.0)
GAD-7评分[分,M(Q₁,Q₃)]	1.0(0.0,1.0)
ISI评分[分,M(Q₁,Q₃)]	1.5(1.0,3.0)

心理量表评分	B-Pa-L-M组(11例)	B-Pa-L组(23例)	U值	Holm校正P值
PHQ-9评分	1.0(0.5,2.0)	1.0(0.0,1.5)	142.500	0.548
GAD-7评分	1.0(1.0,2.0)	1.0(0.0,1.0)	181.000	0.076
ISI评分	2.0(1.0,4.0)	1.0(1.0,2.0)	155.500	0.548

患者序号	地区	性别	年龄 (岁)	不良事件	临床表现	发生时间 (周)	是否中断治疗	是否使用莫西沙星	转归	PHQ-9 评分	GAD-7 评分	ISI 评分
1	宁夏	女	30	双足麻木	入睡困难、睡眠不实、焦虑	20	否	有	换药	8	8	13
2	湖南	男	45	贫血	入睡困难、食欲下降	4	否	有	未停药	8	2	11
3	内蒙古	男	44	转氨酶轻度升高	无	20	否	无	未停药	0	1	0
4	新疆	女	45	贫血	无	8	否	有	未停药	1	2	1
5	郑州	女	20	恶心	无	4	否	有	未停药	0	1	1
6	河南	男	28	双足麻木	无	20	否	无	未停药	3	0	2

接受含普托马尼短程方案治疗的利福平耐药肺结核患者抑郁、焦虑及失眠症状评估

Assessment of depressive, anxious, and insomnia symptoms in patients with rifampicin-resistant pulmonary tuberculosis receiving a pretomanid-containing short-course regimen

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