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

doi:10.19982/j.issn.1000-6621.20260460

Abstract

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

CLC Number:

R521

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

Figures/Tables 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