Effectiveness and safety of Yujieli as a nutritional supplement in newly diagnosed, nutritionally deficient patients with rifampicin-sensitive active pulmonary tuberculosis: a multicenter, randomized, controlled clinical trial

doi:10.19982/j.issn.1000-6621.20250481

Abstract

Abstract:

Objective: To evaluate the effectiveness and safety of Yujieli^® (Isolated Protein Multi-vitamin and Mineral Special Food Powder) as a nutritional intervention in newly diagnosed active pulmonary tuberculosis patients with moderate to severe malnutrition. Methods: This is a multicenter, randomized, open-label, parallel-controlled superiority clinical trial. A total of 438 patients with newly diagnosed rifampicin-sensitive active pulmonary tuberculosis and moderate to severe malnutrition are planned to be enrolled. Participants will be randomly assigned with a 1∶1 ratio to either the study group (anti-tuberculosis therapy+conventional diet+Yujieli for 3 months) or the control group (anti-tuberculosis therapy+conventional diet). The primary effectiveness endpoint is the treatment success rate (cured+treatment completed). Secondary endpoints include sputum conversion rate and time, improvement in imaging findings, nutritional status indicators (BMI, albumin, hemoglobin, prealbumin, etc.), physical function, immune function, psychological status, and the incidence of adverse reactions. Conclusion: This study will provide high-level medical evidence for the application of the tuberculosis-specific nutritional formula “Yujieli” in newly treated active pulmonary tuberculosis patients with malnutrition and inform strategies for optimizing comprehensive tuberculosis treatment.

Key words: Tuberculosis, Malnutrition, Nutritional support, Randomized controlled research, Clinical protocol lnutrition

CLC Number:

Zeng Yi, Gao Weiwei, Shi Cuilin, Su Shifang, Wang Hua, Tang Jun, Shi Jichan, Nie Qi, Sun Yan, Cui Junwei, Yang Junjun, Fan Jiahua. Effectiveness and safety of Yujieli as a nutritional supplement in newly diagnosed, nutritionally deficient patients with rifampicin-sensitive active pulmonary tuberculosis: a multicenter, randomized, controlled clinical trial[J]. Chinese Journal of Antituberculosis, 2026, 48(7): 925-932. doi: 10.19982/j.issn.1000-6621.20250481

Figures/Tables 4

References 19

[1]	Diarra B, Cissé A B, Kodio O, et al. Screening new tuberculosis patients in Mali for rifampicin resistance at 2 months[J]. Int J Mycobacteriol, 2016, 5(suppl 1): S42-S43. doi:10.1016/j.ijmyco.2016.09.052.
[2]	屈燕, 李涛, 马文斌, 等. 世界卫生组织《2025年全球结核病报告》解读[J]. 结核与肺部疾病杂志, 2025, 6(6): 613-623. doi:10.19983/j.issn.2096-8493.20250178.
[3]	World Health Organization. WHO consolidated guidelines on tuberculosis: module 6: tuberculosis and comorbidities, 2nd ed[R]. Geneva: World Health Organization, 2025.
[4]	毛晓峰. 联合营养管理在结核监护室患者管理中的应用[J]. 中医药管理杂志, 2019, 27(8): 131-132. doi:10.16690/j.cnki.1007-9203.2019.08.064.
[5]	中国人民解放军总医院第八医学中心结核病医学部, 全军结核病研究所, 全军结核病防治重点实验室, 等. 结核病重症患者营养评估及营养支持治疗专家共识[J]. 中国防痨杂志, 2022, 44(5): 421-432. doi:10.19982/j.issn.1000-6621.20220041.
[6]	Sinha P, Lönnroth K, Bhargava A, et al. Food for thought: addressing undernutrition to end tuberculosis[J]. Lancet Infect Dis, 2021, 21(10): e318-e325. doi:10.1016/S1473-3099(20)30792-1. pmid: 33770535
[7]	范琳, 唐细良, 张哲民. 临床结核病营养学[M]. 北京: 科学出版社, 2022.
[8]	World Health Organization. Global tuberculosis report 2023[R]. Geneva: World Health Organization, 2023.
[9]	Sinha P, Ezhumalai K, Du X, et al. Undernourished Household Contacts Are at Increased Risk of Tuberculosis (TB) Disease,but not TB Infection-a Multicenter Prospective Cohort Analysis[J]. Clin Infect Dis, 2024, 79(1): 233-236. doi:10.1093/cid/ciae149.
[10]	Saunders M J, Cegielski J P, Clark R A, et al. Body mass index and tuberculosis risk: an updated systematic literature review and dose-response meta-analysis[J]. Int J Epidemiol, 2025, 54(5): dyaf154. doi:10.1093/ije/dyaf154.
[11]	Si Z L, Kang L L, Shen X B, et al. Adjuvant Efficacy of Nutrition Support During Pulmonary Tuberculosis Treating Course: Systematic Review and Meta-analysis[J]. Chin Med J (Engl), 2015, 128(23): 3219-3230. doi:10.4103/0366-6999.170255.
[12]	中华人民共和国卫生与计划生育委员会. WS 288—2017肺结核诊断[J]. 结核与肺部疾病杂志, 2024, 5(4): 376-378. doi:10.19983/j.issn.2096-8493.2024022.
[13]	阮晓莉, 石汉平, 刘芬. GLIM标准的肌肉质量评价研究现状系统综述[J]. 肿瘤代谢与营养电子杂志, 2022, 9(2): 148-159.
[14]	Li Q, Zhang X, Tang M, et al. Different muscle mass indices of the global leadership initiative on malnutrition in diagnosing malnutrition and predicting survival of patients with gastric cancer[J]. Nutrition, 2021, 89: 111286. doi:10.1016/j.nut.2021.111286.
[15]	中华人民共和国国家卫生健康委员会办公厅. 中国结核病预防控制工作技术规范(2020年版)[S]. 国卫办疾控函〔2020〕279号. 2020.
[16]	中华医学会结核病学分会. 抗结核药物超说明书用法专家共识(2023年更新版)[J]. 中华结核和呼吸杂志, 2023, 46(11): 1085-1102. doi:10.3760/cma.j.cn112147-20230809-00062.
[17]	中国营养学会. 中国居民膳食指南(2022)[M]. 北京: 人民卫生出版社, 2022.
[18]	中国营养学会. 中国居民膳食营养素参考摄入量(2013年版)[M]. 北京: 科学出版社, 2014.
[19]	Grobler L, Nagpal S, Sudarsanam T D, et al. Nutritional supplements for people being treated for active tuberculosis[J]. Cochrane Database Syst Rev, 2016, 2016(6): CD006086. doi:10.1002/14651858.CD006086.pub4.

药品名称	每日用量(g)
药品名称	体质量<50kg	体质量≥50kg
INH	0.30	0.30
RFP	0.45	0.60
PZA	1.50	1.50
EMB	0.75	1.00
Rft	0.45	0.60
Lfx	0.50~0.75
Mfx	0.40

项目	筛选期/ 访视1 -7~0d	访视2 (15±3)d	访视3 (30±3)d	访视4 (45±3)d	访视5 (60±3)d	访视6 (90±3)d	访视7 (120±3)d	访视8 (150±3)d	访视9 (180±3)d	访视10 (270±3)d 若有需要	访视11 (360±3)d 若有需要
签署知情同意书	●
人口学信息	●
病史、既往治疗史	●
体格检查(身高、体质量)	●	●	●	●	●	●	●	●	●	●	●
妊娠检测(若有必要)	○
HIV检查	●
抗结核药物敏感研究(分子生物学/细菌学)	●
心理评估	●		●		●	●			●	●	●
中臂围(MAC)	●		●		●	●			●	●	●
握力、4m步行时间	●	○	●	○	●	●			●	●	●
NRS 2002	●
营养评估GLIM分级	●	○	●	○	●	●			●	●	●
维生素B₁、B₆、D	○		○		○	○
维生素A结合蛋白	○		○		○	○
T淋巴细胞亚群	●					●
细胞因子	○					○
血、尿常规	●		●		●	●	●	●	●	●	●
肝、肾功能	●		●		●	●	●	●	●	●	●
营养指标	●		●		●	●	●	●	●	●	●
C反应蛋白	●					●
电解质	○		○		○	○
血糖	●				●				●	●	●
心电图	●
胸部CT	●					●			●	●	●
痰抗酸杆菌涂片镜检	●	●	●	●	●	●	●	●	●	●	●
痰分枝杆菌培养	●	●	●	●	●	●	●	●	●	●	●
核实纳入和排除标准	●
入组	●
发放营养制剂	●		●		●
不良事件	●		●		●	●	●	●	●	●	●
用药记录	●		●		●	●
填写病例报告表	●	●	●	●	●	●	●	●	●	●	●

级别	定义
1级	恶心和轻微的腹泻,通常腹泻的症状持续时间<2d
2级	短暂的呕吐和能耐受的腹泻,腹泻的时间通常≥2d
3级	呕吐需要治疗,而腹泻已经不能够被耐受了,需要给予相应的治疗
4级	出现了难以控制的呕吐和血性的腹泻