Analysis of influencing factors for adverse reactions to anti-tuberculosis fixed-dose combination therapy in elderly patients with pulmonary tuberculosis

doi:10.19871/j.cnki.xfcrbzz.2026.03.001

Abstract

Abstract: Objective To identify time-dependent risk factors for anti-tuberculosis drug-related adverse drug reactions (ADRs) in elderly patients with pulmonary tuberculosis treated with fixed-dose combination (FDC) formulations, providing evidence-based support for the development of phased monitoring protocols in clinical practice. Method By using retrospective study design, the medical records of 649 elderly tuberculosis patients registered and treated in Yuexiu District, Guangzhou from January 2019 to December 2023 were collected through the "China Disease Prevention and Control Information System" subsystem "Tuberculosis Management Information System" and the "Guangzhou Chest Hospital HIS System". This study analyzed the occurrence of ADRs in elderly tuberculosis patients treated with FDC and employed the Cox proportional hazards regression model to evaluate the influencing factors. Result Among the 649 patients, 385 experienced ADRs (incidence rate 59.48%), with the time range of ADRs occurrence spanning 1 to 288 days, and the median occurrence time was 20 days. Multivariate Cox regression analysis revealed that female patients (aHR=1.705,95%CI: 1.368-2.125), positive sputum smear (aHR=1.423, 95%CI: 1.135-1.784), and estimated glomerular filtration rate (eGFR) 30-<60 ml/min (aHR=1.913,95%CI: 1.495-2.448) were independent risk factors for ADRs in elderly tuberculosis patients receiving anti-tuberculosis FDC therapy. Conclusion Elderly patients with pulmonary tuberculosis have a relatively high incidence of ADRs when receiving anti-tuberculosis treatment with FDC. Female sex, positive etiological findings, and a baseline eGFR of 30-<60ml/min are independent risk factors for ADRs. Clinical monitoring should be strengthened for the above high-risk populations during the early stage of treatment, and ADRs should be identified and managed promptly to improve treatment adherence.

Key words: Fixed-dose combination preparations, Antituberculosis drugs, Adverse drug reactions, Elderly pulmonary tuberculosis, Survival analysis, Cox proportional hazards model

CLC Number:

He Weiyun, Lai Jingwen, Chen Liang. Analysis of influencing factors for adverse reactions to anti-tuberculosis fixed-dose combination therapy in elderly patients with pulmonary tuberculosis[J]. Electronic Journal of Emerging Infectious Diseases, 2026, 11(3): 1-6.

References

[1] 何华伟, 黄爱春, 李纬, 等. WHO 2025年全球结核病报告:全球与中国关键数据分析[J/CD]. 新发传染病电子杂志, 2025, 10(6):1-9.
[2] WORLD HEALTH ORGANIZATION. Global tuberculosis report2024[EB/OL].[2024-1029].https://www.who.int/publications/i/item/9789240101531.
[3] 国家疾病预防控制局. 全国结核病防治规划(2024—2030年)[J/CD].新发传染病电子杂志, 2025, 10(1):94-96.
[4] 中国防痨协会学术工作委员会,《中国防痨杂志》编辑委员会. 抗结核固定剂量复合制剂临床应用专家共识[J]. 中国防痨杂志, 2020, 42(6): 561-568.
[5] ISLAM MM, IQBAL U, WALTHER BA, et al.Gender-based personalized pharmacotherapy: A systematic review[J]. Arch Gynecol Obstet, 2017, 295(6): 1305-1317.
[6] 黄健,武阿龙,徐丙发.合并低蛋白血症重症患者的抗菌药物给药方案调整研究进展[J]. 中国新药杂志,2022, 31(5): 442-447.
[7] 中华人民共和国国家卫生和计划生育委员会. 肺结核诊断标准(WS 288—2017)[J/CD]. 新发传染病电子杂志,2018,3(1):59-61.
[8] 中国疾病预防控制中心. 中国结核病预防控制工作技术规范(2020年版)[M]. 北京:人民卫生出版社,2020.
[9] WORLD HEALTH ORGANIZATION.Global report on aging and health[R]. Geneva: World Health Organization, 2015.
[10] 中华医学会老年医学分会老年内分泌代谢疾病学组, 中华医学会老年医学分会, 中国医师协会老年医学科医师分会. 中国老年人铁缺乏及缺铁性贫血诊断和治疗指南(2025版)[J]. 中华老年医学杂志,2025,44(11):1455-1471.
[11] YU YT, LIU J, HU B, et al.Expert consensus on the use of human serum albumin in critically ill patients[J]. Chin Med J (Engl), 2021, 134(14):1639-1654.
[12] 杨超,张路霞,赵明辉. 2024版KDIGO《慢性肾脏病评估与管理临床实践指南》更新要点及解读[J].中国实用内科杂志, 2024, 44(6): 457-460.
[13] 徐克. 医学影像学[M]. 9版. 北京:人民卫生出版社,2024: 112-116.
[14] 国家药品不良反应监测中心,国家食品药品监督管理局药品评价中心. WHO药品不良反应术语集[M]. 北京:中国医药科技出版社,2003:3-49.
[15] 田春华. 《药品不良反应报告和监测管理办法》修订思考[J]. 中国药物警戒, 2025, 22(11): 1253-1257.
[16] 中华医学会肝病学分会药物性肝病学组. 药物性肝损伤诊治指南(2023 年版)[J]. 中华肝脏病杂志,2023, 31(3): 251-269.
[17] 李鹏鹏,何飞,袁中行,等. 1494例老年肺结核患者临床特征及治疗效果分析[J]. 临床肺科杂志, 2024, 29(11):1729-1734.
[18] 张凯,路晓钦,董志. 抗结核药物的药品不良反应自动监测研究及其影响因素分析[J].中国临床药理学杂志, 2024, 40(7):1059-1062.
[19] 李宛珈, 黄志锋, 廖陈喜, 等. 广州地区2005例成人过敏性疾病患者过敏原特异性IgE检测结果分析[J]. 中国免疫学杂志, 2020, 36(22):2764-2768, 2773.
[20] ZHANG XH, XIE Y, XU QG, et al.Mitochondrial Mutations in Ethambutol-Induced Optic Neuropathy[J]. Front Cell Dev Biol, 2021, 9:754676.
[21] 孙红娜,郑玉粉,于锋.新型口服抗凝药的药物相互作用[J].中国医院药学杂志,2021,41(3):314-320.
[22] 王海燕. 肾脏病学[M]. 四版. 北京:人民卫生出版社, 2020: 1617-1644.
[23] 李东幸,牛紫敏,王皓翔,等. 广州市黄埔区老年人群健康体检的回顾性队列研究[J].中国全科医学,2025, 28(13):1635-1641.
[24] 中国营养学会. 中国居民膳食指南[M]. 北京:人民卫生出版社, 2022: 1-368.
[25] JIANHAI WANG, DONG ZHANG, CHUNNAN DU, et al.Serum Omics Analysis Reveals Tissue Damage and Metabolic Reprogramming in Cavitary Pulmonary Tuberculosisy[J]. J Proteome Res, 2026, 25(1):341-356.
[26] 杨松, 郭建琼, 严晓峰, 等. 宿主N-乙酰转移酶2多态性与异烟肼诱导肝损伤相关性的研究进展[J]. 中华结核和呼吸杂志, 2022, 45(2):227-232.