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新发传染病电子杂志

新发传染病电子杂志 ›› 2026, Vol. 11 ›› Issue (3): 1-6.doi: 10.19871/j.cnki.xfcrbzz.2026.03.001

• 论著 •    下一篇

老年肺结核患者抗结核固定剂量复合剂治疗不良反应的影响因素分析

何蔚云1, 赖静文2, 陈亮1   

  1. 1.广州市胸科医院办公室,广东 广州 510095;
    2.广州市胸科医院一分所,广东 广州 510095
  • 收稿日期:2026-02-08 出版日期:2026-06-30 发布日期:2026-07-17
  • 通讯作者: 陈亮,Email：18928929722@126.com
  • 基金资助:
    国家科技重大专项（2025ZD01908101）

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

He Weiyun1, Lai Jingwen2, Chen Liang1   

  1. 1. Department of Office, Guangzhou Chest Hospital, Guangdong Guangzhou 510095, China;
    2. Department of First Branch, Guangzhou Chest Hospital, Guangdong Guangzhou 510095, China
  • Received:2026-02-08 Online:2026-06-30 Published:2026-07-17

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摘要： 目的 识别老年肺结核患者使用抗结核固定剂量复合制剂（fixed-dose combination,FDC）治疗时发生药物不良反应（adverse drug reactions,ADRs）的时间依赖型危险因素,为临床制定分阶段监测方案提供循证依据。方法 采用回顾性研究设计,通过“中国疾病预防控制信息系统”子系统“结核病管理信息系统”以及“广州市胸科医院HIS系统”收集2019年1月至2023年12月广州市越秀区登记治疗的649例老年肺结核患者病案信息。分析老年肺结核患者使用FDC抗结核治疗ADRs的发生情况,并采用多因素Cox比例风险回归模型分析ADRs发生的影响因素。结果 649例患者中,385例发生ADRs（发生率59.48%）,ADRs发生时间范围为1~288d,中位发生时间为20d。多因素Cox比例风险回归分析结果显示,女性（aHR=1.705,95%CI：1.368~2.125）、病原学阳性（aHR=1.423,95%CI：1.135~1.784）、基线估算肾小球滤过率（estimated glomerular filtration rate,eGFR）30~<60ml/min（aHR=1.913,95%CI：1.495~2.448）均为老年肺结核患者使用FDC抗结核治疗时发生ADRs的独立危险因素。结论 老年肺结核患者采用FDC抗结核治疗时,ADRs发生率较高。女性、病原学阳性及基线eGFR处于30~<60ml/min区间是发生ADRs的独立危险因素。治疗早期应加强上述高危人群临床监测,及时识别并处理ADRs,以提升治疗依从性。

关键词: 固定剂量复合制剂, 抗结核药物, 药品不良反应, 老年肺结核, 生存分析, Cox比例风险模型

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

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