目的 通过分析结核病患者服用固定剂型一线抗结核药物血药浓度监测情况，探讨抗结核药物血药浓度的影响因素。 方法 采用回顾性研究方法，选取2020年1月至2024年12月在广州市胸科医院就诊并于强化期采用标准治疗方案治疗且进行了一线抗结核药物血药浓度监测的224例患者作为研究对象。本研究数据锁库时间为2025年1月，所有纳入患者的临床资料及血药浓度数据均截至该时间点锁定；数据分析周期为2025年1—2月。收集性别、年龄、低白蛋白血症（血清白蛋白< 35 g/L）、肾小球滤过率（GFR）等8项基线数据，采用单因素χ2检验和多因素logistic回归分析影响异烟肼（INH）、利福平（RFP）血药浓度的独立危险因素。 结果 研究对象血药浓度低于参考浓度范围者分别为INH 71.43%（160/224）、RFP 41.07%（92/224）。INH、RFP平均血药浓度分别为（2.532 ± 1.371）mg/L、（9.428 ± 4.317）mg/L。单因素分析显示，性别、病原学检查与RFP血药浓度低于参考范围发生显著相关（均P < 0.05）。多因素回归分析表明，男性（OR = 1.992，95%CI：1.094 ~ 3.628）、病原学阳性（OR = 1.929，95%CI：1.058 ~ 3.517）是RFP低血药浓度的独立危险因素。 结论 在接受RFP治疗的结核病患者中，治疗药物监测发现低血药浓度现象较为常见。男性和病原学检查阳性是RFP低血药浓度的独立危险因素。对于具备这些特征的患者，应尤为警惕其发生RFP血药浓度不足的风险，并及时进行TDM以指导个体化给药，对改善治疗效果、预防耐药产生具有重要意义。

Objective To explore the factors influencing blood drug concentrations of first-line anti-tuberculosis drugs in fixed-dose combinations by analyzing therapeutic drug monitoring data from tuberculosis patients receiving these regimens. Methods This retrospective study enrolled 224 patients who received treatment at Guangzhou Chest Hospital between January 2020 and December 2024. All participants underwent standardized therapy during the intensive phase， with therapeutic drug monitoring of first-line anti-tuberculosis drugs （ANTDs）， including isoniazid （INH） and rifampicin （RFP）. Data collection was completed in January 2025， at which time clinical records and measured INH and RFP plasma concentrations were updated. Data analysis was conducted from January to February 2025. Eight baseline variables—gender， age， hypoproteinemia （serum albumin < 35 g/L）， glomerular filtration rate （GFR）， and others—were collected. Univariate chi-square tests and multivariate logistic regression analyses were performed to identify independent risk factors associated with subtherapeutic INH and RFP plasma concentrations. Results Among the study participants， 71.43% （160/224） exhibited blood drug concentrations below the reference range for INH， compared to 41.07% （92/224） for RFP. The mean blood concentrations （mg/L， ± SD） were 2.532 ± 1.371 for INH and 9.428 ± 4.317 for RFP， respectively. One-way analysis indicated significant associations between male gender， positive etiological test results， and subtherapeutic RFP concentrations （P < 0.05）， suggesting statistically significant differences. Multivariate regression analysis further revealed that male gender （OR = 1.992， 95%CI： 1.094 ~ 3.628） and positive etiological tests （OR = 1.929， 95%CI： 1.058 ~ 3.517） were independent risk factors for low RFP levels. Conclusions This study demonstrates that therapeutic drug monitoring （TDM） frequently identifies subtherapeutic RFP concentrations in tuberculosis patients undergoing treatment. Multivariate analysis reveals that male sex and positive pathogen test results are independent risk factors associated with low RFP plasma levels. Consequently， clinicians should exercise heightened vigilance in patients exhibiting these characteristics， promptly implementing TDM to guide individualized dose adjustments. Such an approach is crucial for optimizing treatment efficacy and minimizing the risk of drug resistance development.