目的 回顾性分析利福平耐药结核病患者使用贝达喹啉（Bedaquilin，BDQ）抗结核治疗后，BDQ血药浓度与临床相关因素及疾病预后的相关性。 方法 收集2022年2月至2024年10月期间就诊于我院结核病区，使用含BDQ方案治疗的22例利福平耐药结核病（rifampicin-resistant tuberculosis， RR-TB）或耐多药结核病（multi-drug resistant tuberculosis， MDR-TB）或准广泛耐药结核病（pre-extensively drug-resistant tuberculosis，Pre-XDR-TB）患者作为研究对象，其中RR-TB患者6例（27.27%）、MDR-TB患者12例（54.55%）、Pre-XDR-TB患者4例（18.18%）。收集患者治疗不同时间服药后2 h外周血，通过质谱-液相色谱（LC-MS/MS）分析技术监测BDQ血药浓度，通过R studio调取ggplot2及corrplot包，编写相关代码，分析BDQ血药浓度、心电图QTcF（按Fridericia法校正的QT间期）、肝肾功、体质量、年龄、体质量指数（BMI）、性别、血尿酸、血清肌酐（Scr）等相关指标并进行Spearman相关性分析，多元线性回归分析确立影响BDQ血药浓度的独立因素。 结果 22例接受含BDQ治疗患者，服药1.5周后血药浓度达到高峰，2周后逐渐趋于平稳维持在1 ~ 3 μg/mL之间，24周停用BDQ抗结核治疗，直至抗结核治疗36周仍能在外周血中检测出BDQ，约为1 μg/mL。BDQ血药浓度与年龄、体质量、BMI、谷丙转氨酶（ALT）、谷草转氨酶（AST）、γ-谷氨酰转移酶（GGT）、总胆红素（TDiL）、尿素、尿酸、QTcF无明显相关性，Spearman相关分析结果显示，BDQ血药浓度与痰涂片抗酸染色变化存在相关性（r = 0.35，P < 0.05）。BDQ血药浓度变化与血清肌酐有相关性（r = 0.34，P < 0.05）。多元线性回归分析结果显示BDQ血药浓度与Scr正相关，是影响BDQ血药浓度的因素。22例患者的治疗结局：20例（90.9%，20/22）治愈，1例死于新型冠状病毒感染，1例复发。 结论 含BDQ的抗结核治疗方案对于利福平/耐多药肺结核/准广泛耐药肺结核患者安全性较高，且患者耐受性及预后相对良好，尚未发现与BDQ直接相关的不良事件，BDQ血药浓度与SCr相关，需密切检测BDQ血药浓度及肾功能。

Objective To conduct a retrospective analysis of the correlation among bedaquiline （BDQ） plasma concentrations， relevant clinical factors， and disease prognosis. Methods In this retrospective study， 22 patients diagnosed with rifampicin-resistant tuberculosis （RR-TB）， multidrug-resistant tuberculosis （MDR-TB）， or pre-extensively drug-resistant tuberculosis （pre-XDR-TB） were enrolled. These patients were admitted to the tuberculosis ward of our hospital between February 2022 and October 2024. All patients were administered a treatment regimen containing BDQ. The cohort comprised 6 RR-TB patients （27.27%）， 12 MDR-TB patients （54.55%）， and 4 pre-XDR-TB patients （18.18%）. Peripheral blood samples were collected 2 hours after the oral administration of Bedaquiline. The plasma concentration of Bedaquiline was measured using liquid chromatography-tandem mass spectrometry （LC-MS/MS）. Spearman correlation analysis was performed using R studio software with the ggplot2 and corrplot packages. The factors included the blood concentration of bedaquiline， electrocardiogram QTcF （QT interval corrected by the Fridericia method）， liver and kidney function parameters， weight， age， body mass index， sex， blood uric acid level， serum creatinine level， and other relevant indicators. Results In 22 patients treated with BDQ， the plasma concentration reached a peak after 1.5 weeks of administration， and gradually stabilized after 2 weeks. The plasma concentration was approximately 1-3 μg/mL. After 24 weeks of withdrawal of bedaquiline， patients were continued to monitor their bedaquiline concentration and found that BDQ blood concentration in peripheral blood was approximate 1 μg /mL up to 36 weeks. The serum concentration of BDQ was not correlated with age， body weight， BMI， ALT， AST， GGT， TDiL， urea， uric acid and QT interval， but correlated with sputum negative transformation and serum creatinine. The correlation analysis between serum concentration of BDQ and acid-fast staining of sputum smear showed， the difference was significant （r = 0.35， P < 0.05）. In addition， the correlation analysis between serum BDQ concentration and serum creatinine showed， the difference was significant （r = 0.34， P < 0.05）. The results of multiple linear regression analysis showed that BDQ blood concentration was positively correlated with Scr level， and Scr was an independent factor affecting BDQ blood concentration. 20 cases （90.9%， 20/22） were cured， 1 case died of Covid-19 virus infection， 1 case was recurrence. Conclusions Regimens containing bedaquiline seem to exhibit relatively high safety profiles and good tolerability among patients with rifampicin-resistant， multidrug-resistant， or pre-extensively drug-resistant tuberculosis， typically yielding favorable treatment outcomes. The BDQ shows a positive correlation with serum creatinine （SCr）. Consequently， close surveillance of BDQ levels and renal function remains of utmost importance throughout the treatment course.