脊柱结核患者血浆中3种抗结核药物浓度测定方法的建立及临床应用-中国药房

脊柱结核患者血浆中3种抗结核药物浓度测定方法的建立及临床应用

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篇名：	脊柱结核患者血浆中3种抗结核药物浓度测定方法的建立及临床应用
TITLE：	Establishment and clinical application of a method for the determination of three anti-tuberculosis drugs concentrations in plasma of patients with spinal tuberculosis
摘要：	目的建立同时测定脊柱结核患者血浆中3种抗结核药物浓度的方法，并将该法应用于临床。方法以苯海拉明为内标，采用液相色谱-串联质谱（LC-MS/MS）技术建立同时测定脊柱结核患者血浆中异烟肼、利福平和吡嗪酰胺浓度的方法。以Chema‐linkCM-C18T为色谱柱，0.1%甲酸-甲醇溶液为流动相进行梯度洗脱，流速为0.4mL/min，进样体积为2μL；采用电喷雾离子源在正离子模式下进行多反应监测，用于定量分析的离子对分别为m/z138.0→121.0（异烟肼）、m/z823.3→791.3（利福平）、m/z124.1→79.0（吡嗪酰胺）、m/z256.0→167.0（苯海拉明）。选择2023年1月－2025年6月在青海省人民医院住院的53例脊柱结核患者，采用上述方法测定患者血浆中异烟肼、利福平和吡嗪酰胺浓度。结果异烟肼、利福平和吡嗪酰胺的线性范围分别为0.5～16、2～64、2.5～80μg/mL（r不低于0.9987），准确度为90.20%～108.64%（n＝5），日内精密度的RSD均小于6.63%（n＝5），日间精密度的RSD均小于8.42%（n＝3），基质效应为88.60%～115.41%（n＝5），稳定性试验的相对偏差均在±15%范围内，残留效应对测定无干扰。临床应用结果显示，脊柱结核患者体内异烟肼、利福平、吡嗪酰胺的平均血药浓度分别为（3.62±2.80）、（8.55±4.57）、（20.12±6.56）μg/mL，血药浓度低于有效峰浓度的发生率分别为49.06%、58.49%、60.38%。结论本研究所建立的方法快速准确、稳定性好，可用于临床监测脊柱结核患者血浆中异烟肼、利福平和吡嗪酰胺的浓度。
ABSTRACT：	OBJECTIVE To establish a method for simultaneously determining three anti-tuberculosis drugs in the plasma of patients with spinal tuberculosis and apply it in clinical practice. METHODS LC-MS/MS method was established for the quantitative determination of the concentrations of isoniazid， rifampicin and pyrazinamide in the plasma of patients with spinal tuberculosis， using diphenhydramine as the internal standard. The determination was carried out using Chemalink CM-C18T column， with mobile phase consisting of 0.1% formic acid-methanol solution （gradient elution）， at the flow rate of 0.4 mL/min and an injection volume of 2 μL. Multiple reaction monitoring was conducted using an electrospray ionization source in positive ion mode. The ion pairs used for quantitative analysis were m/z 138.0→121.0（ for isoniazid）， m/z 823.3→791.3（ for rifampicin）， m/z 124.1→ 79.0 （for pyrazinamide）， and m/z 256.0→167.0 （for diphenhydramine）. Fifty-three patients diagnosed with spinal tuberculosis in Qinghai Provincial People’s Hospital from January 2023 to June 2025 were selected， and the plasma concentrations of isoniazid， rifampicin and pyrazinamide in these patients were measured using the above method. RESULTS The linear ranges for isoniazid， rifampicin and pyrazinamide were 0.5-16， 2-64， and 2.5-80 μg/mL， respectively （r≥0.998 7）. The accuracy ranged from 90.20% to 108.64% （n＝5）. RSDs for intra-day precision were all less than 6.63% （n＝5）， while those for inter-day precision were all less than 8.42% （n＝3）. The matrix effects ranged from 88.60% to 115.41% （n＝5）. The relative deviations in the stability tests were all within the ±15% range， and the carry-over effect did not interfere with the determination. The results of clinical application showed that the mean plasma drug concentrations of isoniazid， rifampicin and pyrazinamide in patients with spinal tuberculosis were （3.62±2.80），（8.55±4.57）， and （20.12±6.56） μg/mL， respectively. The incidences of plasma drug concentrations falling below the effective peak concentrations were 49.06%， 58.49% and 60.38%， respectively. CONCLUSIONS The method established in this study is rapid， accurate， and demonstrates good stability， making it suitable for clinical monitoring of the plasma concentrations of isoniazid， rifampicin and pyrazinamide in patients with spinal tuberculosis.
期刊：	2026年第37卷第01期
作者：	牟妍红；吴雪花；李永芳；车晓明
AUTHORS：	MOU Yanhong，WU Xuehua，LI Yongfang，CHE Xiaoming
关键字：	脊柱结核；抗结核药物；治疗药物监测；LC-MS/MS法；异烟肼；利福平；吡嗪酰胺
KEYWORDS：	spinal tuberculosis； anti-tuberculosis drugs； therapeutic drug monitoring； LC-MS/MS method； isoniazid；
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