Page 141 - 南京医科大学学报自然科学版

第43卷第9期 南京医科大学学报（自然科学版）
2023年9月 Journal of Nanjing Medical University（Natural Sciences） ·1319 ·

·综 述·

治疗药物监测在西罗莫司用于儿童期脉管异常中的研究进展

赵越桃 ，胡雅慧 ，郭宏丽 ，章媛媛 ，王 洁 ，陈 峰 1*
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1
南京医科大学附属儿童医院药学部药学研究中心，江苏 南京 210008；中国药科大学基础医学与临床药学学院，江苏 南
1 2
京 210009
［摘 要］ 西罗莫司（sirolimus，SRL）近年来被广泛应用于治疗脉管异常疾病。由于其治疗窗狭窄，药代动力学参数存在较大
的个体内和个体间变异性，需要常规进行治疗药物监测以确保疗效和避免不良反应。因此，本文回顾了SRL的血药浓度监测
方法以及不同检测方法之间的对比研究，并讨论SRL在脉管异常群体中应维持的浓度范围。SRL浓度检测方法包括免疫法和
色谱法两类，免疫法与色谱法相比存在显著的阳性偏倚，液相色谱串联质谱法是大多数实验室采用的“金标准”方法。SRL的
目标血药浓度范围多为5~15 ng/mL或10~15 ng/mL。但脉管异常疾病存在多个分类，SRL在该疾病的临床应用情况较为复杂，
治疗药物监测也无可供参考的指南。未来需进一步研究，以获取更多高级别的循证医学证据来指导SRL的治疗性监测及个体
化用药。
［关键词］ 西罗莫司；脉管异常；治疗药物监测；血药浓度
［中图分类号］ R725.4 ［文献标志码］ A ［文章编号］ 1007⁃4368（2023）09⁃1319⁃05
doi：10.7655/NYDXBNS20230922

Recent advances in therapeutic drug monitoring of sirolimus in the treatment of childhood
vascular anomalies

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ZHAO Yuetao ，HU Yahui ，GUO Hongli ，ZHANG Yuanyuan ，WANG Jie ，CHEN Feng 1*
1 Pharmaceutical Sciences Research Center，Department of Pharmacy，the Affiliated Children’s Hospital of Nanjing
Medical University，Nanjing 210008；School of Basic Medicine and Clinical Pharmacy，China Pharmaceutical
2
University，Nanjing 210009，China
［Abstract］ Sirolimus（SRL） has been widely used to treat vascular anomalies in recent years. The routine therapeutic drug
monitoring for SRL is required to ensure efficacy and prevent adverse effects，due to its narrow therapeutic window and large intra⁃ and
inter ⁃ individual variability in pharmacokinetics. This article reviewed the analytical methods for SRL blood concentration and the
comparison studies between different assays，and discussed the target blood concentration range of SRL in vascular anomalies. The
analytical methods for determination of SRL include immunoassays and liquid chromatography⁃based methods. Immunoassays exhibit
significant positive bias，compared to chromatography. Liquid chromatography tandem mass spectrometry is regarded as the“gold
standard”in most clinical labs. Generally，goal SRL blood concentrations maintain at 5-15 ng/mL or 10-15 ng/mL. However，there are
several classifications of vascular anomalies，and treatment of SRL in these diseases is complicated，and no guidelines for the
implementation of therapeutic drug monitoring can be adhered. Future investigations are needed to obtain a more high⁃level evidence⁃
based medical evidence to guide the therapeutic monitoring and individualized medication of SRL.
［Key words］ sirolimus；vascular anomalies；therapeutic drug monitoring；blood concentration of drug
［J Nanjing Med Univ，2023，43（09）：1319⁃1323］

［基金项目］ 江苏省卫生健康委员会特聘医学专家项目（2019）
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通信作者（Corresponding author），E⁃mail：cy.chen508@gmail.com