治疗药物监测在西罗莫司用于儿童期脉管异常临床实践中的研究进展
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南京医科大学附属儿童医院药学部药学研究中心

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Recent Advances in Therapeutic Drug Monitoring of Sirolimus in the Treatment of Childhood Vascular Anomalies
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Pharmaceutical Sciences Research Center,Department of Pharmacy,Children’s Hospital of Nanjing Medical University,Nanjing,China

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    摘要:

    西罗莫司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帮助确保疗效和避免不良反应。因此,本文回顾了西罗莫司的血药浓度监测方法以及不同检测方法之间的对比研究,并讨论了西罗莫司在脉管异常群体中应维持的浓度范围。西罗莫司浓度的检测方法包括免疫法和色谱法两类,免疫法与色谱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。西罗莫司的目标血药浓度范围多数为5–15 ng/mL或10–15 ng/mL。但脉管异常疾病存在多个分类,西罗莫司在该疾病领域的临床应用情况较为复杂,关于治疗药物监测的实施也无可供参考的指南。未来需要进一步研究,以获取更多高级别的循证医学证据来指导西罗莫司的治疗性监测及个体化用药。

    Abstract:

    Sirolimus has been widely used to treat vascular anomalies in recent years. Routine therapeutic drug monitoring for sirolimus 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 sirolimus blood concentration and the comparison studies between different assays, and the target blood concentration range of sirolimus in vascular anomalies was discussed. The analytical methods for determination of sirolimus 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 sirolimus blood concentrations maintain at 5–15 ng/mL or 10–15 ng/mL. However, there are several classifications of vascular anomalies. The treatment of sirolimus in this disease area is complicated, and no guidelines for the implementation of therapeutic drug monitoring could be adhered. Further researches are needed to obtain more high-level evidence-based medical evidence to guidance the therapeutic monitoring and individualized medication of sirolimus.

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  • 收稿日期:2022-12-08
  • 最后修改日期:2023-01-30
  • 录用日期:2023-08-29
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