单克隆抗体药物临床监测研究进展

Research progress on clinical monitoring of monoclonal antibody drugs

单克隆抗体(单抗)药物属于蛋白质类药物, 具有相对分子质量大、极性强和跨膜受限等特点, 药物代谢动力学有一定的特殊性和复杂性, 临床应用中存在治疗效果个体差异大、生物效应多样和治疗响应丢失等问题。影响单抗药物血药浓度的因素包括靶部位受体数量、抗药物抗体水平、药物间相互作用等。早期开展治疗药物监测有助于及时调整单抗药物给药剂量, 提高疗效, 避免或减少不良反应的发生。应积极开展药物临床监测, 提高单抗药物合理用药水平和不良反应预警能力, 减少对患者的伤害。

Monoclonal antibody(mAb)drugs belong to protein drugs,which are characterized by high relative molecular weight,strong polarity,and limited transmembrane.Their pharmacokinetics have certain particularity and complexity,and problems such as large individual differences in therapeutic effects,diverse biological effects,and loss of therapeutic response exist in clinical application.The blood concentration of mAb drugs is affected by many factors including the number of receptors at the target site,the level of anti‑drug antibody,and the interaction between drugs.Early monitoring is helpful to timely adjust the dose of mAb drugs,improve the efficacy,and avoid or reduce the occurrence of adverse reac‑tions.Clinical monitoring should be actively carried out to improve the level of rational use of mAb drugs and the ability of early warning of adverse reactions,so as to reduce the drug‑induced injury in patients.