《胃肠间质瘤靶向药物的治疗药物监测中国专家共识》解读

Interpretation of Chinese Expert Consensus on Therapeutic Drug Monitoring of Targeted Drugs in Gastrointestinal Stromal Tumor

靶向药物在胃肠间质瘤(GIST)治疗中具有里程碑式的意义,不仅显著延长患者生存期,而且有望使GIST逐步进入“慢性病”范畴。然而,靶向药物常以固定剂量给药,药动学个体差异大,导致部分患者耐药或疾病进展,而部分患者可能发生严重不良反应。研究表明,GIST靶向治疗药物血药浓度与临床疗效相关,可通过治疗药物监测(TDM)优化剂量调整。因此,中国药学会医院药学专委会和中国药理学会治疗药物监测研究专委会于2021年联合发布《胃肠间质瘤靶向药物的治疗药物监测中国专家共识》。该共识对GIST靶向药物治疗药物监测的必要性、目标人群、技术方法、结果解读以及个体化剂量调整五个方面进行具体分析并给出推荐意见。该文结合国内外最新研究进展对共识内容进行具体论证分析,以加深临床医生、药师等对GIST靶向药物TDM的认识和理解,推动GIST靶向药物的个体化治疗。

Targeted drugs play a milestone role in treating gastrointestinal stromal tumors(GIST),which not only significantly prolongs the survival rate of patients but is also expected to move GIST into the category of“chronic disease”gradually.However,targeted drugs are administered at fixed doses with large individual inter-and intra-variabilities in pharmacokinetics.Some patients may experience drug resistance or disease progression,while others may experience serious adverse reactions.Recent studies have shown that the pharmacokinetics of targeted therapy drugs are significantly correlated with clinical efficacy and/or adverse reactions,suggesting that therapeutic drug monitoring(TDM)can be a strategy to realize individualized therapy.The Hospital Pharmacy Committee of the Chinese Pharmaceutical Association and the Division of Therapeutic Drug Monitoring,Chinese Pharmacological Society have formulated and published the Chinese Expert Consensus on Therapeutic Drug Monitoring of Targeted Drugs for Gastrointestinal Stromal Tumors in 2021.The consensus made specific analysis and recommendations on five aspects,including the necessity,target population,technical methods,interpretation of results,and individualized dose adjustment of TDM for GIST-targeted drug therapy.Based on the consensus content and the latest research progress at home and abroad,this paper conducted specific demonstration and analysis of the consensus content,in order to deepen the knowledge and understanding of clinicians and pharmacists on TDM of GIST-targeted drugs to promote the individualized therapy of GIST targeted drugs.