抗体药物偶联物的临床应用与安全性研究进展  

Clinical application and safety evaluation of listed antibody-drug conjugates at home and abroad

作　　者：闫奕龙 朱斌[1] 赵志刚[1] YAN Yilong;ZHU Bin;ZHAO Zhigang(Department of Pharmacy,Beijing Tiantan Hospital,Capital Medical University,Beijing 100070,China)

机构地区：[1]首都医科大学附属北京天坛医院药学部,北京100070

出　　处：《临床药物治疗杂志》2025年第2期10-16,共7页Clinical Medication Journal

基　　金：北京市医院管理局重点医学专业发展计划(ZYLX201827)。

摘　　要：抗体药物偶联物(ADC)是一类将单克隆抗体与细胞毒性药物通过化学连接子结合的靶向治疗药物。自2000年首个ADC药物gemtuzumab ozogamicin获批以来,全球已有15种ADC上市,其中中国已批准7种。这些药物广泛用于白血病、淋巴瘤、乳腺癌等多种癌症的治疗。ADC通过抗体的靶向作用,将细胞毒性药物精确地输送至肿瘤细胞,从而有效减少对健康细胞的损害。然而,ADC的临床应用伴随多种不良反应风险,如眼毒性、肝毒性及间质性肺病等,FDA黑框警告对此进行了体现。本文回顾了国内外ADC的临床应用现状,重点分析基于FDA药品说明书和中国药品说明书的安全性评价,为合理使用ADC提供依据。Antibody-drug conjugate(ADC)are a class of targeted therapeutic agents that combine monoclonal antibodies with cytotoxic drugs through chemical linkers.Since the approval of the first ADC drug gemtuzumab ozogamicin in 2000,a total of 15 ADC drugs have been approved globally,and 7 of them have been approved in China.These drugs are widely used in the treatment of various cancers,including leukemia,lymphoma,and breast cancer.ADCs leverage the targeting capability of antibodies to deliver cytotoxic drugs directly to tumor cells,thereby minimizing damage to healthy cells.However,the clinical application of ADC is associated with various risks of adverse reactions,such as ocular toxicity,hepatotoxicity,and interstitial lung disease,which are reflected in the FDA's black box warnings.This article reviews the current clinical application status of ADC both domestically and internationally,with a focus on analyzing safety evaluations based on the FDA label warnings and Chinese labels,providing a scientific basis for the rational use of ADC.

关 键 词：抗体药物偶联物 疗效 安全性 黑框警告 

分 类 号：R979.1[医药卫生—药品]