抗肿瘤复方药物研发现状与挑战  

Challenges to the current development of fixed-dose antitumor drug combinations

作　　者：江海燕 周甜雨 范潇予 李万芳[1,3] 包捷 靳洪涛[1,3,4] JIANG Haiyan;ZHOU Tianyu;FAN Xiaoyu;LI Wanfang;BAO Jie;JIN Hongtao(New Drug Safety Evaluation Center,Institute of Materia Medica,Chinese Academy of Medical Sciences and Peking Union Medical College,Beijing 100050,China;College of Pharmacy,Shaanxi University of Traditional Chinese Medicine,Xianyang Shanxi 712046,China;Beijing Union-Genius Pharmaceutical Technology Development Co.,Ltd.,Beijing 100176,China;NMPA Key Laboratory for Safety Research and Evaluation of Innovative Drug,Beijing 102206,China)

机构地区：[1]中国医学科学院北京协和医学院药物研究所新药安全评价研究中心,北京100050 [2]陕西中医药大学药学院,陕西咸阳712046 [3]北京协和建昊医药技术开发有限责任公司,北京100176 [4]国家药品监督管理局创新药物安全研究与评价重点实验室,北京102206

出　　处：《中国药物警戒》2024年第9期961-966,共6页Chinese Journal of Pharmacovigilance

基　　金：国家自然科学基金资助项目(82074104、22177134);中国毒理学会临床毒理课题(CST2021CT101)。

摘　　要：目的 综述复方药物在抗肿瘤药物研发中的特点,以期为抗肿瘤复方药物研发提供参考。方法 通过检索国内外相关文献及数据库,对已上市的抗肿瘤复方药物及近3年美国食品药品监督管理局(FDA)批准的药物联合治疗方案进行分析。结果 目前上市的抗肿瘤复方药物通过多靶点协同作用或改善给药途径等方式,可提高药物治疗效果,改善患者依从性并降低药物毒性作用。结论 抗肿瘤复方药物具有治疗优势,但在研发过程中仍面临诸多挑战,未来人工智能可为复方药物研发提供技术支撑和创新动力。Objective To summarize the characteristics of fixed-dose combinations in the development of antitumor drugs so as to provide references for the development of related combinations.Methods By searching for relevant literature from domestic and overseas databases,the marketed fixed-dose antitumor drug combinations and combination therapies approved by the US FDA in the past three years were analyzed.Results The marketed fixed-dose antitumor drug combinations could significantly improve the therapeutic effects of drugs,improve patient compliance and reduce drug toxicity through multi-target synergistic effects or by improving drug delivery routes.Conclusion Fixed-dose antitumor drug combinations enjoy significant advantages in clinic but still face many challenges in the course of development.In the future,artificial intelligence can provide strong technical support and innovation incentives for the development of drugs.

关 键 词：复方药物 肿瘤治疗 多靶点 联合用药 药物研发 

分 类 号：R916[医药卫生—药学] R979.1