摘要
目的促进临床肿瘤靶向药物的合理使用。方法统计肿瘤靶向药物的分类、作用靶点、特点、临床应用及纳入国家医保目录的药物,并比较其在中国和美国的上市情况和适应证差异。结果肿瘤靶向药物可分为单克隆抗体和小分子抑制剂两类,具有疗效好、副作用小等特点,其作用靶点包括B淋巴细胞抗原CD20、人表皮生长因子受体2、血管内皮细胞生长因子、表皮生长因子受体等,可用于治疗白血病、淋巴瘤、乳腺癌、前列腺癌、肺癌、肾癌、胃癌、结直肠癌、多发性骨髓瘤等。截至2020年底,共有47种肿瘤靶向药物纳入国家医保目录,包括伊尼妥单抗、替雷利珠单抗、特瑞普利单抗、氟马替尼、阿美替尼等;美国食品药物管理局获批上市的抗肿瘤靶向药物超过100种,其中27种为单克隆抗体;我国国家药品监督管理局共批准49种肿瘤靶向药物上市,包括14种国产原研药物;部分药物在中、美两国获批的适应证不同,包括厄洛替尼、利妥昔单抗、舒尼替尼、贝伐珠单抗等。结论临床用药应在遵循指南的基础上,评估使用肿瘤靶向药物的可能性,并结合个体因素制订个体化方案,最大限度地延长患者的生存期。
Objective To promote the rational clinical application of anti-tumor-targeted drugs.Methods The classification,action targets,characteristics,clinical application of anti-tumor-targeted drugs and those included in the China’s National Reimbursement Drug List(NRDL)were summarized,and differences in the marketing situation and indications of anti-tumor-targeted drugs between China and the United States were compared.Results Anti-tumor-targeted drugs can be divided into two types:monoclonal antibodies and small molecule inhibitors.They have excellent efficacy and low side effects,their targets include B lymphocyte antigen CD20,human epidermal growth factor receptor 2,vascular endothelial growth factor and epidermal growth factor receptor,which can be used in the treatment of leukemia,lymphoma,breast cancer,prostate cancer,lung cancer,kidney cancer,gastric cancer,colorectal cancer,multiple myeloma and so on.As of 2020,a total of 47 anti-tumor-targeted drugs had been included in the NRDL,including inetetamab,tislelizumab,toripalimab,flumatinib,almonertinib and so on.There are more than 100 anti-tumor-targeted drugs approved by the Food and Drug Administration(FDA),of which 27 are monoclonal antibodies.There are 49 anti-tumor targeted drugs approved for marketing by the National Medical Products Administration(NMPA),including 14 domestic original drugs.Some drugs have different approved indications in China and the United States,including erlotinib,rituximab,sunitinib,bevacizumab and so on.Conclusion In order to maximize the survival time of patients,the clinical medication should evaluate the possibility of patients using anti-tumor-targeted drugs and formulate individual plans on the basis of relevant guidelines.
作者
李雁铭
赵志刚
LI Yanming;ZHAO Zhigang(Department of Pharmacy,Beijing Tiantan Hospital,Capital Medical University,Beijing,China 100070;School of Pharmaceutical Sciences,Capital Medical University,Beijing,China 100069)
出处
《中国药业》
CAS
2021年第21期128-128,I0001-I0004,F0003,F0004,共7页
China Pharmaceuticals
基金
北京市医院管理局重点医学专业发展计划[ZYLX201827]。
关键词
肿瘤
靶向药物
单克隆抗体
小分子抑制剂
合理用药
tumor
targeted drugs
monoclonal antibody
small molecule inhibitors
rational drug use