治疗转移性结直肠癌的抗血管生成单克隆抗体的药品遴选量化评估

Quantitative evaluation of anti-angiogenic monoclonal antibodies for metastatic colorectal cancer

目的对治疗转移性结直肠癌的抗血管生成单克隆抗体进行药品遴选量化评估,为医疗机构药品遴选和合理使用提供依据。方法参考《中国医疗机构药品遴选指南》,通过收集药品药效学、药动学的基本资料和有效性、安全性方面的循证医学证据等,采取量化评分的方式,从药学特性、有效性、安全性、经济性、医保属性、基本药物、贮藏条件、药品有效期、全球使用情况和生产企业状况十个方面,对4种抗血管生成单克隆抗体药品进行量化评估。结果贝伐珠单抗及其国产仿制药得分分别为75分和74.9分,优势主要体现在药学特性、有效性和经济性三个方面,推荐进入医疗机构用药目录。阿柏西普和雷莫芦单抗在转移性结直肠癌的治疗中循证医学证据不及贝伐珠单抗,安全性可,经济性无优势,评估总分分别为63.9分和62.3分,弱推荐进入医疗机构用药目录。结论贝伐珠单抗及其国产仿制药是治疗转移性结直肠癌的优选抗血管生成单克隆抗体。

AIM To quantitative evaluate of anti-angiogenic monoclonal antibodies in treatment of metastatic colorectal cancer,and provide reference for drug selection and rational use.METHODS Referring to the“Guideline for drug evaluation and selection in Chinese medical institutions”,by collecting the basic data of pharmacodynamics and pharmacokinetics as well as evidence-based medical evidence of effectiveness and safety,four anti-angiogenic monoclonal antibodies were comprehensively evaluated by quantitative scoring from the ten aspects of pharmaceutical characteristics,effectiveness,safety,economics,medical insurance attributes,base medicine attributes,storage conditions,expiration date,global use,and corporate credibility.RESULTS Bevacizumab and its domestic generic agents scored 75 points and 74.9 points,respectively.Their advantages were mainly reflected in pharmaceutical characteristics,effectiveness and economics,which were recommended to enter the catalogue of medical institutions.The evidence-based medical evidence of aflibercept and ramucirumab in the treatment of metastatic colorectal cancer was less than that of bevacizumab.The safety was acceptable,but the economics had no advantages.The total scores of this evaluation were 63.9 points and 62.3 points,respectively,and it was weakly recommended to enter the drug catalogue of medical institutions.CONCLUSION Bevacizumab and its domestic generic agents are the preferred anti-angiogenic monoclonal antibodies for the treatment of metastatic colorectal cancer.