抗肿瘤中成药上市后研究要点探讨与思考  

Key Points of Post-marketing Study of Anti-tumor Chinese Patent Medicines

作　　者：许博文 张潇潇 李杰[1] 高瑞珂 朱广辉 吴喆 XU Bowen;ZHANG Xiaoxiao;LI Jie;GAO Ruike;ZHU Guanghui;WU Zhe(Guang'anmen Hospital,China Academy of Chinese Medical Sciences,Beijing 100053,China;Beijing University of Chinese Medicine,Beijing 100029,China)

机构地区：[1]中国中医科学院广安门医院,北京100053 [2]北京中医药大学,北京100029

出　　处：《世界中医药》2022年第14期2036-2040,共5页World Chinese Medicine

基　　金：国家重点研发计划项目(2018YFC1707405);国家自然科学基金项目(81774289);北京市科技计划重大基金资助项目(D161100005116004);中国中医科学院院级自主选题(ZZ11-028)。

摘　　要：抗肿瘤中成药是中医药治疗肿瘤的重要手段之一,但适应证宽泛、循证证据不足,严重制约临床推广应用,势必要不断进行上市后研究,以凸显中成药治疗的疗效与优势。基于此,现提出“以评促研、以研促评”的闭环式抗肿瘤中成药上市后研究要点。首先在评价抗肿瘤中成药在临床广泛应用后的安全性、有效性和经济性基础上,完善临床用药方案与循证评价;再基于再评价结果,挖掘并创造性地提出有价值的临床假说,进行开放式探索研究,评价与验证假说,强化抗肿瘤中成药的价值与临床定位。二者不断反馈循环,互为前提,可加速抗肿瘤中成药产品转型,致力于精准化用药和增强行业信心,进行中医药规范化、标准化和现代化研发。Anti-tumor Chinese patent medicines are one of the important means of treating tumors with Chinese medicine.However,the broad indications and insufficient evidence-based evidence seriously restrict the clinical promotion and application.It is necessary to continuously carry out the post-marketing study to highlight the efficacies and advantages of Chinese patent medicine treatment.Based on this,this paper put forward the key points of the post-marketing study of closed-loop anti-tumor Chinese patent medicines,which was“to promote research with evaluation and promote evaluation with research”.First of all,the clinical medication regimen and evidence-based evaluation should be improved based on the evaluation of the safety,efficacy,and economy of anti-tumor Chinese patent medicines after extensive clinical application.Secondly,based on the results of re-evaluation,the valuable clinical hypotheses should be excavated and creatively proposed,with the conduction of open exploration studies.The hypotheses should be evaluated and verified,and the value and clinical positioning of anti-tumor Chinese patent medicines should be strengthened.The continuous feedback cycle is the foundation to accelerate the transformation of anti-tumor Chinese patent medicines,and makes contributions to precise medication and enhancement of industrial confidence,thus realizing the normalization,standardization,and modernization of Chinese medicine research and development.

关 键 词：上市后 肿瘤 中成药 再评价 安全性 有效性 经济学 药品再评价 

分 类 号：R288[医药卫生—中药学] R273[医药卫生—中医学]