抗肿瘤中成药上市后研究要点探讨与思考
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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)


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

    Abstract:

    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.

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许博文,张潇潇,李杰,高瑞珂,朱广辉,吴喆.抗肿瘤中成药上市后研究要点探讨与思考[J].世界中医药,2022,(14).

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  • 收稿日期:2020-11-09
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  • 在线发布日期: 2022-09-01
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