| 引用本文:许博文1,2，张潇潇1，李杰1，高瑞珂1，朱广辉1,2，吴喆1.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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| 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 |
| 投稿时间：2020-11-09 |
| DOI：10.3969/j.issn.1673-7202.2022.14.015 |
| 中文关键词: 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 |
| English Keywords:Post-marketing Tumor Chinese patent medicines Re-evaluation Safety Efficacy Economy Medicine re-evaluation |
| 基金项目: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） |
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| 中文摘要: |
| 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。 |
| English Summary: |
| 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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