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历年《新型抗肿瘤药物临床应用指导原则》概况与变迁 Δ

藕顺龙 ，罗 静 ，王 松 ，宋 饶 ，蒋 倩 （1.四川省肿瘤医院研究所/四川省癌症防治中心/电子科技大学
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医学院附属肿瘤医院临床药学部，成都 610041；2.电子科技大学医学院，成都 610041）
中图分类号 R979.1 文献标志码 A 文章编号 1001-0408（2022）11-1392-05
DOI 10.6039/j.issn.1001-0408.2022.11.19

摘 要 目的 为《新型抗肿瘤药物临床应用指导原则》（简称《指导原则》）的后续更新提供建议及参考。方法 对比2018－2021年
版《指导原则》的更新情况，分析其体例变迁以及其中新型抗肿瘤药物的品种数量、适应证分类、作用靶点、医保纳入等情况，并总
结其变迁趋势及可能存在的问题。结果 2020年版《指导原则》的体例较前2版发生了较大变化，删除了“临床应用管理”项，增添
了“附表”项。2018年版《指导原则》纳入新型抗肿瘤药物品种33个，2019、2020、2021年版分别增加至46、60、77个，且新增品种纳
入《指导原则》的时间均为该品种在国内上市当年或之后 1 年。2018 年版《指导原则》纳入的国家医保谈判品种有 26 个，2019、
2020、2021 年版分别在前一版的基础上新增了 8、10、12 个。2018 年版《指导原则》中新型抗肿瘤药物主要作用于 EGFR、HRE2、
VEGFR等传统靶点；但自2019年版《指导原则》起，作用于PD-1、PARP、ALK、CDK等新兴靶点的药物品种数量不断增加，其中国
产原研品种的占比较大。结论《指导原则》体例的更新旨在进一步从卫生专业技术层面指导新型抗肿瘤药物的临床应用；新增品
种、适应证符合科学性、动态性原则；国产原研品种发展迅速，作用于新兴靶点的创新品种涌现。后续《指导原则》的更新应参考国
内外权威诊疗指南、高质量的循证证据，并关注治疗药物缺乏的肿瘤类型和新型抗肿瘤药物的临床价值。
关键词 新型抗肿瘤药物；指导原则；作用靶点；更新；变迁
Overview and changes of Guiding Principles of Clinical Application of Novel Anti-tumor Drugs over the
years
OU Shunlong ，LUO Jing ，WANG Song ，SONG Rao ，JIANG Qian（1. Dept. of Clinical Pharmacy，Sichuan
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Cancer Hospital Institute/Sichuan Cancer Center/the Affiliated Cancer Hospital，School of Medicine，University
of Electronic Science and Technology of China，Chengdu 610041，China；2. School of Medicine，University of
Electronic Science and Technology of China，Chengdu 610041，China）
ABSTRACT OBJECTIVE To provide the suggestions and reference for the follow-up update of Guiding Principles of Clinical
Application of Novel Anti-tumor Drugs（hereinafter referred to as“Guiding Principles”）. METHODS The update of 2018-2021
editions of Guiding Principles were compared；the changes of its style，the variety and quantity of novel anti-tumor drugs，the
classification of indications，the target，the inclusion of medical insurance and other aspects were analyzed. Its change trend and
possible problems were summarized. RESULTS There was a great change in the style of Guiding Principles in 2020 edition，i.e.
deleting the item of“clinical application management”and adding the item of“attached table”. Totally 33 novel anti-tumor drugs
were included in the 2018 edition of Guiding Principles，and the number of novel anti-tumor varieties increased to 46，60 and 77
in 2019，2020 and 2021 editions，respectively. The time when the new varieties were included in Guiding Principles was the same
year or one year after the domestic market time. Totally 26 varieties of national medical insurance negotiation were included in the
2018 edition of Guiding Principles，and 8，10 and 12 varieties were added respectively in 2019，2020 and 2021 editions on the
basis of the previous edition. Novel anti-tumor drug in the 2018 edition of Guiding Principles mainly focused on traditional targets
such as EGFR，HRE2 and VEGFR. However，since 2019，the number of new targets such as PD-1，PARP，ALK and CDK had been
increasing，among which domestic original drugs accounted for a large proportion. CONCLUSIONS The revision of Guiding
Principles aims to further guide the clinical application of novel anti-tumor drugs from the professional level of health technology.
The new varieties and indications conform to the principles of scientificity and dynamics；domestic original varieties have
developed rapidly，and innovative varieties to novel target have emerged. The follow-up update of Guiding Principles should refer
to authoritative medical guidelines and high-quality evidence-
Δ 基金项目：中央高校基本科研业务费项目（面向基础前沿类）
（No.ZYGX2021J038）；四 川 省 卫 生 健 康 委 员 会 医 学 科 技 项 目 based evidence. Attention should be paid to the types of
（No.21PJ115） tumors lacking therapeutic drugs and the clinical value of
＊主管药师，硕士研究生。研究方向：临床药学。E-mail：oushun- novel anti-tumor drugs.
long@sohu.com KEYWORDS novel anti-tumor drugs；guiding principles；
# 通信作者：副主任药师，博士。研究方向：药事管理学研究与实 targets；update；change
践、循证决策与管理。E-mail：jiangqian_3805.student@sina.com

·1392 · China Pharmacy 2022 Vol. 33 No. 11 中国药房 2022年第33卷第11期