Page 114 - 《中国药房》2022年1期

·药师与药学服务·

分级诊疗背景下我国单克隆抗体药物的利用分析 Δ

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李 悦 ，许星莹 ，魏 理 ，赖云锋 （1.广州中医药大学公共卫生与管理学院，广州 510006；2.广州医科大学
附属第一医院药学部，广州 510120）
中图分类号 R95；R979.1；R979.5 文献标志码 A 文章编号 1001-0408（2022）01-0104-07
DOI 10.6039/j.issn.1001-0408.2022.01.18

摘 要 目的 深入了解我国单克隆抗体（后文简称“单抗”）药物在不同级别医疗机构中的使用情况，为进一步推进分级诊疗制度
提供实证依据。方法 通过国家药品监督管理局、国家医疗保障局等政府机构官方网站收集我国已上市单抗药物的基本信息，以
了解我国单抗药物的整体发展现状；数据收集的截止时间为2021年5月。通过米内网的“中国公立医疗机构化学药终端”数据库
收集所有抗肿瘤药和免疫机能调节剂类别中单抗药物2015－2019年的临床利用数据，分析单抗药物在不同级别医疗机构的临床
应用情况。结果 截至2021年5月，共有53个单抗药物在我国获批上市，包括31个进口单抗药物和22个国产单抗药物。2015－
2019年，城市医疗机构单抗药物的用药金额和用药数量在3个级别医疗机构中均最高（连续5年两者占比均在95％以上），但县级
医疗机构的用药量增速最快。2019年，用药频度排名前10位的单抗药物用药频度和用药金额累计占比均在县级医疗机构中最
高，分别为97.09％和94.16％。从2015－2019年单抗药物的日均费用变化趋势来看，西妥昔单抗的日均费用降幅最大（70.32％），
然后是曲妥珠单抗（67.29％）和贝伐珠单抗（62.89％）。2015－2019年，每年用药金额排名前10位的单抗药物排序比不小于1的
数量分别是6、6、6、7、5个。结论 我国单抗药物的整体获批上市速度加快、使用量快速增长、可及性提高，其中以县级医疗机构使
用量增速最快，且以医保用药为主，分级诊疗制度的效果逐渐显现。
关键词 单克隆抗体药物；药物利用；分级诊疗；医疗机构

Utilization analysis of monoclonal antibodies in China under the background of tiered healthcare delivery
system
LI Yue ，XU Xingying ，WEI Li ，LAI Yunfeng （1. School of Public Health and Management，Guangzhou
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University of Chinese Medicine，Guangzhou 510006，China；2. Dept. of Pharmacy，the First Affiliated Hospital
of Guangzhou Medical University，Guangzhou 510120，China）
ABSTRACT OBJECTIVE To deeply understand the utilization of monoclonal antibody drugs in different levels of medical
institutions in China，so as to provide an empirical basis for further promoting tiered healthcare delivery system. METHODS The
basic informations of listed monoclonal antibody drugs in China as of May 2021 were collected through the official websites of
government agencies such as National Medical Products Administration and National Healthcare Security Administration，so as to
understand the overall development status of monoclonal antibody drugs in China. The clinical utilization data of monoclonal
antibody drugs in all categories of antitumor drugs and immune modulators were collected through“chemical drug terminal of
Chinese public medical institutions” database of Metnet； the clinical application of monoclonal antibody drugs in medical
institutions at different levels was analyzed. RESULTS As of May 2021，there were 53 monoclonal antibody drugs had been
approved for listing in China，including 31 imported monoclonal antibody drugs and 22 domestic monoclonal antibody drugs. From
2015 to 2019，the amount and quantity of monoclonal antibody drugs used in urban medical institutions were the highest among the
three levels of medical institutions（both accounted for more than 95％ for five consecutive years），but the growth rate of drug use
in county-level medical institutions was the fastest. In 2019，the cumulative proportion of DDDs and drug amount of the top 10
monoclonal antibody drugs ranked in DDDs were the highest among county-level medical institutions，being 97.09％ and 94.16％
respectively. From the change trend of DDDc of monoclonal antibody drugs from 2015 to 2019，DDDc of cetuximab decreased the
most （70.32％），followed by trastuzumab （67.29％） and
Δ 基金项目：广州市科技计划项目（No.202102010186）；广东省中
bevacizumab（62.89％）. From 2015 to 2019，the number of
医药局科研项目（No.20204003）
monoclonal antibody drugs with B/A value of no less than 1
＊ 硕 士 研 究 生 。 研 究 方 向 ：药 物 经 济 与 政 策 。 电 话 ：020-
ranked the top 10 of the annual cost were 6，6，6，7 and 5，
39358970。E-mail：11752259322@qq.com
# 通信作者：讲师，博士。研究方向：药物经济与政策、数字健 respectively. CONCLUSIONS In China，the overall approval
康。电话：020-39358970。E-mail：yunfeng.lai@hotmail.com and listing speed of monoclonal antibody drugs has

·104 · China Pharmacy 2022 Vol. 33 No. 1 中国药房 2022年第33卷第1期