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分级诊疗背景下我国单克隆抗体药物的利用分析
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| 篇名： | 分级诊疗背景下我国单克隆抗体药物的利用分析 |
| TITLE： | Utilization analysis of monoclonal antibodies in China under the background of tiered healthcare delivery system |
| 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。 |
| ABSTRACT： | OBJECT IVE To deeply unders tand 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 bevacizumab（62.89％）. From 2015 to 2019，the number of monoclonal antibody drugs with B/A value of no less than 1 ranked the top 10 of the annual cost were 6，6，6，7 and 5， respectively. CONCLUSIONS In China ，the overall approval and listing speed of monoclonal antibody drugs has accelerated，their quantity has increased rapidly ，and the accessibility is also improved. Among them ，the quantity of monoclonal antibody drugs has increased the fastest in county-level medical institutions ，and they are mainly medical insurance drugs ，and the effect of tiered healthcare delivery system has gradually appeared. |
| 期刊： | 2022年第33卷第01期 |
| 作者： | 李悦，许星莹，魏理，赖云锋 |
| AUTHORS： | LI Yue，XU Xingying ，WEI Li，LAI Yunfeng |
| 关键字： | 单克隆抗体药物；药物利用；分级诊疗；医疗机构 |
| KEYWORDS： | monoclonal antibody drugs ；drug utilization ；tiered healthcare delivery ；medical institution |
| 阅读数： | 330 次 |
| 本月下载数： | 8 次 |
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