目的: 分析国家药品集中带量采购政策对公立医疗机构药品采购接续期政策效应的持续性。方法: 基于国家药品供应保障综合管理信息平台2018年1月至2020年12月的药品采购数据和两干预点的中断时间序列分析模型,分析7个试点城市公立医疗机构不同中标情况下药品采购量、采购金额、日均费用变化。结果: 试点期中标但接续期未中标的过评仿制药,在试点期政策干预后DDDs水平变化显著（β₂=18713.23,p<0.001）;接续期DDDs水平变化显著（β₄=-22287.48,p=0.002）,趋势变化显著（β₅=-1943.60,p=0.022）,采购金额水平变化显著（β₂=-21869.97,p=0.002）。试点期未中标但接续期中标的药品,在接续期政策干预后DDDs水平变化显著（β₄=19442.77,p<0.001）, 采购金额水平变化显著（β₄=8840.89,p<0.001）。集采品种未过评仿制药品在试点期采购金额水平下降（β₂=-89005.99,p<0.001）,在接续期采购金额呈长期上升趋势（β₄=2538.91,p=0.046）,且采购金额占比在接续期也呈长期上升趋势（β₄=0.52,p=0.011）。结论: 应监测未过评仿制药品日均费用,完善未过评仿制药品挂网退出机制;监测试点期、接续期均未中标药品日均费用,研判其是否存在不合理增长;坚持推进集中带量采购政策,完善配套措施。

Objective: The paper evaluates the impact of national centralized volume-based procurement (NCVBP) on the renewal period in public medical institutions. Methods: Data on the procurement records of drugs from January 2018 to December 2020 were obtained from the China Drug Supply Information Platform (CDSIP). The change of purchase volume, purchase expenditure and daily cost of drugs with different winning bids in the public medical institutions from 7 pilot cities was analyzed. Interrupted time-series analysis (ITSA) with two intervention points was used in this study. Results: The DDDs level of generic drugs passing the consistency evaluation of quality and efficacy (CEQE) which won the bid during the agreement period but failed in the renewal period changed significantly during the agreement period (β₂=18713.23,p<0.001). The change in the DDDs level (β₄ =-22287.48,p=0.002) , the trend (β₅=-1943.60,p=0.022) , and the level of purchase expenditure (β₂=-21869.97,p=0.002) was significant in the renewal period. The DDDs level of drugs which failed in the bid during the agreement period but won the bid during the renewal period changed significantly during the renewal period (β₄=19442.77,p<0.001), and the change of purchase expenditure (β₄=8840.89,p<0.001) was significant. The results showed that purchase expenditure (β₂=-89005.99,p<0.001) of generic drugs which didn’t pass the CEQE in selected drugs decreased during the agreement period. The trend of purchase expenditure (β₄=2538.91,p=0.046) and its proportion (β₄=0.52,p=0.011) was upward in the renewal period. Conclusions: The daily average cost of unapproved generic drugs should be monitored, and the mechanism for listing and unlisting unapproved generic drugs should be improved. We should monitor whether there is an unreasonable increase in the daily cost of drugs failed in the agreement and renewal period, also we should adhere to the policy of centralized NCVBP and improve supporting measures.