基于真实世界数据的国内外吻合器临床经济性比较研究  

Comparative Study on the Clinical Economy of Domestic and Imported Stapler Based on Real World Data

作　　者：顾伟 周阳 刘杨 潘常青[2] GU Wei;ZHOU Yang;LIU Yang;PAN Changqing(Center of Procurement,Shanghai Chest Hospital,Shanghai 200030,China;Office of Hospital,Shanghai Chest Hospital,Shanghai 200030,China;College of Medical Instruments,Shanghai University of Medicine&Health Sciences,Shanghai 201318,China)

机构地区：[1]上海市胸科医院/上海交通大学医学院附属胸科医院采购中心,上海200030 [2]上海市胸科医院/上海交通大学医学院附属胸科医院院办,上海200030 [3]上海健康医学院医疗器械学院,上海201318

出　　处：《中国医疗设备》2024年第8期126-131,共6页China Medical Devices

基　　金：上海市医院协会医院管理研究基金2022年立项课题(X2022053);国家卫生健康委医院管理研究所课题(20210313)。

摘　　要：目的从经济性角度对国产和进口吻合器在临床手术中的相关费用指标进行分析评价,为同类型产品临床评价的统计学分析及评价方法选择提供参考。方法基于国家制定的真实世界数据指导原则,结合吻合器临床应用,提出吻合器相关真实世界数据研究的路径方法。选取上海市胸科医院胸外科和肿瘤外科2019—2021年共计2000例使用吻合器的手术,其中1000例使用国产吻合器,另外1000例使用进口吻合器,采用描述性统计分析、倾向性评分校正等方法对两组数据中的使用患者、使用效率和经济性差异进行分析。结果使用国产吻合器的手术组平均每台手术吻合器费用和平均每台手术止血耗材费用均显著低于使用进口吻合器的手术组(P<0.001);两组手术时长差异无统计学意义(P=0.900);相关性分析显示吻合器费用与手术时间具有强相关性(r=0.987,P=0.002);而使用进口吻合器与国产吻合器时,吻合器费用占比与止血耗材费用占比差异均无统计学意义(P>0.05)。结论国产吻合器在影响手术直接耗材及相关耗材费用方面具有一定积极作用,建议建立国产吻合器专家共识,为国产医疗器械精细化管理和未来创新技术的发展提供一定的参考依据。Objective To analyze and evaluate the relevant cost indicators of domestic and imported staplers in clinical surgery from an economic perspective,and to provide references for statistical analysis and evaluation method selection of clinical evaluation of similar products.Methods Based on the guiding principles of the real world data formulated by the state and combined with the clinical application of staplers,the path and method of the study of the real world data related to staplers was put forward.A total of 2000 surgical procedures using staplers were selected from the Department of Thoracic Surgery and the Department of Surgical Oncology of Shanghai Chest Hospital from 2019 to 2021,of which 1000 cases used domestic staplers and the other 1000 cases used imported staplers.Descriptive statistical analysis and bias score correction were used to analyze the differences in patients,efficiency and economy of the two groups of data.Results The average cost of stapler per operation and hemostatic consumables per operation in the operation group using domestic stapler were significantly lower than those in the operation group using imported stapler(P<0.001).There was no significant difference in operation duration between the two groups(P=0.900).Correlation analysis showed that stapler cost was strongly correlated with operation time(r=0.987,P=0.002).There was no significant difference in the proportion of stapler cost and hemostatic consumables cost between imported stapler and domestic stapler(P>0.05).Conclusion Domestic staplers have a certain positive effect on affecting the cost of surgical direct consumables and related consumables.It is suggested to establish a consensus of domestic stapler experts to provide a certain reference basis for the fine management of domestic medical devices and the development of future innovative technologies.

关 键 词：吻合器 真实世界数据 医疗器械临床经济性评价 疾病干预结果 

分 类 号：R144[医药卫生—公共卫生与预防医学] R737.9