支气管内径向超声成像系统临床应用的综合评价研究  

Comprehensive Evaluation of the Clinical Application of the Radial Endobronchial Ultrasound System

作　　者：童润 邓明明 杨震[2] 孙加源 尹燕[4] 侯刚 TONG Run;DENG Mingming;YANG Zhen;SUN Jiayuan;YIN Yan;HOU Gang(Department of Respiratory and Critical Care Medicine,Respiratory Center,China-Japan Friendship Hospital(National Center for Respiratory Medicine/Institute of Respiratory Medicine,Chinese Academy of Medical Sciences/National Research Center for Respiratory Diseases/World Health Organization Collaborating Center for Tobacco Cessation and Respiratory Disease Prevention),Beijing 100029,China;Department of Respiratory and Critical Care Medicine,PLA General Hospital,Beijing 100853,China;Department of Respiratory and Critical Care Medicine,Respiratory Endoscopy Center,Shanghai Chest Hospital,Shanghai Jiaotong University,Shanghai 200030,China;Department of Respiratory and Critical Care Medicine,The First Hospital of China Medical University,Shenyang Liaoning 110001,China)

机构地区：[1]中日友好医院呼吸中心(国家呼吸医学中心/中国医学科学院呼吸病学研究院/国家呼吸疾病临床医学研究中心/世界卫生组织戒烟与呼吸疾病预防合作中心)呼吸与危重症医学科,北京100029 [2]解放军总医院呼吸与危重症医学科,北京100853 [3]上海市交通大学附属胸科医院呼吸内镜中心呼吸与危重医学科,上海200030 [4]中国医科大学附属第一医院呼吸与危重症医学科,辽宁沈阳110001

出　　处：《中国医疗设备》2022年第7期68-71,共4页China Medical Devices

基　　金：国家重点研发项目(2018YFC0116203,2018YFC0116203);中国医学科学院中央级公益性科研院所基本科研业务费专项资金资助项目(2020-PT-320-001)。

摘　　要：目的对比北京华科创智公司自主研发的呼吸腔内超声成像系统Vsonic 600 B超声成像系统(由Vsonic 600超声图像处理器、Vsonic Pro2017C超声探头组成)及国外同类呼吸腔内高频超声设备主流产品(奥林巴斯医疗株式会社的EU-ME2超声内镜图像处理装置、UM-S20-17S内镜用超声探头)的技术性能,总结国产产品的优缺点并为产品的改进提供依据。方法通过多中心自身对照研究对比了Vsonic 600 B超声成像系统(试验组)和EU-ME2相关系统(对照组)的图像优秀率、优良率、病变识别率、机器操作时间、机器使用安全性、机器使用稳定性以及不良事件发生的情况。结果本研究共入组受试者75例,男女比例为42∶33,年龄(57.30±10.46)周岁。试验组超声探头的成像能力与对照探头相当,试验设备的超声成像效果与对照设备相当。本研究中试验组及对照组操作中位时间均为8 min,无统计学差异(P>0.05)。对机器使用安全性和机器使用稳定性的统计分析表明,试验组和对照组在临床试验过程中均未发生使用故障,机器均稳定、安全;两组均无不良事件发生。结论本研究证实了国产的Vsonic 600 B超声成像系统在对气管及支气管进行腔内超声成像时的安全性、有效性与已上市的进口同类产品效果相当。Objective To compare the technical performance of Vsonic 600 B ultrasound imaging system(consisting of Vsonic 600 ultrasound image processor and Vsonic Pro2017C ultrasound probe)independently developed by Beijing Huake Chuangzhi Co.,Ltd.and the mainstream products of similar foreign high-frequency endobronchial ultrasound equipment(Olympus EU-ME2 ultrasound endoscope image processor and the UM-S20-17S endoscope ultrasound probe),and to summarize the advantages and disadvantages of domestic products and provide a basis evidence for product improvement.Methods Through a multi-center self-controlled study,the Vsonic 600 B ultrasound imaging system(experimental group)and the EU-ME2 related system(control group)were compared in image excellence rate,image eligible rate,lesion recognition rate,machine operation time,machine safety,machine stability and the occurrence of adverse events.Results A total of 75 subjects were enrolled,the ratio of male to female was 42∶33,with the age ranging(57.30±10.46)years.The imaging capability of the ultrasound probes of the experimental group was equivalent to that of the control probes;thus the ultrasound imaging effect of the experimental equipment was not inferior to the control equipment.In this study,the median operation time of the experimental group and the control group was both 8 min,there was no statistical difference(P>0.05).The statistical analysis of the machine safety and the stability showed that neither the experimental group nor the control group had any malfunction during the clinical trial,and the machine was stable and safe.There were no adverse events in either group.Conclusion This clinical trial verifies the safety and effectiveness of the domestic Vsonic 600 B ultrasound imaging system in endobronchial ultrasound imaging of trachea and bronchus are equivalent to those of imported similar products on the market.

关 键 词：介入肺脏病学 支气管镜 超声支气管镜 腔内超声 国产医疗设备 

分 类 号：R197.39[医药卫生—卫生事业管理]