共聚焦显微成像系统P9000图像质量评价临床研究  

Clinical Study on Image Quality Evaluation of Confocal Microscopic Imaging System P9000

作　　者：高霞 王林恒[2] 左秀丽[3] 邓佩 宗奕辰 谢金池 孟捷[2] GAO Xia;WANG Linheng;ZUO Xiuli;DENG Pei;ZONG Yichen;XIE Jinchi;MENG Jie(The Second Clinical Medical College,Beijing University of Chinese Medicine,Beijing 100029,China;Department of Gastroenterology,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing 100078,China;Department of Gastroenterology,Qilu Hospital of Shandong University,Jinan Shandong 250012,China)

机构地区：[1]北京中医药大学第二临床医学院,北京100029 [2]北京中医药大学东方医院消化内科,北京100078 [3]山东大学齐鲁医院消化内科,山东济南250012

出　　处：《中国医疗设备》2024年第5期15-19,54,共6页China Medical Devices

基　　金：北京市科技计划项目(Z161100000516058);北京中医药大学重点攻关项目(2020-JYB-ZDGG-132)。

摘　　要：目的评价共聚焦显微成像系统P9000检测人体消化道相关组织的有效性和安全性。方法选取2021年8月至2022年6月在北京中医药大学东方医院和山东大学齐鲁医院行内镜检查的96例患者为研究对象。94例受试者纳入全分析集(Full Analysis Set,FAS),90例患者纳入符合方案集(Per Protocol Set,PPS)。通过多中心、随机、自身对照研究,统计共聚焦显微成像系统P9000与国际公认的Cellvizio®系统检测人体消化道相关组织的图像质量评分一致性和95%CI,以及两组的操作时间和不良反应发生情况。结果FAS和PPS两款器械图像质量评分一致性和95%CI分别为92.55%(87.25%~97.86%)和92.22%(86.69%~97.76%),两者95%CI下限均大于目标值84.6%;两组器械操作时间相当,差异无统计学意义(P>0.05);两组均无设备导致的不良反应发生。结论共聚焦显微成像系统P9000的临床使用有效性和安全性达到了设计要求,值得临床推广应用。Objective To evaluate the effectiveness and safety of confocal microscopic imaging system P9000 in detecting human digestive tract tissues.Methods A total of 96 patients who underwent endoscopy in Dongfang Hospital of Beijing University of Chinese Medicine and Qilu Hospital of Shandong University from August 2021 to June 2022 were selected as study objects.A total of patients were included in the full analysis set(FAS)and 90 were included in the per protocol set(PPS).Through multicenter,randomized and self-controlled study,the consistency rate of image quality score and 95%CI of human digestive tract related tissues were detected by®confocal microscopic imaging system P9000 and internationally recognized Cellvizio system.At the same time,the operation time and adverse reactions of the two groups were also compared.Results In FAS and PPS,the consistency rate of image quality score and 95%CI of the two devices were 92.55%(87.25%-97.86%)and 92.22%(86.69%-97.76%),respectively,and the lower limit of 95%CI of the two analysis sets were greater than the target value of 84.6%.There was no significant difference in the operation time between the two groups(P>0.05).No adverse reactions caused by the equipment occurred in both groups.Conclusion The effectiveness and safety of the confocal microscopic imaging system P9000 can meet the design requirements,and it is worthy of clinical application.

关 键 词：共聚焦显微成像系统 探头式共聚焦激光显微内镜 共聚焦激光显微内镜 图像质量 

分 类 号：R197.39[医药卫生—卫生事业管理]