国产医用内镜图像处理器及氙灯冷光源的临床效果研究

发布时间：2018-09-10 12:42

【摘要】：目的分析国产澳华AQ-100型医用内镜图像处理器及AQL-100型氙灯冷光源的临床效果。方法该临床试验采用前瞻性、随机、对照试验设计,将需做电子内镜检查且符合入排选标准的100例患者随机分成试验组与对照组,试验组采用上海澳华光电内镜有限公司生产的AQ-100型医用内镜图像处理器和AQL-100型氙灯冷光源进行内镜检查,而对照组采用OLYMPUS公司生产的CV-260SL型图像处理装置及CLV-260SL型内镜冷光源进行内镜检查。评价两种内镜系统主要结构、性能等要素是否实质性等同,以及是否具有同样的安全性和有效性。结果试验组与对照组在图像清晰度、色彩定制、血红蛋白强化、图像结构和轮廓强化、冻结回放及存储等图像处理、白平衡、数字放大、分光染色、内镜自动识别、字符显示功能和冷光源气泵性能以及故障率等12个临床评价项目上无实质性差别(P0.05),具有同样的临床效果和安全性。结论该临床试验产品,可以满足内镜临床诊治的要求。国产内镜与进口设备的巨大的差距正在不断缩小,使内镜的诊疗在基层医院开展成为可能。
[Abstract]:Objective to analyze the clinical effect of Australian AQ-100 medical endoscopic image processor and AQL-100 xenon lamp cold light source. Methods the clinical trial was conducted in a prospective, randomized, controlled trial. 100 patients who met the criteria of admission and selection were randomly divided into two groups: the experimental group and the control group. The experimental group used AQ-100 medical endoscopy image processor and AQL-100 xenon lamp cold light source produced by Shanghai Aohua photoelectric Endoscope Co., Ltd to carry out endoscopy. In the control group, CV-260SL image processing device and CLV-260SL cold light source were used for endoscopy. To evaluate the main structure of the two endoscopes, whether the performance of the two systems are substantially equivalent, and whether they have the same safety and effectiveness. Results the experimental group and control group were treated with image definition, color customization, hemoglobin enhancement, image structure and contour enhancement, frozen playback and storage, white balance, digital amplification, spectrophotometric staining, endoscopy automatic recognition, etc. There was no substantial difference in the 12 clinical evaluation items such as character display function cold light source air pump performance and failure rate (P0.05). It had the same clinical effect and safety. Conclusion this clinical trial product can meet the requirements of endoscopic clinical diagnosis and treatment. The huge gap between domestic endoscopy and imported equipment is narrowing, which makes endoscopic diagnosis and treatment possible in primary hospitals.
【作者单位】：复旦大学附属中山医院内镜中心;
【基金】：上海市科委产学研医合作项目(N0:13DZ1940402) 上海市科委医学重点项目(N0:13411950800) 复旦大学附属中山医院青年科学基金(No:2013ZSQN17)
【分类号】：R57

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