国产医用内镜图像处理器及氙 灯冷光源的临床效果研究

The clinical effect of domestic medical endoscope image processor and Xenon lamp cold light source

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（P <0.05），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 AQ-100 medical endoscope image processor and AQL-100 xenon lamp cold light source. 【Methods】 This is a prospective design, randomized, controlled clinical trial, in which 100 patients were randomly divided into the experimental group and the control group. The experiment group adopted the Aohua (Shanghai) endoscopic system, while the control group was treated by OLYMPUS endoscopic system. The main structure, performance, and the safety and the effectiveness were evaluated. 【Results】 The 12 clinical factors in experimental group and the control group including the definition of image enhancement, color customization, HbE, image structure and contour enhancement, frozen playback and storage of image processing, white balance, digital zoom, light staining (CBI), endoscopy automatic identification, character display function and a cold light source pump performance and failure rate, were no significantly differences (P <0.05). The clinical effect and safety was the same in the two groups. 【Conclusion】 The products could meet the requirements of clinical endoscopic diagnosis and treatment. The huge gap between the domestic endoscopy and imported equipment is narrowing, and the endoscopic treatment used in basic hospital is possible.