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磁控胶囊内镜系统用于人体胃部检查的可行性和安全性:一项在健康志愿者中的初步研究

Feasibility and safety of magnetic-controlled capsule endoscopy system in examination of human stomach: a pilot study in healthy volunteers.

作者信息

Liao Zhuan, Duan Xiao-Dong, Xin Lei, Bo Lu-Min, Wang Xin-Hong, Xiao Guo-Hua, Hu Liang-Hao, Zhuang Song-Lin, Li Zhao-Shen

机构信息

Digestive Endoscopy Center, Department of Gastroenterology, Chinghai Hospital, Second Military Medical University, Shanghai, China.

University of Shanghai for Science & Technology, Shanghai, China.

出版信息

J Interv Gastroenterol. 2012 Oct-Dec;2(4):155-160. doi: 10.4161/jig.23751. Epub 2012 Oct 1.

Abstract

OBJECTIVE

To assess the feasibility and safety of magnetic-controlled capsule endoscopy (MCE) system for examination of human stomach.

METHODS

This pilot study enrolled 34 healthy volunteers. All subjects swallowed the MCE and gas-producing powder for gastric distention. An external robot was used to generate magnetic field to manipulate MCE inside the stomach. The primary measurements included safety, gastric preparation, maneuverability and visualization of gastric mucosa.

RESULTS

Gastric preparation and examination was well accepted by subjects and there were no adverse events. The examination in the stomach takes 43.8±10.0min (27-60). The cleanliness was evaluated as good in the 30 (88.2%) subjects and as moderate in 4 (11.8%) subjects. The distention of gastric cavity was evaluated as good in the 29 (85.3%) subjects and moderate in 5 (14.7%) subjects. Maneuverability of the MCE to movements of the guidance magnet robot was graded as good in 29 (85.3%) subjects and moderate in 5 (14.7%) subjects. More than 75% gastric mucosa was visualized in 27 (79.4%) subjects and 50% to 75% in 7 (20.6%) subjects. Visualization of the gastric cardia, fundus, body, angulus, antrum and pylorus was subjectively assessed as complete in 82.4%, 85.3%, 100.0%, 100.0%, 100.0% and 100.0%, respectively. Polyp and erosive lesions were found in 7 subjects.

CONCLUSION

Magnetic-controlled capsule endoscopy used for examination of the human stomach is feasible and safe.

摘要

目的

评估磁控胶囊内镜(MCE)系统用于人体胃部检查的可行性和安全性。

方法

这项初步研究纳入了34名健康志愿者。所有受试者吞服了MCE和用于胃扩张的产气粉。使用外部机器人产生磁场以在胃内操纵MCE。主要测量指标包括安全性、胃准备情况、可操作性以及胃黏膜的可视化情况。

结果

受试者对胃准备和检查接受良好,未发生不良事件。胃部检查耗时43.8±10.0分钟(27 - 60分钟)。30名(88.2%)受试者的清洁度评估为良好,4名(11.8%)受试者为中等。29名(85.3%)受试者的胃腔扩张评估为良好,5名(14.7%)受试者为中等。MCE对引导磁体机器人运动的可操作性在29名(85.3%)受试者中评为良好,5名(14.7%)受试者为中等。27名(79.4%)受试者的胃黏膜可视化程度超过75%,7名(20.6%)受试者为50%至75%。胃贲门、胃底、胃体、胃角、胃窦和幽门的可视化主观评估完整性分别为82.4%、85.3%、100.0%、100.0%、100.0%和100.0%。7名受试者发现息肉和糜烂性病变。

结论

磁控胶囊内镜用于人体胃部检查是可行且安全的。

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