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磁控胶囊内窥镜与标准视频内窥镜胃部检查的盲法随机对照研究

A blind RCT study of gastric examination between capsule endoscope with magnetic guidance and standard video endoscopy
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摘要 目的:对比分析磁控胶囊内窥镜(MCE)与标准视频内窥镜行胃部检查的检测效果。方法:选取在医院行胃部疾病检查的100例患者,采用随机数表法将其分为观察组和对照组,每组50例,对照组采用标准视频内窥镜进行检查,观察组采用MCE进行检查。对比两组胃部息肉、溃疡、胃黏膜下隆起、胃癌等局部病灶检出率,胃内贲门、胃底、胃体、胃角、胃窦、幽门等主要结构可视度,吞咽时间、胃腔检查时间和整体检查时间,以及不良反应发生情况。结果:MCE检查出局灶性病变47例,检出率为94%,高于标准视频内窥镜检出率(80%),差异具有统计学意义(x^(2)=4.332,P<0.05)。MCE检查的可视度中贲门100%、胃底100%、胃体100%、胃角94%、胃窦96%、幽门90%,标准视频内窥镜检查的可视度中贲门92%、胃底90%、胃体92%、胃角80%、胃窦96%、幽门88%,MCE检查的可视度优于标准视频内窥镜检查,其中贲门、胃底、胃体及胃角检查可视度具有统计学意义(x^(2)=4.166,x^(2)=5.263,x^(2)=4.166,x^(2)=4.332;P<0.05)。观察组吞咽时间、胃腔检查时间和整体检查时间均较对照组低,差异有统计学意义(t=3.317,t=6.930,t=9.634;P<0.05);观察组的诊断灵敏度为97.9%,高于对照组的90.9%,差异有统计学意义(x^(2)=5.021,P<0.05);检查过程中观察组不良反应发生率为6.00%,对照组为20.00%,差异有统计学意义(x^(2)=4.332,P<0.05)。结论:采用MCE对胃部检查其可视度较好,能够准确的检查出胃部病灶,虽检查时间较长,检查过程中被检查者的接受度较好且不良反应较少。 Objective:To explore the detection effects of capsule endoscopy with magnetic control and standard video endoscopy in undergoing gastric examination.Methods:A total of 100 patients who underwent gastric examination in the hospital were selected and they were randomly divide them into observation group and control group,with fifty cases in each group.The control group adopted standard video endoscopy to conduct examination,and the observation group adopted capsule endoscopy with magnetic guidance to conduct examination.The detection rates of local lesions of gastric polyps,ulcers,gastric submucosal protrusions and gastric cancer,and the visibilities of main tissues such as gastric cardia,gastric fundus,gastric body,gastric horn,gastric antrum and pylorus,and the swallowing time,the time of gastric cavity examination and the time of the overall examination,as well as the incidence of the adverse reaction,between two groups were compared.Results:The capsule endoscopy with magnetic control diagnosed 47 cases of focal lesions,and the detection rate was 94%,which was significantly higher than that(80%)of the standard video endoscopy,and the difference was statistically significant(x^(2)=4.332,P<0.05).The visibilities of capsule endoscopy with magnetic control for gastric cardia,gastric fundus,gastric body,gastric horn,gastric antrum and pylorus were respectively 100%,100%,100%,94%,96%and 90%%,while the visibilities of standard video endoscopy for them were respectively 92%,90%,92%,80%,96%and 88%,respectively.The visibility of capsule endoscopy with magnetic control was better than that of standard video endoscopy,and the differences of the gastric cardia,gastric fundus,gastric body and gastric horn between two groups were statistically significant(x^(2)=4.166,x^(2)=5.263,x^(2)=4.166,x^(2)=4.332,P<0.05),respectively.The swallowing time,the time of gastric cavity examination and the time of overall examination of the observation group were significantly lower than those in the control group,and the differences of them were statistically significant(t=3.317,t=6.930,t=9.634,P<0.05),respectively.The diagnostic sensitivity of the observation group was 97.9%,which was significantly higher than 90.9%of the control group,and the difference was statistically significant(x^(2)=5.021,P<0.05).During the examination,the incidence of adverse reaction of the observation group was 6.00%,and that of the control group was 20.00%,and the difference was statistically significant(x^(2)=4.332,P<0.05).Conclusion:The capsule endoscope with magnetic control has better visibility for gastric examination,and it can accurately detect gastric lesions.Although the time of examination is longer,the acceptance of the examinees is better during the examination and the adverse reaction of that is less.
作者 朱励 朱金水 达伟 张靖 ZHU Li;ZHU Jin-shui;DA Wei(Department of Gastroenterology,Shanghai Sixth People's Hospital Affiliated to Shanghai JiaoTong University,Shanghai 200233,China)
出处 《中国医学装备》 2023年第10期118-122,共5页 China Medical Equipment
基金 上海市科学技术委员会科研计划(18DZ1930309)“胶囊式内窥镜系统在食管疾病患者复查随访中的应用研究”。
关键词 磁控胶囊内窥镜(MCE) 标准视频内窥镜 胃癌 胃部解剖结构 可视度 Capsule endoscope with magnetic control(MCE) Conventional video endoscope Gastric cancer Anatomical structure of the stomach Visibility
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