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无线胆道造影剂推注系统临床应用安全性和有效性研究

朱皓阳 汤博 刘立科 居然 陶诗然 刘科 李龙 谭文君 胡良硕 吕毅

中国实用外科杂志2024,Vol.44Issue(3):326-330,5.
中国实用外科杂志2024,Vol.44Issue(3):326-330,5.DOI:10.19538/j.cjps.issn1005-2208.2024.03.18

无线胆道造影剂推注系统临床应用安全性和有效性研究

Clinical application of a wireless biliary contrast agent injection system:a safety and efficacy study

朱皓阳 1汤博 2刘立科 3居然 4陶诗然 4刘科 5李龙 5谭文君 6胡良硕 6吕毅6

作者信息

  • 1. 西安交通大学第一附属医院麻醉手术部,陕西西安 710061||西安迈格纳特医疗科技有限公司,陕西西安 710077
  • 2. 西安迈格纳特医疗科技有限公司,陕西西安 710077||精准外科与再生医学国家地方联合工程研究中心,陕西西安 710061
  • 3. 陕西省医疗器械质量检验院质量科,陕西咸阳 712046
  • 4. 西安交通大学医学部临床医学系,陕西西安 710061
  • 5. 西安迈格纳特医疗科技有限公司,陕西西安 710077
  • 6. 西安交通大学第一附属医院肝胆外科,陕西西安 710061||精准外科与再生医学国家地方联合工程研究中心,陕西西安 710061
  • 折叠

摘要

Abstract

Objective To investigate the safety and efficacy of wireless biliary contrast agent injection systems in clinical applications.Methods A prospective,randomized,controlled clinical trial was designed in the First Affiliated Hospital of Xi'an Jiaotong University(June to October 2022).A total of 200 patients requiring cholangiography were randomly divided into an equipment group and a manual group.Cholangiography was performed using a wireless biliary contrast agent injection system and a traditional manual injection method,respectively.The angiographic effect,incidence of post-angiographic complications,and the amount of ionizing radiation suffered by the operator were compared between the two groups.Results A total of 95 patients in the equipment group and 98 patients in the manual group were included in this study.There was no significant difference in the angiographic effect between the two groups,and the structure of the biliary system and the location of the lesion could be displayed.The incidence of post-contrast complications in the equipment group was 5.3%,which was significantly lower than 14.3%in the manual group(P<0.05).The operator in the equipment group had a radiation dose of 0.01(0.01,0.01)μSv during angiography,which was much lower than 3.72(5.15,1.71)μSv in the manual group(P<0.001).Conclusion A Wireless biliary contrast agent injection system is a safe and effective new cholangiography program,that can eliminate the occupational exposure of operators and reduce the adverse reactions of patients while ensuring the contrast effect.It is worthy of being widely popularized in clinical applications.Future studies should further investigate the applicability and advantages of this system in different types of biliary tract diseases and different routes of cholangiography.

关键词

胆道造影/无线推注系统/职业暴露/临床研究

Key words

cholangiography/wireless injection system/occupational exposure/clinical research

分类

医药卫生

引用本文复制引用

朱皓阳,汤博,刘立科,居然,陶诗然,刘科,李龙,谭文君,胡良硕,吕毅..无线胆道造影剂推注系统临床应用安全性和有效性研究[J].中国实用外科杂志,2024,44(3):326-330,5.

基金项目

陕西省自然科学基础研究计划项目(No.2023-JC-QN-0905) (No.2023-JC-QN-0905)

陕西省重点研发计划项目(No.2021GXLH-Z-004) (No.2021GXLH-Z-004)

中国实用外科杂志

OA北大核心CSTPCD

1005-2208

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