中国实用外科杂志

中国实用外科杂志 ›› 2024, Vol. 44 ›› Issue (03): 326-330.DOI: 10.19538/j.cjps.issn1005-2208.2024.03.18

• 论著 • 上一篇    下一篇

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1a，5，刘立科2，居    然3，陶诗然3，刘    科4，李    龙4，谭文君1b，5，胡良硕1b，5，吕    毅1b，5、汤    博4，5   

  1. 1西安交通大学第一附属医院 a.麻醉手术部    b.肝胆外科，陕西西安710061；2陕西省医疗器械质量检验院质量科，陕西咸阳712046；3西安交通大学医学部临床医学系，陕西西安710061；4西安迈格纳特医疗科技有限公司，陕西西安710077；5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
  • 出版日期:2024-03-01 发布日期:2024-04-07

  • Online:2024-03-01 Published:2024-04-07

摘要： 目的    探讨无线胆道造影剂推注系统在临床应用中的安全性和有效性。方法    西安交通大学第一附属医院设计了一项前瞻性、随机、对照的临床试验（2022年6~10月），共纳入200例需要进行胆道造影的病人，随机分为设备组和手动组，分别使用无线胆道造影剂推注系统和传统的手动推注方法进行胆道造影。比较两组病人的造影效果、造影后并发症发生率及操作者遭受的电离辐射量。结果    共纳入设备组95例、手动组98例，两组病人的造影效果差异无统计学意义，均能清晰显示胆道系统结构和病变部位。设备组的造影后并发症发生率为5.3%，显著低于手动组的14.3%（P＜0.05）。设备组的操作者在造影过程中的辐射剂量为0.01（0.01，0.01）μSv，远远低于手动组的3.72（5.15，1.71）μSv（P＜0.001）。结论    无线胆道造影剂推注系统是一种安全有效的胆道造影新方案，在确保造影效果的同时，可以消除操作人员的职业暴露，减少病人的不良反应，值得在临床上推广应用。未来的研究应进一步探讨该系统在不同类型的胆道疾病和不同途径的胆道造影中的适用性和优势。

关键词: 胆道造影, 无线推注系统, 职业暴露, 临床研究

Abstract: Clinical application of a wireless biliary contrast agent injection system: a safety and efficacy study        ZHU Hao-yang*，LIU Li-ke，JU Ran，et al. *Department of Anesthesia and Surgery，the First Affiliated Hospital of Xi’an Jiaotong University，National-Local Joint Engineering Research Center for Precision Surgery & Regenerative Medicine，Xi’an 710061，China
Corresponding author：TANG Bo，E-mail:xamgnt@163.com
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.

Key words: cholangiography, wireless injection system, occupational exposure, clinical research