新型一体化可携带^(125)I粒子胆道内外引流管的设计与临床应用

A new integrated portable biliary internal-external drainage catheter loaded with ^(125)I seeds: its design and clinical application

目的设计新型一体化可携带125I粒子的胆道内外引流管,用于治疗胆管恶性梗阻病变,以达到胆汁引流和腔道内近距离放疗的双重效果。方法 2016年9月至2018年1月郑州大学第一附属医院15例恶性梗阻性黄疸患者行胆管支架植入术,后引入新型一体化可携带125I粒子的胆道内外引流管。评价技术成功率,临床有效率,并发症,支架通畅时间和患者生存期。结果引流管置入简单顺利,技术均获成功。术后1个月胆红素水平较术前明显下降(P<0.01),血象和免疫指标较前无明显变化(P>0.05)。术后2例(13.3%)患者发生胆管炎,2例(13.3%)胆道少量出血,对症治疗后恢复正常。未出现胆管穿孔、严重出血、放射性肠炎和放射源泄漏等严重并发症。随访55～402 d,6例(40.0%)发生胆管再梗阻,支架中位通畅时间255 d,6个月通畅率64.5%。5例死亡,10例存活,9个月存活率64.3%,中位生存时间368 d。结论新型一体化可携带125I粒子的胆道内外引流管可同期实现胆汁引流和近距离放疗,初步临床使用可行、安全、有效,长期疗效需进一步随访观察和对照研究。

Objective To design a new integrated portable biliary internal-external drainage catheter carrying125 I seeds used for the treatment of malignant biliary obstruction lesions so as to achieve the dual curative effects of biliary drainage and brachytherapy. Methods A total of 15 patients with malignant obstructive jaundice, who were admitted to the First Affiliated Hospital of Zhengzhou University, China,during the period from September 2016 to January 2018, were enrolled in this study. Biliary stent implantation was performed in all patients, which was followed by insertion of a new integrated portable biliary internal-external drainage catheter carrying125 I seeds. The technical success rate, clinical success rate, complications, stent patency time and patient survival rate were evaluated. Results The placement of the drainage tube was simple and smooth, and the technical procedure was successful in all patients. One month after treatment, the bilirubin level was decreased significantly when compared with preoperative one(P<0.01), while the blood indexes and immunological indicators showed no obvious changes(P>0.05). After treatment, 2 patients(13.3%) developed cholangitis and 2 patients(13.3%) had small amount of biliary bleeding, which returned to normal after symptomatic treatment. No severe complications such as perforation of bile duct, massive bleeding, radiation enteritis and radioactive source leakage, etc., occurred. The patients were followed up for 55-402 days, 6 patients(40.0%) developed biliary re-obstruction. The median patency time of stent was 255 days, and 6-month stent patency rate was 64.5%. Five patients died and 10 patients survived, the 9-month survival rate was 64.3%, the median survival time was 368 days. Conclusion By using the new integrated portable biliary internal-external drainage catheter carrying125 I seeds, the effects of bile drainage and brachytherapy can be simultaneously achieved. Preliminary clinical practice indicates that this new drainage catheter is feasible, safe and effective, although its long-term efficacy needs to be clarified with further follow-up observations and controlled studies.