一种改良超长胆管支架对胆管狭窄的疗效及安全性分析  

Efficacy and safety analysis of an improved overlength biliary stent in the treatment of biliary stricture

作　　者：李欣 黄永辉[2] 范雪[1] 李海龙[1] 曾冉冉 王泓懿 白鹏 王丽 张蕾[1] 林香春 Li Xin;Huang Yonghui;Fan Xue;Li Hailong;Zeng Ranran;Wang Hongyi;Bai Peng;Wang Li;Zhang Lei;Lin Xiangchun(Department of Gastroenterology,Peking University International Hospital,Beijing 102206,China;Department of Gastroenterology,Peking University Third Hospital,Beijing 100191,China)

机构地区：[1]北京大学国际医院消化内科,北京102206 [2]北京大学第三医院消化内科,北京100191

出　　处：《中华医学杂志》2023年第37期2959-2963,共5页National Medical Journal of China

基　　金：北京大学国际医院院内科研基金重点课题(YN2017ZD05)

摘　　要：目的评估一种改良超长胆管支架治疗胆管狭窄的疗效及安全性。方法前瞻性随机对照研究。将2016年2月至2021年6月于北京大学国际医院确诊为胆管狭窄的患者采用信封随机法分为放置传统塑料胆管支架(CPBS)组和放置改良超长胆管支架(IOBS)组,在内镜下逆行胰胆管造影术(ERCP)乳头插管成功并经造影确定狭窄长度后,分别放置CPBS或IOBS。比较2组患者术后并发症的发生率、术后支架中位通畅时间和6个月内再次手术率等情况,采用Kaplan-Meier法绘制生存曲线,并行log-rank检验,评价IOBS在治疗胆管狭窄中的安全性及有效性。结果共纳入90例患者,IOBS组45例,男28例,女17例,年龄(67.2±11.7)岁;CPBS组45例,男26例,女19例,年龄(64.6±14.4)岁,2组患者均衡可比。2组患者手术成功率、操作时间、住院时间、手术费用、术后并发症发生率间的差异均无统计学意义(均P>0.05)。2组患者术前与术后72 h肝功能指标变化值间的差异均无统计学意义(均P>0.05)。IOBS组支架中位通畅时间长于CPBS组[M(Q_(1),Q_(3)),201(155,246)比109(55,167)d,P=0.002]。6个月内再次手术率IOBS组低于CPBS组[46.2%(18/39)比78.9%(30/38),P=0.003]。结论IOBS治疗胆管狭窄安全性良好,临床疗效优于CPBS。Objective To evaluate the efficacy and safety of an improved overlength biliary stent in the treatment of bile duct stricture.Methods Prospective randomized controlled study.Patients with bile duct stricture in Peking University International Hospital from February 2016 to June 2021 were randomly divided into the conventional plastic biliary stents(CPBS)group and the improved overlength biliary stents(IOBS)group by envelope random method.CPBS or IOBS were placed after endoscopic retrograde cholangiopancreatography(ERCP)breast catheterization was successfully conducted and the stenosis length was determined by angiography.The incidence of postoperative complications,median patency time of postoperative stent and reoperation rate within 6 months were compared between the two groups,Kaplan-Meier method was used to draw the survival curve,and log-rank test was conducted to evaluate the safety and efficacy of IOBS in the treatment of bile duct stricture.Results A total of 90 patients were included.There were 45 patients in IOBS group,including 28 males and 17 females,aged(67.2±11.7)years.There were 45 patients in CPBS group,including 26 males and 19 females,aged(64.6±14.4)years.The patients in the both groups were balanced and comparable.There were no significant differences in success rate of operation,operation time,hospitalization time,operation cost and prospective complication rate between the two groups(all P>0.05).There were no significant differences in the changes of liver function index before and 72 hours after operation between the two groups(both P>0.05).The median patency time of stents in IOBS group was longer than that in CPBS group[M(Q_(1),Q_(3)),201(155,246)vs 109(55,167)d,P=0.002].The IOBS group had lower reoperation rate than the CPBS group within 6 months[46.2%(18/39)vs 78.9%(30/38),P=0.003].Conclusion IOBS has good safety in the treatment of bile duct stricture and the clinical efficacy is superior to CPBS.

关 键 词：胆道疾病 狭窄 支架 安全性 疗效 

分 类 号：R657.4[医药卫生—外科学]