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多重双猪尾巴(pigtail)式胆管支架内加入利胆剂对老年难取性胆总管结石有效吗一项前瞻性多中心研究

发布日期:2014-1-29 12:40:13 文章来源:GIE(July,2011) 作者次数:1301

    多重双猪尾巴(pigtail)式胆管支架内加入利胆剂对老年难取性胆总管结石有效吗?一项前瞻性,多中心研究

    背景
    临时性胆管内植入支架在技术上是容易可行的,而且像熊去氧胆酸(UDCA)和一种萜烯制剂的利胆剂可以有效减小结石尺寸。然而关于利胆剂有效性比较资料很少。
    目的
    探讨多重双猪尾巴(pigtail)式胆管支架内加或不加熊去氧胆酸(UDCA)和萜烯对难取性胆总管(CBD) 结石的效能,
    设计方案
    一项前瞻性 ,多中心研究
    环境
    四所第三保健转诊中心(Four tertiary-care referral centers)。
    患者
    此项研究共有51例患者。
    干预
    总体上,用传统方法很难治疗难取性胆总管(CBD)结石,51例患这种结石的老年共病患者被随机分成A、B两组,这两组都需要接受为期6个月的治疗,不同的是A组仅接受多重7F双猪尾巴(pigtail)式支架治疗,B组除接受支架治疗外,还加入UDCA 和萜烯作辅助治疗。
    主要评价指标
    结石直径缩小,成功清除胆管结石及并发症。
    结果
    內镜下完全清除胆管阻塞的,A组有14例,占总数的73.7%;B组有19例,占总数的86.4%(P=0.826)。术前A、B两组CBD结石平均直径(横/纵向直径,平均值±SD)分别为19.12 ± 4.48 mm/20.47 ± 3.86 mm,21.30 ± 7.08 mm/22.58 ± 7.61 mm;术后两组各自缩小到12.04 ± 3.26 mm/13.31 ± 5.12 mm ,13.67 ± 5.40 mm/14.04 ± 6.12 mm(P < .01)。由此看出虽然A、B两组各自减小幅度都很明显,但是两组之间减小幅度没有统计学差异(P = 0.685, P = 0.289)。研究中除了A组中有1例发生胆管炎和B组中有2例支架远端移位外,没有观察到与支架或內镜下操作相关的严重并发症。
    局限性
    东亚患者人数少
    结论
    临时多重双猪尾巴式胆管支架植入术是一种安全可行的治疗老年难取性和大体积CBD结石的方法。它有助于缩小结石直径,成功清除胆道异物。然而加入利胆剂对结石直径减小或管道清除成功率影响无统计学差异。
     
    缩写:CBD为难取性胆总管,UDCA为熊去氧胆酸
     
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    Is the addition of choleretic agents in multiple double-pigtail biliary stents effective for difficult common bile duct stones in elderly patients? A prospective, multicenter study

    Background
    Temporary biliary stenting is both technically easy and feasible, and choleretic agents such as ursodeoxycholic acid (UDCA) and a terpene preparation may promote a reduction in stone size. However, there are few comparative data on the effectiveness of choleretic agents available.
     
    Objective
    To investigate the efficacy of multiple double-pigtail stents with or without UDCA and terpene on difficult common bile duct (CBD) stones.
     
    Design
    A prospective, multicenter study.
     
    Setting
    Four tertiary-care referral centers.
     
    Patients
    This study involved 51 patients.
     
    Intervention
    In total, 51 elderly patients with comorbidities who had difficult CBD stones refractory to conventional methods were randomized to receive either multiple 7F double-pigtail stents (group A) or stents in combination with UDCA and terpene (group B) for a period of 6 months.
     
    Main Outcome Measurements
    Stone size reduction, successful duct clearance, and complications.
     
    Results
    Complete endoscopic duct clearance was achieved in 14 patients (73.7%) in group A and 19 patients (86.4%) in group B (P = .826). The mean size of CBD stones (transverse/longitudinal diameter, mean ± SD) was 19.12 ± 4.48 mm/20.47 ± 3.86 mm in group A and 21.30 ± 7.08 mm/22.58 ± 7.61 mm in group B. Stone size decreased significantly to 12.04 ± 3.26 mm/13.31 ± 5.12 mm and 13.67 ± 5.40 mm/14.04 ± 6.12 mm, respectively (P < .01). However, there was no statistical difference in stone size reduction between the two groups (P = .685, P = .289). No serious complications related to the stent or endoscopic procedures were observed, except for cholangitis (n = 1, group A) and distal stent migration (n = 2, group B).
     
    Limitations
    Small number of patients in East Asia.
     
    Conclusion
    Temporary multiple double-pigtail biliary stenting was a safe and feasible method of treating difficult and large CBD stones in elderly patients and contributed to a reduction in stone size and successful duct clearance. However, the addition of choleretic agents did not result in a statistical difference in stone size or rate of successful duct clearance.
     
    Abbreviations: CBD, common bile duct, UDCA, ursodeoxycholic acid
     
     
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