全覆膜自膨式金属支架和多根塑料支架治疗良性胆管狭窄的对比研究
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南京医科大学附属杭州医院消化内科

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浙江省自然科学基金(LY17H030003);杭州卫生科技计划(2016ZD01)


Comparison of fully covered self‑expanding metal stents and multiple plastic stents for benign biliary strictures
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Department of Gastroenterolpgy,Hangzhou hospital,Affiliated Nanjing Medical University

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Natural Science Foundation of Zhejiang Province (LY17H030003); Hangzhou Health Science and Technology Plan (2016ZD01)

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    摘要:

    目的:比较全覆膜自膨式金属支架(fully covered self-expanding metal stents,FCSEMS)和多根塑料支架(multiple plastic stents ,MPS)治疗良性胆管狭窄的有效性、安全性和成本效益。 方法:回顾性分析2013年1月—2019年6月在杭州市第一人民医院通过经内镜逆行胰胆管造影术(endoscopic retrograde cholangiopancreatography,ERCP)置入FCSEMS或MPS的107例良性胆管狭窄患者的临床资料。FCSEMS组和MPS组患者分别有54例和53例。患者由CT、磁共振胰胆管成像术(magnetic resonance cholangiopancreatography, MRCP)或超声内镜证实患有良性胆管狭窄。主要研究指标为狭窄缓解率,次要研究指标为狭窄复发率、ERCP相关并发症率、支架迁移率、住院时间和费用等。 结果:FCSEMS组和MPS组中位随访时间分别为10.0(6.5,18.0)个月和12.0(9.0,20.0)个月(P>0.05)。两组患者的狭窄缓解率分别为87.0%(47/54) 和83.0%(44/53),狭窄复发率分别为14.6%(6/41) 和 23.5%(8/34),ERCP相关并发症发生率分别为14.8%(8/54) 和11.9%(13/109),差异均无统计学意义(P均>0.05)。两组患者的支架迁移率分别为22.9%(11/54) 和2.8%(3/109),差异有统计学意义(P<0.001)。成本效益分析表明,两组患者中位ERCP干预次数分别为2(2,2)次及3(2,4)次(P<0.001),中位住院时间分别为6.0(4.0,11.0)d和9.0(6.5,16.0) d (P=0.009)。两组患者中位住院费用分别为44 646元和51 355元,差异无统计学意义(P>0.05)。 结论:FCSEMS在良性胆管狭窄中的有效性、安全性和治疗费用与MPS相似,但减少了ERCP干预次数和治疗周期,即使有一定的迁移率,仍可成为一线治疗方案。

    Abstract:

    Objective To compare the fully covered self-expanding metal stents (FCSEMS) and multiple plastic stents (MPS) in the effectiveness, safety and cost-effectiveness for benign bile duct strictures. Methods A single-center retrospective study was conducted to analyze the clinical data of 107 patients with benign biliary strictures who underwent FCSEMS or MPS implantation through endoscopic retrograde cholangiopancreatography (ERCP) in Hangzhou First People's Hospital from January 2013 to June 2019.There were 54 cases in group FCSEMS and 53 cases in group MPS. Benign biliary stricture was confirmed by computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) and endoscopic ultrasonography. The primary index was the rate of stricture remission, and the secondary indices were the incidence of stricture recurrence, ERCP-related complications, the rate of stent migration, hospital stay and charges. Results The median follow-up times were 10.0 (6.5, 18.0) months and 12.0 (9.0, 20.0) months in group FCSEMS and in group MPS respectively (P>0.05). The rates of stricture remission in the two groups were 87.0% (47/54) and 83.0% (44/53), the incidences of stricture recurrence were 14.6% (6/41) and 23.5% (8/34), and the incidences of ERCP-related complications were 14.8% (8/54) and 11.9% (13/109), respectively. And the differences were not statistically significant (all P>0.05). But the stent migration rates of the two groups were 22.9% (11/54) and 2.8% (3/109) with significant difference (P<0.001). Cost-effectiveness analysis showed that the median numbers of ERCP intervention in the two groups were 2 (2,2) times and 3 (2,4) times (P<0.001), and the median hospital stays were 6.0 (4.0,11.0) days and 9.0 (6.5,16.0) days respectively (P=0.009). The median hospitalization expenses of the two groups were 44 646 yuan and 51 355 yuan without significant difference (P>0.05). Conclusion The effectiveness, safety and cost of FCSEMS for benign bile duct stenosis are similar to those of MPS, but it reduces ERCP intervention and treatment cycles. Even with a certain migration rate, it can still be a first-line treatment approach.

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毛易燊,贾慧,沈红璋,等.全覆膜自膨式金属支架和多根塑料支架治疗良性胆管狭窄的对比研究[J].中华消化内镜杂志,2022,39(3):192-197.

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  • 收稿日期:2020-11-18
  • 最后修改日期:2022-03-01
  • 录用日期:2021-02-26
  • 在线发布日期: 2022-03-01
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