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浙江大学学报（医学版）
浙江大学学报（医学版）  2017, Vol. 46 Issue (6): 649-655    DOI: 10.3785/j.issn.1008-9292.2017.12.12
原著     
分段式可降解食管支架的临床前评价
曹洋1(),冯亚东1,焦春花1,施瑞华1,2,*()
1. 南京医科大学第一附属医院消化科, 江苏 南京 210029
2. 东南大学中大医院消化科, 江苏 南京 210009
Segmented biodegradable esophageal stents in a porcine model: preclinical evaluation of degradation, complications and tissue reactions
CAO Yang1(),FENG Yadong1,JIAO Chunhua1,SHI Ruihua1,2,*()
1. Department of Gastroenterology, the First Affiliated Hospital of Nanjing Medical University, Nanjing 210029, China
2. Department of Gastroenterology, Zhongda Hospital, Southeast University, Nanjing 210009, China
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摘要：

目的: 评估分段式无覆膜和全覆膜可降解食管支架应用于难治性良性食管狭窄的可行性。方法: 将无覆膜和全覆膜分段可降解食管支架分别植入巴马猪食管腔内（各6只），每周内镜观察并比较支架降解、支架相关并发症和食管黏膜组织反应。结果: 所有巴马猪健康状态均良好，进食正常，无食欲下降、体质量下降、营养不良和死亡，内镜观察无食管黏膜出血、穿孔、溃疡形成和支架移位发生。两种支架均在第3周开始降解。无覆膜支架在第7~8周出现结构破坏，第9~10周完全降解; 全覆膜支架在第8~9周出现结构破坏，第10~11周完全降解。与无覆膜支架相比，全覆膜支架降解时间较长，支架降解前期黏膜增生组织程度较轻（均P < 0.05）。结论: 分段式可降解食管支架在难治性良性食管狭窄中的应用值得进一步评估。全覆膜支架因具有较长的降解时间，可能更具临床应用优势。
关键词： 食管狭窄/病理学;  支架;  生物降解, 环境;  评价研究;  动物实验    
Abstract:

Objective: To evaluate the feasibility of two types of segmented biodegradable esophageal stents in treatment of refractory benign esophagus strictures. Methods: Uncovered biodegradable segmented stent and fully-covered biodegradable segmented stent were implanted into the porcine esophagus (6 for each). Data on biodegradation, complications, and tissue reactions were compared between two groups. Results: All animals kept good general conditions; no death, decreased food intake, weight loss and malnutrition were observed. No perforation, ulcer, hemorrhage, stent migration and severe complications occurred. Stents degradation commenced at week 3. Stents structure breakage and complete stents absorption occurred at week 7-8 and week 9-10 in uncovered stents. While in fully-covered stents, stents structure breakage and complete stents absorption occurred at week 8-9 and week 10-11. Hyperplasia was prominent at week 1-3 and ameliorated at week 6 after stent implantation. A longer degradation period was present in fully-covered stents than in uncovered stents, while fully-covered stents induced tissue reactions at early stage were mild. Conclusions: The application of biodegradable esophageal stents with a segmented trunk in refractory benign esophagus strictures worth further investigation. The fully-covered stent has longer degradation period, which may be more suitable for clinical use.
Key words: Esophageal stenosis/pathology    Stents    Biodegradation, environmental    Evaluation studies    Animal experimentation
收稿日期: 2017-05-12 出版日期: 2017-12-25
CLC:  R571+.1  
基金资助: 江苏省科技计划(BY2014020)
通讯作者: 施瑞华     E-mail: caoyang@jsph.org.cn;ruihuashi@126.com
作者简介: 曹洋(1973-), 女, 博士, 主任医师, 主要从事食管早期癌的诊断和治疗以及食管良恶性狭窄内镜下扩张和支架置入研究; E-mail:caoyang@jsph.org.cn; https://orcid.org/0000-0003-0565-943X
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曹洋
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引用本文:

曹洋,冯亚东,焦春花,施瑞华. 分段式可降解食管支架的临床前评价[J]. 浙江大学学报（医学版）, 2017, 46(6): 649-655.

CAO Yang,FENG Yadong,JIAO Chunhua,SHI Ruihua. Segmented biodegradable esophageal stents in a porcine model: preclinical evaluation of degradation, complications and tissue reactions. J Zhejiang Univ (Med Sci), 2017, 46(6): 649-655.

链接本文:

http://www.zjujournals.com/med/CN/10.3785/j.issn.1008-9292.2017.12.12    或    http://www.zjujournals.com/med/CN/Y2017/V46/I6/649

图 1  无覆膜和全覆膜分段可降解食管支架示意图
图 2  支架推送系统
评分 增生表现
0 正常食管黏膜，无炎症反应和增生结节
1 局限的炎症反应，增生结节不超过支架平面
2 增生结节超过支架平面，单个增生结节直径小于5 mm
3 增生结节超过支架平面，单个结节直径5~10 mm
4 弥漫性炎症，增生结节直径大于10 mm
5 增生组织部分堵塞食管腔
表 1  食管黏膜组织增生程度分级标准(TRS评分)
图 3  分段可降解食管支架置入体内后降解过程内镜所见
图 4  分段可降解食管支架置入体内后不同时间食管黏膜组织反应内镜所见
($\bar x \pm s$)
组别 n 1周 2周 3周 4周 5周 6周 7周 8周 9周 10周 11周 12周
  —:无相关数据.
无覆膜支架组 6 2.50±0.55 3.33±0.52 3.67±0.52 2.50±0.55 1.83±0.41 1.50±0.55 1.56±0.75 1.00±0.00 1.00±0.00 0.00±0.00 0.00±0.00 0.00±0.00
全覆膜支架组 6 1.67±0.52 2.50±0.54 2.52±0.50 2.33±0.52 2.33±0.52 2.17±0.75 1.83±0.75 1.33±0.52 1.66±0.52 1.00±0.61 0.83±0.41 0.00±0.00
检验值 — 0.022 0.022 0.04 0.559 0.092 0.11 0.664 0.145 0.01 0.003 0.001 —
P值 — ＜0.05 ＜0.05 ＜0.05 ＞0.05 ＞0.05 ＞0.05 ＞0.05 ＞0.05 ＜0.05 ＜0.01 ＜0.01 —
表 2  分段可降解食管支架置入后不同时间食管黏膜组织反应评分比较
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