胆道可吸收支架的体内实验研究

The Study of the Biodegradable Biliary Duct Stent in Vivo

评价一种可吸收胆道支架在家犬胆肠吻合术中应用的安全性和有效性。将18只急性梗阻性黄疸家犬随机分为实验组和对照组,每组9只。对照组单纯行Roux-en-Y胆肠吻合术;实验组行Roux-en-Y胆肠吻合术,并在胆肠吻合口置入可吸收支架。通过为期3个月的观察,了解支架体内降解特点和组织相容性。结果显示:对照组胆漏发生率明显高于实验组,但组间无显著差异(P>0.05);体外X线摄影发现:体内胆管支架轮廓完整,固定良好;术后对照组较实验组家犬胆肠吻合口直径明显缩窄(P<0.05);支架内无明显胆泥附着。组织学检查显示实验组胆管及十二指肠黏膜未见明显炎症反应和上皮增生。因此,左旋聚乳酸(PLLA)和聚乳酸乙醇酸(PLGA)共混制成的胆道支架具有体内降解周期较长(>3月),组织相容性良好的特点,能有效防止胆肠吻合术后胆漏、胆肠吻合口狭窄的发生。

The present paper is aimed to evaluate safety and efficiency of a biodegradable biliary stent used in the Roux-en-Y cholangiojejunostomy of dogs in vivo.We separated 18 hybrid dogs into control group and experimental group randomly,with each group 9 dogs.The Roux-en-Y cholangiojejunostomy was carried out in the two groups.We placed the biodegradable stents into the anastomotic stoma of the dogs in the experimental group during the operation.After 3 months＇ close observation,we evaluated the degradable property and biocompatibility of the stents.We found that the morbidity rate of bile leakage in the dogs in the control group was much higher than that in the experimental group（P0.05）.The X-ray photograph showed that the figures of the stents were complete and the stents were fixed at right place throughout the experimental period.The diameter of the dogs＇ common bile ducts of control group narrowed down obviously compared to those in the experimental group（P0.05）.There were no impure materials adhered to the inside walls of the stents.The pathological test showed that there were no inflammation signs in mucous membrane and abnormal epithelium hyperplasia of the bile tract and jejunum.It can be concluded that the biliary duct stent,which was made with a mixture of poly-L-lactic acid（PLLA） and poly lactide-co-glycolide（PLGA）,possesses qualities of relatively long degradable period（3 months） and good biocompatibility.Moreover,using the stent can effectively prevent bile leakage and anastomotic stom stenosis in the cholangio-intestinal anastomosis from happening.