新型可降解防移位食管支架实验研究

Experimental study on novel biodegradable and anti-displacement esophageal stents

目的通过动物实验探讨新型可降解防移位食管支架的安全性、降解性能及设计策略。方法采用医用聚对二氧环己酮[poly(p-dioxanone),PPDO]编制有"倒刺结"结构(实验组)和无"倒刺结"结构(对照组)的全覆膜分段式食管支架,分别植入巴马猪食管。术后每周1次胃镜检查,直至支架降解滑落。胃镜下观察支架移位、支架降解和食管黏膜增生情况。结果实验组(n=9)、对照组(n=9)实验猪分别植入有"倒刺结"、无"倒刺结"食管支架各9枚,手术均获成功。未出现食管破裂出血、生命体征异常等并发症。术后1、2、4周两组支架移位程度评分差异有统计学意义(P<0.05)。两组支架降解和黏膜增生反应相当,每周评分差异均无统计学意义(P>0.05)。结论新型可降解防移位食管支架植入安全,未发生严重并发症。早期(1~4周内)防移位效果显著,不影响支架降解,不增加食管黏膜增生,有一定的临床应用前景。

Objective To investigate the safety, degradation property and the design of a novel biodegradable and anti-displacement esophageal stent through animal experiment. Methods The novel biodegradable full-covered segmented esophageal stents made with polydioxanone were used in this study.Implantation of stent in Bama pig’s esophagus was performed by using the stent carrying a "barbed knot"(experimental group) or with the stent having no a "barbed knot"(control group). After the implantation of stent, gastroscopic examination was performed once a week until the stents were fully degraded. Observation of stent displacement, stent degradation process, and esophageal mucosal hyperplasia were carried out with gastroscopy. Results The stent with "barbed knot" and the stent with no "barbed knot" were implanted in the pigs of experimental group(n=9) and the the pigs of control group(n=9) separately, and successful implantation was accomplished in all pigs. No complications such as esophageal rupture, hemorrhage and abnormal vital signs occurred. One, 2 and 4 weeks after operation, the difference in stent shifting degree score between the two groups was statistically significant(P<0.05). The stent degradation and mucosal hyperplasia in both groups were similar, and no statistically significant difference in weekly scoring value existed between the two groups(P>0.05). Conclusion The implantation of novel biodegradable and anti-displacement esophageal stent is safe with no severe complications. Its early anti-displacement effect(within 1-4 weeks) is remarkable. The stent degradation process is not affected and the esophageal mucosal hyperplasia will not increase. Therefore, this novel biodegradable and anti-displacement esophageal stent has certain clinical application prospect.