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目的设计及制作放射性塑料胆管支架,评价其可行性和安全性。方法设计及制作携带~(125)Ⅰ粒子的塑料支架。选用健康家养猪16只,胆总管植入放射性塑料胆管支架,放射计划系统(TPS)计算距粒子轴心5 mm处的参考点剂量,根据剂量不同分为3个照射组:50 Gy照射组(n=4)、100Gy照射组(n=4)、150Gy照射组(n=4)。另选同级别猪4只,分为2组:空白对照组(n=2),仅作胆管造影,不植入支架;支架对照组(n=2),植入无放射活性碘粒子的塑料支架。术前及支架植入后第1、7、14、30和60天分别检测血常规、血清淀粉酶、肝功能和肾功能。在支架植入后第14、30和60天分别处死动物,观察腹腔有无出血、积液和腹膜炎性反应,胆管有无穿孔、狭窄或者扩张,支架周围脏器有无损伤。胆管组织经H-E染色,光学显微镜分析并摄像。结果成功制作并植入放射性塑料胆管支架,各剂量照射组支架周围脏器无渗出、出血和坏死,未发现胆管穿孔。胆总管病理检查:对照组黏膜和黏膜腺体明显增生;各剂量照射组支架周围黏膜层明显坏死,50 Gy照射组黏膜上皮层缺损,黏膜腺体轻度增生;100 Gy照射组黏膜上皮层消失,黏膜腺体无明显增生;150Gy照射组黏膜上皮层消失,黏膜腺体明显减少。各组外周血实验室检查未见明显变化。结论放射性塑料胆管支架的设计安全、可行,除对胆总管黏膜有机械作用外,照射作用明显。
Objective To design and manufacture a radioactive plastic biliary stent to evaluate its feasibility and safety. Methods Design and manufacture of plastic stent carrying ~ (125) Ⅰ particles. Sixteen healthy pigs were enrolled in this study. Radioactive plastic biliary stents were implanted into the common bile duct. The reference point dose was calculated at 5 mm from the axis of the particle by TPS. According to the dosage, the dose was divided into three groups: 50 Gy group (n = 4), 100Gy irradiation group (n = 4) and 150Gy irradiation group (n = 4). Another 4 pigs of the same level were divided into 2 groups: blank control group (n = 2), only for cholangiography, without stenting; stents control group (n = 2), plastic without radioactive iodine particles Bracket. Blood samples, serum amylase, liver function and renal function were detected on the 1st, 7th, 14th, 30th and 60th day after operation. The animals were sacrificed on the 14th, 30th and 60th day after stent implantation respectively to observe whether the peritoneal cavity had hemorrhage, effusion and peritoneal inflammatory reaction, perforation, stenosis or dilatation of the bile duct, and whether there was damage to the organs around the stent. Biliary tissue was stained with H-E, analyzed by light microscopy and photographed. Results Successful production and implantation of radioactive plastic biliary stents showed no exudation, hemorrhage and necrosis in the organs around the scaffolds in each dose group. No bile duct perforation was found. The pathological examination of the common bile duct: the mucosa and mucosal glands of the control group were significantly proliferated; the mucosal layers around the scaffolds of each dose group were obviously necrotic. The mucosal epithelium defect and mild mucosal gland hyperplasia were observed in 50 Gy irradiation group; , No obvious proliferation of mucosal glands; 150Gy irradiation group mucosal epithelial layer disappeared, mucosal glands significantly reduced. No significant changes in peripheral blood laboratory tests in each group. Conclusion The design of radioactive plastic biliary stents is safe and feasible. In addition to the mechanical effect on common bile duct mucosa, the irradiation is obvious.