食管内放射NiTi支架的研制及临床应用结果

Development and Clinical Application of Esophageal Radiotherapy Stent

目的:针对食管癌"易发,晚期患者生活质量差"的现状,结合普通NiTi记忆合金覆膜支架技术和近距离放射治疗技术,使用网格自扩张式支架形式,在成形NiTi裸支架表面固化一层含放射性同位素125I的医用高分子膜制造成食管内放射NiTi支架。其可设计成局部带放射区域的局部放疗支架,配合带定位功能的输送装置将支架放送到病患部位,达到选择性放疗的目的。方法:通过随机入组的方法招募晚期食管癌或贲门癌患者72例,分别进行普通支架植入(对照组)与食管内放射NiTi支架(试验组)治疗。试验将"消化道梗阻缓解状况"作为主要观察指标,以术后2个月的"消化道梗阻缓解状况"评分下降值作为主要疗效指标。次要观察指标主要为:肉芽组织增生评价、肿瘤大小客观评价、总生存期、血液毒性评价、甲状腺功能评价及产品的使用性能及可操作性评价。结论:125I食管内放射NiTi支架的腔内适形放疗,早期临床使用产生了令人鼓舞的肿瘤局部控制率。由于放射性同位素物理剂量在支架表面的均匀分布,避免了近距离治疗的"冷点"或"盲区",对正常组织的损伤明显降低,与外照射相比,降低了每个照射剂量单位的生物损伤效应。通过对"食管内放射NiTi支架"近百例的临床应用,结果表明治疗效果显著且甲状腺毒性及其他不良反应发生概率与普通NiTi记忆合金食管支架相同,而且此种技术的支架临床使用与普通支架操作一样简单、方便,利于普及。

Purpose： Esophageal cancer has high morbidity, patients lived with poor quality of life. The radioactive stent was developed to help radiotherapy. This stent combined with ordinary NiTi memory alloy coat stent and brachytherapy technology. Which can self-expandable with grid type and with radioisotope 125Ⅰ curing on the surface. The stent can be designed as partial radiotherapy stent. Which can be putted into the lesion parts with the help of positioning function device to achieve the purpose of selectiveradiotherapy. Method： 72 patients with advanced esophageal or cardia cancer patients were recruited, randomized grouping them in two groups. The first group implant ordinary stents and the other group implant radiation NiTi stents. The ＂Relief status of tract obstruction＂ is observed as main index. The observe period last two months. Secondary observe indexes include： granulation tissue, tumor size, overall survival, blood toxicity, thyroid function, product performance and operability. Conclude： The 125I NiTi stent achieved encouraging local tumor control rate. As radioisotope on the surface is uniform distributed, which can avoid ＇Cold Spot＇ or ＇Blind Spot＇ caused by branchytherapy, and reduce the damage to normal tissues. Biological damage per dose is also reduced. By observed about 100 cases of clinical application, the result show that the NiTi stent have significant treatment effect and have the same probability of thyroid toxicity and other adverse reactions compared with ordinary stent. Also it is simple to use and popularize.