新型可舒缩泪道支架组织相容性研究  

Histocompatibility of a novel dilatable lacrimal duct stent

作　　者：刘春雨 廖桂仪 黄心瑜 牛国桢 张娟 毕燕龙[1] LIU Chun yu;LIAO Gui yi;HUANG Xin yu;NIU Guo zhen;ZHANG Juan;BI Yan long(Dept.of Ophthalmology,Tongji Hospital,Tongji University,Shanghai 200065,China）Abstract Objective To evaluate the histocompability and safety of a novel dilatable lacrimal duc)

机构地区：[1]同济大学附属同济医院眼科,上海200065

出　　处：《同济大学学报（医学版）》2018年第5期44-48,共5页Journal of Tongji University(Medical Science)

基　　金：上海市普陀区高层次A类人才科研创新项目(2014-A-25);上海市申康医院发展中心-三年行动计划-专科疾病临床"五新"转化项目(16CR3027A);上海市"科技创新行动计划"实验动物研究领域项目(16140900900)

摘　　要：目的评估新型可舒缩泪道支架的组织相容性与材料安全性。方法选取新型可舒缩泪道支架和普通泪道扩张引流管,以浸提液或片段形式作用于实验动物,针对组织相容性各评价指标行随机对照实验。观察比较两种泪道支架作用于实验动物前后的临床表现、组织镜检及生理指标的变化情况。采用方差分析或t检验行统计分析。结果毒性试验两组均无全身中毒反应;局部无明显炎症刺激反应;平均体质量、RBC及WBC手术前后差别均无统计学意义;肌肉刺激试验双侧植入部位未见明显炎症反应;术后4周H-E染色示两组见少量炎症细胞浸润及纤维、血管等结缔组织生长;术后12周H-E染色示实验组肌纤维细胞核位于纤维周边部,组织结构清晰;对照组间质见少量炎症细胞浸润。过敏试验两组小鼠背部皮下注射处均未见明显刺激反应。热原试验两组体温升高均在0. 4℃以内。结论新型可舒缩泪道支架组织相容性检测各指标与传统泪道扩张引流管相比无差异,符合国际医疗器械生物学评价标准。Objective To evaluate the histocompability and safety of a novel dilatable lacrimal ductstent. Methods The histocompability and safety tests were performed with experimental animals onthe extract liquid or fragmant of a novel dilatable lacrimal duct stent （ study group ） and theconventional nasolacrimal duct expansion drainage tube （ control group ）. The indexes ofhistocompatibility and the changes of manifestation and histopathology were compared between twogroups. Results Toxicity test on Kunming mice showed that no systemic toxic reactions and localirritation were observed in both groups; there were no significant differences in the body weight ofmice, RBC count and WBC count before and 2 weeks after treatment between two groups. Musclestimulation test on New Zealand white rabitts showed that no obvious inflammatory responses wereobserved; after 4 weeks of implantation slightly fibrosis and neovascularization were observed in bothgroups; after 12 weeks of implantation in study group muscle fiber nucleus located on the rim of thecell and clear histological structure were observed, while in control group slightly inflammatory cellinfiltration in interstitial was observed. Allergy test on mice showed that no obvious irritation wasobserved after the subcutaneous injection of exract liquid in both groups. Pyrogen test on rabitts showedthat the rise of temperature was less than 0- 4 ℃ after intravenous injection of extract liquid in bothgroups. Conclusion The histocompability and toxicity of the novel dilatable lacrimal duct stent is notdifferent to the conventional nasolacrimal duct expansion drainage tube, indicating that it meets thestandard of biological evaluation of medical device.

关 键 词：泪道支架 可舒缩 组织相容性 泪道阻塞性疾病 泪道扩张引流管 

分 类 号：R77[医药卫生—眼科]