可降解室间隔缺损封堵器的安全性与有效性的动物实验研究

Animal study on safety and effectiveness of absorbable ventricular septal occluder

目的评价新型可吸收封堵器的生物安全性、相容性、可行性和有效性,为临床应用提供参考。方法选取实验动物成年比格犬27只,17只实验组用犬通过开胸B超引导下经右室游离壁穿刺室间隔方法复制室间隔缺损(VSD)动物模型,模型犬复制后,即刻植入可吸收VSD封堵器,术后抽血查生化指标,并在第3、6、9和12个月随机处死3只实验组犬和2只对照组犬,取其心脏及其他脏器标本。通过比较血液生化指标、心脏大体标本、病理学、免疫组织化学检查,对其他器官进行病理学检查,评价新型可吸收封堵器植入后的安全性及有效性。结果所有实验用犬均存活,无并发症,病理组织学检查示封堵器逐渐被破坏吸收并完全被纤维组织及内皮细胞覆盖,免疫组织化学检查示封堵器表面逐渐出现上皮细胞,并可见新生血管组织。结论新型可吸收封堵器设计科学合理、操作简便,具有很好的生物相容性,其内皮化完全且迅速,并发症少,可有效的封堵VSD,具有良好的临床安全性应用前景。

Objective To evaluate the safety, biocompatibility and effectiveness of the new absorbable occluder. Methods A total of 27 adult Beagle dogs were enrolled and divided into 2 groups. Ventricular septal defect （VSD） animal models were prepared in experimental group （17 dogs） by open chest. VSD was punctured and the new absorbable occluder was implanted by guiding of transthoracic echocardiography. Laboratory examinations were done after surgery and pathological samples were obtained after euthanasia in the 3rd, 6th, 9th and 12th month. Then the safety and effectiveness were evaluated by comparing laboratory results, clinical and histopathological manifestations of the 2 groups. Results All dogs survived. No complications occurred. Histopathological examination showed the occluders were biocompatible and immunohistochemical examination showed epithelial cells and new vessels were growing on the occluder surface. Conclusions The new absorbable occluder has been proven to be safe, effective and biocompatible in this study.