中国组织工程研究

中国组织工程研究 ›› 2012, Vol. 16 ›› Issue (43): 8071-8077.doi: 10.3969/j.issn.2095-4344.2012.43.020

• 材料生物相容性 material biocompatibility • 上一篇    下一篇

冠状动脉内可吸收的镁合金支架

王 萍1，雷力成1，王丽丽1，王汝鹏1，陈丽丽1，崔淯夏1，刘 延1，王 爽1，杨 诺1，徐桂玉1，赵楠楠1，昌 红2，高 丽3， 王尔德4，吴 坤4，崔福斋5，杨静罄5，朱锦文5，杨水祥1   

  1. 首都医科大学附属北京世纪坛医院，1心内科， 2病理科，3动物室，北京市 100038；4哈尔滨工业大学材料系，黑龙江省哈尔滨市 150006；5清华大学材料系，北京市 100084
  • 收稿日期:2012-01-07 修回日期:2012-02-20 出版日期:2012-10-21 发布日期:2012-10-21
  • 通讯作者: 杨水祥，博士，主任医师，教授，首都医科大学附属北京世纪坛医院心内科，北京市 100038 sxyang68@ 163.com
  • 作者简介:王萍☆，女，1977年生，湖北省武汉市人，汉族，2006年阜外医院毕业，博士，主治医师，主要从事心血管内科的临床及实验研究。

Absorbable magnesium alloy stents in the coronary artery

Wang Ping1, Lei Li-cheng1, Wang Li-li1, Wang Ru-peng1, Chen Li-li1, Cui Yu-xia1, Liu Yan1, Wang Shuang1, Yang Nuo1, Xu Gui-yu1, Zhao Nan-nan1, Chang Hong2, Gao Li3, Wang Er-de4, Wu Kun4, Cui Fu-zhai5, Yang Jing-qing5, Zhu Jin-wen5, Yang Shui-xiang1   

  1. 1Department of Cardiology, 2Department of Pathology, 3Animal Rooms, Affiliated Beijing Shijitan Hospital of Capital Medical University, Beijing 100084, China; 4Department of Materials, Harbin Institute of Technology, Harbin 150006, Heilongjiang Province, China; 5Department of Materials, Tsinghua University, Beijing 100084, China
  • Received:2012-01-07 Revised:2012-02-20 Online:2012-10-21 Published:2012-10-21
  • Contact: Yang Shui-xiang, Doctor, Chief physician, Professor, Department of Cardiology, Affiliated Beijing Shijitan Hospital of Capital Medical University, Beijing 100084, China sxyang68@163.com
  • About author:Wang Ping☆, Doctor, Attending physician, Department of Cardiology, Affiliated Beijing Shijitan Hospital of Capital Medical University, Beijing 100084, China

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摘要：

背景：目前以钴铬合金为基础的冠状动脉内药物洗脱支架不能从根本上解决亚急性血栓形成和再狭窄问题，于是生物可吸收支架成为关注的焦点。
目的：评估自行设计制作冠状动脉内可吸收镁合金支架的生物相容性、有效性和安全性。
方法：35只犬均于冠状动脉和/或股动脉置入可吸收镁合金支架1枚，分别于支架置入后24 h、3 d、5 d、1周、2周、3周、4周(n=5)复查冠状动脉及血管造影后取材，分离支架段血管行组织病理观察及计算机图像分析，测量内弹力板面积、管腔面积、内膜增生面积及内膜增生面积百分比。
结果与结论：51枚支架成功置入35只犬的冠状动脉和股动脉，支架置入后不同时点各组冠状动脉及股动脉造影均证实管腔通畅，无狭窄病变，无血栓形成，置入后1周左右支架完全降解。组织病理学结果显示，支架置入后2周开始出现轻微内膜增生，内膜增生面积百分比随着时间的推移逐渐增高。提示自行研发的冠状动脉内可吸收镁合金支架1周内降解，置入早期未见明显炎症反应及血栓形成，再狭窄程度轻，具有良好的生物相容性，安全有效。

关键词: 可吸收镁合金, 支架, 冠状动脉, 病理学, 生物相容性, 生物材料

Abstract:

BACKGROUND: At present, the subacute thrombosis and restenosis cannot be fundamentally resolved by the local drug-eluting stent which is based on cobalt-chromium alloy in the coronary artery. Therefore, the bio-absorbable stents have become the focus.
OBJECTIVE: To evaluate the biocompatibility, effectiveness and safety of absorbable magnesium alloy stents in the coronary artery.
METHODS: Totally 35 immunized hybrid dogs were all implanted an absorbable magnesium alloy stent in the coronary artery and/or the femoral artery. Each dog received the coronary and femoral angiography after implantation for 24 hours, 3 days, 5 days, 1 week, 2 weeks, 3 weeks and 4 weeks respectively. And then the stent arteries were isolated for histopathological analysis and computer image analysis, besides, the elastic lamina area, lumen area, and the percentage of intimal hyperplasia area were measured.
RESULTS AND CONCLUSION: Fifty-one stents were implanted in 35 dog’s coronary and femoral arteries successfully. The angiography of the coronary and femoral arteries at different time points after implantation was found the clear lumen, as well as no constriction and thrombosis; besides, the stent was completely degraded at 1 week after implantation. The results of histopathological analysis showed that there was a slight intimal hyperplasia at week 2 after implantation, and the percentage of hyperplasia area was increased with time. These findings suggest that the absorbable magnesium alloy stent in the coronary artery can be degraded within 1 week, and no significant inflammatory response and thrombosis formation were found, what’s more, restenosis degree was slight. Therefore, this kind of stent has good biocompatibility, effectiveness and safet

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