一种适用糖尿病患者的新型血管支架材料的生物学效应研究

With the development of society and change of life style, diabetes is becoming the 3rd serious non-infections disease fllowing tumor and cardiovascular disease. The diabetic foot is one of the most severe complication of diabetes, its high incidence and mutilation rate have been a public health problem. Among which, lower extremity vascular disease in diabetics has been considered to be an important reason of diabetic foot development, and also the key factor for the prognosis of patients. In recent years, on the basis of traditional treatment, the implementation of percutaneous angioplasty combined with stent implantation for the treatment of diabetic foot is an emerging clinical approach. The key to be stent materials for diabetics is vascular endothelialization and antibacterial performance. However there are many problems in conventional drug-eluting stent and biodegradable stent with weak bonding force, poor thermostability, and lack of release rule. By adding Cu into the NiTi alloy, endothelialization and antibacterial performance could be realized with long lasting and steady release of cupric ions under high-level glucose. The research on biological effect of NiTi-Cu stent for diabetics is a novel cross of disciplines in the diabetes field, and useful attempt for biomaterials in precision medical.

随着社会发展和生活方式的改变，糖尿病已成为继肿瘤、心血管疾病之后的第三大慢性非传染性疾病。糖尿病足是糖尿病最严重的并发症之一，其高发病率与致残率已成为一个严峻的公共卫生问题。糖尿病患者下肢血管病变是糖尿病足发生发展的重要原因，也是影响糖尿病足预后的重要因素。在传统治疗的基础上，开展经皮血管成形术联合支架植入术治疗糖尿病足是近年新兴的临床手段。糖尿病患者适用的血管支架材料的关键在于兼具促血管内皮化和抗菌功能。然而常规使用的药物洗脱支架和可降解支架尚存在涂层结合力弱、热稳定性差及药物释放速率不规律等问题，在高糖环境下更是难以发挥预期的生物学功能。本项目拟将多功能的铜元素添加至镍钛合金中，实现在高糖环境下能长期持续、安全稳定地释放铜离子，发挥促进血管内皮化和抗菌功能。糖尿病患者适用的新型镍钛铜合金血管支架的生物学效应研究，是糖尿病医学领域中的一次学科交叉尝试，也是生物材料在精准医疗中的有益应用。

随着社会发展和生活方式的改变，糖尿病已成为继肿瘤、心血管疾病之后的第三大慢性非传染性疾病。糖尿病足是糖尿病最严重的并发症之一，其高发病率与致残率已成为一个严峻的公共卫生问题。糖尿病患者下肢血管病变是糖尿病足发生发展的重要原因，也是影响糖尿病足预后的重要因素。在传统治疗的基础上，开展经皮血管成形术联合支架植入术治疗糖尿病足是近年新兴的临床手段。糖尿病患者适用的血管支架材料的关键在于兼具促血管内皮化和抗菌功能。然而常规使用的药物洗脱支架和可降解支架尚存在涂层结合力弱、热稳定性差及药物释放速率不规律等问题，在高糖环境下更是难以发挥预期的生物学功能。本项目将多功能的铜元素添加至镍钛合金中，获得新型镍钛铜合金（NiTi-xCu, x =0, 1, 3, 5 wt.%）。其在高糖环境下长期稳定地促血管内皮化和抗菌功能化，实现糖尿病患者安全、持续和有效地促进目标血管段愈合，并抑制再狭窄的发生。本项目有望有效地预防糖尿病患者介入手术中发生植入物感染和支架植入后再狭窄的发生，实现高糖环境下血管病变的安全有效治疗，为发展糖尿病患者适用的生物医用材料奠定基础，为对糠尿病患者的精准化医疗提供一个新途径。