可降解冠脉支架的体内外降解研究进展

doi:10.16153/j.1002-7777.2021.02.017

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中国药事 ›› 2021, Vol. 35 ›› Issue (2) : 237-242. DOI: 10.16153/j.1002-7777.2021.02.017

研究进展

可降解冠脉支架的体内外降解研究进展

李敏^1,2#, 付步芳^2#, 于浩^1,2, 姜爱莉^1,*, 付海洋^1,2,*

作者信息 +

Research Progress on Degradation of Biodegradable Scaffolds in vivo and in vitro

Li Min^1,2#, Fu Bufang^2#, Yu Hao^1,2, Jiang Aili^1,*, Fu Haiyang^1,2,*

Author information +

文章历史 +

摘要

目的：收集整理国内外文献对于可降解冠脉支架的研究成果,对其代表性材料进行深入分析,以期对可降解支架的研发与优化提供参考。方法：采用文献研究法,检索PubMed数据库、中国知网数据库、中国万方数据库1998至2020年的文献,从可降解冠脉支架代表性材料的特性、体内外降解情况及面临的挑战方面分别论述。结果与结论：目前的研究方向主要分为可降解金属支架和可降解聚合物支架, 研究较多的冠脉支架材料是镁、铁、锌合金与聚乳酸材料。可降解金属支架支撑性好但降解时间长,且降解速率仍需改善;可降解聚合物支架生物相容性好且降解时间短,但机械性能较弱。不管是金属还是聚合物材料,研究都仅仅处于初期,以后还会有更多可降解材料的发现,可降解冠脉支架是一个持续研究的课题。

Abstract

Objective: To summarize domestic and foreign literature on the research of degradable coronary stents, and conduct in-depth analysis of its representative materials, so as to provide references for the development and optimization of degradable stents. Methods: Using the literature research method, we searched PubMed database, CNKI database, and China Wanfang database from 1998 to 2020, and analyzed the characteristics of representative materials of biodegradable coronary stents, in vivo and in vitro degradation, and challenges. Results and Conclusion: The current research directions are mainly divided into degradable metal stents and degradable polymer stents. The most researched coronary stent materials are magnesium, iron, zinc alloy and polylactic acid materials. The degradable metal stent has good supportability but a long degradation time, and the degradation rate still needs to be improved; the degradable polymer stent has good biocompatibility and shorter degradation time, but its mechanical capacities are weaker. Regardless of whether they are metal or polymer materials, the research is only in the initial stage, and more biodegradable materials will be discovered in the future. Biodegradable coronary stent is an ongoing research topic.

导出引用

李敏, 付步芳, 于浩, 姜爱莉, 付海洋. 可降解冠脉支架的体内外降解研究进展[J]. 中国药事, 2021, 35(2): 237-242 https://doi.org/10.16153/j.1002-7777.2021.02.017

Li Min, Fu Bufang, Yu Hao, Jiang Aili, Fu Haiyang. Research Progress on Degradation of Biodegradable Scaffolds in vivo and in vitro[J]. Chinese Pharmaceutical Affairs, 2021, 35(2): 237-242 https://doi.org/10.16153/j.1002-7777.2021.02.017

中图分类号： R197.39 R9

参考文献

[1] 张啸飞,胡大一,丁荣晶,等. 中国心脑血管疾病死亡现况及流行趋势[J]. 中华高血压杂志,2012,20(6):600.
[2] Mehlika K,Richard P,Geoffrey D R.Abiotic and Biotic Environmental Degradation of the Bioplastic Polymer Poly (lactic acid):A Review[J]. Polymer Degradation and Stability,2017,137:122-130.
[3] Zheng YF,Gu XN,Witte F.Biodegradable Metals[J]. Mater.Sci.Eng.,2014,R77:1.
[4] 杨广鑫,栾景源. 生物可降解金属血管支架研究进展[J]. 中国微创外科杂志,2018,18(8):753-757+760.
[5] Erne P,Schier M,Resink TJ.The Road to Bioabsorbable Stents:Reaching Clinical Reality[J]. Cardiovascular and Interventional Radiology,2006,29(1):11-16.
[6] 吴戍戌,王守仁,刘文涛. 镁及镁合金植入性医疗器械的应用研究进展[J]. 山东科学,2018,31(2):36- 44+54.
[7] 奚廷斐,魏利娜,刘婧,等. 镁合金全降解血管支架研究进展[J]. 金属学报,2017,53(10):1153-1167.
[8] 张小青,李鑫. 可降解AZ31镁合金支架在兔腹主动脉内的降解时间和降解效果[J]. 中国组织工程研究, 2016,20(30):4456-4462.
[9] Zhang J,Li HY,Wang W,et al.The Degradation and Transport Mechanism of a Mg-Nd-Zn-Zr Stent in Rabbit Common Carotid Artery:A20-month Study[J]. Acta Biomaterialia,2018,69:372-384.
[10] Haude M,InceHüseyin,Toelg R,et al.Safety and Performance of the Second-generation Drug-eluting Absorbable Metal Scaffold(DREAMS 2G)in Patients with De Novo Coronary Lesions:Three-year Clinical Results and Angiographic Findings of the BIOSOLVE-II First-in-man Trial[J]. EuroIntervention:Journal of EuroPCR in Collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology,2020,15(15):e1375-e1382.
[11] Andrews NC.Disorders Ofiron Metabolism[J]. New Engl. J.Med.,1999,341:1986-1995.
[12] 徐文利,吴竞尧,谭丽丽,等. 可降解铁基心血管支架材料的研究进展[J]. 材料导报,2012,26(1):75-78.
[13] Zhang E,Chen HY,Shen F.Biocorrosion Properties and Blood and Cell Compatibility of Pure Iron as a Biodegradable Biomaterial[J]. Journal of Materials Science. Materials in Medicine,2010,21(7):2151-2163.
[14] 刘艳秋. 表面沉积薄膜的铁基支架材料与生物机体相互作用研究[D]. 西南交通大学,2015.
[15] Lin WJ,Zhang DY,Zhang G,et al.Design and Characterization of a Novel Biocorrodible Iron-based Drug-eluting Coronary Scaffold[J]. Materials & Design, 2016,91:72-79.
[16] Lin WJ,Qin L,Qi HP,et al.Long-term in Vivo Corrosion Behavior,Biocompatibility and Bioresorption Mechanism of a Bioresorbable Nitrided Iron Scaffold[J]. Acta Biomaterialia,2017,54:454-468.
[17] Chen YQ,Zhang WT,Manfred F M, et al.Comparative Corrosion Behavior of Zn with Fe and Mg in the Course of Immersion Degradation in Phosphate Buffered Saline[J]. Pergamon,2016,111:541-555.
[18] 王利卿,任玉平,秦高梧. 生物可降解锌基合金的研究进展[J]. 稀有金属,2017,41(5):571-578.
[19] Zhao S.Structural Characteristics and Corrosion Behavior of Biodegradable Zn-Li Alloys in Stent Application[D]. MICHIGAN Technological University,2017.
[20] Yang HT,Wang C,Liu CQ,et al.Evolution of the Degradation Mechanism of Pure Zinc Stent in the One-year Study of Rabbit Abdominal Aorta Model[J]. Biomaterials, 2017,145:92-105.
[21] 朱月琳,汤文浩,胡双龙,等. 生物可降解材料聚乳酸在血管支架制备中的应用[J]. 血管与腔内血管外科杂志,2017,3(5):968-971+976.
[22] Ren J.Biodegradable Poly(lactic acid):Synthesis, Modification,Processing and Applications[M]. Beijing: Tsinghua University Press,2011.
[23] Wu YZ,Shen L,Yin JS,et al.Twelve-month Angiographic and Clinical Outcomes of the XINSORB Bioresorbablesirolimus-eluting Scaffold and a Metallic Stent in Patients with Coronary Artery Disease[J]. International Journal of Cardiology,2019,293:61-66.
[24] Wu YZ,Shen L,Yin JS,et al.5 Years of Serial Intravascular Imaging Outcomes of XINSORB Sirolimus- Eluting Bioresorbable Vascular Scaffold[J]. JACC. Cardiovascular Interventions,2019,12(6):602-603.
[25] Xu K,Fu GS,Xu B,et al.Safety and Efficacy of the Novel Sirolimus-eluting Bioresorbable Scaffold for the Treatment of De Novo Coronary Artery Disease:One-year Results from a Prospective Patient-level Pooled Analysis of NeoVastrials[J]. Catheterization and Cardiovascular Interventions: Official Journal of the Society for Cardiac Angiography & Interventions,2019,93(S1):832-838.
[26] Han YL,Xu B,Fu GS,et al.A Randomized Trial Comparing the NeoVasSirolimus-Eluting Bioresorbable Scaffold and Metallic Everolimus-Eluting Stents[J]. JACC. Cardiovascular interventions,2018,11(3):260-272.
[27] Song L,Sun Z,Guan C,et al.First-in-man Study of a Thinner-strut Sirolimus-eluting Bioresorbable Scaffold (FUTURE-I):Three-year Clinical and Imaging Outcomes[J]. Catheter Cardiovasc Interv. 2020, 95Suppl1:648-657.
[28] Xu B,Guan CD,Gao RL.TCT-428 A First-in- Man Study of the Firesorb Sirolimus Target Eluting Bioresorbable Vascular Scaffold in Patients with Coronary Artery Disease(FUTURE-I):Two-Year Clinical and Imaging Outcomes[J]. Journal of the American College of Cardiology,2018,72(13):B172-B173.
[29] Onuma Y,Garg S,Okamura T,et al. Ten-year Follow-up of the IGAKI-TAMAI Stent.A Posthumous Tribute to the Scientific Work of Dr.Hideo Tamai[J]. Eurointervention,2009,5 Suppl F(F):F109-11.
[30] Foin N,Gutiérrez-Chico JL,Nakatani S,et al.Incomplete Stent Apposition Causes High Shear Flow Disturbances and Delay in Neointimal Coverage as a Function of Strut to Wall Detachment Distance: Implications for the Management of Incomplete Stent Apposition[J]. Circulation Cardiovascular Interventions, 2014,7(2):180-189.
[31] Yamawaki T,Shimokawa H,Kozai T,et al.Intramural Delivery of a Specific Tyrosine Kinase Inhibitor with Biodegradable Stent Suppresses the Restenotic Changes of the Coronary Artery in Pigs in Vivo[J]. Journal of the American College of Cardiology,1998,32(3):780-786.
[32] 杨磊,朱良均,杨明英,等. 丝素组织工程支架的研究进展[J]. 蚕业科学,2011,37(2):296-302.
[33] 千建峰,蔡丽慧,亓卫东,等. 不同孔径丝素蛋白支架体内降解观察[J]. 中国生物医学工程学报,2016,35(4):507-511.
[34] 杨磊,陈宇,朱良均,等. 一种新型丝素支架材料的体内降解试验[J]. 蚕业科学,2011,37(4):713-718.