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用于介入心脏病学应用且具有充分药物释放功能的生物可吸收支架的制造与评估。

Fabrication and evaluation of bioresorbable scaffolds for interventional cardiology application with sufficient drug release.

作者信息

Sadeghabadi Asghar, Sadrnezhaad Seyed Khatiboleslam, Asefnejad Azadeh, Hassanzadeh Nemati Nahid

机构信息

Department of Biomedical Engineering, Science and Research Branch, Islamic Azad University, Tehran, Iran.

Department of Materials Science and Engineering, Sharif University of Technology, Tehran, Iran.

出版信息

Iran J Basic Med Sci. 2022 Mar;25(3):372-382. doi: 10.22038/IJBMS.2022.62759.13889.

Abstract

OBJECTIVES

Bioresorbable scaffolds have been advocated as the new generation in interventional cardiology because they could provide temporary scaffolds and then disappear with resorption. Although, the available stents in clinical trials exhibited biosafety, efficacy, no death, and no apparent thrombosis, Mg-substrate degradation on drug release has not been investigated.

MATERIALS AND METHODS

Therefore, more research has been needed to legitimize the replacement of current stents with Mg-based stents. UV-Vis spectrophotometer, scanning electron microscope (SEM), X-ray diffraction (XRD), pH measurement, H₂ evolution, and corrosion tests determined the change in hybrid properties and drug release rate.

RESULTS

The effect of Mg degradation on drug release from poly-L-lactide (PLLA) specimen was much higher than that of the L605/PLLA sample. Hydrogen evolution caused by magnesium degradation compelled everolimus out without significant PLLA decomposition during the first 100 days, while formation of Mg(OH) caused the PLLA to deform and crack.

CONCLUSION

A combined mechanism of lattice/hole diffusion-dissolution governed the release of everolimus with the activation energies of 5.409 kJ/mol and 4.936 kJ/mol for the first 24 hr and diffusion coefficients 6.06×10 and 3.64×10cm/s for the 50 to 100 days. Prolonged suppression of hyperplasia within the smooth muscle cells by hybrid stent insertion could bring about the cessation of restenosis.

摘要

目的

生物可吸收支架被视为介入心脏病学的新一代产品,因为它们能够提供临时支架,随后随着吸收而消失。尽管临床试验中现有的支架显示出生物安全性、有效性、无死亡和无明显血栓形成,但尚未对药物释放时镁基质的降解情况进行研究。

材料与方法

因此,需要更多研究来使镁基支架替代当前支架合法化。紫外可见分光光度计、扫描电子显微镜(SEM)、X射线衍射(XRD)、pH测量、氢气释放和腐蚀测试确定了混合性能的变化和药物释放速率。

结果

镁降解对聚-L-丙交酯(PLLA)样品药物释放的影响远高于L605/PLLA样品。在最初100天内,镁降解引起的氢气释放促使依维莫司排出,而PLLA无明显分解,同时氢氧化镁的形成导致PLLA变形和开裂。

结论

依维莫司的释放受晶格/孔扩散-溶解的联合机制控制,前24小时的活化能为5.409 kJ/mol和4.936 kJ/mol,50至100天的扩散系数为6.06×10和3.64×10cm/s。通过植入混合支架长期抑制平滑肌细胞内的增生可导致再狭窄停止。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/a335/9148394/070427c580e0/IJBMS-25-372-g001.jpg

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