临床前研究角鲨烷作为药物涂层球囊的赋形剂。
Pre-Clinical Investigation of Keratose as an Excipient of Drug Coated Balloons.
机构信息
Department of Mechanical Engineering, University of South Alabama, Mobile, AL 36688, USA.
iC42 Clinical Research and Development, Department of Anesthesiology, University of Colorado; Aurora, CO 80045, USA.
出版信息
Molecules. 2020 Mar 31;25(7):1596. doi: 10.3390/molecules25071596.
BACKGROUND
Drug-coated balloons (DCBs), which deliver anti-proliferative drugs with the aid of excipients, have emerged as a new endovascular therapy for the treatment of peripheral arterial disease. In this study, we evaluated the use of keratose (KOS) as a novel DCB-coating excipient to deliver and retain paclitaxel.
METHODS
A custom coating method was developed to deposit KOS and paclitaxel on uncoated angioplasty balloons. The retention of the KOS-paclitaxel coating, in comparison to a commercially available DCB, was evaluated using a novel vascular-motion simulating flow model at 1 h and 3 days. Additionally, the locoregional biological response of the KOS-paclitaxel coating was evaluated in a rabbit ilio-femoral injury model at 14 days.
RESULTS
The KOS coating exhibited greater retention of the paclitaxel at 3 days under pulsatile conditions with vascular motion as compared to the commercially available DCB (14.89 ± 4.12 ng/mg vs. 0.60 ± 0.26 ng/mg, = 0.018). Histological analysis of the KOS-paclitaxel-treated arteries demonstrated a significant reduction in neointimal thickness as compared to the uncoated balloons, KOS-only balloon and paclitaxel-only balloon.
CONCLUSIONS
The ability to enhance drug delivery and retention in targeted arterial segments can ultimately improve clinical peripheral endovascular outcomes.
背景
载药球囊（DCB）利用赋形剂输送抗增殖药物，已成为治疗外周动脉疾病的一种新的血管内治疗方法。本研究旨在评估角蛋白（KOS）作为一种新型 DCB 涂层赋形剂用于递送和保留紫杉醇的效果。
方法
开发了一种定制的涂层方法，将 KOS 和紫杉醇沉积在未涂层的血管成形术球囊上。使用新型血管运动模拟流动模型在 1 小时和 3 天评估 KOS-紫杉醇涂层的保留情况，并与市售 DCB 进行比较。此外，在 14 天的兔髂股损伤模型中评估 KOS-紫杉醇涂层的局部生物反应。
结果
与市售 DCB 相比，KOS 涂层在具有血管运动的脉动条件下，在 3 天内保留更多的紫杉醇（14.89 ± 4.12 ng/mg 比 0.60 ± 0.26 ng/mg， = 0.018）。用 KOS-紫杉醇处理的动脉的组织学分析表明，与未涂层球囊、仅 KOS 球囊和仅紫杉醇球囊相比，新生内膜厚度显著减少。
结论
能够增强靶向动脉段的药物输送和保留能力，最终可以改善外周血管腔内治疗的临床结局。
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