药物涂层球囊扩张时间与血管吸收药物量的离体实验研究

In Vitro Experiments of Inflation Time and Drug-transfer to Vessel for Drug-coated Balloon

药物涂层球囊是使抑制增生的药物包裹在球囊外表面从而向病变部位转移药物的医疗器械,目前已经被临床广泛应用于治疗血管原位狭窄病变、支架内再狭窄等,并且取得了较好的效果。扩张时间在药物涂层球囊的临床使用中是一个非常重要的因素。该文定量分析药物涂层球囊在植入后扩张时间与血管吸收药物量的关系,为药物球囊的研发和临床使用提供指导。将药物球囊用于离体动物血管试验,测量不同的扩张时间下血管中的药物含量,分析血管吸收药物量与球囊扩张时间的关系。实验结果发现:球囊扩张时间在120s以内,血管对药物的吸收量随着扩张时间的增加而几乎呈线性增加。120s后,血管对药物的吸收量基本维持在15%左右,不再有明显增加。因此,血管对药物吸收量与药物涂层球囊扩张时间之间的关系是非线性的,不同的药物涂层球囊应该通过离体实验确定其在治疗血管狭窄时的最优扩张时间,从而可以使药物涂层球囊治疗效果达到最佳。

Drug-coated balloon(DCB)is a medical device that wraps drugs that inhibit proliferation on the outer surfece of the balloon to transfer drugs to the lesion site,and has been widely used in clinical treatment of vascular stenosis lesions,stent restenosis,etc.,and has achieved good results.Inflation time is a very important factor in the clinical use of drug-coated balloons.The article quantitatively analyzed the relationship between the inflation time of DCB after implantation and the drug-transfer to the vessel to provide guidance for the development and clinical application of DCB.DCBs were used for in vitro animal vascular test to measure the drug content in blood vessel under the different inflation times,and the relationship between the drug-transfer to the vessel and the inflation time was analyzed.The results indicated an almost linear increase of drug-transfer to the vessel with the increase of the inflation time but less than 120s.When the inflation time exceeded 120s,drug-transfer to the vessel was basically maintained at about 15%,no longer raised significantly.The following conclusions are drawn that the relationship between the drug-transfer to the vessel and inflation time is nonlinear,and the optimal inflation time of DCB in the treatment of vascular stenosis should be determined by in vitro testing in order to improve the treatment outcomes.