论文部分内容阅读
目的对重叠药物洗脱支架对冠状动脉长病变的治疗效果及非临床评价进行研究。方法对重叠药物洗脱支架在冠状动脉长病变中的应用;药物洗脱支架不同品种的比较;引起支架内血栓的影响因素;以及非临床实验要求,进行了归纳和分析。结果与结论大量临床研究显示,重叠药物洗脱支架的使用在降低再狭窄的同时不会增加心梗或心脏病发作的风险。并且随着重叠药物洗脱支架的大量应用和备受关注,美国食品药品监督管理局(FDA)也颁布了非临床试验要求指南,为广大生产商针对重叠药物洗脱支架的临床前和临床研究进行了指导及规范。
Objective To investigate the therapeutic effect and non-clinical evaluation of overlapping drug eluting stents on long coronary lesions. Methods The application of overlapping drug-eluting stents in long coronary lesions; Comparison of different types of drug-eluting stents; Influencing factors of stent thrombosis; and non-clinical experimental requirements were summarized and analyzed. Results and Conclusions A large number of clinical studies have shown that the use of overlapping drug-eluting stents does not increase the risk of myocardial infarction or heart attack while reducing restenosis. And with the large number of applications and concerns of overlapping drug eluting stents, the U.S. Food and Drug Administration (FDA) has also issued guidelines for nonclinical trial requirements for the majority of manufacturers of pre-clinical and clinical studies of overlapping drug-eluting stents Guided and standardized.