摘要
支架置入术后仍有大约20—30％的患者出现再狭窄，这已成为影响经皮冠状动脉介入治疗(PCI)远期疗效的主要障碍。虽然目前非生物降解药物洗脱支架(drug eluting stent，DES)(如Cypher雷帕霉素洗脱支架，Cordis公司；和Taxus紫杉醇洗脱支架，Boston Scientific公司)在试验和临床应用方面取得了令人瞩目的成就，但非生物降解DES所存在的内皮化延迟、支架内血栓形成、晚期的支架贴壁不良、支架处动脉瘤形成、多聚物引起的炎症反应和过敏反应也越来越引起人们的注意。研究显示，目前使用的非生物降解DES并不减少死亡和急性心肌梗死的发生率。这一结果提示非生物降解DES的支架结构可能需要进一步改进。而可生物降解DES由于可以在体内完全降解，很可能是今后DES发展的一个重要方向。现在我国使用非生物降解DES还较多依赖进口，价格昂贵，限制了其在国内的使用，所以其国产化也势在必行。到目前为止，有关雷帕霉素DES的体内药物代谢动力学研究十分稀少，药物浓度的测定方法也多采用精度较低的高压液相色谱(HPLC)法，而且至今尚无有关可生物降解涂层雷帕霉素DES的体内药物代谢动力学文献报道。
目的
为了研制新一代生物降解DES，并实现其国产化，本研究探索①国产生物降解雷帕霉素药物洗脱支架的构建和体外药物代谢动力学；
Backgroud
The long-term clinical efficacy of intracoronary stenting is limited by restenosis, which occurs in 20% to 30% of patients. The efficiency of the nonbiodegradable drug-eluting stent (DES) (such as Cypher stent from Cordis Inc. and Taxus stent from Boston Scientific Inc.) for preventing in-stent-restenosis (ISR) have been proved by many animal and clinical studies. However, recently, more attentions have been paid to problems of the nonbioabsorbable DES such as delaying of endothelialization, late in stent thrombosis, malapposition, stent related aneurysm, polymer caused inflammatory reaction and allergic response, etc. As pointed out by some studies, up to now, the nonbioabsorbable DES in use can not decrease the mortality rate and the incidence of acute myocardial infarction. These results indicate the nonbioabsorbable DES needs more improvements. Therefore, the bioabsorbable DES which has a complete degradation profile may be a new important direction of DES. So far most of DES are imported from US or European countries. It is necessary to approach a way to manufacture the Drug-eluting stent in
引文
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