课题背景：自雷帕霉素药物洗脱支架(Cypher 强生) 2002年在欧洲市场上市，2003年在美国上市，已有大量临床实验证明它在择期经皮冠状动脉介入治疗中应用有较强的安全性和较好的生物相容性,并可以明显降低再狭窄发生率。但涂层药物在抑制平滑肌细胞增殖的同时也抑制了正常内皮细胞的再生,导致支架置入后血管内皮化过程延迟，出现支架术后急性、亚急性血栓形成的问题。和稳定的冠心病患者相比较,急性心肌梗死患者具有更强的血栓负荷, 药物洗脱支架应用于急诊经皮冠状动脉介入治疗的安全性和有效性目前仍有较大争议。

应用要点：本实验应用雷帕霉素药物洗脱支架治疗老年急性心肌梗死患者71例，验证药物洗脱支架在老年急性心肌梗死急诊介入治疗应用的有效性及安全性，同时对比了国产及进口雷帕霉素药物洗脱支架的临床应用效果。

偏倚或不足：试验在设计中未应用盲法，观察时间短，入选病例偏少，同时由于设备条件限制，缺乏冠状动脉内超声资料，对结果的可靠性有一定影响。

摘要
目的：比较国产雷帕霉素洗脱支架（Firebird支架）和进口雷帕霉素洗脱支架（Cypher支架）在老年急性心肌梗死急诊冠状动脉介入治疗后的生物相容性及其安全性。
方法：选择2005-06/2007-01就诊于唐山工人医院心内科诊断急性心肌梗死且年龄 > 70岁患者共71 例, 患者及家属对治疗和实验知情同意。①采用计算机随机编码分成Cypher支架组37例和Firebird支架组34例。②行急诊介入治疗,共置入Cypher支架43枚,Firebird支架39枚。③随访6~9个月，观察比较置入两种支架后患者心绞痛再发率及主要不良心脏事件。6~9 个月复查冠状动脉造影,测量支架内最小管腔直径、病变节段内最小管腔直径、支架内晚期管腔丢失及节段内晚期管腔丢失。
结果：①两组患者一般情况、病变血管特征、冠状动脉介入治疗手术情况等差异无显著性意义。②临床随访9个月61例，总随访率85.9%（61/71），其中Cypher支架组86.5%（32/37）、Firebird支架组85.3%（29/34），两组比较差异无显著性意义。③主要不良心脏事件：Cypher支架组15.6%, Firbird支架组17.2%，两组比较差异无显著性意义。④复查冠状动脉造影，提示两组患者支架内再狭窄率、支架内最小管腔直径、节段内最小管腔直径、支架内晚期管腔丢失、节段内晚期管腔丢失差异无显著性意义（P > 0.05）。
结论：国产和进口雷帕霉素药物洗脱支架置入老年急性心肌梗死冠状动脉后临床效果有效，无特殊生物相容性和安全性问题，两种支架无明显差异。
关键词：急性心肌梗死；老年患者；雷帕霉素药物洗脱支架；国产；进口

耿学斌，李莉，刘晓坤，赵碧琼，田美蓉．国产及进口雷帕霉素涂层支架在老年急性心肌梗死患者急诊介入治疗中的应用：随机分组随访比较[J].中国组织工程研究与临床康复，2008，12(9):1613-1617
[www.zglckf.com/zglckf/ejournal/upfiles/08-9/9k-1613(ps).pdf]

Domestic versus foreign Rapamycin-eluting stents for emergency percutaneous coronary intervention in elder patients with acute myocardial infarction: Randomized grouping follow-ups

Abstract
AIM: To evaluate the biocompatibility and safety of domestic and foreign Rapamycin-eluting stents (Firebird and Cypher) in emergency percutaneous coronary intervention (PCI) in elder patients with acute myocardial infarction (AMI).
METHODS: From June 2005 to January 2007, seventy-one elder patients (age > 70 years) with AMI were enrolled from Department of Cardiology in Tangshan Worker's Hospital. Informed consents were obtained from all the patients and their relatives.①The patients were divided into two groups at random: Cypher group (n =37) and Firbird group (n =34).②The patients treated with emergency PCI were implanted with 43 Cypher stents and 39 Firebird stents.③The patients were followed up for 6–9 months, then the major adverse cardiac event (MACE) and recurrence ratio of angina pectoris were recorded. In-stent minimal lumen diameter (MLD), in-segment MLD, in-stent late lumen loss (LLL) and in-segment LLL were measured by coronary angiography in two Rapamycin-eluting stents.
RESULTS: ①There were not significant differences in the general conditions, characteristics of affected vessels and the data of PCI between the two groups.②The clinical data in 61 cases for 9 months were not significant different, and the total follow-up rate reached 85.9% (61/71), including 86.5% (32/37) in Cypher group and 85.3% in Firebird group (29/34).③In the follow-up, MACE ratios of the two groups were 15.6% and 17.2%, respectively.④The target restenosis, in-stent MLD, in-segment MLD, in-stent LLL, in-segment LLL were all of no significant differences (P > 0.05).
CONCLUSION: Domestic and foreign Rapamycin-eluting stents are safe and efficient for emergency PCI in elder patients with AMI, without biocompatibility and safety. There are no evident differences in two type stents.

Geng XB, Li L, Liu XK, Zhao BQ, Tian MR.Domestic versus foreign Rapamycin-eluting stents for emergency percutaneous coronary intervention in elder patients with acute myocardial infarction: Randomized grouping follow-ups．Zhongguo Zuzhi Gongcheng Yanjiu yu Linchuang Kangfu 2008;12(9):1613-1617(China)
[www.zglckf.com/zglckf/ejournal/upfiles/08-9/9k-1613(ps).pdf]