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目的：观察国产雷帕霉素药物洗脱支架在冠心病介入治疗中有效性及安全性。方法：2010 年1 月至2010 年12 月我院心血管内科收治并行国产雷帕霉素药物洗脱支架（Firebird 支架）置入术患者124 例，收治并行进口雷帕霉素药物洗脱支架（Cypher^TM支架）置入术患者167例，于不同支架置入患者中各随机选68 例，命名为国产组与进口组。术后1 年、5 年分别随访两组，观察两组患者支架置入后在不同时间段不良心血管事件发生情况及冠脉造影复查结果。结果：两组患者不良事件比较，国产组术后1 年随访结果与术后5 年随访结果比较，差异无统计学意义（P＞0.05）；进口组术后1 年随访结果与术后5 年随访结果比较，差异无统计学意义（P＞0.05）；国产组术后5 年随访结果与进口组术后5 年随访结果比较，差异无统计学意义（P＞0.05）。两组患者冠脉造影复查结果比较，差异无统计学意义（P＞0.05）。结论：国产雷帕霉素药物洗脱支架在冠脉介入治疗中具有安全性和有效性，与进口雷帕霉素药物洗脱支架比较无明显差异，值得临床推广应用。

英文摘要:

Objective:To evaluate the clinical efficacy and safety of domestic rapamycin drug-eluting stents in the interventional therapy of coronary heart disease (CHD).Methods:From January 2010 to December 2010 in Nuclear Industry 215 Hospital of Shaanxi Province, 124 patients with CHD underwent an operation of domestic rapamycin Drug-eluting Stents on the heart (group I)and 167 patients, imported rapamycin Drug-eluting Stents on the heart (group II). Then 68 patients were randomly selected from the two groups, respectively and named domestic and imported group, respectively. The patients in the two groups were followed up a year and five years after operation. The adverse cardiovascular events were observed and compared between the two groups at different time after stent implantation.Results:There were no statistical significance in the incidence of adverse events of the two groups , follow-up results between 1 year and 5 years after surgery in group I and II and follow-up results of 5 years after surgery between group I and II (P>0.05). There were no statistical significance in the results of coronary angiography between the two groups (P>0.05).Conclusion:Domestic rapamycin drug-eluting stent is safe and effective in the interventional therapy of patients with coronary heart disease, and it has no obvious difference compared with the imported one, so it is worthy of clinical application.

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