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目的探讨应用国产及进口西罗莫司洗脱支架在糖尿病患者冠状动脉介入治疗中效果是否相似。方法连续入选行冠状动脉介入治疗的糖尿病患者70例,应用Cypher(进口组;35例78个病变部位)或Firebird(国产组,35例66个病变部位)西罗莫司洗脱支架,术后6个月随访冠脉造影结果及临床事件发生情况。结果术后6个月,进口组患者晚期管腔丢失及支架内再狭窄百分比显著低于国产组,差异有高度统计学意义(P<0.01)。但两组间临床不良事件(包括心源性死亡、急性心肌梗死、靶病变重建、靶血管重建)的差异均无统计学意义(P>0.05)。两组患者在随访期间均未发生支架内血栓。结论进口西罗莫司洗脱支架术后6个月时在造影结果上具有一定的优势,但并没有体现在临床获益上,尚需进一步随访进行深入探讨。
Objective To investigate whether the effects of domestic and imported sirolimus-eluting stents on coronary intervention in patients with diabetes mellitus are similar. Methods Seventy consecutive diabetic patients undergoing coronary artery intervention were enrolled in this study. Cypher (imported group; 35 patients with 78 lesions) or Firebird (native group, 35 patients with 66 lesions) 6-month follow-up of coronary angiography and clinical events. Results At 6 months after operation, the late luminal loss and in-stent restenosis percentage in the imported group were significantly lower than those in the domestic group (P <0.01). However, there was no significant difference in clinical adverse events (including cardiac death, acute myocardial infarction, target lesion reconstruction and target vessel reconstruction) between the two groups (P> 0.05). No stent thrombosis occurred during follow-up in both groups. Conclusions Imported sirolimus-eluting stent has certain advantages in angiography at 6 months after its operation, but it does not reflect the clinical benefit. Further investigation is needed for further follow-up.