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目的:探讨低剂量吡格列酮对冠心病合并糖尿病患者接受药物洗脱支架(DES)介入治疗后血管内膜增生和不良临床事件的影响。方法:研究对象包括329例合并糖尿病的冠状动脉(冠脉)疾病患者,常规使用DES,被随机分配到服用吡格列酮组(161例,除应用其他降糖药物外,患者每日服用15mg吡格列酮)和对照组(168例,只接受基础降糖和安慰剂治疗)。术后平均随访时间1年。主要终点为支架内再狭窄(ISR),次要终点为全因死亡、再发心肌梗死、靶血管重建和支架内血栓形成。结果:随访1年,定量冠脉造影分析两组支架内再狭窄率差异有统计学意义(P<0.05)。吡格列酮组心血管不良事件发生率较对照组显著降低(6.08%∶12.08%,P<0.05)。吡格列酮组和对照组全因死亡(0∶1.34%)、再发心肌梗死(2.70%∶4.70%)、靶血管重建(2.03%∶4.03%)和支架内血栓形成(1.35%∶2.01%)的发生率均差异有统计学意义(均P<0.05)。单因素和多因素Cox回归分析基线数据发现,糖化血红蛋白(HbA1c)、是否使用吡格列酮和病变血管支数有预测再狭窄的作用,多因素分析证实只有后两项有独立预测作用。结论:吡格列酮可以减少冠心病合并糖尿病患者接受DES的支架内再狭窄率和不良心血管事件的概率。
Objective: To investigate the effect of low-dose pioglitazone on intimal hyperplasia and adverse clinical events after coronary intervention in patients with coronary heart disease complicated with diabetes mellitus (DES). METHODS: Subjects included 329 patients with coronary artery disease (coronary artery disease) with diabetes mellitus who were randomized to receive pioglitazone (161 patients, taking 15 mg of pioglitazone daily except for other hypoglycemic agents) and Control group (168 patients, only receiving hypoglycemic and placebo). The mean follow-up time was 1 year. The primary endpoint was in-stent restenosis (ISR), with a secondary end point of all-cause death, recurrent myocardial infarction, target revascularization, and stent thrombosis. Results: After one year of follow-up, there was significant difference between the two groups in the rate of coronary artery stenosis by quantitative coronary angiography (P <0.05). The incidence of cardiovascular adverse events in the pioglitazone group was significantly lower than that in the control group (6.08% vs12.08%, P <0.05). Pioglitazone group and control group all-cause death (0: 1.34%), recurrent myocardial infarction (2.70%: 4.70%), target revascularization (2.03%: 4.03%) and stent thrombosis The incidence was significantly different (all P <0.05). Univariate and multivariate Cox regression analysis of baseline data showed that HbA1c, whether or not pioglitazone was used and lesion vessel count were predictive of restenosis. Multivariate analysis confirmed that only the latter two had independent predictors. Conclusion: Pioglitazone can reduce the probability of in-stent restenosis and adverse cardiovascular events in patients with coronary heart disease complicated with diabetes.