罗格列酮对2型糖尿病及糖尿病前期患者大血管事件影响的系统评价

Effects of rosiglitazone on macrovascular events in patients with type 2 diabetes mellitus and prediabetes:a systematic review

目的讨论罗格列酮对2型糖尿病及糖尿病前期患者大血管事件的影响。方法按照国际Cochrane协作网的系统评价方法 ,检索关于罗格列酮对2型糖尿病或糖尿病前期患者大血管系统影响的临床随机对照试验,对照治疗包括安慰剂或阳性对照药物,其随访时间至少1年以上。由两位研究者独立地对符合纳入标准的试验进行质量评价和资料提取。采用下列指标对罗格列酮对2型糖尿病及糖尿病前期患者大血管系统的影响进行Meta分析:全因死亡、全部心血管事件、心肌梗死事件、心力衰竭事件、心血管死亡事件、脑卒中事件、周围血管事件。结果 5个试验符合纳入标准,包括11871例2型糖尿病及糖尿病前期患者。长期罗格列酮治疗与其它对照治疗比较,可能增加其心力衰竭事件(P<0.01)的发生率,但是对其全因死亡事件(P=0.42)、全部心血管事件(P=0.11)、心肌梗死事件(P=0.09)、心血管死亡事件(P=0.80)、脑卒中事件(P=0.18)及周围血管事件(P=0.32)发生率的影响差异无统计学意义。结论罗格列酮治疗糖尿病及糖尿病前期患者可能增加心力衰竭事件的发生,对于全因死亡事件、全部心血管事件、心血管死亡事件、脑卒中事件、周围血管事件等影响不大;而对于心肌梗死事件则有一定的增加其风险的趋势,但差异并不显著。

Objective To assess the effect of rosiglitazone on macrovascular events in patients of type 2 diabetes mellitus and prediabetes by systematic review. Methods According to the guideline of Cochrane, all randommised controlled trims （RCT） concerning effects of rosglitazone on macrovascular events for type 2 diabetes mellitus or prediabetes were searched. Control group included placebo or controlled positive drugs, and the duration of follow-up was required at least for one year. Data extraction and quality assessment of relevant RCTs were performed by two reviewers independently. The follow- ings were used to Meta analyse for the effects of rosiglitazone on macrovascular events ： all-cause mortality, all cardiovas- cular events, myocardial infarction, heart failure, cardiovascular death, stroke, peripheral vascular events. Results Five RCTs including 11 871 patients of type 2 diabetes mellitus and prediabetes met the inclution criterias. Heart failure events （P〈0.01） increased significantly in the long-term rosiglitazone group than in the control group. But no differences were found in the incidence of all-cause mortality （P=0.42）, all cardiovascular events （P=0.11）, myocardial infarction events （P= 0.09）, cardiovascular death events （P=0.80）, stroke events （P=0.18） and peripheral vascular events （P=0.32）. Conclusions This review indicated that rosiglitazone may increase the heart failure events, but affect little on all-cause mortality, all cardiovascular events, cardiovascular death, stroke and peripheral vascular events. It may increase the potential risk of myocardial infarction, but the effect is not obvious.