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他汀类药物治疗对糖尿病患者血管内皮功能影响的荟萃分析。

Meta-analysis of the effects of statin therapy on endothelial function in patients with diabetes mellitus.

机构信息

Department of Cardiology, Fuwai Hospital and Cardiovascular Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.

出版信息

Atherosclerosis. 2012 Jul;223(1):78-85. doi: 10.1016/j.atherosclerosis.2012.01.031. Epub 2012 Jan 23.

Abstract

BACKGROUND

Controversies exist among trials reporting the effects of statins on endothelial dysfunction in patients with diabetes mellitus (DM). Therefore, we performed a meta-analysis to determine whether statin therapy could improve endothelial dysfunction in patients with DM.

METHODS

PubMed, Cochrane and Embase were searched for randomized controlled trials of statins. Only trials reporting changes in flow-mediated dilatation (FMD) were included in this analysis. A meta-analysis was performed to assess the relationship between statin therapy and improvements in endothelial dysfunction. Meta-regression and subgroup analyses were done to identify sources of heterogeneity.

RESULTS

Ten statin studies (845 patients) were included in this analysis. Statin therapy significantly improved FMD in patients with DM [weighted mean difference (WMD): 0.94%; 95% CI: 0.38%, 1.5%; P<0.001]. Although heterogeneity among trials was found (I(2): 67%), no significant publication bias was detected. Subgroup analyses showed that patients did not benefit from statin therapy if their body mass index (BMI) was>27.6 kg/m(2) (four trials; I(2): 0%; WMD: 0.11%; 95% CI: -0.47%, 0.70%; P=0.70). However, FMD was significantly improved among patients with BMI ≤27.6 kg/m(2) (five trials; I(2): 14%; WMD: 1.52%; 95% CI: 1.19%, 1.85%; P<0.001). Type 1 diabetes, younger age, lower baseline blood lipid levels and blood pressure were all associated with improvements in FMD. The meta-regression analysis yielded similar results.

CONCLUSION

Statins significantly improved the FMD only in patients with better endothelial functions. The use of FMD in evaluating therapeutic outcomes should be careful in populations at high risk.

摘要

背景

在报告他汀类药物对糖尿病患者内皮功能影响的临床试验中存在争议。因此,我们进行了一项荟萃分析,以确定他汀类药物治疗是否可以改善糖尿病患者的内皮功能障碍。

方法

我们检索了 PubMed、Cochrane 和 Embase 中的随机对照试验。只有报告血流介导的扩张(FMD)变化的试验才包括在本分析中。进行荟萃分析以评估他汀类药物治疗与改善内皮功能障碍之间的关系。进行了荟萃回归和亚组分析以确定异质性的来源。

结果

本分析纳入了 10 项他汀类药物研究(845 例患者)。他汀类药物治疗可显著改善糖尿病患者的 FMD[加权平均差异(WMD):0.94%;95%CI:0.38%,1.5%;P<0.001]。尽管试验之间存在异质性(I²:67%),但未检测到显著的发表偏倚。亚组分析表明,如果患者的体重指数(BMI)>27.6 kg/m²(四项试验;I²:0%;WMD:0.11%;95%CI:-0.47%,0.70%;P=0.70),则患者无法从他汀类药物治疗中获益。然而,BMI≤27.6 kg/m²的患者中 FMD 显著改善(五项试验;I²:14%;WMD:1.52%;95%CI:1.19%,1.85%;P<0.001)。1 型糖尿病、年龄较小、较低的基线血脂水平和血压均与 FMD 的改善相关。荟萃回归分析得出了类似的结果。

结论

他汀类药物仅在具有更好内皮功能的患者中显著改善 FMD。在高危人群中,使用 FMD 评估治疗结果时应谨慎。

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