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2 型糖尿病中基线 HbA1c、HbA1c 变化和 HbA1c 目标<7%与胰岛素类似物的关系:一项随机对照试验的荟萃分析。

Relationship of baseline HbA1c, HbA1c change and HbA1c target of < 7% with insulin analogues in type 2 diabetes: a meta-analysis of randomised controlled trials.

机构信息

Department of Geriatrics and Metabolic Diseases, Second University of Naples, Naples, Italy.

出版信息

Int J Clin Pract. 2011 May;65(5):602-12. doi: 10.1111/j.1742-1241.2010.02619.x.

Abstract

AIM

We performed a meta-analysis of randomised controlled trials (RCTs) with insulin analogues in type 2 diabetes utilising a least-squared regression model in order to assess the relationship between baseline HbA1c, the magnitude of HbA1c decrease and attainment of HbA1c target of < 7%.

METHODS

Randomised controlled trials involving insulin regimens (basal, prandial, biphasic and basal-bolus) were identified through electronic searches (MEDLINE, EMBASE, CINAHL and The Cochrane Library) through September 2010. We included any study arm of RCTs if they were at least 12 weeks in duration; the number of patients in any arm was more than 30 and reported the baseline HbA1c and change from baseline HbA1c.

RESULTS

We found 87 studies, with a total of 135 arms, and 38,803 patients. The weighted R(2) values for the overall analysis assessing the association between baseline HbA1c and absolute change in HbA1c or the proportion of patients at target were 0.485 (p < 0.001) and 0.146 (p < 0.001), respectively. Subanalyses of insulin regimens for the association between basal HbA1c and absolute decrease of HbA1c produced weighted R(2), which were significant for all insulin regimens with the highest association for basal-bolus (R(2) = 0.719, p < 0.001).

CONCLUSIONS

The strong positive relationship between baseline HbA1c and the magnitude of HbA1c change we found in RCTs using insulin analogues in type 2 diabetes should be considered when assessing the clinical efficacy of insulin therapies.

摘要

目的

我们采用最小二乘法回归模型对 2 型糖尿病中使用胰岛素类似物的随机对照试验(RCT)进行了荟萃分析,以评估基线 HbA1c、HbA1c 降低幅度与 HbA1c 目标<7%达标率之间的关系。

方法

通过电子检索(MEDLINE、EMBASE、CINAHL 和 Cochrane Library),于 2010 年 9 月前检索到包含胰岛素方案(基础、餐时、双相和基础-餐时)的 RCT。如果研究臂的 RCT 至少持续 12 周,任何研究臂的患者人数超过 30 人,并且报告了基线 HbA1c 和基线 HbA1c 的变化,则纳入任何研究臂。

结果

我们发现了 87 项研究,共有 135 个研究臂,涉及 38803 名患者。总体分析评估基线 HbA1c 与 HbA1c 绝对变化或达标患者比例之间的相关性的加权 R²值分别为 0.485(p<0.001)和 0.146(p<0.001)。对胰岛素方案的亚组分析显示,基础 HbA1c 与 HbA1c 绝对降低量之间存在相关性,所有胰岛素方案的加权 R²均有显著差异,其中基础-餐时胰岛素方案的相关性最高(R²=0.719,p<0.001)。

结论

我们在使用胰岛素类似物治疗 2 型糖尿病的 RCT 中发现了基线 HbA1c 与 HbA1c 降低幅度之间的强正相关关系,在评估胰岛素治疗的临床疗效时应予以考虑。

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