Phatak Hemant M, Yin Donald D
The State University of New Jersey, Piscataway, NJ 08854, USA.
Curr Med Res Opin. 2006 Nov;22(11):2267-78. doi: 10.1185/030079906X148328.
To examine factors affecting the size of the HbA(1c) response to thiazolidinedione (TZD) therapy.
Meta-analysis of randomized TZD controlled trials which were identified using PubMed, EBSCO and Sci-lit databases and were published in English. Sociodemographic and clinical data were extracted from each trial. HbA(1c) effect size was defined as either a placebo-subtracted change in HbA(1c) or a change in HbA(1c) from baseline. Weighted multivariable regression was used to examine factors associated with changes in HbA(1c). Bootstrapped smearing estimates were computed to obtain reliable estimates of HbA(1c) effect size.
Forty-two trials yielded 60 trial arms which represented 8322 patients treated with thiazolidinediones. Weighted placebo-subtracted change in HbA(1c) was -0.99% +/- 0.02% with an average baseline HbA(1c) of 9.1% +/- 1.0%. Weighted bootstrapped smearing estimate of the placebo-subtracted change in HbA(1c) was -1.02% +/- 0.004%. After controlling for other variables, the baseline HbA(1c) level had a significant negative association with placebo-subtracted HbA(1c) change (p = 0.004) and also with change in HbA(1c) from baseline (p = 0.002). Longer trial duration was associated with greater placebo-subtracted HbA(1c) change (p = 0.01) but not with the change in HbA(1c) from baseline. The multivariable models explained 72% of the variation in placebo-subtracted HbA(1c) change. It was not possible to estimate effects of the run-in period and obesity on TZD effect size.
Baseline HbA(1c) and trial duration significantly impacted the effect size of TZD therapy on HbA(1c). Age, gender, duration of diabetes and prior use of anti-diabetic therapy were not associated with the TZD effect size.
研究影响噻唑烷二酮（TZD）治疗后糖化血红蛋白（HbA1c）反应大小的因素。
对随机TZD对照试验进行荟萃分析，这些试验通过PubMed、EBSCO和Sci-lit数据库检索得到，且以英文发表。从每个试验中提取社会人口统计学和临床数据。HbA1c效应大小定义为HbA1c的安慰剂减去变化值或HbA1c相对于基线的变化值。采用加权多变量回归分析与HbA1c变化相关的因素。计算自抽样涂抹估计值以获得HbA1c效应大小的可靠估计值。
42项试验产生了60个试验组，代表8322例接受噻唑烷二酮治疗的患者。HbA1c的加权安慰剂减去变化值为-0.99%±0.02%，平均基线HbA1c为9.1%±1.0%。HbA1c的安慰剂减去变化值的加权自抽样涂抹估计值为-1.02%±0.004%。在控制其他变量后，基线HbA1c水平与安慰剂减去的HbA1c变化（p = 0.004）以及HbA1c相对于基线的变化（p = 0.002）均呈显著负相关。试验持续时间越长，安慰剂减去的HbA1c变化越大（p = 0.01），但与HbA1c相对于基线的变化无关。多变量模型解释了安慰剂减去的HbA1c变化中72%的变异。无法估计导入期和肥胖对TZD效应大小的影响。
基线HbA1c和试验持续时间显著影响TZD治疗对HbA1c的效应大小。年龄、性别、糖尿病病程和既往抗糖尿病治疗的使用与TZD效应大小无关。
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