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皮肤自发荧光测量值在 6 周和 12 周时的变异性及苯磷硫胺治疗的影响。

Variability of skin autofluorescence measurement over 6 and 12 weeks and the influence of benfotiamine treatment.

机构信息

Diabetes Clinic, Heart and Diabetes Center NR, Ruhr University Bochum, Bad Oeynhausen, Germany.

出版信息

Diabetes Technol Ther. 2013 Sep;15(9):733-7. doi: 10.1089/dia.2013.0103. Epub 2013 Aug 21.

DOI:10.1089/dia.2013.0103
PMID:23964994
Abstract

BACKGROUND

Measurements of skin autofluorescence (SAF) allow for a simple and noninvasive quantification of tissue advanced glycation end-products (AGEs), a marker linked to the risk of diabetes complications. The aim of this study was to test the repeatability of SAF over 6 and 12 weeks and to test whether benfotiamine, a thiamine prodrug suggested to reduce AGEs formation under hyperglycemic conditions, is able to attenuate SAF when administered over 6 weeks.

PATIENTS AND METHODS

In a double-blind, placebo-controlled, randomized, crossover study, 22 patients with type 2 diabetes mellitus (T2DM) received 900 mg/day benfotiamine or placebo for 6 weeks (washout period of 6 weeks between). At the beginning and at the end of each treatment period, SAF was assessed in the fasting state, as well as 2, 4, and 6 h following a mixed test meal.

RESULTS

The respective intra-individual and inter-individual variability of fasting SAF was 6.9% and 24.5% within 6 weeks and 10.9% and 23.1% within 12 weeks. The respective variability calculated for triplicate comparisons was 9.9% and 27.7%. A short-term therapy with benfotiamine did not influence SAF significantly, nor did we find a significant postprandial SAF increase.

CONCLUSIONS

In patients with T2DM, repeated, timely spaced SAF measurements have an intra-subject variability of below 11%. Using these data, sample sizes were calculated for interventional studies aiming at reducing SAF. Benfotiamine treatment for 6 weeks did not significantly influence SAF; for this, a longer-term therapy is probably needed.

摘要

背景

皮肤 autofluorescence(SAF)的测量可实现组织晚期糖基化终产物(AGEs)的简单且非侵入性定量,AGEs 是与糖尿病并发症风险相关的标志物。本研究旨在检测 SAF 在 6 周和 12 周时的可重复性,并检验在高血糖条件下,作为减少 AGEs 形成的前体药物的苯磷硫胺,是否能够在 6 周的给药期内减弱 SAF。

患者和方法

在一项双盲、安慰剂对照、随机、交叉研究中,22 例 2 型糖尿病(T2DM)患者接受 900mg/天苯磷硫胺或安慰剂治疗 6 周(两次治疗期之间的洗脱期为 6 周)。在每个治疗期的开始和结束时,均在空腹状态下以及混合餐测试后 2、4 和 6 小时评估 SAF。

结果

在 6 周内,空腹 SAF 的个体内和个体间变异性分别为 6.9%和 24.5%,在 12 周内分别为 10.9%和 23.1%。对于三次重复比较计算的变异性分别为 9.9%和 27.7%。短期苯磷硫胺治疗对 SAF 没有显著影响,我们也没有发现餐后 SAF 显著增加。

结论

在 T2DM 患者中,重复、定时间隔的 SAF 测量具有低于 11%的个体内变异性。使用这些数据,计算了旨在降低 SAF 的干预研究的样本量。苯磷硫胺治疗 6 周对 SAF 没有显著影响;可能需要更长时间的治疗。

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