A 6-month, randomized, double-masked, placebo-controlled study evaluating the effects of the protein kinase C-β inhibitor ruboxistaurin on skin microvascular blood flow and other measures of diabetic peripheral neuropathy

A 6-month, randomized, double-masked, placebo-controlled study evaluating the effects of the protein kinase C-β inhibitor ruboxistaurin on skin microvascular blood flow and other measures of diabetic peripheral neuropathy
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DOI:
10.2337/dc06-1699
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发表时间:
2007-04-01
期刊:
影响因子:
16.2
通讯作者:
Vinik, Aaron I.
Vinik, Aaron I.
中科院分区:
医学1区
文献类型:
--
作者:
Casellini, Carolina M.;Barlow, Patricia M.;Vinik, Aaron I.

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目的:糖尿病导致蛋白激酶C(PKC)-β过度激活和微血管功能障碍,可能导致糖尿病周围神经病变(DPN)患者皮肤微血管血流(SkBF)紊乱等改变。我们研究了异构体选择性PKC-β抑制剂甲磺酸Ruboxistaurin对DPN的神经血管功能和其他指标的影响。研究设计和方法:内皮依赖和C纤维介导的SkBF、感觉症状、神经功能缺陷、神经纤维形态测量、定量感觉和自主功能测试、神经传导研究、生活质量(使用诺福克糖尿病神经病变生活质量问卷[QOL-DN])和不良事件评估20名服用安慰剂和20名Ruboxistaurin治疗(32 mg/d)的DPN患者(年龄和年龄=18岁;患有I型或2型糖尿病和Alc)。
OBJECTIVE - Diabetes leads to protein kinase C (PKC)-beta overactivation and microvascular dysfunction, possibly resulting in disordered skin microvascular blood flow (SkBF) and other changes observed in diabetic peripheral neuropathy (DPN) patients. We investigate the effect, of the isoform-selective PKC-beta inhibitor ruboxistaurin mesylate on neurovascular function and other measures of DPN.RESEARCH DESIGN AND METHODS - Endothelium-dependent and C fiber-mediated SkBF, sensory symptoms, neurological deficits, nerve fiber morphometry, quantitative sensory and autonomic function testing, nerve conduction studies, quality of life (using the Norfolk Quality-of-Life Questionnaire for Diabetic Neuropathy [QOL-DN]), and adverse events were evaluated for 20 placebo- and 20 ruboxistaurin-treated (32 mg/day) DPN patients (aged >= 18 years; with type I or type 2 diabetes and AlC