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High Dephosphorylated-Uncarboxylated MGP in Hemodialysis patients: risk factors and response to vitamin K 2 , A pre-post intervention clinical trial

机译:血液透析患者中​​高脱磷酸-非羧化MGP:危险因素和对维生素K 2的反应,一项干预前临床试验

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Background Vascular calcifications are highly prevalent in hemodialysis patients. Dephosphorylated-uncarboxylated MGP (dp-ucMGP) was found to increase in vitamin K-deficient patients and may be associated with vascular calcifications. Supplementation of hemodialysis patients with vitamin K2 (menaquinone-7) has been studied in Europe with a maximum 61% drop of dp-ucMGP levels. The aim of this study is to assess first the drop of dp-ucMGP in an Eastern Mediterranean cohort after vitamin K2 treatment and second the correlation between baseline dp-ucMGP and vascular calcification score. Methods This is a prospective, pre-post intervention clinical trial involving 50 hemodialysis patients who received daily 360?μg of menaquinone-7 for 4?weeks. At baseline they were assessed for plasma dp-ucMGP levels and vascular calcification scores (AC-24) as well as for other demographic, clinical and biological variables. Dp-ucMGP levels were measured a second time at 4?weeks. Results At baseline, dp-ucMGP levels were extremely elevated with a median of 3179.15 (1825.25; 4339.50) pM and correlated significantly with AC-24 (Spearman’s rho?=?0.43, P =?0.002). Using a bivariate regression analysis, the association between dp-ucMGP levels and AC-24 was most significant when comparing dp-ucMGP levels less than 1000 to those more than 1000 pM ( P =?0.02). Dp-ucMGP levels higher than 5000 pM were significantly associated with females, patients with recent fracture and patients with lower serum albumin (respectively P =?0.02, 0.004 and 0.046). The average drop of dp-ucMGP at 4?weeks of treatment was found to be 86% with diabetics having the lowest drop rate ( P =?0.01). Conclusion Vitamin K deficiency, as assessed by high dp-ucMGP levels, is profound in hemodialysis patients from the Eastern Mediterranean region and it is significantly correlated with vascular calcifications. Daily 360?μg of menaquinone-7, given for 4?weeks, effectively reduces dp-ucMGP in this population. Future studies are needed to assess the changes in vascular calcifications in hemodialysis patients treated with vitamin K2 over a longer follow-up period. Trial registration The clinical trial was registered on clinicaltrials.gov (Identification number NCT02876354 , on August 11, 2016).
机译:背景技术血管钙化在血液透析患者中​​非常普遍。发现去磷酸化-未羧化的MGP(dp-ucMGP)在缺乏维生素K的患者中增加,可能与血管钙化有关。在欧洲,已经对血液透析患者补充维生素K 2 (甲萘醌7)进行了研究,其dp-ucMGP水平最多下降了61%。这项研究的目的是首先评估维生素K 2 治疗后地中海东部队列中dp-ucMGP的下降,其次评估基线dp-ucMGP与血管钙化评分之间的相关性。方法这是一项前瞻性,干预后的临床前试验,涉及50名血液透析患者,每天接受360?μgMenaquinone-7注射4周。在基线时,对他们的血浆dp-ucMGP水平和血管钙化评分(AC-24)以及其他人口统计学,临床和生物学变量进行了评估。在4周时第二次测量Dp-ucMGP水平。结果在基线时,dp-ucMGP水平极度升高,中位数为3179.15(1825.25; 4339.50)pM,并且与AC-24显着相关(Spearman的rho?=?0.43,P =?0.002)。使用双变量回归分析,当比较dp-ucMGP水平低于1000和大于1000 pM时,dp-ucMGP水平与AC-24之间的关联最为显着(P =?0.02)。高于5000 pM的Dp-ucMGP水平与女性,近期骨折的患者和血清白蛋白较低的患者显着相关(分别为P =?0.02、0.004和0.046)。发现在治疗4周时dp-ucMGP的平均下降为86%,而糖尿病患者的下降率最低(P =?0.01)。结论通过高dp-ucMGP水平评估的维生素K缺乏症在地中海东部地区的血液透析患者中​​意义深远,并且与血管钙化密切相关。每天服用360微克甲萘醌7,持续4周,可有效降低该人群中的dp-ucMGP。需要进行长期研究,以评估接受维生素K 2 治疗的血液透析患者的血管钙化变化。试验注册临床试验已在Clinicaltrials.gov上注册(标识号NCT02876354,于2016年8月11日)。

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