磷酸二甲萘二酚(Menadiol Sodium Diphosphate)

概要

基本信息

药物类型

小分子化药

别名

2-methyl-1,4-naphthalenediol diphosphate、Menadiol bis(dihydrogen phosphate)、Menadiol phosphate

+ [4]

靶点-

作用机制-

治疗领域

内分泌与代谢疾病血液及淋巴系统疾病

在研适应症-

非在研适应症

维生素K缺乏症

原研机构

Hoffmann-La Roche, Inc.

在研机构

广东爱民药业有限公司

江苏四环生物股份有限公司无锡嘉菱医药有限公司

非在研机构

Hoffmann-La Roche, Inc.

Eli Lilly & Co.

最高研发阶段临床2期

首次获批日期

美国 (1941-07-15),

维生素K缺乏症

最高研发阶段(中国)临床2期

特殊审评-

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结构

分子式C11H12O8P2

InChIKeyJTNHOVZOOVVGHI-UHFFFAOYSA-N

CAS号84-98-0

查看全部结构式(2)

关联

3

项与磷酸二甲萘二酚相关的临床试验

CTR20132129 / Recruiting临床1期

甲萘氢醌二磷酸酯钠注射液单中心、随机、开放I期人体药代动力学试验

健康受试者进行甲萘氢醌二磷酸酯钠注射液的药代动力学试验，为制定甲萘氢醌二磷酸酯钠注射液II期临床试验方案提供试验依据，为临床用药的给药剂量提供依据。

开始日期-

申办/合作机构

广东爱民药业有限公司

[+1]

CTR20131649 / Completed临床1期

甲萘氢醌二磷酸酯钠片单中心、随机、开放I期人体药代动力学试验

考察健康人对甲萘氢醌二磷酸酯钠片的药代动力学特征，为制定本品的Ⅱ期临床试验提供依据。

开始日期2012-09-22

申办/合作机构

广东爱民药业有限公司

[+1]

CTR20130573 / Recruiting临床2期

甲萘氢醌二磷酸酯钠片治疗获得性维生素K依赖性凝血因子缺乏症的有效性和安全性研究

以醋酸甲萘氢醌片为对照，评价甲萘氢醌二磷酸酯钠片治疗获得性维生素K依赖性凝血因子缺乏症的有效性和安全性。

开始日期2011-09-07

申办/合作机构

广东爱民药业有限公司

[+1]

100 项与磷酸二甲萘二酚相关的临床结果

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100 项与磷酸二甲萘二酚相关的转化医学

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100 项与磷酸二甲萘二酚相关的专利（医药）

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37

项与磷酸二甲萘二酚相关的文献（医药）

2022-01-01·American Journal of Transplantation

Vitamin K supplementation and vascular health after kidney transplantation

Letter

作者: de Borst, M H ; Te Velde-Keyzer, C A

In the study by Lees et al, biol. efficacy was tested in 72/90 patients.Yet, the majority of these patients had dp-ucMGP levels <900 pmol/L at both timepoints, and were therefore defined as 900 pmol/L (figure 2 in the paper by Lees et al).Therefore, the biol. efficacy seems merely based on a small subgroup of patients with more severe vitamin K deficiency.This is a concern since dp-ucMGP was the only vitamin K status marker used and the efficacy of menadiol diphosphate to improve vascular vitamin K status had not been previously studied.Moreover, the efficacy of vitamin K supplementation in a population that was in majority vitamin Ksufficient may be questioned.

2021-10-01·American Journal of Transplantation1区 · 医学

The ViKTORIES trial: A randomized, double-blind, placebo-controlled trial of vitamin K supplementation to improve vascular health in kidney transplant recipients

1区 · 医学

Article

作者: Rutherford, Elaine ; Lees, Jennifer S ; Mangion, Kenneth ; Roditi, Giles H ; Witham, Miles D ; Rankin, Alastair J ; Zhu, Luke Y ; Jardine, Alan G ; Mark, Patrick B ; Panarelli, Maurizio ; Gillis, Keith A ; Chantler, Donna

Premature cardiovascular disease and death with a functioning graft are leading causes of death and graft loss, respectively, in kidney transplant recipients (KTRs). Vascular stiffness and calcification are markers of cardiovascular disease that are prevalent in KTR and associated with subclinical vitamin K deficiency. We performed a single-center, phase II, parallel-group, randomized, double-blind, placebo-controlled trial (ISRCTN22012044) to test whether vitamin K supplementation reduced vascular stiffness (MRI-based aortic distensibility) or calcification (coronary artery calcium score on computed tomography) in KTR over 1 year of treatment. The primary outcome was between-group difference in vascular stiffness (ascending aortic distensibility). KTRs were recruited between September 2017 and June 2018, and randomized 1:1 to vitamin K (menadiol diphosphate 5 mg; n = 45) or placebo (n = 45) thrice weekly. Baseline demographics, clinical history, and immunosuppression regimens were similar between groups. There was no impact of vitamin K on vascular stiffness (treatment effect -0.23 [95% CI -0.75 to 0.29] × 10^-3 mmHg^-1 ; p = .377), vascular calcification (treatment effect -141 [95% CI - 320 to 38] units; p = .124), nor any other outcome measure. In this heterogeneous cohort of prevalent KTR, vitamin K supplementation did not reduce vascular stiffness or calcification over 1 year. Improving vascular health in KTR is likely to require a multifaceted approach.

2021-06-01·Skin Health and Disease

Prevalence and treatment of vitamin K deficiency in paediatric patients with recessive dystrophic epidermolysis bullosa‐severe subtype

Article

作者: Martinez, A. ; Yerlett, N. ; Holsgrove, K. ; Petrof, G.

AbstractIntroductionPatients with recessive dystrophic epidermolysis bullosa‐severe subtype (RDEB‐S) are at risk of vitamin K deficiency, potentially causing abnormal clotting, excessive bleeding, poor bone metabolism and abnormal vascular calcification. This study quantifies vitamin K deficiency prevalence in this cohort and identifies potential risk‐factors to prevent deficiency.MethodsPatients with RDEB‐S who attended the EB service between 2014 and 2020 were included. Serum vitamin K and PIVKAII were measured as part of the usual nutritional blood screen. Dietetic and medical notes were reviewed to establish: antibiotic use, enteral feed intake and micronutrient supplementation.ResultsA total of 16/25 64% (10/16 female), of children aged 22–180 months, had serum vitamin K and PIVKAII analysed. Six of sixteen (37.5%) patients had vitamin K deficiency requiring supplementation. Two of six (33.3%) normalized serum vitamin K after 12 weeks supplementation with oral menadiol diphosphate. Four of six (66.6%) await retesting following supplementation. Six of six (100%) patients with vitamin K deficiency were not consuming a gastrostomy/sip feed. Nine of ten (90%) patients with sufficient vitamin K levels were consuming either; more than 200 ml prescribed sip feed or more than 400–800 ml gastrostomy feed daily (containing 5.9–11 µg/100 ml vitamin K). Patients who were consuming either more than 200 ml prescribed sip feed or more than 400–800 ml gastrostomy feed daily (containing 5.9–11 µg/100 ml vitamin K) were significantly less likely to suffer from vitamin K deficiency (0.08 odds ratio [(1/7)/(5/3)] with significance level p = 0.0342 [95% CI: 0.0074–0.8275]). Sixteen of sixteen (100%) received antibiotics (range 0–4 courses/year; median, 3; IQR, 3). Patients with the most frequent antibiotics (n = 4) had normal vitamin K and PIVKAII levels if they consumed a minimum of 200 ml prescribed sip feed or 400–800 ml gastrostomy feed daily. Sixteen of sixteen (100%) patients took a multivitamin/mineral supplement; none contained vitamin K.SummaryThe prevalence of vitamin K deficiency is 37.5% in this cohort. Patients whom were not consuming gastrostomy/sip feeds of at least 200 ml daily were at greatest risk of vitamin K deficiency. Patients on a micronutrient supplement remain at risk of vitamin K deficiency, as most contain no vitamin K. Prescribing a vitamin/mineral supplement that contains vitamin K is recommended. Twelve‐week supplementation of oral vitamin K (5 mg/day for 1–10 years and 10 mg/day for 12–17 years) adequately improved stores.

100 项与磷酸二甲萘二酚相关的药物交易

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