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营养补充剂 BlastiMin 复合物对骨质疏松或骨量减少女性的促骨生成作用:一项开放性干预临床试验。

Pro-Osteogenic Effect of the Nutraceutical BlastiMin Complex in Women with Osteoporosis or Osteopenia: An Open Intervention Clinical Trial.

机构信息

Clinic of Endocrinology and Metabolic Diseases, Department of Clinical and Molecular Sciences, Università Politecnica delle Marche, 60126 Ancona, Italy.

R&D Department, Mivell S.r.l.s., 61032 Fano, Italy.

出版信息

Int J Mol Sci. 2024 Aug 6;25(16):8565. doi: 10.3390/ijms25168565.

Abstract

Osteoporosis is a chronic disease that affects millions of patients worldwide and is characterized by low bone mineral density (BMD) and increased risk of fractures. Notably, natural molecules can increase BMD and exert pro-osteogenic effects. Noteworthily, the nutraceutical BlastiMin Complex (Mivell, Italy, European Patent Application EP4205733A1) can induce differentiation of human bone marrow mesenchymal stem cells (BM-MSCs) in osteoblasts and can exert in vitro pro-osteogenic and anti-inflammatory effects. Thus, the purpose of this study was to verify the effects of BlastiMin Complex on bone turnover markers (BTMs) and BMD in patients with senile and postmenopausal osteopenia or osteoporosis. The efficacy of BlastiMin Complex on BTMs in serum was evaluated through biochemical assays. BMD values were analyzed by dual-energy X-ray absorptiometry (DXA) and Radiofrequency Echographic Multi Spectrometry (R.E.M.S.) techniques, and the SNPs with a role in osteoporosis development were evaluated by PCR. Clinical data obtained after 12 months of treatment showed an increase in bone turnover index, a decrease in C-reactive protein levels, and a remarkable increase in P1NP levels, indicating the induction of osteoblast proliferation and activity in the cohort of 100% female patients recruited for the study. These findings show that the nutraceutical BlastiMin Complex could be used as an adjuvant in combination with synthetic drugs for the treatment of osteoporosis pathology.

摘要

骨质疏松症是一种影响全球数以百万计患者的慢性疾病,其特征是骨矿物质密度(BMD)降低和骨折风险增加。值得注意的是,天然分子可以增加 BMD 并发挥促成骨作用。值得注意的是,营养保健品 BlastiMin 复合物(意大利 Mivell,欧洲专利申请 EP4205733A1)可以诱导人骨髓间充质干细胞(BM-MSCs)向成骨细胞分化,并具有体外促成骨和抗炎作用。因此,本研究旨在验证 BlastiMin 复合物对老年和绝经后骨质疏松症或骨质减少症患者的骨转换标志物(BTMs)和 BMD 的影响。通过生化分析评估 BlastiMin 复合物对血清 BTMs 的疗效。通过双能 X 射线吸收法(DXA)和射频超声多谱仪(R.E.M.S.)技术分析 BMD 值,并通过 PCR 评估与骨质疏松症发展相关的 SNP。治疗 12 个月后获得的临床数据显示,骨转换指数增加,C 反应蛋白水平降低,P1NP 水平显著升高,这表明在招募的 100%女性患者队列中诱导了成骨细胞增殖和活性。这些发现表明,营养保健品 BlastiMin 复合物可与合成药物联合用作治疗骨质疏松症的辅助药物。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/144f/11354786/517edccf50a5/ijms-25-08565-g001.jpg

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