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一项评估口服微小剂量金纳米颗粒(AuNP)对关节炎患者膝关节健康和功能的安全性及有效性的临床研究。

A Clinical Study to Evaluate the Safety and Efficacy of Oral Administration of Microscopic Dose Gold Nanoparticle (AuNP) on Knee Joint Health and Function in Arthritis Patients.

作者信息

Han Xuesheng, Avelar Edlynne, Mathai Amber, Vollmer David, Lehman Richard

机构信息

4Life Research, Scientific Research Division, Sandy, UT 84070, USA.

Professional Athletic Orthopedics, St. Louis, MO 63122, USA.

出版信息

J Funct Morphol Kinesiol. 2022 Jun 22;7(3):52. doi: 10.3390/jfmk7030052.

DOI:10.3390/jfmk7030052
PMID:35893326
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9326595/
Abstract

The purpose of this clinical study was to determine whether gold nanoparticle (AuNP) supplementation at a dosage of 0.34 mg elemental gold per day can improve knee joint health, function, and quality of life for arthritis patients. A total of 51 participants (24 male and 27 female, age 62.1 ± 13.1) were followed for 20 weeks through a three-phase longitudinal study. Both subjective and objective parameters were used to measure changes in joint health and function, as well as quality of life. The study found patients' Knee injury and Osteoarthritis Outcome Score (KOOS) improved with statistical significance. It was reported that 71.42% of the cohort experienced improvements in their perceived knee pain and 61.22% with improvements in knee stiffness. Majority of objective measurements such as pain with range of motion and specific exercises requiring proper knee health and function did not show statistically significant improvement but did show a positive improving trend in support of AuNP supplement. Study cohort showed statistically significant improvements in two specific exercises: sit-to-stand and single-leg squat. By the end of the study, 70% of the study cohort indicated that they would continue to take the supplement even after the study concluded. Though the study has limitations and is not definitely conclusive, it was the first clinical study to show that oral micro-dosage of AuNP as low as 0.34 mg daily is safe and effective for both rheumatoid arthritis and osteoarthritis patients. This study opened way for the use of AuNP in both clinical and daily settings to improve joint health and function for both average and athletic users.

摘要

这项临床研究的目的是确定每天补充剂量为0.34毫克元素金的金纳米颗粒(AuNP)是否可以改善关节炎患者的膝关节健康、功能和生活质量。通过一项三阶段纵向研究,对总共51名参与者(24名男性和27名女性,年龄62.1±13.1岁)进行了20周的跟踪。主观和客观参数均用于衡量关节健康和功能以及生活质量的变化。研究发现患者的膝关节损伤和骨关节炎疗效评分(KOOS)有统计学意义的改善。据报道,该队列中有71.42%的人感觉膝关节疼痛有所改善,61.22%的人膝关节僵硬有所改善。大多数客观测量指标,如活动范围疼痛和需要适当膝关节健康及功能的特定运动,虽未显示出统计学意义上的显著改善,但确实显示出支持补充AuNP的积极改善趋势。研究队列在两项特定运动中显示出统计学意义上的改善:从坐到站和单腿深蹲。到研究结束时,70%的研究队列表示,即使在研究结束后,他们仍会继续服用该补充剂。尽管该研究有局限性且并非绝对结论性,但它是第一项临床研究表明,每天口服低至0.34毫克的AuNP对类风湿性关节炎和骨关节炎患者都是安全有效的。这项研究为在临床和日常环境中使用AuNP改善普通和运动人群的关节健康及功能开辟了道路。

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