关节内注射金微颗粒与透明质酸治疗膝关节骨关节炎疼痛。
Intra-articular injection of gold micro-particles with hyaluronic acid for painful knee osteoarthritis.
机构信息
Department of Clinical Medicine, Aalborg University, 249 Selma Lagerløfs Vej, Gistrup, 9260, Denmark.
Department of Orthopedic Surgery, Sport and Arthroscopy, Aalborg University Hospital, Aalborg, Denmark.
出版信息
BMC Musculoskelet Disord. 2024 Mar 12;25(1):211. doi: 10.1186/s12891-024-07321-4.
BACKGROUND
Recently, in an open pilot study, we found up to two years, a potential pain-relieving effect of intra-articular gold micro-particles using the patient's synovial fluid for patients with knee osteoarthritis (KOA). During the study the excluded group of patients, due to multisite pain, co-morbidities, and other exclusion criteria., received intra-articular gold micro-particles using hyaluronic acid,. We aimed to identify if pre-treatment characteristics influence the global outcome two years after intra-articular treatment for painful KOA with gold microparticles using hyaluronic acid.
METHODS
Using hyaluronic acid as the carrier, 136 patients with KOA received intraarticular injections with 20 mg gold microparticles (72.000 particles, 20-40 μm in diameter). In the analysis, we included the Global Rating of Change Scale, Pain Detect Questionnaire (PDQ), Body Mass Index (BMI), and Kellgren & Lawrence score at the inclusion, Western Ontario, and McMaster Universities Osteoarthritis Index (WOMAC) sub-scores for pain, stiffness, and function at inclusion and two years.
RESULTS
On the Global Rating Change Scale, 69.1% of patients reported a positive effect, 28.7% no effect, and 2.2% worse. PDQ and the three WOMAC subscores all improved at two years of follow-up. PDQ ≥ 13 (P = 0.028), BMI (P = 0.022) and Kellgren & Lawrence grade 4 (P = 0.028) at inclusion reduced the effect with a minor odds ratio compared to the baseline effect of treatment (P = 0.025). WOMAC subscores at inclusion did not influence the outcome (P > 0.5).
CONCLUSIONS
Severe osteoarthritis, obesity, and neuropathic pain, reduced the effect of intra-articular gold microparticles for knee OA.
TRIAL REGISTRATION
The study followed the principles of the Declaration of Helsinki and was approved by the local ethics committee of the North Denmark Region by 27/07/2016 (N-20,160,045). The regional data protection agency approved the project by 06/07/2016 (2008-58-0028, ID 2016 - 116) and registered in ClinicalTrial.Gov by 04/01/2018 (NCT03389906).
背景
最近，在一项开放性的初步研究中，我们发现，对于膝关节骨关节炎（KOA）患者，使用患者自身的滑膜液注射关节内金微颗粒，在长达两年的时间内具有潜在的止痛作用。在研究过程中，由于多部位疼痛、合并症和其他排除标准，排除在外的患者接受了关节内金微颗粒联合透明质酸注射。我们旨在确定在使用透明质酸进行关节内治疗疼痛性 KOA 两年后，治疗前的特征是否会影响总体疗效。
方法
136 例 KOA 患者使用透明质酸作为载体，接受关节内注射 20mg 金微颗粒（72000 个颗粒，直径 20-40μm）。在分析中，我们纳入了整体变化量表（Global Rating of Change Scale）、疼痛检测问卷（Pain Detect Questionnaire，PDQ）、身体质量指数（Body Mass Index，BMI）和克里格伦和劳伦斯评分（Kellgren & Lawrence score），纳入时和两年时还包括 Western Ontario 和 McMaster 大学骨关节炎指数（Western Ontario and McMaster Universities Osteoarthritis Index，WOMAC）疼痛、僵硬和功能的亚评分。
结果
在整体变化量表上，69.1%的患者报告有积极的效果，28.7%没有效果，2.2%的患者效果更差。PDQ 和三个 WOMAC 亚评分在两年的随访中均有改善。PDQ≥13（P=0.028）、纳入时 BMI（P=0.022）和克里格伦和劳伦斯 4 级（P=0.028）与治疗的基线效果相比，降低了疗效的优势比（P=0.025）。纳入时的 WOMAC 亚评分对结果没有影响（P＞0.5）。
结论
严重的骨关节炎、肥胖和神经病理性疼痛会降低关节内金微颗粒治疗膝骨关节炎的疗效。
试验注册
该研究遵循《赫尔辛基宣言》的原则，并于 2016 年 7 月 27 日获得北丹麦地区的地方伦理委员会批准（N-20、160、045）。地区数据保护局于 2016 年 7 月 6 日批准了该项目（2008-58-0028，ID 2016-116），并于 2018 年 4 月 4 日在 ClinicalTrial.Gov 注册（NCT03389906）。
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