碳酸氢钠和葡萄糖酸钙治疗双膝骨关节炎的双盲、活性对照临床试验

A Double-Blind, Active-Controlled Clinical Trial of Sodium Bicarbonate and Calcium Gluconate in the Treatment of Bilateral Osteoarthritis of the Knee.

作者信息

Caamaño María Del Carmen, García-Padilla Sandra, Duarte-Vázquez Miguel Ángel, González-Romero Karla Elena, Rosado Jorge L

机构信息

School of Natural Sciences, Universidad Autónoma de Querétaro, Santiago de Querétaro, Mexico.

Department of Research and Development, Nucitec S.A. de C.V., Santiago de Querétaro, Mexico.

出版信息

Clin Med Insights Arthritis Musculoskelet Disord. 2017 Feb 16;10:1179544116688899. doi: 10.1177/1179544116688899. eCollection 2017.

DOI:10.1177/1179544116688899

PMID:28469486

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC5385469/

Abstract

OBJECTIVE

To evaluate the effect of intra-articular injections of sodium bicarbonate with a single (SBCG1) or double dose (SBCG2) of calcium gluconate administered monthly compared with methylprednisolone (MP) for treatment of knee osteoarthritis.

METHODS

A 3-month, randomized, double-blind clinical trial with patients diagnosed with knee osteoarthritis (OA). The outcome variables were the Western Ontario-McMaster University Osteoarthritis Index (WOMAC) and the Lequesne functional index.

RESULTS

After 3 months, all treatments significantly improved in overall WOMAC and Lequesne scores. Mean changes (95% confidence interval) in WOMAC total score and the Lequesne index, respectively, for SBCG1 (-12.5 [-14.3, -10.7]; -9.0 [-11.4, -6.7]) and SBCG2 (-12.3 [-14.3, -10.4]; -8.9 [-10.4, -7.4]) were significantly greater than for MP (-5.0 [-7.2, -2.8]; -3.2 [-4.9, -1.5]) ( < .001).

CONCLUSIONS

Intra-articular injections of sodium bicarbonate and calcium gluconate are useful for short-term relief of OA symptoms in patients with bilateral knee osteoarthritis. Both treatments are more effective than MP injections in the reduction of knee OA symptoms.

TRIAL REGISTRATION

Clinicaltrials.gov NCT00977444.

摘要

目的

评估每月关节腔内注射单剂量（SBCG1）或双剂量（SBCG2）葡萄糖酸钙的碳酸氢钠与甲基强的松龙（MP）相比治疗膝骨关节炎的效果。

方法

对诊断为膝骨关节炎（OA）的患者进行为期3个月的随机双盲临床试验。观察指标为西安大略和麦克马斯特大学骨关节炎指数（WOMAC）和勒凯斯内功能指数。

结果

3个月后，所有治疗组的WOMAC和勒凯斯内总分均显著改善。SBCG1组（-12.5 [-14.3, -10.7]；-9.0 [-11.4, -6.7]）和SBCG2组（-12.3 [-14.3, -10.4]；-8.9 [-10.4, -7.4]）的WOMAC总分和勒凯斯内指数的平均变化（95%置信区间）显著大于MP组（-5.0 [-7.2, -2.8]；-3.2 [-4.9, -1.5]）（P<0.001）。