氨基葡萄糖和/或硫酸软骨素对膝关节骨关节炎进展的影响：来自氨基葡萄糖/软骨素关节炎干预试验的报告。
The effect of glucosamine and/or chondroitin sulfate on the progression of knee osteoarthritis: a report from the glucosamine/chondroitin arthritis intervention trial.
作者信息
Sawitzke Allen D, Shi Helen, Finco Martha F, Dunlop Dorothy D, Bingham Clifton O, Harris Crystal L, Singer Nora G, Bradley John D, Silver David, Jackson Christopher G, Lane Nancy E, Oddis Chester V, Wolfe Fred, Lisse Jeffrey, Furst Daniel E, Reda Domenic J, Moskowitz Roland W, Williams H James, Clegg Daniel O
机构信息
University of Utah School of Medicine, Salt Lake City, UT 84132, USA.
出版信息
Arthritis Rheum. 2008 Oct;58(10):3183-91. doi: 10.1002/art.23973.
OBJECTIVE
Osteoarthritis (OA) of the knee causes significant morbidity and current medical treatment is limited to symptom relief, while therapies able to slow structural damage remain elusive. This study was undertaken to evaluate the effect of glucosamine and chondroitin sulfate (CS), alone or in combination, as well as celecoxib and placebo on progressive loss of joint space width (JSW) in patients with knee OA.
METHODS
A 24-month, double-blind, placebo-controlled study, conducted at 9 sites in the United States as part of the Glucosamine/Chondroitin Arthritis Intervention Trial (GAIT), enrolled 572 patients with knee OA who satisfied radiographic criteria (Kellgren/Lawrence [K/L] grade 2 or grade 3 changes and JSW of at least 2 mm at baseline). Patients with primarily lateral compartment narrowing at any time point were excluded. Patients who had been randomized to 1 of the 5 groups in the GAIT continued to receive glucosamine 500 mg 3 times daily, CS 400 mg 3 times daily, the combination of glucosamine and CS, celecoxib 200 mg daily, or placebo over 24 months. The minimum medial tibiofemoral JSW was measured at baseline, 12 months, and 24 months. The primary outcome measure was the mean change in JSW from baseline.
RESULTS
The mean JSW loss at 2 years in knees with OA in the placebo group, adjusted for design and clinical factors, was 0.166 mm. No statistically significant difference in mean JSW loss was observed in any treatment group compared with the placebo group. Treatment effects on K/L grade 2 knees, but not on K/L grade 3 knees, showed a trend toward improvement relative to the placebo group. The power of the study was diminished by the limited sample size, variance of JSW measurement, and a smaller than expected loss in JSW.
CONCLUSION
At 2 years, no treatment achieved a predefined threshold of clinically important difference in JSW loss as compared with placebo. However, knees with K/L grade 2 radiographic OA appeared to have the greatest potential for modification by these treatments.
目的
膝关节骨关节炎（OA）会导致严重的发病情况，目前的药物治疗仅限于缓解症状，而能够减缓结构损伤的疗法仍未找到。本研究旨在评估氨基葡萄糖和硫酸软骨素（CS）单独使用或联合使用，以及塞来昔布和安慰剂对膝关节OA患者关节间隙宽度（JSW）渐进性丢失的影响。
方法
作为氨基葡萄糖/硫酸软骨素关节炎干预试验（GAIT）的一部分，在美国9个地点进行了一项为期24个月的双盲、安慰剂对照研究，纳入了572例符合影像学标准（Kellgren/Lawrence [K/L] 2级或3级改变且基线时JSW至少2 mm）的膝关节OA患者。任何时间点主要为外侧间室狭窄的患者被排除。在GAIT中被随机分配到5组之一的患者在24个月内继续每日3次服用500 mg氨基葡萄糖、每日3次服用400 mg CS、氨基葡萄糖和CS联合用药、每日200 mg塞来昔布或安慰剂。在基线、12个月和24个月时测量最小内侧胫股关节JSW。主要结局指标是JSW相对于基线的平均变化。
结果
在对设计和临床因素进行调整后，安慰剂组OA膝关节2年时的平均JSW丢失为0.166 mm。与安慰剂组相比，任何治疗组在平均JSW丢失方面均未观察到统计学上的显著差异。相对于安慰剂组，治疗对K/L 2级膝关节有改善趋势，但对K/L 3级膝关节无改善趋势。研究的效能因样本量有限、JSW测量的方差以及JSW小于预期的丢失而降低。
结论
在2年时，与安慰剂相比，没有一种治疗在JSW丢失方面达到临床重要差异的预定义阈值。然而，K/L 2级影像学OA的膝关节似乎最有可能通过这些治疗得到改善。
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