Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis
Glucosamine, chondroitin sulfate, and the two in combination for painful knee osteoarthritis
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DOI：
10.1056/nejmoa052771
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发表时间：
2006-02-23
影响因子：
158.5
通讯作者：
Williams, HJ
中科院分区：
文献类型：
--
作者：
Clegg, DO;Reda, DJ;Williams, HJ
背景：氨基葡萄糖和硫酸软骨素被用于治疗骨关节炎。多中心、双盲、安慰剂和塞来昔布对照的葡萄糖胺/软骨素关节炎干预试验（步态）评估了它们作为骨关节炎膝关节疼痛治疗的疗效和安全性。方法：我们随机分配1583例有症状的膝关节骨性关节炎患者接受每日1500毫克葡萄糖胺、每日1200毫克硫酸软骨素、每日200毫克塞来昔布或安慰剂治疗，疗程为24周。对乙酰氨基酚每日可达4000毫克作为抢救性镇痛。根据膝关节疼痛的严重程度进行分层（轻度[N=1229]与中度至重度[N=354]）。主要结果测量是膝关节疼痛从基线到第24周减少20%。结果：患者平均年龄59岁，女性占64%。总的来说，氨基葡萄糖和硫酸软骨素在减轻20%的膝关节疼痛方面并没有明显优于安慰剂。与安慰剂的有效率（60.1%）相比，葡萄糖胺的有效率高3.9个百分点（P=0.30），硫酸软骨素的有效率高5.3个百分点（P=0.17），联合治疗的有效率高6.5个百分点（P=0.09）。塞来昔布对照组的有效率比安慰剂对照组高10.0个百分点（P=0.008）。对于基线时中度至重度疼痛的患者，联合治疗的有效率明显高于安慰剂（79.2% vs. 54.3%， P=0.002）。不良事件轻微，不常见，各组间分布均匀。结论：葡萄糖胺和硫酸软骨素单独或联合应用均不能有效减轻膝关节骨性关节炎患者的疼痛。探索性分析表明，葡萄糖胺和硫酸软骨素联合应用可能对中重度膝关节疼痛患者有效。
BACKGROUND:Glucosamine and chondroitin sulfate are used to treat osteoarthritis. The multicenter, double-blind, placebo- and celecoxib-controlled Glucosamine/chondroitin Arthritis Intervention Trial (GAIT) evaluated their efficacy and safety as a treatment for knee pain from osteoarthritis.METHODS:We randomly assigned 1583 patients with symptomatic knee osteoarthritis to receive 1500 mg of glucosamine daily, 1200 mg of chondroitin sulfate daily, both glucosamine and chondroitin sulfate, 200 mg of celecoxib daily, or placebo for 24 weeks. Up to 4000 mg of acetaminophen daily was allowed as rescue analgesia. Assignment was stratified according to the severity of knee pain (mild [N=1229] vs. moderate to severe [N=354]). The primary outcome measure was a 20 percent decrease in knee pain from baseline to week 24.RESULTS:The mean age of the patients was 59 years, and 64 percent were women. Overall, glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain by 20 percent. As compared with the rate of response to placebo (60.1 percent), the rate of response to glucosamine was 3.9 percentage points higher (P=0.30), the rate of response to chondroitin sulfate was 5.3 percentage points higher (P=0.17), and the rate of response to combined treatment was 6.5 percentage points higher (P=0.09). The rate of response in the celecoxib control group was 10.0 percentage points higher than that in the placebo control group (P=0.008). For patients with moderate-to-severe pain at baseline, the rate of response was significantly higher with combined therapy than with placebo (79.2 percent vs. 54.3 percent, P=0.002). Adverse events were mild, infrequent, and evenly distributed among the groups.CONCLUSIONS:Glucosamine and chondroitin sulfate alone or in combination did not reduce pain effectively in the overall group of patients with osteoarthritis of the knee. Exploratory analyses suggest that the combination of glucosamine and chondroitin sulfate may be effective in the subgroup of patients with moderate-to-severe knee pain.