Glucosamine sulfate compared to ibuprofen in osteoarthritis of the knee.
Glucosamine sulfate compared to ibuprofen in osteoarthritis of the knee.
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DOI：
10.1016/s1063-4584(05)80007-x
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发表时间：
1994-03-01
影响因子：
7
通讯作者：
Setnikar, I
中科院分区：
文献类型：
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作者：
Muller-Fassbender, H;Bach, G L;Setnikar, I
硫酸氨基葡萄糖能够刺激软骨细胞合成蛋白多糖，并具有轻度抗炎特性。在临床试验中，硫酸氨基葡萄糖在控制骨关节炎（OA）症状方面比安慰剂更有效。为了更好地表征这种治疗活性，我们进行了一项随机、双盲、平行组研究，分别使用硫酸氨基葡萄糖500 mg t.d vs布洛芬400 mg t.d，口服4周。该研究纳入了200名患有活动性膝关节炎的住院患者，症状持续至少3个月，Lequesne指数至少为7分。每周对患者进行评估。应答定义为如果入组值高于12分，Lequesne指数降低至少2分；如果入组值低于或等于12分，Lequesne指数降低至少1分，同时研究者给出了积极的总体评价。布洛芬组的改善速度更快（治疗第一周后缓解者为48%，治疗第一周后缓解者为28%；P = 0.06, Fisher's Exact检验），但从第二周开始没有差异，治疗结束时布洛芬组的成功率为52%，氨基葡萄糖组的成功率为48% （P = 0.67）。入学时Lequesne's指数平均在16点左右，两组均下降了6点以上，再次符合上述趋势。另一方面，35%的布洛芬患者报告了不良事件，主要是胃肠道来源，而葡萄糖胺患者报告了6%的不良事件（P < 0.001, Fisher's Exact检验）。两组的不良事件相关退出人数不同（分别为7% vs 1%； P = 0.035）。因此，硫酸氨基葡萄糖与布洛芬对膝关节OA症状同样有效。这些数据证实硫酸氨基葡萄糖是治疗OA的一种安全的症状性慢作用药物。
Glucosamine sulfate is able to stimulate proteoglycan synthesis by chondrocytes and has mild anti-inflammatory properties. In clinical trials, glucosamine sulfate was more effective than placebo in controlling the symptoms of osteoarthritis (OA). In order to better characterize this therapeutic activity, we conducted a randomized, double-blind, parallel-group study of glucosamine sulfate 500 mg t.i.d. vs ibuprofen 400 mg t.i.d., orally for 4 weeks. The study included 200 hospitalized patients with active OA of the knee, symptoms for at least 3 months and a Lequesne's index of at least 7 points. Patients were evaluated weekly. Response was defined as a reduction in the Lequesne's index by at least 2 points if the enrollment value was higher than 12 points, or by at least 1 point if the enrollment value was 12 or less points, together with a positive overall assessment by the investigator. The improvement tended to be sooner under ibuprofen (48% responders vs 28% after the 1st treatment week; P = 0.06, Fisher's Exact test), but there was no difference from the 2nd week onward, with a success rate of 52% in the ibuprofen group and of 48% in the glucosamine group (P = 0.67) at the end of treatment. The average Lequesne's index at enrollment was around 16 points and decreased by over 6 points in both groups, again with the above described trend. On the other hand, 35% of patients on ibuprofen reported adverse events, mainly of gastrointestinal origin, vs 6% adverse events with glucosamine (P < 0.001, Fisher's Exact test). The number of adverse event related drop-outs was different between the two groups (7% vs 1%, respectively; P = 0.035). Glucosamine sulfate was therefore as effective as ibuprofen on symptoms of knee OA. These data confirm glucosamine sulfate as a safe symptomatic Slow Acting Drug for OA.