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硫酸葡萄糖胺与布洛芬治疗膝骨关节炎患者的疗效与安全性比较

Efficacy and safety of glucosamine sulfate versus ibuprofen in patients with knee osteoarthritis.

作者信息

Qiu G X, Gao S N, Giacovelli G, Rovati L, Setnikar I

机构信息

Peking Union Medical College Hospital, The People's Republic of China.

出版信息

Arzneimittelforschung. 1998 May;48(5):469-74.

PMID:9638313
Abstract

A double-blind therapeutic investigation was performed on 178 Chinese patients suffering from osteoarthritis of the knee randomized into two groups, one treated for 4 weeks with glucosamine sulfate (GS, CAS 29031-19-4, Viartril-S) at the daily dose of 1,500 mg and the other with ibuprofen (IBU, CAS 15687-27-1) at the daily dose of 1,200 mg. Knee pain at rest, at movement and at pressure, knee swelling, improvement and therapeutic utility as well as adverse events and drop-outs were recorded after 2 and 4 weeks of treatment. The variables were recorded also after 2 weeks of treatment discontinuation in order to appreciate the remnant therapeutic effect. Both GS and IBU significantly reduced the symptoms of osteoarthritis with the trend of GS to be more effective. After 2 weeks of drug discontinuation there was a remnant therapeutic effect in both groups, with the trend to be more pronounced in the GS group. GS was significantly better tolerated than IBU, as shown by the adverse drug reactions (6% in the patients of the GS group and 16% in the IBU group--p = 0.02) and by the drug-related drop-outs (0% of the patients in the GS group and 10% in the IBU group--p = 0.0017). The better tolerability of GS is explained by its mode of action, because GS specifically curbs the pathogenic mechanisms of osteoarthritis and does not inhibit the cyclo-oxygenases as the non-steroidal anti-inflammatory drugs (NSAIDs) do, with the consequent anti-inflammatory analgesic activities but also with the several adverse reactions due to this not targeted effect. The present study confirms that GS is a selective drug for osteoarthritis, as effective on the symptoms of the disease as NSAIDs but significantly better tolerated. For these properties GS seems particularly indicated in the long-term treatments needed in osteoarthritis.

摘要

对178名患有膝关节骨关节炎的中国患者进行了一项双盲治疗研究,这些患者被随机分为两组,一组接受硫酸葡萄糖胺(GS,化学物质登记号29031-19-4,维骨力)治疗,每日剂量为1500毫克,为期4周;另一组接受布洛芬(IBU,化学物质登记号15687-27-1)治疗,每日剂量为1200毫克。在治疗2周和4周后,记录静息时、活动时和按压时的膝关节疼痛、膝关节肿胀、改善情况和治疗效用以及不良事件和退出情况。在停药2周后也记录这些变量,以评估残余治疗效果。GS和IBU均显著减轻了骨关节炎的症状,且GS的效果更明显。停药2周后,两组均有残余治疗效果,且在GS组中更为显著。GS的耐受性明显优于IBU,药物不良反应(GS组患者为6%,IBU组为16%——p = 0.02)和与药物相关的退出率(GS组患者为0%,IBU组为10%——p = 0.0017)均表明了这一点。GS更好的耐受性可由其作用方式解释,因为GS特异性地抑制骨关节炎的致病机制,不像非甾体抗炎药(NSAIDs)那样抑制环氧化酶,因此既有抗炎镇痛活性,也有因这种非靶向作用导致的多种不良反应。本研究证实,GS是一种治疗骨关节炎的选择性药物,对该疾病症状的疗效与NSAIDs相当,但耐受性明显更好。由于这些特性,GS似乎特别适用于骨关节炎所需的长期治疗。

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