Giordano Nicola, Fioravanti Antonella, Papakostas Panagiotis, Montella Antonio, Giorgi Giorgio, Nuti Ranuccio
Department of Internal Medicine, University of Siena, Siena, Italy.
Rheumatology Unit, Department of Clinical Medicine and Immunological Sciences, University of Siena, Siena, Italy.
Curr Ther Res Clin Exp. 2009 Jun;70(3):185-96. doi: 10.1016/j.curtheres.2009.05.004.
Osteoarthritis (OA) is the most common form of arthritis and is often associated with disability and impaired quality of life.
The aim of the study was to assess the efficacy and tolerability of glucosamine sulfate (GS) in the treatment of knee OA.
Consecutive outpatients affected by primary monolateral or bilateral knee OA were enrolled in this double-blind, double-dummy, prospective, randomized, placebo-controlled trial. One group received GS 1500 mg QD for 12 weeks, and the other group received placebo QD for 12 weeks. The treatment period was followed by a 12-week treatment-free observation phase. Each patient was examined at baseline and at weeks 4, 8, 12, 16, 20, and 24. The primary efficacy criteria were pain at rest and during movement, assessed on a visual analog scale (VAS) of 0 to 100 mm. The secondary criteria included the Western Ontario and McMaster Universities (WOMAC) index for total pain score (W-TPS), total stiffness score (W-TSS), and total physical function score (W-TPFS). VAS, W-TPS, W-TSS, and W-TPFS were evaluated at baseline and at weeks 4, 8, 12, 16, 20, and 24. Analgesic drug consumption (ie, acetaminophen or NSAIDs) was also assessed.
Patient demographics were similar in the GS and placebo groups. Of 60 randomized patients (30 per group), 56 completed the study (28 treated with GS and 28 who received placebo). Statistically significant improvements in symptomatic knee OA were observed, as measured by differences in resting pain at weeks 8, 12, and 16 (all, P < 0.05 vs placebo) and in pain during movement at weeks 12 and 16 (both, P < 0.05). W-TPS was lower with GS than placebo at weeks 8, 12, and 16 (all, P < 0.01), and at week 20 (P < 0.05). W-TSS was also lower with GS than placebo at weeks 8, 12, 16, and 20 (all, P < 0.05). W-TPFS was lower with GS than placebo at weeks 8 (P < 0.05), 12 (P < 0.01), 16 (P < 0.05), and 20 (P < 0.05). Drug consumption was lower in the GS group than the placebo group at weeks 8, 12, 16, and 20 (all, P < 0.05). The incidence of adverse events was 36.7% with GS and 40.0% with placebo.
GS 1500 mg QD PO for 12 weeks was associated with statistically significant reductions in pain and improvements in functioning, with decreased analgesic consumption, compared with baseline and placebo in these patients with knee OA. A carryover effect was detected after treatment ended.
骨关节炎（OA）是最常见的关节炎形式，常与残疾和生活质量受损相关。
本研究旨在评估硫酸葡萄糖胺（GS）治疗膝骨关节炎的疗效和耐受性。
本双盲、双模拟、前瞻性、随机、安慰剂对照试验纳入了连续的原发性单侧或双侧膝骨关节炎门诊患者。一组接受GS 1500 mg每日一次，共12周，另一组接受安慰剂每日一次，共12周。治疗期后为12周的无治疗观察期。每位患者在基线以及第4、8、12、16、20和24周进行检查。主要疗效标准为静息时和活动时的疼痛，采用0至100 mm的视觉模拟量表（VAS）进行评估。次要标准包括西安大略和麦克马斯特大学（WOMAC）指数中的总疼痛评分（W-TPS）、总僵硬评分（W-TSS）和总身体功能评分（W-TPFS）。在基线以及第4、8、12、16、20和24周评估VAS、W-TPS、W-TSS和W-TPFS。还评估了镇痛药的消耗量（即对乙酰氨基酚或非甾体抗炎药）。
GS组和安慰剂组的患者人口统计学特征相似。60例随机分组患者（每组30例）中，56例完成了研究（28例接受GS治疗，28例接受安慰剂治疗）。通过第8、12和16周静息疼痛的差异（均与安慰剂相比，P<0.05）以及第12和16周活动时疼痛的差异（均P<0.05）测量，观察到症状性膝骨关节炎有统计学意义的改善。在第8、12和16周以及第20周，GS组的W-TPS低于安慰剂组（均P<0.01），在第20周（P<0.05）。在第8、12、16和20周，GS组的W-TSS也低于安慰剂组（均P<0.05）。在第8周（P<0.05）、12周（P<0.01）、16周（P<0.05）和20周（P<0.05），GS组的W-TPFS低于安慰剂组。在第8、12、16和20周，GS组的药物消耗量低于安慰剂组（均P<0.05）。GS组不良事件发生率为36.7%，安慰剂组为40.0%。
与这些膝骨关节炎患者的基线和安慰剂相比，每日口服GS 1500 mg共12周与疼痛的统计学显著减轻、功能改善以及镇痛药消耗量减少相关。治疗结束后检测到有延续效应。
