Pavelká Karel, Gatterová Jindriska, Olejarová Marta, Machacek Stanislav, Giacovelli Giampaolo, Rovati Lucio C
Department of Medicine and Rheumatology, Charles University, Prague, Czech Republic.
Arch Intern Med. 2002 Oct 14;162(18):2113-23. doi: 10.1001/archinte.162.18.2113.
Conventional symptomatic treatments for osteoarthritis do not favorably affect disease progression. The aim of this randomized, placebo-controlled trial was to determine whether long-term (3-year) treatment with glucosamine sulfate can modify the progression of joint structure and symptom changes in knee osteoarthritis, as previously suggested.
Two hundred two patients with knee osteoarthritis (using American College of Rheumatology criteria) were randomized to receive oral glucosamine sulfate, 1500 mg once a day, or placebo. Changes in radiographic minimum joint space width were measured in the medial compartment of the tibiofemoral joint, and symptoms were assessed using the algo-functional indexes of Lequesne and WOMAC (Western Ontario and McMaster Universities).
Osteoarthritis was of mild to moderate severity at enrollment, with average joint space widths of slightly less than 4 mm and a Lequesne index score of less than 9 points. Progressive joint space narrowing with placebo use was -0.19 mm (95% confidence interval, -0.29 to -0.09 mm) after 3 years. Conversely, there was no average change with glucosamine sulfate use (0.04 mm; 95% confidence interval, -0.06 to 0.14 mm), with a significant difference between groups (P =.001). Fewer patients treated with glucosamine sulfate experienced predefined severe narrowings (>0.5 mm): 5% vs 14% (P =.05). Symptoms improved modestly with placebo use but as much as 20% to 25% with glucosamine sulfate use, with significant final differences on the Lequesne index and the WOMAC total index and pain, function, and stiffness subscales. Safety was good and without differences between groups.
Long-term treatment with glucosamine sulfate retarded the progression of knee osteoarthritis, possibly determining disease modification.
骨关节炎的传统对症治疗对疾病进展没有积极影响。本随机、安慰剂对照试验的目的是确定硫酸氨基葡萄糖长期(3年)治疗是否能如先前研究所暗示的那样改变膝关节骨关节炎的关节结构进展和症状变化。
202例符合美国风湿病学会标准的膝关节骨关节炎患者被随机分为两组,分别接受每日1500毫克口服硫酸氨基葡萄糖或安慰剂治疗。测量胫股关节内侧间室的放射学最小关节间隙宽度变化,并使用Lequesne算法功能指数和WOMAC(西安大略和麦克马斯特大学)指数评估症状。
入组时骨关节炎为轻至中度严重程度,平均关节间隙宽度略小于4毫米,Lequesne指数评分小于9分。使用安慰剂3年后,关节间隙逐渐变窄,为-0.19毫米(95%置信区间,-0.29至-0.09毫米)。相反,使用硫酸氨基葡萄糖后平均没有变化(0.04毫米;95%置信区间,-0.06至0.14毫米),两组间差异显著(P = 0.001)。接受硫酸氨基葡萄糖治疗的患者中,出现预定义严重狭窄(>0.5毫米)的人数较少:5% 对14%(P = 0.05)。使用安慰剂后症状有适度改善,但使用硫酸氨基葡萄糖后改善多达20%至25%,在Lequesne指数、WOMAC总指数以及疼痛、功能和僵硬子量表上有显著的最终差异。安全性良好,两组间无差异。
硫酸氨基葡萄糖长期治疗可延缓膝关节骨关节炎的进展,可能具有疾病修饰作用。