Herrero-Beaumont Gabriel, Ivorra José Andrés Román, Del Carmen Trabado María, Blanco Francisco Javier, Benito Pere, Martín-Mola Emilio, Paulino Javier, Marenco José Luis, Porto Armando, Laffon Armando, Araújo Domingos, Figueroa Manuel, Branco Jaime
Rheumatology Department, Fundación Jiménez Díaz-Capio, Madrid, Spain.
Arthritis Rheum. 2007 Feb;56(2):555-67. doi: 10.1002/art.22371.
To assess the effects of the prescription formulation of glucosamine sulfate (1,500 mg administered once daily) on the symptoms of knee osteoarthritis (OA) during a 6-month treatment course.
Three hundred eighteen patients were enrolled in this randomized, placebo-controlled, double-blind trial in which acetaminophen, the currently preferred medication for symptomatic treatment of OA, was used as a side comparator. Patients were randomly assigned to receive oral glucosamine sulfate 1,500 mg once daily (n = 106), acetaminophen 3 gm/day (n = 108), or placebo (n = 104). The primary efficacy outcome measure was the change in the Lequesne index after 6 months. Secondary parameters included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and response according to the Osteoarthritis Research Society International criteria. These outcome measures were assessed using an intent-to-treat analysis.
At baseline, the study patients had moderately severe OA symptoms (mean Lequesne index approximately 11 points). Glucosamine sulfate was more effective than placebo in improving the Lequesne score, with a final decrease of 3.1 points, versus 1.9 with placebo (difference between glucosamine sulfate and placebo -1.2 [95% confidence interval -2.3, -0.8]) (P = 0.032). The 2.7-point decrease with acetaminophen was not significantly different from that with placebo (difference -0.8 [95% confidence interval -1.9, 0.3]) (P = 0.18). Similar results were observed for the WOMAC. There were more responders to glucosamine sulfate (39.6%) and acetaminophen (33.3%) than to placebo (21.2%) (P = 0.004 and P = 0.047, respectively, versus placebo). Safety was good, and was comparable among groups.
The findings of this study indicate that glucosamine sulfate at the oral once-daily dosage of 1,500 mg is more effective than placebo in treating knee OA symptoms. Although acetaminophen also had a higher responder rate compared with placebo, it failed to show significant effects on the algofunctional indexes.
评估硫酸氨基葡萄糖处方制剂（每日一次服用1500毫克）在6个月治疗疗程中对膝关节骨关节炎（OA）症状的影响。
318名患者参与了这项随机、安慰剂对照、双盲试验，其中对乙酰氨基酚作为对照药物，它是目前治疗OA症状的首选药物。患者被随机分配为每日一次口服1500毫克硫酸氨基葡萄糖（n = 106）、每日3克对乙酰氨基酚（n = 108）或安慰剂（n = 104）。主要疗效指标是6个月后Lequesne指数的变化。次要参数包括西安大略和麦克马斯特大学骨关节炎指数（WOMAC）以及根据国际骨关节炎研究学会标准的反应情况。这些疗效指标采用意向性分析进行评估。
在基线时，研究患者有中度至重度OA症状（平均Lequesne指数约为11分）。硫酸氨基葡萄糖在改善Lequesne评分方面比安慰剂更有效，最终降低了3.1分，而安慰剂降低了1.9分（硫酸氨基葡萄糖与安慰剂的差值为 -1.2 [95%置信区间 -2.3, -0.8]）（P = 0.032）。对乙酰氨基酚降低2.7分与安慰剂相比无显著差异（差值为 -0.8 [95%置信区间 -1.9, 0.3]）（P = 0.18）。WOMAC也观察到类似结果。与安慰剂相比，硫酸氨基葡萄糖（39.6%）和对乙酰氨基酚（33.3%）的反应者更多（分别与安慰剂相比，P = 0.004和P = 0.047）。安全性良好，且各组间相当。
本研究结果表明，每日一次口服1500毫克硫酸氨基葡萄糖在治疗膝关节OA症状方面比安慰剂更有效。尽管与安慰剂相比，对乙酰氨基酚的反应率也较高，但它在疼痛功能指标上未显示出显著效果。
