Pavelka K, Sedlácková M, Gatterová J, Becvár R, Pavelka K
Institute of Rheumatology, Prague, Czech Republic.
Osteoarthritis Cartilage. 1995 Mar;3(1):15-23. doi: 10.1016/s1063-4584(05)80034-2.
We studied the efficacy and tolerability of glycosaminoglycan polysulfuric acid (GAGPS) in 80 patients with osteoarthritis (OA) of the knee. Patients received two series of five intra-articular injections, at 1-week intervals, of 25 mg (0.5 ml) GAGPS into the knee in a double-blind, parallel, randomized, placebo-controlled trial. There was an immediate decrease in pain after the injections of 43% with GAGPS and 33% with placebo (P = 0.047) (Jezek pain index). Pain relief of GAGPS vs placebo was not different at other intervals (10, 14, 22, 26 weeks after start of treatment). At 6 weeks the Lequesne index decreased 20% after GAGPS and 9% after placebo (P = 0.17). At 10 weeks the Lequesne index decreased 24% after GAGPS and 13% after placebo (P = 0.20). The decrease in Lequesne index at 14 weeks was 31% after GAGPS and 15% after placebo (P = 0.06). The other measured parameters tended to be more favorably influenced by GAGPS than placebo. GAGPS was well tolerated, with associated mild adverse reactions in 8% of cases. GAGPS may have a role as a symptomatic slow acting drug for OA. Further study appears appropriate.
我们研究了硫酸氨基聚糖（GAGPS）对80例膝骨关节炎（OA）患者的疗效和耐受性。在一项双盲、平行、随机、安慰剂对照试验中，患者每隔1周接受两系列共5次膝关节内注射，每次注射25mg（0.5ml）GAGPS。注射后，GAGPS组疼痛立即减轻43%，安慰剂组减轻33%（P = 0.047）（耶泽克疼痛指数）。在治疗开始后的其他时间间隔（10、14、22、26周），GAGPS组与安慰剂组的疼痛缓解情况无差异。6周时，GAGPS组的勒凯斯内指数下降20%，安慰剂组下降9%（P = 0.17）。10周时，GAGPS组的勒凯斯内指数下降24%，安慰剂组下降13%（P = 0.20）。14周时，GAGPS组的勒凯斯内指数下降31%，安慰剂组下降15%（P = 0.06）。与安慰剂相比，GAGPS对其他测量参数的影响往往更有利。GAGPS耐受性良好，8%的病例出现轻度不良反应。GAGPS可能作为OA的一种症状性慢作用药物发挥作用。进一步的研究似乎是合适的。
