Efficacy and safety of intramuscular glucosamine sulfate in osteoarthritis of the knee. A randomised, placebo-controlled, double-blind study.
Efficacy and safety of intramuscular glucosamine sulfate in osteoarthritis of the knee. A randomised, placebo-controlled, double-blind study.
复制标题
肌肉注射硫酸氨基葡萄糖治疗膝骨关节炎的疗效和安全性。
DOI：
--
复制
发表时间：
1994
期刊：
影响因子：
--
通讯作者：
I. Setnikar
中科院分区：
文献类型：
--
作者：
A. Reichelt;Forster Kk;Michael A Fischer;L. Rovati;I. Setnikar
氨基葡萄糖硫酸盐(DONA，CAS 29031-19-4)是一种用于治疗骨关节炎的药物。口服时，它在缓解骨关节炎症状方面比安慰剂更有效，至少与非类固醇抗炎药一样有效。这项多中心、随机、安慰剂对照、双盲、平行分组研究的目的是评估在相同参数下肌肉注射硫酸氨基葡萄糖的有效性和安全性。对155例膝关节骨性关节炎(Lequesne标准)，放射学分期I~III，Lequesne严重程度指数至少4分，症状至少6个月的患者进行肌注治疗。氨基葡萄糖硫酸盐(或安慰剂)400毫克，每周两次，共6周。在两周基线后，在治疗期间和停药后两周，每周一次进行临床访问。治疗应答者被认为是那些在Lequesne指数中至少下降3分的患者，同时调查者的总体判断是积极的。在治疗开始时，两组的Lequesne指数平均略高于10分。与安慰剂相比，氨基葡萄糖的指数显著下降(分别为3.3分和2.0分；P<；0.05，学生t检验)。在可评估的患者中，氨基葡萄糖有效率为55%(n=73)，安慰剂有效率仅为33%(n=69)(p=0.012，Fisher‘s Exact Test)。根据意向治疗方法，考虑到中途辍学，这些比例分别为51%和30%(p=0.015)。
Glucosamine sulfate (Dona, CAS 29031-19-4) is a drug used in the treatment of osteoarthritis. When orally given, it is more effective than placebo and at least as effective as non-steroidal anti-inflammatory drugs in relieving osteoarthritis symptoms. The aim of this multicentre, randomised, placebo-controlled, double-blind, parallel-group study was to assess the efficacy and safety of glucosamine sulfate intramuscularly given on the same parameters. 155 out-patients with knee osteoarthritis (Lequesne's criteria), radiological stage between I and III, Lequesne's severity index of at least 4 points and symptoms for at least 6 months, were treated with i.m. glucosamine sulfate (or placebo) 400 mg twice a week for 6 weeks. Clinic visits were performed at enrollment, after a 2-week baseline, at weekly intervals during treatment and 2 weeks after drug discontinuation. Responders to treatment were considered those patients with a reduction of at least 3 points in the Lequesne index, together with a positive overall judgement by the investigator. The Lequesne index was slightly over 10 points in average in both groups at the beginning of treatment. A significant decrease in the index was observed for glucosamine compared to placebo (3.3 vs. 2.0 points in average, respectively; p < 0.05, Student's t-test). The responder rate in the evaluable patients was 55% with glucosamine (n = 73) and only 33% (n = 69) with placebo (p = 0.012, Fisher's Exact Test). According to the intention-to-treat approach, considering also drop-outs, these proportions were 51% vs. 30% (p = 0.015).(ABSTRACT TRUNCATED AT 250 WORDS)