盐酸/硫酸氨基葡萄糖治疗骨关节炎的平行对照临床研究

目的评价盐酸/硫酸氨基葡萄糖治疗膝骨关节炎的疗效和安全性。方法采用多中心、随机、阳性药平行对照临床研究方法,将142例膝骨关节炎患者随机分为2组,试验组和对照组各为71例,分别给予盐酸氨基葡萄糖480mg/次和硫酸氨基葡萄糖500mg/次,每天口服药物3次,共治疗4周,停药后继续观察2周。采用Lequesne指数作为疗效评分标准,观察服药前后的膝关节症状变化包括休息痛、运动痛、压痛、肿胀、晨僵和行走能力的改善程度,纪录不良反应及实验室生化指标等。结果治疗4周后,试验组和对照组的Lequesne指数总评分与基础值相比分别下降至3.4±1.9(P<0.05)和3.4±1.8(P<0.05),症状改善率分别为91.4%(64/70)和90.0%(63/70),两组间差异无统计学意义(P>0.05);停药两周后,两组皆维持原有的治疗效果,症状改善率分别为92.4%(61/66)和91.2%(62/68),组间差异无统计学意义(P>0.05);试验组和对照组的不良反应发生率分别为4.2%(3/71)和7.0%(5/71),主要表现为轻中度胃部不适和便秘。结论盐酸氨基葡萄糖治疗骨关节炎的疗效和安全性与硫酸氨基葡萄糖相似,是一种治疗骨关节炎的安全、有效的药物。

A multi-central, randomized, controlled clinical trial of glucosamine hydrochloride/sulfate in the treatment of knee osteoarthritis

OBJECTIVE: To evaluate the efficacy and safety of glucosamine hydrochloride (GH) in the treatment of patients with knee osteoarthritis (OA) comparing with glucosamine sulfate (GS). METHODS: A multi-central, randomized, parallel-controlled clinical trial of GH vs GS was performed. 142 patients suffering from knee OA were randomized into 2 groups, treated with GH and GS for 480 mg and 500 mg one time respectively. Patients received medicine 3 times daily with total 1440 mg per day for GH group and 1500 mg for GS group, orally for 4 weeks and were assessed for drug efficacy and safety for 2 more weeks. Knee pain at rest, at movement and at pressure, knee swelling, morning stiffness and walking ability were recorded at 1, 2, 3, 4 and 6 week according to Lequesne's criteria. Other features such as therapeutic efficacy, adverse events and laboratory parameters were also recorded. RESULTS: A considerable improvement in OA symptoms and a reduce of total Lequesne's score were observed in both groups after the 4-week treatment. The Lequesne's score decreased to 3.4 +/- 1.9 (P < 0.05) and 3.4 +/- 1.8 (P < 0.05) after 4-week treatment comparing to 0-week in the GH (9.4 +/- 1.8) group and GS (9.5 +/- 1.4) group respectively. There was no significant difference between 2 groups in decreasing the Lequesne's score (P > 0.05). The symptomatic improvement rates in patients were 91.4% and 90.0% at 4-week treatment in the GH and GS group respectively (P > 0.05). There was a remnant therapeutic effect in both groups at 2 weeks after discontinuation of the treatment. And 4.2% (3/71) of patients on GH reported adverse events, vs 7.0% (5/71) adverse events with GS group (P > 0.05), mainly mild stomach discomfort and constipation. CONCLUSION: There were no significant differences in efficacy and safety between GH and GS groups in the treatment of knee OA. Glucosamine hydrochloride is as effective and safe as glucosamine sulfate.