盐酸氨基葡萄糖治疗骨性关节炎有效性与安全性评价

Efficacy and safety evaluation of glucosamine hydrochloride in the treatment of osteoarthritis

目的评价盐酸氨基葡萄糖胶囊治疗骨性关节炎的有效性和安全性。方法多中心、随机、阳性药物对照研究。143例膝和髋骨关节炎患者被随机分为两组,盐酸氨基葡萄糖研究组1粒/次,每日2次;硫酸氨基葡萄糖对照组2粒/次,每日3次,疗程均为6周。结果治疗6周后,盐酸氨基葡萄糖在改善行走疼痛、夜间静息痛、晨僵几方面优于硫酸氨基葡萄糖,差异有统计学意义(P<0.05)。总有效率评价显示盐酸氨基葡萄糖有效率为75.4%,硫酸氨基葡萄糖为60.6%,两组间差异无统计学意义,提示两种氨基葡萄糖治疗骨关节炎疗效相当。盐酸氨基葡萄糖组发生不良反应3例,硫酸氨基葡萄糖组2例,均较轻微,无严重不良事件发生。结论盐酸氨基葡萄糖胶囊治疗骨关节炎安全、有效,与硫酸氨基葡萄糖疗效相当。

Objective To evaluate the efficacy and safety of glucosamine hydrochloride for the treatment of osteoarthritis. Methods A multi-central, randomized, controlled clinical trial of glucosamine hydrochloride comparing glucosamine sulfate for the treatment of osteoarthritis was performed. One hundred and forty-throe patients suffering from knee or hip osteoarthritis were randomized into study （ glucosamine hydrochloride） or control （glucosamine sulfate） group. Patients in study group orally took glucosamine hydrochloride 2 times daily for 6 weeks, each time 1 capsule, and those in control group took glucosamine sulfate 3 times daily for 6 weeks also, each time 2 capsules. Results The symptomatic improvement of joint pain at walking, at rest and stiffness after 6 week treatment with glucosamine hydrochloride was better than those with glucosamine sulfate. The results had significant difference （ P 〈 0. 05 ）. Total effective rates of patients with glucosamine hydrochloride was 75.4% and 60. 6% with glucosamine sulfate, but no statistical difference. The results suggested both glucosamine had the considerable efficacy in the treatment of osteoarthritis. Three cases in study group and 2 in control group reported mild adverse events. No severe adverse events （SAE） was observed. Conclusion Glucosamine hydrochloride is as effective and safe as glucosamine sulfate for the treatment of osteoarthritis.