摘要
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.
出处
《中华外科杂志》
CAS
CSCD
北大核心
2007年第14期998-1001,共4页
Chinese Journal of Surgery