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目的评价硫酸氨基葡萄糖胶囊(商品名:加古力)治疗膝骨关节炎的有效性和安全性。方法采用多中心、随机、双盲双模拟、平行对照临床试验,共入选病例240例,进入PPS分析集211例,其中试验组107例,予硫酸氨基葡萄糖胶囊1粒+维固力模拟胶囊2粒,tid;对照组104例,予维固力胶囊2粒+硫酸氨基葡萄糖模拟胶囊1粒,tid。疗程均为10周。结果治疗后两组疗效FAS和PPS的结果显示症状改善率、治疗改善率、总有效率试验组与对照组之间差异均无统计学意义。不良反应发生率试验组(14.17%)略高于对照组(10.00%),但两组间比较差异也无统计学意义。结论硫酸氨基葡萄糖胶囊治疗膝骨关节炎疗效与维固力相近似,不良反应少见,安全性较好,可作为在临床上对膝骨关节炎综合治疗中可供选择的一种药物。
Abstract:AIM To evaluate the efficacy and safety of glucosamine sulfate capsules in the treatment of the knee joint osteoarthritis.METHODS A multicenter,randomized,double-blind,controlled clinical trial was conducted for treatment of 240 patients with the knee joint osteoarthritis.There were 211 patients for per-protocol(PP) analysis.Totally 107 patients in trial group were given one capsule of glucosamine sulfate and two capsules of Viartril-s mimetic agent, rid,while 104 patients in control group were given two Viartril-s capsules and one capsule of glucosamine sulfate mimetic agent,tid.The treatment duration for both groups was 10 weeks.RESULTS No significant differences were observed between the trial group and the control group with respect to the clinical efficacy and the incidence of adverse drug reactions(P>0.05).CONCLUSION Glucosamine sulfate capsules are effective and safe in the treatment of the knee joint osteoarthritis.
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基本信息:
DOI:10.19577/j.cnki.issn10074406.2013.04.001
中图分类号:R684.3
引用信息:
[1]陈怡,朱光辉,徐华梓,等.硫酸氨基葡萄糖胶囊治疗膝骨关节炎的随机双盲多中心对照试验[J].中国临床药学杂志,2013,22(04):197-201.DOI:10.19577/j.cnki.issn10074406.2013.04.001.
2013-07-25
2013-07-25