外用1%双氯芬酸钾凝胶治疗骨关节炎的疗效观察  

Effectiveness and safety of 1% diclofenac potassium gel for external application in the treatment of patients with osteoarthritis

作　　者：帅宗文[1] 李向培[2] 吴键[3] 孙桂华[1] 徐胜前[1] 

机构地区：[1]安徽医科大学第一附属医院风湿免疫科,合肥230022 [2]安徽省立医院风湿科,合肥230001 [3]中国人民解放军105医院骨科,合肥230031

出　　处：《安徽医药》2002年第1期24-26,共3页Anhui Medical and Pharmaceutical Journal

摘　　要：目的　探讨 1%的双氯芬酸钾凝胶 (diclofenacpotassium gel,DPG)局部外用治疗骨关节炎 (osteoarthritis,OA)的疗效和安全性。方法　用随机、开放、多中心平行性临床研究方法 ,将 12 0例膝关节OA患者随机分为两组 ,分别局部外用 1%DPG和1%的双氯芬酸钠凝胶 (diclofenacsodiumgel,DSG) ,疗程 2wk ,观察疗效和不良反应。 结果　 1%DPG和 1%DSG均能明显改善OA的多种临床指标 ,经治疗 1wk时DPG组和DSG组的总有效率分别为 6 8 33%和 6 0 0 0 % (P =0 2 92 ) ,2周时分别为76 6 7%和 71 6 7% (P =0 75 2 ) ;不良反应为局部皮肤的水肿、皮疹、瘙痒等 ,轻度可耐受 ,发生率DPG和DSG组分别为 5 0 0 %和 3 33% (P >0 5 )。结论　外用 1%DPG治疗OA安全有效 。AIM To investigate the effectiveness and safety of 1% diclofenac potassium gel(DPG) for external application in the treatment of patients with osteoarthritis(OA). METHODS A randomized, opened, multi centred and parallel clinical trial of 1% DPG versus 1% diclofenac sodium gel(DSG) was carried out in 120 patients with knee osteoarthritis. All the patients was allocated randomly to receive one or other of the two agents (3 to 4 gram) 3 to 4 times daily for two weeks. The efficacy and tolerability of 1% DPG were observed and compared with that of 1% DSG. RESULTS Either 1% DPG or 1% DSG could significantly improve the clinical parameters that indicated the severity of OA. After one week therapy, the effective rates in DPG group and DSG group were 68 33% and 60 00% ( P =0 292), respectively. At the end of two week treatment, these rates were 76 67% in DPG group and 71 67% ( P =0 752) in DSG group. The adverse effects associated with the two preparations in DPG group and DSG group were very slight, and the incidences were 5 00% and 3 33% ( P >0 5), respectively. CONCLUSIONS 1% DPG is effectiveness and safety in the treatment of OA, and well tolerated.

关 键 词：双氯芬酸钾 双氯芬酸钠 骨关节炎 临床试验 局部用药 非甾体类抗炎药 

分 类 号：R684.3[医药卫生—骨科学] R978.7[医药卫生—外科学]