外用1%双氯芬酸钾凝胶治疗骨关节炎的疗效观察

目的探讨1%的双氯芬酸钾凝胶(diclofenac potassmm 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120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(diclofenac sodium gel,DSG),疗程2 wk,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1 wk时DPG组和DSG组的总有效率分别为68.33%和60.00%(P=0.292),2周时分别为76.67%和71.67%(P=0.752);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5.00%和3.33%(P＞0.5).结论外用1%DPG治疗OA安全有效,且耐受性好.

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

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.