外用1%双氯芬酸钾凝胶治疗骨关节炎的临床疗效  

Effect and safety of 1% diclofenac potassium gel for external application in 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,安徽合肥230022 [2]安徽省立医院风湿科,安徽合肥230001 [3]中国人民解放军105医院骨科,安徽合肥230031

出　　处：《中国新药与临床杂志》2002年第9期532-535,共4页Chinese Journal of New Drugs and Clinical Remedies

摘　　要：目的 :探讨 1%的双氯芬酸钾凝胶 (DPG )局部外用治疗骨关节炎 (OA)的疗效和安全性。方法 :用随机、双盲、多中心平行性临床研究方法 ,将12 0例膝关节OA病人随机分为 2组 ,分别局部外用 1%DPG和 1%的双氯芬酸钠凝胶 (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%和 6 0 % (P >0 .0 5 ) ,2wk时分别为 77%和72 % (P >0 .0 5 ) ;镇痛起效时间DPG组和DSG组分别为 (12 6± 30 )min和 (146± 33)min (P <0 .0 5 )。不良反应发生率DPG和DSG组分别为 5 %和 3% (P >0 .0 5 )。结论 :外用 1%DPG治疗OA安全有效 ,且耐受性好 ,其起效时间较外用AIM: To investigate the effect and safety of 1 % diclofenac potassium gel(DPG) for external application in the treatment of patients with osteoarthritis(OA). METHODS: A randomized, double-blind, multi-centre and parallel clinical trial of 1 % DPG versus 1 % diclofenac sodium gel(DSG) was carried out in one hundred and twenty patients with knee osteoarthritis. All the patients were allocated randomly to receive one or other of the two agents (3-4 g) three to four times daily for 2 wk. The effects and adverse reactions 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 of OA. After 1 wk therapy, the effective rates in DPG group and DSG group were 68 % and 60 %(P> 0.05), respectively. At the end of 2 wk treatment, these rates were 77 % in DPG group and 72 %(P> 0.05) in DSG group. After the first application, the remissions of pain at rest in DPG group and DSG group occurred in (126±30) min and (146±33)min (P< 0.05), respectively. The adverse reactions associated with the two preparations were very slight, and the incidence was 5 % in DPG group and 3 %(P> 0.05) in DSG group. CONCLUSION: 1 % DPG is effective and safe in the treatment of OA, and well tolerated. Its analgetic action seems more rapid than 1 % DSG.

关 键 词：外用 双氯芬酸钾凝胶 治疗 骨关节炎 临床疗效 

分 类 号：R971.1[医药卫生—药品] R684.3[医药卫生—药学]