双氯芬酸二乙胺盐凝胶与双氯芬酸钠凝胶镇痛抗炎对照试验

A Clinical Study of Therapeutic Effect of Diclofenac Diethylamine Salt Gel in Anti-inflammatory and Analgesic Treatment

目的 :考察双氯芬酸二乙胺盐凝胶治疗闭合性创伤和扭伤镇痛抗炎的临床疗效和安全性。方法 :4 0例患者随机分为双氯芬酸二乙胺盐凝胶组和双氯芬酸钠凝胶组进行临床对照试验 ,分别采用局部涂擦给药法 ,tid ,14d为 1疗程。结果 :两组有效率分别为 90 .0 %和 80 .0 % (P >0 .0 5 ) ,不良反应发生率分别为 10 .0 %和 2 5 .0 % ,主要表现为皮肤瘙痒、发红和丘疹 ,停药后可自行消失。结论 :双氯芬酸二乙胺盐凝胶是安全有效的外用镇痛抗炎药。

Objective: To evaluate the clinical efficacy and safety of diclofenac diethylamine salt gel in the treatment of closed trauma and sprain. Methods: All the patients recruited were randomized into the diclofenac diethylamine salt gel and diclofenac sodium gel groups and treated with local application three times daily for 14 days respectively. Result: The clinical effective rates in the diclofenac diethylamine salt gel group and diclofenac sodium gel group were 90% vs 80% and the incidence of adverse reaction in the two groups were 10% vs 25%. There were no significant differences between the two groups( P > 0.05 ). Conclusion: The diclofenac diethylamine salt gel is a kind of effective and safe anti-inflammatory and analgesic drug.