依托芬那酯凝胶治疗关节痛的多中心随机开放对照研究

A multicenter,randomized,controlled,open,paralleled study for evaluating efficacy and safety of etofenamate gel in patients with arthralgia

目的:以双氯芬酸钠乳膏为对照,研究依托芬那酯凝胶对关节痛患者的疗效及安全性。方法:150例关节痛患者随机分成试验组(依托芬那酯凝胶凝胶)和对照组(双氯芬酸钠乳膏),临床观察时间为1周。对两药治疗前后关节疼痛、压痛、活动痛和研究者对总体疗效的评价进行比较。结果:两组在治疗1周时平均关节疼痛、压痛和活动痛的变化及起效时间差异无统计学意义;两组的不良事件发生率差异无统计学意义,两组皆无严重不良事件发生。结论:依托芬那酯凝胶与双氯芬酸钠乳膏对关节痛的止痛作用和不良反应相似,无严重不良事件发生。

Objective： To compare the clinical efficacy of etofenamate gel（Ordofen）,a new nonsteroidal anti-inflammatory drug,with that of diclofenac sodium cream in patients with arthralgia,and to evaluate the safety and tolerability of etofenamate gel.Methods： A multicenter,randomized,open,active comparator-controlled,paralleled trail was performed in 150 patients with arthralgia.Patients were randomized to 2 groups,and treated with etofenamate gel and diclofenac sodium cream,three times a day.Clinical efficacy and safety were evaluated after 1-week treatment.Results： Etofenamate gel showed its efficacy in relieving arthralgia,which was not significantly different from that of diclofenac sodium cream.There was no difference in adverse effects between two groups,and no serious adverse effects occurred.Conclusion： Etofenamate gel has the same clinical efficacy and adverse effects as diclofenac sodium cream in patients with arthralgia.