复方乳酸软膏治疗寻常型鱼鳞病随机双盲基质对照多中心临床研究

Double blind randomized controlled clinical trial of lactic acid compound ointment in the treatment of ichthyosis vulgaris

目的 评价复方乳酸软膏治疗寻常型鱼鳞病的疗效和安全性。方法用随机、基质对照临床试验,共126例,其中试验组62例,对照组64例。局部用药,每日2次,共用4周。结果 客观指标为鳞屑、角化、皲裂,试验组和对照组有效率分別为100.0％和73.3％,主观指标为干燥、瘙痒、疼痛,试验组和对照组有效率分别为98.4％和63.3％。各项指标比较差异均有统计学意义(P<0.001)。药物不良事件仅对照组发生1例,发生率为0.8％,两组比较差异无统计学意义。结论 复方乳酸软膏治疗寻常型鱼鳞病疗效高,安全性好,使用方便。

Objective To evaluate the efficacy and safety of lactic acid compound ointment in the treatment of ichthyosis vulgars. Methods A randomized , vehicle controlled clinical trial was conducted . One hundred twenty-six patients with ichthyosis vulgaris were randomized divided into lactic acid compound ointment group and vehicle group. They were administerd topically with lactic acid compound ointment or vehicle twice per day for 4 weeks. Results Objective symptoms (dry, pruritus, pain)the effective rates in two groups were 100.0% and 73.3%, respectively. Subjective symptoms (scale, hyperkeratosis, fissure) the effective rates were 98.4% and 63.3%, respectively.There are statistically significant difference between the two groups (P<0.001). The adverse drug reaction is only in (0.8%)controlled group. Conclusion The treatment of ichthyosis vulgaris with lactic acid compound ointment is effective and safely