复方乳酸软膏治疗寻常型鱼鳞病和手足皲裂症的临床疗效观察

A randomized,double-blind,compared clinical trial of the compound lactic acid ointment in the treatment of ichthyosis vulgaris and rhagadia manus and pedalis

目的:观察复方乳酸软膏治疗寻常型鱼鳞病和手足皲裂症的临床疗效和安全性。方法:采用随机双盲、基质对照的临床试验方法,结合开放临床试验,对复方乳酸软膏2次d外用进行观察。结果:97例患者随机分为试验组、对照组和开放组,28d治疗后,试验组鱼鳞病和手足皲裂的有效率均为100%、对照组则分别为91.7%和27.3%。两组临床疗效有显著差异。开放组鱼鳞病和手足皲裂的有效率分别为95.7%、95.8%。复方乳酸软膏的不良事件为1.37%。结论:复方乳酸软膏治疗寻常型鱼鳞病和手足皲裂症的临床疗效优于软膏基质,其安全性与软膏基质类似。

Objective:To evaluate the efficacy and safety of the compound lactic acid ointment in the treatment of patients with ichthyosis vulgaris and rhagadia manus and pedalis.Methods:A randomized,double-blind,vehicle compared study and the combination opens trial was used to compare the efficacy and safety of the compound lactic acid ointment,external use,twice daily in the treatment of patients with ichthyosis vulgaris and rhagadia manus and pedalis.Results:97 cases were randomly divided into three groups.After 28 days treatment,respectively the efficacy rates were 100%,100% for ichthyosis vulgaris and rhagadia manus and pedalis in test group,vs.91.7%,27.3% in the vehicle group,95.7%,95.8% in the open group.There was significant difference between group and the vehicle group.The adverse drug event rates was 1.37% for the compound lactic acid ointment.Conclusion:The efficacy of the compound lactic acid ointment was better than the vehicle in the treatment of ichthyosis vulgaris and rhagadia manus and pedalis.The safety of the compound lactic acid ointment was similar to the vehicle.