0.05%地奈德乳剂治疗内源性湿疹的临床研究

Clinic Study of Endogenous Eczema Treated by 0.05% Desonide Cream

目的 评价 0 .0 5 %地奈德乳剂治疗内源性湿疹包括特应性皮炎 3周的疗效和安全性。方法 入组包括特应性皮炎在内的内源性湿疹 84例 ,采用随机、双盲、基质对照、平行组对比研究 ,受试者外涂药物于受累区域 ,2次 /d ,连续治疗 3周。结果 试验组靶皮损总积分 (TSS)由治疗前 8.3 1± 1.85降至 1.19± 1.69,TSS改善 84.99% ;对照组TSS由 8.43± 1.67降至 3 .10± 2 .2 4,TSS改善 63 .5 4%。试验组与对照组靶皮损各项观察指标均得到改善 ,但试验组的改善优于对照组。总体改善评价试验组总有效率为 80 .95 % ,对照组为 5 2 .3 8% ,两组比较差异有显著性 (P <0 .0 5 )。 结论 0 .0 5 %地奈德乳剂治疗内源性湿疹的临床治愈率、总体疗效优于基质 ,且不良反应发生率低 ,是一种安全有效的外用皮质类固醇激素。

Objective To assess the effect and safety of 0.05% Desonide cream versus vehicle in 3 week treatment of endogenous eczema including atopic dermatitis. Methods 84 cases of endogenous eczema including atopic dermatitis were recruited.The creams were applied twice a day for 3 week.A randomized,double blind, vehicle control,parallel grouping trial was conducted. Results TSS of test group improved 84.99% was decreased from baseline 8.31±1.85 to 1.19±1.69,TSS of control group improved 63.54% was decreased from 8.43±1.67 to 3.10±2.24. Every observating mark in both groups were improved,though the improvement was greater in test group than control group.In general improvement assess,total response rate was 80.95% in test group and 52.38% in control group.There was significant difference of response rate( P <0.05)between two groups.Conclusion Desonide cream is safe and effective external use corticosteroid, which clinical cure rate and general efficacy in treating endogenous eczema is better than that of vehicle,and the side effect is low.