糠酸莫米松洗剂治疗神经性皮炎和湿疹的多中心临床研究

目的：了解0．1％糠酸莫米松洗剂治疗神经性皮炎和湿疹临床疗效和安全性。方法：采用随机、双盲、双模拟、平行对照的多中心临床研究方法，以0．1％糠酸莫米松乳膏做对照。受试者每天外用药物1次，先用洗剂，干燥后再用乳膏，疗程4周。在治疗始、治疗后1、2,4周对各观察指标进行评估记录。结果：共有133例神经性皮炎、141例湿疹患者参加本次研究，其中试验组137例，对照组、138例。治疗后1～4周，两组患者各项症状／体征指标计分及总计分均有明显下降，试验组和对照组组问比较无显著差异。治疗后4周，神经性皮炎患者试验组的痊愈率和有效率分别为59．09％和98．48％，对照组的痊愈率和有效率分别为71．21％和98．48％；湿疹患者中，试验组的痊愈率和有效率分别为49．30％和98．59％，对照组的痊愈率和有效率分别为58．57％和100％，两组间比较均无显著差异。试验组不良反应发生率为3．6％，对照组为2．9％，均为局部不良反应，两组比较无显著差异。结论：0．1％糠酸莫米松洗剂治疗神经性皮炎和湿疹临床疗效好，安全性好，应用方便。

Treatment of Eczema and Neurodermatitis with 0.1% Mometasone Furoate Lotion: a Multi-center Clinical Trial

Objective:To observe the clinical efficacy and safety of 0.1% monetasone furoate lotion in the topical treatment of neurodermatitis and eczema. Methods: A randomized double-blind double-simulation parallel controlled clinical trial was conducted. 0. 1% monetasone furoate cream (trade name:Alosonne) was in control. Patients used the cream firstly then the lotion once daily for 4 weeks. Symptom/sign scores were evaluated at the beginning of the treatment and at the 1st.2nd,4th week after the initiation of the treatment. Results: 133 patients with neurodermatitis and 141 patients with eczema were enrolled. There were 137 patients in the treatment group and 138 patients in the control group respectively. All symptom/sign scores and total scores were significantly decreased 1,2 and 4 weeks after the treatment. No statistically significant difference was observed between the two groups. The cure rate and improvement rate in neurodermatitis patients were 59. 09% and 98. 48% in the test group; 71. 21 % and 98. 48% in the control group; respectively. While the cure rate and improvement rate in eczema patients were 49. 30% and 98. 59% ; 58. 57% and 100% in the control group; respectively. No statistically significant difference in efficacy was observed between the two groups. The side effect rate in the test group was 3. 6% ,2. 9% in the control group; respectively. No statistically significant difference in side effect was observed between the two groups. Conclusion:These results suggest that 0. 1 % monetasone furoate lotion is an effective and safe drug in the treatment of neurodermatitis and eczema.