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  

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

作　　者：胡东艳[1] 李明[1] 潘琳[1] 王强[1] 吴国勤[1] 傅雯雯[2] 顾军[3] 金雪娟[4] 张博恒[4] 

机构地区：[1]复旦大学附属中山医院皮肤科,上海200032 [2]复旦大学附属华山医院皮肤科,上海200040 [3]第二军医大学长海医院皮肤科,上海200433 [4]复旦大学循证医学中心,上海200032

出　　处：《中国临床医学》2006年第2期302-304,共3页Chinese Journal of Clinical Medicine

摘　　要：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, 试验组和对照组组间比较无显著差异。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。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.

关 键 词：0.1%糠酸莫米松洗剂 神经性皮炎 湿疹 

分 类 号：R977.11[医药卫生—药品]