糠酸莫米松乳膏治疗湿疹皮炎类皮肤病多中心临床研究

Treatment of Eczema and Neurodermatitis with 0.1% Mometasone Furoate Cream: A Multi-Center Clinical Trial

目的评价0.1%糠酸莫米松乳膏治疗湿疹皮炎类皮肤病疗效和安全性。方法本研究采用随机、双盲、平行对照的临床研究方法。受试者分别接受国产糠酸莫米松乳膏和艾洛松治疗。患者每日局部涂药1次,连续用药4周。在治疗始及治疗后第1～4周对各观察指标进行评估记录。结果本研究共入选受试者284例(试验组和对照组各142例)中湿疹143例,神经性皮炎141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差异无统计学意义。治疗结束时,湿疹患者试验组基愈率和总有效率分别为78.87%、97.18%;对照组基愈率和总有效率分别为84.51%、92.96%。神经性皮炎患者试验组基愈率和有效率分别为75.71%、100%;对照组基愈率和总有效率分别为80.28%、94.37%。两组患者总体评价试验组基愈率77.30%,有效率98.58%。对照组基愈率82.39%,有效率93.64%。两组间疗效比较差异无统计学意义。研究中两组均未发生不良反应。试验组发生接触性皮炎1例。结论0.1%糠酸莫米松乳膏治疗湿疹、神经性皮炎使用方便,安全性好。

Objective To observe the clinical efficacy and safety of 0.1% mometasone furoate cream in the topical treatment of eczematous dermatoses including neurodermatitis and eczema. Methods A randomized double-blind parallel controlled clinical trial was conducted. The home made mometasone furoate cream or imported Eloson cream was topically used in patients with such dermatoses once daily for 4 weeks, respectively. Symptom/sign scores were evaluated at the beginning of the treatment and at the 1st, 2nd, 3rd, 4th week after the initiation of the treatment. Results Two hundred and eighty-four patients were enrolled in the trial, including 143 patients with eczema and 141 patients with neurodermatitis. There are 142 patients each in test group and control group separately. All symptom/sign scores and total scores were significantly decreased 1, 2, 3, and 4 week after the treatment. No statistically significant difference was observed between the two groups. The cure rate and improvement rate in eczema patients were 78.87% and 97.18% in the test group; 84.51% and 92.96% in the control group; respectively. While the cure rate and improvement rate in neurodermatitis patients were 75.71% and 100% in the test group; 80.28% and 94.37% in the control group; respectively. The cure rate and improvement rate of total patients were 77.30% and 98.58% in the test group; 82.39% and 93.64% in the control group; respectively. No statistically significant difference in efficacy was observed between the two groups. There was no severe side effect in the two groups. One patient had mild contact dermatitis in the test group. Conclusions These results suggest that 0.1% mometasone furoate cream is an effective and safe drug in the treatment of neurodermatitis and eczema.