复方硝酸益康唑乳膏治疗足癣和体股癣随机双盲对照临床试验

A Double Blind Randomized Controlled Clinical Trial of Econazole-Triamcinolon Acetonide Cream in the Treatment of Tinea Pedis and Tinea Corporis & Cruris

目的：评价复方硝酸益康唑乳膏治疗足癣和体股癣的疗效及安全性, 并与1%硝酸益康唑霜对比。方法：每天外用2次,疗程体股癣2周, 足癣 4周，随访2周。 足癣可疗效评价病例，试验组38例，对照组33例。体股癣试验组33例，对照组35例。结果：试验组对足癣,在第4周时脱屑症状的改善和临床的综合改善明显优于对照组（P<0.01）; 在停药后2周, 角化、浸渍和瘙痒症状的改善和临床的综合改善优于对照组(P<0.05)。试验组对体股癣，在第1周时瘙痒症状的改善和临床的综合改善优于对照组（P<0.05）; 在停药后2周, 丘疹症状的改善优于对照组(P<0.05)。试验组对足癣,在第2周时临床有效率57.89%(对照组51.52%),真菌学清除率71.05%(对照组72.73%)；在第4周分别为94.74%(对照组81.82%)和94.74%(对照组100%)；在停药后2周分别为100%(对照组81.82%,P<0.05)和100%(对照组93.94%)。试验组对体股癣, 在第1周的临床有效率87.88%(对照组60.00%,P<0.01),真菌学清除率90.91%(对照组88.57%)；在第2周分别为96.97%(对照组91.43%)和100%(对照组97.14%)；在停药后2周分别为100%(对照组100%)和100%(对照组100%)。试验组不良反应发生率2.74%（对照组2.86%），表现为局部轻度刺激。结论：复方硝酸益康唑乳膏治疗足癣和体股癣,可在短时间内抑?

OBJECTIVE: This study is to assess the efficacy and safety of econazole nitrate 1%-triamcinolone acetonide 1% cream. METHODS: Econazole nitrate 1%-triamcinolone acetonide 0.1% cream compared to econazole nitrate 1% cream applied twice daily for 4 weeks in the treatment of tinea pedis and for 2 weeks in the treatment of tinea corporis & cruris, both treatment groups had 2 weeks of follow-up observation after the end of treatment. 38 cases in trial group and 33 cases in control group were enrolled for tinea pedis; 33 cases in trial group and 35 cases in control group were enrolled for tinea corporis & cruris.RESULTS: The improvement of scale and total clinical score of trial group for tinea pedis were superior to control group (P<0.01) at 4 weeks; superior to control group(P<0.05) for hyperkeratosis, maceration , itching and total clinical score at follow up 2 weeks. The improvement of itching and total clinical score of trial group for tinea corporis & cruris were superior to control group (P<0.05) at 1 weeks; superior to control group(P<0.05) for papule at follow up 2 weeks. Overall effective treatment rates for tinea pedis at 2 weeks were 57.89% in trial group and 51.52% in control group; 94.74% versus 81.82% at 4 weeks respectively;and 100% versus 81.82%(P<0.05) at follow-up 2 weeks respectively. Mycological cure rates for tinea pedis at 2 weeks were 71.05% in trial group and 72.73% in control group; 94.74% versus 100% at 4 weeks respectively; and 100% versus 93.94% at follow-up 2 weeks. Overall effective treatment rates for tinea corporis & cruris at 1 week were 87.88% in trial group and 60.00% in control group(P<0.01); 96.97% versus 91.43% at 2 weeks respectively; and 100% versus 100% at follow-up 2 weeks respectively. Mycological cure rates for tinea corporis & cruris at 1 week were 90.91% in trial group and 88.57% in control group; 100% versus 97.14% at 2 weeks respectively; and 100% versus 100% at follow-up 2 weeks. An local irritation occurred equally treatments but was well tolerated by the patients.Adverse reaction rate were 2.74% in trial group and 2.86% in control group. CONCLUSION: Econazole nitrate 1%-triamcinolone acetonide 0.1% cream in the treatment tinea pedis and tinea corporis & cruris is more rapid for the reduction of inflammatory symptom, shorter treatment course and higher efficacy than econazole nitrate 1% cream, as same antifungal effect as econazole nitrate 1% cream .