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世界核心医学期刊文摘（皮肤病学分册） 2005年第8期1卷 19-20页

作者： Schulze H.- J. Cribier B. Requena L. 李政霄 fachklinik hornheide Dorbaumstr. 300 48157 M¨ unster Germany

Background: Imiquimod is an immune response modifier that acts through toll- like receptor 7 to induce cytokine production and a subsequent innate and adaptive cell- mediated immune response. Clinical studies have demonstrated clinical and histological clearance of superficial basal cell carcinoma (sBCC) after treatment with imiquimod 5% cream. Objectives: To evaluate the safety and clinical efficacy of imiquimod (Aldara.; 3M Pharmaceuticals, St Paul, MN, U.S.A.) 5% cream for the treatment of sBCC in a multicentre, randomized, parallel, vehicle- controlled, double- blind, phase III clinical study conducted at 26 centres in Europe. Methods: Subjects who had at least one histologically confirmed sBCC tumour were randomized to apply imiquimod or vehicle cream to the target tumour once daily, seven times, per week (7 x/week)for 6 weeks. The target tumour location was identified with an indelible ink mark before treatment initiation. The treated tumour site was clinically assessed for treatment response at 12 weeks post- treatment and was then excised for histological evaluation. Efficacy assessments included the composite response rates (proportion of subjects with clinical and histological clearance) and response rates solely based on histology (proportion of subjects with histological clearance). Safety assessments, which included adverse events and scoring of local skin reactions (LSRs), were carried out throughout the study. Results: In total, 166 subjects were enrolled in this study. For the intent- to- treat dataset, there was a statistically significant difference between imiquimod and vehicle groups for both composite clearance rates (clinical and histological assessments) and histological clearance rates. Composite clearance was demonstrated in 77% and 6% of subjects treated with imiquimod and vehicle cream, respectively. Histological clearance was demonstrated in 80% and 6% of subjects treated with imiquimod and vehicle cream, respectively. The most frequently

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