Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents
Safety and efficacy of pimecrolimus (ASM 981) cream 1% in the treatment of mild and moderate atopic dermatitis in children and adolescents
复制标题
DOI：
10.1067/mjd.2002.122187
复制
发表时间：
2002-04-01
影响因子：
13.8
通讯作者：
Boguniewicz, M
中科院分区：
文献类型：
--
作者：
Eichenfield, LF;Lucky, AW;Boguniewicz, M
背景子囊霉素衍生物吡美莫司（ASM 981）是一种细胞选择性细胞因子抑制剂，专门用于治疗炎症性皮肤病。目的：1%吡美莫司乳膏外用治疗炎症性皮肤病，包括儿童和成人的特应性皮炎（AD）、过敏性接触性皮炎和成人的慢性接触性刺激性手部皮炎。在两项独立的6周、随机化、多中心、设计相同的研究中，比较了1%吡美莫司乳膏与溶媒在以中度AD为主的儿童中的疗效和安全性。在分析中使用了来自总共403名患者的汇总数据。主要疗效参数为研究者总体评估（伊加）评分。次要参数包括瘙痒面积和严重程度指数（EASI）和瘙痒严重程度评分。受试者也被要求评估他们的疾病控制不受控制，有限的，良好的，或complete.Results：显着的治疗效果相对于车辆观察吡美莫司治疗组在第一次疗效评估，8天后，首次应用的研究药物（例如，缓解瘙痒）。在随后的每次基线后访视中，吡美莫司治疗的患者在所有疗效指标方面均显示出相对于对照组的显著改善。药物耐受性良好。结论：吡美莫司乳膏1%似乎是一个安全，有效的替代目前使用的治疗AD。
Background. The ascomycin derivative pimecrolimus (ASM 981) is a cell-selective cytokine inhibitor, specifically developed for the treatment of inflammatory skin diseases.Objective: When applied topically, pimecrolimus cream 1% has shown promise as a treatment for inflammatory skin conditions, including atopic dermatitis (AD) in children and adults, allergic contact dermatitis, and chronic contact irritant hand dermatitis in adults.Methods: In two independent 6-week, randomized, multicenter studies of identical design, the efficacy and safety of pimecrolimus cream 1% in children with predominantly moderate AD were compared with vehicle. Pooled data from a total of 403 patients were used in the analysis. The primary efficacy parameter was the Investigator's Global Assessment (IGA) score. Secondary parameters included Eczema Area and Severity Index (EASI) and severity of pruritus scores. Subjects were also asked to assess their disease control as uncontrolled, limited, good, or complete.Results: Significant therapeutic benefits relative to vehicle were observed in the pimecrolimus-treated group at the first efficacy assessment, 8 days after initial application of the study medication (eg, relief of pruritus). At each subsequent postbaseline visit, pimecrolimus-treated patients showed significant improvement relative to controls in all efficacy measures. The medication was well tolerated.Conclusion: Pimecrolimus cream 1% appears to be a safe and effective alternative to currently used therapies for AD.