Sunderkötter Cord, Weiss Johannes M, Bextermöller Raphael, Löffler Helena, Schneider Dirk
Department of Dermatology and Allergology, University of Ulm, Germany.
J Dtsch Dermatol Ges. 2006 Apr;4(4):301-6. doi: 10.1111/j.1610-0387.2006.05932.x.
Topical application of the calcineurin inhibitors pimecrolimus and tacrolimus is a current major advance in the therapy of atopic dermatitis. The aims of this post-marketing surveillance were: a) to acquire data on the efficacy and tolerability of pimecrolimus ointment (Elidel) on a very large cohort of patients from outpatient clinics, and b) to assess changes in their quality of life, a parameter not often considered in previous studies.
Included were 5,665 patients with atopic dermatitis. During the observation period, data on efficacy and tolerability were obtained at the beginning of the study, 3 to 10 days after initiation of therapy and after 4 to 6 weeks. Evaluation of symptoms as well as assessment of efficacy and tolerability were based on linear scales and on the percentage of the body surface area (% BSA) involved. Quality of life was assessed by the German version of the "Dermatology Life Quality Index (DLQI)" or the "Children's Dermatology Life Quality Index (CDLQI)".
In this largest post-marketing surveillance hitherto performed in Germany, the efficacy of pimecrolimus was judged as "good" by 79.3 % of physicians and by 76.5 % of patients. Tolerability was assessed as "good" by 87.2 % of physicians and by 83.1 % of patients. Major symptoms of atopic dermatitis such as pruritus, erythema or lichenification showed marked reduction after just 3 to 10 days, signalling general improvement of the skin disease. In addition, application of pimecrolimus resulted in a significant improvement of the quality of life scores in both children and adults.
The present study demonstrates that the good efficacy and tolerability of pimecrolimus ointment which had been shown in controlled trials: i) could also be demonstrated on a very large cohort of patients with atopic dermatitis when used in the outpatient setting, and ii) were paralleled by a significant improvement in the quality of life.
局部应用钙调神经磷酸酶抑制剂吡美莫司和他克莫司是目前特应性皮炎治疗的一项重大进展。本次上市后监测的目的是：a）获取关于吡美莫司乳膏（爱宁达）对大量门诊患者疗效和耐受性的数据，b）评估他们生活质量的变化，这是以往研究中较少考虑的一个参数。
纳入5665例特应性皮炎患者。在观察期内，在研究开始时、治疗开始后3至10天以及4至6周后获取疗效和耐受性数据。症状评估以及疗效和耐受性评估基于线性量表和受累体表面积百分比（% BSA）。生活质量通过德文版的“皮肤病生活质量指数（DLQI）”或“儿童皮肤病生活质量指数（CDLQI）”进行评估。
在德国迄今进行的这项最大规模的上市后监测中，79.3%的医生和76.5%的患者认为吡美莫司的疗效“良好”。87.2%的医生和83.1%的患者将耐受性评估为“良好”。特应性皮炎的主要症状，如瘙痒、红斑或苔藓化在仅3至10天后就有明显减轻，表明皮肤病总体有所改善。此外，应用吡美莫司使儿童和成人的生活质量评分均有显著提高。
本研究表明，吡美莫司乳膏在对照试验中显示出的良好疗效和耐受性：i）在门诊环境中用于大量特应性皮炎患者时也能得到证实，ii）同时伴有生活质量的显著改善。
