Center for Evidence-based Health Care (ZEGV), Medical Faculty Carl Gustav Carus, TU Dresden, Dresden, Germany.
University Allergy Center (UAC), Carl Gustav Carus University Medical Center, TU Dresden, Dresden, Germany.
J Dtsch Dermatol Ges. 2017 Jan;15(1):49-59. doi: 10.1111/ddg.12958. Epub 2016 Nov 10.
The goal of clinical registries is to document the use and effectiveness of therapeutic interventions under real-life conditions. They are an indispensable prerequisite of evidence-based health care.
Initiated in 2011, the German Atopic Dermatitis Registry TREATgermany is the first registry of patients with severe atopic dermatitis worldwide. Adults with severe atopic dermatitis (current/prior systemic antiinflammatory treatment and/or objective SCORAD ≥ 40) are prospectively followed over the course of 24 months. Employed treatment modalities are documented, and validated measuring tools are used to assess clinical disease severity (EASI, objective SCORAD), quality of life (DLQI), symptoms (POEM), global disease severity, as well as patient satisfaction. Herein, we describe the characteristics, therapeutic selection, and effectiveness of systemic antiinflammatory treatments of patients enrolled in the registry until October 2014.
Overall, 78 individuals (mean age 39 years, 61 % men) were enrolled at five recruitment centers. Patients frequently made use of inpatient and outpatient services. Not only was cyclosporine the most frequently administered systemic treatment, but also the most effective (EASI 50 response rate 51 %; EASI 75 response rate 34 % at 12 weeks). Azathioprine, methotrexate, oral prednisolone, mycophenolate, alitretinoin, and leflunomide were also used in some patients.
The present analysis of the German Atopic Dermatitis Registry provides important data with respect to current medical care of adults with severe atopic dermatitis in Germany. It shows the high disease burden, the benefits of current treatment options, and the need for additional effective and safe long-term treatment options.
临床注册的目标是记录治疗干预措施在实际情况下的使用和效果。它们是循证医疗保健不可或缺的前提条件。
德国特应性皮炎注册研究 TREATgermany 于 2011 年启动，是全球首个严重特应性皮炎患者注册研究。研究前瞻性地随访 24 个月，纳入患有严重特应性皮炎的成年人（当前/既往全身抗炎治疗和/或客观 SCORAD≥40）。记录所采用的治疗方式，并使用经过验证的测量工具评估临床疾病严重程度（EASI、客观 SCORAD）、生活质量（DLQI）、症状（POEM）、总体疾病严重程度以及患者满意度。在此，我们描述了截至 2014 年 10 月，登记注册患者的系统抗炎治疗的特点、治疗选择和疗效。
总体而言，5 个招募中心共纳入 78 名患者（平均年龄 39 岁，61%为男性）。患者经常使用住院和门诊服务。环孢素不仅是最常使用的系统治疗药物，而且也是最有效的（12 周时 EASI50 应答率为 51%，EASI75 应答率为 34%）。阿扎胞苷、甲氨蝶呤、口服泼尼松龙、霉酚酸酯、阿利维甲酸和来氟米特也在一些患者中使用。
德国特应性皮炎注册研究的本次分析提供了德国成人严重特应性皮炎当前医疗护理的重要数据。它表明了疾病负担高，现有治疗方案的获益，以及需要额外有效和安全的长期治疗方案。
