Department of Medicine, Division of Dermatology, John Stroger Jr. Hospital of Cook County, Chicago, IL 60612, USA.
Lupus. 2010 Aug;19(9):1137-43. doi: 10.1177/0961203310370049.
Cutaneous lupus erythematosus (CLE) is a clinically heterogeneous group of rare skin diseases that only rarely have been subjected to controlled clinical trials. This may have been partly due to a lack of suitable validated outcome instruments. Recently, the Food and Drug Administration (FDA) mandated that organ-specific trials for lupus erythematosus need to use a combination of different outcome measures. The patient's condition needs to be assessed in terms of quality of life, the patient's global response, and organ-specific instruments that measure activity of the disease as well as damage due to the disease. For the skin, the only formally validated and published instrument is currently the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI). This paper discusses the background of the development of the CLASI as well as issues related to its use and interpretation in the context of clinical research of CLE.
皮肤红斑狼疮（CLE）是一组临床异质性的罕见皮肤疾病，仅极少数情况下进行过对照临床试验。这可能部分归因于缺乏合适的经验证的结局指标。最近，美国食品和药物管理局（FDA）要求红斑狼疮的器官特异性试验需要使用不同结局指标的组合。患者的病情需要从生活质量、患者的总体反应以及评估疾病活动度和疾病导致的损害的器官特异性工具等方面进行评估。对于皮肤，目前唯一经过正式验证和发表的工具是皮肤红斑狼疮疾病面积和严重度指数（CLASI）。本文讨论了 CLASI 的发展背景，以及在 CLE 的临床研究背景下使用和解释 CLASI 时相关的问题。
