Department of Rheumatic Diseases, Tokyo Metropolitan Tama Medical Center, 2-8-29 Musashidai, Fuchu, Tokyo 183-8524, Japan.
Mod Rheumatol. 2013 Mar;23(2):318-22. doi: 10.1007/s10165-012-0656-3. Epub 2012 May 12.
Hydroxychloroquine (HCQ) is not available in Japan. To design a clinical trial of HCQ, we evaluated the response to HCQ in Japanese patients with lupus-related skin disease using the cutaneous lupus erythematosus disease area and severity index (CLASI).
Twenty-seven patients with lupus-related skin disease who started HCQ at four hospitals were included. Patients were categorized into responders by the CLASI response criteria. The points and the rate of improvement in the CLASI activity score after 16 weeks of treatment were analyzed, focusing on six parameters: systemic lupus erythematosus (SLE), skin manifestations, disease duration, prednisolone, smoking, and severity.
Twenty-seven patients, including 17 with SLE (6 with SLE/Sjögren's syndrome), were analyzed retrospectively. Twenty-three patients (85 %) were categorized as responders. The mean CLASI activity score improved from 10.1 to 4.5 (p < 0.0001). The improvement rate did not differ in these parameters except for that of annular erythema (81.6 versus 34.3 %, p = 0.036). On multivariate analysis, the baseline CLASI activity score (CLASI ≥9) correlated with the greatest decrease in CLASI activity score (F = 69.7, p < 0.0001).
CLASI is a reliable indicator to evaluate the efficacy of the drug, and HCQ is an effective treatment for Japanese patients with lupus-related skin disease.
羟氯喹（HCQ）在日本不可用。为了设计 HCQ 的临床试验，我们使用皮肤红斑狼疮疾病面积和严重程度指数（CLASI）评估了日本狼疮相关皮肤病患者对 HCQ 的反应。
纳入了在四家医院开始使用 HCQ 的 27 例狼疮相关皮肤病患者。根据 CLASI 缓解标准，将患者分为缓解者。分析了治疗 16 周后 CLASI 活动评分的积分和改善率，重点关注六个参数：系统性红斑狼疮（SLE）、皮肤表现、疾病持续时间、泼尼松龙、吸烟和严重程度。
回顾性分析了 27 例患者，其中 17 例（6 例 SLE/Sjögren 综合征）为 SLE。23 例（85%）患者被归类为缓解者。CLASI 活动评分从 10.1 改善至 4.5（p<0.0001）。除环形红斑外，这些参数的改善率无差异（81.6%比 34.3%，p=0.036）。多变量分析显示，基线 CLASI 活动评分（CLASI≥9）与 CLASI 活动评分的最大降幅相关（F=69.7，p<0.0001）。
CLASI 是评估药物疗效的可靠指标，HCQ 是治疗日本狼疮相关皮肤病患者的有效药物。
