Fukasawa Takemichi, Yoshizaki-Ogawa Asako, Enomoto Atsushi, Miyagawa Kiyoshi, Sato Shinichi, Yoshizaki Ayumi
Department of Dermatology, Systemic Sclerosis Centre, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.
Department of Clinical Cannabinoid Research, The University of Tokyo Graduate School of Medicine, Tokyo, Japan.
Clin Exp Dermatol. 2024 Dec 23;50(1):21-28. doi: 10.1093/ced/llae236.
Although topical agents have been used to treat cutaneous lupus erythematosus (CLE), there was previously no high-quality evidence of which agents were most effective and which clinical scores were most suitable. On 22 December 2023, a search was conducted across five databases to identify randomized controlled trials (RCTs) for CLE. Two authors independently screened the titles and abstracts of articles based on predetermined criteria. Selected articles were then assessed for inclusion in a blinded manner, with any disagreements resolved through consensus. Data were abstracted in duplicate, and a random-effects model was utilized for network meta-analysis. The certainty of the evidence was evaluated according to the PRISMA guidelines, using the GRADE approach. The analysis was finalized in January 2024, with the primary outcome focused on the change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) from baseline. Seven RCTs involving 231 participants were analysed. The network meta-analysis revealed that nicotinamide 4% demonstrated the highest probability of achieving the intended outcomes, with a mean difference (MD) of 3.10 and a 95% confidence interval (CI) of 1.99-4.21. Additionally, clobetasol 0.05%, nicotinamide 2% and tacrolimus 0.1% also exhibited statistically significant differences, with MDs of 2.30 (95% CI of 0.73-3.88), 2.30 (95% CI 0.97-3.63) and 1.30 (95% CI 0.03-2.57), respectively. This NMA demonstrates with a high level of evidence that nicotinamide 4%, clobetasol 0.05%, nicotinamide 2% and tacrolimus 0.1% are statistically significant topical agents for CLE. CLASI may be an appropriate outcome to evaluate drug efficacy in CLE.
尽管局部用药已被用于治疗皮肤红斑狼疮（CLE），但此前尚无高质量证据表明哪种药物最有效以及哪种临床评分最适用。2023年12月22日，对五个数据库进行了检索，以确定CLE的随机对照试验（RCT）。两位作者根据预定标准独立筛选文章标题和摘要。然后对选定的文章进行盲法评估以确定是否纳入，任何分歧通过共识解决。数据进行了重复提取，并采用随机效应模型进行网络荟萃分析。根据PRISMA指南，使用GRADE方法评估证据的确定性。分析于2024年1月完成，主要结局集中在皮肤红斑狼疮疾病面积和严重程度指数（CLASI）相对于基线的变化。分析了涉及231名参与者的7项RCT。网络荟萃分析显示，4%烟酰胺达到预期结果的概率最高，平均差（MD）为3.10，95%置信区间（CI）为1.99 - 4.21。此外，0.05%丙酸氯倍他索、2%烟酰胺和0.1%他克莫司也显示出统计学显著差异，MD分别为2.30（95%CI为0.73 - 3.88）、2.30（95%CI为0.97 - 3.63）和1.30（95%CI为0.03 - 2.57）。这项网络荟萃分析以高水平证据表明，4%烟酰胺、0.05%丙酸氯倍他索、2%烟酰胺和0.1%他克莫司是治疗CLE的统计学显著有效的局部用药。CLASI可能是评估CLE药物疗效的合适结局指标。
