You Jianhua, Li Huanmei, Wang Zhongyun, Zhao Yunfei
Department of Dermatology, Zhejiang Institute of Skin Disease Control, Huzhou, Zhejiang, China.
Department of Aesthetic Physiotherapy, Zhejiang Institute of Skin Disease Control, Huzhou, Zhejiang, China.
Br J Hosp Med (Lond). 2025 Jan 24;86(1):1-19. doi: 10.12968/hmed.2024.0575.
Atopic dermatitis (AD) is a common chronic inflammatory skin disorder globally. Crisaborole, a nonsteroidal topical phosphodiesterase 4 inhibitor (PDE4i), has been utilized in treating AD. Crisaborole regulates the production of inflammatory cytokines, which are usually overactive among AD patients. Therefore, this study aimed to explore the efficacy and safety of crisaborole in treating AD in patients aged ≤18 years. A literature search was performed across PubMed, MEDLINE, Embase, Cochrane, and Google Scholar. The inclusion criteria involved primary studies evaluating the effect of crisaborole in treating dermatitis, articles exploring the use of crisaborole in AD patients below 18 years (>two years), and articles published in English between 2000 and 2022. However, the studies evaluating AD in adult patients, those reporting treatments other than crisaborole, those published before 2000, and articles written in languages other than English were excluded from this analysis. Furthermore, secondary data sources such as case reports, newspaper articles, magazines, and other systematic reviews and meta-analyses were excluded. A meta-analysis was conducted using RevMan 5.4. The risk of bias in the manuscripts was assessed using the Cochrane tool. The I-square test statistic was used to determine heterogeneity, and Egger's test was used to evaluate publication bias. Ten studies met the eligibility criteria and were included in the final analysis. Most of the studies exhibited a low risk of bias with no publication bias. Meta-analysis indicated a significant difference in the number of patients attaining Investigator Static Global Assessment (ISGA) success at day 29, with significantly higher patients in the crisaborole group than in the vehicle group (odds ratio (OR) 1.56, 95% CI 1.24 to 1.96; I = 77%; = 0.0001). Similarly, pruritus improvement was significant between the two cohorts at day 29, indicating significantly higher heterogeneity (OR 1.70, 95% CI 1.10 to 2.63; I = 91%; = 0.02). Furthermore, the safety profiling of the treatments was insignificant, demonstrating no statistical difference in the treatment-emergent adverse events (TEAEs) between the two groups with high heterogeneity (OR 0.53, 95% CI 0.14 to 1.98; I = 99%; = 0.35). Crisaborole demonstrates substantial efficacy in treating mild to moderate AD compared to vehicle therapies, as it reduces the signs and symptoms of the disease. Furthermore, crisaborole is well tolerated and has an acceptable safety profile in treating mild to moderate AD patients.
特应性皮炎(AD)是一种全球常见的慢性炎症性皮肤病。克立硼罗是一种非甾体类外用磷酸二酯酶4抑制剂(PDE4i),已被用于治疗AD。克立硼罗可调节炎症细胞因子的产生,而这些细胞因子在AD患者中通常过度活跃。因此,本研究旨在探讨克立硼罗治疗≤18岁AD患者的疗效和安全性。我们在PubMed、MEDLINE、Embase、Cochrane和谷歌学术上进行了文献检索。纳入标准包括评估克立硼罗治疗皮炎效果的原始研究、探讨克立硼罗在18岁以下(>2岁)AD患者中应用的文章,以及2000年至2022年期间发表的英文文章。然而,评估成年AD患者的研究、报告除克立硼罗以外治疗方法的研究、2000年以前发表的研究以及非英文撰写的文章均被排除在本分析之外。此外,病例报告、报纸文章、杂志以及其他系统评价和荟萃分析等二级数据源也被排除。使用RevMan 5.4进行荟萃分析。使用Cochrane工具评估手稿中的偏倚风险。I²检验统计量用于确定异质性,Egger检验用于评估发表偏倚。十项研究符合纳入标准并被纳入最终分析。大多数研究显示偏倚风险较低且无发表偏倚。荟萃分析表明,在第29天时,达到研究者静态整体评估(ISGA)成功的患者数量存在显著差异,克立硼罗组的患者明显多于赋形剂组(优势比(OR)1.56,95%置信区间1.24至1.96;I² = 77%;P = 0.0001)。同样,在第29天时,两组之间瘙痒改善情况显著,表明异质性明显更高(OR 1.70,95%置信区间1.10至2.63;I² = 91%;P = 0.02)。此外,治疗的安全性分析无显著差异,两组之间治疗中出现的不良事件(TEAE)无统计学差异,异质性高(OR 0.53,95%置信区间0.14至1.98;I² = 99%;P = 0.35)。与赋形剂治疗相比,克立硼罗在治疗轻度至中度AD方面显示出显著疗效,因为它可减轻疾病的体征和症状。此外,克立硼罗耐受性良好,在治疗轻度至中度AD患者时具有可接受的安全性。