Department of Dermatology, The Second Affiliated Hospital, Zhejiang University School of Medicine , Hangzhou , China.
Department of Dermatology, The Fourth Affiliated Hospital, Zhejiang University School of Medicine , Yiwu , China.
Artif Cells Nanomed Biotechnol. 2019 Dec;47(1):3540-3547. doi: 10.1080/21691401.2019.1640709.
Allergen-specific immunotherapy is widely used for allergic rhinitis and asthma treatment worldwide. This study explored the efficacy and safety of sublingual immunotherapy (SLIT) with the extracts of ( Drops) on house dust mites (HDM)-induced atopic dermatitis (AD). 239 patients with HDM-induced AD were recruited and exposure to a multi-centre, randomized, double-blind, and placebo-controlled clinical trials for 36 weeks, which were randomly divided into placebo and sublingual Drops groups (high-dose, medium-dose and low-dose), respectively. Statistical analysis was performed in three groups: Full Analysis Set, Per Protocol Set and Safety Set. 48 cases have withdrawn from the study before the end of study. As primary outcomes, significant decreases in scoring atopic dermatitis and total medication score were showed in medium-dose and high-dose Drops groups. In the sixth visit, the skin lesion area showed a statistically significant difference between high-dose/medium-dose Drops group and placebo group ( < .05). Most adverse events are slight, and no life-threatening adverse drug reaction happened. Our research demonstrates the beneficial effect of SLIT with high or medium dose Drops on AD, and the treatment was well tolerated.
变应原特异性免疫疗法被广泛用于治疗全球范围内的过敏性鼻炎和哮喘。本研究旨在探讨舌下免疫疗法（SLIT）用粉尘螨（HDM）诱导的特应性皮炎（AD）提取物（滴剂）的疗效和安全性。239 例 HDM 诱导的 AD 患者被招募并进行了一项多中心、随机、双盲、安慰剂对照临床试验，共 36 周，随机分为安慰剂和舌下滴剂组（高剂量、中剂量和低剂量）。分别在全分析集、符合方案集和安全性集进行了统计学分析。研究结束前有 48 例患者退出。作为主要结局，中剂量和高剂量滴剂组在特应性皮炎评分和总用药评分上均有显著下降。在第六次就诊时，高剂量/中剂量滴剂组与安慰剂组的皮损面积有统计学差异（<0.05）。大多数不良反应轻微，无危及生命的药物不良反应。本研究表明高剂量或中剂量滴剂 SLIT 对 AD 有有益的治疗效果，且治疗耐受良好。
