Cadario Gianni, Galluccio Antonia G, Pezza Michele, Appino Antonella, Milani Massimo, Pecora Silvia, Mastrandrea Fulvio
S. Giovanni Battista Hospital, Allergy Clinical Immunology, Turin, Italy.
Curr Med Res Opin. 2007 Oct;23(10):2503-6. doi: 10.1185/030079907X226096.
Specific subcutaneous immunotherapy (SCIT) with house dust mite (HDM) preparation has recently been shown to improve eczema in patients with atopic dermatitis (AD). So far, there is less data regarding efficacy and safety of specific sublingual immunotherapy (SLIT) in patients with AD.
To evaluate in an open non-controlled, non-randomized pilot trial the effect of SLIT with HDM allergen extracts preparation (SLITone, ALK Abellò Italy) on SCORAD in adult patients with mild-moderate AD.
86 Subjects (53 females and 33 males) between 3 and 60 years of age with AD and IgE-proved (Class > 2) HDM sensitization were enrolled after their informed consent in the trial. Exclusion criteria were severe asthma and treatment with systemic or high potent topical corticosteroids or immunosuppressant agents. Patients were treated with SLIT (Dermatophagoides pteronyssinus and Dermatophagoides farinae extracts: SLITone, ALK-Abellò) for at least 12 months. SCORAD was evaluated at baseline and after 12 months of treatment.
Baseline SCORAD value, mean +/- SD, was 43.3 +/- 13.7 (range 15-84). After 1 year of SLIT, mean +/- SD, SCORAD value was reduced to 23.7 +/- 13.3 (range: 0-65) (p = 0.0001; unpaired t-test vs. baseline). This was a 46% reduction in SCORAD in comparison with baseline value. A significant improvement, defined as a SCORAD reduction of > 30%, was observed in 51 out of 86 patients (59%). In 5 patients (5.8%) SCORAD values did not change at the end of the observation period. In 30 patients (35%) the SCORAD reduction after SIT was <or= 30% in comparison with baseline. Total and specific IgE serum levels were significantly (p = 0.001) reduced after SLIT. No severe adverse events were observed during the trial.
In this open non-controlled trial SLIT with HDM extracts in patients with mild to moderate AD was effective in reducing the SCORAD after 1 year of SLIT treatment. In addition the treatment was very well tolerated. Treatment with SLIT, furthermore, has allowed a gradual and relevant reduction of concomitant therapies with topical corticosteroids or immunosuppressants. Present results require further controlled trials in order to confirm the potential clinical benefit of SLIT in this clinical setting.
近期研究表明,使用屋尘螨(HDM)制剂进行特异性皮下免疫疗法(SCIT)可改善特应性皮炎(AD)患者的湿疹症状。迄今为止,关于特异性舌下免疫疗法(SLIT)在AD患者中的疗效和安全性的数据较少。
在一项开放、非对照、非随机的试验中,评估使用HDM变应原提取物制剂(SLITone,ALK Abellò意大利公司)进行SLIT对轻度至中度AD成年患者SCORAD的影响。
86名年龄在3至60岁之间、患有AD且经IgE证实(分级>2)对HDM过敏的受试者在签署知情同意书后纳入试验。排除标准为重度哮喘以及正在接受全身性或强效局部糖皮质激素或免疫抑制剂治疗。患者接受SLIT(粉尘螨和屋尘螨提取物:SLITone,ALK-Abellò)治疗至少12个月。在基线和治疗12个月后评估SCORAD。
基线时SCORAD值,平均值±标准差,为43.3±13.7(范围15 - 84)。SLIT治疗1年后,平均值±标准差,SCORAD值降至23.7±13.3(范围:0 - 65)(p = 0.0001;与基线相比的非配对t检验)。与基线值相比,SCORAD降低了46%。86名患者中有51名(59%)出现了显著改善,定义为SCORAD降低>30%。5名患者(5.8%)在观察期结束时SCORAD值未改变。30名患者(35%)SLIT后SCORAD降低与基线相比≤30%。SLIT后总IgE和特异性IgE血清水平显著降低(p = 0.001)。试验期间未观察到严重不良事件。
在这项开放非对照试验中,轻度至中度AD患者使用HDM提取物进行SLIT在治疗1年后有效降低了SCORAD。此外,该治疗耐受性良好。此外,SLIT治疗使局部糖皮质激素或免疫抑制剂的联合治疗逐渐且显著减少。目前的结果需要进一步的对照试验来证实SLIT在这种临床情况下的潜在临床益处。