Bernardini Roberto, Campodonico Patrizia, Burastero Samuele, Azzari Chiara, Novembre Elio, Pucci Neri, Massai Cristina, De Martino Maurizio, Vierucci Alberto
Paediatric Allergy and Pneumology Centre, Anna Meyer Children's Hospital, Florence, Italy.
Curr Med Res Opin. 2006 Aug;22(8):1515-22. doi: 10.1185/030079906X115711.
Natural rubber latex (NRL) allergy remains an important allergic disease triggering urticaria, asthma, angioedema and anaphylaxis. Specific immunotherapy can help to solve problems related to NRL allergy. So far, no controlled clinical trials have been performed in children suffering from NRL allergy.
To evaluate the safety and efficacy of sublingual immunotherapy (SLIT) with a commercial NRL extract in children with NRL allergy.
Randomized, double-blind, placebo-controlled, 12-month trial.
Twenty-six children (aged 4-15 years) with NRL allergy, who had cutaneous and/or respiratory symptoms, including oral allergy syndrome to fruits containing cross-reactive allergens, were recruited. Twelve children were randomized to SLIT with a commercial NRL extract and eight to placebo (3:2). An additional six children with NRL allergy served as untreated controls.
A glove use test was utilized to monitor skin and systemic symptoms triggered by NRL exposure at baseline and 3, 6, 9 and 12 months later. Oral allergy symptoms were also monitored.
No side effects related to treatments were observed in any patient. A significant improvement of symptom score in treated patients in comparison with baseline values was observed at 3 months (p = 0.01) and consolidated after 1 year of treatment (p = 0.0005). In comparison with placebo, significant improvements were observed starting at 9 months from study start (p = 0.015) and at 12 months (p = 0.005). The number of foods triggering oral allergy symptoms increased in placebo and control subjects, but not in active treated patients (p = 0.05).
Latex SLIT was safe and efficacious in paediatric patients with NRL allergy.
天然橡胶乳胶（NRL）过敏仍是引发荨麻疹、哮喘、血管性水肿和过敏反应的一种重要过敏性疾病。特异性免疫疗法有助于解决与NRL过敏相关的问题。迄今为止，尚未在患有NRL过敏的儿童中进行对照临床试验。
评估使用市售NRL提取物进行舌下免疫疗法（SLIT）治疗NRL过敏儿童的安全性和有效性。
随机、双盲、安慰剂对照、为期12个月的试验。
招募了26名患有NRL过敏的儿童（4至15岁），他们有皮肤和/或呼吸道症状，包括对含有交叉反应性过敏原的水果出现口腔过敏综合征。12名儿童被随机分配接受市售NRL提取物的SLIT治疗，8名儿童接受安慰剂治疗（3:2）。另外6名患有NRL过敏的儿童作为未治疗对照。
采用手套使用试验来监测在基线以及3、6、9和12个月后接触NRL引发的皮肤和全身症状。还监测口腔过敏症状。
未在任何患者中观察到与治疗相关的副作用。与基线值相比，治疗患者的症状评分在3个月时显著改善（p =
0.01），并在治疗1年后巩固（p = 0.0005）。与安慰剂相比，从研究开始9个月时（p = 0.015）和12个月时（p = 0.005）观察到显著改善。引发口腔过敏症状的食物数量在安慰剂组和对照组中增加，但在接受活性治疗的患者中未增加（p = 0.05）。
乳胶SLIT对患有NRL过敏的儿科患者安全有效。
