Bodemer Christine, Guillet Gerard, Cambazard Frederic, Boralevi Franck, Ballarini Stefania, Milliet Christian, Bertuccio Paola, La Vecchia Carlo, Bach Jean-François, de Prost Yves
Assistance Publique-Hôpitaux de Paris, Hôpital Necker-Enfants Malades, Department of Dermatology, Paris, France.
Université de Poitiers, Department of Dermatology, Poitiers, France.
PLoS One. 2017 Mar 23;12(3):e0161555. doi: 10.1371/journal.pone.0161555. eCollection 2017.
Environmental factors play a major role on atopic dermatitis (AD) which shows a constant rise in prevalence in western countries over the last decades. The Hygiene Hypothesis suggesting an inverse relationship between incidence of infections and the increase in atopic diseases in these countries, is one of the working hypothesis proposed to explain this trend.
This study tested the efficacy and safety of oral administration of the bacterial lysate OM-85 (Broncho-Vaxom®, Broncho-Munal®, Ommunal®, Paxoral®, Vaxoral®), in the treatment of established AD in children.
Children aged 6 months to 7 years, with confirmed AD diagnosis, were randomized in a double-blind, placebo-controlled trial to receive, in addition to conventional treatment with emollients and topical corticosteroids, 3.5mg of the bacterial extract OM-85 or placebo daily for 9 months. The primary end-point was the difference between groups in the occurrence of new flares (NF) during the study period, evaluated by Hazard Ratio (HR) derived from conditional Cox proportional hazard regression models accounting for repeated events.
Among the 179 randomized children, 170 were analysed, 88 in the OM-85 and 82 in the placebo group. As expected most children in both treatment groups experienced at least 1 NF during the study period (75 (85%) patients in the OM-85 group and 72 (88%) in the placebo group). Patients treated with OM-85 as adjuvant therapy had significantly fewer and delayed NFs (HR of repeated flares = 0.80; 95% confidence interval (CI): 0.67-0.96), also when potential confounding factors, as family history of atopy and corticosteroids use, were taken into account (HR = 0.82; 95% CI: 0.69-0.98). No major side effect was reported, with comparable and good tolerability for OM-85 and placebo.
Results show an adjuvant therapeutic effect of a well standardized bacterial lysate OM-85 on established AD.
环境因素在特应性皮炎（AD）中起主要作用，在过去几十年里，西方国家AD的患病率持续上升。卫生假说提出，在这些国家感染发病率与特应性疾病增加之间存在反比关系，这是为解释这一趋势而提出的可行假说之一。
本研究测试口服细菌裂解物OM-85（泛福舒、百康、奥莫罗、帕索罗、沃索罗）治疗儿童确诊AD的疗效和安全性。
6个月至7岁确诊为AD的儿童，在一项双盲、安慰剂对照试验中随机分组，除使用润肤剂和外用皮质类固醇进行常规治疗外，每天接受3.5mg细菌提取物OM-85或安慰剂，持续9个月。主要终点是研究期间两组新发作（NF）发生率的差异，通过考虑重复事件的条件Cox比例风险回归模型得出的风险比（HR）进行评估。
在179名随机分组儿童中，分析了170名，OM-85组88名，安慰剂组82名。正如预期的那样，两个治疗组中的大多数儿童在研究期间至少经历了1次NF（OM-85组75名（85%）患者，安慰剂组72名（88%））。当将潜在混杂因素，如特应性家族史和皮质类固醇使用情况考虑在内时，接受OM-85作为辅助治疗的患者NF显著减少且延迟（重复发作的HR = 0.80；95%置信区间（CI）：0.67 - 0.96）（HR = 0.82；95% CI：0.69 - 0.98）。未报告重大副作用，OM-85和安慰剂的耐受性相当且良好。
结果显示，标准化良好的细菌裂解物OM-85对确诊的AD有辅助治疗作用。
