Paupe J
Hôpital des Enfants Malades, Paris, France.
Respiration. 1991;58(3-4):150-4. doi: 10.1159/000195916.
The efficacy of Broncho-Vaxom/Imocur (OM-85 BV), an orally administered lyophilized bacterial extract, for recurrent respiratory and ear, nose and throat (ENT) infections was evaluated in 116 children aged 6 months to 19 years by comparing its activity in 61 children with that of a placebo in 55 children. The study was randomized, double-blind, and comprised a 90-day treatment period followed by a 90-day follow-up period without test drugs. Over the 180 days, 39.5% of patients taking OM-85 BV remained free from infection compared with 16.5% on placebo (p less than 0.01). 44% on OM-85 BV did not need antibiotics compared with 23.5% on placebo (p less than 0.05). These differences were even greater in the subgroup of children aged 6 years and less (34 vs. 3.5% for the absence of infections, p less than 0.01 and 37 vs. 10% for the need of antibiotics, p less than 0.05). Tolerance to OM-85 BV was excellent, and laboratory investigations showed no abnormalities attributable to this product. This work confirms that the immunomodulator OM-85 BV is an effective immunotherapy for recurrent respiratory and ENT infections in children.
通过比较116名6个月至19岁儿童中61名服用口服冻干细菌提取物Broncho-Vaxom/Imocur（OM-85 BV）的活性与55名服用安慰剂儿童的活性，评估了该药物对复发性呼吸道及耳鼻喉（ENT）感染的疗效。该研究为随机、双盲试验，包括90天的治疗期，随后是90天不使用受试药物的随访期。在180天内，服用OM-85 BV的患者中有39.5%未发生感染，而服用安慰剂的患者中这一比例为16.5%（p<0.01）。服用OM-85 BV的患者中有44%不需要使用抗生素，而服用安慰剂的患者中这一比例为23.5%（p<0.05）。在6岁及以下儿童亚组中，这些差异更为明显（无感染率分别为34%和3.5%，p<0.01；抗生素使用率分别为37%和10%，p<0.05）。对OM-85 BV的耐受性良好，实验室检查未发现该产品导致的异常。这项研究证实，免疫调节剂OM-85 BV是治疗儿童复发性呼吸道及耳鼻喉感染的一种有效免疫疗法。
