多年来,OM-85,21种常见细菌性呼吸道病原体的裂解液,已被证明可以防止儿童呼吸复发。然而,需要进一步的研究来探索OM-85在预防儿童呼吸道感染(RTIs)中的真正重要性.这项研究计划进一步有助于评估OM-85在预防儿童复发性RTI中的作用。
这项研究是随机的(3:3:1),安慰剂对照,双盲,单中心,在意大利进行的IV期试验,以评估OM-85的疗效(Broncho-Vaxom®;ViforPharma;Meyrin2/Geneva,瑞士)减少了288名1至6岁有复发性RTI病史的儿童的新RTI发作次数,并比较了6个月内标准3个月方案与OM-85给药6个月的疗效。
接受OM-85治疗3个月的患者的RTI和至少经历过一次RTI的儿童数量明显低于接受安慰剂的患者(33%vs65.1%,p<0.0001)。较高RTI的差异具有统计学意义(即,普通感冒/病毒性咽炎和急性中耳炎;分别为p<0.0001和p=0.006)。在接受OM-85治疗3个月的儿童组中,儿童的日托缺勤天数和父母损失的工作日显着低于安慰剂组(分别为p=0.007和p=0.004)。接受OM-853个月的儿童和接受OM-856个月的儿童之间没有差异。特应性的患病率以及反复喘息的病史和研究儿童的年龄对结果没有影响。在有频繁复发病史的儿童中,获益最明显。OM-85具有良好的耐受性和安全性,甚至在接受流感疫苗接种的儿童中。
每次连续10天的3系列中使用OM-853个月可降低儿童复发性RTI的风险,具有良好的安全性。在易于发生几次呼吸发作的儿童中观察到的比在非易发儿童中观察到的更大的效果似乎表明,这种裂解物应特别适用于已证明对RTI高度敏感的儿童。
Over many years, OM-85, a lysate of 21 common bacterial respiratory pathogens, has been demonstrated to prevent respiratory recurrences in children. However, further studies are needed to explore the true importance of OM-85 in the prevention of respiratory tract infections (RTIs) in children. This
study was planned to further contribute to the evaluation of the role played by OM-85 in prevention of recurrent RTIs in children.
This
study was a randomized (3:3:1), placebo-controlled, double-blind, single-centre, phase IV
trial carried out in Italy to assess the efficacy of OM-85 (Broncho-Vaxom®; Vifor Pharma; Meyrin 2/Geneva, Switzerland) in reducing the number of new RTI episodes in 288 children aged 1 to 6 years with a history of recurrent RTIs and to compare the efficacy of the standard 3-month regimen with that of administration of OM-85 for 6 months during a 6-month
study period.
The number of RTIs and of children who experienced at least one RTI were significantly lower among patients receiving OM-85 for 3 months than among those given placebo (33% vs 65.1%, p < 0.0001). Differences were statistically significant for upper RTIs (i.e., common cold/viral pharyngitis and acute otitis media; p < 0.0001 and p = 0.006, respectively). Days of absence from day-care for children and working days lost by parents were significantly lower in the group with children treated with OM-85 for 3 months than in the placebo group (p = 0.007 and p = 0.004, respectively). No difference was seen between children who received OM-85 for 3 and those who received OM-85 for 6 months. The prevalence of atopy as well as the history of recurrent wheezing and age of the
study child did not influence the results. Benefit was maximally evident among children with a history of frequent recurrences. OM-85 was well tolerated and safe, even in children who received an influenza vaccination.
The use of OM-85 for 3 months in 3 series of 10 consecutive days each time reduces the risk of recurrent RTIs in children, with a favourable safety profile. The greater effect observed in children prone to several respiratory episodes than in non-prone children seems to indicate that this lysate should be administered especially to children with a proven high susceptibility to RTIs.