Pediatric Clinic, Department of Surgical and Biomedical Sciences, Università degli Studi di Perugia, 06132 Perugia, Italy.
Università degli Studi di Milano, 20146 Milan, Italy.
Int J Environ Res Public Health. 2019 Mar 25;16(6):1065. doi: 10.3390/ijerph16061065.
In otherwise healthy infants and young children, respiratory tract infections (RTIs) are extremely common. Clinical data have shown that OM-85 could prevent respiratory recurrences in children. However, further studies are needed to explore the true importance of OM-85 in clinical practice. In addition, an unsolved problem is the efficacy of OM-85 when it is administered for two consecutive years. Moreover, another open question is the safety of OM-85 when co-administered with the influenza vaccine. In order to solve these unanswered issues, 200 children aged three to six years with a history of recurrent RTIs, defined as at least six documented episodes of acute RTI in a single year, who had received OM-85 (Broncho-Vaxom; OM Pharma, a Vifor Pharma Group Company, Geneva, Switzerland) for two consecutive years (3.5 mg once a day for 10 days for 3 months of each year) were selected and matched based on age, sex, and period of evaluation with children with recurrent RTIs who did not receive OM-85. In the group of children treated with OM-85, the number of patients who did not experience any new episode of RTI, as well as the number of RTIs, wheezing episodes, medical visits, and prescribed antibiotic courses, were significantly lower than that in the group not treated with OM-85. The results were similar in the first and second year of OM-85 administration. A minority of patients showed mild adverse events, and the safety profile was overall good, including in the 49 children who received the influenza vaccination within one month from the beginning of the first cycle of OM-85. Our data suggest that OM-85 can effectively and safely reduce the risk of new infective episodes in children with recurrent RTIs and that a second yearly course of lysate administration can be useful to maintain protection, particularly when the diagnosis of recurrent RTIs is made in younger children for whom it is likely that definitive maturation of the immune system still requires a long time.
在其他方面健康的婴儿和幼儿中，呼吸道感染（RTIs）极为常见。临床数据表明，OM-85 可以预防儿童呼吸道复发。然而，需要进一步的研究来探索 OM-85 在临床实践中的真正重要性。此外，一个悬而未决的问题是 OM-85 连续两年给药的疗效。此外，另一个悬而未决的问题是 OM-85 与流感疫苗联合使用的安全性。为了解决这些未解决的问题，选择了 200 名年龄在 3 至 6 岁之间、有反复发作性 RTIs 病史的儿童，这些儿童定义为每年至少有 6 次急性 RTI 记录在案，他们连续两年接受 OM-85（Broncho-Vaxom；OM Pharma，Vifor Pharma Group 公司，瑞士日内瓦）治疗（每年 3 个月，每天 3.5 毫克，连续 10 天），并根据年龄、性别和评估期与未接受 OM-85 治疗的反复发作性 RTIs 儿童相匹配。在接受 OM-85 治疗的儿童组中，未经历任何新 RTI 发作的患者数量以及 RTI、喘息发作、就诊次数和处方抗生素疗程的数量明显低于未接受 OM-85 治疗的儿童组。在 OM-85 给药的第一年和第二年，结果相似。少数患者出现轻度不良反应，总体安全性良好，包括在开始 OM-85 第一个周期后一个月内接受流感疫苗接种的 49 名儿童。我们的数据表明，OM-85 可以有效且安全地降低反复发作性 RTIs 儿童新感染发作的风险，并且每年给予第二年度的裂解物治疗可能有助于维持保护作用，尤其是在 RTIs 反复发作的年龄较小的儿童中，因为免疫系统的最终成熟可能仍需要很长时间。
