Clinical and Immunological Benefits of OM-85 Bacterial Lysate in Patients with Allergic Rhinitis, Asthma, and COPD and Recurrent Respiratory Infections
Clinical and Immunological Benefits of OM-85 Bacterial Lysate in Patients with Allergic Rhinitis, Asthma, and COPD and Recurrent Respiratory Infections
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DOI：
10.1007/s00408-016-9880-5
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发表时间：
2016-08-01
期刊：
影响因子：
5
通讯作者：
Alter, Adriana J.
中科院分区：
文献类型：
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作者：
Koatz, Ana M.;Coe, Noemi A.;Alter, Adriana J.
本研究的目的是评估OM-85在降低过敏性鼻炎、哮喘或慢性阻塞性肺病（COPD）患者呼吸道感染（RTI）发生率方面的疗效，以及对免疫学参数（即血清和分泌型伊加水平）的影响。这是一项开放标签、前瞻性、序贯研究，包括84例年龄在16-65岁的连续患者，在研究入组前一年内出现复发性（三次或以上）呼吸道感染的患者。在研究的第一年，患者根据其基础疾病（哮喘、过敏性鼻炎或COPD）接受标准优化治疗（SOC）。第二年，患者接受OM-85口服细菌裂解物治疗（每天一粒7 mg胶囊，每月连续10天，持续3个月），随访6个月。病史、临床症状、血清和分泌型伊加水平，在OM-85治疗期之前，RTI的总数减少，（仅SOC）与研究开始前一年相比[69/266（对应于74%减少）]和OM-85处理后的额外减少[38/69（对应于45%减少）]; p < 0.05。与患者基础疾病相关的急性加重总数也显著减少，OM-85（+SOC）治疗期间从55例减少至35例，相当于减少36%。此外，血清和分泌型伊加水平的增加，这与OM-85的管理相一致的是observed.Our结果显示OM-85在减少RTI和恶化的潜在的医疗条件，在过敏性鼻炎，哮喘，或COPD患者的临床效益。
The aim of this study was to evaluate the efficacy of OM-85 in reducing the incidence of respiratory tract infections (RTIs) in patients with allergic rhinitis, asthma, or chronic obstructive pulmonary disease (COPD), and its effect on immunological parameters, namely serum and secretory IgA levels.This was an open-label, prospective, sequential study which included 84 consecutive patients aged 16-65 years, who presented with recurrent (three or more) respiratory infections during the year prior to study entry. In the first year of the study, patients received standard optimized care (SOC), according to their underlying disease condition (asthma, allergic rhinitis, or COPD). In the following year, patients received treatment with OM-85 oral bacterial lysate (one 7 mg capsule daily for ten consecutive days per month, for 3 months), with a 6-month follow-up. Medical history, clinical symptoms, serum, and secretory IgA levels, and the number of infections and exacerbations were evaluated before and after treatment.There was a decrease in the total number of RTIs before the OM-85 treatment period (SOC only) compared to the year before the study start [69/266 (corresponding to a 74 % reduction)] and an additional decrease [38/69 (corresponding to a 45 % reduction)] after OM-85 treatment; p < 0.05. There was also a significant reduction in the total number of exacerbations related to the patients' underlying medical conditions, which decreased from 55 to 35 during OM-85 (+SOC) treatment, corresponding to a reduction of 36 %. In addition, an increase in serum and secretory IgA levels which coincided with the administration of OM-85 was observed.Our results showed the clinical benefits of OM-85 in reducing RTIs and exacerbations of the underlying medical condition, in patients with allergic rhinitis, asthma, or COPD.