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口腔细菌裂解物OM-85预防哮喘患者的呼吸道感染:OMRIA真实世界证据研究

Oral Bacterial Lysate OM-85 Prevents Respiratory Tract Infections in Asthma: The OMRIA RWE Study.

作者信息

Christopoulou Maria Elpida, Panteli Lilia S, Moisidis John A, Christopoulos Ioannis A, Kasimeri Maria Eleni, Tryphonidou Amalia S, Christopoulos Antonios I

机构信息

Asthma Clinics, Primary Care Clinics for Asthma, Allergy & Respiratory Health Athens, Patras, Kalavryta, Greece.

Clinic of Pneumology, Medical Center-University of Freiburg, Faculty of Medicine, University of Freiburg, Freiburg, Germany.

出版信息

J Asthma Allergy. 2025 Jun 2;18:891-902. doi: 10.2147/JAA.S517194. eCollection 2025.

DOI:10.2147/JAA.S517194
PMID:40487798
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12143292/
Abstract

BACKGROUND

OM-85 is a well-characterized bacterial lysate with antiviral properties, enhancement of airway epithelial barrier function, and tolerance induction. However, real-world evidence is needed to evaluate its effectiveness as an add-on therapy in patients with allergic asthma.

METHODS

This retrospective cohort study analyzed medical records of 137 adults with moderate to severe allergic asthma over 12 months. Patients receiving standard of care (SoC) asthma therapy alone (GINA step 4, n = 67) were compared to those on SoC+OM-85 (n = 70). All symptom episodes (CEPs) indicative of respiratory tract infections (RTIs) were recorded, and a 3-scale mean severity index (mSI) was calculated. Propensity score weighting was used for Poisson and linear regression analyses.

RESULTS

Patients on OM-85 demonstrated significant reductions in the number of CEPs (60%), asthma exacerbations (71%), unscheduled visits (72%), oral corticosteroid courses (73%), and antibiotic cycles (67%). The mSI was 1.15 points lower in the OM-85 group (p < 0.001).

CONCLUSION

OM-85 as an add-on to standard asthma therapy significantly reduced RTI-related episodes, exacerbations, and healthcare utilization while lowering symptom severity in adults with allergic asthma.

摘要

背景

OM-85是一种特性明确的细菌裂解物,具有抗病毒特性、增强气道上皮屏障功能以及诱导耐受性。然而,需要真实世界的证据来评估其作为过敏性哮喘患者附加治疗的有效性。

方法

这项回顾性队列研究分析了137例中度至重度过敏性哮喘成人患者12个月的病历。将仅接受哮喘标准治疗(SoC)(全球哮喘防治创议第4步,n = 67)的患者与接受SoC+OM-85治疗(n = 70)的患者进行比较。记录所有表明呼吸道感染(RTI)的症状发作(CEP),并计算3级平均严重程度指数(mSI)。倾向评分加权用于泊松回归和线性回归分析。

结果

接受OM-85治疗的患者在CEP数量(60%)、哮喘加重次数(71%)、非计划就诊次数(72%)、口服糖皮质激素疗程(73%)和抗生素使用周期(67%)方面均有显著减少。OM-85组的mSI低1.15分(p < 0.001)。

结论

OM-85作为标准哮喘治疗的附加药物,可显著减少与RTI相关的发作、加重次数以及医疗资源利用,同时降低过敏性哮喘成人患者的症状严重程度。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ca/12143292/0825f67618b1/JAA-18-891-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ca/12143292/cc8d7344c0bb/JAA-18-891-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ca/12143292/0825f67618b1/JAA-18-891-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ca/12143292/cc8d7344c0bb/JAA-18-891-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/c3ca/12143292/0825f67618b1/JAA-18-891-g0002.jpg

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Update on Asthma Management Guidelines.哮喘管理指南更新。
Mo Med. 2024 Sep-Oct;121(5):364-367.
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Expert consensus on the role of OM-85 in the management of recurrent respiratory infections: A Delphi study.关于 OM-85 在反复呼吸道感染管理中作用的专家共识:一项 Delphi 研究。
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A Meta-Analysis on the Efficacy and Safety of Bacterial Lysates in Chronic Obstructive Pulmonary Disease.细菌溶解产物治疗慢性阻塞性肺疾病疗效与安全性的Meta分析
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Advances in the Rapid Diagnostic of Viral Respiratory Tract Infections.病毒呼吸道感染的快速诊断进展。
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Airway administration of OM-85, a bacterial lysate, blocks experimental asthma by targeting dendritic cells and the epithelium/IL-33/ILC2 axis.气道给予 OM-85(一种细菌裂解物)可通过靶向树突状细胞和上皮细胞/IL-33/ILC2 轴来阻断实验性哮喘。
J Allergy Clin Immunol. 2022 Mar;149(3):943-956. doi: 10.1016/j.jaci.2021.09.013. Epub 2021 Sep 22.
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Viruses and asthma: the role of common respiratory viruses in asthma and its potential meaning for SARS-CoV-2.病毒与哮喘:常见呼吸道病毒在哮喘中的作用及其对 SARS-CoV-2 的潜在意义。
Immunology. 2020 Oct;161(2):83-93. doi: 10.1111/imm.13240. Epub 2020 Aug 17.
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Epithelial dysfunction, respiratory infections and asthma: the importance of immunomodulation. A focus on OM-85.上皮功能障碍、呼吸道感染和哮喘:免疫调节的重要性。聚焦 OM-85。
Expert Rev Respir Med. 2020 Oct;14(10):1019-1026. doi: 10.1080/17476348.2020.1793673. Epub 2020 Jul 15.
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A randomized, placebo-controlled, double-blinded, single-centre, phase IV trial to assess the efficacy and safety of OM-85 in children suffering from recurrent respiratory tract infections.一项评估 OM-85 治疗儿童反复呼吸道感染的疗效和安全性的随机、安慰剂对照、双盲、单中心、四期临床试验。
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