VIP Geriatric Ward, Division of Nursing, the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, People's Republic of China.
Department of Pharmacy, the Second Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, People's Republic of China.
Drug Des Devel Ther. 2024 Oct 1;18:4387-4399. doi: 10.2147/DDDT.S484897. eCollection 2024.
Bacterial lysates are known for having immunomodulatory properties and have been used mainly for the prevention and treatment of respiratory tract infections (RTIs). However, rigorous studies are needed to confirm the clinical efficacy of bacterial lysates with various bacterial antigen components, preparation methods, administration routes and course of treatment. OM-85, an oral standardized lysate prepared by alkaline lysis of 21 strains from 8 species of common respiratory tract pathogens, is indicated as immunotherapy for prevention of recurrent RTIs and acute infectious exacerbations of chronic bronchitis. OM-85 acts on multiple innate and adaptive immune targets and can restore type 1 helper T (Th1)/Th2 balance. Sporadic studies have shown advances in pharmacology and therapeutics of OM-85, and thus an update review is necessary.
Literature was retrieved by searching PubMed, Web of science, Embase, CNKI, and Full Text Database of Chinese Medical Journals.
New roles of OM-85 were discovered in prevention and treatment of lung cancer, pulmonary tuberculosis, SARS-CoV-2 infection, allergic rhinitis, pulmonary fibrosis, atopic dermatitis, and nephrotic syndrome. Pharmacoeconomic values of OM-85 were demonstrated in prophylaxis and treatment of RTIs, chronic obstructive pulmonary disease, asthma, chronic bronchitis, rhinosinusitis and allergic rhinitis. Two consecutive courses of OM-85 (6 or 12 months apart) could prevent recurrent RTIs in children. Maternal OM-85 treatment could offer benefits for offspring. Product-specific response was observed. The efficacy of OM-85 may be associated with patient's characteristics (eg, severity of the disease, age, immune response pattern, malignancy risk stratification).
OM-85 can improve effectiveness of standard care for some primary diseases, and carry significant pharmacoeconomic implications. The benefits shown by OM-85 in vitro and in vivo, when extrapolated to humans, are exciting but also require caution. Individualized treatment may need to be considered. It is necessary to compare the efficacy and safety of various bacterial lysate preparations.
细菌裂解物具有免疫调节特性，主要用于预防和治疗呼吸道感染（RTIs）。然而，需要严格的研究来证实具有各种细菌抗原成分、制备方法、给药途径和治疗疗程的细菌裂解物的临床疗效。OM-85 是一种口服标准化裂解物，通过对来自 8 种常见呼吸道病原体的 21 株细菌进行碱性裂解制备而成，被指示用于预防复发性 RTIs 和慢性支气管炎的急性感染加重的免疫治疗。OM-85 作用于多个先天和适应性免疫靶点，可以恢复 1 型辅助 T（Th1）/Th2 平衡。零星研究表明 OM-85 在药理学和治疗学方面取得了进展，因此有必要进行更新综述。
通过搜索 PubMed、Web of science、Embase、CNKI 和中文医学期刊全文数据库检索文献。
发现 OM-85 在预防和治疗肺癌、肺结核、SARS-CoV-2 感染、过敏性鼻炎、肺纤维化、特应性皮炎和肾病综合征方面具有新的作用。OM-85 的药物经济学价值在 RTIs、慢性阻塞性肺疾病、哮喘、慢性支气管炎、鼻-鼻窦炎和过敏性鼻炎的预防和治疗中得到了证明。连续两个疗程的 OM-85（相隔 6 或 12 个月）可预防儿童复发性 RTIs。母亲接受 OM-85 治疗可为后代带来益处。观察到了特定产品的反应。OM-85 的疗效可能与患者的特征（例如疾病的严重程度、年龄、免疫反应模式、恶性肿瘤风险分层）有关。
OM-85 可以提高某些原发性疾病的标准治疗效果，并具有重要的药物经济学意义。OM-85 在体外和体内显示出的益处，当外推到人类时，令人兴奋但也需要谨慎。可能需要考虑个体化治疗。有必要比较各种细菌裂解物制剂的疗效和安全性。
