Oral Bacterial Lysate OM-85: Advances in Pharmacology and Therapeutics.

IF 4.7 2区医学 Q1 CHEMISTRY, MEDICINAL Drug Design, Development and Therapy Pub Date : 2024-10-01 eCollection Date: 2024-01-01 DOI:10.2147/DDDT.S484897

Ling-Ling Zhu, Yan-Hong Wang, Jian-Hua Feng, Quan Zhou

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Abstract

Background: 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.

Methods: Literature was retrieved by searching PubMed, Web of science, Embase, CNKI, and Full Text Database of Chinese Medical Journals.

Results: 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).

Conclusion: 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.

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口腔细菌裂解物 OM-85：药理学和治疗学的进展。

背景：众所周知，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（RTI）。然而，需要进行严格的研究，以确认细菌裂解物的各种细菌抗原成分、制备方法、给药途径和疗程的临床疗效。OM-85 是一种口服标准化裂解液，由 8 种常见呼吸道病原体中的 21 种菌株经碱性裂解制备而成，可作为免疫疗法用于预防复发性 RTI 和慢性支气管炎急性感染性加重。OM-85 作用于多个先天性和适应性免疫靶点，可恢复 1 型辅助 T（Th1）/Th2 平衡。零星研究显示，OM-85 的药理学和治疗学取得了进展，因此有必要对其进行更新综述：方法：通过检索PubMed、Web of science、Embase、CNKI和《中国医学期刊全文数据库》检索文献：结果：发现了 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的新作用。OM-85 在预防和治疗 RTI、慢性阻塞性肺病、哮喘、慢性支气管炎、鼻炎和过敏性鼻炎方面的药物经济学价值得到了证实。连续服用两个疗程的 OM-85（间隔 6 个月或 12 个月）可预防儿童的 RTI 复发。母体接受 OM-85 治疗可为后代带来益处。观察到了产品特异性反应。OM-85的疗效可能与患者的特征（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：结论：OM-85 可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。将 OM-85 在体外和体内显示出的益处推广到人体，令人兴奋，但也需要谨慎。可能需要考虑个体化治疗。有必要对各种细菌裂解物制剂的疗效和安全性进行比较。

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来源期刊

Drug Design, Development and Therapy CHEMISTRY, MEDICINAL-PHARMACOLOGY & PHARMACY

CiteScore

9.00

自引率

0.00%

发文量

382

审稿时长

>12 weeks

期刊介绍： Drug Design, Development and Therapy is an international, peer-reviewed, open access journal that spans the spectrum of drug design, discovery and development through to clinical applications. The journal is characterized by the rapid reporting of high-quality original research, reviews, expert opinions, commentary and clinical studies in all therapeutic areas. Specific topics covered by the journal include: Drug target identification and validation Phenotypic screening and target deconvolution Biochemical analyses of drug targets and their pathways New methods or relevant applications in molecular/drug design and computer-aided drug discovery* Design, synthesis, and biological evaluation of novel biologically active compounds (including diagnostics or chemical probes) Structural or molecular biological studies elucidating molecular recognition processes Fragment-based drug discovery Pharmaceutical/red biotechnology Isolation, structural characterization, (bio)synthesis, bioengineering and pharmacological evaluation of natural products** Distribution, pharmacokinetics and metabolic transformations of drugs or biologically active compounds in drug development Drug delivery and formulation (design and characterization of dosage forms, release mechanisms and in vivo testing) Preclinical development studies Translational animal models Mechanisms of action and signalling pathways Toxicology Gene therapy, cell therapy and immunotherapy Personalized medicine and pharmacogenomics Clinical drug evaluation Patient safety and sustained use of medicines.