OM-85, a Bacterial Lysate, Reduces Pulmonary Nodule Malignant Probability: A Retrospective Study

IF 2.3 4区医学 Q3 RESPIRATORY SYSTEM

Clinical Respiratory Journal Pub Date : 2025-07-21 DOI:10.1111/crj.70109

Mengting Sun, Yuqing Ni, Xueling Wu, Hao Tian, Yijun Song, Yinzhou Feng, Yunxin Guo, Yong Zhang, Jun Yin, Charles A. Powell, Chunxue Bai, Yuanlin Song, Dawei Yang

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Abstract

Introduction

The current clinical management of pulmonary nodules relies heavily on CT follow-up, without early intervention. This retrospective study investigated the efficacy of OM-85, a standardized lysate of human respiratory bacteria, in the treatment of high-risk pulmonary nodules detected by computed tomography (CT) in patients with chronic bronchitis.

Methods

This study included 72 patients (93 enrolled nodules) who underwent treatment with OM-85 and a matched control group of 90 patients (111 control nodules). The primary endpoint included reduced size of high-risk ground glass nodules based on thin-layer CT scans during follow-up. Flow cytometry, multiplex immunofluorescence (mIF) analysis, and scRNA-seq data were employed to determine differences in the immune cell subsets between the treatment and control groups.

Results

Oral OM-85 treatment significantly reduced lung nodule diameter (p = 0.031), the risk probability of malignancy (p = 0.003), and the likelihood of clinical disease progression (p = 0.0091). The effects of OM-85 treatment were more pronounced in older patients (> 65-year-old) (p = 0.029) and those with longer follow-up cycles (> 200 days) (p = 0.011). The peripheral blood samples showed a significantly higher proportion of natural killer (NK) cells in the treatment group. Furthermore, mIF staining of the pulmonary nodules and scRNA-seq data demonstrated a higher percentage of NK cells in the treatment group compared with the control group (p = 0.0003).

Conclusion

OM-85 reduced the size of high-risk pulmonary nodules and decreased the risk of malignant probability and disease progression in patients with chronic bronchitis by increasing the proportion of NK cells. Therefore, OM-85 is a potential drug for the treatment of high-risk pulmonary nodules in patients with chronic bronchitis.

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细菌裂解物OM-85降低肺结节恶性概率：一项回顾性研究

目前临床对肺结节的处理主要依靠CT随访，缺乏早期干预。本回顾性研究探讨了OM-85（一种人类呼吸道细菌的标准化裂解物）治疗慢性支气管炎患者计算机断层扫描（CT）检测到的高危肺结节的疗效。方法本研究包括72例接受OM-85治疗的患者（93个登记的结节）和匹配的对照组90例（111个对照结节）。主要终点包括随访期间基于薄层CT扫描的高风险磨砂玻璃结节的缩小。采用流式细胞术、多重免疫荧光（mIF）分析和scRNA-seq数据来确定治疗组和对照组之间免疫细胞亚群的差异。结果口服OM-85治疗可显著降低肺结节直径（p = 0.031）、发生恶性肿瘤的危险概率（p = 0.003）和临床疾病进展的可能性（p = 0.0091）。OM-85治疗的效果在老年患者（65岁）（p = 0.029）和随访周期较长的患者（200天）（p = 0.011）中更为明显。治疗组外周血自然杀伤细胞（NK）比例明显增高。此外，肺结节的mIF染色和scRNA-seq数据显示，与对照组相比，治疗组的NK细胞百分比更高（p = 0.0003）。结论OM-85通过增加NK细胞的比例降低慢性支气管炎患者高危肺结节的大小，降低恶性概率和疾病进展的风险。因此，OM-85是治疗慢性支气管炎高危肺结节的潜在药物。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinical Respiratory Journal 医学-呼吸系统

CiteScore

3.70

自引率

0.00%

发文量

104

审稿时长

>12 weeks

期刊介绍： Overview Effective with the 2016 volume, this journal will be published in an online-only format. Aims and Scope The Clinical Respiratory Journal (CRJ) provides a forum for clinical research in all areas of respiratory medicine from clinical lung disease to basic research relevant to the clinic. We publish original research, review articles, case studies, editorials and book reviews in all areas of clinical lung disease including: Asthma Allergy COPD Non-invasive ventilation Sleep related breathing disorders Interstitial lung diseases Lung cancer Clinical genetics Rhinitis Airway and lung infection Epidemiology Pediatrics CRJ provides a fast-track service for selected Phase II and Phase III trial studies. Keywords Clinical Respiratory Journal, respiratory, pulmonary, medicine, clinical, lung disease, Abstracting and Indexing Information Academic Search (EBSCO Publishing) Academic Search Alumni Edition (EBSCO Publishing) Embase (Elsevier) Health & Medical Collection (ProQuest) Health Research Premium Collection (ProQuest) HEED: Health Economic Evaluations Database (Wiley-Blackwell) Hospital Premium Collection (ProQuest) Journal Citation Reports/Science Edition (Clarivate Analytics) MEDLINE/PubMed (NLM) ProQuest Central (ProQuest) Science Citation Index Expanded (Clarivate Analytics) SCOPUS (Elsevier)