Sun Mengting, Ni Yuqing, Wu Xueling, Tian Hao, Song Yijun, Feng Yinzhou, Guo Yunxin, Zhang Yong, Yin Jun, Powell Charles A, Bai Chunxue, Song Yuanlin, Yang Dawei
Department of Pulmonary and Critical Care Medicine, Zhongshan Hospital Fudan University, Shanghai, China.
Department of Pulmonology, Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Clin Respir J. 2025 Jul;19(7):e70109. doi: 10.1111/crj.70109.
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.
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.
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).
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.
目前肺结节的临床管理严重依赖于CT随访，缺乏早期干预。本回顾性研究调查了人呼吸道细菌标准化裂解物OM-85对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治疗效果。
本研究纳入72例接受OM-85治疗的患者（93个纳入结节）和90例匹配的对照组患者（111个对照结节）。主要终点包括随访期间基于薄层CT扫描的高危磨玻璃结节尺寸缩小。采用流式细胞术、多重免疫荧光（mIF）分析和单细胞RNA测序（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。
口服OM-85治疗显著降低了肺结节直径（p = 0.031）、恶性风险概率（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（＞200天）的患者中更为显著（p = 0.011）。外周血样本显示治疗组中自然杀伤（NK）细胞的比例显著更高。此外，肺结节的mIF染色和scRNA-seq数据表明，与对照组相比，治疗组中NK细胞的百分比更高（p = 0.0003）。
OM-85通过增加NK细胞比例，缩小了慢性支气管炎患者高危肺结节的尺寸，并降低了恶性概率和疾病进展风险。因此，OM-85是治疗慢性支气管炎患者高危肺结节的一种潜在药物。
