Center for Cognitive Disorders and Dementia, Catanzaro Lido, ASP Catanzaro, Italy.
Geriatrics Division, Azienda Ospedale Università di Padova, Department of Medicine (DIMED), University of Padua, Italy.
Rev Recent Clin Trials. 2023;18(3):223-227. doi: 10.2174/1574887118666230518112806.
In older patients, prevention of acute respiratory tract infections (RTIs) is challenging. Experimental studies have consistently underlined an immune-potentiating effect of the bacterial lysates product OM85, on both cellular and humoral responses.
This work aimed to assess the potential efficacy of OM-85 for RTIs' prevention in older individuals.
This explorative longitudinal study included 24 patients aged 65 years or older recruited in the GeroCovid Observational Study- home and outpatient care cohort. For the study purposes, we included 8 patients treated with OM-85 from December 2020 to June 2021 (group A), and a control group of 16 patients, matched for sex and age, who did not receive bacterial lysates (group B). RTIs were recorded from the participants' medical documentation in an e-registry from March 2020 to December 2021.
In 2020, group A experienced a total of 8 RTIs, which affected 6 out of 8 patients (75%); group B reported 21 RTIs, with at least one event in 11 out of 16 patients (68.7%). In 2021, RTIs affected 2 out of 8 patients (25%) in group A (p < 0.02), and 13 out of 16 patients (81.2%) in group B (within this group, 5 patients had two RTIs). The RTIs' cumulative incidence over the observation period significantly differed between groups (66.7% in group A vs. 24.3% in group B; p < 0.002), as well as the decrease in RTIs frequency from 2020 to 2021. No patients in group A were affected by COVID-19 during the observation period, while among controls, two patients had SARS-CoV-2 infection, notwithstanding three doses of vaccine.
This study suggests that bacterial lysates may provide clinical benefits for preventing RTIs. Additional research involving larger cohorts is required to verify the effectiveness of OM-85 in preventing RTIs in older adults.
在老年患者中，预防急性呼吸道感染（RTIs）具有挑战性。实验研究一致强调了细菌裂解物 OM85 对细胞和体液反应的免疫增强作用。
本研究旨在评估 OM-85 预防老年人 RTIs 的潜在疗效。
这项探索性纵向研究纳入了 2020 年 12 月至 2021 年 6 月期间招募的 24 名年龄在 65 岁或以上的患者，这些患者来自 GeroCovid 观察性研究-家庭和门诊护理队列。为了研究目的，我们纳入了 8 名接受 OM-85 治疗的患者（组 A），并纳入了 16 名未接受细菌裂解物治疗的年龄和性别相匹配的对照患者（组 B）。从 2020 年 3 月至 2021 年 12 月，参与者的 RTIs 记录在电子登记册中。
2020 年，组 A 共发生 8 次 RTIs，8 名患者中有 6 名（75%）受影响；组 B 报告了 21 次 RTIs，16 名患者中有 11 名（68.7%）至少发生了一次。2021 年，组 A 有 2 名患者（25%）发生 RTIs（p < 0.02），组 B 有 16 名患者（81.2%）发生 RTIs（其中 5 名患者发生了 2 次 RTIs）。观察期间，两组间 RTIs 的累积发病率差异有统计学意义（组 A 为 66.7%，组 B 为 24.3%；p < 0.002），以及 2020 年至 2021 年 RTIs 频率的下降。在观察期间，组 A 中没有患者感染 COVID-19，而对照组中有 2 名患者感染了 SARS-CoV-2，尽管他们接种了三剂疫苗。
本研究表明，细菌裂解物可能为预防 RTIs 提供临床获益。需要更大规模的队列研究来验证 OM-85 在预防老年人 RTIs 中的有效性。
