Retrospective analysis of the efficacy and safety of omadacycline in the treatment of pulmonary infections

Objective To investigate the efficacy and safety of omadacycline in the treatment of pulmonary infections in a tertiary hospital.Methods A retrospective analysis was conducted on the clinical data of patients with pulmonary infections who received omadacycline treatment from January 2023 to June 2025. The efficacy and safety of the treatment were evaluated, and univariate and multivariate logistic regression analyses were performed to identify the factors associated with treatment failure of omadacycline for pulmonary infections.Results A total of 107 patients were enrolled, including 72 cases of community-acquired pneumonia. The overall clinical response rate was 80.4% (86/107), and the microbiological eradication rate was 62.5% (15/24). Targeted therapy was administered in 52 patients, among whom 24 had multidrug-resistant bacterial infections. The efficacy of monotherapy was significantly higher than that of combination therapy (58.1% vs. 41.9%, P=0.001), and there was no statistically significant difference in efficacy among different classes of combined anti-infective agents (P>0.05). Significant differences were detected in body temperature, white blood cell count, neutrophil percentage, C-reactive protein and procalcitonin between pre-treatment and post-treatment in all patients and the clinical response group (P<0.05). Hepatic injury occurred in 4 cases (5.2%), acute kidney injury (AKI) in 1 case (1.4%), decreased prothrombin time in 31 cases (64.6%), decreased D-dimer in 22 cases (59.5%), and decreased fibrinogen in 32 cases (66.7%). Multivariate logistic regression analysis demonstrated that age, APACHE II score, SOFA score, ICU admission, endotracheal intubation, continuous renal replacement therapy, targeted therapy, combination therapy and multidrug-resistant bacterial infections were risk factors for omadacycline treatment failure. In contrast, hypofibrinogenemia, on-label drug use and non-severe community-acquired pneumonia were protective factors for favorable clinical outcomes with omadacycline.Conclusion In clinical practice, omadacycline should be administered in accordance with its approved indications, and combination therapy is not recommended. Close monitoring of liver function and fibrinogen levels were warranted during treatment.

目的：探讨奥马环素（omadacycline）在三级医院治疗肺部感染的有效性与安全性。方法：对2023年1月至2025年6月期间接受奥马环素治疗的肺部感染患者的临床资料进行回顾性分析。评估该治疗方案的有效性与安全性，并通过单因素及多因素logistic回归分析，明确与奥马环素治疗肺部感染失败相关的影响因素。结果：本研究共纳入107例患者，其中72例为社区获得性肺炎。总体临床应答率为80.4%（86/107），微生物清除率为62.5%（15/24）。52例患者接受了靶向治疗，其中24例为多重耐药菌感染。单药治疗的有效性显著高于联合治疗（58.1% vs 41.9%，P=0.001），不同类别联合抗感染药物的疗效差异无统计学意义（P>0.05）。所有患者及临床应答组患者的治疗前后体温、白细胞计数、中性粒细胞百分比、C反应蛋白及降钙素原水平均存在显著差异（P<0.05）。治疗期间共出现肝损伤4例（5.2%）、急性肾损伤（AKI）1例（1.4%）、凝血酶原时间降低31例（64.6%）、D-二聚体降低22例（59.5%）、纤维蛋白原降低32例（66.7%）。多因素logistic回归分析显示，年龄、APACHE II评分、SOFA评分、ICU收治、气管插管、连续性肾脏替代治疗、靶向治疗、联合治疗及多重耐药菌感染均为奥马环素治疗失败的危险因素。反之，低纤维蛋白原血症、符合获批适应症用药及非重症社区获得性肺炎为奥马环素获得良好临床结局的保护因素。结论：临床实践中，奥马环素应严格按照其获批适应症使用，不推荐联合治疗。治疗期间需密切监测肝功能及纤维蛋白原水平。