依拉环素治疗肺部感染的临床疗效:多中心真实世界研究

Clinical Efficacy of Eravacycline in the Treatment of Pneumonia:A Multicenter Real World Stud

  • 摘要: 目的 基于真实世界数据,评估依拉环素治疗肺部感染的疗效和安全性。方法:本研究为多中心观察性研究,纳入2023年9月—2024年9月全国21个省市接受依拉环素治疗的肺部感染患者。分析病原谱特征、临床与微生物学疗效、患者预后及用药安全性,并比较单一感染与混合感染、依拉环素单药治疗与联合治疗的疗效差异。结果:共纳入2859例接受依拉环素治疗的肺部感染患者。患者主要来自重症监护病房(48.6%)。在明确检出病原体的患者中,以单一感染为主要类型(91.0%,2029/2230),混合感染较为少见(9.0%,201/2230)。单一感染组病原体主要为鲍曼不动杆菌(55.0%)、肺炎克雷伯菌(25.8%)。依拉环素单药治疗组1218例(42.6%),联合治疗组1641例(57.4%)。94.4%(2699/2859)的患者接受标准剂量(1 mg/kg,每12 h给药一次),其平均治疗疗程为9.0 d。依拉环素治疗结束时,总临床有效率为89.7%(2565/2859),微生物学有效率为90.2%(2580/2859),治疗结束后30 d随访时患者好转出院率为82.7%(2365/2859),全因死亡率为12.1%(347/2859);单一感染组依拉环素治疗结束时,临床有效率(90.5%比83.1%,P=0.001)、微生物学有效率(91%比83.1%,P < 0.001),及治疗结束后30 d随访时患者好转出院率(83.2%比74.1%,P=0.001)均高于混合感染组。单药治疗组与联合治疗组依拉环素治疗结束时临床有效性、微生物学有效性及治疗结束后30 d随访时患者预后方面均无显著差异(P均>0.05)。用药期间,药物相关不良事件发生率为2.4%(69/2859),以轻度胃肠道反应为主(0.9%,27/2859),仅1例(0.03%)出现严重肝损伤。结论 依拉环素治疗肺部感染临床疗效和微生物有效率均较高,临床不良反应轻微。

     

    Abstract: Objective: To evaluate the efficacy and safety of eravacycline in the treatment of pulmonary infections based on real-world data. Methods: This multicenter,observational study enrolled patients with pulmonary infections who received eravacycline treatment from September 2023 to September 2024 across 21 provinces in China.The analysis included pathogen profile characteristics,clinical and microbiological efficacy,patient outcomes,and drug safety,with comparisons made between monomicrobial and polymicrobial infections,as well as between monotherapy and combination therapy. Results: A total of 2859 patients with pulmonary infections treated with eravacycline were included.The majority of patients were from the intensive care unit (48.6%).Among patients with clearly identified pathogens,monomicrobial infection was the predominant type (91.0%,2029/2230),while polymicrobial infection was less common (9.0%,201/2230).The main pathogens in the monomicrobial infection group were Acinetobacter baumannii (55.0%) and Klebsiella pneumoniae (25.8%).There were 1218 patients (42.6%) in the eravacycline monotherapy group and 1641 patients (57.4%) in the combination therapy group.The majority of patients (94.4%,2699/2859) received the standard dose (1 mg/kg every 12 hours),with a mean treatment duration of 9.0 days.At the end of eravacycline treatment,the overall clinical response rate was 89.7%(2565/2859),and the microbiological eradication rate was 90.2%(2580/2859).At the 30-day follow-up after treatment completion,the rate of improvement and discharge was 82.7%(2365/2859),and the all-cause mortality rate was 12.1%(347/2859).In the monomicrobial infection group,the clinical response rate (90.5% vs.83.1%,P=0.001),microbiological eradication rate (91.0% vs.83.1%,P<0.001),and the rate of improvement and discharge at the 30-day follow-up (83.2% vs.74.1%,P=0.001) were all significantly higher than those in the polymicrobial infection group.No significant differences were observed in the clinical response rate,microbiological eradication rate at the end of treatment,or patient outcomes at the 30-day follow-up between the monotherapy and combination therapy groups (P>0.05).During the treatment period,the incidence of drug-related adverse events was 2.4%(69/2859),primarily mild gastrointestinal reactions (0.9%,27/2859),with only one case (0.03%) of severe liver injury reported. Conclusion: Eravacycline demonstrates high clinical and microbiological efficacy in the treatment of pulmonary infections,with a favorable safety profile characterized by mild adverse reactions.

     

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