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 Study

  • 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 本研究为多中心回顾性队列研究,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小时给药一次),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(91.0%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 retrospective cohort study enrolled patients with pulmonary infections who received eravacycline treatment across 21 provinces/cities in China from September 2023 to September 2024. Pathogen spectrum characteristics, clinical and microbiological efficacy, patient outcomes, and medication safety were analyzed. Differences in efficacy were compared between mono-infection and co-infection cases, as well as between eravacycline monotherapy and combination therapy.
    Results A total of 2859 patients with pulmonary infections receiving eravacycline were enrolled. Patients were primarily from intensive care units (48.6%). Among patients with identified pathogens, mono-infection was the predominant type (91.0%, 2029/2230), while co-infections were less common (9.0%, 201/2230). The main pathogens in the mono-infection group were Acinetobacter baumannii (55.0%) and Klebsiella pneumoniae (25.8%). The eravacycline monotherapy group comprised 1218 patients (42.6%), and the combination therapy group comprised 1641 patients (57.4%). Most 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 efficacy rate was 89.7% (2565/2859), and the microbiological efficacy rate was 90.2% (2580/2859). At the 30-day follow-up post-treatment, the rate of patients discharged with improvement was 82.7% (2365/2859), and the all-cause mortality rate was 12.1% (347/2859). At the end of eravacycline treatment, the mono-infection group showed significantly higher clinical efficacy (90.5% vs. 83.1%, P=0.001), microbiological efficacy (91.0% vs. 83.1%, P < 0.001), and rate of discharge with improvement at the 30-day follow-up (83.2% vs. 74.1%, P=0.001) compared to the co-infection group. No significant differences were observed between the monotherapy and combination therapy groups in clinical efficacy, microbiological efficacy at treatment end, or patient outcomes at the 30-day follow-up (all P > 0.05). During treatment, 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.
    Conclusion Eravacycline demonstrates high clinical and microbiological efficacy in treating pulmonary infections, with a favorable safety profile and mild adverse reactions.

     

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