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一项关于静脉注射奥马环素治疗耐碳青霉烯类严重肺炎的配对前瞻性队列研究。

A matched pilot cohort study of intravenous omadacycline in the treatment of severe pneumonia associated with carbapenem-resistant .

作者信息

Chen Dayu, Chen Yechao, Hu Na, Gu Qiaoling, Kan Jingjing, Liu Jinchun, Zhang Haixia

机构信息

Department of Pharmacy, Nanjing Drum Tower Hospital, Nanjing, China.

Department of Pharmacy, School of Basic Medicine and Clinical Pharmacy, Nanjing Drum Tower Hospital, China Pharmaceutical University, Nanjing, China.

出版信息

Front Microbiol. 2025 Jul 23;16:1597860. doi: 10.3389/fmicb.2025.1597860. eCollection 2025.

Abstract

BACKGROUND

Carbapenem-resistant (CRAB)-caused severe pneumonia is associated with high mortality rates, and treatment options are limited. Tetracyclines, including tigecycline and omadacycline, have activity against CRAB. We conducted this study to explore the efficacy of omadacycline in CRAB-caused severe pneumonia.

METHODS

This retrospective cohort study was performed by collecting data on severe CRAB-caused pneumonia cases treated with omadacycline or tigecycline at Nanjing Drum Tower Hospital from January 2022 to June 2024. A 1:1 propensity score-based matching design based on baseline characteristics was utilized. We compared the incidence of clinical response at day 14 or at the end of treatment (EOT) and other clinical outcomes between the two cohorts.

RESULTS

A total of 40 patients were analyzed, with 20 patients in each cohort. The clinical success rate at day 14 or at the EOT was 65% (13/20) in the omadacycline group compared to 55% (11/20) in the tigecycline group. Both groups had an equal mortality rate, with 8 patients dying within 28 days. Development of tigecycline resistance was observed in one patient. The average duration of invasive mechanical ventilation, vasopressor, renal replacement therapy was also comparable in both groups. Adverse events occurred in 50% (10/20) of patients in the omadacycline group and 75% (15/20) in the tigecycline group, with coagulopathy being significantly lower in the omadacycline group (1/20, 5% vs. 7/20, 35%). Gastrointestinal events were reported in 10% (2/20) of the omadacycline group compared to 30% (6/20) in the tigecycline group. Abnormal liver function was observed in 9/20 patients (45%) in the omadacycline group and 6/20 patients (30%) in the tigecycline group.

CONCLUSION

This pilot study was the first to explore the efficacy and safety of omadacycline in CRAB-caused pneumonia. Omadacycline demonstrated comparable efficacy to tigecycline in this small pilot study in the treatment of CRAB-caused pneumonia and has a lower incidence of coagulopathy compared to tigecycline, suggesting it may be a viable option, for treating CRAB-caused severe pneumonia, but further prospective research with larger sample sizes is needed to confirm these findings.

摘要

背景

耐碳青霉烯类鲍曼不动杆菌(CRAB)所致的严重肺炎死亡率高,治疗选择有限。四环素类药物,包括替加环素和奥马环素,对CRAB有活性。我们开展本研究以探索奥马环素治疗CRAB所致严重肺炎的疗效。

方法

本回顾性队列研究通过收集2022年1月至2024年6月在南京鼓楼医院接受奥马环素或替加环素治疗的严重CRAB所致肺炎病例的数据进行。采用基于基线特征的1:1倾向评分匹配设计。我们比较了两组在第14天或治疗结束时(EOT)的临床反应发生率及其他临床结局。

结果

共分析了40例患者,每组20例。奥马环素组在第14天或EOT时的临床成功率为65%(13/20),而替加环素组为55%(11/20)。两组死亡率相同,28天内均有8例患者死亡。1例患者出现替加环素耐药。两组有创机械通气、血管活性药物、肾脏替代治疗的平均持续时间也相当。奥马环素组50%(10/20)的患者发生不良事件,替加环素组为75%(15/20),奥马环素组凝血障碍的发生率显著更低(1/20,5% 对比7/20,35%)。奥马环素组10%(2/20)的患者报告有胃肠道事件,而替加环素组为30%(6/20)。奥马环素组9/20例患者(45%)出现肝功能异常,替加环素组6/20例患者(30%)出现肝功能异常。

结论

这项前瞻性研究首次探索了奥马环素治疗CRAB所致肺炎的疗效和安全性。在这项治疗CRAB所致肺炎的小型前瞻性研究中,奥马环素显示出与替加环素相当的疗效,且与替加环素相比凝血障碍的发生率更低,这表明它可能是治疗CRAB所致严重肺炎的一个可行选择,但需要进一步开展更大样本量的前瞻性研究来证实这些发现。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/7af4/12325336/1c1e980fa45a/fmicb-16-1597860-g001.jpg

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