基于硫酸黏菌素的联合疗法治疗重症监护病房耐碳青霉烯类微生物引起的感染：一项多中心、前瞻性、观察性临床试验
Colistin Sulfate-Based Combination Therapy for Infections Caused by Carbapenem-Resistant Organisms in Intensive Care Units: A Multicenter, Prospective, Observational Clinical Trial.
作者信息
Zhang Fan, Peng Danyang, He Faming, Liu Ying, Zang Binbin, Gao Yanqiu, Qin Chao, Guo Suping, Qi Yawei, Zheng Xisheng, Guo Lin, Zhao Tingting, Jin Yue, Su Rongqi, Du Juan, Pan Jiazhan, Qin Bingyu, Shao Huanzhang
机构信息
Department of Critical Care Medicine, Henan Provincial People's Hospital, Weiwu Road No. 7, Zhengzhou, 450003, Henan, China.
Department of Critical Care Medicine, People's Hospital of Zhengzhou University, Zhengzhou, China.
出版信息
Infect Dis Ther. 2025 Jun 29. doi: 10.1007/s40121-025-01176-5.
INTRODUCTION
With the rapid spread of carbapenem-resistant Gram-negative bacterial infections, polymyxins have reemerged as a critical "salvage" antibiotic option.
METHODS
This multicenter observational study assessed the effectiveness and safety of colistin sulfate-based treatment for carbapenem-resistant organism (CRO) infections in patients in intensive care across ten clinical sites in China. Clinical and microbiological responses, 28-day all-cause mortality, and associated risk factors were analyzed. Nephrotoxicity was assessed using Kidney Disease Improving Global Outcomes (KDIGO) criteria.
RESULTS
Of 240 critically ill adult patients with confirmed CRO infection, 91.3% had pulmonary infection, and 77.1% and 52.5% achieved clinical and microbiological response, respectively. Subgroup analyses showed associations between outcomes and patient age and colistin sulfate treatment duration. The 28-day all-cause mortality was 27.1%. Clinical response and mortality were significantly associated with Sequential Organ Failure Assessment (SOFA) score and colistin sulfate treatment duration. Analysis of the receiver operating characteristic (ROC) curve revealed that the thresholds for colistin treatment duration for predicting clinical response and survival were > 9.5 days (area under the curve [AUC] > 0.7). Nephrotoxicity was reported in 13.1% of patients not receiving continuous renal replacement therapy (CRRT), with no significant duration-dependent increase. Post-treatment serum creatinine (Scr) levels remained stable or improved across all renal function subgroups.
CONCLUSIONS
Colistin sulfate in combination with other antimicrobials can be considered a reasonable and safe treatment option for CRO infections. Understanding the factors involved in this potential beneficial treatment can enable more careful follow-up of patients.
TRIAL REGISTRATION
ChiCTR, ChiCTR2100044866. Registered on 30 March 2021, https://www.chictr.org.cn/showproj.html?proj=124119 .
引言
随着耐碳青霉烯类革兰氏阴性菌感染的迅速传播，多粘菌素已重新成为一种关键的“挽救性”抗生素选择。
方法
这项多中心观察性研究评估了在中国十个临床地点对重症监护患者基于硫酸多粘菌素治疗耐碳青霉烯类病原体（CRO）感染的有效性和安全性。分析了临床和微生物学反应、28天全因死亡率及相关危险因素。使用改善全球肾脏病预后组织（KDIGO）标准评估肾毒性。
结果
在240例确诊为CRO感染的成年重症患者中，91.3%患有肺部感染，77.1%和52.5%的患者分别实现了临床和微生物学反应。亚组分析显示结局与患者年龄及硫酸多粘菌素治疗持续时间之间存在关联。28天全因死亡率为27.1%。临床反应和死亡率与序贯器官衰竭评估（SOFA）评分及硫酸多粘菌素治疗持续时间显著相关。受试者工作特征（ROC）曲线分析显示，预测临床反应和生存的硫酸多粘菌素治疗持续时间阈值>9.5天（曲线下面积[AUC]>0.7）。在未接受连续性肾脏替代治疗（CRRT）的患者中，13.1%报告有肾毒性，且无明显的持续时间依赖性增加。所有肾功能亚组治疗后血清肌酐（Scr）水平保持稳定或有所改善。
结论
硫酸多粘菌素联合其他抗菌药物可被视为治疗CRO感染的合理且安全的选择。了解这种潜在有益治疗所涉及的因素能够对患者进行更密切的随访。
试验注册
中国临床试验注册中心，ChiCTR2100044866。于2021年3月30日注册，https://www.chictr.org.cn/showproj.html?proj=124119 。
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