低蛋白血症患者替加环素相关低纤维蛋白原血症的真实世界研究

doi:10.5246/jcps.2025.06.044

中国药学(英文版) ›› 2025, Vol. 34 ›› Issue (6): 581-591.DOI: 10.5246/jcps.2025.06.044

• 【研究论文】 • 上一篇

低蛋白血症患者替加环素相关低纤维蛋白原血症的真实世界研究

刘秀珍^*(), 刘建军, 薛未菊, 邢海燕, 赵营莉, 方兴

合肥市第二人民医院, 药学部, 安徽合肥 230000

收稿日期:2025-02-10 修回日期:2025-03-15 接受日期:2025-03-20 出版日期:2025-07-03 发布日期:2025-07-03
通讯作者: 刘秀珍

Retrospective analysis of tigecycline-associated hypofibrinogenemia in patients with hypoproteinemia

Xiuzhen Liu^*(), Jianjun Liu, Weiju Xue, Haiyan Xing, Yingli Zhao, Xing Fang

Department of Pharmacy, Second People's Hospital of Hefei, Hefei 230000, Anhui, China

Received:2025-02-10 Revised:2025-03-15 Accepted:2025-03-20 Online:2025-07-03 Published:2025-07-03
Contact: Xiuzhen Liu
Supported by:
Anhui Provincial Traditional Chinese Medicine Inheritance and Innovation Research Project (Clinical category) (Anhui Traditional Chinese Medicine Development Secretary No. 20, 2024).

摘要/Abstract

摘要：

本研究旨在探究真实世界替加环素(tigecycline, TGC)治疗伴有低蛋白血症的感染患者引起低纤维蛋白(fibrinogen, FIB)发生情况和危险因素, 为临床安全用药提供参考。回顾性收集2020年1月1日至2023年12月31日合肥市第二人民医院住院期间住院期间使用替加环素抗感染治疗的低蛋白血症患者病历, 记录每位患者年龄、性别、体重、血液疾病史、用药剂量、治疗疗程、合并用药情况、用药前后血清蛋白水平、是否肝肾功能不全、低纤维蛋白血症不良反应等信息, 统计低蛋白血症患者使用替加环素引起低纤维蛋白血症的基本特征; 并将患者分ADR和非ADR组, 比较两组患者基本特征和药物治疗的差异, 进一步探讨低蛋白血症患者使用替加环素引起FIB降低的影响因素。结果发现, 共纳入符合条件的222例患者, 发生低纤维蛋白血症为71例, 占比31.98%; 通过对两组患者基本特征、既往病史情况、实验室检查结果、药物治疗等信息进行收集和统计, 并开展单因素分析, 结果显示替加环素的治疗疗程、患者治疗前基础FIB值、清蛋白值、联合头孢哌酮舒巴坦、联合脂肪乳和肝素治疗五个指标两组之间差异有统计学意义(P < 0.05)。多因素Logistic回归分析显示基础FIB水平< 5.1 g/L、与头孢哌酮舒巴坦联用是导致患者发生FIB降低的独立影响因素; 而疗程< 9 d、清蛋白值(轻/中/重)是降低其风险的独立影响因素。替加环素相关的低纤维蛋白血症是临床常见不良反应, 尤其是低蛋白血症患者使用该药物临床使用前应评估患者病理状态, 使用前应关注基础FIB值和清蛋白水平, 避免长疗程使用、使用过程中尽量减少影响凝血功能的药物联合用药, 以次避免或降低替加环素相关低纤维蛋白血症的发生。

关键词: 替加环素, 低蛋白血症, 低纤维蛋白血症, 真实世界研究

Abstract:

This study aimed to investigate the prevalence and risk factors associated with tigecycline-induced hypofibrinogenemia, providing critical insights for safer clinical drug use. A retrospective analysis was conducted on the medical records of patients with hypoproteinemia who received tigecycline treatment during hospitalization between January 1, 2020, and December 31, 2023. Key patient information was collected, including age, gender, weight, history of hematological diseases, medication dosage, treatment duration, concomitant medications, serum albumin and fibrinogen (FIB) levels before and after tigecycline administration, hepatic and renal function parameters, and other clinical characteristics. Patients were categorized into adverse drug reaction (ADR) and non-ADR groups, and comparisons were made to identify baseline characteristics and drug-related factors influencing tigecycline-induced FIB level reductions. Among 222 eligible patients, 71 (31.98%) developed hypofibrinogenemia. Univariate analysis identified significant associations between hypofibrinogenemia and treatment duration (P = 0.000), baseline FIB levels (P = 0.006), concomitant use of cefoperazone-sulbactam (P = 0.034), and concurrent administration of fat emulsion and heparin sodium injections (P < 0.044). Further multivariate logistic regression analysis revealed that a baseline FIB level below 5.1 g/L and concomitant use with cefoperazone-sulbactam were independent risk factors for tigecycline-induced FIB reduction. Conversely, a treatment duration of fewer than 9 d and higher albumin levels (light/medium/weight) were protective factors that reduced the risk of hypofibrinogenemia. This study highlighted that tigecycline-induced hypofibrinogenemia was a frequently encountered adverse effect in clinical practice. Patients with hypoproteinemia should undergo thorough evaluation prior to tigecycline administration, with particular attention to baseline FIB and albumin levels. Long-term use should be avoided, and combinations with medications that impair coagulation function should be minimized to mitigate the risk of hypofibrinogenemia associated with tigecycline.

Key words: Tigecycline, Hypoproteinemia, Hypofibrinogenemia, Real-world study

Supporting:

刘秀珍, 刘建军, 薛未菊, 邢海燕, 赵营莉, 方兴. 低蛋白血症患者替加环素相关低纤维蛋白原血症的真实世界研究[J]. 中国药学(英文版), 2025, 34(6): 581-591.

Xiuzhen Liu, Jianjun Liu, Weiju Xue, Haiyan Xing, Yingli Zhao, Xing Fang. Retrospective analysis of tigecycline-associated hypofibrinogenemia in patients with hypoproteinemia[J]. Journal of Chinese Pharmaceutical Sciences, 2025, 34(6): 581-591.

图/表 5

Figure 1. Study flowchart for patient enrollment.

Table 1. Basic information of 222 included patients.

Table 2. Clinical data statistics and univariate analysis of included patients.

Table 3. Statistical table of multivariate logistic regression analysis.

Table 4. Statistical table of patient information in the ADR group.

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低蛋白血症患者替加环素相关低纤维蛋白原血症的真实世界研究

Retrospective analysis of tigecycline-associated hypofibrinogenemia in patients with hypoproteinemia

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