Xiaohui Liu, Xuefeng Yuan, Long Wen, Xin Tan, Qian Sui, Jiheng Liu
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Among the 24 patients who developed hypofibrinogenemia, three gastrointestinal bleeding events were observed, and four of these patients required fibrinogen administration. We identified the total therapeutic dose (odds ratio (OR) = 15.28, 95% confidence interval (CI) 2.10–111.02, <i>p</i> = 0.01) and a baseline direct bilirubin level greater than 0.4 mg/dL (OR = 5.79, 95% CI 1.13–27.98, <i>p</i> = 0.04) as risk factors for tigecycline-induced hypofibrinogenemia. Conversely, a baseline fibrinogen level (OR = 0.53, 95% CI 0.29–0.97, <i>p</i> = 0.04) appeared to be a protective factor. Healthcare professionals should be aware that the administration of tigecycline may be associated with hypofibrinogenemia and severe adverse reactions. Regular monitoring of coagulation is essential, particularly for patients with liver dysfunction, low baseline fibrinogen levels, elevated baseline direct bilirubin levels, or those receiving higher total therapeutic doses.</p>","PeriodicalId":50610,"journal":{"name":"Cts-Clinical and Translational Science","volume":"18 4","pages":""},"PeriodicalIF":3.1000,"publicationDate":"2025-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://onlinelibrary.wiley.com/doi/epdf/10.1111/cts.70213","citationCount":"0","resultStr":"{\"title\":\"Identification of Risk Factors and Predictive Indicators for Tigecycline-Associated Hypofibrinogenemia\",\"authors\":\"Xiaohui Liu, Xuefeng Yuan, Long Wen, Xin Tan, Qian Sui, Jiheng Liu\",\"doi\":\"10.1111/cts.70213\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p>To investigate the prevalence, clinical manifestations, and risk factors of hypofibrinogenemia after tigecycline use, which can disrupt coagulation and potentially hinder antimicrobial therapy. This observational study was conducted from January to December 2021 at a tertiary general hospital in China. All patients over 18 years old who received tigecycline for more than 48 h were included. After treatment with tigecycline, patients were divided into two groups based on fibrinogen plasma concentrations of less than 2.0 g/L. Multivariable logistic regression was performed to identify risk factors for hypofibrinogenemia associated with tigecycline. A total of 50 patients (mean age 71.3 ± 20.2 years) were analyzed. The median duration of treatment was 8 days (range: 3 to 20 days). Among the 24 patients who developed hypofibrinogenemia, three gastrointestinal bleeding events were observed, and four of these patients required fibrinogen administration. We identified the total therapeutic dose (odds ratio (OR) = 15.28, 95% confidence interval (CI) 2.10–111.02, <i>p</i> = 0.01) and a baseline direct bilirubin level greater than 0.4 mg/dL (OR = 5.79, 95% CI 1.13–27.98, <i>p</i> = 0.04) as risk factors for tigecycline-induced hypofibrinogenemia. Conversely, a baseline fibrinogen level (OR = 0.53, 95% CI 0.29–0.97, <i>p</i> = 0.04) appeared to be a protective factor. Healthcare professionals should be aware that the administration of tigecycline may be associated with hypofibrinogenemia and severe adverse reactions. 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引用次数: 0
摘要
目的:探讨使用替加环素后低纤维蛋白原血症的患病率、临床表现和危险因素,低纤维蛋白原血症可破坏凝血并可能阻碍抗菌药物治疗。本观察性研究于2021年1月至12月在中国一家三级综合医院进行。所有18岁以上接受替加环素治疗超过48小时的患者均被纳入研究。替加环素治疗后,根据纤维蛋白原血浆浓度< 2.0 g/L分为两组。采用多变量logistic回归来确定与替加环素相关的低纤维蛋白原血症的危险因素。共分析50例患者(平均年龄71.3±20.2岁)。治疗中位持续时间为8天(范围:3至20天)。在24例发生低纤维蛋白原血症的患者中,观察到3例胃肠道出血事件,其中4例需要给予纤维蛋白原。我们确定总治疗剂量(优势比(OR) = 15.28, 95%可信区间(CI) 2.10-111.02, p = 0.01)和基线直接胆红素水平大于0.4 mg/dL (OR = 5.79, 95% CI 1.13-27.98, p = 0.04)是替加环素诱导的低纤维蛋白原血症的危险因素。相反,基线纤维蛋白原水平(OR = 0.53, 95% CI 0.29-0.97, p = 0.04)似乎是一个保护因素。医疗保健专业人员应该意识到,替加环素的管理可能与低纤维蛋白原血症和严重的不良反应有关。定期监测凝血是必要的,特别是对于肝功能障碍、基线纤维蛋白原水平低、基线直接胆红素水平升高或接受较高总治疗剂量的患者。
Identification of Risk Factors and Predictive Indicators for Tigecycline-Associated Hypofibrinogenemia
To investigate the prevalence, clinical manifestations, and risk factors of hypofibrinogenemia after tigecycline use, which can disrupt coagulation and potentially hinder antimicrobial therapy. This observational study was conducted from January to December 2021 at a tertiary general hospital in China. All patients over 18 years old who received tigecycline for more than 48 h were included. After treatment with tigecycline, patients were divided into two groups based on fibrinogen plasma concentrations of less than 2.0 g/L. Multivariable logistic regression was performed to identify risk factors for hypofibrinogenemia associated with tigecycline. A total of 50 patients (mean age 71.3 ± 20.2 years) were analyzed. The median duration of treatment was 8 days (range: 3 to 20 days). Among the 24 patients who developed hypofibrinogenemia, three gastrointestinal bleeding events were observed, and four of these patients required fibrinogen administration. We identified the total therapeutic dose (odds ratio (OR) = 15.28, 95% confidence interval (CI) 2.10–111.02, p = 0.01) and a baseline direct bilirubin level greater than 0.4 mg/dL (OR = 5.79, 95% CI 1.13–27.98, p = 0.04) as risk factors for tigecycline-induced hypofibrinogenemia. Conversely, a baseline fibrinogen level (OR = 0.53, 95% CI 0.29–0.97, p = 0.04) appeared to be a protective factor. Healthcare professionals should be aware that the administration of tigecycline may be associated with hypofibrinogenemia and severe adverse reactions. Regular monitoring of coagulation is essential, particularly for patients with liver dysfunction, low baseline fibrinogen levels, elevated baseline direct bilirubin levels, or those receiving higher total therapeutic doses.
期刊介绍:
Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.