Risk Factors for Tigecycline‐Associated Hepatotoxicity in Patients in the Intensive Care Units of 2 Tertiary Hospitals: A Retrospective Study

Jiang, Tingting; Huang, Xuhui; Liu, Qinghua; Feng, Hangwei; Huang, Yi-Ting; Lin, Jian; Huang, Long; Chen, Shu-Fang; Zhuang, Yingfeng; Weng, Cui-Lian

doi:10.1002/jcph.2099

Cited by 3 publications

(2 citation statements)

References 20 publications

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“…[23]. В 2021 г. был описан случай клинически значимого острого повреждения печени при введении меропенема: через 3 сут после начала антибиотикотерапии у пациентки развилось смешанное гепатоцеллюлярное и холестатическое поражение печени с желтухой Гепатотоксические свойства тигециклина подтверждены в исследованиях in vitro, однако механизм поражения клеток печени не уточнен [37].…”

Section: материалы и методыunclassified

Antibiotic-Associated Drug-Induced Liver Injury in Critically Ill Children: A Prospective Observational Study

Vlasova,

Shubina,

Sychev

2023

Bezopasnost' i risk farmakoterapii

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Scientific relevance. Drug-induced liver injury (DILI) is associated, among other things, with the use of antibiotics. Children with DILI are at risk of acute liver failure and even death. However, the literature on the subject provides little information on the possibility of distinguishing the types of hepatic lesions to diagnose potentially life-threatening DILI in time.Aim. The study aimed to describe the phenotype of new-onset DILI associated with antibiotics in critically ill children with nosocomial infection.Materials and methods. The authors conducted a prospective observational study in the resuscitation and intensive care units of the Morozov Children’s City Clinical Hospital from 1 February 2020 to 1 September 2021. The study assessed the incidence of antibiotic-associated DILI using the Global Trigger Tool. The study enrolled 100 critically ill children with nosocomial infection aged 0 to 17 years (44 boys and 56 girls).Results. Signs of hepatotoxicity were detected in 19 patients, including 8 with abnormal liver function tests but normal liver function and 11 with abnormal liver function tests and clinically apparent liver disease. Thus, the incidence of new-onset hepatotoxicity associated with antibiotics amounted to 12.9 cases per 100,000 paediatric patients, and the incidence of DILI was 7.5 cases per 100,000 children. Based on the analysis of medical records, biochemical findings, and relationships between the time of dosing and the manifestation of signs of liver disorder in 11 children, the authors characterised the phenotype of idiosyncratic cholestatic hepatitis. Critically ill children treated with antibiotics showed alanine transaminase activity up to 10 times the upper limit of normal (ULN), bilirubin levels up to 4.45 times the ULN, and gamma-glutamyl transferase activity up to 5 times the ULN. The odds of developing new-onset DILI were the highest with tigecycline (OR: 4.07; 95% CI: 1.32–12.50) and meropenem (OR: 1.84; 95% CI: 1.01–3.36). In 6 patients, clinical signs of idiosyncratic cholestatic hepatitis resolved within a few weeks after antibiotic discontinuation. The other 5 patients with clinical signs of idiosyncratic cholestatic hepatitis died.Conclusions. The authors described the phenotype of idiosyncratic cholestatic liver injury associated with antibiotics in critically ill children. The role of pharmacogenetic markers in the development of DILI associated with antibiotics in critically ill children needs to be assessed further to implement a risk-based approach and mitigate the risks.

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Section: материалы и методыunclassified

Antibiotic-Associated Drug-Induced Liver Injury in Critically Ill Children: A Prospective Observational Study

Vlasova,

Shubina,

Sychev

2023

Bezopasnost' i risk farmakoterapii

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“…Previous authors have utilized this system to grade the severity of AEs related to SMT 5,[32][33][34] . CTCAE is becoming a standard measurement system and is used in other fields, such as cancer therapies 35 , pharmacology 36 , and surgery 37 .…”

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A retrospective analysis of the incidence of severe adverse events among recipients of chiropractic spinal manipulative therapy

Chu¹,

Trager

Lee

et al. 2023

Sci Rep

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This study examined the incidence and severity of adverse events (AEs) of patients receiving chiropractic spinal manipulative therapy (SMT), with the hypothesis that < 1 per 100,000 SMT sessions results in a grade ≥ 3 (severe) AE. A secondary objective was to examine independent predictors of grade ≥ 3 AEs. We identified patients with SMT-related AEs from January 2017 through August 2022 across 30 chiropractic clinics in Hong Kong. AE data were extracted from a complaint log, including solicited patient surveys, complaints, and clinician reports, and corroborated by medical records. AEs were independently graded 1–5 based on severity (1-mild, 2-moderate, 3-severe, 4-life-threatening, 5-death). Among 960,140 SMT sessions for 54,846 patients, 39 AEs were identified, two were grade 3, both of which were rib fractures occurring in women age > 60 with osteoporosis, while none were grade ≥ 4, yielding an incidence of grade ≥ 3 AEs of 0.21 per 100,000 SMT sessions (95% CI 0.00, 0.56 per 100,000). There were no AEs related to stroke or cauda equina syndrome. The sample size was insufficient to identify predictors of grade ≥ 3 AEs using multiple logistic regression. In this study, severe SMT-related AEs were reassuringly very rare.

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Serum concentration threshold and risk factors of tigecycline-induced hypofibrinogenaemia in critically ill patients

Li,

He,

Dong

et al. 2024

Journal of Antimicrobial Chemotherapy

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Objectives Hypofibrinogenaemia is a serious adverse reaction associated with tigecycline (TGC) therapy and may lead to the discontinuation of the treatment. This study aimed to explore the relevant factors of TGC-induced hypofibrinogenaemia and determine the thresholds of serum concentration as a predictive indicator of TGC-induced hypofibrinogenaemia. Methods A retrospective single-centre study was conducted on patients with severe infection who were treated with TGC. Clinical data and serum concentration parameters were extracted from the electronic medical records of these patients. Patients were divided into the hypofibrinogenaemia group (< 2.0 g/L) and the normal fibrinogen group (≥ 2.0 g/L) in order to evaluate risk factors associated with TGC-induced hypofibrinogenaemia. Logistic regression analysis and receiver operating characteristic curves were utilized to identify the risk factors associated with TGC-induced hypofibrinogenaemia and to establish plasma concentration thresholds as predictive indicators. Results A total of 114 patients were enrolled in this study, with 59.6% experiencing hypofibrinogenaemia. The multivariate regression analysis indicated that baseline fibrinogen level, trough concentration (Cmin), peak concentration (Cmax), the concentration at 6 h after the dosing (C6h) and the area under the concentration–time curve over a 24-h period (AUC0–24) were significantly associated with hypofibrinogenaemia (P < 0.05). Furthermore, it was found that AUC0–24 is the optimal predictor of TGC-induced hypofibrinogenaemia. The optimal cut-off for the AUC0–24 of TGC in ICU patients was determined to be 17.03 mg h/L. Conclusions TGC exposure is highly predictive of TGC-induced hypofibrinogenaemia. We recommend closely monitoring plasma concentrations of TGC in patients to ensure patient efficacy and safety.

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Risk Factors for Tigecycline‐Associated Hepatotoxicity in Patients in the Intensive Care Units of 2 Tertiary Hospitals: A Retrospective Study

Cited by 3 publications

References 20 publications

Antibiotic-Associated Drug-Induced Liver Injury in Critically Ill Children: A Prospective Observational Study

Antibiotic-Associated Drug-Induced Liver Injury in Critically Ill Children: A Prospective Observational Study

A retrospective analysis of the incidence of severe adverse events among recipients of chiropractic spinal manipulative therapy

Serum concentration threshold and risk factors of tigecycline-induced hypofibrinogenaemia in critically ill patients

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