Gut Liver.  2024 Sep;18(5):906-914. 10.5009/gnl230326.

Immune-Enhancing Treatment among Acute Necrotizing Pancreatitis Patients with Metabolic Abnormalities: A Post Hoc Analysis of a Randomized Clinical Trial

Affiliations
  • 1Department of Emergency and Critical Care Medicine, Affiliated Hospital of Integrated Traditional Chinese and Western Medicine, Nanjing University of Chinese Medicine, Nanjing, China
  • 2Department of Emergency and Critical Care Medicine, Jiangsu Province Academy of Traditional Chinese Medicine, Nanjing, China
  • 3Department of Critical Care Medicine, Jinling Hospital, Medical School of Nanjing University, Nanjing, China
  • 4Department of Emergency and Critical Care Medicine, Nanjing Jiangning District Hospital of Traditional Chinese Medicine, Nanjing, China
  • 5Department of Anesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg, Germany
  • 6Department of Cardiac Anesthesiology and Intensive Care Medicine, German Heart Center Charité Berlin, Berlin, Germany
  • 7National Institute of Healthcare Data Science, Nanjing University, Nanjing, China

Abstract

Background/Aims
Metabolic syndrome is common in patients with acute pancreatitis and its components have been reported to be associated with infectious complications. In this post hoc analysis, we aimed to evaluate whether metabolic abnormalities impact the effect of immuneenhancing thymosin alpha-1 (Tα1) therapy in acute necrotizing pancreatitis (ANP) patients.
Methods
All data were obtained from the database for a multicenter randomized clinical trial that evaluated the efficacy of Tα1 in ANP patients. Patients who discontinued the Tα1 treatment prematurely were excluded. The primary outcome was 90-day infected pancreatic necrosis (IPN) after randomization. Three post hoc subgroups were defined based on the presence of hyperglycemia, hypertriglyceridemia, or both at the time of randomization. In each subgroup, the correlation between Tα1 and 90-day IPN was assessed using the Cox proportional-hazards regression model. Multivariable propensity-score methods were used to control potential bias.
Results
Overall, 502 participants were included in this post hoc analysis (248 received Tα1 treatment and 254 received matching placebo treatment). Among them, 271 (54.0%) had hyperglycemia, 371 (73.9%) had hypertriglyceridemia and 229 (45.6%) had both. Tα1 therapy was associated with reduced incidence of IPN among patients with hyperglycemia (18.8% vs 29.7%: hazard ratio, 0.80; 95% confidence interval, 0.37 to 0.97; p=0.03), but not in the other subgroups. Additional multivariate regression models using three propensity-score methods yielded similar results.
Conclusions
Among ANP patients with hyperglycemia, immune-enhancing Tα1 treatment was associated with a reduced risk of IPN (ClinicalTrials.gov, Registry number: NCT02473406).

Keyword

Metabolic syndrome; Hyperglycemia; Acute necrotizing pancreatitis; Infection; Thymosin alpha1
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