AI Article Synopsis

  • Infected pancreatic necrosis (IPN) is a severe complication of acute necrotising pancreatitis (ANP), and this trial investigated whether the immune-enhancing drug Thymosin alpha 1 (Tα1) could lower its incidence in patients with a predicted severe case of ANP.
  • The study was a multicenter, double-blind, randomized trial involving 508 patients who were treated with either Tα1 or a placebo, with the main focus on whether IPN developed during their hospital stay.
  • Results showed no significant difference in IPN incidence between the Tα1 group (15.7%) and the placebo group (18.1%), indicating that Tα1 treatment did not effectively reduce the occurrence

Article Abstract

Purpose: Infected pancreatic necrosis (IPN) is a highly morbid complication of acute necrotising pancreatitis (ANP). Since there is evidence of early-onset immunosuppression in acute pancreatitis, immune enhancement may be a therapeutic option. This trial aimed to evaluate whether early immune-enhancing Thymosin alpha 1 (Tα1) treatment reduces the incidence of IPN in patients with predicted severe ANP.

Methods: We conducted a multicentre, double-blind, randomised, placebo-controlled trial involving ANP patients with an Acute Physiology and Chronic Health Evaluation II (APACHE II) score ≥ 8 and a computed tomography (CT) severity score ≥ 5 admitted within 7 days of the advent of symptoms. Enrolled patients were assigned to receive a subcutaneous injection of Tα1 1.6 mg every 12 h for the first 7 days and 1.6 mg once a day for the subsequent 7 days or matching placebos (normal saline). The primary outcome was the development of IPN during the index admission.

Results: A total of 508 patients were randomised, of whom 254 were assigned to receive Tα1 and 254 placebo. The vast majority of the participants required admission to the intensive care unit (ICU) (479/508, 94.3%). During the index admission, 40/254(15.7%) patients in the Tα1 group developed IPN compared with 46/254 patients (18.1%) in the placebo group (difference -2.4% [95% CI - 7.4 to 5.1%]; p = 0.48). The results were similar across four predefined subgroups. There was no difference in other major complications, including new-onset organ failure (10.6% vs. 15%), bleeding (6.3% vs. 3.5%), and gastrointestinal fistula (2% vs. 2.4%).

Conclusion: The immune-enhancing Tα1 treatment of patients with predicted severe ANP did not reduce the incidence of IPN during the index admission.

Download full-text PDF

Source
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9205279PMC
http://dx.doi.org/10.1007/s00134-022-06745-7DOI Listing

Publication Analysis

Top Keywords

patients predicted
12
predicted severe
12
immune enhancement
8
patients
8
acute necrotising
8
necrotising pancreatitis
8
multicentre double-blind
8
double-blind randomised
8
tα1 treatment
8
incidence ipn
8

Similar Publications

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!