Thymosin alpha-1 · research summary

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

Gut and liver · 2024. Summary drawn from the study's full text. Each statement is followed by the exact sentence it comes from. This is a research summary, not medical advice.

Study type

Post hoc analysis of a multicenter randomized clinical trial
“In this post hoc analysis, we aimed to evaluate whether metabolic abnormalities impact the effect of immune-enhancing thymosin alpha-1 (Tα1) therapy in acute necrotizing pancreatitis (ANP) patients.”

Subjects

Patients with acute necrotizing pancreatitis (ANP)
“From March 18, 2017, to December 10, 2020, patients with ANP who were admitted within 7 days of the onset of abdominal pain were recruited.”

Sample size

502 participants
“Overall, 502 participants were included in this post hoc analysis (248 received Tα1 treatment and 254 received matching placebo treatment).”

Duration

90 days for primary outcome assessment
“The primary outcome was 90-day infected pancreatic necrosis (IPN) after randomization.”

Reported findings

Tα1 therapy was associated with reduced incidence of infected pancreatic necrosis in patients with hyperglycemia
“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.”
No significant difference in IPN incidence was observed in subgroups with hypertriglyceridemia or combined metabolic abnormalities
“Among patients with hypertriglyceridemia or with combined hypertriglyceridemia and hyperglycemia, the use of Tα1 did not lead to a difference in the incidence of IPN (Fig. 1).”

Limitations stated by the authors

Retrospective nature of the post hoc analysis, lack of specific immune parameters, and potential bias in hyperglycemia definition
“Some limitations need to be also acknowledged. (1) the retrospective nature of this post hoc analysis may bring in some inevitable bias; (2) there is a lack of other laboratory parameters reflecting the amelioration of immune suppression after Tα1 treatment; (3) hypertriglyceridemia-induced AP accounts for approximately 50% of the study subjects and alcohol-induced AP only 6%, which differs significantly from cohorts reported in Western countries.38,39 Possible explanations may include changes in dietary habits in China over the last few decades,40 genetic factors,41,42 and different alcohol drinking habits; and (4) the definition of hyperglycemia used in this study is a composite one, and approximately 50% of hyperglycemia patients were diagnosed solely based on random blood glucose levels, which can be impacted by patients' fasting status, the use of dextrose fluid, and glycemic control treatments.”

Source: PubMed 38356344 · DOI 10.5009/gnl230326 · all study summaries

Reported findings

Tα1 therapy was associated with reduced incidence of infected pancreatic necrosis in patients with hyperglycemia

“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.”

No significant difference in IPN incidence was observed in subgroups with hypertriglyceridemia or combined metabolic abnormalities

“Among patients with hypertriglyceridemia or with combined hypertriglyceridemia and hyperglycemia, the use of Tα1 did not lead to a difference in the incidence of IPN (Fig. 1).”

Limitations stated by the authors

Retrospective nature of the post hoc analysis, lack of specific immune parameters, and potential bias in hyperglycemia definition

“Some limitations need to be also acknowledged. (1) the retrospective nature of this post hoc analysis may bring in some inevitable bias; (2) there is a lack of other laboratory parameters reflecting the amelioration of immune suppression after Tα1 treatment; (3) hypertriglyceridemia-induced AP accounts for approximately 50% of the study subjects and alcohol-induced AP only 6%, which differs significantly from cohorts reported in Western countries.38,39 Possible explanations may include changes in dietary habits in China over the last few decades,40 genetic factors,41,42 and different alcohol drinking habits; and (4) the definition of hyperglycemia used in this study is a composite one, and approximately 50% of hyperglycemia patients were diagnosed solely based on random blood glucose levels, which can be impacted by patients' fasting status, the use of dextrose fluid, and glycemic control treatments.”