Thymosin alpha 1 alleviates inflammation and prevents infection in patients with severe acute pancreatitis through immune regulation: a systematic review and meta-analysis.
This systematic review and meta-analysis evaluated the efficacy of Thymosin alpha 1 (Tα1), an immunomodulatory peptide, in patients with severe acute pancreatitis (SAP). Researchers searched five major databases through February 2025 and identified five randomized controlled trials encompassing 706 SAP patients, comparing Tα1 treatment against non-Tα1 controls. The pooled analysis found that Tα1 was associated with increased percentages of CD4+ T cells and improved CD4+/CD8+ ratios, suggesting a positive effect on immune cell balance and reduction of immune suppression. Lower-dose Tα1 was associated with significantly reduced C-reactive protein (CRP) levels, an inflammation marker. Tα1 was also associated with a potential reduction in extrapancreatic infection risk. The authors concluded that Tα1 may regulate immune cell balance and exert anti-inflammatory effects in SAP patients, potentially improving prognosis. Key limitations include the small number of included trials (n=5), the relatively modest total patient population, heterogeneity in dosing protocols, and the predominance of studies from a single country (China), which may limit generalizability. The authors noted that further research is needed to validate these findings.
Why this grade: Although the meta-analysis pools data from randomized controlled trials in human patients, the evidence is graded moderate rather than strong due to the small number of included trials (n=5), limited total sample size (706 patients), potential geographic homogeneity, and dosing heterogeneity across studies.
Background Immune and inflammatory disorders are part of the complex pathophysiological processes that exacerbate severe acute pancreatitis (SAP) and subsequent infection. Thymosin alpha 1 (Tα1) is an important immunomodulatory agent in clinical practice, but there is a lack evidence to prove its effectiveness in improving the condition of SAP patients. In this study, we aimed to evaluate the efficacy in meta-analysis. Methods We systematically searched PubMed, Embase, Web of Science, Cochrane Library and China National Knowledge Infrastructure (CNKI) up to February 1, 2025. Randomized controlled studies comparing the efficacy of Tα1 as intervention measure with non-Tα1 in improving immune regulation for patients with SAP were included. Review Manager 5.3 was used to assess endpoints in the meta-analysis. Results Five randomized controlled trials comprising 706 patients with SAP were included. The results indicated that Tα1 could increase the percentages of CD4 + cells (MD=4.53, 95%CI [3.02, 6.04], P + /CD8 + ratio (MD=0.42, 95%CI [0.26, 0.58], P + cells. For inflammation, lower-dose Tα1 could significantly reduce C-reactive protein (CRP) levels (mg/L) (MD=-30.12, 95%CI [-35.75, -24.49], P Conclusion Tα1 can regulate the balance of immune cells and alleviate immune suppression in SAP patients, including increasing CD4 + T cells and CD4 + /CD8 + ratios. Tα1 may exert anti-inflammatory and extrapancreatic infection-preventive effects on SAP patients and improve their condition or prognosis. More researches are needed to validate the results. Systematic review registration https://www.crd.york.ac.uk/prospero, identifier CRD42024570517.
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