Comparative efficacy and safety of Xuesaitong injection as adjuvant therapy for acute pancreatitis: a systematic review and meta-analysis

Background: Xuesaitong injection has been explored as an off-label adjuvant therapy for acute pancreatitis in China, but its efficacy and safety remain uncertain. This systematic review and meta-analysis evaluated Xuesaitong injection combined with conventional therapy for acute pancreatitis. Methods: Randomized controlled trials of Xuesaitong injection for acute pancreatitis were searched in the Cochrane Library, Embase, Web of Science, PubMed, China National Knowledge Infrastructure, Wanfang Database, VIP Database, and Chinese Biomedical Literature Database from inception to 1 March 2026. Two reviewers independently performed study screening, data extraction, and risk-of-bias assessment. Meta-analysis was conducted using a random-effects model, and certainty of evidence was assessed using the Grading of Recommendations Assessment, Development and Evaluation approach. Results: Sixteen randomized controlled trials involving 1,529 patients were included. Compared with conventional therapy alone, Xuesaitong injection plus conventional therapy improved the clinical response rate (relative risk = 1.15, 95% confidence interval 1.11-1.20), shortened length of hospital stay (mean difference = -5.18 days, 95% confidence interval -6.73 to -3.63), and reduced Acute Physiology and Chronic Health Evaluation II scores (mean difference = -1.99 points, 95% confidence interval -3.54 to -0.43). It also reduced inflammatory markers and amylase levels, including tumor necrosis factor-alpha, C-reactive protein, interleukin-6, interleukin-2, soluble intercellular adhesion molecule-1, serum amylase, and urinary amylase. The incidence of reported safety-related events was 6.43% in the experimental group and 7.04% in the control group. No serious adverse events clearly attributed to Xuesaitong injection were reported. Six studies had a high risk of bias, and the certainty of evidence was low or very low. Conclusion: Xuesaitong injection may provide additional benefits as adjuvant therapy for acute pancreatitis. However, methodological limitations, substantial heterogeneity, possible publication bias, and insufficient safety reporting warrant cautious interpretation. High-quality multicenter randomized controlled trials are needed. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/view/CRD420261335764, identifier CRD420261335764.