Effectiveness and safety of treatments for ulinastatin on sepsis: A systematic review and meta-analysis

BACKGROUND: Sepsis is a life-threatening condition caused by the body’s severe response to infection, leading to widespread inflammation and organ failure. Ulinastatin, a glycoprotein hydrolase inhibitor from human urine, has anti-inflammatory properties and has shown potential in improving the outcomes in sepsis patients. OBJECTIVE: To systematically review the efficacy and safety of ulinastatin to clarify its clinical benefits in the treatment of sepsis. METHODS: Through searches of PubMed, Embase, Cochrane Library, and four Chinese databases (SINOMED, CNKI, VIP, and WANFANG data), we searched for published randomized controlled trials from January 1, 2004, to November 30, 2023. Stata 16.0 software was used to perform the meta-analysis. RESULTS: A total of 39 articles were included (37 in Chinese and 2 in English), involving a total of 2,911 patients. The results of meta-analysis show that the treatment of ulinastatin could reduce mortality (risk ratio [RR] = 0.52, 95% confidence interval [CI] [0.43,0.63], P < 0.05), multiple organ dysfunction syndrome (RR = 0.30, 95% CI [0.18,0.49], P < 0.05), length of intensive care unit stay (mean difference [MD] = −5.42, 95% CI [−8.13, −2.71], P < 0.05), time on mechanical ventilation (MD = −5.84, 95% CI [−7.60, −4.07], P < 0.05), and length of hospital stay (MD = −12.40, 95% CI [−15.03, −9.77], P < 0.05). Nine articles reported adverse reactions, of which 1 article reported no obvious adverse reactions. CONCLUSIONS: The results of this meta-analysis show that ulinastatin reduces sepsis case-fatality rate and improves other related outcomes, suggest that ulinastatin is effective in the treatment of sepsis.