Abstract
<jats:p>Objective. To evaluate the efficacy and safety of ulinastatin in patients with postoperative abdominal sepsis (AS) in intensive care units. Materials and methods. This randomized study included 60 patients with AS divided into two groups: the ulinastatin group (n = 30) received standard intensive therapy combined with intravenous ulinastatin (200,000 IU three times daily for 3 days, followed by 100,000 IU three times daily for 4 days); the control group (n = 30) received standard intensive therapy alone. Clinical outcomes, organ dysfunction (SOFA score, Glasgow Coma Scale), laboratory markers of inflammation (CRP, PCT, HLA-DR), and cytokine levels (TNF-α, IL-6) were assessed before and after therapy. The primary endpoint was 28-day mortality. Results. Baseline patient characteristics and laboratory parameters were comparable between the groups. The administration of ulinastatin significantly reduced 28-day mortality (10.0 % vs. 33.3 %; p 0.01) and the number of new organ dysfunction cases (10 vs. 26; p = 0.003). Patients in the ulinastatin group showed an increase in ventilator-free days (18.4±7.4 vs. 12.2±5.1; p = 0.035) and a reduced mean hospital stay (by 13.6 days; p 0.001). Patients in the ulinastatin group demonstrated a significant decrease in CRP, PCT, TNF-α and IL-6 levels, and an increase in HLA-DR levels (p 0.05). Multivariate analysis confirmed ulinastatin use as an independent factor for reducing the risk of death (OR=0.45; 95 % CI: 0.21–0.74; p = 0.018). Conclusions. The inclusion of ulinastatin in the comprehensive treatment of postoperative AS significantly suppresses the inflammatory response, improves clinical outcomes, and reduces 28-day mortality. These findings justify the use of ulinastatin in the management of this severe patient population and require confirmation in large randomized studies.</jats:p>