A retrospective study of the effectiveness of ulinastatin in the treatment of sepsis

Jiangbo Zhu, Qing Liu, Gaojian Cheng, Zhongheng Zhang, Xue Wang

Abstract

Background: Ulinastatin (UTI) as a urinary trypsin inhibitor can inhibit the function of various enzymes. UTI has been shown to reduce the inflammatory response, suppress lymphocyte apoptosis, and improve the microcirculation, protecting the organs. However, there is no uniform recommended dose to use UTI on treating sepsis, and some studies indicate that UTI has dose-dependent effects, we aimed to explore the effects and appropriate dosage of UTI in sepsis treatment.
Methods: Patients with sepsis in the intensive care unit (ICU) of the First Affiliated Hospital of Xi’an Jiaotong University from January 2012 through December 2017 were enrolled. We collected basic data, treatments, and outcomes. All patients were divided into two groups: the UTI group and the control group. Data analysis was performed with the chi-square test, t-test, and Cox multifactor regression analysis.
Results: A total of 295 patients (181 males; mean age 59.98±17.78 years) were enrolled. Univariate Cox regression analysis showed that the hazard ratio (HR) for mortality with UTI treatment was 0.805 (95% confidence interval: 0.530–1.222, P>0.05). After adjustment, there are 13 factors that might affect prognosis with multivariable Cox regression analysis, the adjusted HR for mortality with UTI treatment was 0.560 (95% confidence interval: 0.346–0.906, P<0.05). We found that using higher maximum dose (≥160×104 U), the adjusted HR for mortality with UTI treatment was 0.370 (95% confidence interval: 0.204–0.672, P=0.001). And with the rising of cumulative dose (≥120×104 U), the adjusted HR for mortality with UTI treatment was 0.418 (95% confidence interval: 0.224–0.781, P<0.05). the days of UTI use during (5–8 days), the adjusted HR for mortality with UTI treatment was 0.153 (95% confidence interval: 0.074–0.318, P<0.001).
Conclusions: Cox regression analysis showed that higher maximum dose, cumulative dose, and days of UTI use increased the protective effect. UTI reduced the HR for death in patients with sepsis. When the cumulative dose of UTI was less than 1,200,000 IU and the treatment duration was less than 5 days, there was no significant effect on the HR for death in patients with sepsis.