Ulinastatin as an Adjunctive Therapy for Severe Diabetic Ketoacidosis:Efficacy and Safety Analysis

ZANG Wenjun; XU Hui; LI Yan; HUANG Hailian; ZHANG Xue

doi:10.13919/j.issn.2095-6274.ZHJY202507045

Abstract：Objective To investigate the clinical efficacy and safety of combining ulinastatin with standard intra-venous insulin therapy in the treatment of patients with severe diabetic ketoacidosis(DKA).Methods A total of 86 pa-tients with severe DKA admitted between January 2021 and October 2024 were enrolled.According to the random number table method,they were divided into a control group(n=43,receiving standard intensive DKA treatment)and an observa-tion group(n=43,receiving intravenous infusion of ulinastatin 100,000 IU twice daily for 5-7 days in addition to the con-trol group's treatment).The metabolic crisis correction times(time to blood ketone<0.6 mmol/L,time to pH>7.3),changes in inflammatory markers(CRP,IL-6,PCT),blood glucose levels and improvement time,hospital stay,and incidence of adverse reactions were compared between the two groups.Results On the 3rd and 7th day after treatment,the levels of CRP,IL-6,and PCT in the observation group were significantly lower than those in the control group(P<0.05).The time to achieve blood glucose target,time for urine ketone bodies to turn negative,time for acidosis correction,and hospital stay in the observation group were significantly shorter than those in the control group(P<0.001).After 2 weeks of treatment,the levels of fasting blood glucose(P<0.05)and 2-hour postprandial blood glucose(P<0.001)in the observation group were also significantly lower than those in the control group.The total incidence of adverse reactions in the observation group was significantly lower than that in the control group(9.30%vs.34.88%,P=0.004).Conclusion Early combination of ulinastatin with standard therapy can effectively suppress systemic inflammatory response in patients with severe DKA,accelerate the metabolic correction of ketoacidosis and blood glucose control,shorten hospital stay,and demonstrates good safety.It is an effective adjuvant treatment for improving the prognosis of severe DKA.