BACKGROUND AND PURPOSE:Gabexate mesilate (GM) is a promising anticoagulation treatment for disseminated intravascular coagulation (DIC). This study was designed to examine the effect of GM on DIC associated with the development of infection after abdominal surgery in the intensive care unit (ICU). METHODS:From January 1999 to March 2002, 50 consecutive ICU patients suffering DIC associated with the development of infection after abdominal surgery were enrolled in this study. Twenty five of the patients were randomized to receive treatment with GM by central intravenous infusion at 1 mg/kg/hour for 5 days or longer, while the remaining 25 were not treated. Blood clotting tests were performed and cytokine levels including tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6) were examined on days 1, 3, and 7 after admission. General blood tests and D-dimer tests were conducted before and after GM administration. The gender, age, mortality, Acute Physiology and Chronic Health Evaluation II (APACHE-II) scores and severity of DIC were compared between the 2 groups. RESULTS: No significant difference was found between the 2 groups in TNF-alpha and IL-6 concentration on days 1, 3, and 7. The mortality rate was similar between the 2 groups. However, DIC and APACHE-II scores were significantly lower in the GM-treated patients than in controls. CONCLUSION: In this study, GM (1 mg/kg/hour) did not reduce the concentration of TNF-alpha and IL-6, or alter the mortality rate in patients with DIC resulting from infectious complications after surgery. Nevertheless, APACHE-II scores indicated that GM reduced the DIC severity and improved the clinical condition of patients.
RCT Entities:
BACKGROUND AND PURPOSE:Gabexate mesilate (GM) is a promising anticoagulation treatment for disseminated intravascular coagulation (DIC). This study was designed to examine the effect of GM on DIC associated with the development of infection after abdominal surgery in the intensive care unit (ICU). METHODS: From January 1999 to March 2002, 50 consecutive ICU patients suffering DIC associated with the development of infection after abdominal surgery were enrolled in this study. Twenty five of the patients were randomized to receive treatment with GM by central intravenous infusion at 1 mg/kg/hour for 5 days or longer, while the remaining 25 were not treated. Blood clotting tests were performed and cytokine levels including tumor necrosis factor-alpha (TNF-alpha) and interleukin-6 (IL-6) were examined on days 1, 3, and 7 after admission. General blood tests and D-dimer tests were conducted before and after GM administration. The gender, age, mortality, Acute Physiology and Chronic Health Evaluation II (APACHE-II) scores and severity of DIC were compared between the 2 groups. RESULTS: No significant difference was found between the 2 groups in TNF-alpha and IL-6 concentration on days 1, 3, and 7. The mortality rate was similar between the 2 groups. However, DIC and APACHE-II scores were significantly lower in the GM-treated patients than in controls. CONCLUSION: In this study, GM (1 mg/kg/hour) did not reduce the concentration of TNF-alpha and IL-6, or alter the mortality rate in patients with DIC resulting from infectious complications after surgery. Nevertheless, APACHE-II scores indicated that GM reduced the DIC severity and improved the clinical condition of patients.