The results of a multicenter retrospective controlled clinical study of the efficacy and safety of L-lysine aescinate® in the treatment of traumatic and postoperative cerebral edema
Keywords:severe traumatic brain injury, cerebral edema, intracranial pressure, intracranial hypertension, L-lysine aescinate®
AbstractIn modern guidelines, the control of intracranial pressure is recognized as an important prerequisite for quality reco-very of brain functions after severe traumatic brain injury (TBI). Among the relatively new approaches to the control of intracranial pressure in severe TBI, a combination drug L-lysine aescinate® is considered. It has endotheliotropic, venotonic, anti-inflammatory, antiplatelet and other effects that allow it to be regarded as a mean for preventing and reducing cerebral edema after TBI. To evaluate the efficacy and effects of L-lysine aescinate®, a multicenter retrospective study was conducted that included 988 patients aged 18 to 65 years with isolated or combined severe or moderate TBI. The median injury severity index was 17 points, i.e. most people had a serious injury. Patients were randomized into two groups, one of which (n = 335) received only standard therapy, while the other (n = 653) — additionally L-lysine aescinate®. L-lysine aescinate® was prescribed on the first day of hospitalization (median — 2.75 hours) and for a course of 2 to 8 days (median — 7 days). Mortality in the intensive care unit (primary endpoint) was 10.3 and 24.2 % in the main and control groups, respectively (difference 13.9 %; 95% confidence interval (CI): 8.93–19.21 %; p < 0.001). Logistic regression method revealed that L-lysine aescinate® was the most important factor influencing patient survival (p < 0.001). Its use increased the chances of survival of a patient with TBI in the intensive care unit by 3.3 times (odds ratio (OR) = 3.311; 95% CI: 2.108–5.200). Similar results were obtained for 30-day hospital mortality. The frequency of recovery of clear consciousness during the hospital stay was 87.0 % in the group of L-lysine aescinate® and 66.0 % in the control group, with a significant difference between them (p < 0.001). Administration of L-lysine aescinate® increased the chances for restoring clear consciousness in a patient with TBI by 3.8 times (OR = 3.823; 95% CI: 2.535–5.765). The results of the study allow us to recommend the inclusion of L-lysine aescinate® in the standard therapy of patients with isolated or combined severe or moderate TBI.
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