OBJECTIVE

To determine the optimal criteria for selecting patients for a randomized clinical trial of effectiveness of meglumine sodium succinate in patients with alcohol-nutritional acute pancreatitis (AP) considering analysis of individual outcomes of disease.

MATERIAL AND METHODS

We analyzed effectiveness of treatment in 199 patients aged 18—75 years with moderate-to-severe alcohol-alimentary AP. Data collection was carried out by specialists from 14 medical centers according to a single protocol of observational program. Patients were treated in accordance with the generally accepted standards. Meglumine sodium succinate 1.5% (Reamberin) was used in all patients. Patients were divided into 2 groups depending on the outcome of disease: group 1 (n=149) — survivors, group 2 (n=50) — lethal outcome. We analyzed demographic characteristics of patients in both groups, anamnesis of life and disease, objective data, standard laboratory and instrumental findings. Final results were statistically processed.

RESULTS

We confirmed prognostic value of some laboratory parameters (platelet count, ionized serum calcium, blood glucose, urea and creatinine) and identified new potential predictors (sex, body weight, height, total serum protein, diastolic blood pressure before intensive therapy, volume of infusion and diuresis on the second day of treatment, serum creatinine after 48 hours of treatment). We established threshold values for blood glucose, blood urea, blood creatinine, volume of infusions on the second day of treatment and dynamics of blood creatinine after 48 hours of treatment. Excess of these values significantly increase the risk of adverse outcomes despite ongoing therapy with meglumine sodium succinate.

CONCLUSION

Effectiveness of meglumine sodium succinate for alcoholic-alimentary acute pancreatitis should be studied in patients undergoing treatment before appearance of these markers of adverse outcomes. At the same time, the use of “complex” factors (application of the “and” rule when evaluating several indicators according to the calculated cut-off thresholds) seems to the authors to be an overly specific approach. The last one does not allow sufficient consideration of the risk of death in acute pancreatitis. We propose to use the entire complex of predictors for the most complete coverage of clinical characteristics of each patient.