ПРИМЕНЕНИЕ СТАТИСТИЧЕСКИХ МЕТОДОВ ПРИ ОЦЕНКЕ РЕЗУЛЬТАТОВ КЛИНИЧЕСКОГО ИССЛЕДОВАНИЯ ПРЕПАРАТА БОВГИАЛУРОНИДАЗЫ АЗОКСИМЕРА У КОШЕК С УРОЛОГИЧЕСКИМИ БОЛЕЗНЯМИ

Abstract

In the period from November 2018 to August 2020, we conducted a randomized blind placebo-controlled confirmatory clinical trial in parallel groups on the basis of network of veterinary clinics in Saint Petersburg and Saint Petersburg state university of veterinary medicine. The purpose of the study: to evaluate the effectiveness of Bovhualonidaze azoximer(BA) in patients subjected to surgical intervention on the urethra and bladder, to prevent postoperative complications and relapses of the underlying disease. The frequency of complications was taken as an indicator of effectiveness. 80 cats were evaluated according to the criteria for inclusion in the study, after evaluation and randomization, 53 patients (24 and 29 cats in the experimental and control groups, respectively) who had indications for surgery on the urethra and/or bladder were included in the study. After the withdrawal of some patients, 38 cats were analyzed (17 and 23 cats in the experimental and control groups, respectively). Animals in the experimental group received BA drugs in addition to conventional therapy, and animals in the control group received placebo. The rate of complications in the experimental group was 11.8 %, in the control group-61.9 %. The relative risk was 19.0 %, and the relative risk reduction was 80.9 %. The chance of developing complications in the animals of the experimental group is 12.2 times lower than in animals of the control group.. Absolute risk reduction — 50.1 %, and the number of patients to be treated — 2 patients. The confidence interval for the risk of side effects of BA drugs in cats was 0.0-10.1 %. Based on the results of our clinical study, we proved that the use of BA drugs is effective for preventing complications during surgical interventions on the urethra and bladder, and the risk of side effects when using BA drugs in cats is insignificant