FEATURES OF THE NEW DETOXICANT TOLERANCE IN HEALTHY VOLUNTEERS

Bilenkyi G. Z., Makarenko O. V.

CLINICAL AND EXPERIMENTAL MEDICINE

Scentific article

One of the pharmacotherapy directions of modern surgery is the reduction of endogenous intoxication in the pre- and postoperative period, for example, in pancreatitis, peritonitis, mechanical jaundice, etc. Therefore, the search for new detoxicants is a very urgent problem of modern pharmacology. The new fixed combination of sodium hypochlorite and taurine with the working title “Neoreodez” showed detoxification, antimicrobial, wound healing properties in the experiment. That data subsequently led to the next step in research, namely, the establishment of drug tolerability and clinical efficacy. The purpose of this work was to evaluate the drug tolerability of healthy volunteers by assessing the data of laboratory and instrumental examination, the nature of subjective complaints, the presence and severity of adverse reactions against the background of the introduction of the «Neoreodez». The study were involved 18 volunteers aged 19-35 years. At the screening stage an objective examination of the volunteers was carried out, including auscultation of the heart and lungs, abdomen palpation, of the skin and visible mucous membranes examination, measurement of heart rate, blood pressure and body temperature. The examination data showed that the hemodynamic parameters (HR, BP) in all volunteers of both groups were within the age limit, the body temperature was not increased. At palpation and percussion of an abdomen it was not revealed pathology in any case. At the lung auscultation vesicular breathing was determined in all patients included in the study. According to the ECG at rest none of the patients was showed any abnormality. So, no pathological changes were detected that prevented the volunteers from participating in the study. A general blood test, an assessment of biochemical parameters and urea analysis were also performed. The obtained results enabled all 18 volunteers to be included in the study of a new infusion solution «Neoreodez». According to the indicated administration regimens of the «Neoreodez» volunteers were distributed to 3 groups. It was established that no adverse reactions/side effects were detected during the study. In no case there was a local or general reaction to the introduction of the study drug «Neoreodez». Also, there was not observed delayed hypersensitivity reactions, hyperthermic reactions, sharp fluctuations in hemodynamic parameters. The skin and visible mucous membranes remained clean, peripheral edema was not observed, the abdomen was soft and painless when palpated. During the study, there was no worsening of the general condition or exacerbation of chronic diseases in any case. When assessing ECG data after the infusion of the study drug, there was no negative dynamics in any case. Considering the absence of adverse reactions/side effects, the absence of negative changes in laboratory and objective data, tolerability of treatment with the drug “Neoreodez” was in all cases regarded as good. In the future, it is planned to study the clinical efficacy and tolerability of the “Neoreodez” in a background of basic therapy in patients with acute pancreatitis.

Neoreodez, healthy volunteers, phase І of clinical trial

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«Bulletin of problems biology and medicine» Issue 3 (145), 2018 year, 88-91 pages, index UDK 615.279:615.015.5:616-057.786

10.29254/2077-4214-2018-3-1-145-88-91