CC BY
32
UDC 615.038
A REACTION OF HEART RATE VARIABILITY SPECTRAL PARAMETERS IN THE PHARMACOLOGICAL TEST WITH MEBICAR IN HEALTHY VOLUNTEERS
Radchenko A. O., Belal S. A. S., Nazarenko E. O.
V. N. Karazin Kharkiv National University, Kharkiv, Ukraine
On 13 conditionally healthy volunteers aged from 18 to 46 years (mean age - 22±7,6 years) the variability of the total power (TP, ms2) of the spectrum, very low frequency (VLF, ms2), low frequency (LF, ms2) and high frequency (HF, ms2) domains of heart rate variability (HRV) in 5 minute intervals of ECG in I standard lead before and 30 minutes after oral admission of 500 mg of mebicar were evaluated. The data were processed by methods of nonparametric statistics. No significant changes in TP, VLF, LF, HF HRV after 30 minutes (maximum time declared by pharmacodynamics action) after administration of 500 mg of mebicar were noted by us. Accordingly, the effectiveness of mebicar as an adaptogen without evidence-based research cannot be postulated.
KEY WORDS: mebicar, adaptogen, healthy volunteers, pharmacological test
РЕАКЦ1Я СПЕКТРАЛЬНИХ ПАРАМЕТР1В ВАР1АБЕЛЬНОСТ1 СЕРЦЕВОГО РИТМУ У ФАРМАКОЛОГ1ЧН1Й ПРОБ1 З МЕБ1КАРОМ У ЗДОРОВИХ ДОБРОВОЛЬЦА
Радченко А. О., Белая С. А. С., Назаренко €. О.
Харювський нацюнальний ушверситет iменi В. Н. Каразша, м. Харюв, Укра!на
На 13-ти умовно здорових добровольцях у вщ вщ 18 до 46 роюв (середнш вш - 22 ± 7,6 роюв) оцшена мшливють загально! потужносп спектра (ТР, мс2), потужностей дуже низькочастотного (VLF, мс2), низькочастотного (ЪР, мс2) i високочастотного (ОТ, мс2) домену спектра варiабельностi серцевого ритму (ВСР) в 5-хвилинних штервалах ЕКГ в I стандартному вщведенш до i через 30 хвилин тсля перорального прийому 500 мг мебшару. Даш оброблялися методами непараметрично! статистики. Достовiрних змш ТР, VLF, LF, HF ВСР через 30 хвилин (декларований час максимуму фармакодинамiчноl дп) пiсля прийому мебiкару в дозi 500 мг нами вiдзначено не було. Вщповщно до цього ефектившсть мебiкару як адаптогена без проведення доказових дослiджень не може бути постульована.
КЛЮЧОВ1 СЛОВА: мебшар, адаптоген, здоровi добровольцi, фармакологiчна проба
РЕАКЦИЯ СПЕКТРАЛЬНЫХ ПАРАМЕТРОВ ВАРИАБЕЛЬНОСТИ СЕРДЕЧНОГО РИТМА В ФАРМАКОЛОГИЧЕСКОЙ ПРОБЕ С МЕБИКАРОМ У ЗДОРОВЫХ ДОБРОВОЛЬЦЕВ
Радченко А. О., Белая С. А. С., Назаренко Е. О.
Харьковский национальный университет имени В. Н. Каразина, г. Харьков, Украина
На 13-ти условно здоровых добровольцах в возрасте от 18 до 46 лет (средний возраст - 22 ± 7,6 лет) оценена изменчивость общей мощности спектра (ТР, мс2), мощностей очень низкочастотного мс ), низкочастотного (LF, мс ) и высокочастотного домена спектра (НР, мс ) вариабельности сердечного ритма (ВСР) в 5-минутных интервалах ЭКГ в I стандартном отведении до и через 30 минут после перорального приёма 500 мг мебикара. Данные обрабатывались методами непараметрической статистики. Достоверных изменений в ТР, УЪР, LF, НР ВСР спустя 30 минут (декларируемое время максимума фармакодинамического действия) после приема мебикара в дозе 500 мг нами отмечено не было. В соответствии с этим эффективность мебикара как адаптогена без проведения доказательных исследований не может постулироваться.
КЛЮЧЕВЫЕ СЛОВА: мебикар, адаптоген, здоровые добровольцы, фармакологическая проба
INTRODUCTION
© Radchenko A. O., Belal S. A. S., Nazarenko E. O., 2016
The global pharmaceutical industry in recent years devotes more and more attention
Journal of V. N. Karazin KhNU. 2016
to various adaptogens that contribute easier carrying of daily life distress [1].
Mebicar positioned as a drug that can affect the serotonergic system of the body and exert anxiolytic, mild sedative and expressed nootropic effect [2-3]. These effects should ensure the rapid restoration of the balance of the regulatory systems of the body, however there is the views about low efficiency of the drug.
Among noninvasive methods to assess autonomic nervous system regulation of heart activity measurement of heart rate variability (HRV) is the most informative and widely used in clinical practice [4].
Given the direct dependence of the adaptive capacities of the organism from the state of regulatory systems [5-6], it is of interest to evaluate their variability in the pharmacological test with mebicar in healthy volunteers.
The study was performed as a part of KhNU research «Development and research of system of automatic control of heart rate variability», № registration 0109U000622.
OBJECTIVE
The purpose of the study was to evaluate the reaction of spectral parameters of HRV in the pharmacological test with mebicar in healthy volunteers.
MATERIALS AND METHODS
The study included 13 conditionally healthy volunteers from 18 to 46 years (mean age - 22 ± 7,6 years). Exclusion criteria were: bad habits, taking medications during last 3 months, resting heart rate less than 60 beats/min, blood pressure less than 100/60 mm Hg.
In accordance with the purpose of the study, in all volunteers were conducted registration of HRV before and 30 minutes after oral admission of 500 mg of mebicar when it [7] reaches peak concentration in the body and when it maximum pharmacodynamics action is declared.
HRV indices were estimated in 5-minute intervals of ECG in the I standard lead in computer-diagnostic complex CardioLab 2009: total power (TP, ms2), powers of very low frequency (VLF, ms2), low frequency (LF, ms2) and the high frequency (HF, ms2) domains of spectrum [8].
Statistical analysis was performed by using Microsoft Excel. In the table were recorded average values (M) and standard deviations (sd) of TP, VLF, LF, HF on each volunteer before and after ingestion of the drug. The significance of differences of each of the indexes was determined by using the Wilcoxon T-test.
RESULTS AND DISCUSSION
The study included 13 conditionally healthy volunteers from 18 to 46 years (mean age - 22 ± 7,6 years). Exclusion criteria were: bad habits, taking medications during last 3 months, resting heart rate less than 60 beats/min, blood pressure less than 100/60 mm Hg.
In accordance with the purpose of the study, in all volunteers were conducted registration of HRV before and 30 minutes after oral admission of 500mg of mebicar when it [7] reaches peak concentration in the body and when it maximum pharmacodynamics action is declared.
HRV indices were estimated in 5-minute intervals of ECG in the I standard lead in computer-diagnostic complex CardioLab 2009: total power (TP, ms2), powers of very low frequency (VLF, ms2), low frequency (LF, ms2) and the high frequency (HF, ms2) domains of spectrum [8].
Statistical analysis was performed by using Microsoft Excel. In the table were recorded average values (M) and standard deviations (sd) of TP, VLF, LF, HF on each volunteer before and after ingestion of the drug. The significance of differences of each of the indexes was determined by using the Wilcoxon T-test.
Table
HRV values before (1) and 30 minutes after (2) reception of mebicar in healthy volunteers (M ± sd)
Indexes Phases of research
1 2
TP, ms2 2715,08 ± 1800,15 4893,08 ± 5046,70
VLF, ms2 805,54 ± 617,30 1832,23 ± 2269,48
LF, ms2 1217,77 ± 911,33 2139,69 ± 2513,29
HF, ms2 604,23 ± 471,64 872,23 ± 850,55
Notes: * - p < 0,01 against baseline values.
Mebicar is widely promoted as an effective means of increasing the body's adaptive mechanisms that are implemented by the serotonergic system for the prevention of chronic distress is constantly growing modern living conditions [9-10]. These effects should be mediated in changes of HRV, which, however, were unable to confirm in the present study: before and 30 minutes after administration of 500 mg of mebicar in healthy volunteers values of TP, VLF, LF and HF of HRV were not significantly different, which allows doubt, at least in the quick effect of the drug on the body's regulatory system and its effectiveness as an adaptogen without evidence-based research cannot be postulated.
REFERENCES
CONCLUSIONS
1. Mebicar in the dose of 500 mg after 30 minutes (declared time of pharmacodynamics action maximum) after a single admission had no significant effect on the TP, VLF, LF, HF of HRV in healthy volunteers.
2. Ability to use mebicar as an adaptogen without evidence-based research cannot be postulated.
PROSPECTS FOR FUTURE STUDIES
It is interesting to evaluate the volatility of HRV parameters in healthy volunteers with a long reception of mebicar.
1. Panossian A. Stimulating Effect of Adaptogens: An Overview with Particular Reference to their Efficacy following Single Dose Administration. / A. Panossian, H. Wagner. // Phytotherapy Research, Wiley Online Library. - 2005. - 19. - P. 819-838.
2. Mokina T. V. Use of Adaptol in the Treatment of Chronic Fatigue Syndrome in Patients with Chronic Cerebral Ischemia. / T. V. Mokina, E. A. Antipenko, A. V. Gustov. // Neuroscience and Behavioral Physiology. - 2010. - 40 (7). - P.757-759.
3. Khaziakhmetova V. N. Experimental comparative study of the analgesic activity of the diurnal anxiolytic mebicar, amitriptyline, and diazepam. / V. N. Khaziakhmetova, K. V. Luchai, L. E. Ziganshina. // Eksperimental'naja i Klinicheskaja Farmakologija. - 2015. - 78 (3). - P. 9-12.
4. Benoît Tavernier, Mathieu Jeanne. Monitoring Technologies in Acute Care Environments; 2013. - P. 109115.
5. Rhoades R.A. Medical Physiology: Principles for Clinical Medicine. 4th ed. / R.A. Rhoades, D.R. Bell. -Baltimore, MD: Lippincott Williams & Wilkins, a Wolters Kluwer business; 2013. - P. 311-325.
6. Grippo A.J. Stress, depression and cardiovascular dysregulation: a review of neurobiological mechanisms and the integration of research from preclinical disease models / A. J. Grippo, A. K. Johnson // Stress. -2009. - № 12 (1). - P. 1-21.
7. Mebikar [Yelektronniy resurs]. - Rezhim dostupu do resursu: http://www.piluli.kharkov.ua/drugs/drug/mebikar/.
8. Yabluchanskiy N.I., Martynenko A.V. Variabel'nost' serdechnogo ritma v pomoshch' prakticheskomu vrachu. Dlya nastoyashchikh vrachey. Khar'kov, 2010, 131 s.
9. Kivimäki M. Work Stress as a Risk Factor for Cardiovascular Disease / M. Kivimäki, I. Kawachi // Curr Cardiol Rep. - 2015. - Vol. 17 (9). - p. 630.
10. Cavigelli S. A. Sex, social status and physiological stress in primates: the importance of social and glucocorticoid dynamics / S. A. Cavigelli, M. J. Caruso // Philos Trans R Soc Lond B Biol Sci. - 2015. -Vol. 370(1669). - p. 20140103.
