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REPORT on the research on the topic: Estimation of additional therapeutic possibilities of phytoconcentrates Neurin, Cordevit and Crystal in cardiology practice (final)

INTRODUCTION 

 The modern stage of development of pharmacotherapy is characterized, on the one hand, by certain achievements in improving the quality and life expectancy of patients with a cardiology profile, and on the other hand, the increasing volume of documented information on cases of side effects of drugs used in official clinical medicine [1]. An alternative approach that ensures adequate treatment safety and in many cases is clinically effective is the use of high-tech phytocomposites (phytoconcentrates) [2, 3].
In the framework of the above-mentioned direction, previous clinical studies have shown that favorable myopic-trophic and regulatory influence on the myocardium in patients with initial heart failure Сordevit phytoconcentrate and the reliable antiarrhythmic action of the latter when combined with phytoconcentrate Neurin, which mono-application reveals an independent negative chronotropic effect, along with the ability to change autonomic balance of the myocardium in the direction of enhancement of parasympathetic regulatory influences [2, 3, 4]. Based on these results, it seems expedient to further study the therapeutic capabilities of these phytocompositions in the cardiology clinic.
I. It is known that in the modern treatment of arterial hypertension (AH) and coronary heart disease (CHD), calcium antagonists and, above all, nifedipine are widely used. At the same time, it is known that the use of this drug tends to increase the frequency of heart rate, which is not only poorly tolerated by many patients (tachycardia, especially during exercise), but is also potentially dangerous from a prognostic point of view, taking into account permanent sympatho-adrenal activation [5].
The relevance of further search in this direction is confirmed, first of all, by known data (including those obtained through meta-analysis) that antihypertensive treatment of short-acting calcium antagonists (nifedipine) is associated with an increase in the incidence of myocardial infarction compared with beta-blockers and diuretics [6,7], and this is due precisely to the ability of the drug to reflexively activate the sympathic-adrenal system [8].
In order to eliminate this undesirable effect, it is recommended to add to the beta-blocker treatment regimen, but this increases the risk of side effects. Therefore, the purpose of this fragment of research was to study the possibilities of phytoconcentrate Neurin in the prevention of reflex acceleration of the cardiac rhythm under the influence of nifedipine in patients with hypertension and CHD.
II. It is known that already at the initial stages of heart failure in response to a decrease in cardiac output, there is a peripheral vasoconstriction, which leads to tissue hypoxia, including skeletal muscle. This mechanism, in particular, underlies the reduction of tolerance to physical activity in this category of patients [9].

Taking into account the information on the mechanisms of action of phytoconcentrates Сordevit and Crystal, it seems expedient to express a hypothesis and to investigate the possible beneficial effects of the combination of these agents on the tolerance to physical activity of patients with the first stage of heart failure (HF) when a clinically effective reorganization of peripheral tissue metabolism is still possible.

Material and methods
In the first fragment of the research, 31 patients (22 men, 8 women) with an average  age of 49.0 + 3.7 years without symptoms of heart failure or myocardial infarction, in history, were observed. 19 patients suffered from hypertension in stage I, 8 patients suffering from hypertonic disease in stage II, 6 - patients with coronary artery disease; a combination of CHD and AH occurred in 6 cases.
The study did not include patients with severe concomitant diseases / syndromes (oncological, infectious and endocrine diseases, liver and kidney insufficiency), as well as with pauses more than 2.5 s, and - v block II - III degrees, complete blockage of the right or left legs of the Gisa beam, registered with daily Holter ECG monitoring.
After initial examination patients were given clinical indications of nifedipine (Corinfart retard AWD) at a daily dose of 40 mg (20 mg twice daily). After re-examination on the background of treatment with nifedipine, Neurin was added to the therapy (30 drops x 3 times a day in a tablespoon of water - 20 people, 15 drops x 3 times a day - 11 people), which patients took for 2 weeks, after which a control test was carried out.
The examination at each of the 3 stages included Holter's daily monitoring of the ECG using the following standard method [10]. 
All patients were operated using the Holter Diagnostic System DRG (USA), 24-hour ECG monitoring, systolic and diastolic blood pressure. In addition to the parameters of ectopic activity, according to the daily heart rate monitoring, the statistical variables that reflect the severity of the parasympathetic regulatory effects on the heart (SDNN, SDNN index, rMSSD, pNN50) were evaluated in accordance with the recommendations of the European Society of Cardiologists and the North American Society for Electro Cardiomyocytes and Electrophysiology (SDNN-standard (square root) deviation of the RR RR, SDNN index -the average value of SDNN of all 5-minute registers recorded; gMSSD-square the root is the value of the mean square difference of successive RR intervals; pNN50 is the percentage of successive RR intervals, the difference between which exceeds 50 ms [10]. 

The second part of the work includes the data of the clinical and instrumental study of 20 patients with heart failure and the clinical stage, which after the initial examination (echocardiography by standard method and bicycle ergometric test) was prescribed a combination of phytoconcentrates Сordevit and Crystal (each of 15 drops 3 times a day) during Two weeks after that, they were re-examined using the same methods. 

Processing of the received data was carried out on a computer on the basis of standard statistical programs.

 As can be seen from Table 1, the use of Corinfuff-retard resulted in an increase in the mean daily heart rate (HR) of 9.7%, but after Neurin treatment, this acceleration was substantially reduced (by 7.5%). Expressed acceleration of the average daily maximum. HR (by 11.4%) against the background of the administration of nifedipine was statistically significantly reduced to almost the original values (Table 1). The analysis of cardiac rhythm disturbances showed that there was a marked increase in the number of supraventricular and ventricular extrasystoles seen on the background of the Corinfarat Retard receiving, but after joining the Neurin Therapy Scheme, their number decreased, respectively by 26.7% and 25.2% (Table 2).

Analysis of daily heart rate (M ± m) Table 1

Indexes

In the original state

Nifedipine

Niferdipine + Neurin

Average HR (speed / min)

63,1 ±  1,2

69,2 ±  2,0

 

(+ 9,7 %)

64,0 ± 1,6

(- 7,5 %)

Maximum HR (speed / min)

102,2 ±  3,5

113,9 ±  3,9

(+ 11,4 %)

103,7 ±  3,2*

(- 9,0 %)

 ** p <0,05 in comparison with research on the background of nifedipine administration. 

Heart rhythm disturbance analysis (M ± m) Table 2 

Amount of extrasystoles per day

Indexes

In the original state

Nifedipine

Superventricular extrasystoles

162,2 ±  20,6

236,4 ±  35,7

173,2 ±  26,1

(- 26,7 %)

Ventricular extrasystoles

22,8 ±  3,7

31,3  ±  5,9

23,4 ±  4,8

( - 25,2 %)


According to the study of heart rate variability (HRV), with the background of clinically adequate therapy "Corinfar" (normalization of blood pressure), there was a decrease in the main statistical indicators of HBS, which indicates an adverse (pathophysiologically and prognostic) [11] increase in sympathetic cardiac effects (Table. 3). Admission Neurin already in the dose of 30 drops per day contributed to a decrease in the degree of these changes (Table Z), which may indicate its favorable counterregulatory effect in the reflex activation of the sympathetic department of the autonomic nervous system caused by dihydropyridine derivatives and, in particular, nifedipine [12 , 13 ].

Analysis of heart rate variability (M ± m) Table 3

Indexes

In the original state

Nifedipine

Niferdipine + Neurin

SDNN

138,4 ±  3,8

125,2 ±  4,5

( - 9,5 %)

136,6 ±  5,2*

( +9,1 %)

SDАNN

130,5 ±  3,8

115,2 ±  3,4

( - 11,7 %)

126,6 ±  5,0

( + 9,9 %)

<0.05 compared with the study on the background of nifedipine receiving

The analysis of the results obtained in the second part of the study showed that taking the combination of Kordewit and Crystal significantly increased the tolerance to physical activity, but did not affect the size of the left ventricular ejection fraction according to the echocardiography and blood pressure levels at the same level of veloergometric loading. Instead, the statistically significant restriction of the heart rate increase during the exercise was revealed, which was reflected in a decrease (by 11,5%) of the values of the double product - the commonly used marker of consumption of the myocardium of oxygen.

The power of the threshold BEM - load (W), the left ventricular ejection fraction (FV), and the hemodynamic index (HR, AD system, PD) at the identical loading level to (1) and after (2) the accession of Neurin to the standard treatment regimen in patients with initial heart failure (M ± m)

Table 4 

Stages of the study

Indexes

W

FV,%

HR,

speed / min,

ident

AD сист.,

mm

PD

 

1

87,6 ±  5,8

41,4 ±  6,5

130,0 ±  5,2

134,4 ±  8,5

177,2 ±  11,1

2

102,6 ±  7,0

41,6 ±  4,3

119,4 ±  6,3

136,1 ±  7,4

152,3 ±  9,8

p

<0,05

>0,5

<0,05

>0,5

>0,1

Notes: 
HR - heart rate 
AD systems - systolic blood pressure 

PD - double product (HR x AD system/100).

The obtained results testify to the ability of the combined use of Сordevit and Crystal to increase the tolerance to the physical activity of patients with initial heart failure to a certain extent. The basis of this phenomenon is obviously the ability of the given phytotherapeutic combination to reduce the energy consumption of the myocardium by improving the autonomic regulation of the cardiac rhythm (increasing parasympathetic tone, slowing the heart rate) when performing an identical level of physical activity (Table 4).

CONCLUSIONS
1. Admission to nifedipine ("Corinfar") is accompanied, despite its adequate antihypertensive effect, by adverse cardio-regulatory changes, consisting of: a) accelerating the frequency of cardiac contractions in rest and exercise, b) increasing the daily ectopic activity of the myocardium, in ) decreased heart rate variability, which reflects the activation of the sympathetic department of the autonomic nervous system.
2. 2. Adding to nifedipine phytoconcentrate Neurin in a daily dose of 30-60 drops allows blocking of these negative cardio-regulating shifts by increasing the parasympathetic link of the regulation of the heart.
3. The phytotherapeutic combination of Сordevit and Crystal reveals the ability to moderate, but to significantly improve the physical performance of patients with an initial stage of heart failure (according to bicycle ergometric loading test). The most probable mechanism of this effect can be considered reduction of energy consumption of the myocardium due to improvement (economization) of hemodynamic maintenance of physical activity.
4. Reception Neurin in a dose of 30-60 drops per day can be recommended as a means of preventing side effects of nifedipine (reflex tachycardia, excessive pacemaker rhythm during exercise).

5. The combination of Сordevit and Crystal can be used as an adjuvant in a comprehensive, standard treatment for initial heart failure.

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