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Efficiency Studies of the biologically active nutrition additive "REKITSEN-RD" in various diseases

версия для печати

St.-Petersburg S.M. Kirov Military-medical Academy The principal of tests - doctor of medical sciences professor Uspenski Yu. P.

(For Closed Corporation "Yagodnoye", Kirov City) The report on REKITSEN-RD

It is known, that the intestinal microbiocenosis carries out truly outstanding physiological functions on a macro-organism level. Thus the most important of them are: protective, immunological, metabolic and hormonal.

The protective function is caused by that the intestinal microflora, as the part of a complex formed by micro-organisms with intestinal mucosa, ajusts its metabolic and enzymatic activity, physical and chemical properties of a chyme, the peristalsis of an intestine and functions as a natural barrier for hostile microorganisms trying to settle in a gastrointestinal tract.

It is known also, that the intestinal microflora carries out a role of an adjuvant, that sensitizes mucosal immunocompetent cells to development of the high-grade immune response, in particular, to synthesis of a secretory component of an immunoglobulin A.

The hormonal function of an intestinal microflora is synthesis of estrogens, colchicine and other hormones and hormone-like substances.

The metabolic activity of intestinal microorganisms exceeds metabolic potential of a liver, taking part in an albuminous, lipide and carbohydrate metabolic ways of an organism.

The infringement of intestinal ecosystem structure, accompanying numerous pathological processes in an organism was named a dysbacteriosis. Irrespective of its gravity the dysbacteriosis is characterized by the decrease of the main intestinas microflora representation: lacto- and bifido-bactena, amounting up to 95% of transitional intestinal flora.

In this connection special attention is paid to a nutritional component of domestic manufacture REKITSEN-RD. Due to prebiotic properties the substance can also be considered as a medicinal agent capable to render favorable effect on a macro-organism through a selective stimulation of body height and activity of the main intestinal microflora representatives (bifidum- and lactobacteria).

It's extremely important, that we found REKITSEN-RD to have promoting effect on bifido- and lactogenic flora even on the background of continuing antibacterial therapy.

For example, REKITSEN-RD showed high efficiency in complex therapy of the peptic ulcer patients administering various antihelicobacter antibacterial medicines (macrolids, hemisynthetic penicillines, nitroimidazoles). Probiotic activity of REKITSEN-RD was not "cancelled" by anti-infectives, moreover tests of patients' feces for dysbacteriosis revealed positive changes in microbal landscape: the ascending representation of the main intestinal microflora (bifidum- and lactobacteria), high-grade Escherichia coli, disappearance of yeast-like funguses, decrease of the conditionally pathogenic microorganisms contents.

It is especially important, that proscribing of REKITSEN-RD had positive influence on a psychological status of the patients decreasing a degree of their social disadaptation, uneasiness and hypochondric phenomena alongside with formation of a harmonious type of the attitude to illness.

Aiming to find out separate mechanisms of REKITSEN-RD correcting effect on a system homeostasis on a background of complex antiulcerous therapy, we investigated basic parameters of lipide and carbohydrate metabolism and some enzymes of peroxide protection system in a peptic ulcer patients administering REKITSEN-RD alongside with antiulcerous therapy in comparison with group taking classic antiulcerous treatment.

Peptic ulcer patients not treated with REKITSEN-RD were found to have enlarged contents of cholesterol, triglycerides and glucose during treatment. They were also found to have the attrition of antioxidative enzymes stocks in parallel, that promotes intensifying of free-radical peroxidation of lipids. At the same time, on a background of application of a medical complex including REKITSEN-RD, expressed hypoglycemic and hypolipidemic effects were marked. It is especially important, that the latter was accompanied with antiatherogenous fraction of lipoproteins of high density augmentation. One more positive metabolic effect observed on the background of REKITSEN-RD therapy was augmentation of antioxidative enzymatic activity.

The results of gauging of mechanical properties of erythrocytes in the peptic ulcer patients receiving REKITSEN-RD in addition to classic schemes revealed decrease of erythrocytes with rather high rigidity of plasmolemma (poikilocytes, initial forms, discothoroid forms), whereas the amount of easily deformable fine-thorn cells on the contrary tended to augmentation. The result should be treated as certainly positive, as the large percentage of erythrocytes with rigid plasmolemmas in blood worsens processes of a tissue metabolism.

Results of comparative analysis of REKITSEN-RD with systemic homeostasis effects of such well known intestinal sorptive agent, as POLYPHEPANUM, we consider to have special interest. Both medicines were prescribed to peptic ulcer patient receiving complex antiulcerous therapy, including antibiotics.

The data show REKITSEN-RD to have obvious advantages of influence on a homeostasis in comparison with POLYPHEPANUM. The sorptive ability of POLYPHEPANUM was not as selective as REKITSEN-RD, and it lowered levels of saprophytic flora alongside with conditionally pathogenic microorganisms; diminished not only general lipoproteins, but also antiatherogenous fraction of lipoproteins of high density, that was naturally accompanied with reducing of stocks of antioxidative protective enzymes.

The revealed positive properties of REKITSEN-RD define it perspective for treatment of patients with a angry intestine syndrome - one of the most frequently observed pathologic syndrome not only in gastroenterology, but in clinic of internal diseases in whole. Treatment of angry intestine syndrome using REKITSEN-RD resulted in reliably faster regress of intestinal dyspepsia: the decrease or disappearance of an abdominal distention and murmuring in an intestine was marked, the normal consistence and frequency of a stools was restored.

It is important to note the expressed positive effect REKITSEN-RD for treatment of both diarrhea and constipation in the patients with angry intestine syndrome. The effect develops both due to restoration of an intestinal microbiocenosis for the account of its bifido- and lactogenic component and due to properties of bran as one of the components of REKITSEN-RD and its ability to absorb water and expand in volume. The feces analysis data of patients with angry intestine syndrome administering REKITSEN-RD, evidence about regress of maldigestion signs.

However spectrum of the indications to REKITSEN-RD application is not limited with the diseases specified. Using REKITSEN-RD in treatment of the patients with chronic cholecystitis and biliar dyskinesia also marks essential positive clinical efficiency.

As follows from the results, the most appreciable positive changes are observed in parameters describing evacuatory function of biliar system: the degree of dyskinesia of a gall bladder and heterogeneity of its contents decrease, the contractile function of a gall bladder improves and therefore its sizes diminish alongside with bile pass improvement due to a general bile duct relaxation. The decrease of the liver left lobe sizes is probably caused by regress of reactive changes of the organ. As the essential positive phenomenon is necessary to regard the decrease of the cholesterol contents in bile of the patients administering REKITSEN-RD, that shows the decrease of a risk of cholelithiasis development.

The studies of blood biochemical parameters in patients with chronic hepatitis and hepatoses has revealed partial or complete regress cytolytic and cholestatic syndromes (decrease of activity or normalization of levels AsT, AIT, bilirubin, AlcFL-Y-TP).

The dynamic analysis of immunological parameters in these patients revealed decrease of a CIC levels, tendency to restoration of normal helper/suppressor ratio in T-lymphocytes pool, that evidences about the regress of an immune inflammation.

Besides, on a background of treatment with REKITSEN-RD in chronic pancreatitis patients the positive changes in enzyme producing function of pancreas were marked (levels of trypsine, inhibitor of trypsine, amylase and lipase in blood serum). Expressiveness of the enzymes evasion phenomenon in initial data was maximal and naturally reduced in process of REKITSEN-RD administering. The most sensitive enzyme was amylase, whereas variations of serum lipase level appear rather insignificant.

Both wine yeast derived prebiotic effect of REKITSEN-RD and its enteric sorptive properties connected with presence of alimentary fibers in its structure have found natural application in eliminative therapy of toxiferous metals and xenobiotics The data presented below characterize the expressed antitoxicogenic effect of the medicine.

In patients with combinations of gastroenterologic diseases and allergy (both initial and drug-induced), such as dermal itching, relapsing urticaria, Quincke's edema, the administering of REKITSEN-RD was accompanied with the fast disappearance of allergic signs.

Parameters of a peripheric blood in the patients receiving REKITSEN-RD, showed rising of a haemoglobin level (on the average on 10%). The latter is obviously achieved at the expense of regress of a sideropenic syndrome resulting from regress of malabsorption and improvement of an iron adsorption in a small bowel.

The reducing of acute phase parameters was also revealed (regress of a leukocytosis, relating to stab neutrophile shift of neutrocytes, BSV), evidencing about decrease of inflammatory process activity.

Thus, REKITSEN-RD is a pharmacological agent with multiple range of clinical efficiency. Alongside with sorptive properties, it has expressed bifido- and lactogenic influence on intestinal microflora. As a result of rising its protective and regulatory ability REKITSEN-RD renders antitoxicogenic, hypoglycemizing, hypolipidemizing, immunomodulating and antioxidant effects. These positive properties of REKITSEN-RD allow to expand a spectrum of its indications in therapeutic practice. The pharmacological agent has no contraindications and by-effects. Its overdosage is impossible. The doubtless advantage of REKITSEN-RD in comparison with other medical agents of similar orientation is also its low cost caused by domestic manufacture.

Pharmacotherapeutic regimens used in treatment of the duodenal ulcer patients

Triplex-therapy n1=30 Quadruple-therapy n2=30

1. Omeprasole (40 mg/day) *

2. Amoxacilline (1500 mg/day) **

3. De-Nol (480 mg/day) **

4.REKITSEN-RD (300 мг/kg day) *

 

1.Omeprasole (40 mg/day) *

2.Klacid (500 mg/day) **

3.De-Nol (480 mg/day) **

4.Tinidazolum (1000 mg/day) *'

5.REKITSEN-RD (300 мг/kg in
   day)*

* - course of treatment - untill achievement of a clinical and endoscopic
remission of ulcer; ** - 7 days course of treatment.

Changes of the basic microorganisms contents of an intestine at the ulcer patients, receiving complex triplex- or quadric-therapy as an additional medicine REKITSEN-RD

Microorganism
Average amount of microorganisms per 1 g of
feces of the ulcer patients
Before treatmen
After treatment
1. Bifidobacteria
7х108
6х109
2. Lactobacteria
8х105
107
3. High-grade     Escherichia coli
107
2х107
4. Atypical forms of     Escherichia coli
8х105
4х105
5. Conditionally     pathogenic     enterobacteria
4х104
5х104
6. Enterococci
1,5х104
1,2х104
7. Candida funguses
104
0

Changes of types of the attitude to illness depending on a phase of existence of ulcerative defect in peptic ulcer patients administering REKITSEN-RD

Abscissas - types of the attitude to illness: A - harmonic; В - ergopathic; С -alarming; D - hypochiondrial; E - neurasthenic; F - melancholic; G - apathetic; H -egocentric; I - dysphoric. Ordinates - frequency, %.
- Stationary phase,
- Phase of an active reparation.

Changes of the average contents of lipoproteins of blood serum and glucose in ulcer patients, administering complex triplex- or quadruple-therapy

Parameter
Before treatment
On 10-14 day
Triglycerides, mg/dl
97,3+/-5,4
112,5+/-6,1**
Cholesterin, mg/dl
140,2+/-11,4
147,5+/-8,6*
Ch LPLD, mg/dl
71,5+/-2,9
77,0+/-3,4**
Ch LPHD, mg/dl
47,5+/-2,2
40,4+/-2,4**
Glucose, mmol/l
4,9+/-0,2
5,4+/-0,1

Therapy complemented with REKITSEN-RD

Parameter
Before treatment
On 10-14 day
Triglycerides, mg/dl
115,3+/-8,7
97,5+/-6,1**
Cholesterin, mg/dl
142,3+/-8,6
138,4+/-7,2*
Ch LPLD, mg/dl
85,4+/-4,2
76,1+/-2,7**
Ch LPHD, mg/dl
41,2+/-1,1
49,5+/-3,8**
Glucose, mmol/l
5,0+/-0,1
4,4+/-0,2*
* - differences are statistically reliable (p < 0,05).

Dynamics of the average contents of a catalase and SOD of erythrocytes in the ulcer patients, receiving complex triplex- or quadruple therapy
Parameter
Before treatment
On 10-14 day
p
Catalase of erythrocytes, MCat/g of tissue
479,44±29,5
385,8±20,1
<0,05
SOD of erythrocytes, ED/mg of tissue
9,1±0,5
8,8±0,2
>0,05

Therapy complemented REKITSEN-RD

Parameter
Before treatment
On 10-14 day
p
Catalase of erythrocytes, MCat/g of tissue
630,01±27,8
759,52±26,8
<0,05
SOD of erythrocytes, ED/mg of tissue
9,1±0,5
10,1±0,1
>0,05

Dynamics of erythrocytes mechanical properties parameters of peptic ulcer patients by a with a relapse of the disease receiving REKITSEN-RD*

Type of cells
Before treatment
After treatment
P
Discotoroids I
17,36+/-8,94
8,55+/-5,24
>0,05
Discotoroids II
8,64+/-4,76
0
>0,05
Initial I
35,81+/-15,81
15,6+/-8,38
>0,05
Initial II
11,37+/-7,76
0
>0,05
Rough-thorned I
38,29+/-19,24
42,26+/-18,7
>0,05
Rough-thorned II
49,22+/-27,18
63,76+/-14,64
>0,05
Fine-thorned I
8,54+/-3,12
33,59+/-26,71
>0,05
Fine-thorned II
30,77+/-10,75
36,24+/-27,18
>0,05
* - amount of post-relaxation forms of erythrocytes in isoosmotic medium (%) (first test - in 3-5 minutes after a capture, second - in 18-20 minutes).

Comparison of metabolic effects of REKITSEN-RD and POLYPHEPANUM in treatment of the peptic ulcer patients

Parameter
Polyphepanum
REKITSEN-RD
Conditionally pathogenic intestinal flora
Decreasing
Decreasing
Бифидо- and лактофлора of an intestine
Rising
Decreasing
Cholesterin of Serum of a blood Decreasing
Decreasing
Decreasing
Antiatherogenous fraction of lipoproteins of high density
Rising
Decreasing
Antioxydant enzyme of erythrocytes catalase
Rising
Decreasing

Parameters of feces study in angry intestine syndrome patients receiving
REKITSEN-RD

Parameters
Before treatment
After treatment
Muscular fibers digested
++
+
Muscular fibers undigested
+++
+/-
Intracellular grains of amylum
++
+/-
Extracellular grains of amylum
++
+/-
Neutral Adeps
++
+/-
Iodine affine flora
++
+

Functional - structural characteristics of hepatic and biliar system in patients with chronic cholecystitis and dyskinesia of biliar ducts, administering receiving REKITSEN-RD, according to ultrasonographic

Period of observation
Ultrasonographic characteristic
The longitudinal size of a gall bladder, sm
The transversal size of a gall bladder, sm
Thickness of a wall of a gall bladder, mm
Ultrasonographic attributes of a gall bladder dyskinesia
Heterogeneous contents of a gall bladder
Before treatment

6,28

6,31

2,8

2,7

2,7

3,3

17

38

15

9

After treatment

6,24

6,30

2,5*

2,5*

2,7

2,9*

10*

14*

12*

8

Period of observation
Ultrasonographic characteristic
Diameter of a general bile duct, sm
The size of the left lobe of a liver, sm
The size of the right lobe of a liver, sm
Before treatment

0,37

0,38

7,3

7,2

5,7

5,8

After treatment

0,42*

0,41*

7,1*

7,1

5,7

5,8

The note. The first parameter - for the patients with a bile ducts dyskinesia, second - for the patients with a chronic cholecystitis; * - the differences are statistically reliable (p<0,05).

Changes of biochemical structure of vesical bile in the patients with chronic cholecystitis and with a bile ducts dyskinesia administering REKITSEN-RD

Component
Before treatment
After treatment
P
Cholesterol, ммоль/л
131,7+/-4,2
83,4+/-5,8
<0,05
Cholic acid, ммоль/л
624,7+/-10,9
528,3+/-11,4
>0,05
Cholate-cholesterol factor
4,7+/-0,12
6,3+/-0,25
<0,05

Changes of biochemical parameters of a blood in patients with chronic
hepatitis and hepatoses administering REKITSEN-RD

Parameter
Before treatment
After treatment
P
AsT, mmol/hr*l
0,72+/-0,12
0,53+/-0,10
>0,05
AIT, mmol/hr*l
0,94+/-0,11
0,55+/-0,14
<0,05
Bilirubin,
25,1+/-3,2
12,5+/-1,4
<0,05
Alkaline phosphatase
0,035+/-0,001
0,020+/-0,001
<0,05
g-glutamyltranspeptidase
58+/-3,4
41,3+/-4,1
<0,05

Dynamics of the average values of some parameters of the immunological status in patients with chronic hepatitis and hepatoses administering REKITSEN-RD

Parameter
Before treatment
After treatment
P
T-lymphocytes, diagnostic number
64,7+/-7,45
50,7+/-4,5
p>0,05
B-lymphocytes, diagnostic number
13,3+/-7,07
11,9+/-4,6
p>0,05
T-helpers, %
53,9+/-9,45
40,9+/-2,28
p<0,05
T-suppressors, %
10,7+/-5,68
9,7+/-6,15
p>0,05
CIC, units
52,4+/-12,13
29,8+/-9,31
p<0,05
Helpers/suppressors
5,03+/-1,45
4,22+/-0,36
p>0,05

Dynamics of blood plasma pancreatic enzymes in patients with chronic pancreatitis before and after course of REKITSEN-RD

Parameter
Initial data
After course of REKITSEN-RD
P
Amylase, g/hr*l
47+/-2,4
27+/-2,5
<0,05
Lipase, IU/I
25+/-0,8
22+/-1,1
>0,05
Trypsinum, nmol/l
64,3+/-7,5
44+/-2,8
<0,05
Inhibitor of trypsinum, mmol/hr*l
17,4+/-3,1
26,3+/-2,3
<0,05

Efficiency of eliminative therapy on the basis of application REKITSEN-RD

Medium

Chemical component

% Decrease of concentration after treatment
Urine, мг/дмЗ
Benzole
-100,0
Butanol
-91,0
Formic aldehyde
-77,3
Fluor-ions
-44,9
m-, n-xylol
-32,7
Hair, мкг/г
Leader
-47,8
Chromium
-55,5
Manganese
-56,1

Indications to REKITSEN-RD application

  1. Set of symptoms of an angry intestine.
  2. Dysbacteriosis.
  3. Dyskinesia of biliar ducts.
  4. Chronic cholecystitis.
  5. Fatty.hepatoses.
  6. Chronic hepatitis.
  7. Peptic ulcer on a background of complex therapy including
    • antihelicobacter
    • antibacterial drugs.
  8. Cardiovascular diseases combined with atherogenous dyslipoproteidemy
  9. Allergic diseases.
  10. As an enteroprotective agent in all patients receiving antibacterial therapy.

 

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