Clinical Study of the biologically active peptide bioregulator Svetinorm

Svetinorm®

A report of the results of clinical study of the biologically active peptide bioregulator of liver origin:

Biologically Active Food Additive Svetinorm® is a complex of low-molecular peptides with molecular weight up to 10 000 Da, isolated from liver of young animals - calves aged up to 12 months. Isolated peptides possess tissue-specific action to liver cells, thus restoring metabolism and normalizing their functional activity.

Svetinorm® is manufactured in the form of capsules, containing 10 mg of active peptides.

The clinical studies of Svetinorm® were carried out at the Medical Center of the Saint Petersburg Institute of Bioregulation and Gerontology of the Northwest Branch of the Russian Academy of Medical Sciences in patients with chronic hepatitis and oncological patients after the course of radiation and chemotherapy during the period from October 2003 till January 2004.

Svetinorm® was administered per os 10-15 minutes before meal 1-2 capsules 2 times a day for 10-20 days depending on severity of the pathological process.

Now we see an increase in the number of patients with chronic liver diseases, which affect mostly able-bodies persons. They are mainly caused by unfavorable social and environmental factors. Chronic hepatitis is not an outcome of acute infectious process, but the form of clinical course of infectious process (2, 3).

Now the treatment of patients with chronic hepatitis in view of pathogenic mechanisms is carried out using the following traditional therapeutic agents (1):

 

·         Drugs, which improve metabolism of hepatic cells (hepatoprotectors, essentiale, legalon, sirepar)

·         bile secretion stimulators (Liv-52)

·         B group vitamins (B1, B6, B12), ascorbic acid etc.)

Clinical characteristic of the patients

 

The clinical studies were carried out in 47 patient with chronic hepatitis and oncological patients after the course of chemotherapy, including 30 men and 17 women in the age from 35 to 68 years (table 1).   The disease period has made from 3 to 10 years old.  The patients of the main group have also been taking Svetinorm® in addition to the general purpose medicines - 2 capsules, 2 times a day before meal for 15-20 days.

 

The control groups consisted of 38 similar patients, which have only general purpose treatment.

 

Table 1

 

Distribution of the patients by clinical entities, sex and age

 

Diagnosis

Age

(years)

Men

Women

In total

Chronic persisting hepatitis

35-56

 

21

 

13

 

34

 

State after chemotherapy course in oncological patients

53-68

 

9

 

4

 

13

 

In total

 

30

17

47

Most patients were complaining of the pain in the right hypochondrium, general weakness and rapid fatigability, 73% of patients had dyspepsia. 53% of patients had bilirubinemia, increase in the level of alanine aminotransferase, increase in the globulin fraction of the blood proteins, mainly due to M immunoglobulin fraction, which is a sign of specific activity of chronic inflammation process.

 

Examination methods

 

The complaints were assessed subjectively at different times. The following tests were carried out: general clinical test of blood and urine, biochemical and immunological blood test (determination of immunoglobulins using Mancini method), liver ultrasound.

 

Examination results

After treatment using Svetinorm®, most patients noticed elimination of fatigability, improvement of appetite and working capacity. 53% of patients have noticed considerable decrease in intensity of pain syndrome.

 

Oncological patients have noticed condition improvement, decrease in fatigability, decrease in intensity of dyspeptic disorders.

 

Table 2

 

Influence of Svetinorm® on Biochemical parameters of peripheral blood in patients with chronic hepatitis

 

Parameter

 

Before treatment

After treatment with general purpose medicines.

After treatment

using

Svetinorm®

Cholesterol, (mmol/l)

4,6±0,2

5,2±0,3

5,0±0,4

Bilirubin, (mcmol/l)

27,1±1,2

23,6±1,4

20,1±0,8*

AST, (mmol/h×l)

41,0±2,5

39,1±2,7

38,8±2,6

ALT, (mmol/h×l)

52,5±4,1

46,1±3,8*

43,5±3,5*

g-GT, (mmol/h×l)

44,7±4,3

42,6±4,0

41,4±4,1

Triglycerides, (mmol/l)

2,3±0,1

2,1±0,4

1,7±0,6*

* Р<0.05 – reliable in comparison with the parameter before treatment

At the analysis of Svetinorm® efficiency special attention should be paid to the assessment of the results of biochemical examinations, characterizing aminotransferase activity, pigment and protein-synthesis function of liver. Objectively, most patients after Svetinorm® treatment have noticed stabilization of biochemical indices: bilirubin level, alanine aminotransferase level (table 2). Analysis of immunoglobulins of peripheral blood, being significant criterion of activity of inflammatory process after the course of treatment using Svetinorm®, has resulted in a decrease in IgM level (table 3).

Thus the obtained results testify hepatoprotective properties of Svetinorm® and expediency of its use for complex treatment of acute and chronic liver disorders, in oncological patients after radiation and chemotherapy, and also for prophylaxis of various liver diseases and their complications.

During clinical studies of Svetinorm® there were no side effects, contraindications, complications and drug dependence.

 

Table 3

 

Influence of Svetinorm® on immunological parameters of patients with chronic hepatitis

 

Parameter

 

Before treatment

After treatment with general purpose medicines.

After treatment

using

Svetinorm®

IgA, (g/l)

2,20±0,1

2,30±0,04

2,10±0,06

IgM, (g/l)

3,90±0,05

2,30±0,07*

1,60±0,04*

IgG, (g/l)

14,5±1,0

13,7±1,1

14,0±1,2

* Р<0.05 – reliable in comparison with the parameters before treatment

Recommendations for use

Svetinorm® is recommended for acceleration of restoration of liver function at acute and chronic affection, at treatment with antibiotics and other medicines with unfavorable liver effect, at hypoalimentation, in oncological patients after radiation and chemotherapy, at influence on the organism of various factors.  It is also indicated to elderly people for maintenance of the liver function.

It is recommended to take Svetinorm® per os 10-15 minutes before meal 1-2 capsules, 2-3 times a day for 15-20 days.

It may be desired to have one more course in 3-6 months.

References

1.       Mashkovsky M.D. Medicines: Pharmacotherapy for doctors, manual: 2 parts. - Vilnius: ZAO “Gamta”, 1993.

2.       Podymova S.D. Liver diseases. - M.: Medicine, 1984. - 480 pages

3.       Rakhmanova A.G., Prigozhina V.K., Neverov V.A. Infectious diseases: Manual for general practitioners. - M.-SPb.: Pub. “SSZ”, 1995. - 304 pages