Content

A report of the results of clinical study of the biologically active peptide bioregulator of liver origin Clinical characteristic of the patients Examination methods Examination results Recommendations for use References

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

 

Nature’s Marvels™ Liver peptide bioregulator, 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.

Nature’s Marvels™ Liver peptide bioregulator is manufactured in the form of capsules, containing 10 mg of active peptides.

The clinical studies of Liver Peptide Bioregulators 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.

Liver Peptide Bioregulators were 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 Liver Peptide Bioregulators 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 Liver Peptide Bioregulators, 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 Liver Peptide Bioregulators on Biochemical parameters of peripheral blood in patients with chronic hepatitis

 

Parameter

 

Before treatment After treatment with general purpose medicines. After treatment using Liver Peptide Bioregulators
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 the efficiency of Liver Peptide Bioregulators, 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 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 Liver Peptide Bioregulators, has resulted in a decrease in IgM level (table 3).

Thus the obtained results testify hepatoprotective properties of Liver Peptide Bioregulators 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 Liver Peptide Bioregulators, there were no side effects, contraindications, complications and drug dependence.

 

Table 3

Influence of Liver Peptide Bioregulators on immunological parameters of patients with chronic hepatitis

 

Parameter

 

Before treatment After treatment with general purpose medicines. After treatment using Liver Peptide Bioregulators
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

 

Liver Peptide Bioregulators are 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 Liver Peptide Bioregulators 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