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The effect of intraperitoneal administration of Phlogenzym on the development of accelerated glomerulosclerosis in Goldblatt hypertensive rats

Šebeková K.1, Heidland A.2 , Krivošíková Z., Daemmrich J.
1 Clinic of Pharmcotherapy, Institute of Preventive and Clinical Medicine Bratislava, Slovakia
2  Medizinische Klini, University of Wuerzburg, Wuerzburg, Germany
Study No.:MU-697411
Report on an experimental in vivo study, June 23, 1997

 Introduction
Hypertensive nephrosclerosis is one of the most important causes of the end-stage renal failure. The contralateral, non-clipped kidney, of two-kidney one-clip (2K1C) Goldblatt renovascular hypertensive rats is used as a model of hypertensive nephrosclerosis. Except for the hypertensive damage of glomeruli, other mechanisms, such as cell proliferation, participation of mononuclear cells (lymphocytes and macrophages) at extraglomerular site, and accumulation of extracellular matrix molecules participate during the development of hypertensive damage. Though, except for glomeruli, the tubules and the interstitium are actively involved. The contribution of the altered protease activities in the development of hypertensive renal injury is well documented, however, the exact role of the growth factors and cytokines still remains to be elucidated.
Recently, evidence was given, that oral enzyme treatment may have beneficial effects even in non-immune mediated diseases. Our last data in the rat model of subtotal nephrectomy indicated, that systemic treatment with proteases retards the progression of renal disease. Therefore, we raised the question, whether enzyme treatment might be beneficial in the retardation of the renal injury in the Goldblatt hypertensive rats.
Aim of the study
Primary aim
The primary study tasks were:
to investigate the effect of a 7 weeks long intraperitoneal administration of Phlogenzym® on the development of hypertensive glomerulosclerosis in Goldblatt hypertensive rats,
to evaluate renal histology of the non-clipped kidney at the end of the study.
Secondary aims
to study the effect of Phlogenzym® treatment on the development of renal hypertension
to confirm, whether i.p. administration of Phlogenzym® might exert a catabolic effect in this model of renal damage (employing the pair-feeding of the animals)
to investigate the effect of i.p. administration of Phlogenzym® on standard biochemical parameters, acid-base balance, and blood picture
to investigate the effect of systemic treatment with proteases in the Goldblatt rats on the activities of proteases in isolated glomeruli and tubules
in studies of the role of growth factors, adhesion molecules and cytokines in the development of hypertensive nephrosclerosis the following investigations should be done:
- evaluation of the effect of Phlogenzym® administration on the renal excretion of TGF-
- in the case the standard histology shows beneficial effect of the treatment, the staining of the deep-frozen renal tissues for adhesion molecules, growth factors and cytokines should be performed to elucidate their participation in the course of the disease and during the treatment
since chronic renal insufficiency induces hypertrophy of the heart and damage of the heart muscle in subtotally nephrectomized rats. Specimen of heart will be preserved into formalin as well as by deep-freezing for potential evaluation of the changes induced during renal hypertension, and the effect of the treatment might be evaluated
as rutosid in Phlogenzym® acts as a scavenger, the total antioxidant status (TAS), gluthation peroxidase (GPX) as well as superoxid dismutase (SOD) activities determination at the end of the study might be of importance, elucidating the potential ratio in isolated glomeruli and tubules may have changed, therefore the expression of the activities per mg DNA, as well as the protein/DNA ratio changes are expected to be conclusive.
Conclusions
Tolerability and Toxicity
I.p. administration of Phlogenzym to Goldblatt hypertensive rats was well tolerated without visible toxicity.
Physical Parameters
I.p. administration of the enzymes exerts slight catabolic effect. Lower heart weight of the enzyme treated rats in spite of the high blood pressure might point to the prevention of cardiac hypertrophy.
Blood Chemistry
Trends towards lower serum creatinine and urea concentration were observed in the enzyme treated Goldblatt hypertensive rats in comparison to the placebo group.
Renal Function
As a consequence of renal injury serum creatinine tended to higher levels, while serum urea increased significantly, and proteinuria was higher, too. Enzyme treatment prevented the rise in proteinuria. Trends towards lower serum creatinine and urea concentration, as well as higher creatinine and urea clearance were observed in the enzyme treated Goldblatt hypertensive rats in comparison to the placebo group.
Morphological Analysis
57% of the untreated animals with renovascular hypertension developed the classical changes of malignant nephrosclerosis, which particularly involved the small renal arteries. Tubulointerstitial expansion was associated with infiltration of monocytes/macrophages and T-helper cells. The interstitial volume index increased by a factor of two.
Discussion
Summarising, our data demonstrate, that sustained systemic treatment with proteases in the model of 2K1C renovascular hypertension in rats ameliorates the severity of nephrosclerosis and tubulointerstitial fibrosis, although the rise in blood pressure remained unaffected. It is assumed that the administered proteolytic enzymes induce the proteolytic effects by cleavage of adhesion molecules and increased clearance of growth promoters and cytokines due to their binding to an activated a2-protease complex. Therefore, proteases may modulate the various amplifying mechanisms involved in the progressive kidney damage. For more detailed discussion see the submitted manuscript.