Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
1999-10-04
2001-07-17
Travers, Russell (Department: 1627)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S093500
Reexamination Certificate
active
06261588
ABSTRACT:
TECHNICAL FIELD
The present invention relates to prophylactics and remedies for renal diseases and more specifically to prophylactics and remedies for renal diseases, which comprise, as an effective component, a hydrophilic solvent-extract of mushroom, prophylactics and remedies for progressive renal failure in undialyzed patients suffering from renal failure or foods having renal function-improving effect.
BACKGROUND ART
Up to this time, there has never been known any decisively effective drug for maintaining or recovering the renal function of patients suffering from end-stage renal disease and the only existing means for prolonging the life of these patients are dialytic therapy and kidney transplantation, which would force a great burden upon these patients and which are attended with a danger of death.
On the other hand, the hydrophilic solvent-extract of mushroom possesses an effect of suppressing production of, for instance, indole and scatol in feces and have accordingly been used as a deodorant, in particular, a food for deodorizing feces (see Japanese Un-Examined Patent Publication (hereunder referred to as “J.P. KOKAI”) No. Hei 2-277456). However, it has never been known that the hydrophilic solvent-extract of mushroom is effective for the recovery from the symptoms of uremia, in particular, progressive renal failure in undialyzed patients suffering from end-stage renal disease.
DISCLOSURE OF THE INVENTION
Accordingly, it is an object of the present invention to provide a prophylactic or remedy for renal diseases.
It is another object of the present invention to provide a prophylactic or remedy for progressive renal failure in undialyzed patients suffering from end-stage renal disease.
It is still another object of the present invention to provide a food, which is effective for preventing or treating progressive renal failure in undialyzed patients suffering from end-stage renal disease.
It is a further object of the present invention to provide a prophylactic or remedy, in particular, a food for renal diseases, which permits the elimination or retardation of the initiation of renal dialysis in patients suffering from end-stage renal disease, whose basic treating means is diet therapy, and which can rescue patients from any irreversible loss of renal functions.
It is a still further object of the present invention to provide a prophylactic or remedy for renal diseases, which comprises a hydrophilic solvent-extract of mushroom, as an effective component.
It is a further object of the present invention to provide a method for preventing or treating renal diseases.
It is a still further object of the present invention to provide a method for preventing or treating progressive renal failure in undialyzed patients suffering from end-stage renal disease.
It is a further object of the present invention to provide a method for preventing or treating renal diseases, which permits the elimination or retardation of the initiation of dialysis therapy in patients suffering from end-stage renal disease, whose basic treating means is diet therapy, and which can rescue patients from any irreversible loss of renal functions.
According to the present invention, there is provided a prophylactic or remedy for renal diseases, which comprises a hydrophilic solvent-extract of mushroom, as an effective component.
According to another aspect of the present invention, there is provided a method for preventing or treating renal diseases, which comprises administering a hydrophilic solvent-extract of mushroom to patients who require the prevention or treatment of renal diseases.
BEST MODE FOR CARRYING OUT THE INVENTION
The inventors of this invention have used an adsorbent having a high ability of adsorbing creatinine in the intestine, while adopting, as a basic therapy, the diet therapy which makes use of a diet mainly comprising low protein content and high energy components, in order to control the progress of renal failure in chronic renal disease patients. The renal function is evaluated by the 1/Cr value in blood (reciprocal of the creatinine level in the serum; an index of the renal function; the higher the value, the lower the renal function) and the dialysis of a patient is in general started at an instance when the value reaches a level of not higher than 0.1 dl/mg.
The inventors of this invention have surprisingly found that when a hydrophilic solvent-extract of mushroom is administered to an undialyzed renal failure patient, the renal function thereof which has steadily progressed is considerably improved and that the initiation of or requirement for the dialytic therapy could be eliminated and have thus completed the present invention based on such a finding.
Thus, the present invention relates to a food for preventing or treating renal failure, which comprises a hydrophilic solvent-extract of mushroom as an effective component. The present invention also relates to a remedy for progressive renal failure, which comprises a hydrophilic solvent-extract of mushroom as an effective component.
The present invention will now be described in more detail below.
In the present invention, the term “undialyzed patient suffering from renal failure (hereunder referred to as undialyzed renal failure patient)” means a renal failure patient suffering from, for instance, chronic nephritis (or nephrosis) such as mesangial proliferative glomerulonephritis, membrane proliferative glomerulonephritis, membranaceous nephritis, lupus nephritis and diabetic nephrosis; glomerulosclerosis, nephrotic syndrome or renal ischemia, and who is not treated by the dialysis therapy. More specifically, the undialyzed uremia patients mainly means end-stage terminal renal disease patients whose degree of progressive renal failure is not less than 0.1 dl/mg and not more than 0.5 dl/mg as expressed in terms of the 1/Cr value (reciprocal of the creatinine level in the serum; an index of the renal function) or not less than 5 ml/min and not more than 70 ml/min as expressed in terms of the CCr value (creatinine clearance value; an index of renal function). These patients are appropriate subjects for the present invention.
The foregoing pathema is a condition which is on the very threshold of the initiation of the dialysis therapy, i.e., the very stage in which the renal function still remains in the patient, but it would be lost within a short period of time if leaving the patient untreated. However, a better effect would be attained if the hydrophilic solvent-extract of mushroom according to the present invention is administered even to the patient at this stage, who is subjected to the usual diet therapy. In other words, the hydrophilic solvent-extract of mushroom directly or indirectly acts on the kidney of the patient to thus markedly maintain or improve the functions of such an impaired kidney.
The hydrophilic solvent-extract of champignon mushroom (
Agaricus bisporus
) is disclosed, in detail, in J.P. KOKAI No. Hei 2-277456 (U.S. patent application Ser. No. 08/107333, now U.S. Pat No. 5,639,470; E.P. Patent No. 0381055). The mushroom per se is a food and accordingly, the hydrophilic solvent-extract thereof is not toxic at all.
The fruit body of the mushroom comprises different components depending on the maturity and specific sites thereof. It is preferred to appropriately select the growth period of the fruit body of mushroom and to properly select the extraction method depending on the sites thereof selected, in order to obtain the extract of the present invention.
The mycelia in compost also comprise effective components, but they do not provide an extract suitably used for oral ingestion, since the rate of extraction is very low and the resulting extract may contain a large amount of contaminants originated from the compost.
The fruit-body of mushroom, which is in general used as a food, is in the course of growth and has closed pileus. It is preferred, in the present invention, to use the fruit-body harvested at this stage from the viewpoint of its color tone. In the present invention, the whole fruit-body may b
Oblon & Spivak, McClelland, Maier & Neustadt P.C.
Ricom Shoji Corp.
Travers Russell
Wang Shengjun
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