Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Carbohydrate doai
Patent
1998-02-20
1999-10-26
Kunz, Gary L.
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Carbohydrate doai
514 25, 514 54, 536 41, 5361231, 53612313, A61K 3170, C07H 304, C07H 306
Patent
active
059729058
DESCRIPTION:
BRIEF SUMMARY
TECHNICAL FIELD
This invention relates to a new pharmaceutical composition for alleviation of various syndromes, in particular pruritus cutaneus, characteristic to renal failure and hemodialysis patients.
BACKGROUND ART
Among the countries all over the world, the hemodialysis therapy is most widely practiced in Japan. This therapy over an extended time, however, induces various serious problems. The hemodialysis therapy for a long time, for example, causes the onset of complications such as cardiovascular disorder, anemia, abnormal bone metabolism, dysbolism, and/or immunodeficiency. In addition, it is said that 60-80% of the hemodialysis patients suffer from pruritus cutaneus. Although pruritus cutaneus itself does not impose direct threatening on the life of the patients, its persistent and chronic torment, night and day, is unbearable to the patients, both physically and mentally. From the view point of the maintenance and improvement in the quality of life, pruritus cutaneus is now a big problem in the treatment of the patients.
As a possible cause of pruritus cutaneus, 1. stimulation of the nerve ending by a certain substance accumulated in the blood by renal failure, 2. a decline in the pruritus threshold value due to change in the pH value, etc., or 3. abnormal secretion by the skin glands such as sebaceous glands and sweat glands, is suspected but it Is not yet clear what is responsible for it. For its treatment, antihistaminic agent is generally administered but it has limitation in its efficacy. Besides, due to its side effects like drowsiness, vertigo or generalized malaise, its administration must be discontinued in many cases. In addition, anti-allergic agent, adrenocortical agent or tranquilizer is administered but no agent alone can relieve the patients from the torment and establishment of an effective therapy has been expected.
DISCLOSURE OF INVENTION
The applicants of this invention have been conducting their research focusing on alleviation of pruritus cutaneus, among other complications, developed in renal failure patients treated with the hemodialysis therapy for a long time.
As the most potential substances that induce pruritus, recent studies suggest accumulation of uremic toxins and active oxygen. Since the removal rate of those substances by hemodialysis is very low, the applicants of this invention conducted clinical trials on the assumption that suppression of production of uremic toxins would prompt improvement in pruritus cutaneus.
As a result, administration of lactulose for one or two months decreased significantly toxic amino acid metabolites responsible for aggravation of uremia such as guanidino compounds like methylguanidine and guanidinosuccinic acid, indolacetic acid, p-cresol and declined methylguadinine/creatinine that is considered to be a physical active oxygen marker of the renal hemodialysis patients. The applicants of this invention found the correlation between the decrease in those uremic toxins and decline in the active oxygen marker and improvement in pruritus cutaneus, thus, completed this invention. This invention provides a pharmaceutical agent containing one, two or more kind or kinds of oligosaccharide or oligosaccharides as an effective ingredient for improvement in pruritus cutaneus associated with renal failure.
BEST MODE FOR CARRYING OUT THE INVENTION
Details of the invention are described below.
In addition to lactulose which has long been known as a growth factor of bifidobacteria, there have been found various kinds oligosaccharide that show the same effect. It is known that oligosaccharide such as, but not limited to, fructo-oligosaccharide, galactooligosaccharide, lacto-sucrose, maltooligosaccharide and xylooligosaccharide grow remarkably bifidobacteria in stool and reduce significantly toxic substances like ammonia, amine phenol and cresol in it. There has, however, been no report made so far on the effect of such oligosaccharide on the treatment of renal failure, in particular, on alleviation of pruritus. It is well known that ammoni
REFERENCES:
patent: 3793461 (1974-02-01), Yuen et al.
Y. Matsuda et al., "Effect of Lactulose on Acute Renal Failure in Rabbits", Igaku to Yakugaku (Medicine and Pharmacy), vol. 27, No. 1, p. 49-54, 1992.
The Merck Index, Twelfth Edition, Merck & Co., Inc., 1996, p. 913.
Ando Kunio
Hosokawa Tomoyoshi
Nakamura Tetsuo
Shimaoka Tatsuro
Institute of Immunology Co., Ltd.
Kunz Gary L.
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