The present invention relates to a method for the treatment of inflammatory bowel diseases, and more in detail, to a method for the treatment of inflammatory bowel diseases, comprising administering to a patient a pharmaceutical composition for inflammatory bowel diseases, which comprises a spherical activated carbon as active ingredient.
Inflammatory bowel disease (IBD) is a general term for the intestinal troubles with an inflammation. The representative cases of inflammatory bowel diseases are ulcerative colitis and Crohn's disease of unknown etiology. No effective therapeutic method is available for either of these diseases.
Ulcerative colitis is an unaccountable disease of diffuse nonspecific inflammation of the colon which attacks the mucous membrane and often forms an erosion or ulcer. The lesion is chiefly submucosal. The clinical symptoms of this disease are viscous-hemafecia, celialgia, hemafecia, watery stool, fervescence, loss of appetite, nausea and vomiting. Also, ulcerative colitis may be attended by such troubles as arthritis, stricture of the large intestine and copious bleeding, but their incidence is not high. Salazosulfapyridine (Salazopyrin.RTM.), adrenocortical steroids, immuno-suppressants and the like are used as therapeutic agents for ulcerative colitis, but these medicines are unsatisfactory in these therapeutic effect therefor.
Crohn's disease is an idiopathic chronic enteritis of unknown etiology. This disease occurs most frequently in human beings of both sexes in their twenties and becomes chronic. It is a granulomatous lesion with fibrosis or ulceration and may be attacked with in the whole alimentary tract from mouth to anus. The clinical symptoms of Crohn's disease are celialgia, general malaise, diarrhea, melena and occult bleeding positive, fervescence, loss of body weight, anemia, ileus, abdominal tumor and peritonitis.
Crohn's disease tends to cause trophic disturbance and various other serious digestive and extra intestinal complications such as intestinal stenosis, abdominal abscess, copious bleeding, intestinal perforation, etc., which usually necessitate an enteric operation. Relapse of the disease after the operation occurs at a high percentage. Therefore, no surgical treatment is conducted unless the irreversible imperforation is combined therewith or curative excision is required. For this reason, the treatment by medication is being tried. For medication, there are used salazosulfapyridine (Salazopyrin.RTM.), metronidazole (Flagyl.RTM.), adrenocortical steroids, immuno-suppressants and the like. These medicines, however, are unsatisfactory in their therapeutic effect for Crohn's disease.
Treatments based on nutrition therapies are now applied for Crohn's disease, and the methods are employed that can heighten the "quality of life" (QOL) of the patient, which includes rehabilitation, and can facilitate remission of the disease.
Salazosulfapyridine used as the medicine for inflammatory bowel diseases is liable to cause adverse reactions or side effects such as abdominal fullness, headache, exanthema, hepatic disorder, leukopenia, agranulocytosis, male sterility, etc. It is also unclear whether this salazosulfapyridine has sufficient relapse suppressive effect in the patient after resection of the affected part of the intestine or in the patient in remission. As for metronidazole, although its potency is admitted in the data on antiphlogistic effect in the reports of control tests, its utility for the clinical improvement is unclear.
Adrenocortical steroids, although their short-time effect has been admitted, are unable to improve long-time prognosis, and it is considered that they should be used for the acute cases only, in view of their side effects such as induced infectious diseases, secondary adrenocortical insufficiency, peptic ulcer, diabetes, mental disorder, steroidal renal trouble, etc. Also, when adrenocortical steroids are administered to the patient having a fistula or abscess, it is liable to cause worsening of infection or delay cure of the lesion to complicate the disease. Immunosuppressants are used for the cases where the side effects of adrenocortical steroids were produced, but the effect of the immuno-suppressants is skeptical and also they have a possibility of inviting a horrific side effect such as carcinogenesis.
As viewed above, no reliable therapy is yet available for the inflammatory bowel diseases, and the development of an effective therapeutic agent for these diseases has been desired. Especially in the case of Crohn's disease, the complicated cases of anal lesion such as anal fistula and hemorrhoids, which develop symptoms at an early stage and may impair QOL in the long process, have a high percentage of occurrence (about 90%) and defy the internal therapies, so that the frequent surgical treatments are necessitated, which gives a great deal of discomfort to the patient. Also, when the affected part of the intestine is resected and a stoma is provided, there may take place such troubles as contact dermatitis, itching, redness, ulceration and other types of inflammation on the skin around preternatural anus, which are complicated diseases, to give great discomfort to the patient.
Under these circumstances, development of an effective therapeutic agent for the inflammatory bowel diseases has been demanded.
As the result of the present inventors' pursued researches on the effective therapeutic agents for inflammatory bowel diseases, especially Crohn's diseases, which are different from the conventionally used medicines, it has been found that a prominent therapeutic effect for inflammatory bowel diseases is produced by oral administration of a spherical activated carbon. Spherical activated carbons have been generally used as an oral therapeutic agent for chronic renal failure, but no report has ever been made on use of such spherical activated carbon as a therapeutic agent for the inflammatory bowel diseases, especially Crohn's disease. In view of this circumstance, the above finding by the present inventors is deemed an unexpected fact based on a novel conception. The present invention has been attained on the basis of the above finding.