Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – 9,10-seco- cyclopentanohydrophenanthrene ring system doai
Reexamination Certificate
1999-02-01
2001-02-13
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
9,10-seco- cyclopentanohydrophenanthrene ring system doai
C514S167000, C514S725000
Reexamination Certificate
active
06187764
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to the field of immunology. More specifically, the present invention relates to seasonal allergic rhinitis and the use of vitamins A and D for treatment of seasonal allergic rhinitis.
2. Description of the Related Art
Seasonal allergic rhinitis (SAR), commonly called hay fever, is a disease which was first described in ninth century Islamic and sixteenth century European texts. In Europe, the first case of hay fever was reported in 1595 (Emanuel, 1988). The actual cause of the symptoms in individual predisposed to hay fever was not suspected until 1833. That pollen plant was the sole cause of hay fever was proven experimentally in England in 1877. At about the same time, the pollen of
Ambrosia artemisiaefolia,
or common ragweed, was found to be the most active pollen which produced hay fever in America.
Seasonal allergic rhinitis has now reached epidemic proportions. At the end of the nineteenth century in the United States alone, fifty thousand in a population of fifty million inhabitants suffer from seasonal allergic rhinitis. It is now the most common immunologic disorder in humans. Nearly one fifth of the inhabitants of the temperate zone are afflicted. Seasonal allergic rhinitis affects ten percent of children and twenty percent of adolescents and adults. The usual age of onset is between five and ten years and peaks between ten and twenty with males more often affected than females (Emanuel, M. B. Clinical Allergy, 18:295-304, 1988). In 1975, the United States National Health Survey reported twenty-eight million restricted days and two million lost school days per year attributable to allergic rhinitis. Medical costs per year exceeded one billion dollars. With an increasing population and the rising costs of health care, it has become imperative to find an alternative approach for the treatment and prevention of seasonal allergic rhinitis.
Seasonal allergic rhinitis involves both genetic and environmental factors. In the hypersensitivity reaction of susceptible individuals to pollen exposure, the B cell lymphocytes produce large amounts of IgE antibody molecules. These molecules attach themselves to basophils and to mast cells in the tissues near the capillaries. This binding sensitizes the cells to the antigen. When contact is made again with the allergen, the cells respond with the characteristic hypersensitivity reaction. The response causes irritating and painful symptoms, including sneezing, runny nose, itchy eyes, nose and palate, nasal congestion, airway resistance, post-nasal drip, cough, loss of hearing and smell, headache, fatigue and depression.
Medical management of the symptomatology of seasonal allergic rhinitis is based upon pharmacological therapy, immunotherapy and surgical intervention. Pharmacological treatment of seasonal allergic rhinitis currently involves the use of vasoconstrictors, decongestants, corticosteroids, cromolyn sodium and ipratropium bromide. These medications are either prescribed alone or in combination. When pharmacotherapy fails, immunotherapy using pollen extracts is employed, and finally, surgery is undertaken in intractable cases. However, immunotherapy is controversial due to associated fatalities, and surgery entails high morbidity and unpredictable outcomes.
Vitamins are organic compounds which are required by living organisms for maintaining health and were discovered in the early part of the twentieth century in various foods. They were classified according to their solubility's as water-soluble or fat-soluble and named after the letters of the alphabet according to their chronological discovery. Vitamins act as co-factors for different enzymes, which otherwise could not function.
The role of vitamins in relation to classic deficiency diseases is well documented. Beriberi is a thiamine (B
1
) deficiency first described by the Chinese over 4000 years ago and results in peripheral nervous system disfunction. Scurvy is a deficiency in vitamin C and has been mentioned in medical writings since before 1500 B.C. The symptoms include fatigue, irritability, bleeding and inflamed gums, loosening of teeth, bruising and hemorrhaging. Vitamin D deficiency produces rickets, which is a bone condition resulting in bowed limbs. Vitamin A was the first vitamin to be discovered and deficiencies result in night-blindness. In summary, deficiencies of the water-soluble B complex vitamins and vitamin C cause mainly anemia, nervous system disorders and skin and mucous membrane abnormalities, while deficiencies in the fat-soluble vitamins cause physiological problems including visual impairments, bone abnormalities, blood disorders and fetal death. In all cases, the corresponding pathological condition can be reversed by vitamin supplementation.
It is now believed that vitamins play an important role in the immune system. Cell-mediated immune responses and the role of vitamins as antioxidants and free-radical scavengers has been studied and it is now accepted that vitamin deficiencies affect host defenses. The relationship between vitamins and systemic disorders such as cancer and autoimmune diseases is now better understood. The role of vitamins in humoral responses is currently being studied and evidence suggests that vitamins play a role as immunoregulators. Likewise, substances which require vitamins for their biosynthesis also may exert immunomodulatory influences (DeSimone, 1982).
The prior art is deficient in an effective, inexpensive, curative and preventative treatment for seasonal allergic rhinitis, an atopic disease. The present invention fulfills this long-standing need and desire in the art.
SUMMARY OF THE INVENTION
The present invention describes a method of treatment comprising a combination of vitamin A and D derivatives, specifically retinol and ergocalciferol, to reduce or eliminate the hypersensitive immunological response to allergen exposure that results in seasonal allergic rhinitis.
One object of the present invention is to provide for a curative and preventative treatment for seasonal allergic rhinitis.
In an embodiment of the present invention, there is provided a method of treating or preventing the recurrence of seasonal allergic rhinitis in an individual to thereby reduce or eliminate the hypersensitive immunological response to allergen exposure, comprising the step of administering to the individual a therapeutically effective amount of retinol and ergocalciferol.
In another embodiment of the present invention, there is provided a method of treating or preventing the recurrence of seasonal allergic rhinitis in an individual to thereby reduce or eliminate the hypersensitive immunological response to allergen exposure, comprising the step of: administering to the individual an effective amount of retinol and ergocalciferol, wherein the retinol is administered in an amount of at least 12,000 IU and the ergocalciferol is administered in an amount of at least 60,000 IU, wherein the amount of retinol and the amount of ergocalciferol are administered orally once every 14 days to an individual weighing less than 175 pounds for a period that generally should not exceed 6 consecutive months, wherein the amount of retinol and the amount of ergocalciferol are administered orally once every 10 days to an individual weighing over 175 pounds for a period that generally should not exceed 6 consecutive months.
In yet another embodiment of the present invention, there is provided a method of treating or preventing the reoccurrence of seasonal allergic rhinitis in an individual to thereby reduce or eliminate the hypersensitive immunological response to allergen exposure, comprising the step of: administering to the individual an effective amount of retinol and ergocalciferol, wherein the retinol is administered in an amount of at least 200,000 IU and the ergocalciferol is administered in an amount of at least 300,000 IU, wherein the amount of retinol and the amount of ergocalciferol are administered orally in multiple doses for a period
Adler Benjamin Aaron
Page Thurman K.
Seidleck Brian K.
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