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Details for Patent: 5,872,127

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Details for Patent: 5,872,127

Title: Method of regulating immune function
Abstract:Disclosed are methods for treating a disorder to the immune system or an immunodeficiency state which comprise the steps of administering to a patient an effective amount of at least one serotonin agonist and at least one dopamine agonist, where the combination of the serotonin agonist and the dopamine agonist are present in an amount effective to treat the patient's condition, where administration of each of the agents is confined to the time of day during which the administration is capable of adjusting the prolactin profile of the patient to conform or to approach the standard human prolactin profile.
Inventor(s): Cincotta; Anthony H. (Andover, MA), Meier; Albert H. (Andover, MA)
Assignee: The General Hospital Corporation/Board of Supervisors of Louisiana State University (Boston, MA) N/A (Baton Rouge, LA) Agricultural and Mechanical College (N/A)
Filing Date:Jan 08, 1997
Application Number:08/780,727
Claims:1. A method of treating an immune system dysfunction in a mammal suffering from said dysfunction to at least ameliorate said dysfunction comprising administering to said mammal at least one of:

a prolactin reducer only at a time or times predetermined to reduce the mammal's waking hours prolactin levels to cause the mammal's daytime prolactin profile to conform to or approach the standard daytime prolactin profile; and

a prolactin enhancer only at a time or times predetermined to increase the mammal's night time prolactin levels to cause the mammal's night time prolactin profile to conform to or approach the standard night time prolactin profile.

2. The method of claim 1 wherein said prolactin enhancer is selected from the group consisting of metoclopramide, domperidone, 5-hydroxytryptophan, haloperidol, pimozide, phenothiazine, sulpiride, chlorpromazine, serotonin agonists, pargyline, methadone, estrogens, tryptophan, melatonin, fluoxitane, dexfenfluramine, and non-toxic salts thereof.

3. The method of claim 1 wherein said prolactin reducer is a member selected from the group consisting of bromocriptine, 6-methyl-8-beta-carbobenzyloxy-aminoethyl-10-alpha-ergoline, an 8-acylaminoergoline, ergocornine, 9,10-dihydroergocornine, a D-2-halo-6-alkyl-8-substituted ergoline, carbidopa, L-dihydroxyphenylalanine, lisuride, and pharmaceutically acceptable acid addition salts thereof.

4. The method of claim 3 wherein said mammal in need of treatment is a human, said prolactin reducer is bromocriptine, and said bromocriptine is administered in an amount within the range of 0.8 to 8.0 mg/person/day.

5. The method of claim 2 wherein said prolactin enhancer is melatonin, said mammal is a human and said melatonin is administered in an amount within the range of 0.5-5.0 mg/person/day.

6. A method for treating an autoimmune disease in a mammal suffering from said autoimmune disease comprising administering to said mammal at least one of:

a prolactin reducer only at a time or times predetermined to reduce the patient's daytime prolactin levels to cause the patient's daytime prolactin profile to conform to or approach the standard daytime prolactin profile; and

a prolactin enhancer only at a time or times predetermined to increase the patient's night time prolactin levels to cause the patient's night time prolactin profile to conform to or approach the standard night time prolactin profile.

7. The method of claim 6 wherein said autoimmune disease is selected from the group consisting of Crohn's disease, systemic lupus erythematosus, rheumatoid arthritis and fibromyalgia.

8. The method of claim 7 wherein said prolactin enhancer is selected from the group consisting of metoclopramide, domperidone, 5-hydroxytryptophan, haloperidol, pimozide, phenothiazine, sulpiride, chlorpromazine, serotonin agonists, pargyline, methadone, estrogens, tryptophan, melatonin, fluoxitane, dexfenfluramine, and non-toxic salts thereof.

9. The method of claim 7 wherein said prolactin reducer is a member selected from the group consisting of bromocriptine, 6-methyl-8-beta-carbobenzyloxy-aminoethyl-10-alpha-ergoline, an 8-acylaminoergoline, ergocornine, 9,10-dihydroergocornine, a D-2-halo-6-alkyl-8-substituted ergoline, carbidopa, L-dihydroxyphenylalanine, lisuride, and pharmaceutically acceptable acid addition salts thereof.

10. The method of claim 8 wherein said prolactin enhancer is melatonin, said mammal is a human and said melatonin is administered in an amount within the range of 0.5-5.0 mg/person/day.

11. A method of treating a disorder to the immune system or an immunodeficiency state comprising:

administering to a patient in a need of same an effective amount of at least one serotonin agonist and at least one dopamine agonist

wherein the combination of the serotonin agonist and the dopamine agonist are present in an amount effective to treat the patient's condition, and

confining administration of each of said agents respectively to the time of day during which said administration is capable of adjusting the prolactin profile of said patient to conform or to approach the standard human prolactin profile.

12. The method of claim 6 wherein said autoimmune disease comprises rheumatoid arthritis.

13. The method of claim 6 wherein said autoimmune disease comprises Crohn's disease.

14. The method of claim 6 wherein said autoimmune disease comprises lupus erythematosus.

15. The method of claim 9 wherein said mammal is human and said prolactin reducer is bromocriptine administered at a predetermined time or times between about 05:00 and about 13:00.

16. The method of claim 15 wherein said mammal is human and said bromocriptine is administered at a predetermined time or times between about 05:00 and about 10:30.

17. The method of claim 12 wherein said mammal is human and said prolactin reducer is bromocriptine administered at a predetermined time or times between about 05:00 and about 10:30.

18. The method of claim 13 wherein said mammal is human and said prolactin reducer is bromocriptine administered at a predetermined time or times between about 05:00 and about 10:30.

19. The method of claim 14 wherein said mammal is human and said prolactin reducer is bromocriptine administered at a predetermined time or times between about 05:00 and about 10:30.

20. The method of claim 16 wherein said bromocriptine is administered in an amount in the range of 0.8-8.0 mg/patient/day.

21. The method of claim 17 wherein said bromocriptine is administered in an amount in the range of 0.8-8.0 mg/patient/day.

22. The method of claim 18 wherein said bromocriptine is administered in an amount in the range of 0.8-8.0 mg/patient/day.

23. The method of claim 19 wherein said bromocriptine is administered in an amount in the range of 0.8-8.0 mg/patient/day.
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