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Details for Patent: 5,696,128

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Details for Patent: 5,696,128

Title: Method of regulating immune function
Abstract:Disclosed are methods for rectifying or ameliorating abnormal responses of mammalian immune systems. Also disclosed are methods for modifying normal responses of the mammalian immune system. Further disclosed are methods for accomplishing the foregoing by administering to a mammal a prolactin reducer and/or enhancer at a pre-determined time or times during a 24-hour period that results in modification of the mammal's abnormal prolactin profile so that it approaches or conforms to the prolactin profile of a young, healthy mammal of the same species (or to a standard profile generated from such individuals). Additionally, methods of upregulating or augmenting an immune response in a mammal are disclosed.
Inventor(s): Cincotta; Anthony H. (Andover, MA), Meier; Albert H. (Andover, MA)
Assignee: The Board of Supervisors of Louisiana University and Agricultural and (Baton Rouge, LA) The General Hospital Corporation (Boston, MA)
Filing Date:Jul 07, 1994
Application Number:08/271,881
Claims:1. A method of treating an immune system dysfunction in a mammal suffering from said dysfunction to at least ameliorate said dysfunction, said mammal having a prolactin daily rhythm, comprising the steps of:

comparing the prolactin profile said mammal in need of treatment to a standard prolactin profile for healthy members of the same species and sex as said mammal; and

adjusting the prolactin profile of said mammal in need of treatment said adjusting step comprising at least one of:

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

administering to said 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 further comprising the step of measuring the blood prolactin level of said mammal in need of treatment at spaced apart intervals within a 24-hour period to generate a prolactin profile for said mammal.

3. The method of claim 2 wherein said comparing step reveals that (i) at any two spaced apart time points during waking hours said mammal has blood prolactin levels higher than 1 Standard Error of the Mean ("SEM") above the standard daytime prolactin level for those time points or (ii) at any one time point during waking hours said mammal has a blood prolactin level higher than 2 SEM above the standard daytime prolactin level for that time point; and

said adjusting step comprises administering to said mammal a prolactin reducer only at a time or times predetermined to reduce the mammal's daytime prolactin levels so that the mammal's daytime prolactin profile conforms to or approaches the standard daytime prolactin profile.

4. The method of claim 2 wherein said comparing step reveals that (i) at any two spaced apart time points during night time said mammal has blood prolactin levels lower than 1 Standard Error of the Mean (SEM) below the standard night time prolactin level for those time points or (ii) at any one time point during night time said mammal has a blood prolactin level lower than 2 SEM below the standard night time prolactin level for that time point; and

said adjusting step comprises administering to said mammal a prolactin enhancer only at a time or times predetermined to increase the mammal's night time prolactin levels so that the mammal's night time prolactin profile conforms to or approaches the standard night time prolactin profile.

5. The method of claim 3 wherein said prolactin reducer is bromocriptine.

6. The method of claim 4 wherein said prolactin enhancer is selected from the group consisting of metoclopramide, domperidone, 5-hydroxytryptophan, haloperidol, pimozide, phenothiazine, sulpiride, chlorpromazine, serotonin agonists that are MAO inhibitors, pargyline, methadone, estrogens, tryptophan, melatonin, fluoxitane, dexfenfluramine, and non-toxic salts thereof.

7. The method of claim 5 wherein said mammal in need of treatment is a human and said bromocriptine is administered in an amount within the range from 0.8 to 8.0 mg/person/day.

8. The method of claim 6 wherein said prolactin enhancer is metoclopramide, said mammal is a human and said metoclopramide is administered in an amount within the range of 0.5-5.0 mg/person/day.

9. The method of claim 2 wherein said adjustment is continued until the prolactin rhythm of said mammal is reset to conform to or approach the standard prolactin profile and continues in its reset condition after cessation of said adjustment.

10. A method for treating an immune dysfunction in a patient suffering from said dysfunction to at least ameliorate said dysfunction comprising the steps of:

comparing the blood prolactin level of said patient at each of a plurality of space apart time points during at 24-hour period to the corresponding prolactin level of a baseline prolactin profile for healthy humans of the same sex as said patient; and

adjusting the prolactin level of said patient said adjusting step comprising at least one of:

administering to said patient 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

administering to said patient 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.

11. A method for treating an autoimmune disease in a patient suffering from said autoimmune disease comprising the steps of:

comparing the blood prolactin level of said patient at each of a plurality of spaced apart time points during a 24-hour period to the corresponding prolactin level of a baseline prolactin profile for healthy humans of the same sex as said patient; and

adjusting the prolactin level of said patient by administering to said patient 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.

12. The method of claim 11 wherein the prolactin level of said patient is adjusted by administering to said patient at said predetermined time or times a prolactin reducer when (i) at any two spaced apart time points during waking hours said patient has blood prolactin levels higher than 1 Standard Error of the Mean ("SEM") above the standard daytime prolactin level for those time points or (ii) at any one time point during waking hours said patient has a blood prolactin level higher than 2 SEM above the standard daytime prolactin level for that time point.

13. The method of claim 12 wherein said autoimmune disease is selected from the group consisting of Crohn's disease, systemic lupus erythematosus, rheumatoid arthritis and fibromyalgia.

14. The method of claim 13 wherein said prolactin reducer is bromocriptine and said predetermined time or times is between about 05:00 and about 13:00.

15. The method of claim 14 wherein said bromocriptine is administered in an amount within the range of 0.8-8.0 mg/patient/day.

16. The method of claim 15 wherein said predetermined time or times is between about 05:00 and 10:30 and said bromocriptine amount is within the range of 0.8-3.2 mg/patient/day.

17. The method of claim 11 wherein the prolactin level of said patient is adjusted by administering to said patient at said predetermined time or times a prolactin enhancer when (i) at any two spaced apart time points during night time said patient has blood prolactin levels lower than 1 Standard Error of the Mean ("SEM") below the standard night time prolactin level for those time points or (ii) at any one time point during night time said patient has a blood prolactin level lower than 2 SEM below the standard night time prolactin level for that time point.

18. A method of treating an immune system dysfunction in a mammal suffering from said dysfunction to at least ameliorate said dysfunction, said mammal having a prolactin daily rhythm, comprising adjusting the prolactin profile of said mammal in need of treatment to cause said mammal's prolactin profile to conform to or approach the standard prolactin profile, wherein said adjusting comprises at least one of:

administering to said mammal 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

administering to said mammal 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.

19. The method of claim 18 wherein said immune dysfunction is selected from the group of autoimmune diseases consisting of rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, and fibromyalgia.

20. The method of claim 19 wherein said prolactin reducer is a member selected from the group consisting of 2-bromo-alpha-ergocriptine, 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.

21. The method of claim 20 wherein said prolactin enhancer is selected from the group consisting of metoclopramide, domperidone, 5-hydroxytryptophan, haloperidol, pimozide, phenothiazine, sulpiride, chlorpromazine, serotonin agonists that are MAO inhibitors, pargyline, methadone, estrogens, tryptophan, melatonin, fluoxitane, dexfenfluramine, and non-toxic salts thereof.

22. The method of claim 21 wherein said prolactin reducer is bromocriptine.

23. The method of claim 22 wherein said mammal in need of treatment is a human and said bromocriptine is administered in an amount within the range from 0.8 to 8.0 mg/person/day.

24. The method of claim 23 wherein said prolactin enhancer is metoclopramide, said mammal is a human and said metoclopramide is administered in an amount within the range of 0.5-5.0 mg/person/day.

25. The method of claim 18 wherein said adjusting is continued until the prolactin rhythm of said mammal is reset to conform to or approach the standard prolactin profile and continues in its reset condition after cessation of said adjustment.
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