METHODS OF TREATING HEPATIC ENCEPHALOPATHY
Treatment of hepatic encephalopathy using gastrointestinal specific antibiotics is disclosed. One example of a gastrointestinal specific antibiotic is rifaximin. The instant application also provides methods for determining if a subject has a neurological condition or hepatic encephalopathy by determining the critical flicker frequency and/or the venous ammonia level of the subject at two or more time points. The further provided are methods for treating these subjects.
1 . A method of decreasing blood ammonia levels in a subject comprising:
administering to the subject an effective amount of rifaximin, thereby reducing ammonia blood levels.
2 - 4 . (canceled)
5 . A method of decreasing fatigue in a subject having hepatic encephalopathy comprising:
administering to the subject an effective amount of rifaximin, thereby reducing fatigue in a subject.
6 . A method for treating a subject having HE, comprising:
administering a GI specific antibiotic with lactulose, thereby treating a subject having HE.
7 . (canceled)
8 . (canceled)
9 . The method of claim 6 , further comprising advising a health care worker to administer the GI specific antibiotic prior to, with, or after administration of lactulose.
10 - 14 . (canceled)
15 . The method of claim 6 wherein the GI specific antibiotic is rifaximin.
16 . A method of diagnosing hepatic encephalopathy (HE) in a subject comprising: determining the critical flicker frequency (CFF) of a subject at two or more time points, wherein a decrease in the CFF is indicative that the subject has hepatic encephalopathy.
17 . The method of claim 16 , wherein the CFF comprises the CFF time weighted average.
18 . The method of claim 17 , wherein the CFF time weighted average comprises less than about 24 Hz.
19 . A method of determining a subject's risk of an HE breakthrough event, comprising:
determining the critical flicker frequency (CFF) of a subject at two or more time points, wherein a decrease in the CFF is indicative that the subject has an increased risk of an HE breakthrough event.
20 . The method of claim 19 , wherein the CFF comprises the CFF time weighted average.
21 . The method of claim 20 , wherein the CFF time weighted average comprises less than about 24 Hz.
22 . The method of claim 19 , wherein a average CFF time weighted average 10 Hz is indicative that the subject has the greatest risk of a HE breakthrough event.
23 . A method of determining the prognosis of a subject having HE, comprising:
determining the critical flicker frequency (CFF) of a subject at two or more time points, wherein a decrease in the CFF is indicative that the subject has a poor prognosis.
24 . The method of claim 23 , wherein the CFF is the CFF time weighted average.
25 . The method of claim 24 , wherein the CFF time weighted average comprises less than about 24 Hz.
26 . The method of claim 24 , wherein the CFF time weighted average comprises less than about 20 Hz.
27 . A method of treating or preventing an HE event, comprising:
determining the critical flicker frequency (CFF) of a subject at two or more time points,
administering to a subject having a decrease in the CFF average between the time points an effective amount of a GI specific antibiotic,
thereby treating or preventing an HE event.
28 . The method of claim 27 , wherein the CFF comprises the CFF time weighted average.
29 . The method of claim 28 , wherein the CFF time weighted average comprises less than about 24 Hz.
30 . The method of claim 28 , wherein the subject is administered a GI specific antibiotic when the CFF time weighted average comprises less than 24 Hz.
31 . The method of claim 30 , wherein the GI specific antibiotic is rifaximin.
32 . The method of claim 16 , wherein the risk is increased as compared to a control subject without HE.
33 . The method of claim 16 , wherein the two or more time points occur within one week.
34 . The method of claim 16 , wherein the two or more time points occur within four weeks.
35 . The method of claim 16 , wherein the two or more time points occur within six months or more.
36 . A method of diagnosing hepatic encephalopathy (HE) in a subject comprising:
determining the venous ammonia levels of a subject at two or more time points, wherein an increase in the venous ammonia levels is indicative that the subject has hepatic encephalopathy.
37 . The method of claim 36 , wherein the venous ammonia level comprises the time weighted average venous ammonia levels.
38 . The method of claim 37 , wherein the time weighted average venous ammonia level comprises more than about 100 μmol/L.
39 - 44 . (canceled)
45 . A method of treating or preventing an HE event, comprising:
determining the venous ammonia level of a subject at two or more time points,
administering to a subject having an increase in the venous ammonia level between the time points an effective amount of a GI specific antibiotic,
thereby treating or preventing an HE event.
46 . The method of claim 45 , wherein the GI specific antibiotic is rifaximin.
47 . The method of claim 46 , wherein the venous ammonia level comprises the time weighted average venous ammonia levels.
48 . The method of claim 47 , wherein the time weighted average venous ammonia level is more than about 100 μmol/L.
49 . The method of claim 45 , further comprising administering lactulose.
50 . The method of claim 36 , wherein the two or more time points occur within one week.
51 . The method of claim 36 , wherein the two or more time points occur within four weeks.
52 . The method of claim 36 , wherein the two or more time points occur within six months or more.
53 - 57 . (canceled)
58 . A method of diagnosing a neurological disease in a subject, comprising:
determining the critical flicker frequency (CFF) of a subject at two or more time points, wherein a decrease in the CFF is indicative that the subject has a neurological disease.
59 . (canceled)
60 . The method of claim 58 , wherein the neurological disease or disorder is Alzheimer's disease, Parkinson's disease, brain trauma, migraine, chronic headache, insomnia and other sleep disorders, and/or epilepsy.
61 . A method of determining the prognosis of a subject having a neurological disease, comprising:
determining the critical flicker frequency (CFF) of a subject at two or more time points, wherein a decrease in the CFF is indicative that the subject has a poor prognosis.
62 . The method of claim 61 , wherein the CFF is the CFF time weighted average.
63 . The method of claim 61 , wherein the neurological disease or disorder is Alzheimer's disease or Parkinson's disease.
64 - 66 . (canceled)
67 . A computerized method for identifying subjects having a neurological disease comprising:
maintaining a database of CFFs for subjects at various time points and stages of disease progression;
comparing the results of an individuals CFF results taken at two or more time points to the database;
obtaining the diagnosis of a neurological disease from the computer if subject has CFF results that decrease between measurements.
68 . The method of claim 67 , wherein the CFF comprises the CFF time weighted average.
69 . (canceled)
70 . The method of claim 67 , further comprising controlling a printing device to print a report based on the results of the method.
71 . A business method for decreasing healthcare costs comprising:
determining the critical flicker frequency (CFF) of a subject at two or more time points;
storing patient information on a computer processor;
determining if the subject has a neurological disease by determining if the CFF value has decreased between time points; and
treating the subject as necessary to avoid or delay hospitalization.
72 . (canceled)
73 . A device for determining the risk of an HE event, comprising:
a flicker box, a measurement device to determine CFF, and a computer with an algorithm.
74 . (canceled)