Drug – bio-affecting and body treating compositions – Plant material or plant extract of undetermined constitution...
Reexamination Certificate
2001-02-15
2003-03-11
Tate, Christopher R. (Department: 1651)
Drug, bio-affecting and body treating compositions
Plant material or plant extract of undetermined constitution...
C424S773000
Reexamination Certificate
active
06531161
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to the field of medicine, pharmaceuticals, herbal remedies, and specifically to the treatment of chronic idiopathic thrombocytopenic purpura, especially in cases where the patient is refractive to other treatments.
BACKGROUND OF THE INVENTION
Idiopathic thrombocytopenic purpura (ITP), also known as primary immune thrombocytopenic purpura and autoimmune thrombocytopenic purpura, is defined as isolated thrombocytopenia with normal bone marrow and the absence of other causes for thrombocytopenia. “Idiopathic” indicates that the cause is unknown, “Thrombocytopenic” indicates the blood doesn't have enough platelets, and “Purpura” indicates a person has excessive bruising. For the two types of ITP, the first type affects children, and the second type affects adults. In children, the usual age of onset for ITP is about two to four years of age. Most adults with ITP are young women, but ITP can occur in anyone.
ITP affects women more frequently than men and is more common in children than adults. There is no sex difference in children. Risk factors are unknown. The incidence is 1 out of 10,000 people.
In the US: The incidence of ITP in adults is approximately 66 cases per 1,000,000 per year. An average estimate of the incidence in children is 50 cases per 1,000,000 per year. New cases of chronic refractory ITP are approximately 10 cases per 1,000,000 per year. Internationally: According to studies in Denmark and England, childhood ITP occurs in approximately 10-40 cases per 1,000,000 per year. A study in Kuwait reported a higher incidence of 125 cases per 1,000,000 per year.
This problem is significant because chronic ITP is one of the major blood disorders in both adults and children. They are a source of significant hospitalization and treatment cost at specialized hematological departments in the US and around the world. Approximately 100,000 people in the US have ITP. The percentage rate of ITP cases is increasing. Each year there are approximately 20,000 new cases in the US. More importantly the cost for ITP care and special therapy is extremely high.
ITP is different in children than in adults. Most children with ITP have a very low platelet count that causes sudden bleeding. The usual symptoms are bruises and the tiny red dots on the skin. Nosebleeds and bleeding gums are also common. Although children often recover with no treatment, many doctors recommend careful observation and mitigation of the bleeding symptoms. Children do not always require hospitalization, and often a short treatment with prednisone pills or intravenous infusions (given in a vein) of gamma globulin to increase the platelet count more quickly. Both treatments, however, have substantial side effects and it is therefore desirable to identify a safe and effective remedy for ITP in children which does not have the side effects of the prednisone pills or gamma globulin.
Typically, in most adults, ITP lasts much longer than it does in children. When diagnosed, many adults present increased bleeding and tend to bruise easily for several weeks, or even months. In women, increased menstrual blood flow is a good indicator of ITP.
In cases of adult mild thrombocytopenia, there are often no bleeding symptoms and the diagnosis of ITP occurs when their blood is checked for another reason and a low blood platelet count is found.
Traditional treatment of ITP in adults is aimed at increasing the blood platelet count by suppressing the immune system which then permits accumulation of platelets without changing the nature of the platelets. This does not the cure the patient of the disease. Patients may take prednisone for several weeks, even a month or longer. However, when the medicine is stopped, platelet counts may return to below normal levels.
With patients refractive to prednisone, a spleenectomy may be indicated. In chronic ITP patients, it is the spleen that makes most of the antibodies that destroy the blood platelets and destroys old or damaged blood cells. Removal of the spleen is a dramatic and permanent alteration of the patient's body, and includes all the associated potential complications associated with major surgical procedures such as reactions to anesthesia and infection.
In people with ITP, blood cells are normal except for the blood platelets. Platelets are the tiny cells that seal minor cuts and wounds and form blood clots. A person with too few platelets bruises easily and bleeds for a long time after being injured. Tiny red dots on the skin, called petechiae might also appear. When the platelet count is very low, the person with ITP might have nosebleeds that are hard to stop, or might have bleeding in the intestines.
ITP primarily is a disease of increased peripheral platelet destruction, with most patients having antibodies to specific platelet membrane glycoproteins. Relative marrow failure may contribute to this condition, since studies show that most patients have either normal or diminished platelet production. Traditional medical theory purports that platelets and platelet counts would be normal but for the presence of autoimmune antibodies (autoantibodies) made by the patient's body. Accordingly, traditional medicine attempts to treat a chronic ITP patient by suppressing the immune system, and consequently causing an increase in platelet levels.
Since ITP results from a shortage of platelets, a characteristic bleeding under the skin is often associated with the disease. The disease is believed to be caused when the spleen and lymph tissue produce antibodies against platelets. The antibodies destroy the platelets in the spleen. Symptoms include skin hemorrhage, nosebleed or oral bleeding, easy bruising, abnormal menstrual bleeding, or sudden and severe loss of blood from the gastrointestinal tract may occur, and petechial rash (pinpoint red spots).
Usually, no other abnormal findings are present. In children, the disease is sometimes preceded by a viral infection and runs its course without treatment. In adults, it is usually chronic disease and rarely follows a viral infection.
Acute ITP often follows an acute infection and has a spontaneous resolution within two months. Chronic ITP persists longer than six months without a specific cause.
Hemorrhage represents the most serious complication; intracranial hemorrhage is the most significant. Mortality from hemorrhage is approximately 1% in children and 5% in adults. Older age and previous history of hemorrhage increase the risk of severe bleeding in adult ITP. Spontaneous remission occurs in children in greater than 80% of cases, but it is uncommon in adults.
Diagnosis of chronic ITP often includes examining the patient for an enlarged spleen. Additional tests include CBC with platelet count, bone marrow aspiration or biopsy, PTT (coagulation studies), PT (coagulation studies), platelet associated antibodies, platelet aggregation test Typical treatment of ITP involves initial treatment with prednisone. A splenectomy (removal of the spleen) is indicated if the person does not respond to prednisone. The spleen is the major site of platelet destruction, so a splenectomy will resolve the thrombocytopenia in most people.
Other treatments (when the disease does not respond to initial treatment) are oral danazol, high dose gamma globulin injections, drugs that suppress the immune system, and passage of the blood over a Protein A (Prosorba) column (which filters antibodies out of the blood stream). People with ITP should avoid taking aspirin or ibuprofen, because bleeding may occur.
With acute ITP, the chance of remission is good with prednisone or splenectomy, however, ITP may often become a chronic ailment in adults and reappear even after remission.
The treatment for chronic ITP is indicated generally in patients who are unable to maintain platelet counts consistently over 30,000/&mgr;l. Initial specific treatment is corticosteroids and Splenectomy (surgical removal of the spleen) if the first therapy failed. The treatment of patients who fail to respond to corticosteroids and splenecto
Hoang Ba X.
Levine Stephen A.
Allergy Research Group/Nutricology, Inc.
Dehlinger Peter J.
Perkins Coie LLP
Srivastava Kailash C.
Tate Christopher R.
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