| Methods of treating cardio pulmonary diseases with no group compounds -> Monitor Keywords |
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Methods of treating cardio pulmonary diseases with no group compoundsRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Designated Organic Active Ingredient Containing (doai), (o=)n(=o)-o-c Containing (e.g., Nitrate Ester, Etc.)Methods of treating cardio pulmonary diseases with no group compounds description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070191478, Methods of treating cardio pulmonary diseases with no group compounds. Brief Patent Description - Full Patent Description - Patent Application Claims
TECHNICAL FIELD [0001] This invention relates to the treatment of respiratory, cardiac and blood disorders by delivery into the lungs of compound comprising NO substitute. BACKGROUND OF THE INVENTION [0002] Inhaled NO is used to treat elevated pulmonary pressures and pulmonary disorders associated with hypoxemia. This method of treatment provides distribution tightly matched to perfusion and local effect because of rapid trapping of inhaled NO by hemoglobin. Moreover, this method of treatment can be readily carried out by an anesthesiologist or a critical care physician who is used to administering gases. Side effects include reaction of NO with oxygen or reactive oxygen species to produce NO.sub.2 or other toxic NO.sub.x, the toxicity of which is manifested by inflammation, airway hypereactivity, hemorrhage, delay in clinical improvement, renal impairment or death, and reaction with oxyhemoglobin to interfere with its oxygen delivery function, e.g., by forming methemoglobin. [0003] An alternative to inhaled NO gas is nebulized NO donor where the NO donor is present as solid particles or as particles of liquid. This alternative cannot fully avoid the NO.sub.2/NO.sub.x toxicity problem associated with administration of NO but may produce longer lasting effects than inhaled NO. The distribution in the lungs is according to particle size and is not matched to perfusion so some NO donor deposits in places where it does not reach the blood or small airways. In the general case, these NO compounds have systemic smooth muscle relaxing effects greater than pulmonary effects, which limit usage for treating pulmonary disorders. Furthermore, this method is not as readily carried out by an anesthesiologist since anesthesiologists do not normally administer aerosols or powders. Moreover, some classes of NO donors have additional toxicities, that is, they possess toxicities that are unrelated to NO, but that are instead related to the group to which NO is attached or from which NO is generated. The disadvantages of administering nebulized NO donor are indicated to be meaningful by the fact that inhaled gaseous NO is approved for use over inhaled liquid or inhaled solid NO-releasing compound. [0004] Use of inhaled NO and use of nitric oxide-releasing compounds inhaled as solids or liquids in an aerosol to treat pulmonary vasoconstriction and asthma are described in Zapol U.S. Pat. No. 5,823,180. SUMMARY OF THE INVENTION [0005] It is an object of an embodiment herein to provide selective pulmonary vasodilation and hypoxemia relieving effect by administration to the lungs of a gas without the toxicity associated with NO use. [0006] It is an object of an embodiment herein to systemically deliver NO/SNO by administering into the lungs of a gas without interfering with the oxygen delivery function of hemoglobin. It also is an object of this embodiment to endow hemoglobin with improved and/or novel NO donor/releasing function. [0007] It is an additional object to deliver NO/SNO without the toxicity (loss of specificity) associated with certain classes of NO donors. [0008] One embodiment herein, denoted the first embodiment, is directed to a method for treating a pulmonary disorder associated with hypoxemia and/or smooth muscle constriction in the lungs and/or inflammation in the lungs in a patient having such disorder, said method comprising delivering into the lungs of said patient as a gas, a therapeutically effective amount of a compound having an NO group and having a hypoxemia relieving effect and a smooth muscle constriction relieving effect and/or an anti-inflammatory or inflammation defending effect with said NO group being bound in said compound so it does not form NO.sub.2 or NO.sub.x in the presence of oxygen or reactive oxygen species at body temperature or exert systemic blood pressure compromising effect. [0009] Another embodiment herein, denoted the second embodiment, is directed at a method of treating a cardiac disorder which is characterized by ischemia, pump failure and/or afterload increase in a patient having such disorder, said method comprising delivering into the lungs of said patient as a gas, a therapeutically effective amount of a compound which reacts with cysteine in hemoglobin and/or dissolves in blood and has an NO group which is bound in said compound so it does not form NO.sub.2 or NO.sub.x in the presence of oxygen or reactive oxygen species at body temperature, whereby delivering into the lungs causes a systemic effect but does not compromise blood pressure. [0010] Still another embodiment herein, denoted the third embodiment, is directed at a method of treating a blood disorder which is ameliorated by treatment with NO in a patient having said disorder, said method comprising delivering into the lungs of said patient as a gas, a therapeutically effective amount of a compound which reacts with cysteine in hemoglobin and/or dissolves in blood and has an NO group which is bound in said compound so that it does not form NO.sub.2 or NO.sub.x in the presence of oxygen or reactive oxygen species at body temperature, whereby delivery into the lungs causes a desired systemic effect. [0011] Still another embodiment herein, denoted the fourth embodiment, is directed to a method for treating a patient in need of improvement in tissue oxygenation or dilation of a blood vessel or inhibition of clotting (improved oxygenation, blood flow and/or thinning of blood), said method comprising providing in the patient a therapeutically effective amount of red blood cells loaded with nitrosylated hemoglobin, thereby to cause improved oxygen delivery or blood flow. The red blood cells loaded with nitrosylated hemoglobin can be provided in the patient by methods comprising, for example, (1) delivering into the lungs of the patient as a gas, a red blood cell loading effective amount of a compound which reacts with cysteine in hemoglobin and/or dissolves in blood and has an NO group which is bound in said compound so it does not form NO.sub.2 or NO.sub.x in the presence of oxygen or reactive oxygen species at body temperature, as determined by measurement of nitrosylated hemoglobin in the blood; (2) infusing into the patient a solution of a compound which reacts preferentially with cysteine in hemoglobin and/or dissolves in blood and has an NO group which is bound in said compound so that it does not form NO.sub.2 or NO.sub.x in the presence of oxygen or reactive oxygen species at body temperature, in an amount to load red blood cells in the patient with nitrosylated hemoglobin but insufficient to cause systolic blood pressure to drop below 90; and (3) transfusing into the patient blood containing red blood cells loaded with nitrosylated hemoglobin. [0012] Exemplary of compound useful in the first, second and third embodiments and in (1) of the fourth embodiment is ethyl nitrite, which is also known as O-nitrosoethanol, used in gaseous form. [0013] Advantages of embodiments herein include: (1), elimination of the toxicity caused by NO.sub.2/NO.sub.x formation when NO is administered; (2), the option of administering the compound comprising NO group together with oxygen, without NO.sub.2/NO.sub.x production; (3), no interference with the oxygen carrying function of hemoglobins since compounds administered herein do not react with heme in hemoglobin, so the physiological level in blood of methemoglobin will be less than 5% in blood; (4), NO bioactivity is preserved when the compound administered reacts with cysteine of hemoglobin; (5), is more efficient and selective at loading hemoglobin cysteine with NO group than free NO or nebulized nitric oxide-releasing compound liquid or solid; (6), the advantages associated with administration of a gas including matching ventilation to blood perfusion (ideal distribution), relatively localized lung effect compared to normal systemic administration of solutions and familiarity of anesthesiologists with the procedure whereby the administration is carried out; (6), less expensive administration since administration can be carried out using a ventilator rather than the very expensive machine used for administration of NO; (7), improved oxygenation, without rebound or with less rebound than when NO is administered; (8), some patients respond to administration of ethyl nitrite who do not respond to administration of NO; (9), cardiac output improves whereas this is not the case when NO is administered; (10), improvement in oxygen delivery without risk of hypotension occurring (the pulmonary effect is greater than the systemic effect but the systemic effect occurs in proportion to the oxygen requirement); and (11), loading the endogenous nitrosoglutathione pool. The methods of embodiments employing gaseous treating agent preserve the advantages of both NO gas inhalation and nebulized nitric oxide-releasing compound administration while minimizing the disadvantages associated with these known methods. [0014] As used herein the term NO.sub.x means NO, N.sub.2O.sub.3, N.sub.2O.sub.4, OONO.sup.-, OONO.sup.- and any products of their interaction or their reaction with NO or NO.sub.2. [0015] As used herein the term reactive oxygen species is singlet oxygen, superoxide, hydrogen peroxide or hydroxyl radical. [0016] As used herein the term hypoxemia means low blood oxygen content compared to normal, i.e., a hemoglobin saturation less than 95% and a PaO.sub.2 less than 90 in arterial blood in someone breathing room air. [0017] As used herein the term Pa.sub.O2 means the partial pressure of oxygen in gases in arterial blood. [0018] As used herein the term "red blood cells loaded with nitrosylated hemoglobin" means red blood cells containing from 100 nanomolar to 10 micromolar nitrosylated hemoglobin, above baseline, preferably from 100 nanomolar to 1 micromolar above baseline. In the red blood cells, the nitrosylated hemoglobin is in equilibrium with nitrosoglutathione. [0019] As used herein the term "rebound" is used to mean lowering in blood oxygen level or increase in pulmonary artery pressure or resistance after increased blood oxygen level or decreased pulmonary vascular pressure/resistance is obtained by treatment, by at least 10%, when used in relation to blood oxygen levels or pulmonary hypertension, and in general means decrease from improvement after treatment. [0020] Other embodiments are as follows: [0021] One additional embodiment, denoted the fifth embodiment, is directed to red blood cells loaded with nitrosylated hemoglobin, outside the body. 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