OZONE AND SICKLE CELL ANEMIA
CAPMED, an American Corporation in Philadelphia, received Orphan Drug Designation from the U.S. FDA for the use of ozone oxygen for the treatment of Sickle Cell Anemia in March, 1992.
This coming after they completed clinical trials in cooperation with the National Institute for Scientific Research, Havana, Cuba, the Institute of Hematology and Oncology, Havana, Cuba, and the Salvador Allende Clinic, Havana, Cuba.
These trials were carried out in the years 1989, 1990 and 1991 culminating in ozone oxygen being approved by the Cuban Ministry of health for general use in the treatment of sickle cell crisis, the ulcers ensuant to sickle cell disease, and as a preventative treatment for the disease. The safety and efficacy established in these trials led to the use of ozone oxygen in the general population for healing wounds and diseases of the extremities (e.g., diabetic leg ulcers), where below or above knee amputation would be otherwise indicated.
In patients with sickle cell anemia, the reduction in the availability of oxygen for the cells, produces painful crises, organ infarction, abdominal and/or muscular pains, ulcers, etc.
On the basis of some medical properties of ozone, concerning ability to increase the rate and the capacity of absorption of oxygen in red blood cells, an evaluation about the effectiveness this treatment for the prevention and/or the timely resolution of the crisis was made.
The average time required for resolution of painful sickle cell crisis in ozone oxygen treated patients was half the number of hours required to solve painful crisis in control patients. Frequency and severity of painful crises in sickle cell anemia patients who received ongoing ozone oxygen therapy diminished in the six month followup period, in comparison with control group patients.
Sickle cell anemia, a genetic disease which involves the sickle shape of red blood cells (erythrocytes), when blood oxygen tension is low, is represented by a modified hemoglobin, HbS, due to the substitution of glutamic acid by valine in the amino acid chain.
The crystallization of the molecules of HbS occurs when those cells are deprived of oxygen up to a partial pressure of oxygen PO2 below the threshold level at which the cells sickle. In these conditions, the erythrocytes lose their normal elasticity and shape, also losing their capacity to take and deliver oxygen and increasing the viscosity of the blood.
This leads to a reduction in the availability of oxygen to the cells, producing painful crisis, infarction, abdominal and/or muscular pain, ulcers, etc. This process is reversible in the early stages, for when the HbS molecule is reoxygenated the cell distortion disappears and resumes its normal shape. The longer the period of time necessary for the reoxygenation of the molecules of HbS, the greater number of red cells die. Therefore, the increase in the partial pressure of oxygen and the promptness with which it is normalized are determining factors for the symptoms to diminish and disappear.
Numerous reports have been published on the safety and clinical results obtained by the application of medical ozone oxygen in diseases related to insufficient oxygen supply to tissues and various organs, and/or the disruption of its utilization in the cells. Ozone's virucidal effect has been reported at dose levels at which no undesirable side effects take place, offering promise as a means to inactivate viruses in human body fluids and blood products preparation.
Among the medical properties of ozone documented are the ability to increase the rate and capacity of oxygen absorption in erythrocytes and the activation of glycolysis in the cells via the pentose pathway. This enhances the production of 2,3 DPG, which is known to act as a coadjuvant of oxygen release from oxyhemoglobin at tissue level.
Both effects lead to significant improvement in oxygen supply to the body, demonstrated in vivo by the measurement of PO2 increase in arterial blood as well as the reduction in venous CO2.
In addition, the rheological properties of the blood improve, especially in regard to red blood cell aggregation. Ozone prevents rouleaux formation and clumping of cells. There is an increase in membrane permeability and flexibility, because of the effect of ozone/oxygen on it. As a consequence of these effects, reduction of blood viscosity and enhancement of blood flow are achieved.
Numerous preclinical experiments have been performed in vitro and in vivo to test possible ozone oxygen toxicity related to the therapeutic methods and ways of administration according to which medical ozone oxygen is currently applied. Controlled in vitro testing on the degree of hemolysis and "Heinz Body formation" induced by the administration of ozone to blood at adequate dosage was performed.
Not finding any significant effect, no damage to the red blood cells nor in the resistance of erythrocytes to further oxidative stress. These results are consistent with the fact that ozone stimulates several enzymatic redox systems responsible for cells protection against oxidation. Ozone is a free radical scavenger and natural antioxidant contrary to what an individual is likely to conclude at first glance.
Doses up to more than ten times the maximum therapeutic levels were tested for toxicity. These studies comprised cytotoxicity, organs function, hematological parameters, histological studies by electron microscopy, teratogenicity and cytogenetic testing. All the results demonstrated the nontoxic nature of medical ozone/oxygen within the range of therapeutic dose levels when administered intravascularly, intramuscularly and intrarectally.
Based on the role blood deoxygenation and hypoxia play in the painful sickle cell crisis, and considering the established therapeutic properties of medical ozone oxygen, and the absence of negative side effects, an evaluation of the effectiveness of this treatment for the prevention and/or the timely resolution of the crisis was made, by means of controlled in vitro and clinical trials.
---------------------------------------------------------------------------------
Results from Bethesda Naval Hospital in Bethesda, Maryland, indicate that ozone can also be effective against intracellular viruses when used in higher concentrations. The ozone seems to destroy only infected cells, exposing the viral material to the gas and ultimately deactivating the virus, all without creating toxicity problems.