Methods of assessing the need for and the effectiveness of therapy with antioxidants

Abstract

The invention relates to diagnostic methods for assessing the need of a subject for treatment with an anti-oxidant, or alternatively, for determining the utilization efficiency and ultimate effectiveness of anti-oxidant therapy in subjects having been treated with antioxidants. More specifically, the methods of the present invention are particularly useful in prophylactic assessment of individuals at risk for developing diseases or conditions in which oxidative stress plays a role, such that an appropriate therapeutic regimen can be prescribed for that individual, thus leading to alternative therapies and / or life style changes. The invention further relates to methods for assessing the need for, the utilization efficiency and the effectiveness of therapy in subjects having received therapy with specific antioxidant and immune enhancing formulations. Kits are also provided for measuring the levels of markers of oxidative stress and immune cell numbers.

Description

FIELD OF THE INVENTION [0001] The invention relates to diagnostic methods for assessing the need of a subject for treatment with an anti-oxidant, or alternatively, for determining the effectiveness of anti-oxidant therapy in subjects having been treated with antioxidants. More specifically, it relates to methods for assessing the need for, or effectiveness of therapy in subjects having received therapy with, specific antioxidant and immune enhancing formulations. BACKGROUND OF THE INVENTION [0002] It is generally recognized that many disease processes are attributed to the presence of elevated levels of free radicals and reactive oxygen species (ROS) and reactive nitrogen species (RNS), such as superoxide, hydrogen peroxide, singlet oxygen, peroxynitrite, hydroxyl radicals, hypochlorous acid (and other hypohalous acids) and nitric oxide. [0003] In the eye, cataract, macular degeneration and degenerative retinal damage are attributed to ROS. Among other organs and their ROS-related d...

AI Technical Summary

Benefits of technology

[0012] In its broadest aspect, the present invention relates to methods for assessing the need of a subject for treatment with an antioxidant, or alternatively, if a subject is currently being treated with an anti-oxidant, the invention provides for measuring the utilization efficiency of the anti-oxidant and the subsequent effectiveness of therapy with the anti-oxidant. It is also an

Problems solved by technology

Certain anti-neoplastic drugs such as adriamycin and bleomycin induce severe oxidative damage, especially to the heart, limiting the patient's exposure to the drug.

Radiation poisoning from industrial sources, including leaks from nuclear reactors and exposure to nuclear weapons, are other sources of radiation and radical damage.

Until recently, the lack of specific and dependable methods for evaluating oxidant stress in vivo made it very difficult to establish a cause and effect relationship between free radical-generating agents or conditions and disease pathology.

Furthermore, the various treatment strategies with anti-oxidants have been difficult to monitor due to the lack of techniques sufficiently sensitive to reliably provide an index of oxidative damage in vivo.

Furthermore, there are no set measures to identify high-risk groups that would theoretically benefit most from antioxidant therapies or interventions.

Additionally, there are no reliable means to measure or determine the effectiveness of such interventions in vivo.

In the absence of such methodology, current (and future) clinical trials testing natural (or synthetic) antioxidants, which utilize clinical endpoints, may give incorrect conclusions regarding the role of antioxidants in specific disease states.

This is a possibility because of the inclusion of populations that would not be expected to benefit from antioxidant supplementation, and / or because the dose or agent yielded insufficient antioxidant protection.

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