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Title

AN INSIGHT FOR USING IFN-G, IL-2, IL-4, AND IL-10 BIOMARKERS AS SURROGATE ENDPOINTS FOR SKIN DISORDERS CAUSED BY EXPOSURE TO MUSTARD GAS

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 Start Page 1 | End Page 8

Abstract

 Background and Objective: Here,it is tried to assess an insight behind using IFN-G, IL-2,IL-4, and IL-10 BIOMARKERs as potential SURROGATE ENDPOINTs for skin diseases caused by exposure to MUSTARD GAS. Potentially, a BIOMARKER is a valid surrogate if assessment of the treatment effect based on SURROGATE ENDPOINT leads to the same result based on TRUE CLINICAL ENDPOINT.Materials and Methods: In Sardasht-Iran Cohort study including 328 individuals, 235 subjects exposed to MUSTARD GAS taken from Sardasht as the exposed group and 93 subjects not exposed to MUSTARD GAS taken from Rabat, through comparison of related RISK RATIOs, it is tried to assess whether IFN-G, IL-2, IL-4, and IL-10 BIOMARKERs can be offered as potential surrogates for skin disorders caused by exposure to MUSTARD GAS.Results: It was found out that IL-2 (at three levels of serum, mitogen and mitogen-nill), IL-10 (at four levels of serum, mitogen, mitogen-nill and nill), and IL-4 (at two levels of mitogen and mitogen-nill) can be used as surrogates, because the survey of no exposure effect of MUSTARD GAS based on these BIOMARKERs would led to the same conclusion of the same survey based on existence or non-existence of skin disorders as TRUE CLINICAL ENDPOINT. But IL-4 at serum level and IFN-G at three levels do not have this property.Conclusion: Using IL-2 at three levels, IL-10 at four levels and IL-4 at two levels, the study of no exposure effect of MUSTARD GAS on skin disorders can be tested without waiting for skin disorders as the TRUE CLINICAL ENDPOINTs.

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