Die individuelle Rezeptur in der spezifischen ImmuntherapieNotwendigkeit und Fehlerquellen |
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Authors: | S. May D. Haustein |
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Affiliation: | Paul-Ehrlich-Institut, Langen, DE
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Abstract: | The causal treatment of type I allergies by specific immunotherapy (SIT) is absolutely essential to counter the transformation of rhinitis into bronchial asthma. There are therapy allergens available for this purpose as finished drugs (with marketing authorization and subject to official batch testing) or as named patient products (NPP). Sixty to eighty percent of all preparations for SIT are compounded as NPP for a specific patient by his physician. Because of the enormous number of potential allergens, SIT also requires NPP, as the batchwise production of finished drugs would not be practical for possibly very small groups of patients. However, NPP may become a source of error in treating allergic diseases due to the compilation of mixtures for therapy being attributed to an inadequate anamnesis obtained through physicians without allergological experience, the compilation of mixtures of non cross-reacting allergens that may negatively influence the stability and efficacy of such a mixture, up to total ineffectiveness by proteolytic degradation, and the failure to reach the concentration essential for a clinical effect of each single allergen in a mixture. All these factors can only be controlled by intensive training of practising allergists and their cooperation with responsible acting manufacturers, since up till now efforts to subject NPP to binding regulations, comparable to those existing for preparations with marketing authorization, have failed. |
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