FORSHAG Mark (US),ФОРШАГ Марк (US),UOLTRIP Rojs (US),УОЛТРИП Ройс (US),GARLINGKHAUS Les (US),ГАРЛИНГХАУС Лес (US),BARNETT Uillyam (US),БАРНЕТТ Уилльям (US),FORSHAG Mark,ФОРШАГ Марк,UOLTRIP Rojs,УОЛТРИП Ройс,GARLINGKHAUS Les,ГАРЛИНГХАУС Лес,BARNETT Uillyam,БАРНЕТТ Уилльям
申请号：
RU2014106758
公开号：
RU0002635482C2
申请日:
2012.11.22
申请国别(地区):
RU
年份:
2017
代理人:
摘要：
FIELD: medicine.SUBSTANCE: methods are proposed comprising administration of an effective amount of an alpha1 proteinase inhibitor purified by chromatography (A1PI-HC) to the subject by daily inhalation for a long-term period of time (from 21 days to 10 years). For one version of the method, A1PI-HC is aerosolized and administered using an inhaler in an effective amount of A1PI-HC from about 25 to about 750 mg per day, or from about 0.5 to about 15 mg/kg/day. The patient's age should be at least 12 years. Pulmonary disorder or disease is fibro-cystic degeneration, chronic obstructive pulmonary disease (COPD), deficiency of alpha1 proteinase (A1PI deficiency), emphysema, asthma, mycobacterial infection, pneumonia, bronchiectasis or chronic bronchitis. A version of the method including preliminary identification of subjects with an increased risk of pulmonary diseases exacerbations acceptable for A1PI maintenance therapy is also proposed. The method includes evaluating one or more subject criteria, such as (a) age； (b) history of exacerbations； (c) lungs function (FEV1)； (d) chronic productive cough (with phlegm)； (e) infectious load by the upper and lower respiratory tract pathogen； (f) inflammation markers of the respiratory tract of exhaled gas； (g) response to exogenous provocation for airways hyperreactivity research； (h) number and classes of concomitant medications； (i) the profile of genetic risk for respiratory disease； (j) environmental risk factors, such as smoking history, allergies, occupational risk factors and/or air pollution effects. It is then determined whether or not the subject is a candidate for A1PI maintenance therapy based on the above criteria, and an effective amount of A1PI-HC is administered to the subject by daily inhalation for a long-term period from 21 days to 10 years. For another version of the method, the above-mentioned inhaled administration of A1PI-HC is performed using an aerosol generated by the inhaler one or more times per da
