RU2012111458A - Применение левофлоксацина в форме аэрозоля для лечения муковисцидоза - Google Patents
Применение левофлоксацина в форме аэрозоля для лечения муковисцидоза Download PDFInfo
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Abstract
1. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую Р. aeruginosa, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением снижения плотности Р. aeruginosa в мокроте указанного человека по меньшей мере на 40%.2. Способ по п.1, включающий достижение снижения плотности Р. aeruginosa в мокроте указанного человека по меньшей мере на 0,25 logКОЕ/г мокроты.3. Способ лечения муковисцидоза у человека, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением увеличения FEV(объем форсированного выдоха за 1 секунду) по меньшей мере на 2% и увеличения FEF 25-75 (средняя объемная скорость форсированного выдоха в интервале 25-75% жизненной емкости легких) по меньшей мере на 5%.4. Способ по п.3, включающий достижение увеличения FEVпо меньшей мере на 0,05 л и увеличения FEF 25-75 по меньшей мере на 0,05 л.5. Способ лечения муковисцидоза у человека, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением относительного риска менее 1,0, где относительный риск является показателем снижения потребности в других антипсевдомонадных противомикробных средствах.6. Способ лечения муковисцидоза у человека, которому посредством ингаляции вводят агент, выбранный из группы, состоящей из одного или более из следующих: дорназа альфа, азитромицин,
Claims (30)
1. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую Р. aeruginosa, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением снижения плотности Р. aeruginosa в мокроте указанного человека по меньшей мере на 40%.
2. Способ по п.1, включающий достижение снижения плотности Р. aeruginosa в мокроте указанного человека по меньшей мере на 0,25 log10 КОЕ/г мокроты.
3. Способ лечения муковисцидоза у человека, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением увеличения FEV1 (объем форсированного выдоха за 1 секунду) по меньшей мере на 2% и увеличения FEF 25-75 (средняя объемная скорость форсированного выдоха в интервале 25-75% жизненной емкости легких) по меньшей мере на 5%.
4. Способ по п.3, включающий достижение увеличения FEV1 по меньшей мере на 0,05 л и увеличения FEF 25-75 по меньшей мере на 0,05 л.
5. Способ лечения муковисцидоза у человека, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением относительного риска менее 1,0, где относительный риск является показателем снижения потребности в других антипсевдомонадных противомикробных средствах.
6. Способ лечения муковисцидоза у человека, которому посредством ингаляции вводят агент, выбранный из группы, состоящей из одного или более из следующих: дорназа альфа, азитромицин, сальбутамол, панкрелипаза, хлорид натрия, серетид и ADEK (витамины A, D, Е, К), включающий введение указанному человеку аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион.
7. Способ по п.6, где указанный человек имеет легочную инфекцию, включающую Р. aeruginosa.
8. Способ по п.7, включающий достижение снижения плотности Р aeruginosa в мокроте указанного человека по меньшей мере на 0,25 log10 КОЕ/г мокроты.
9. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую Р. aeruginosa, включающий повторяющееся введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, где указанное повторяющееся введение не приводит у указанного человека к более чем 16-кратному увеличению минимальной ингибирующей концентрации (MIC) в отношении штамма Р. aeruginosa, который характеризуется наивысшей MIC относительно других штаммов Р. aeruginosa.
10. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включая Р. aeruginosa, включающий повторяющееся введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением увеличения в респираторной части CFQ-R (вопросник для пациентов с муковисцидозом, пересмотренный вариант) более чем на 1.
11. Способ снижения сопротивления малых дыхательных путей у человека с муковисцидозом, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением увеличения FEF 25-75 по меньшей мере на 5%.
12. Способ по п.11, включающий достижение увеличения FEF 25-75 по меньшей мере на 0,05 л.
13. Способ введения левофлоксацина или офлоксацина человеку, включающий повторяющееся введение указанному человеку аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, где указанное повторяющееся введение не приводит к возникновению артралгии.
14. Способ по п.13, где указанное введение повторяют по меньшей мере один раз в сутки в течение 14 суток.
15. Способ по п.13, где указанное введение повторяют по меньшей мере два раза в сутки в течение 14 суток.
16. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую Р. aeruginosa, и указанный человек имеет площадь поверхности тела менее 1,5 м2, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением приведенной к дозе сывороточной AUC (площадь под кривой) по меньшей мере 20 (нг.ч/л)/мг дозы.
17. Способ по п.16, где указанный аэрозоль содержит по меньшей мере 80 мг левофлоксацина или офлоксацина, и где указанное введение повторяют один раз в сутки в течение по меньшей мере 14 суток.
18. Способ лечения муковисцидоза у человека, где указанный человек имеет легочную инфекцию, включающую Р. aeruginosa, и указанный человек имеет площадь поверхности тела менее 1,5 м2, включающий введение указанному человеку, нуждающемуся в таком лечении, аэрозоля раствора, содержащего левофлоксацин или офлоксацин и двухвалентный или трехвалентный катион, с достижением приведенной к дозе сывороточной Cmax (максимальная концентрация) более чем 2 мкг/л/мг введенной дозы.
19. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, где раствор состоит по существу из левофлоксацина или офлоксацина и двухвалентного или трехвалентного катиона.
20. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, где раствор не содержит лактозу.
21. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, где раствор содержит двухвалентный или трехвалентный катион в концентрации от примерно 50 мМ до примерно 400 мМ и левофлоксацин или офлоксацин в концентрации от примерно 50 мг/мл до примерно 200 мг/мл.
22. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, где раствор имеет осмоляльность от примерно 300 мосмоль/кг до примерно 500 мосмоль/кг и рН от примерно 5 до примерно 8.
23. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, где раствор содержит хлорид магния.
24. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, где раствор имеет концентрацию левофлоксацина или офлоксацина от примерно 90 мг/мл до примерно 110 мг/мл, концентрацию хлорида магния от примерно 175 мМ до примерно 225 мМ, рН от примерно 5 до примерно 7, осмоляльность от примерно 300 мосмоль/кг до примерно 500 мосмоль/кг и не содержит лактозу.
25. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, где аэрозоль имеет масс-медианный аэродинамический диаметр от примерно 2 микрон до примерно 5 микрон с геометрическим стандартным отклонением, которое меньше или равно примерно 2,5 микрон.
26. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, включающий получение аэрозоля с использованием небулайзера с вибрирующей сеткой-мембраной.
27. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, где по меньшей мере примерно 20 мг левофлоксацина или офлоксацина вводят в легкое.
28. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, дополнительно включающий совместное введение дополнительного активного агента, выбранного из группы, состоящей из антибиотиков, бронхорасширяющих средств, антихолинергических агентов, глюкокортикоидов, ингибиторов эйкозаноидов и их комбинаций.
29. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, включающий введение аэрозоля один раз в сутки.
30. Способ по любому из пп.1, 3, 5, 6, 9, 10, 11, 13, 16 и 18, где легочная инфекция дополнительно включает одну или более бактерий, выбранных из группы, состоящей из Pseudomonas fluorescens, Pseudomonas acidovorans, Pseudomonas alcaligenes и Pseudomonas putida, Stenotrophomonas maltophilia, Aeromonas hydrophilia, Escherichia coli, Citrobacter freundii, Salmonella typhimurium, Salmonella typhi, Salmonella paratyphi, Salmonella enteritidis, Shigella dysenteriae, Shigella flexneri, Shigella sonnei, Enterobacter cloacae, Enterobacter aerogenes, Klebsiella pneumoniae, Klebsiella oxytoca, Serratia marcescens, Morganella morganii, Proteus mirabilis, Proteus vulgaris, Providencia alcalifaciens, Providencia rettgeri, Providencia stuartii, Acinetobacter calcoaceticus, Acinetobacter haemolyticus, Yersinia enterocolitica, Yersinia pestis, Yersinia pseudotuberculosis, Yersinia intermedia, Bordetella pertussis, Bordetella parapertussis, Bordetella bronchiseptica, Haemophilus influenzae, Haemophilus parainfluenzae, Haemophilus haemolyticus, Haemophilus parahaemolyticus, Haemophilus ducreyi, Pasteurella multocida, Pasteurella haemolytica, Helicobacter pylori, Campylobacter fetus, Campylobacterjejuni, Campylobacter coli, Borrelia burgdorferi, Vibrio cholera, Vibrio parahaemolyticus, Legionella pneumophila, Listeria monocytogenes, Neisseria gonorrhoeae, Neisseria meningitidis, Burkholderia cepacia, Francisella tularensis, Kingella и Moraxella.
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US24009209P | 2009-09-04 | 2009-09-04 | |
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US24923109P | 2009-10-06 | 2009-10-06 | |
US61/249,231 | 2009-10-06 | ||
PCT/US2010/047903 WO2011029059A1 (en) | 2009-09-04 | 2010-09-03 | Use of aerosolized levofloxacin for treating cystic fibrosis |
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