Na z\u00e1klade v\u00fdskumu, prezentovan\u00e9ho na medzin\u00e1rodnej konferencii ATS 2010 v New Orleans, vyzeraj\u00fa nov\u00e9 mo\u017enosti lie\u010dby p\u013e\u00facnej infekcie sp\u00f4sobenej bakt\u00e9riou Pseudomonas Aeruginosa\u00a0u pacientov s cystickou fibr\u00f3zou s\u013eubne.<\/p>\n
U pribli\u017ene 80 percent pacientov s CF sa vyv\u00edja chronick\u00e1 p\u013e\u00facna infekcia sp\u00f4soben\u00e1 bakt\u00e9riou P. aeruginosa a rezistencia vo\u010di antibiotickej lie\u010dbe je \u010doraz v\u00e4\u010d\u0161\u00edm probl\u00e9mom. \u201eNa lie\u010dbu CF pacientov s chronickou p\u013e\u00facnou infekciou P. aeruginosa s\u00fa potrebn\u00e9 nov\u00e9 triedy inhalovan\u00fdch bakteriostat\u00edk z d\u00f4vodu ob\u00e1v z narastaj\u00facej antimikrobi\u00e1lnej rezistencie, klesaj\u00facej \u00fa\u010dinnosti a slabej adherencie \/tolerancie v s\u00fa\u010dasnosti dostupn\u00fdch prostriedkov\/,\u201c<\/em><\/strong> povedal ved\u00faci autor v\u00fdskumu, MUDr. Dougals Conrad, docent medic\u00edny Univerzity \u0161t\u00e1tu Kalifornia v San Diegu.<\/p>\n Na testovanie \u00fa\u010dinnosti a bezpe\u010dnosti nov\u00e9ho antibiotika nazvan\u00e9ho MP-376, inhala\u010dn\u00e9ho roztoku levofloxac\u00ednu, v\u00fdskumn\u00edci urobili n\u00e1bor\u00a0 151 pacientov, ktor\u00fdch n\u00e1hodne rozdelili pod\u013ea u\u017e\u00edvania MP-376 v troch r\u00f4znych d\u00e1vkach [ (120mg raz denne (q.d.); 240 mg raz denne alebo 240 mg dva razy denne (b.i.d.) ]alebo placebo. Je zn\u00e1me, \u017ee inhalovan\u00e9 bakteriostatik\u00e1 p\u00f4sobia na zni\u017eovanie z\u00e1\u0165a\u017ee organizmu v d\u00fdchac\u00edch cest\u00e1ch a zlep\u0161uj\u00fa funkciu p\u013e\u00fac u pacientov s CF.<\/p>\n Pacienti mali v priemere 29 rokov, v minulom roku u\u017eili takmer p\u00e4\u0165 k\u00far inhalovan\u00fdch antibiot\u00edk p\u00f4sobiacich proti bakt\u00e9rii P. aeruginosa, absolvovali opakovan\u00fa lie\u010dbu na zvl\u00e1dnutie ich CF p\u013e\u00facneho ochorenia, a mali len\u00a0 nie\u010do vy\u0161e 50 percent predpokladanej p\u013e\u00facnej kapacity zdrav\u00fdch jedincov.<\/p>\n Po 28 d\u0148och lie\u010dby sa u pacientov, u\u017e\u00edvaj\u00facich MP-376, zn\u00ed\u017eila hustota P. aeruginosa v p\u013e\u00facnom sekr\u00e9te v porovnan\u00ed s pacientmi, ktor\u00ed u\u017e\u00edvali placebo, a nevykazovali \u017eiaden d\u00f4kaz antimikrobi\u00e1lnej rezistencie. Najv\u00fdznamnej\u0161\u00ed efekt lie\u010dby bol pozorovan\u00fd u pacientov, ktor\u00ed dost\u00e1vali najvy\u0161\u0161iu d\u00e1vku 240 mg MP-376 dvakr\u00e1t denne. Osem pacientov preru\u0161ilo \u00fa\u010das\u0165 na \u0161t\u00fadii, \u0161iesti z nich kv\u00f4li nepriazniv\u00fdm \u00fa\u010dinkom lie\u010dby. Z t\u00fdchto \u0161iestich pacientov dvaja boli v skupine u\u017e\u00edvaj\u00facej placebo, jeden u\u017e\u00edval 120mg q.d., jeden 240mg q.d. a dvaja 240mg b.i.d.<\/p>\n Funkcia p\u013e\u00fac sa tie\u017e zlep\u0161ila u v\u0161etk\u00fdch skup\u00edn MP-376, pri\u010dom najv\u00e4\u010d\u0161ie zlep\u0161enie sa pozorovalo u t\u00fdch, ktor\u00ed dost\u00e1vali d\u00e1vku 240mg BID,\u00a0s priemern\u00fdm zlep\u0161en\u00edm predikovanej hodnoty FEV1 (n\u00faten\u00e1 vit\u00e1lna kapacita p\u013e\u00fac) 10,9% oproti placebu.<\/strong>\u00a0 Podobn\u00fd efekt bol pozorovan\u00fd aj pri ostatn\u00fdch meraniach funkcie p\u013e\u00fac.<\/p>\n Okrem toho lie\u010dba pomocou MP-376 zn\u00ed\u017eila potrebu lie\u010dby in\u00fdmi anti-pseudomon\u00e1lnymi bakteriostatikami, v skupine u\u017e\u00edvaj\u00facej MP-376 v d\u00e1vke 240mg BID do\u0161lo k 79 percentn\u00e9mu zn\u00ed\u017eeniu v porovnan\u00ed so skupinou u\u017e\u00edvaj\u00facou placebo.<\/p>\n \u201eLiek MP-376 bolo dobre tolerovan\u00fd, so zvy\u0161uj\u00facou sa d\u00e1vkou lieku sa nepreuk\u00e1zalo \u017eiadne zv\u00fd\u0161enie nepriazniv\u00fdch \u00fa\u010dinkov a adherencia k MP-376 bola ve\u013emi dobr\u00e1, vy\u0161e 80 percent pacientov v \u0161t\u00fadii u\u017e\u00edvalo viac ako 90 percent svojho lieku\u201c, kon\u0161tatoval Dr. Conrad.<\/p>\n Zatia\u013e \u010do sa o\u010dak\u00e1valo zn\u00ed\u017eenie hustoty P. aeruginosa v sp\u00fate, stupe\u0148 zlep\u0161enia p\u013e\u00facnej funkcie a zn\u00ed\u017eenia potreby \u010fal\u0161\u00edch antipseudomon\u00e1lnych\u00a0 bakteriostat\u00edk\u00a0 sa pri t\u00fdchto intenz\u00edvne lie\u010den\u00fdch pacientoch neanticipoval.<\/p>\n Ve\u013ek\u00e1 v\u00e4\u010d\u0161ina pacientov dost\u00e1vala dornase alpha, azitromyc\u00edn a\/alebo hypertonick\u00fd slan\u00fd roztok, pri ka\u017edom z nich sa uk\u00e1zalo, \u017ee zlep\u0161uje p\u013e\u00facnu funkciu. Pacienti z\u00fa\u010dastnen\u00ed na \u0161t\u00fadii v predch\u00e1dzaj\u00facich 12 mesiacoch tie\u017e u\u017e\u00edvali priemerne 4,8 k\u00far inhalovan\u00fdch bakteriostat\u00edk, tak\u017ee efekt lie\u010dby vy\u0161e 10 percent predikovanej percentu\u00e1lnej hodnoty FEV1 v skupine MP-376 mg b.i.d. bol neo\u010dak\u00e1van\u00fd, \u201e povedal Conrad.<\/p>\n Testy f\u00e1zy\u00a0 3 s\u00fa pl\u00e1novan\u00e9 na koniec tohto roka. \u201epozit\u00edvne zistenia vo f\u00e1ze 3 a n\u00e1sledn\u00e9 schv\u00e1lenie regula\u010dn\u00fdmi org\u00e1nmi by klinick\u00fdm CF\u00a0 lek\u00e1rom poskytlo \u010fal\u0161iu d\u00f4le\u017eit\u00fa triedu inhalovan\u00fdch bakteriostat\u00edk na lie\u010dbu p\u013e\u00facnych chor\u00f4b pacientov s CF, \u201e povedal Conrad.\u00a0 \u201ePrevencia\u00a0 zhor\u0161enia stavu\u00a0 a zachovanie p\u013e\u00facnej funkcie s\u00fa ve\u013emi d\u00f4le\u017eit\u00e9 pre pacientov s chronickou infekciou P. aeruginosa a na z\u00e1klade tejto \u0161t\u00fadie o\u010dak\u00e1vame vo f\u00e1ze 3 \u0161t\u00fadie pre MP-376 podobn\u00e9 v\u00fdsledky. Liek MP-376 by pacientom poskytol dobre tolerovan\u00e9 inhalovan\u00e9 bakteriostatikum, ktor\u00e9 mo\u017eno u\u017e\u00edva\u0165 dvakr\u00e1t denne inhalovan\u00edm pomocou nebuliz\u00e1tora\u00a0 len po\u010das 4-6 min\u00fat, \u010do zna\u010dne zn\u00ed\u017ei z\u00e1\u0165a\u017e lie\u010dby v porovnan\u00ed s aktu\u00e1lne dostupn\u00fdmi prostriedkami.\u201c<\/p>\n \u201ePhase 2b Study of Inhaled MP-376 (Aeroquin, Levofloxacin Inhalation Solution) in Stable Cystic Fibrosis (CF) Patients with Chronic Pseudomonas Aeruginosa (PA) Lung Infection“ (Session A102, Sunday, May 16, 1:30- 4:00 p.m., CC-Room 388-390 (Third Level), Morial Convention Center; Abstract 420)<\/p>\n Zdroj:\u00a0American Thoracic Society (ATS),\u00a0http:\/\/www.medicalnewstoday.com\/articles\/188924.php<\/a><\/em><\/p>\n","protected":false},"excerpt":{"rendered":"