Vakadzi vane ruzivo rwezveUI vanozobatsirwa
Kufarira mune chirwere cheTI chaipiswa muna 1950, uye kubva ipapo, vatsvakurudzi vave vachitsvaga mushonga unobatsira unodzivirira mabhakitiriya E. coli kubva pakurongedza chivharo uye nokudaro kutanga utachiona. Muna July 2017, FDA yakapa chirwere cheSequoia Sciences 'FimCH UTI nokukurumidza. Kana zvichigamuchirwa, chirwere cheFIMCH chichangova chirongwa chokutanga chekuvhiya kweTI iri kuUnited States.
Maererano neCDA:
Kufambisa tsvina ndiyo nzira yakagadzirirwa kuita kuti hufambire mberi, uye inokurumidza kudzoka kwemishonga yekurapa zvirwere zvakakomba uye kuzadza zvido zvisina kufanira zvekurapa. Chinangwa ndechokukoshesa mishonga mitsva kumurwere kare. Fast Fast Track inotarisana nehuwandu hwemamiriro ezvinhu akaoma.
Background
Pakave nekuwedzera kwehuwandu hwemishonga inorwisa mabhakitiriya inokonzera hutachiona hutachiona hwehutachiona (UTIs) . Ne UTI, hutachiona hunogona kukwira kubva kubhedhi (cystitis) kupinda muitsvo (pyelonephritis). Zvirwere izvi zvinogona kupararira muropa zvichiita sepsis . Kuora kwepoyo, kugadziriswa muzvipatara, uye kunyange rufu ndezvikonzero zvehutachiona hwakanyanya, husina kutorwa UTI.
Mukuona kwekutyisidzira uku kune hutano hwehutano uye hutano hwehupfumi, pane zvave zvichida zvikuru mukudziridza chirongwa chemakiriniki kuti udzivirire ma antibiotic-asingagadziri UTI uye zvinokanganisa zvinodikanwa zvekupedzisira-mishonga inorwisa mabhakitiriya-kushandiswa kunowedzera kuwedzera inferno yemishonga inorwisa mabhakitiriya .
Uyezve, chirwere cheTI chinogona kugadzirisa marwadzo uye kusagadzikana kwevakadzi vakadzidza UTI-kunyanya avo vanotambura nevakadzoka, kana vasingagumi, UTI-nokudaro vachivandudza hupenyu hwemamiriyoni.
FimCH Vaccine
Mushonga weFIMCH ndeyeti -antigen inopinza inowanikwa neFimH bakterial adhesion protein.
Puroteni yeFIMH inodiwa eE coli kuti ikwanise kuronga urani. Iyo mishonga inoita kuti zvirwere zvemuviri zvirambe zvichitsvaga chirongwa cheFimH.
Pamusana pekufambira mberi kweproteinini yekuchenesa uye nekuvandudzwa kwezveDNA teknolojia, kana zvichienzaniswa nemishonga yese-masero, zvirwere-antigen zvinowanzozivikanwa mumakore achangopfuura. Uyezve, zvirwere zvakanyanya zve antigen zvinogona kubatanidzwa.
Maitiro anoshandiswa muzvirwere izvi anogona kujekeswa mune imwe yenzira mbiri. Kutanga, vatsvakurudzi vanogona kushandisa masero emhando (kureva, mu vivo) kana mhando dzemhuka. Chechipiri, vachishandura vaccinology inotsvaga, vatsvakurudzi vanogona kufanotaura maitiro anoshanda maitiro. Mushonga weFIMCH wakawanikwa uchishandisa mhando dzemhuka.
Mushonga weFIMCH hausi mutsva. Chakanga chave chirairirwa neMedimmune uye chakapinda chikamu I uye chikamu chechipiri mishonga yemakiriniki isati yanyura kubva pakugadzirwa. Zvakakosha, chirwere chacho chakaonekwa chakachengeteka panguva yechikamu chekutanga I. Sequioa Sciences ndokubva apa chikwata ichi, chakashandura adjuvant, uye chakapinda mumakiriniki. An adjuvant is suspension iyo yakagadzirwa nemushonga uye inoshandiswa kukurudzira zvirwere zvemuviri.
Zvinyorwa, chikamu I kliniki mitsva inyuchi dzinotsvaga pakati pe20 ne100 vatori vechikamu kuti vaongorore kuchengeteka uye kuyerwa kwemishonga.
Chikamu chechipiri chechipatara mutsva inosvika kune mazana evanhu vatori vechikamu uye inotsvaga kubudirira uye kuipa kwemigumisiro yemishonga. Phase III mishonga inokwanisa kuisa zviuru zvevatori vechikamu uye inotsvaga kubudirira uye kutarisa zvinokanganisa.
Maererano nemitauriri yemashupiti, panguva yeSequoia's phase I miedzo yeFIMCH vaccine, chirwere chacho chakanyatsorambidzwa uye chakaita kuti simba rekudzivirirwa mumuviri rive rakasimba. Kunyanya zvakanyanya, vakadzikadzi 67 vakagamuchira chirwere. Pakati pevakadzi ava, 30 vaiva nenhau yezvekare ya UTI yakatora makore maviri. Zvinonzwisisika, migumisiro yezvikamu izvi I kliniki dzemuedzo hazvina kuparidzirwa zviri mumabhuku.
Ndiani Anofanira Kuvharwa?
Vakadzi vane ruzivo rwekare rweUIDS ndivo vakanyatsokodzera chirwere cheTI.
Cystitis, kana utachiona hwehutachiona, hunenge kusvika 90 muzana yeUI yose. Pakati pe20 ne30 muzana yevakadzi ava vanowanazve kudarika mukati memwedzi mitatu kana mana. Kakawandisa UTIs kunokonzera kusagadzikana kwenguva refu uye kurwadziwa uye kunobatsira kumishonga inorwisa mabhakitiriya nokuti vakadzi vane avo vanowanzotora antibiotic munguva yakawanda yegore.
Ive Nedzimwe Mishonga Yakarongedzwa Ichangopfuura?
GlycoVaxyn uye Janssen Pharmaceuticals vave vachishanda kune imwe chirwere chinonzi UTI chinonzi ExPEC4V, iyo inobata chirwere chekudzivirira chirwere cheEcli bioconjugate. MunaFebruary 2017, Huttner uye vanyori-vanyori vakabudisa zviwanikwa kubva muchikamu chekutanga chekuchirapa kwechirwere ichi.
Pose, makumi mapfumbamwe nemashanu vakadzi vakagamuchira chirwere uye vakadzi 95 vakagamuchira placebo. Vadzidzi vacho vaiva pakati pemakore gumi nemasere nemakumi manomwe nemakore uye vaiva nenhoroondo yeUTI inowanzoitika. Mushonga wacho wakanyatsorambidzwa nevagashiri. Uyezve, chirwere ichi chakaita kuti zvirwere zvemuviri zvirambe zvichiita, uye vakadzi vakagamuchira chirwere vakanga vashoma kudarika UTI yakakonzerwa naE coli.
Mukupedzisa, panguva yekuedzwa kwechipatara, chirwere cheFIMCH chakaratidza chivimbiso mukudzivirira UTIs inokonzerwa neE E. coli. Parizvino, chisarudzo chekubvumira chirongwa ichi chiri kuendeswa mberi neDFA. Kana zvichibvumirwa, chirwere ichi chichadzivirira ma antibiotic-asingagumi UTI uye inobatsira zvikuru kuvakadzi vane UTIs zvakare.
> Sources:
> FDA. Kufambisa. www.fda.gov
> Gupta K, Trautner BW. Urinary Tract Infections, Pyelonephritis, uye Prostatitis. Muna: Kasper D, Fauci A, Hauser S, Longo D, Jameson J, Loscalzo J. eds. Harrison's Principles of Internal Medicine, 19e New York, NY: McGraw-Hill.
> Huttner, A, et al. Kuchengetedza, kusagadziriswa kwezvirwere, uye kupera kwechirwere chechirwere chechirwere chinopesana nemafuta ekudzivirira pathogenic Escherichia coli kuvakadzi vane nhoroondo yekugara muchirwere chetachiona zvirwere zvisingagadziriswi, zvisina mapofu, nzvimbo ye-placebo-inodzorwa chirongwa 1b. The Lancet Infectious Diseases. 2017; 17 (5): 528-537.
> O'Brian, VP, et al. Zvinodhaka uye Kufuridzirwa Kwekugadzirira Kurapa nekudzivirira kweUrinary Tract Infections. Microbiology Spectrum. 2016.