Abasetyhini abane-UTIs eziphindaphindiweyo baya kuzuza
Inomdla kwisigonyo se-UTI yavutha kuma-1950, kwaye ukususela ngoko, abaphandi baye bafuna isitofu sokugonywa esithintela ibhaktheriya u-E. coli ekuqheleni i-vestile kwaye ngaloo ndlela uqalise isifo. NgoJulayi ngo-2017, i-FDA inikeze i-SITOIA Sciences ye-FimCH ye-UTI yokugonya ngokukhawuleza. Ukuba ivunyiwe, isitofu sokugonywa kwe-FIMCH siza kuba yitofu lokuqala lokugonywa kwe-UTI e-United States.
Ngokutsho kwe-FDA:
Ukukhawuleza yinkqubo eyenzelwe ukuphucula ukuphuhliswa, nokukhawuleza ukuhlaziywa kweziyobisi ukunyanga izimo ezinzulu kwaye uzalise imfuno yonyango engagqibekanga. Injongo kukufumana ezibalulekileyo iziyobisi kumguli ngaphambili. I-Track Track idibanisa uluhlu olubanzi lweemeko ezinzulu.
Imvelaphi
Kuye kwanda ukwanda kwinani lama-bacterial anti-antibiotics anobangela obunzima bokungenelela kwe-urinary (UTIs) . Ngo-UTI, ukusuleleka kunokwenyuka kwi-bladder (cystitis) kwizintso (pyelonephritis). Ezi zifo ziyakwazi ukusabalalisa egazini elibangele i- sepsis . Ukulimala kweentso, ukulaliswa esibhedlele, kunye nokufa kuba yimiphumo yesifo sobungozi obunzima, obungaphendulwanga.
Ngenxa yeso sengongelo kwimpilo ngamnye kunye nempilo yoluntu, kuye kwaba nomdla omkhulu ekuphuhliseni i-vaccin yegciwane ukukhusela ii-UTIs ezingamelana ne-antibiotic kwaye oko kungavumelani nesidingo semithi-antibiotic yokugqibela-ekusetshenzisweni okubangela ukuba iqhube i-inferno ye-antibiotic resistance .
Ngaphezu koko, isitofu sokugonywa kwe-UTI sinokuphucula intlungu kunye nokungahambi kakuhle kwabasetyhini abaye bafumana u-UTI-ingakumbi abo banesifo esiphindayo, okanye esingapheliyo, i-UTIs-ngoku kuphucula umgangatho wobomi bezigidi.
Ikhutshulwa yi-FimCH
I-vaccin ye-FimCH yinto- ethile-isitofu sokugonywa kwe-antigen equkethe iprotein ye-adhesive ye-FimH.
Iproteinyini ye-FimH iyimfuneko ku-E. coli ukulungiswa kwindlela yokucoca. Isitofu sokugonywa siphucula impendulo yomzimba ukujolisa kwiproteinyini ye-FimH.
Ngenxa yentuthuko yokucoca iprotheni kunye nokuphuhliswa kwetheknoloji ye-DNA, ngokuthelekiswa neentsholongwane zentsholongwane, ezinye izitofu-antigen zithandwa kakhulu kwiminyaka yamuva. Ukongezelela, izitofu ezithile ze-antigen zingabandakanywa.
Ama-antigen asetyenziswe kulezi zitofu angacaciswa ngenye yeendlela ezimbini. Okokuqala, abaphandi bangasebenzisa imifanekiso yamaseli (okt, in vivo) okanye imifanekiso yezilwanyana. Okwesibini, usebenzisa i-vaccinolo ephindaphindiweyo, abaphandi banokuqikelela i-antigens esebenza kakuhle. I-vaccin ye-FIMCH yafunyanwa ngokusebenzisa imizekelo yezilwanyana.
Ukugonya kwe-FIMCH ayikho entsha. Kwakusekuqaleni ilayisenisi yiMedimmune kwaye yangena isigaba I kunye nesigaba sesi-II sezilingo ngaphambi kokuba siphume ekuphuhlisweni. Okubaluleke kakhulu, isitofu sokugonya sithathwa siphephile ngexesha lovavanyo lwecandelo. I-Squioa Sciences yabe ilayisenisi yokugonywa, yatshintsha i-adjuvant, yangena kwiilingo zeclini. I-adjuvant isimiso esenziwe ngokuchanekileyo kwaye isetyenziswe ekuphuculeni iimpendulo zomzimba.
Ingqalelo, isigaba se-I Iimvavanyo zekliniki zifunwa ngabafundi abathathi-20 no-100 ukuvavanya ukhuseleko kunye nokulingana kweziyobisi.
Izilingo zesigaba se-II zonyango zibandakanya ukuya kumaqela athatha inxaxheba kwaye zihlolisise ukuphumelela kunye nemiphumo emibi yeziyobisi. Uvavanyo lweSigaba III lwezonyango lunokubandakanya amawaka abathathi-nxaxheba kwaye luhlolisise ukusebenza nokubeka iliso kwimiphumo emibi.
Ngokutsho kweengxelo zeendaba, ngexesha le-Sequoia isilingo sovavanyo lwe-FIMCH, isitofu sagxininiswe kakuhle kwaye senza ukuba iimpendulo ezinamandla zokuzivikela. Ngokukodwa, abafazi abangama-67 bafumana isitofu. Kula mabhinqa, i-30 inembali ye-UTI ephindaphinda i-2 iminyaka. Ngokuqinisekileyo, iziphumo zezi zigaba zecandelo leemvavanyo zonyango azizange zishicilelwe ngokusemthethweni kwiincwadi.
Ngubani Ofanele Afumane I-Vaccinated?
Abasetyhini abafumana ii-UTIs eziphindaphindiweyo ngabaviwa abafanelekileyo kwi-UTI yokugonya.
I-Cystitis, okanye intsholongwane ye-bladder, ifikelela kuma-90 ekhulwini kuwo onke ama-UTIs. Phakathi kwama-20 ne-30 ekhulwini la mabhinqa bafumana ukuphindaphinda kwiinyanga ezintathu okanye ezine. Iziphumo ze-UTIs eziqhelekileyo zibangelwa ukungahambi kakuhle kunye nentlungu kunye negalelo ekuphikisweni kwamagciwane ngenxa yokuba abasetyhini banamaxesha amaninzi bathabatha i-antibiotics ngexesha elininzi lonyaka.
Ngaba ezinye izitofu zihlolwe kungekudala?
I-GlycoVaxyn kunye neJanssen Pharmaceuticals sele isebenza kwenye i-UTI yokugonya ebizwa ngokuba yi-ExPEC4V, oyisigxina se-E. coli. NgoFebruwari 2017, i-Huttner kunye nababhali-mbhalisi bakhululwe iziphumo ezivela kwizigaba ze-I Iilingo zonyango le-chrome.
Ingqikithi, abafazi abangama-93 bafumana isitofu kunye nabasetyhini abangama-95 bafumana i-placebo. Abathathi-nxaxheba babephakathi kweminyaka eyi-18 no-70 ubudala kwaye banembali ye-UTIs ephindaphindiweyo. Isitofu sagonywa kakuhle ngabafumanayo. Ukongezelela, isitofu sokugonya senze impendulo ebalulekileyo ye-immune, kwaye abasetyhini abafumene isitofu sokugonya babephantsi kwe-UTIs ebangelwa ngu-E. coli.
Ekugqibeleni, ngexesha leemvavanyo zonyango, ukugonya kwe-FIMCH kubonise isithembiso ekukhuseleni ii-UTIs ezibangelwa ngu-E. coli. Njengamanje, isigqibo sokwamkela esi sigxina sichithwa yi-FDA. Ukuba ivunyiwe, le gonyoza iya kuthintela ii-UTIs ezingamelana ne-antibiotics kwaye iya kuba luncedo ngakumbi kubafazi abane-UTIs eziphindaphindiweyo.
> Imithombo:
> FDA. Itrekhi yokubaleka kakhulu. www.fda.gov
> Gupta K, Trautner BW. Izifo Zogqirha ze-Urinary, i-Pyelonephritis, kunye neProstatitis. Ku: Kasper D, Fauci A, Hauser S, uLongo D, Jameson J, Loscalzo J. eds. Imigaqo yeHarrison ye-Medicine yangaphakathi, i-19e eNew York, NY: McGraw-Hill.
> Huttner, A, et al. Ukukhusela, ukukhutshwa kwe-immunogenicity, kunye nokusebenza kwangaphambili kweklinikhi yokuchithwa ngokuchasene ne-Escherichia coli e-pathogenic kwindoda ebhinqa eneempembelelo zokusuleleka kumathambo okhuseleko olulodwa olungabonakaliyo, olulodwa olungaboniyo, olungaboniyo, olulawulwa yi-placebo. Izifo ezithathelwanayo zeLancet. 2017; 17 (5): 528-537.
> O'Brian, VP, et al. Uphuhliso lweMichiza kunye noPhuhliso lweZigqirha kwiNyango kunye nokuKhuselwa kweziNtsholongwane zoTywala. I-Microbiology Spectrum. 2016.