Chirwere Chenguva refu Chinopupurira Chinonyanya Kuwedzera kune Engerix-B
Heplisav-B chirwere chinoshandiswa kudzivirira zvose subtypes ye hepatitis B. Yakagamuchirwa neU.S. Food and Drug Administration (FDA) musi waNovember 9, 2017 kushandiswa kune vanhu vakuru 18 nekure.
Icho chimwe chezvirwere zvitatu zvino kushandiswa kudzivirira utachiona hwehutachiona hweH hepatitis B (HBV) muUnited States. Izvi zvinosanganisira Recombivax HB, iyo yakagamuchirwa neDFA muna 1986, uye mutungamiriri wemusika Engerix-B, iyo yakagamuchirwa mvumo yakafanana muna 2007.
(Ikoko kunewo katatu mushonga wokubatanidza, unozivikanwa seTwinrix , unobata zvirwere zvose zvechipatara A uye B)
Chimwe chezvibatsiro zvikuru zveHeplisav-B ndechokuti inoda majekiseni mashomanana kwenguva shomanana, chimwe chinhu chinogona kubatsira vanhu kupedzisa nhepfenyuro pane kusimira pfupi.
Pakutanga kuchengetedzwa Kunetseka
Kugamuchirwa kwaHeplisav-B kwakave nemakore mana kurwisana kuunza chirwere chekutengesa. Ive FDA yakanga yakarambidza chirwere ichi munaFebruary 2013 uye gare gare munaNovember 2016 nekuda kwekunyanya kunetseka pamusoro pehutano hwehutachiona hwemyocardial infarction (kurwisa kwemwoyo) uye zvimwe zvirwere zvinokonzerwa nemhuka .
Mushonga wacho wakagamuchirwa wakagamuchirwa zvichienderana nekuti inoda bhodhi mbiri dzakapiwa mwedzi mumwe chete. Zvimwe zvirwere, zvakasiyana, zvinoda zvitatu zvakaparadzana nemwedzi uye kwemwedzi mitanhatu.
Izvi zvaifungidzirwa zvakakosha kubva pane chimwe chezvipingamupinyi zvakanyanya kuHBV kupemha kwave kuri kuteerera.
Chidzidzo che 2008 chakaitwa neDhipatimendi reMishonga Inotapukisa paYunivhesiti yeFlorida muJackville yakashuma kuti, vevanhu 707 vakakodzera kuvharwa kweHBV, chete 503 vakawana kurapwa uye 356 chete vakapedzisa katatu-kutema mutsara. Zvimwe zvidzidzo zvakashuma zvakafanana zvinokanganisa zvinokonzera.
Nokuderedza kupesana pakati pejojo, FDA inofunga kuti kubatsirwa kwechirwere ichi kunopfuura zvakanyanya chero zvinogona kuitika.
Kubudirira
Kugamuchirwa kwaHeplisav-B kwaive kwakabva pamashoko kubva mumatambudziko matatu emakiriniki anosanganisira vanopfuura 14 000 vatori vechikamu vakuru. Chidzidzo chinokosha chakafananidza maitiro maviri-dose yeHeplisav-B kusvika kumatare matatu emiti yeEngerix-B. Pakati pevanokwana 6 665 vakabatanidzwa mukudzidza, 95 kubva muzana vakawana zvakakwirira zvekudzivirirwa kubva kunaHeplisav-B (sekuenzaniswa nemabasa anonzi antibody ) zvichienzanisa ne 81 muzana pane Engerix-B.
Mune chidzidzo chechipiri chinosanganisira vanhu 961 vane chirwere cheshuga chechipiri (vanofunga kuti vari pangozi yehepatitis B), Heplisav-B akaudzwa kuti anopa kudzivirirwa kwepamusoro mu 90 muzana yevaya vakapiwa chirwere maererano ne 65 muzana chete kune avo vakapiwa Engerix -B.
Uyezve, Heplisav-B inozivikanwa kuti inodzivirira kune ose mana mana makuru, serotypespes gumi (A kusvika J), uye 40 subgenotype.
Administration
Heplisav-B inoponeswa nejoka remuviri mukati memusoro we deltoid yemapfudzi. Mushonga hausi mushonga unorarama (unorarama, hutachiona hwehutachiona) asi pane hune hutachiona hunogadziriswa antigen-hunoti avatar yehutachiona-iyo haisi kukonzera chirwere asi zvinokurudzira kudzivirira immune response.
Mushure mokunge iwe upiwa injection yokutanga 0.5-milliliter (mL), yechipiri inogona kuiswa mumwedzi mitanhatu.
Kana, nokuda kwechikonzero chipi nechipi, iwe haugoni kupedzisa nhepfenyuro mukati meyo nguva, taura nachiremba wako nezvekupedzisa nyaya yacho nokukurumidza sezvinobvira. Hazvigone kuti iwe unofanira kutangazve nyaya.
Zvakaipa Kuchinja
Kunyange zvazvo vamwe vanhu vangave vachinzwa kupfurwa, maitiro akawanda ndevamwe uye anogadzirisa mukati memazuva mashoma. Kakawanda, maitiro, kana akamboita, anowanzove akaoma zvikuru pashure pekupfura kwekutanga uye zvishoma kana mushure mechipiri.
Zviratidzo zvinowanzoonekwa (zvinowanikwa mumapoka maviri kubva kune varwere) zvinosanganisira:
- Kurira panzvimbo yejojo - 2.3 muzana
- Runyararo panzvimbo yejojo - 4.1%
- Malaise - 9.2 muzana
- Musoro - 16.9 muzana
- Kuneta - 17.4 muzana
- Pain panzvimbo yejojo - 38.5 muzana
Contraindications
Heplisav-B haifaniri kushandiswa kune vanhu vane nhoroondo yekushushikana kwakanyanya kwevaya kana avo vakamboita zvekare kune chirwere che hepatitis B kana chimwe chezvikamu zvayo, kusanganisira mbiriso. Kudzokororazve kunogona kukonzera kukanganisa kuisa upenyu, muviri wose muviri unogadzirisa unonzi Anaphylaxis.
Kusvika parizvino, pakange kusina kuongororwa kwevanhu mumagariro eHeplisav-B panguva yekudzivirira kana kunwisa. Zvisinei, chidzidzo chemhuka chakashuma pasina zviitiko zvakashata mumakonzo emakamu ekurera kana vana vavo mushure me 0.3 mL dose yeHeplisav-B.
Ndiani Anofanira Kuvharwa?
Hepatitis B chirwere chepachiropa chechiropa chinogona kuva chisingaperi uye chinotungamirira ku- cirrhosis , kenza yeropa, uye rufu.
Maererano neshumo inobva kuUnited States Preventive Services Task Force (USPSTF), kubva kune 700,000 kusvika ku 2.2. Mamiriyoni vanhu vanotenda kuti vane HIV neHBV muUnited States. Mahara ehutachiwana akakwirira pakati pevanhu vakuru kusvika kune makumi matatu kusvika ku49, vazhinji vanowatapukirwa nekuita zvepabonde zvisina kudzivirirwa kana kugoverana kushandiswa kwekushandisa .
Hakuna mushonga wehepatitis B, asi kupora kunobatsira kunogona kudzivirira chirwere. Nokuda kwechikonzero ichocho, Komiti Yemazano Emishonga Yokudzivirira (ACIP) uye ikozvino inorayira kuti vana vose vagamuchire mukana wavo wokutanga weHBV pakuberekwa uye kupedzisa nhepfenyuro pakati pemwedzi mitanhatu nemwedzi 18. Vana vakwegura nevechiri kuyaruka vasina kugamuchira chirwere cheHBV vanofanirwawo kuvharwa.
ICentral for Disease Control and Preventions inokurudzira kuti vose vakuru vari pangozi yakakura yeHBV vachengetwe. Izvi zvinosanganisira:
- Munhu anogara naye kana kuti ane zvepabonde nemunhu ane hepatitis B
- Vanhu vane zvepabonde vasingati vari kwenguva refu, hukama hwemumwe chete
- Vanhu vanoda kutsvaga kana kurapwa kwechirwere chepabonde
- Varume vanoita zvepabonde nevarume
- Vanhu vanorarama neHIV
- Vanhu vanogovana nheyo, seringiri, kana zvimwe zvekushandisa zvinodhaka
- Vashandi vehutano uye vamwe vari panjodzi yekuwedzerwa ropa
- Vanhu vane chirwere chepfungwa chekupedzisira
- Vanhu vane chirwere chisingaperi chechiropa
- Vanhu vane chirwere cheshuga vasati vava nemakore makumi matanhatu, vakatanga nekukurumidza mushure mekunge vaongororwa
- Vafambi vemunyika yose vanoenda kune zvikamu zvine mwero kusvika kune yakakwirira yehepatitis B
- Vanhu vakabva kune dzimwe nyika vachienzanisa nehuwandu hwehutachiona hweH hepatitis B kana vana vakaberekerwa nevabereki vakabva kune dzimwe nyika vasati vaberekwa
- Ani naani anozviona ari pangozi
Iko USPSTF haisati ikurudzira HBV kuvhara kwevanhu vakuru vose sezvo tsika yacho isina kuratidzirwa kuderedza dambudziko rehutano hwehutachiwana hunobata kana kufa.
Kucherechedza kuchengetedzwa Kunetseka
Pasinei nekugamuchirwa kwakanaka nevatungamiriri vehutano, hupfumi hunoramba huchirwisa chirwere ichi chakakanganiswa kare neDFA.
Dhiyabhorosi akatanga kukandira chirwere ichi muna 2013 kubva pane chimwe chezvikamu zvayo, chinozivikanwa seCpG 1018. Ichi ndicho chigadzirwa chinoshandiswa kukurudzira zvirwere zvekudzivirira zvirwere zvekuzvidzivirira uye izvo chete izvo zvinoita kuti zvinyorwa zviviri zvitsva.
Maererano neshoko re FDA, CpG 1018 yakatenda kuti ine simba rekugadzirisa zvimwe zvirwere zvinokonzerwa nemoto, kusanganisira chirwere chetachiona. Kunyange zvazvo zvidzidzo zvepakutanga zvisingaratidzi nhamba yakasiyana pakati peHeplisav-B neEngerix-B, chikumbiro chakanga chakarambwa nokuti chiyero chekudzidza panguva iyoyo chakanga chakaonekwa sechidiki.
Nenguva yekudzokorora, vanhu vanosvika 14 238 vakanga varatidzirwa kune chirwere chinokonzerwa neHashimoto's thyroiditis (chirwere chetachiona) uye imwe nyaya yevitiligo yakashuma.
Gare gare, muna 2016, chirwere chacho chakarambidzwawo apo imwe yeruzidzo yakataura nhamba yakawanda kudarika inotarisirwa yezviitiko zvemoyo, kusanganisira mwoyo. Muchiitiko ichi, FDA yakakumbira ruzivo rwakawedzerwa pamusoro pezvinhu zvisiri izvo zvinobatanidzwa zvinogona kubatsira zviri nani kutsanangura mhinduro.
Pamusoro pekuongororwa kwemamwe mashoko, FDA yakapa kugamuchirwa. Mhedziso yekupedzisira yekutonga yakaratidza 0,1 muzana yehutano hwekurwadziwa kwemoyo kune vanhu vakapa Heplisav-B kusvika 0.2% yakapiwa Engerix-B.
> Sources:
> Bailey, C .; Smith, V .; uye Sands, M. "Mushonga weHepatitis B: wegore rechinomwe chidzidzo chekuteerera mitemo yekudzivirira uye kushanda kwevanhu vakuru veHIV-1-vakanaka." International Journal of Infectious Diseases. August 2008; 12 (6): e88-e83. DOI: 10.1016 / j.ijid.2008.05.1226.
> Centres for Disease Control and Prevention. "Kuwedzera kwekudzivirira zvirwere zvekudzivirira kutapurika kweHerititis B Virus Infection muUnited States - Mazano eDare Rinokurudzira rekudzivirira Kuvhara (ACIP) Chikamu 1: Kuvharirwa kwevana, Vana, uye Vana Vachiri kuyaruka." Kurasika uye Kufa Kwevhiki Yevhiki (MMWR) . December 2005; 54 (RR16): 1-23.
> Janssen, R .; Bennett, S ;; Namini, H. et al. "Immunogenicity nekuchengeteka kweMakiro maviri eInvestigational Heplisav Kuenzaniswa neTatu Doses yeChirongwa cheHerpatitis B Vaccine (Engerix B) muZviri Phase 3 Miedzo." Journal of Hepatology. April 2013; 58 (Suppl 1): S574. DOI: 10.1016 / S0168-8278 (13) 61425-7.
> US Food and Drug Administration. "Pfungwa Dzokunyora Mashoko (Heplisav-B) ." Silver Spring, Maryland; yakabudiswa muna November 2017.
> US Preventive Services Task Force. "Kupedzisira Kunyoreswa Nheyo: Hepatitis B Virus Infection: Kuongorora, 2014." Rockville, Maryland; yakarongedzwa muna December 2016.