Katemera Wotalika Kwambiri Umatsimikizira Kuposa Engerix-B
Heplisav-B ndi katemera woteteza matenda onse a chiwindi a B. Inavomerezedwa ndi US Food and Drug Administration (FDA) pa November 9, 2017 kuti agwiritsidwe ntchito kwa akulu akulu 18 ndi akulu.
Ndi imodzi mwa katemera katatu yomwe ikugwiritsidwa ntchito popewera matenda kuchokera ku matenda a hepatitis B (HBV) ku United States. Izi zikuphatikizapo Recombivax HB, yomwe inavomerezedwa ndi FDA mu 1986, ndi mtsogoleri wa malonda Engerix-B, omwe adalandira chivomerezo chomwecho mu 2007.
(Palinso katemera wothandizira katatu, wotchedwa Twinrix , omwe amachiza matenda a hepatitis A ndi B.)
Chimodzi mwa mapindu aakulu a Heplisav-B ndi chakuti amafunika jekeseni ochepa pafupikitsa nthawi, chinthu chomwe chingathandize anthu kumaliza mndandanda osati kusiya.
Poyamba Kuda nkhawa
Chivomerezo cha Heplisav-B chinagonjetsa zaka zinayi zolimbana ndi katemera kuti agulitse. A FDA anali atakana kale mankhwalawa mu February 2013 ndipo kenako mu November 2016 chifukwa cha nkhawa zokhudzana ndi chiopsezo choopsa cha matenda a mtima wam'mimba komanso matenda enaake.
Katemerayo pomalizira pake anavomerezedwa makamaka chifukwa chakuti amafunika kuti zipolopolo ziwiri zithetsedwe mwezi umodzi padera. Katemera wina, mosiyana, amafunikira katemera katatu kamodzi kamodzi ndi miyezi isanu ndi umodzi.
Izi zinkawoneka kuti ndi zofunika chifukwa chimodzi mwazitsulo zazikulu zowononga katemera wa HBV zakhala zikutsatira.
Phunziro la 2008 la Dipatimenti ya Matenda Opatsirana ku Yunivesite ya Florida ku Jacksonville linati, anthu 707 oyenerera katemera wa HBV, ndi 503 okha omwe adalandira chithandizo ndipo 356 okha ndi amene amaliza masewera atatu. Maphunziro ena awonanso zotsatira zovuta.
Mwa kuchepetsa kusiyana pakati pa jekeseni, a FDA amakhulupirira kuti phindu la katemera limaposa zotsatira zake zonse.
Mphamvu
Chivomerezo cha Heplisav-B chinali chochokera pazitsulo kuchokera ku mayesero atatu a zachipatala okhudzana ndi anthu akuluakulu oposa 14,000. Kuphunzira kwakukulu kunayerekeza njira ya mawiri ya Heplisav-B ku mndandanda wa madola atatu a Engerix-B. Mwa anthu 6,665 omwe amaphunzira nawo, 95 peresenti yafika pamtunda wotetezedwa kuchokera ku Heplisav-B (monga kuyesedwa ndi ntchito ya antibody ) poyerekeza ndi 81 peresenti pa Engerix-B.
Phunziro lachiwiri lophatikizapo anthu 961 omwe ali ndi matenda a shuga a mtundu wa 2 (omwe amawoneka kuti ali pachiopsezo chachikulu cha chiwindi cha mtundu wa B), Heplisav-B adanenedwa kuti amapereka chitetezo chapamwamba pa 90 peresenti ya omwe amapatsidwa katemera oposa 65 peresenti mwa iwo omwe anapatsidwa Engerix -B.
Komanso, Heplisav-B amadziwika kuti amateteza kumagulu onse akuluakulu anayi, khumi ndi awiri (A kupyolera mwa J), ndi makumi asanu ndi awiri (40).
Ulamuliro
Heplisav-B imaperekedwa ndi jekeseni ya m'mimba kumtunda wamtundu wa m'mapewa. Katemerayu si katemera wamoyo (okhala ndi moyo, wofooketsa kachilomboka) koma m'malo mwake ali ndi genetically modified antigen -yomwe imakhala ndi avatar ya kachilombo-yomwe siimayambitsa matenda koma m'malo mwake imalimbikitsa chitetezo cha mthupi.
Mukapatsidwa jekeseni loyamba la 0.5-milliliter (mL), lachiwiri lidzaperekedwa miyezi isanu ndi umodzi.
Ngati, pa chifukwa chilichonse, simungathe kumaliza mndandanda mkati mwa nthawi imeneyo, lankhulani ndi dokotala wanu za kumaliza mwamsanga mndandandawu. N'zosatheka kuti muyambe kuyambanso mndandanda.
Zotsatira Zovuta
Ngakhale anthu ena atha kuwombera, maulendo ambiri ndi ofatsa ndipo amakonza mkati mwa masiku angapo. Mwachidziwikire, zomwe zimachitika, ngati zilipo, zimakhala zovuta kwambiri pambuyo poyombera koyamba komanso osachepera pambuyo pake.
Zizindikiro zofala kwambiri (zomwe zimachitika pa oposa awiri peresenti ya odwala) zikuphatikizapo:
- Kutupa pa malo opangira injection - 2.3 peresenti
- Kufiira pa malo ojambulira - 4.1 peresenti
- Malaise - 9.2 peresenti
- Mutu - 16.9 peresenti
- Kutopa - 17.4 peresenti
- Ululu pa malo opangira injection - 38.5 peresenti
Contraindications
Heplisav-B sayenera kugwiritsidwa ntchito kwa anthu omwe ali ndi mbiri ya zotsatira zoopsa kapena omwe apita kale ku katemera wa hepatitis B kapena mbali zake zonse, kuphatikizapo yisiti. Kuwonetsanso kachiwiri kungapangitse kuti pakhale moyo wowopsya, thupi lonse lopweteka lomwe limatchedwa anaphylaxis.
Mpaka pano, sipanakhale maphunziro aumunthu pa zotsatira za Heplisav-B panthawi yoyembekezera kapena kuyamwitsa. Komabe, phunziro la zinyama silinena zochitika zovuta zomwe zimakhala ndi makoswe a makapu oyembekezera kapena ana awo potsatira mlingo wa 0.3mL wa Heplisav-B.
Ndani ayenera kulandira katemera
Hepatitis B ndi matenda a chiwindi a chiwindi omwe angathe kukhala aakulu ndipo amachititsa matenda a chiwindi , khansa ya chiwindi, ndi imfa.
Malinga ndi lipoti lochokera ku US Preventive Services Task Force (USPSTF), kulikonse kuchokera 700,000 mpaka 2.2. Anthu mamiliyoni amakhulupirira kuti ali ndi kachirombo ka HBV ku United States. Matenda amtunduwu ndi apamwamba kwambiri pakati pa anthu akuluakulu 30 mpaka 49, ambiri amene amachilomboka kudzera mu kugonana kosatetezedwa kapena kugwiritsidwa ntchito pogwiritsa ntchito singano .
Palibe mankhwala a chiwindi cha B, koma katemera wathanzi akhoza kuteteza matendawa. Pachifukwachi, Komiti Yopereka Malangizo Odziletsa (Immagine Practices) (ACIP) ndipo akulangiza kuti ana onse alandire chithandizo choyamba cha HBV pa kubadwa ndi kumaliza mndandanda wa miyezi isanu ndi umodzi ndi 18. Ana okalamba ndi achinyamata omwe sanalandire katemera wa HBV ayenera kupewedwanso.
Zomwe Zimayambitsa Matenda ndi Zowonongeka zimaperekanso kuti onse akuluakulu omwe ali pangozi yaikulu ya HBV ayenera katemera. Izi zikuphatikizapo:
- Munthu amene amakhala naye kapena kugonana ndi munthu yemwe ali ndi chiwindi cha mtundu wa B
- Anthu ogonana omwe sali pa nthawi yayitali, mgwirizano wamodzi wokhawokha
- Anthu ofuna kuyesedwa kapena mankhwala pa matenda opatsirana pogonana
- Amuna omwe amagonana ndi amuna
- Anthu omwe ali ndi HIV
- Anthu omwe amagawana singano, sering'i, kapena zinthu zina zamagetsi
- Ophunzira zaumoyo ndi ena omwe ali pachiopsezo chotenga magazi
- Anthu omwe ali ndi matenda a impso otsiriza
- Anthu omwe ali ndi matenda aakulu a chiwindi
- Anthu omwe ali ndi shuga osakwana zaka 60, adayamba mwamsanga atatha kupeza matenda
- Anthu oyenda m'mayiko osiyanasiyana kupita kumadera okhala ndi chiwindi chapamtunda B
- Anthu omwe achoka ku mayiko omwe ali ndi matenda oopsa kwambiri a chiwindi cha mtundu wa B kapena ana obadwa ndi makolo omwe achoka ku mayiko awo asanabadwe
- Aliyense amene amadziona kuti ali pangozi
USPSTF sichilandira katemera wa HBV kwa anthu achikulire momwe ntchitoyi sinawonetsere kuchepetsa chiopsezo cha matenda okhudzana ndi chiwindi kapena imfa.
Kufufuza Kusamala Kumavuto
Mosasamala kanthu kovomerezeka kwambiri ndi akuluakulu a zaumoyo, magulu oteteza chitetezo akupitirizabe kufala katemera omwe amatsutsidwa ndi a FDA.
Dera la FDA linakana katemerayo mu 2013 pogwiritsa ntchito chimodzi mwa zigawo zake, zomwe zimadziwika kuti CpG 1018. Izi ndizigawo zomwe zimagwiritsidwa ntchito kupititsa patsogolo katemera wa chitetezo cha chitetezo komanso omwe amachititsa kuti mndandandawu ukhale wovuta.
Malingana ndi yankho la FDA, CpG 1018 imakhulupirira kuti ikhoza kuyambitsa matenda enaake, kuphatikizapo matenda a chithokomiro. Ngakhale kuti maphunziro oyambirira sanawonetsere kusiyana kwa chiwerengero pakati pa Heplisav-B ndi Engerix-B, ntchitoyi inatsutsidwa kokha chifukwa kukula kwa phunzirolo pa nthawiyo kunali kochepa kwambiri.
Panthawi yofunsidwa, anthu okwana 14,238 anapezeka pa katemera omwe ali ndi matenda awiri okha a Hashimoto's thyroiditis (mtundu wa matenda a chithokomiro) komanso vuto lina la vitiligo .
Pambuyo pake, mu 2016, katemerawo anakanidwa pamene kafukufuku wina adalemba chiwerengero chachikulu cha zochitika za mtima, kuphatikizapo matenda a mtima. Pankhaniyi, a FDA anapempha zambiri zokhudzana ndi zinthu zina zomwe sizingagwirizane zomwe zingathandize bwino kufotokoza zotsatira.
Powonongeka kwa deta yowonjezera, a FDA adavomereza. Zotsatira zomaliza zowononga zimapereka chiopsezo cha 0.1 peresenti ya matenda a mtima mwa anthu omwe anapatsidwa Heplisav-B motsutsa 0.2 peresenti yopatsidwa Engerix-B.
> Zotsatira:
> Bailey, C .; Smith, V .; ndi Sands, M. "Chitetezo cha Hepatitis B: kafukufuku wazaka zisanu ndi ziŵiri zotsatila malangizo okhudzana ndi katemera ndi mphamvu ku anthu akuluakulu omwe ali ndi kachirombo ka HIV." International Journal of Infectious Diseases. August 2008; 12 (6): e88-e83. DOI: 10.1016 / j.ijid.2008.05.1226.
> Zolinga za Kuletsa ndi Kuteteza Matenda. "Njira Yopangidwira Kwambiri Yopewera Kuteteza Kutentha kwa Chiwindi cha Edzi ku United States - Malangizo a Komiti Yopereka Malangizo Omwe Amapezerapo Katemera (ACIP) Gawo 1: Kutsekemera kwa Ana, Ana, ndi Achinyamata." Kukonzanso kwa mlungu ndi mlungu (MMWR) . December 2005; 54 (RR16): 1-23.
> Janssen, R .; Bennett, S .; Namini, H. et al. "Kusadziwika ndi Kutetezeka kwa Machitidwe Ofufuzira Ambiri a Heplisav Poyerekeza ndi Mavoti atatu Oletsedwa a Hepatitis B Vaccine (Engerix B) mu Mayesero Awiri Achitatu." Journal of Hepatology. April 2013; 58 (Suppl 1): S574. DOI: 10.1016 / S0168-8278 (13) 61425-7.
> Utsogoleri wa US Food and Drug Administration. "Mfundo zazikulu zofotokozera (Heplisav-B) ." Silver Spring, Maryland; adatulutsidwa mu November 2017.
> US Preventive Services Task Force. "Mawu Otchulidwa Otsiriza: Hepatitis B Vuto: Kutsegula, 2014." Rockville, Maryland; zasinthidwa mwezi wa 2016.