I-Vaccine Edelelekile Ibonisa Ukuphakama Ku-Engerix-B
U-Heplisav-B ngumgomo wokuvimbela wonke ama-subtypes we- hepatitis B. Yamukelwa yi-US Food and Drug Administration (FDA) ngoNovemba 9, 2017 ukuze isetshenziswe kubantu abadala 18 nangaphezulu.
Ngenye yemithi emithathu okwamanje esetshenziselwa ukuvimbela ukutheleleka kusuka ku- virus ye - hepatitis B (HBV) e-United States. Lezi zihlanganisa i-Recombivax HB, eyamukelwa yi-FDA ngo-1986, nomholi wemakethe Engerix-B, eyanikwa imvume efanayo ngo-2007.
(Kukhona nomuthi wokugoma wesithathu wokuhlanganiswa, owaziwa ngokuthi yi- Twinrix , okugoma ngokubili kokubili kwesifo sofuba no-B.)
Enye yezinzuzo ezinkulu zeHeplisav-B ukuthi kudinga ukujova okuncane kunesikhathi esifushane, isici esingasiza abantu ukuqedela uchungechunge kunokuba bayeke.
Ukukhathazeka kokuqala kokuphepha
Ukwamukelwa kukaHeplisav-B kwathinteka umzabalazo weminyaka emine ukuletha umgomo wokuthengisa. I-FDA yayiphambene nalesi sidakamizwa ngoFebruwari 2013 futhi kamuva ngoNovemba 2016 ngenxa yokukhathazeka ngokuphepha mayelana neengozi engaba khona ye -infarction ye-myocardial (ukushaya kwenhliziyo) kanye nezifo ezithile ezizimele .
Umgomo wokugcina wagunyazwa ngokusekelwe ikakhulukazi ukuthi kudinga ukudubula okubili okulethwa ngenyanga eyodwa. Leminye imithi, ngokuphambene, idinga izihluthulelo ezintathu ezihlukaniswe ngenyanga kanye nezinyanga eziyisithupha.
Lokhu kubhekwa njengento ebalulekile ngoba enye yezingqinamba ezinkulu ekugonyeni kwe-HBV kuye kwaba ukunamathela.
Ucwaningo lwango-2008 olwenziwa nguMnyango Wezifo Eziphefumulayo eYunivesithi yaseFlorida eJackville, kubike ukuthi, abantu abangu-707 abafanelekile ukugonywa kwe-HBV, kuphela ukutholakala kokwelashwa okungu-503 futhi kuphela 356 abaqede uchungechunge oluthathu. Ezinye izifundo ziye zabika imiphumela efanayo ehlukumezayo.
Ngokunciphisa igebe phakathi kwezijovo, i-FDA ikholelwa ukuthi izinzuzo zomuthi wokugoma zikhulu kakhulu kunoma yimuphi umphumela ongase ube khona.
Ukuphumelela
Ukwamukelwa kukaHeplisav-B kwakuncike emininingweni evela emilingo emithathu yokuhlolwa kwemithi ebandakanya abahlanganyeli abangaphezu kuka-14 000 abadala. Ucwaningo olubalulekile lwaqhathanisa inkambo emibili ye-Heplisav-B eya ochungechungeni lwezintathu ezintathu ze-Engerix-B. Phakathi kwabangu-6 665 ababambe iqhaza kulolu cwaningo, amaphesenti angama-95 azuze amazinga aphakeme okuvikela kuHeplisav-B (njengoba kulinganiswa umsebenzi we-antibody ) uma kuqhathaniswa namaphesenti angu-81 ku-Engerix-B.
Esifundweni sesibili esibandakanya abantu abangu-961 abane-type 2 yesifo sikashukela (abhekwa njengengozi enkulu yokushona kwesibindi B), uHeplisav-B kubikwe ukuthi uzohlinzeka ngokuvikelwa okusezingeni level ezingamaphesenti angama-90 alabo abanikezwa umgomo ngokulingana namaphesenti angu-65 kuphela kulawo anikwe i-Engerix -B.
Ngaphezu kwalokho, u-Heplisav-B waziwa ukuhlinzeka ukuvikelwa kuzo zonke izinhlobo ze-serotypes ezine ezinkulu, ama-genotypes ayishumi (A ngokusebenzisa i-J), nama-subgenotype angu-40.
Ukuphatha
I-Heplisav-B inikezwa umjovo wesibeletho engxenyeni ephezulu ye-deltoid yehlombe. Umgomo awuwona umgomo wokuphila (oqukethe igciwane ephilayo, obuthakathaka) kodwa kunalokho uqukethe i-antigen genetically modified antigen-ngokuyinhloko i-avatar yegciwane-engabangeli izifo kodwa kunalokho ivuselela ukuphendula kwamagciwane okuzivikela.
Ngemuva kokuba unikezwe injection yokuqala ye-0.5-milliliter (mL), okwesibili kuzonikezwa ezinyangeni eziyisithupha.
Uma, nganoma yisiphi isizathu, awukwazi ukuqedela uchungechunge phakathi naleso sikhathi, khuluma nodokotela wakho mayelana nokuqedela uchungechunge ngokushesha ngangokunokwenzeka. Akungabazeki ukuthi kuzodingeka uqalise kabusha uchungechunge.
Ukusabela okubi
Ngenkathi abanye abantu bengase basabele ekuphenduleni, amacala amaningi abumnene futhi axazulule ezinsukwini ezimbalwa. Ngokuvamile, ukusabela, uma kunjalo, kuvame ukuba okujulile ngokulandela ukudubula kokuqala futhi kancane ngemuva kwesibili.
Izimpawu ezivame kakhulu (ezenzeka ezingaphezu kwamaphesenti amabili weziguli) zifaka:
- Ukuvuvukala endaweni yomjovo - amaphesenti angu-2.3
- Ukubomvu endaweni yokujova - amaphesenti angu-4.1
- UMalaise - amaphesenti angu-9.2
- Amakhanda - amaphesenti angu-16.9
- Ukukhathala - amaphesenti angu-17.4
- Ubuhlungu esakhiweni somjovo - amaphesenti angu-38.5
Ukungafani
I-Heplisav-B akufanele isetshenziswe kubantu abanomlando wokuzizwa okunzima kakhulu noma labo abaye baphenduka ngaphambi kokugonywa kwe-hepatitis B noma yiziphi ezinye izingxenye zayo, kufaka phakathi imvubelo. Ukungabonakali kabusha kungaholela ekusongeni ukuphila, umzimba wonke wokuziphendulela obizwa ngokuthi i-anaphylaxis.
Kuze kube manje, akuzange kube khona izifundo zomuntu ezenzakalweni zikaHeplisav-B ngesikhathi sokukhulelwa noma ukuncelisa. Kodwa-ke, isifundo sezilwane asibikezeli izenzakalo ezimbi kunoma yikuphi amakilabhu webele labakhulelwe noma inzalo yabo emva kwesilinganiso esingu-0.3 mL se-Heplisav-B.
Ngubani okufanele athole igciwane
I-Hepatitis B iyisifo segciwane lesibindi esingasiguli futhi siholela e- cirrhosis , umdlavuza wesibindi, nokufa.
Ngokusho kombiko we-US Preventive Services Task Force (USPSTF), noma yikuphi kusuka ku-700,000 kuya ku-2.2. abantu abayizigidi bakholelwa ukuthi bane-HBV e-United States. Amanani okutheleleka aphezulu phakathi kwabantu abadala kuya ku-30 kuya ku-49, iningi lalabo abangenwa yingculaza engavikelekile noma abasebenzisa inaliti esetshenziswayo .
Ayikho ikhambi ye-hepatitis B, kepha ukugoma okusebenzayo kungavimbela lesi sifo. Ngenxa yalesi sizathu, iKomidi Elilulekayo Lokuzivocavoca (ACIP) futhi okwamanje lincoma ukuthi zonke izingane zithole umthamo wazo wokuqala we-HBV ngesikhathi sokuzalwa bese uqedela uchungechunge oluphakathi kwezinyanga eziyisithupha nesishiyagalolunye. Izingane ezindala nezintsha ezingazange zithole umgomo we-HBV kufanele nazo zigonywe.
I-Centers for Disease Control and Proventions iphinde ikhuthaze ukuthi bonke abadala abasengozini enkulu ye-HBV bagonywe. Lokhu kufaka:
- Umuntu ohlala naye noma ocansini nomuntu one-hepatitis B
- Abantu abanocansi abangenalo isikhathi eside, ubudlelwane bomunye nomunye
- Abantu abafuna ukuhlolwa noma ukwelashwa ngesifo socansi
- Amadoda alala nobulili namadoda
- Abantu abaphila negciwane lesandulela ngculazi
- Abantu ababelana ngezinaliti, izilinganiso, noma ezinye izidakamizwa
- Ochwepheshe bezempilo kanye nabanye abasengozini yokuchayeka kwegazi
- Abantu abanesifo sengqondo sokuphela kwezinso
- Abantu abanezifo ezingapheli zesibindi
- Abantu abanesifo sikashukela abangaphansi kweminyaka engama-60, baqala ngokushesha ngemuva kokuxilongwa
- Abahambi bamazwe ngamazwe baya ezifundeni ezinezilinganiso eziphezulu ukuya kwesilinganiso esiphakeme se-hepatitis B
- Abantu abaye basuka emazweni abanomthelela kuya emazingeni aphezulu we-hepatitis B noma abantwana abazalwa abazali abaye basuka kula mazwe ngaphambi kokuzalwa kwabo
- Noma ubani ozibheka njengengozini
I-USPSTF okwamanje ayincoma ukugonywa kwe-HBV kubantu abaningi abadala njengoba umkhuba ungazange uboniswe ukunciphisa ubungozi bokugula noma ukufa okuhlobene nesibindi.
Ukuhlola ukukhathazeka kokuphepha
Naphezu kokwamukelwa okuhle yizikhulu zezempilo zomphakathi, ukukhathazeka kokuphepha kuqhubeka nokushaya umgomo wokugonywa kokuqala yi-FDA.
I-FDA yaqala ukwenqaba umuthi wokugoma ngo-2013 ngokusekelwe kwesinye sezingxenye zayo, eyaziwa njengeCpG 1018. Leli yinkimbinkimbi esetshenziselwa ukukhulisa amandla omzimba wokugoma omzimba kanye nomunye owenza uchungechunge lwezinto ezimbili.
Ngokusho kwe-FDA impendulo, i-CpG 1018 ikholelwa ukuthi inamandla okubangela ukukhathazeka okuthile okuzimele, kuhlanganise nesifo se-thyroid. Ngenkathi izifundo zakuqala zingabonisi umehluko wezibalo phakathi kukaHeplisav-B no-Engerix-B, isicelo saphikiswa nje ngoba ubukhulu besifundo ngaleso sikhathi babhekwa njengabancane kakhulu.
Ngesikhathi sokuphindaphinda, abantu abangu-14 238 babethelwe emtholampilo abanezimpawu ezimbili kuphela ze- Hashimoto's thyroiditis (uhlobo lwesifo segciwane) kanye necala elilodwa le- vitiligo elibikiwe.
Kamuva, ngo-2016, lo mgomo nawo wanqatshwa lapho isifundo esisodwa sichaza inombolo enkulu kunalindelekile yemicimbi yezinhliziyo, kuhlanganise nokuhlaselwa kwenhliziyo. Kulesi simo, i-FDA icele imininingwane eyengeziwe mayelana nanoma yiziphi izici ezingahlosiwe ezingasiza ekuchazeni kangcono imiphumela.
Phezu kokubuyekezwa kwedatha eyengeziwe, i-FDA inikeze imvume. Imiphumela yokugcina yesigameko ibike ingozi yesilinganiso esingu-0.1% yokuhlaselwa kwenhliziyo kubantu abanikezwa i-Heplisav-B ngokumelene namaphesenti angu-0.2 anikwe i-Engerix-B.
> Imithombo:
> Bailey, C .; Smith, V .; kanye ne-Sands, M. "Ukugonywa kwe-Hepatitis B: isifundo seminyaka eyisikhombisa sokunamathela emitholampilo yokugoma nokusebenza kubantu abadala abane-HIV-1." I- International Journal of Infectious Diseases. Agasti 2008; 12 (6): e88-e83. I-DOI: 10.1016 / j.ijid.2008.05.1226.
> Amasevisi Okulawula Nokuvimbela Izifo. " Isisombululo Sokugoma Okuphelele Ukuqeda Ukwedluliswa Kwe- Hepatitis B Virus Infection e-United States - Izincomo zeKomidi Eluleka Ngezindlela Zokugoma (ACIP) Ingxenye 1: Ukugonywa Kwezingane, Izingane Nezingane Zakhudlwana." Ukuhlaziywa Kwamaviki Namaviki Ukubukezwa Kwamaviki (MMWR) . Disemba 2005; 54 (RR16): 1-23.
> Janssen, R .; UBennett, uS .; UNamini, H. et al. "Immunogenicity and Safety of Two Doses of Investigational Heplisav Ngokuqhathaniswa Nezintathu Ze-I-Hepatitis B Yokugoma Ilayisensi (Engerix B) Ezivivinyo Zesibili Sigaba 3." Journal of Hepatology. Ephreli 2013; 58 (I-Suppl 1): S574. I-DOI: 10.1016 / S0168-8278 (13) 61425-7.
> Ukuphathwa Kwezokudla Nezidakamizwa zase-US. "Amaphuzu avelele ekuchazeni ulwazi (Heplisav-B) ." Silver Spring, Maryland; ikhishwe ngoNovemba 2017.
> I-US Preventive Services Task Force. Isitatimende Sokugcina Esiphakanyisiwe: I-Hepatitis B Virus Infection: Ukuhlolwa, 2014. "Rockville, Maryland; ibuyekeziwe ngo-December 2016.