Isifo sokugonya esilinde ixesha elide sibonisa ukuba sikhezulu kwi-Engerix-B
I-Heplisav-B isitofu sokugonywa esetyenziselwa ukuthintela zonke i-subtypes ze- hepatitis B. Yavunywe yi-US Food and Drug Administration (FDA) ngoNovemba 9, 2017 ukuze isebenzise kubantu abadala 18 nangaphezulu.
Ingomnye wezithathu zokugonya ezisetyenziswayo ukukhusela intsholongwane evela kwintsholongwane ye- hepatitis B (HBV) e-United States. Ezi ziquka i-Recombivax HB, eyavunywa yi-FDA ngowe-1986, kunye nomlawuli weemarike u-Engerix-B, owanikwa imvume efanayo ngo-2007.
(Kukho nesigxina sesithathu sokugonywa, esaziwa njengeTwinrix , esigonyo ngokuchasene ne-hepatitis A kunye no-B.)
Enye yeenzuzo ezinkulu zeHeplisav-B kukuba ifuna injections embalwa ngaphantsi kwexesha elifutshane, into enokukunceda abantu bazalise iichungechunge kunokuba bayeke.
Ukukhathazeka kokuqala
Ukuvunyelwa kwe-Heplisav-B kwathintela umzabalazo weminyaka emine ukuzisa isitofu sokuthengisa. I-FDA yayilahlile ngaphambili isilwanyana ngo-Febhuwari 2013 kwaye kamva ngoNovemba 2016 ngenxa yokukhathazeka ngokukhuselekileyo malunga nomngcipheko omkhulu we -myocardial infarction (isifo senhliziyo) kunye nezifo ezithile ezizimele .
Ugqirha wagqitywa ekugqibeleni ngokusekelwe ngokukodwa kwinto yokuba kudinga iibhotshi ezimbini ngaphandle kwenyanga enye. Ezinye izitofu, ngokuchaseneyo, zidinga izihlunu ezintathu ezahlukana ngenyanga enye emva kweenyanga ezintandathu.
Oku kubonwa njengento ebalulekileyo kuba enye yezona ziphazamiso ezinkulu kwi-HBV yokugonywa zihambelane.
Ucwaningo olwenziwa ngo-2008 yiSebe leZifo ezithathelwanayo kwiYunivesithi yaseFlorida e-Jacksonville libikile ukuba, abantu abangama-707 abanelungelo lokugonywa kwe-HBV, kuphela i-503 yokufumana unyango kunye ne-356 kuphela. Olunye uphando luchaze neziphumo eziphazamisayo ezifanayo.
Ngokunciphisa isikhala phakathi kweenjini, i-FDA ikholelwa ukuba iinzuzo zesigonyilo zigqithise kakhulu naziphi na iziphumo.
Impumelelo
Ukuvunyelwa kwe-Heplisav-B kwakusekelwe kwiinkcukacha ezivela kwizilingo ezintathu zonyango ezibandakanya abathathi-nxaxheba abangaphezu kwe-14,000. Uvavanyo oluphambili luqhathanisa izifundo ezimbini ze-Heplisav-B ukuya kwichungechunge lomthamo we-Engerix-B. Phakathi kwabangu-6 665 abathathi-nxaxheba ababandakanyekayo ekufundeni, amaphesenti angama-95 aphumelele amanqanaba aphezulu okukhusela kuHeplisav-B (njengoko kulinganiswa ngumsebenzi wophulophu ) xa kuthelekiswa nama-81 ekhulwini kwi-Engerix-B.
Kwisifundo sesibini esibandakanya abantu abangama-961 abane-type 2 yeswekile yesifo sikashukela (esicatshulwa ukuba basemngciphekweni omkhulu we-hepatitis B), uHeplisav-B wachazwa ukubonelela ngokukhuseleka kwinqanaba eliphezulu kuma-90 ekhulwini abo banikwe igonyamelo ngokumalunga nama-65 ekhulwini kulawo anikeziweyo. -B.
Ngaphezu koko, i-Heplisav-B yaziwa ngokukhusela kuzo zonke ezine ezine-serotypes ezinkulu, i-genotype ezilishumi (A ngeJ) kunye nama-subgenotypes angama-40.
Lawulo
I-Heplisav-B ihanjiswa ngumjovo weesram kwi-upper muscle of shoulder. Ukugonywa akusiyo isitofu esiphilayo (esinezinto eziphilayo, ezinobuthakathaka), kodwa kunokuba iqulethe i-antigen-i-avatar egugu-isifo esingazibangela izifo kodwa kunokuba ivuselele iimpendulo zomzimba.
Emva kokunikezelwa kwe-0.5-milliliter (mL) injection yokuqala, yesibini iya kuhanjiswa kwiinyanga ezintandathu.
Ukuba, nangaliphi na isizathu, awukwazi ukugqiba iilumnxeba ngelo xesha, uthetha ugqirha wakho malunga nokugqiba iichungechunge ngokukhawuleza. Akunakwenzeka ukuba kufuneka uqalise kwakhona uchungechunge.
Izimpembelelo ezimbi
Ngelixa abanye abantu bangasabela njani kwisibheno, amaninzi amaninzi ayenzileyo kwaye azisombulule kwiintsuku ezimbalwa. Ngokubanzi, iimpendulo, ukuba zikhona, zivame ukuba zinzulu ngakumbi emva kokudubula kokuqala kwaye zingaphantsi emva kweyesibini.
Iimpawu eziqhelekileyo (ezenzeka ngaphezu kweepesenti ezimbini zezigulane) ziquka:
- Ukuvuvukala kwiziko lokungenwa - 2.3 pesenti
- Ubomvu kwiziko lokuxilisa - iipesenti ezi-4.1
- Malaise - iipesenti ezi-9.2
- Intloko - 16.9 ekhulwini
- Ukukhathala - iipesenti ezingama-17.4
- Ubuhlungu kwisiza sokungeniswa - i-38.5 ekhulwini
Ukungqinelana
I-Heplisav-B ayifanele isetyenziswe kubantu abaneembali ezinzima zokuphendula okanye abaye baphendulwa kwangaphambili kwisifo sokugonya kwe-hepatitis B okanye nayiphi na into yayo, kuquka imvubelo. Ukuchazwa kwakhona kwakhona kunokubangela ukuba usongele ubomi, umzimba wonke uphendule okubizwa ngokuba yi-anaphylaxis.
Ukuza kubekho namhlanje, akubangakho uphando lwabantu kumphumo weHeplisav-B ngexesha lokukhulelwa okanye ukuncelisa. Nangona kunjalo, uphando lwezilwanyana alubikho iziganeko ezingathandekiyo kwimiba yeebhan ekhulelweyo okanye inzala yabo emva kwe-0.3 mL dose yeHeplisav-B.
Ngubani omele afumane i-Vaccinated
I-Hepatitis B yintsholongwane ye-virus yesibindi esingaba sisigxina kwaye iholele kwi- cirrhosis , umdlavuza wesibindi kunye nokufa.
Ngokombiko ovela kwi-US Preventive Services Task Force (USPSTF), naphi na kwi-700,000 ukuya kwi-2.2. izigidi zabantu bakholelwa ukuba unesifo se-HBV e-United States. Amaxabiso okusuleleka aphezulu phakathi kwabantu abadala ukuya ku-30 ukuya ku-49, abaninzi banesifo ngenxa yesini esingakhuselekanga okanye ukusetyenziswa kwesalane esabelana .
Akukho nonyango ye-hepatitis B, kodwa ukugonywa ngempumelelo kunokukhusela isifo. Ngenxa yeso sizathu, iKomidi elicebisi ngeZenzo zokuNgcwaba (ACIP) kwaye okwangoku licebisa ukuba bonke abantwana bafumane umthamo wokuqala wokugonya kwe-HBV ngexesha lokuzalwa baze bazalise uluhlu oluphakathi kweenyanga ezintandathu ne-18. Abantwana abadala kunye nabantwana abaselula abangazange bafumane i-HBV yokugonya kufuneka banokugonywa.
Amaziko okuLawula izifo kunye nokuQulunqelwa kwakhona aphakamisa ukuba bonke abadala abasengozini enkulu ye-HBV mabagonywe. Ezi ziquka:
- Umntu ohlala naye okanye olala nomntu one-hepatitis B
- Abantu abanobulili abangekho kwixesha elide, ubudlelwane bomntu oyedwa
- Abantu abafuna ukuvavanywa okanye unyango kwisifo sosulele ngesondo
- Amadoda abelana ngesondo kunye namadoda
- Abantu abaphila ne-HIV
- Abantu ababelana ngeesaliti, iisringana, okanye ezinye izidakamizwa
- Abaqeqeshi bezempilo kunye nabanye abasengozini yokutyalwa kwegazi
- Abantu abanezifo zesifo sokuphela kwesigxina
- Abantu abanezifo ezingapheliyo zesibindi
- Abantu abanesifo sikashukela abangaphantsi kweminyaka engama-60, baqale ngokukhawuleza emva kokuxilongwa
- Abahambi bamazwe ngamazwe baye kwiindawo ezinomlinganiselo ophezulu kwi-hepatitis B
- Abantu abafudukela kumazwe banomlinganiselo ophezulu ukuya kumazinga aphezulu e-hepatitis B okanye abantwana abazalwa ngabazali abafudukela kumazwe ngaphambi kokuzalwa kwabo
- Nabani na ozijonga njengobungozi
I-USPSTF ayicetyiselanga ngokugonywa kwe-HBV kubantu abadala abadala njengoko umkhwa ungakhange uboniswe ukunciphisa umngcipheko wokugula okanye ukufa.
Ukuphonononga ukukhathazeka kwezoKhuseleko
Nangona ukwamkeleka okukhulu kwamagosa ezempilo karhulumente, ukuxhalabisa ukhuseleko kuyaqhubeka nokubethelela isitofu sokugonywa kwangaphambili kwi-FDA.
I-FDA yaqala ukukhanyela isigonyilo ngo-2013 esekelwe kwelinye lalo candelo, elaziwa njengeCpG 1018. Le yile iqela elisetyenziselwa ukukhulisa amandla okugonya okukhusela i-immune kunye neyona nto eyenza i-series-shot shot.
Ngokwempendulo ye-FDA, i-CpG 1018 yayikholelwa ukuba inokubangela ukuphazamiseka kwemithi ethile, kuquka nesifo se-thyroid. Nangona izifundo zakuqala zazingabonanga umahluko phakathi kwe-Heplisav-B kunye no-Engerix-B, isicelo sachithwa ngenxa yokuba ubungakanani besifundo ngexesha lwakucatshangelwa kakhulu.
Ngethuba lokuphindaphinda, abantu abayi-14,238 babeye bavelelwa kwisitofu sokugonywa ngamatyala amabini kuphela e- Hashimoto's thyroiditis (uhlobo lwesifo se-thyroid) kunye nesinye isimo se- vitiligo .
Kamva, ngowama-2016, isitofu sagxothwa kwakhona xa isifundo esinye sichaza inani elikhulu kunelo lilindelekileyo, kuquka nokuhlaselwa kwentliziyo. Kule meko, i-FDA icele ulwazi olongezelelweyo malunga naluphina izinto ezinxulumene nazo ezinokukunceda ngcono ukuchaza iziphumo.
Emva kokuphononongwa kwedatha eyongezelelweyo, i-FDA inikwe imvume. Iziphumo zokugqibela zetyala zachaza ingozi ye-0,1 yepesenti yokuhlaselwa intliziyo kubantu abanikwe i-Heplisav-B ngokumalunga ne-0.2 ekhulwini banikezwa i-Engerix-B.
> Imithombo:
> Bailey, C .; Smith, V .; kunye neSands, M. "Isifo sokugonya i-Hepatitis B: isifundo seminyaka esixhenxe sokumamathela kwizikhokelo zokugonywa kunye nokusebenza kwabasebenzi abadala abane-HIV-1." I-Journal International yezifo ezithathelwanayo. Agasti 2008; 12 (6): e88-e83. INGXELO: 10.1016 / j.ijid.2008.05.1226.
> Amacandelo okuLawula nokuLawula izifo. Isicwangciso esipheleleyo sokugonywa sokupheliswa kwesifo se-Hepatitis B kwiNtsholongwane yaseUnited States - Iingcebiso zeKomidi elicebisayo malunga neMigudu yokuNgcwaba (ACIP) Icandelo 1: Ukugonywa kweintsana, abantwana kunye no-Adolescents. . Disemba 2005; 54 (RR16): 1-23.
> Janssen, R .; Bennett, S .; UNamini, H. et al. "I-Immunogenicity kunye noKhuseleko lweeMvavanyo ezimbini ze-Heplisav ngokuthelekiswa neZithathu zeMvavanyo ye-Hepatitis B (i-Engerix B) kwiSigaba sesi-3 seMvavanyo." Umbhalo we-Hepatology. Epreli 2013; 58 (iSiza 1): S574. INGXELO: 10.1016 / S0168-8278 (13) 61425-7.
> Ulawulo lweZiko lokuTya kunye neDrug. "Amaphukula ephambili ekuchazeni ulwazi (Heplisav-B) ." I-Silver Spring, eMaldin; kukhutshwa ngoNovemba 2017.
> I-US Preventive Services Task Force. Isitatimende sokugqibela esinconywayo: I-Hepatitis B ye-Virus Infection: Ukucoca, ngo-2014. "I-Rockville, eMaldin; kuhlaziywa ngoDisemba 2016.