Dogon lokacin da aka jinkirta ya zama Mafi Girma ga Engerix-B
Heplisav-B wata maganin alurar rigakafi ne don hana dukkanin cututtukan hepatitis B. Cibiyar Abinci da Druggun Amurka (FDA) ta amince da shi ranar 9 ga Nuwamba, 2017 don amfani da manya 18 da tsufa.
Yana daya daga cikin maganin rigakafi uku da ake amfani dasu don hana rigakafi daga cutar Hizzanci (HBV) a Amurka. Wadannan sun haɗa da Recombivax HB, wanda FDA ya amince da shi a shekarar 1986, da kuma jagoran kasuwar Engerix-B, wanda aka ba da izini a 2007.
(Akwai kuma maganin rigakafi na uku, wanda aka sani da Twinrix , wanda ke maganin alurar rigakafi da duka hepatitis A da B.)
Daya daga cikin manyan amfanin Heplisav-B shi ne cewa yana bukatar ƙananan haɓaka a kan ɗan gajeren lokacin, wani abu wanda zai iya taimaka wa mutane su kammala jerin maimakon tsayawa takaice.
Na farko Tsaro Damuwa
Yardar da Heplisav-B ya yi ta gwagwarmaya ta shekaru hudu don kawo maganin alurar rigakafi. FDA ta ƙi yin amfani da miyagun ƙwayoyi a watan Fabrairun 2013 kuma daga bisani a watan Nuwamba 2016 saboda damuwar tsaro game da hadarin mummunar infarction na sirrin (ciwon zuciya) da wasu cututtuka na asibiti .
An riga an yarda da maganin rigakafin da yafi dacewa akan gaskiyar cewa yana buƙatar guda biyu da aka ba da wata guda baya. Sauran maganin alurar rigakafi, da bambanci, yana buƙatar lakabi uku da suka rabu da wata guda da kuma watanni shida.
Wannan ya zama muhimmin abu tun lokacin daya daga cikin manyan matsalolin rigakafin HBV sun kasance haɗuwa.
Aikin binciken na 2008 da Ma'aikatar Magunguna ta Florida ta Jami'ar Florida dake Jacksonville ta bayar da rahoton cewa, kimanin mutane 707 da suka cancanci yin rigakafi na HBV, kawai 503 sun isa maganin kuma kawai 356 sun kammala jerin sakonni uku. Sauran binciken sun bayar da rahoton irin wannan mummunan sakamako.
Ta hanyar raguwa da rata tsakanin injections, FDA ta yi imanin cewa amfanin alurar rigakafi ba zai yiwu ba.
Amfani
Shawarwarin Heplisav-B ya samo asali ne daga bayanan gwaji uku da suka shafi fiye da 14,000 mahalarta mahalarta. Binciken da ya shafi mahimmanci ya yi la'akari da kashi biyu na kashi na Heplisav-B zuwa jerin kashi uku na Engerix-B. Daga cikin mahalarta 6,665 da suka shiga cikin binciken, kashi 95 cikin dari sun sami babban kariya daga Heplisav-B (kamar yadda aka auna ta hanyar antibody ) idan aka kwatanta da kashi 81 a Engerix-B.
A wani binciken na biyu wanda ya shafi 961 mutane da ciwon sukari na 2 (wanda ake zaton sun kamu da cutar hepatitis B), An bayar da rahoton cewa Heplisav-B ya bayar da kariya mai girma a kashi 90 cikin 100 na waɗanda aka ba maganin kawai da kashi 65 cikin 100 a cikin wadanda aka ba Engerix -B.
Bugu da ƙari kuma, Heplisav-B yana da masaniyar samar da kariya ga dukkanin manyan serotypes guda hudu, goma jinsin (A ta J), da kuma subgenotypes 40.
Gudanarwa
Heplisav-B ana kawo shi ta hanyar intramuscular allura a cikin babba deltoid na kafada. Alurar ba maganin alurar riga kafi (dauke da rayayye, raunana cutar) amma a maimakon haka ya ƙunshi magungunan antigen-wanda ya zama magungunan cutar-wanda ba ya haifar da cutar amma ya haifar da amsar rashin lafiya.
Bayan an ba ku da ingancin farko na 0.5-milliliter (mL), za a ba da na biyu cikin watanni shida.
Idan, saboda kowane dalili, baza ku iya kammala jerin a lokacin ba, ku yi magana da likitanku game da kammalawa jerin a wuri-wuri. Yana da wuya za ku sake farawa jerin.
Ayyukan Mugunta
Duk da yake wasu mutane suna iya fuskantar irin wannan harbi, mafi yawancin lokuta suna da sauƙi kuma suna warwarewa a cikin 'yan kwanaki. By da yawa, halayen, idan akwai wani, ya kasance ya fi zurfin bin bayanan farko da ƙasa don haka bayan na biyu.
Mafi yawan bayyanar cututtuka (faruwa a cikin kashi biyu cikin dari na marasa lafiya) sun hada da:
- Kusawa a shafin intanet - 2.3 bisa dari
- Redness a wurin injection - 4.1 kashi
- Malaise - kashi 9.2
- Ciwon kai - kashi 16.9
- Riga - 17.4 bisa dari
- Pain a wurin ginin - kashi 38.5
Contraindications
Heplisav-B ba za a yi amfani da shi ba a cikin mutane da tarihin cututtuka mai tsanani mai tsanani ko waɗanda suka yi maganin baya ga maganin ciwon hepatitis B ko wani abu da aka gyara, ciki har da yisti. Rashin sakewa zai iya haifar da mummunan barazanar rai, duk abin da ke cikin rashin lafiyar jiki wanda ake kira anaphylaxis.
Har zuwa yau, babu nazarin ɗan adam a sakamakon Heplisav-B a lokacin daukar ciki ko nono. Duk da haka, binciken dabba ba ya bayar da rahoton wani abu mai ban mamaki a cikin ratsi masu ciki ciki ko zuriyarsu ba bayan kashi 0.3 mL na Heplisav-B.
Wanda Ya Kamata Samun Gurasa
Hepatitis B shine cututtukan ciwon huhu na hanta wanda zai iya zama na yau da kullum kuma ya kai ga cirrhosis , ciwon daji da mutuwa.
A cewar wani rahoto daga Ƙungiyar Harkokin Kasuwancin Tsaro na Amurka (USPSTF), ko'ina daga 700,000 zuwa 2.2. Mutane da yawa ana ganin sun kamu da HBV a Amurka. Ƙididdigar cututtuka sun fi girma a cikin manya 30 zuwa 49, yawancin wadanda ke kamuwa da cutar ta hanyar jima'i ba tare da karewa ba ko kuma amfani da allura .
Babu magani ga hepatitis B, amma maganin alurar riga kafi zai iya hana cutar. A saboda haka, kwamitin Shawarar Kwaskwarima kan Alurar rigakafi (ACIP) kuma a halin yanzu yana bada shawarar cewa duk yara su karbi maganin farko na HBV a lokacin haihuwar su kuma kammala jerin tsakanin watanni shida da 18. Yara da yara da basu karbi maganin rigakafi na HBV ya kamata a yi alurar riga kafi.
Cibiyoyin Cibiyar Kula da Cututtuka na Ƙari ta kara bada shawarar cewa an yi alurar riga kafi ga dukan manya a babban haɗarin HBV. Wadannan sun haɗa da:
- Mutumin da ke zaune tare ko ya yi jima'i da wanda ke da ciwon hauka B
- Ma'aikatan jima'i da ba su cikin lokaci mai tsawo, dangantakar juna guda daya
- Mutane masu neman gwadawa ko magani don kamuwa da cutar ta hanyar jima'i
- Maza maza da suka yi jima'i da maza
- Mutane da ke zaune tare da kwayar cutar HIV
- Mutanen da suka raba ragamar ƙwayoyi, shinge, ko wasu kayan aikin magani
- Ma'aikatan kiwon lafiya da sauransu suna fuskantar hadarin jini
- Mutanen da ke fama da cutar koda
- Mutane masu fama da ciwon hanta
- Mutane da ke fama da ciwon sukari a karkashin shekara 60, sun fara da wuri-wuri bayan ganewar asali
- Matafiya na kasa da kasa zuwa yankuna da matsanancin ƙwayar cutar hepatitis B
- Mutanen da suka yi ƙaura daga ƙasashe masu yawa zuwa hawan hepatitis B ko 'ya'ya da aka haifa ga iyaye waɗanda suka yi hijira daga waɗannan ƙasashe kafin a haife su
- Duk wanda ya dauki kansu a cikin hadari
USPSTF ba ta bayar da alurar riga kafi na HBV ba domin yawancin jama'a na girma kamar yadda ba a nuna wannan aikin don rage haɗarin cutar ko hasara ba.
Binciken Masifar Tsaro
Duk da karfin da aka samu daga jami'an kiwon lafiyar jama'a, matsalolin tsaro sun ci gaba da cutar da maganin da FDA ta yi da farko.
A farkon farko dai FDA ta ƙi maganin alurar rigakafi a shekarar 2013 bisa ga ɗaya daga cikin abubuwan da aka gyara, wanda aka sani da CpG 1018. Wannan ita ce filin da ake amfani dashi wajen inganta ciwon maganin rigakafi da kuma abin da ke iya samar da jerin samfurori guda biyu.
Bisa ga amsawar FDA, CpG 1018 an yi imanin cewa yana da yiwuwar jawo wasu cututtuka na kamfanoni, ciki har da cutar thyroid. Duk da yake binciken farko ba ya nuna bambanci na ilimin lissafi tsakanin Heplisav-B da Engerix-B ba, an ƙyale aikace-aikacen kawai saboda yawan binciken da aka yi a wannan lokaci an yi la'akari kadan.
A lokacin da aka yi amfani da shi, mutane 14,238 sun kamu da kwayar cutar kawai tare da lokuta biyu na thyroiditis na Hashimoto (wani nau'i na maganin thyroid) da kuma wani akwati na vitiligo .
Daga bisani, a shekarar 2016, an hana maganin alurar rigakafi yayin da binciken daya yayi rahoton ya fi girma fiye da yawan abubuwan da ke faruwa na zuciya, ciki har da hare-haren zuciya. A wannan yanayin, FDA ta buƙaci ƙarin bayani game da duk wani abin da ba'a haɗuwa ba wanda zai iya taimakawa wajen bayyana sakamakon.
Bayan sake duba ƙarin bayanan, FDA ta ba da izini. Sakamakon gwajin karshe ya bayar da rahoto game da hadarin zuciya na kashi 0.1 cikin mutanen da aka ba Heplisav-B akan kashi 0.2 da aka ba Engerix-B.
> Sources:
> Bailey, C. Smith, V .; da Sands, M. "Kanjamau na Hepatitis B: nazarin shekaru bakwai na kula da maganin rigakafi da inganci a cikin masu dauke da kwayar cutar HIV-1." Jaridar International Journal of Disease Diseases. Agusta 2008; 12 (6): e88-e83. DOI: 10.1016 / j.ijid.2008.05.1226.
> Cibiyoyin Kula da Cututtuka da Cututtuka. "Tsarin Lura Kan Taimakon Yaduwar Yadiga B a Amurka - Shawarar da Shawarar Shawara kan Kwayoyin rigakafi (ACIP) Sashe na 1: Samun rigakafi na jarirai, Yara, da matasa." Ƙwararruwar Kwararru da Mutuwa (Weekly Review) (MMWR) . Disamba 2005; 54 (RR16): 1-23.
> Janssen, R .; Bennett, S .; Namini, H. et al. "Immunogenicity da Tsaro na Harkokin Bincike guda biyu da aka ƙaddara da aka kwatanta da abubuwa uku da aka ba da izini na Hepatitis B Vaccine (Engerix B) a cikin Hanya na Biyu na 3." Journal of Hepatology. Afrilu 2013; 58 (Sanya 1): S574. DOI: 10.1016 / S0168-8278 (13) 61425-7.
> Cibiyar Abinci da Drug. "Karin Bayani na Bayanan Bayyanawa (Heplisav-B) ". Silver Spring, Maryland; bayar da Nuwamba 2017.
> Ƙungiyar Ayyukan Tsaro ta Amurka. "Bayanin Shawarar Farko: Ciwon Haɗari B Ƙwayar cuta: Nunawa, 2014." Rockville, Maryland; sabunta watan Disamba 2016.