Iziyobisi ze-biologic , eziye zithengiswa ngeentlobo ezithile zesifo samathambo ukususela ngo-1998, zilawulwa ngokunyuswa okanye ukujova . Imiphumo emibi, enokuthi yenzeke ngala mayeza, ibizwa ngokuba yi-infusion response or reaction site site. Izandi ziyatshisa, akunjalo? Kodwa, ufanele wazi ukuba iimpendulo aziqhelananga kwaye zihlala zidlula ngaphandle kokungenelela.
Iimpembelelo eziPhezulu eziPhakathi
Iingxaki eziqhelekileyo ezinxulumene nokuphendulwa kwe-infusion zingabandakanya intloko, i-urticaria (i-hives), i-pruritus (itching), i-rash, i-pruritus, i-fever, i-chills, i-tachycardia (intliziyo yokukhawuleza) kunye ne-dyspnea (ukuphefumula ubunzima).
Nangona kungenqabile, ukuphendula okunzima okanye ukuphendula kwe-anaphylactic kunokwenzeka. Kwiimeko ezinjalo, ukuxinwa kwesifuba, i-bronchospasm, i-hypotension (uxinzelelo lwegazi oluphantsi), i-diaphoresis (i-sweating), okanye i-anaphylaxis (isenzo esiphezulu sokwenyuka kwiprotheyini yangaphandle esiphumela kwi-protein yangaphandle) ingenzeka. Ukuba impendulo enzima ikhula, unyango lwe-biologic kufuneka lubekwe ngokukhawuleza kwaye unonophelo lwengxamiseko olunikeziwe. Kwezinye iimeko, i-pre-medication kunye ne-acetaminophen, i-antihistamine kunye ne-corticosteroid encinane eyenza inokukunceda ukuthintela ukuphendula kwe-infusion.
Ngokwababhali be- Arthritis yeRumatoid Arthritis: I-diagnosis ye-Early diagnosis and Treatment , i-trial ye-clinical trial yachaza ukuba ngelixa i-20% yezigulane ziphathwa nge- Remicade (i-infliximab) i-reaction infusion. kuphela i-2.5% yeempendulo zokunyuswa kwamagciwane kwizigulane eziphathwe ngokutsha zikhokelela ekunqanyeni ukusetyenziswa kweziyobisi.
Ngokuqhelekileyo, iimpendulo zokunyusa ukuxhamla ezihambisana ne-Remicade zenzeke ngexesha lokunyuka okanye emva kweeyure ezimbini emva kokuba ukufakelwa kwamanzi kugqityiwe.
Makhe siqwalasele ukuba ukuchazwa kolwazi kwezinye izidakamizwa ze-biologic ukubonakalisa, ukugcina engqondweni ukuba izilingo ezahlukeneyo zeeklinikhi azikwazi ukuthelekiswa (umz., Ukukhutshwa kweziphumo zezilingo akunakufaniswa nemiphumo yesilingo e-Simponi) kwaye idatha yesilingo ye-kliniki ayinakufanisana nokufikelela kwimiba ekhoyo ngokwenene ku sebenza.
- I-Simponi Aria: Kwinqanaba elilawulwayo lovavanyo 1 (ngeveki yama-24), i-1.1% ye-Simponi Aria infusions yayinxulumene ne-reaction infusion ifaniswa ne-0.2% ye-infusions kwiqela lokulawula. I-Rash yiyona nto isabela ngayo. Akukho mpendulo echanekileyo yokunyuswa kwegazi.
- U-Orencia (abatacept): U- Orencia izifundo III, IV, kunye neV zibonakalisa ukuba ukunyuswa kwamanzi okuqhelekileyo kwakuqhelekileyo kwizigulane eziphathwe i-Orencia ngokuthelekiswa ne-placebo (9% vs. 6% ngokulandelanayo). Iziganeko ezichazwe ngokugqithiseleyo kwakuyizondlo, intloko, kunye ne-hypotension (1-2%). Ngaphantsi kwe-1% yezigulane eziphethwe yi-Orencia ziyeke ukusetyenziswa kweziyobisi ngenxa yokuphendula ngokunyuka kwamanzi. I-Anaphylaxis yenzeka ngaphantsi kwe-0.1% yezigulane eziphathwe ngo-Orencia.
- I-Actemra (tocilizumb): Kwiisifundo zeeklinikhi ezilawulwa ngeeveki ezingama-24, ukuphendula ngokunyuka kwamanzi ku-7-8% yezigulane, kuxhomekeke kwiyiphi i-doim e-Actemra esetyenzisiweyo, xa kuthelekiswa ne-5% kwiqela le-placebo. Isiganeko esivame ukuqhutyelwa ngethuba lokunyuka kwegazi kwakuyi-hypertension (1%). Iziganeko eziqhelekileyo kwiiyure ezingama-24 zokungeniswa kwakuyikhanda (1%) kunye neempatho zesikhumba (1%). Iziganeko azizange zenze ukuyeka okanye ukunciphisa unyango.
- I-Rituxan (rituximab): Ulawulo lwe-Rituxan lunokubangela ukuba lube lukhulu, kubandakanywa ukuphazamiseka kwamandla okubulala. Ukufa kwiintsuku ezingama-24 ze-Rituxan infusion zenzeke. Phantse i-80% yeempembelelo zokufelwa kwegazi ezifayo zenzeke ngokubambisana no-infusion wokuqala.
Kwi-Rituxan RA idibene i-placebo elawulwa yi-placebo, i-infusion response (fever, chills, rigors, pruritus, urticaria okanye i-rash, i-angioedema, i-pruritus, ukucaphuka komqala, ukukhwehlela, okanye i-bronchospasm, kunye noxinzelelo oluxhatshaziweyo okanye uxinzelelo lwegazi). I-% yezigulane eziphathwe ngeRituxan emva kokunyuswa kwawo kokuqala, xa kuthelekiswa ne-19% yeqela le-placebo. Isiganeko sempembelelo yokunyuka kwamanzi ngokulandela ukunyuka kwe-Rituxan okanye indawo ye-placebo yesibini kuyehla ukuya kwi-9% kunye no-11%, ngokulandelanayo. Ukuphendula ngokuthe ngqo kwamagciwane okuye kwangena kwi <1% yezigulane kwinqanaba leyeza.
Ukuguqulwa kwamathambo kwakudingeka kwi-10% yezigulane eziphathwe ngeRituxan kunye ne-2% yeqela le-placebo.
Iimpembelelo eziPhezulu eziPhakathi
Ngeziyobisi ze-biologic ezilawulwa ngaphantsi, i-reaction site site ingenziwa kodwa ngokungekho unyango olufunekayo kwaye ukuyeka ukusetyenziswa kweziyobisi akuyimfuneko.
Abaphandi baye bakhangela idatha yesilingo yesilingo ukuze bavavanye ukuphindaphindiwe kwezimpendulo ze-injection site. Ngelixa linikela ngcamango ethile, khumbula, izilingo ezahlukeneyo zeekliniki azikwazi ukuthelekiswa kwaye idatha yesilingo yesilingo ayibonakali ukuba yintoni eyenzekayo ngokwenene.
- I-Enbrel (etanercept): Kwizilingo ezilawulwa yi-placebo kwiimeko ze-rheumatologicalic, malunga nama-37% yezigulane eziphathwe nge-Enbrel zenzeke izimpendulo zesayithi. Zonke izimpendulo zendawo ye-injection zachazwa njengomoya ophantsi ukuya kumodareyitha (i-erythema, ukubetha, intlungu, ukukhukhuma, ukuphuma kwamanzi, ukutyumza) kwaye ngokuqhelekileyo ayizange ikhoke ekunqandeni izidakamizwa. Ukuphendulwa kwendawo ye-injection, ubuninzi beentsuku ezi-3 ukuya kwezi-5 eziqhelekileyo, ngokuqhelekileyo zenzeke ngenyanga yokuqala kwaye zancipha ngokuphindaphindiweyo.
- Humira (adalimumab): Kwizilingo ezilawulwa yi-placebo, i-20% yezigulane ziphathwa nge-Humira zenze i-reaction effect site (i-erythema, itching, i-hemorrhage, intlungu okanye ukuvuvukala), xa kuthelekiswa ne-14% yezigulane ezifumana indawo ye-placebo. Uninzi lwama-site reaction injini lwachazwa njengomnene kwaye ngokubanzi alufunanga ukuyeka ukusetyenziswa kweziyobisi.
- I-Simponi (golimumab): Kwizilingo zeSigaba II / III ezilawulwayo, i-3.4% yezigulane eziphathwe ngokulula nje zineempendulo ze-injection site xa kuthelekiswa ne-1.5% kwiqela lolawulo. Uninzi lwezimpendulo zendawo ye-injection zazingenangqondo kwaye ziphakathi, kunye nokubonakaliswa ngokuthe rhoqo kwe-erythema.
- I-Cimzia (certolizumab pegol): Kukho ukukhankanywa kwimeko yokuphendula isayithi kunye neCimzia kwiinkcukacha zokumisela, ezichazwe njengezinto ezinqabileyo, kodwa akukho nkcukacha ezongeziweyo zinikezelwa.
Imithombo:
I-Rheumatoid Arthritis: Ukwelashwa kwangaphambili kunye nokuxilongwa. Cush, Weinblatt, eKavanaugh. 2010. Inkqubo yesithathu. Iinkcukacha zoNxibelelwano, Inc.