I-Novantrone (i-mitoxantrone) ne- Tysabri (natalizumab) zombili zisetshenziselwa izimo ezifanayo zokwelapha izifo eziningi - kubantu ababuhlungu ngokuphindaphindiwe-ukukhipha ama-multiple sclerosis (i-RRMS) noma okuqhubekayo-ukuphindaphinda kabusha i-multiple sclerosis (i-PRMS). I-Novantrone iboniswe nge-multiple-progressive multiple sclerosis (i-SPMS), kanti uTysabri angasiza ema-SPMS lapho izilonda ezisebenzayo zibonakala khona kuma-MRIs, futhi.
Ayikho enye ye-MS ehamba phambili.
Lokhu kusho ukuthi abantu abaningi abanalolu hlobo lwe-MS banokukhetha ukwenza: iTysabri noma i-Novantrone. Nakuba kungaba kuhle uma umuntu enomkhawulo omkhulu wezinzuzo ngaphezu komunye kuzo zonke izici, akunjalo. Njengazo zonke ezinye nge-MS kubonakala sengathi, isinqumo se-Tysabri vs. Novantrone sisekelwe esixukwini sezinto eziyinkimbinkimbi. Ukuzikhethela kudinga ukususelwa ekuthandweni kanye nokuphila kwakho, izincomo zodokotela nokufinyelela, nezinye izinto ezifana nezindleko, ukwesaba kwemiphumela emibi kanye nemigomo yokuqapha.
Kulesi sihloko, ngenze konke okusemandleni ami ukuqhathanisa i-Tysabri noNovantrone ngokuhlangene ngezici eziningi zokwelashwa engazi ukuthi abantu banesithakazelo kakhulu. Ake ngibhale ukuthi lezi zidakamizwa zineendlela ezihlukene ngokuphelele zesenzo , ngakho-ke akunjengokuthi umuthi owodwa wenza umsebenzi wakhe "kangcono" - benza izinto ezihlukene, kodwa ngomgomo ofanayo wokunciphisa ukukhubazeka kokukhubazeka nokuvimbela i-MS iphinda ibuyele.
I-Tysabri iyi-anti-monoglonal anti-antibody evimbela ama-T-cells athile ukuba angaweleki ukuvinjelwa kwegazi, kanti i-Novantrone iyimithi ye-chemotherapy evikela umsebenzi we-immune.
Nazi ezinye izinto okufanele uzicabangele uma wenza okukhethayo:
Ukufinyelela kweDokotela wakho kanye nokuFinyelela
Odokotela kuphela ababhaliswe ne-TOUCH Uhlelo lokuqapha bangachaza iTysabri.
Abantu abaningi abahlengikazi abangenakho ukufinyelela eTysabri baqeda ukushintshela kwesazi sezinzwa esinezinzwa. Noma yiliphi udokotela angakwazi ukumisa uNovantrone, noma kunjalo, kunconywa ukuba iphathwe udokotela onolwazi ekuqaphelisweni nasekunakekeleni iziguli ezithola imithi yokwelapha yalolu hlobo.
Imiphumela emibi nokuphepha
Ngenkathi amaphrofayli engozini kokubili uTysabri noNovantrone ahluke ngokuphelele, bobabili benza ukuthi abantu abaningi bangabe besabela kabi noma besaba - iTysabri inomlando we-PML noNovantrone yi-chemotherapy. Nayi ingqikithi ye-Novantrone cishe engakwenza ube nomuzwa we-yucky emva kokumnika izinsuku eziningana, nezinto ezinjengokuhlanza / isisindo sokunambitheka, ingozi eyengeziwe yokwelashwa kwesibindi kanye nokuphefumula, futhi, kahle, ungase ulahlekelwe ezinye izinwele zakho. Ku-Tysabri, cishe ngeke uzizwe ukhuluphele ezinsukwini ezilandelayo ukumnika ukukhipha, njengoba imiphumela emibi kakhulu efana nokuphendula kwamasayithi, ukukhathala, izinhlungu kanye nobuhlungu obuhlangene. Isici esinqumayo sabantu abaningi singase sihlele ukukhetha phakathi kwe-1.2 (10,000 kuya kwezingu-10,000) engozini ye-PML ne-Tysabri nengozi ye-leukemia (7.4 per 1,000) noma ukulimala komzimba noNovantrone.
Ukuvama
I-Tysabri ilawulwa nge-intravenously (nge-IV esikhungweni se-infusion noma ehhovisi likadokotela wakho) kanye ngenyanga.
I-Novantrone ilawulwa njalo ngaphakathi kwezinyanga ezintathu.
Ukusebenzisa isikhathi eside
I-Tysabri (kuleli qophelo ngesikhathi) ingasetshenziswa ngokungapheli, nakuba ukuphepha kwesidakamizwa emva kweminyaka emibili yokusetshenziswa kungaziwa. I-Novantrone, ngakolunye uhlangothi, ingasetshenziswa kuphela kuze kube yiminyaka emibili kuya kweyithathu (10 noma 11 ukulinganisa inani) esikhathini sokuphila kwesiguli.
Ukuphumelela
Ukusebenza kwezidakamizwa kubonakala kufana kakhulu, kodwa kunzima ukuqhathanisa ngokuqondile, ngenxa yokungafani kokuklanywa kokutadisha. Esifundweni seminyaka emibili, uma kuqhathaniswa ne-placebo, i-Novantrone iboniswe ukunciphisa inani lokubuyiselwa kabusha, linciphisa isikhathi phakathi kokubuyela emuva, kuboniswe ukunciphisa amaphesenti angu-61 ekudakaleni kokukwazi ukuhlanganyela kwabahlanganyeli ukuhamba nokukhubazeka okuncane kakhulu kwegazi.
I-Tysabri ibonise ukunciphisa okungu-68% kokubuyela emuva eminyakeni emibili, kanye nokunciphisa ukuqhubekela phambili kokukhubazeka nokunciphisa inani lokubuyela kabusha okusha.
Ukukhulelwa (Okwamanje Nekusasa) Nokuncelisa
Abesifazane abakhulelwe noma abazama ukukhulelwa akufanele bathathe i-Tysabri noma i-Novantrone, futhi kufanele futhi basebenzise abesifazane abancancisayo. I-Tysabri ibhekwa ukuthi ikhona "ekukhuleni isigaba C," okusho ukuthi kubangele ukulimala emashumini ezifundweni zesilwane kodwa umphumela kubantu awuziwa. I-Tysabri kufanele imiswe isikhathi esithile ngaphambi kokuzama ukukhulelwa (ngokuvamile inyanga eyodwa kuya kwezintathu; xoxa ngalokhu nodokotela wakho). I-Novantrone ibhekwa ukuthi ikhona "esigabeni sesigaba sokukhulelwa D," okusho ukuthi singabangela ukulimala komfutho lapho kunikezwa owesifazane okhulelwe. Abafazi bokukhula kweminyaka badinga ukuhlolwa kokukhulelwa ngaphambi kokuthola isilinganiso ngasinye seNovantrone.
ISAZISO ESIBALULEKILE: Abanye besifazane (5-30%) abaqedile inkambo ephelele yeNovantrone abazange baqale isikhathi sabo futhi bangabanjwanga (abakwazi ukukhulelwa). Kubaluleke kakhulu ukucabangela lokhu kungenzeka uma unquma ukuthi ungayisebenzisi noma ungayisebenzisi yini uNovantrone nokuthi uxoxisane nomyeni wakho noma umlingani wakho. Ucwaningo lwamuva lubonisa ukuthi amathuba okubeletha abesifazane anganciphisa ukusetshenziswa kwezidakamizwa ze-hormone (izidakamizwa ze-estroprogestinic) ngenkathi ukwelashwa noNovantrone futhi lokhu kufanele kukhulunywe nodokotela wakho.
Solu-Medrol
I-Solu-Medrol, i-corticosteroid engenalutho esetshenziselwa ukunciphisa ubude nobukhulu bokubuyela emuva, ngokuvamile ayinconywa kubantu abasebenzisa i-Tysabri okungenani inyanga ngaphambi noma emva kokumnika ukugcina, ngenxa yokwanda kwe-immunosuppression, nakuba kunezinye odokotela abazobe bewunquma ukuphindaphinda futhi ngiye ngazwa ngokulinganisa okulinganiselwe (125 kuya ku-500 mg) enikezwe ngesikhathi esisodwa njengokungenwa kwe-Tysabri ukusiza ngokuphendula okuncane kwe-Tysabri. Ngakolunye uhlangothi, i-Solu-Medrol ivame ukunikezwa ngesikhathi esisodwa njenge-Novantrone ukumnika futhi inganikezwa ngokukhululekile uma kwenzeka ukuphindaphinda phakathi kwe-Novantrone infusions.
Ukuqapha
Ngaphambi kokuqala u-Novantrone, uzothatha lezi zivivinyo ezilandelayo: ukuhlolwa kwegazi (i-CBC, umsebenzi wesibindi, ukukhulelwa kwabesifazane), i-electrocardiogram (EKG), kanye ne-echocardiogram njengendlela yokuhlola okuyisisekelo kwengxenyana ye-ejection ye-ejection (LVEF) engakwesokunxele kumele iyenziwe ngaphambi kokuthi wonke umthamo kaNovantrone. Ukwelashwa kwe-Novantrone kufanele kuphele uma i-LVEF ishintsha kakhulu noma ihlala ngaphansi kwama-50%. Zonke izivivinyo zizophindwaphindwa ngaphambi kokwelashwa ngalunye. I-Tysabri inganikezwa kuphela esikhungweni sokungeniswa esibhalisiwe ngohlelo lwe- "TOUCH". "UKUQHUBA" kusho "Ukuzibophezela kwe-Tysabri: Ukuzibophezela Kwamanye Empilo" futhi uhlelo olubekwe endaweni emzamweni wokubamba noma yiziphi izimo ezenzekayo ze-PML ezinkathini zokuqala, kanye nokuzivimbela. Uzohlolwa ngudokotela noma umhlengikazi bese uthola i-MRI ngaphambi kokuqala i-Tysabri, bese uhlola zonke izinyanga ezintathu kuya kwezingu-6 ukuze ushintsho lwe-neurologic. Uzocelwa ukuba ubuyekeze ulwazi lokuphepha kwesiguli bese ugcwalisa ucwaningo oluncane ngaphambi kokukhipha.
Ukungafani
I-Novantrone ayifanele isetshenziswe ngabantu abanesifo senhliziyo noma ukuthatha ezinye izidakamizwa ezingalimaza inhliziyo, izinkinga zesibindi, izibalo ezibomvu nezibomvu zegazi, izinkinga zokuvala igazi, umdlavuza noma umlando wezokwelapha ezedlule. I-Tysabri akufanele ithathwe ngabantu abathatha imithi yokuzivikela noma izivikeli ezizivivinya umzimba noma abantu abanamasosha omzimba athintekile. Isidakamizwa akufanele sithathwe ngabantu abanezifo zamanje.
Izindleko
I-Tysabri ingenye yezokwelapha ezibiza kakhulu ze-MS ezitholakalayo, ngo-$ 28,400 ngonyaka ngeTysabri ngokwayo. I-Novantrone ibiza cishe u-$ 3,000 ngonyaka ngomuthi, okwenza kube kubi kakhulu. Zombili ziza nezindleko ezengeziwe ze-infusion centre.
Ngaphansi
Isinqumo sokusebenzisa i-Tysabri noma i-Novantrone ingumuntu siqu, okungenzeka kube lula noma okunzima, kuye ngokuthi yiziphi izici ozigxila kuzo noma ezisebenza kuwe (isibonelo, umuntu okumele akhokhe ephaketheni angathola uNovantrone okuningi okukhangayo, kuyilapho owesifazane osemusha ofuna izingane esikhathini esizayo angase athembele kakhulu eTysabri). Uma udokotela wakho enombono onamandla kakhulu ngandlela-thile, qiniseka ukuthi umcela ukuba achaze izizathu. Njalo uzizwe ukhululekile ukuthola enye imibono uma ungakapheli. Kungenzeka ukuthi udokotela wakho akanakho ukufinyelela eTysabri - uma ufuna, thola omunye udokotela owenzayo futhi abuze umbono wakhe. Ngakolunye uhlangothi, kungenzeka ukuthi udokotela wakho akakhululekile ukusebenzisa izidakamizwa ze-chemotherapy, kodwa kunabanye odokotela abaningi abaye basebenzisa iNovantrone ngamakhulu iziguli ezinemiphumela emihle. Hlala ufuna izimpendulo uze unelisekile.
> Imithombo:
> Cocco E, Sardu C, Gallo P, Capra R, MP MP, Trojano M, Uccelli A, Marrosu MG; I-FEMIMS Group. "Ukuphindaphindiwe kanye nezingozi ze-amenorrhea eyenziwa yi-mitoxantrone e-sclerosis eminingi: isifundo se-FEMIMS." I- Mult Scler. 2008 Nov; 14 (9): 1225-33.
> Debouverie M. "Ukulandelwa kwemitholampilo kweziguli ezingu-304 ezine-multiple sclerosis emva kweminyaka emithathu emva kokwelashwa kwe-mitoxantrone." I- Mult Scler. Juni 1 2007; 13 (5): 626-3.1
> Fox EJ. "Ukulawulwa kwe-multiple sclerosis nge-mitoxantrone: ukubuyekezwa." I- Clin Ther. 2006 Apr; 28 (4): 461-74.
> Hartung HP; I-Gonsette R; Konig N; Kwiecinski H; > Guseo > A; Morrissey SP; Krapf H; I-Zwingers T. "I-Mitoxantrone ekuqhubekeni kwe-multiple sclerosis: i-placebo elawulwa yi-placebo, ephindwe kabili-eyimpumputhe, > engahleliwe >, ekulinganisweni kwe-multicentre." I- Lancet. 2002. 28; 360 (9350): 2018-25.
> Markus Krumbholz, MD; UHannah Pellkofer, MD; I-Ralf Gold, MD; ULisa Ann Hoffmann, MD; U-Reinhard Hohlfeld, MD; U-Tania Kümpfel, MD. Ukubhekana Ne-allergenic Yehlisiwe> Ukuhlanganiswa Kwama-Natalizumab> Nokuqalwa Kwangaphambili Kwezingqinamba Zokulwa Nezintambo . Arch Neurol. 2007; 64: 1331-1333.
> Polman CH, O'Connor PW, Havrdova E, Hutchinson M, Kappos L, Miller DH, Phillips JT, Lublin FD, Giovannoni G, Wajgt A, Toal M, Lynn F, Panzara MA, Sandrock AW; Abaphenyi be-AFFIRM. Isivivinyo esilawulwa ngokungahleliwe, esilawulwa yi-placebo sohlobo lwe-natalizumab sokubuyiselwa kwe-multiple sclerosis. N Engl J Med. 2006 Mar 2; 354 (9): 899-910.
> Rudick RA, Stuart WH, Calabresi PA, Confavreux C, Galetta SL, Radue EW, Lublin FD, Weinstock-Guttman B, Wynn DR, Lynn F, Panzara MA, Sandrock AW; Abaphenyi be-SENTINEL. I-Natalizumab kanye ne-interferon beta-1a yokubuyiselwa kwezifo eziningi. N Engl J Med. 2006 Mar 2; 354 (9): 911-23.
> "Ukusetshenziswa kwe-mitoxantrone (Novantrone) yokwelashwa kwe-multiple sclerosis: Umbiko we-Therapeutics and Technology Assessment Committee ye-American Academy of Neurology." I- Neurology. 2003; 61: 1332-1338.