Inhloso yokwelashwa kwe-migraine yokuvimbela ukunciphisa inani nenkinga yekhanda le- migraine.
Noma kunjalo imishanguzo yokuvikela imithi yangasese, efana ne-Topamax (topiramate), i-Inderal (propranolol), ne-Elavil (amitriptyline), kaningi ayiphumeli ngendlela abantu abangathanda ngayo. Ngaphezu kwalokho, le mithi inemiphumela emibi evame ukuholela ekuqedeni.
Izindaba ezinhle ukuthi abacwaningi manje bagxila kakhulu ekuthuthukiseni imithi yokuvimbela i-novel migraine. Enye iprotheni ethize ayibhekene nale mithi yi -peptide ehlobene ne - calcitonin ye-gene (CGRP), etholakala ukuthi iphakanyiswe kubantu ngesikhathi sokuhlasela kwe-migraine.
Ngokuqondile, izidakamizwa ezimbili, i-fremanezumab ne-erenumab, zibonise isithembiso ekuhlolweni kwesigaba sesi-3-isikhathi esijabulisayo sabantu abathintekayo kanye nodokotela nabathandekayo babo.
Ake sihlolisise lezi zidakamizwa ezivelayo ze-CGRP.
I-Erenumab yokuvimbela i-Epradic Migraine
I-Erenumab i-anti-monoglonal anti-humicised antibody, futhi ibophezela kumamukeli we-CGRP (isayithi lokuvimbela amaprotheni).
Nakuba indlela yokusebenza ye-erenumab engacaciswanga ngokugcwele, ochwepheshe bayazi ukuthi i-CGRP ikhishwa kumafayili omzimba we-trigeminal ngesikhathi sokuhlasela kwe-migraine. Uma usukhululiwe, i-CGRP ayibandakanyeki kuphela ekudlulisweni kwezibonakaliso zobuhlungu, kodwa futhi yenza ukuhlanza imithwalo yegazi ngaphandle nangaphakathi kwe-skull.
Ngalokho, nge-erenumab evimbela isayithi elijwayelekile lokuqapha i-CGRP, abacwaningi bacabanga ukuthi ukuhlasela kwe-migraine kungalimaza-futhi manje kukhona idatha enhle yokusekela le mbono.
Esivivinyweni sesigaba sesi-3 eNew England Journal of Medicine , abangaphezu kuka-900 abahlanganyeli abane-migraine episodic (echazwe njengezingaphansi kuka-15 ukuhamba ngezinyanga ngenyanga), bekungakahleleki ukuthola enye yalezi zindlela ezintathu zokwelapha njalo ngenyanga izinyanga eziyisithupha:
- I-70-mg engaphansi kwe-subcutaneous (ngaphansi kwesikhumba ibe yi-fatty issue) umjovo we-erenumab
- I-140-mg injection subcutaneous ye-erenumab
- Ijozi elingenalutho le-placebo
Abahlanganyeli noma abaphenyi babengazi ukuthi ngubani othola i-erenumab ngokumelene nomjovo we-placebo, yingakho lesi sifundo sibhalwe isifundo se-double blind.
Imiphumela
Imiphumela yocwaningo yembula ukuthi inani lezinsuku ze-migraine ngenyanga liyancishiswa yizinsuku ezingu-3.2 ezinkampanini zokwelashwa ezingama-70-mg kanye nezinsuku ezingu-3.7 ezinkampanini zokwelapha ezingama-140, uma kuqhathaniswa nezinsuku ezingu-1.8 eqenjini le-placebo.
Ngemuva kokuhlaziywa kwezibalo, abaphenyi banqume ukuthi le miphumela ibalulekile. Lokhu kusho ukuthi ukunciphisa okuphezulu ekwakheni ukwelashwa kwakungokoqobo (ngenxa yomphumela womuthi) hhayi iphutha lokutadisha okungahleliwe.
Imiphumela yabonisa ukuthi cishe ingxenye yezingxenye zabahlanganyeli ezithola i-erenumab zithole amaphesenti angu-50 noma ngaphezulu ukunciphisa inani labo eliphakathi kwezinsuku ze-migraine ngenyanga uma kuqhathaniswa nengxenye yekota kulabo beqembu le-placebo-futhi, lo mphumela wawuphawulekayo.
Amaqembu wokwelapha nawo ayehlise kakhulu inani lamalanga adingekayo ukusebenzisa imishanguzo ye-migraine , uma kuqhathaniswa neqembu le-placebo.
Okokugcina, abahlanganyeli ocwaningweni bagcwalisa isikali esibizwa ngokuthi i-Migraine Physical Function Impact Diary, lapho amaphuzu aphezulu abonisa umthwalo omkhulu wokugudluza ekusebenzeni.
Izibalo zokukhubazeka ngokomzimba kanye nemisebenzi yansuku zonke zithuthukisiwe kakhulu kumaqembu wokwelashwa uma kuqhathaniswa neqembu le-placebo.
Imiphumela emibi
Izinga lezigameko ezimbi zifanayo phakathi kwabahlanganyeli abathola i-erenumab nabahlanganyeli abathola i-placebo. Ngokubanzi, amaphesenti angaphansi kuka-3 kubo bonke ababambiqhaza bayeke ukuhlolwa ngenxa yemiphumela emibi.
Isiphetho
Le miphumela ibonisa ukuthi i-erenumab iyasebenza (kokubili amanani) ekuvikeleni i-episodic migraine kwabanye abantu. I-Erenumab nayo ibonakala inesiprofetho esihle sokuphepha. Lokhu kwamukela izindaba njengamanje imithi yokuvimbela i-migraine ngokuvamile ivaliwe ngenxa yemiphumela emibi engathandeki.
I-Fremanezumab yokuvimbela i-Chronic Migraine
I-Fremanezumab iyi-anti-monoplonal ephilayo ene-humanized ehlanganiswa futhi ivimbela iphrotheni yangempela CGRP, ngokumelene ne-receptor yayo (njenge-erenumab).
Esivivinyweni sesigaba sesi-3 eNew England Journal of Medicine , abantu abangaphezu kwesigidi abane-migraine engapheli (echazwe ngokuthi bangaphezu kuka-15 abahamba ngezinyanga okungenani izinyanga ezintathu), bekungakahleleki ukuthola enye yale mibandela emithathu ngaphezulu kweviki eli-12 isikhathi:
- Ukujova okukodwa kwe-fremanezumab okuyisisekelo, kulandelwa umjovo we-placebo ongaphansi kweviki 4 nesonto 8 (ebizwa ngokuthi umjovo wekota)
- Izijovo ezintathu ezingaphansi kwe-fremanezumab enye esiswini, eyodwa ngeviki 4, kanti enye ngesonto 8 (ebizwa ngomjovo wenyanga)
- Umjovo we-placebo ongaphansi kwesisekelo, isonto 4, nesonto 8
Njengesivivinyo se-erenumab, abahlanganyeli kanye nabaphenyi babengazi ukuthi ngubani othola imithi ehambisana neyayithola i-placebo.
Ngesikhathi abahlanganyeli behlelwe ukuvakashelwa amahlanu (ekuhlolweni, okuyisisekelo, isonto eli-4, isonto lesishiyagalombili, bese-ke ngesonto 12), yonke idatha yabo yesifo yabhalwa nsuku zonke ngokusebenzisa i-headset-idayari yedivayisi. Isibonelo sedatha yekhanda kufaka phakathi ukuthi kwenzeka yini ikhanda, isikhathi sayo, nobuhlungu bayo obukhulu.
Imiphumela
Imiphumela yalolu cwaningo yembula ukuthi labo abahlanganyelayo abathola isisindo esisodwa se-fremanezumab noma izijovo ezintathu zenyanga ze-fremanezumab banciphise kakhulu inani eliphakathi kwezinsuku ze- migraine ngenyanga, uma kuqhathaniswa neqembu le-placebo.
Ngokuqondile, abahlanganyeli abathola i-placebo banesilinganiso sezinsuku ezingu-10.4 ze-migraine kulabo abathola i-fremanezumab ngekota ngayinye (izinsuku eziyi-8.5) nenyanga zonke (izinsuku ezingu-8.0).
Ngaphezu kwalokho, kwaba nokunciphisa okukhulu kunani eliphakathi kwezinsuku abahlanganyeli abadingekayo ukuze basebenzise imishanguzo ye-migraine eqondile eqenjini lokwelapha ngokumelene neqembu le-placebo.
Ekugcineni, kunciphisa okukhulu ukukhubazeka okuhlobene nengqondo (njengoba kulinganiswa ngesilinganiso esibizwa ngokuthi i-Headache Impact Test) yeqembu lokwelapha ngokumelene neqembu le-placebo.
Imiphumela emibi
Umthelela omubi kunazo zonke ekutadisheni kwaba ubuhlungu endaweni yomjovo, okwenzeke kaningi kubahlanganyeli abathola i-fremanezumab kunabahlanganyeli abathola indawobo. Noma kunjalo, ubukhulu bezenzo abuzange buhluke phakathi kwamaqembu, okwenzeka cishe cishe isilinganiso esifanayo kuwo wonke amaqembu amathathu.
Ngaphezu kwalokho, kwakukhona ukuphakama okunamandla kwezinga le-enzyme yesibindi kwabayisishiyagalombili kubahlanganyeli abathatha i-fremanezumab. Amazinga, noma kunjalo, abuyela emuva evamile, ngakho abahlanganyeli abazange bayeke ekutadisheni.
Empeleni, ngabaphenyi besifundo, bonke laba bahlanganyeli basebenzise imithi efana ne-nonsteroidal anti-inflammatory (NSAIDs) noma i-Tylenol (i-acetaminophen) kaningi noma ama-anti-depressants nsuku zonke. Ukudla kwala mithi kungachaza lezi zinkukhu eziphakeme ze-enzyme yesibindi, ikakhulukazi kusukela i-fremanezumab ingasetshenzisiwe esibindi.
Isiphetho
Kulesi sivivinyo sesigaba sesi-3, i-fremanezumab inikezwe noma i-quarterly noma inyanga ngayinye yayizuzisa ekuvimbeleni ukungenwa kwengculaza okungapheli. Akukona nje ukunciphisa inani lezinsuku ze-migraine ngenyanga (cishe ngaphansi kwezingu-2), kodwa kunciphise ukukhubazeka okuhlobene ne-migraine.
Izwi elivela
Okubalulekile lapha ukuthi le mithi, eqondisa ngqo imithi ye-migraines (imithi yangaphambili yokuvimbela yenzelwe ukwelapha ezinye izimo, njengokugubha nokucindezeleka), inika ithemba kanye nokunye okukhethwa ngabantu. Nokho, abaphelele, ukusekela ingqondo ukuthi inqubo yesilingo nesiphambeko isadingeka lapho uhlela uhlelo lwakho lokuvimbela i-migraine.
Ngaphezu kokusebenza ngokuphumelelayo ekuvimbeleni i-migraines kwabanye abantu, lezi zidakamizwa ezimbili ezibhekiswe ku-CGRP zibekezelelwe kahle-ibhonasi kabili. Lokho kusho ukuthi kunezifundo ezengeziwe ezidingekayo ukuze zihlolwe ukuphepha kwesikhathi eside nokusebenza kwezidakamizwa.
Ngaphezu kwalokho, izigulane zombili kulezi zifundo zazingekho uma zingakaphenduli emakilasini amabili angaphambi kwemithi yokuvimbela i-migraine. Ngakho-ke, kunzima ukusho ukuthi i-erenumab, i-fremanezumab, noma ezinye izidakamizwa ezibhekiswe ku-CGRP kule pipeline ziyoba izinketho eziphumelelayo kubantu abane- migraine engabonakali .
Ukwengeza, lezi zifundo zahlola abantu abadala kuphela, ngakho-ke izidingo ezihlolisisa izingane kanye nentsha nge-migraine nazo ziyadingeka.
> Imithombo:
> Bigal ME, Walter S, Rapport AM. I-peptide ehlobene negciwane le-Calcitonin (CGRP) nokuqonda kwe-migraine yamanje kanye nesimo sokuthuthukiswa. Izinwele . 2013 Sep; 53 (8): 1230-44.
> Buse DC et al. Ukwelashwa okungapheli kwe-migraine, ukukhubazeka, kanye nezenhlalo: imiphumela evela ku-American Migraine Prevalence and Prevention Study. Izinwele. 2012 Nov-Dec; 52 (10): 1456-70.
> Goadsby PJ et al. Isivivinyo esilawulwayo se-erenumab for migraine episodic. N Engl J Med 2017; 377: 2123-32.
> I-Schuster NM, i-Rapport AM. I-Calcitonin ehlobene ne-genetic-targeted therapies ye-migraine ne-cluster headaches: Ukubuyekezwa. I-Clin Neuropharmacol . 2017 Jul / Aug; 40 (4): 169-74.
> Silberstein SD et al. I-Fremanezumab yokwelapha okuvimbela ukwelapha okungapheli. N Engl J Med 2017; 377: 2113-22.