Idivaysi entsha ithatha imishanguzo ngemva kokuqala
Imigraines kunzima ukuphatha. Imithi yokulwa ne-anti-migraine inemiphumela emibi futhi ngokuvamile ayisebenziseki kahle. Ngaphezu kwalokho, uma kuthathwa njalo, imishanguzo ye-anti-migraine ingabangela inhloko "ikhronification," noma ikhanda liyanda. Ngenxa yalokho, kuye kwaba nesithakazelo esikhulu ekuthuthukiseni ukwelashwa okungewona okwelapha imithi ye-migraine, kuhlanganise neurostimulation (okungukuthi, ukugqugquzelwa kwesibindi).
I-Cefaly idivayisi yangaphandle ye-trigeminal nerve stimulator (e-TNS) ethumela izimpande ngokusebenzisa i-electrode ebeka ebunzini. Isebenza ngokuvuselela inzwa ye-ophthalmic, okuyinto igatsha lezintambo ze-trigeminal. Idivayisi ye-Cefaly yamukelwa ngaphambilini yi-FDA yokuvimbela i-migraine. Ngo-December 2017, ikhishwe ukwelashwa kwama -migraine alula futhi angasetshenziswa ngemuva kokuqala kwe-migraine.
Iyini idivayisi ye-Cefaly?
Idivayisi ye-Cefaly yi-headband eyenza i-current constant isebenzisa amabhethri amabili AAA. Amanje asetshenziswe kulo lonke isikhumba ebunzini, esebenzisa i-electrode yokuzibamba. I-Cefaly igqugquzela amagatsha e-supratrochlear ne-supraorbital we-nerve ophthalmic, okuyinto ephinde ibe igatsha lezintathu zokuhlala. I-nerve trigeminal idlala indima enkulu emakhanda e-migraine.
U-Cefaly ufika ezinhlobonhlobo ezintathu: Cefaly Acute, Cefaly Prevent, noCefaly Dual. I-Cefaly Acute isebenzisa ukuhlasela okujulile kwe-migraine.
I-Cefaly Prevent isetshenziselwa ukuvimbela ama-migraines. Futhi u-Cefaly Dual unamasethingi kokubili.
I-Cefaly Acute inikeza ukuphakama okukhulu, iseshini yokuvuselela amaminithi angu-60. I-Cefaly Prevent imvamisa ephansi futhi ingasetshenziswa nsuku zonke.
Ngokusho kwabenzi balo, idivayisi yeCefaly iyakhula kancane kancane phakathi nemizuzu engu-14 yokuqala yokusebenzisa.
Ngalesi sikhathi, uma i-current iba namandla kakhulu, ungacindezela inkinobho ukuze uqinise ukuqina futhi unqande noma yikuphi ukwanda okuqhubekayo kokuqina.
Umkhiqizi ubeka uhlu lwezingqinamba kwiwebhusayithi yayo, esebenza kubantu abane:
- idivayisi ehlanganisiwe yensimbi noma i-electronic ekhanda
- ehlushwa ebuhlungu obungenalwazi
- i-pacemaker ye-cardiac noma i-defibrillator egqoke noma efakekayo, engase ibangele ukuphazanyiswa ukuhamba ngegazi, ukushuswa kagesi noma ukufa
Imodi yesenzo lapho i-TNS isebenza khona ngokucacile. Ekuqaleni, ochwepheshe baveza ukuthi ukuvimbela ukuvimbela ukuvuthwa kwegazi kuqhubekela phambili emithonjeni yobuhlungu. Noma kunjalo, le ngqondo ayisekelwe yiziphumo zokucwaninga. Ngakolunye uhlangothi, kuye kwaphakanyiswa ukuthi i-e-TNS iguqule ukulawulwa kobuhlungu ngendlela ephezulu-phansi.
Ukugunyazwa kwe-FDA ku-Cefaly njengokwelashwa kwe-prophylactic kwakusekelwe emiphumeleni yezilingo ezimbili zaseYurophu: Isivivinyo se-PREMICE kanye noFundo Lokuhlola Ukukhangisa kwe-European Post-Marketing.
I-PREMICE Trial
I-PREMICE Trial kwaba ukuhlolwa okungahleliwe okulawulwa kweCefaly, okwenziwa phakathi kuka-2009 no-2011 yiBelgium Headache Society. Lolu cwaningo lwaluyinkinga yokufunda, noma yesikhathi eside, okubandakanya iziguli ezingama-67 ezinokuhlasela okungenani ezimbili kwe-migraine inyanga ngayinye.
Kulesi sivivinyo, kwakukhona isikhathi sokuqala sezinyanga eyodwa ngaphambi kokuba abathintekayo babelwe ukuthi bangempela noma bajabhe (okungukuthi, ukukhohlisa). Isikhathi sokwelapha sahlala izinyanga ezintathu.
Nazi imiphumela yocwaningo:
- Labo abathola ukwelashwa kwe-Cefaly babhekana nokunciphisa okukhulu kokubili kwezinsuku zokugula kanye nezinsizwa ngenyanga yesithathu yokwelapha.
- Iziguli ezathola ukwelashwa kwe-Cefaly zathola amaphesenti angu-29.7 ambalwa ezinsuku zokufuduka kanye namaphesenti angama-32.3 ambalwa kwezinsuku ezikhanda ikhanda.
- Esikhathini sokulawula noma ukuhlambalaza, iqembu, ukunciphisa izinsuku ze-migraine nezinsuku zezinsizwa kwakuyizingxenye ezingu-4,9 namaphesenti angu-3.4, ngokulandelana.
- Eqenjini lokuhlola, noma labo abathola ukwelashwa kwe-Cefaly, amaphesenti angu-38.2 weziguli athole okungenani amaphesenti angu-50 ekunciphiseni kwezinsuku zenyanga ze-migraine.
- Esiqenjini sokulawula, amaphesenti angu-12.1 wabathintekayo abhekana nokunciphisa okungenani amaphesenti angu-50 ezinyangeni zenyanga zenyanga.
- Ngokuvamile, kunciphise ngokuphawulekayo kwezinsuku ze-migraine eqenjini lokuhlola.
- Nakuba kungabonakali ngokuphawulekayo, labo abathola ukwelashwa kwe-Cefaly babike ukunciphisa ubukhulu be-migraines.
- Labo abathintekayo basebenzisa uCefaly badinga imithi engaphansi kwamaphesenti angama-36.7 ukuphatha ikhanda le-migraine.
- Kulabo abathola ukwelashwa ngamanyala, kwaba nokwanda kwamaphesenti angu-0.4 emithini yokulwa ne-anti-migraine.
- Kwakungekho nemiphumela emibi emibi kulabo abasebenzisa i-Cefaly.
- I-Cefaly ingaba nenzuzo kakhulu kubantu abane-migraines ephindaphindiwe, noma ngaphezulu kwezinyanga ezine (okungukuthi, izinsuku eziyisikhombisa ze-migraine). Ngokusobala, kwenziwa ucwaningo olwengeziwe lokuhlola lesi siguli esithile sesiguli.
Ucwaningo lwe-European Post-Marketing Surveillance Study
Ukubhaliswa kwasungulwa kuzo zonke iziguli ezathola ithuluzi leCefaly phakathi kukaSepthemba 2009 noJuni 2012. Abaningi balaba abathengi babehlala eFrance naseBelgium. Ngemva kokusebenzisa le divayisi phakathi kwezinsuku ezingu-40 no-80, lezi ziguli zacelwa ukuba zihlanganyele ocwaningweni ekuhloleni ukwaneliseka nokukhathazeka ngemiphumela emibi emibi.
Imiphumela yalolu cwaningo lokuthunyelwa kokukhangisa kubonise ukuthi cishe amaphesenti angu-53 iziguli anelisekile ukwelashwa futhi wayefuna ukuqhubeka nokusebenzisa idivayisi. Cishe amaphesenti angu-4 weziguli ayengenelisekile ngedivayisi. Ayikho yalezi zikhalo ezibandakanya imiphumela emibi kakhulu. Ngokuqondile, laba abathengi bakhononda ngokuzwa okubangelwa yidivaysi (okungukuthi, "ukulinganisa"), ukulala phakathi neseshini, nokukhanda ikhanda ngemuva kweseshini.
Cefaly for Attack Migraine
Ngokusekelwe emiphumeleni yokuhlolwa kwe-placebo okungahleliwe, okuthiwa yi-ACME (Acute Treatment of Migraine ne-External trigeminal nerve stimulation), ngo-December 2017, i-FDA ibuye yavumela uCefaly ukuthi ilashwe ukuhlasela kwe-migraine njengoba kwenzeka. Ngenxa yalezi zibonakaliso zemitholampilo eyengeziwe, inani labantu abane-migraines abazozuza ku-Cefaly liye landa kathathu. Kulesi sifundo, kube nokunciphisa amaphesenti angu-65 ebubilini be-migraines, kanti amaphesenti angu-32 wabathintekayo abenabuhlungu phakathi nehora.
Imiphumela evela kulesi sivivinyo evulekile ehlola ukuphepha nokusebenza kweCefaly yokwelashwa kwe-migraine ephawulekayo yanyatheliswa encwadini ye- Neuromodulation ngo-Okthoba 2017. Kulesi sifundo, u-Chou kanye nozakwethu bahlola ukusetshenziswa kukaCefaly kuziguli ezingama-30 ezazibhekene nemigraines kungaba nge-aura noma ngaphandle. Ukuze kufakwe ocwaningweni, lezi ziguli kumele zibe nokuhlaselwa kwe-migraine okungapheli amahora amathathu. Ngaphezu kwalokho, laba bantu akufanele bathathe noma yimiphi imithi yokuhlasela kwe-migraine.
Ukwelashwa noCefaly kunikezwe ihora elilodwa. Kuzo zombili amahora amabili nambili emva kokuqala ukwelashwa, abahlanganyeli babuzwa ukuthi balinganise ubuhlungu babo ngokusebenzisa izikali zobuhlungu.
Ngokusho kukaChou kanye nabalobi ababambisene nabo, nansi imiphumela yesifundo sabo seCefaly:
Ngokuqondene nokusebenza kahle, ubuhlungu obukhulu bubuhlungu buye buyancishiswa kakhulu ngamaphesenti angu-57.0 ngemva kokuphathwa kwehora elilodwa futhi ngamaphesenti angu-52.8 emahoreni amabili. Ukulingana okufanayo ngesikhathi samaphuzu amabili kubonisa ukuthi ukunciphisa ubuhlungu kugcinwa kahle okungenani ihora ngemva kokuphela kwe-neurostimulation. Iphesenti yeziguli ezingasebenzisi imithi yokulondoloza kwaba amaphesenti angu-100 emva kwamahora amabili kanye namaphesenti angu-65.4 emva kwamahora angu-24. Isibalo seziguli ezingathathi imithi yokuphulula amahora angama-24 emaqenjini ase-placebo ngokuhlolwa kwama-acraine acraine ajwayelekile ajwayelekile okubhekwa ukuthi abe amaphesenti angama-32.
Okuphawulayo, "imithi yokukhulula" ibhekisela emithini ezithathwe imithi lapho imishanguzo ye-line yokuqala ihluleka ukusiza. Kulesi sifundo, uma iseshini se-Cefaly siphumelelanga, abahlanganyeli bangathatha imithi yokusiza. Ukutholakala kwemithi yokuhlengwa kubhalwe amahora amabili namahora angu-24.
Ngaphandle kokwelapha ngokuphumelelayo ukuhlaselwa kwe-migraine, i-Chou kanye nozakwethu abazange babone izenzakalo ezimbi, futhi akekho omunye wabahlanganyeli okhononda mayelana nokwelapha.
Kunzima ukuqhathanisa ukusebenza kukaCefaly ngemithi esetshenziselwa ukwelapha i-migraine ngenxa yokungafani kokuklanywa kwezilingo phakathi kokufundwa. Noma ngabe kunjalo, ukuhlola okuhlukile kuye kwathola ukuthi ihora elilodwa ngemuva kokuthatha i-NSAID diclofenac (i-Voltaren), iziguli zibike ukunciphisa amaphesenti angama-26,8 ezinkampanini ezibuhlungu uma kuqhathaniswa nokunciphisa amaphesenti angu-17.1 ekuhlukuneni kwe-migraine kulabo abathatha i-sumatriptan, kanye no-52.7 ukunciphisa amaphesenti kulabo abathola iseshini seCefaly.
Mayelana nokudliwa kwemithi yokunakekelwa, olunye ucwaningo lubonisa ukuthi phakathi kwamaphesenti angu-20 kanye namaphesenti angu-34 abantu kudingeka bathathe imithi yokuphulula phakathi kwamahora amabili nama-24 ngemuva kokuthatha i-triptan. Ngaphezu kwalokho, ngokwesilinganiso, amaphesenti angu-37 abantu abathola isidingo se-NSAID sokuthatha imithi yokusiza. Nakuba, amaphesenti angama-34.6 weziguli ezithola iseshini yeCefaly adinga ukuthatha imithi yokuhlengwa.
Ekugcineni, kubonakala sengathi uCefaly usebenza kanye nezinye izifo zokwelashwa kwe-migraine kuhlanganise ne-triptans nama-NSAID. Ngokungafani naleminye imithi, Cefaly ayinayo imiphumela emibi kakhulu. Ngaphezu kwalokho, abacwaningi basikisela ukuthi idivayisi yeCefaly ingasebenza nakakhulu uma isetshenziswe ngaphambi kwamahora amathathu ekuhlaselweni.
Ulwazi oluthe xaxa Mayelana neMigraines
Amaphesenti angaba ngu-12 aseMelika ahlakulela i-migraines. I-Migraines ijwayelekile kaningi kulaba besifazane. Ngokusho kwe-Global Burden of Disease Study 2013, i-migraines yiyona yesithupha yokukhubaza kakhulu emhlabeni jikelele futhi kubangele ukukhubazeka okukhulu kwekhwalithi yokuphila.
Imigraines ikhona ekuhlaselweni kokuhlunga okulinganayo kuya ebuhlungu obukhulu. Ikhwalithi yezinhlungu iyaphonsa noma iphoqa-ngokuvamile ithinta uhlangothi olulodwa lwekhanda. Ngesikhathi sokuhlaselwa kwe-migraine, abantu babhekana nokuzwela okukhulu ukukhanya nokuzwakala. Abagulayo be-Migraine bangase babe nesisulu sokuhlanza nokuhlanza.
Abanye abantu babhekana nokuphazamiseka kwemizwelo ngaphambi noma ngesikhathi sokuhlasela kwe-migraine. Lokhu ukuphazamiseka kwemizwa kuthiwa yi-aura. Lezi ziphazamiso zingabonwa, njengezibani ezikhanyayo noma izindawo eziyimpumputhe. Bangabonakala futhi njengokungena ezandleni noma ebusweni.
Izimbangela ze-Migraine zifaka:
- Ukucindezeleka
- Ukukhathazeka
- Ukungabi nokulala
- Ukuveza ukukhanya
- Izinguquko ze-Hormonal
Abaphathi be-migraines bangaba nzima noma bavimbele. Ukwelapha okunamandla kusetshenziselwa ukumisa ukuhlasela kwe-migraine bese ubuyisela ukusebenza okujwayelekile. Ukuvimbela ukuvimbela kuhlose ukuguqula imvamisa yokuhlasela nokuqina.
Izidakamizwa ezisetshenziselwa ukwelapha okunzima kwe-migraine zifaka:
- Ama-NSAID
- I-Analgesic
- I-Triptans
Nazi izindlela zokuvimbela i-migraine:
- Beta-blockers (isb., I-metoprolol, i-propranolol, i-bisoprolol, ne-candesartan)
- Ama-blockers wesiteshi se-calcium (isb., I-flunarizine ne-verapamil)
- Ama-anticonvulsants (isb., I-topiramate ne-valproate)
I-Nutraceuticals, kuhlanganise i-riboflavin, i-coenzyme Q10, ne-magnesium, ine-effectiveness ephansi ekuvimbeleni ukuhlaselwa kwe-migraine.
Ukubhala eCephalalgia , Dodick, noMartin ukuphawula ngemiphumela emibi ye-triptans:
Nakuba kubonakala sengathi iqoqo elidinga izidakamizwa, imiphumela evela ekuhlaziyweni kwe-meta yembula ukuhluka okuphawulekayo ekuphumeleleni nasekubekezekeni phakathi kwama-triptans omlomo. Isimo semiphumela emibi yesimiso se-nervous system (CNS) esinezidakamizwa ezinye ze-triptans ziphakeme ngamaphesenti angu-15 futhi zingase zihlotshaniswe nokukhubazeka okusebenzayo nokukhiqizwa okunciphise. Ukuvela kwezenzakalo ezimbi ezihlobene ne-triptans ngokujwayelekile, kanye nemiphumela emibi ye-CNS, kungabangela ukulibala ekuqaliseni noma ngisho nokugwema ukwelashwa okunye okuphumelelayo.
> Imithombo:
> Iwebhusayithi yeCefaly. www.cefaly.us.
> Chou DE, et al. Ukuxilongwa Kwangaphandle Kwemigudu Yokuzivocavoca Kwe-Acute Treatment of Migraine: Isivivinyo Sokuvula I-Open on Safety and Efficiency. 2017; 20: 678-683.
> De Novo Ukufakwa Isicelo seCefaly Device . I-FDA.
> I-migraine. I-MedlinePlus.
> I-Riederer F, i-Penning S, i-Schoenen J. Transcutaneous Supraorbital Nerve stimulation (t-SNS) ne-Cefaly [1] Idivayisi ye-Migraine Prevention: Ukubuyekezwa Kwemininingwane Ekhona. Ubuhlungu nokuTherapy. 2015; 4: 135-137.