Isixhobo esitsha senza imigraines emva kokuqala
Imigraines kunzima ukuyiphatha. Ulwaphulo lokulwa ne-anti-migraine lunemiphumo emibi kwaye kaninzi aluphumelelanga. Ngaphezu koko, xa kuthathwa rhoqo, iyeza-anti-migraine zingabangela intloko yekhanda "i-chronification," okanye intloko ibuhlungu. Ngenxa yoko, kuye kwaba nomdla omkhulu ekuphuhliseni unyango lwe -pharmacological for migraine, kubandakanya i-neurostimulation (oko kukuthi, ukuvuselelwa kwesibindi).
Isixhobo seCefaly sisishukumisi se-nerve (ex-nerve stimulator) esithumela ngaphandle (e-TNS) esithumela imijikelezo ngokusebenzisa i-electrode efakwe ebunzini. Isebenza ngokuvuselela i-nerph ostthalmic, eyisebe le-nerve trigeminal. Isixhobo seCefaly saye savunywa ngaphambili yi-FDA yokuthintela imida. NgoDisemba ngo-2017, wakhululwa ngokunyanga kwama -migraines anzima kwaye unokusetyenziswa emva kokuba i-migraine iqalile.
Yintoni iCefaly Device?
Isixhobo se-Cefaly yintloko ebalulekileyo eyenza i-current current isebenzisa amabhetri amabini AAA. Okwangoku kusetshenziswe kwesikhumba sebunzi, usebenzisa i-electrode yokuzibamba. I-Cefaly ivuselela ama-supratrochlear kunye nama-supraorbital amagatsha e-ophthalmic nererve, ephindaphinda i-branch of the triginal nerve. I-nerve trigeminal idlala indima enkulu kwi-headraps head.
UCefaly uvela emithathu imizekelo: Cefaly Acute, Cefaly Prevent, kunye noCefaly Dual. I-Cefaly Acute isebenzelana nokuhlaselwa kwe-migraine.
I-Cefaly Prevent isetyenziselwa ukuthintela imigraines. Futhi uCefaly Dual unesethingi bobabini.
I-Cefaly Acute inikezela ngamandla, iseshoni yokuvuselela iminzuzu engama-60. I-Cefaly Prevent i-frequency ephantsi kwaye isetyenziswe imihla ngemihla.
Ngokutsho kwabenzi balo, iCefaly icandelo landa ngokunyaniseka kwimizuzu eyi-14 yokuqala yokusetyenziswa.
Ngeli thuba, ukuba ikhoyo ngoku iyanzima kakhulu, unokucofa iqhosha ukuze uzinze umthamo kwaye unqamle nayiphi na ukunyuka kwenyameko.
Umenzi ubonisa uluhlu lweengqungquthela kwiwebhusayithi yalo, esebenza kubantu:
- ifowuni okanye ifowuni ye-elektroniki entloko
- ubandezeleka entlungu engaziwayo
- i-pacemaker ye-cardiac okanye i-defibrillator enokugqoka, engabangela ukuphazamiseka nokuhamba, ukutshatyalaliswa kombane okanye ukufa
Imodi yesenzo apho i-TNS isebenza ngokucacileyo. Ekuqaleni, iingcali zenza ukuba izithintelo zenyango zikhuphuka eziphambanweni zentlungu. Nangona kunjalo, le ngcamango ayixhaswanga ngophando. Ngokuchaseneyo, kucetyiswa ukuba i-e-TNS iguqulwe ukulawula ubuhlungu kwintambo ephezulu.
Imvume ye-FDA yeCefaly njengonyango lweprophylactic isekelwe kwimiphumo yezilingo ezimbini zaseYurophu: Uvavanyo lwe-PREMICE kunye noFundo lokuPhonononga kwe-Post Post Marketing.
I-PREMICE Trial
Icandelo le-PREMICE Trial lilingo olulawulwa ngokungapheliyo lweCefaly, olwenziwa phakathi kuka-2009 no-2011 nguMbutho weNtloko eBelgium. Olu pho nonongo lwabafundi bexesha elide, olude lubandakanya izigulane ezingama-67 ezinokubanjelwa kwembulini ezimbini ngenyanga.
Kulo vavanyo, kwakukho ixesha lokuqala lenyanga ngaphambi kokuba abathathi-nxaxheba babelwe ukuba bangene okanye bathambile (oko kukuthi, inkohliso) yokuvuselela. Ixesha lokunyanga lahlala iinyanga ezintathu.
Nazi iziphumo zesifundo:
- Abo bafumana unyango lwe-Cefaly bafumana ukuhla kwehla kokubili kwimihla yokunyuka kweentloko kunye nentloko yinyanga yesithathu yonyango.
- Izigulane ezafumana unyango lwe-Cefaly zafumana i-29.7 yeepesenti ezincinane iintsuku ze-migraine kunye ne-32.3 yeepesenti ezincinci iintsuku.
- Kulawulo okanye uhlazo, iqela, ukunciphisa iintsuku ze-migraine kunye neentsuku zeentloko zi-4.9 ekhulwini kunye ne-3.4 ekhulwini, ngokulandelana.
- Kwinqanaba lokulinga, okanye abo bafumana unyango lwe-Cefaly, iipesenti ezingama-38.2 zezigulane zafumana ubuncinane bokunciphisa ama-50 ekhulwini kwiintsuku ze-migraine zenyanga.
- Kwiqela lolawulo, i-12.1 ipesenti yabathathi-nxaxheba bafumana ubuncinane ukunciphisa ama-50 ekhulwini kwiintsuku ze-migraine zenyanga.
- Ngokubanzi, kukho ukunciphisa amanqaku okunciphisa kwiintsuku ze-migraine kwiqela lokulinga.
- Nangona kungabalulekanga, abo bafumana unyango lweCefaly babika ukunciphisa ubunzima be-migraines.
- Abo bathathi-nxaxheba basebenzisa iCefaly bafuna imithi engama-36.7 engaphantsi kweyeza ukunyanga i-migraine intloko.
- Kulabo bafumana unyango lwamahloni, kwakukho ukwanda kwama-0.4 ekhulwini kwiyeza zokulwa ne-migraine.
- Kwakungekho miphumo emibi kulabo basebenzisa uCefaly.
- I-Cefaly inokuba luncedo kakhulu kubantu abane-migraines ephindaphindiweyo, okanye ngaphezulu kwezine ngenyanga (oko kukuthi, iintsuku ezisixhenxe ze-migraine). Kubonakala ukuba uphando oluninzi lwenziwa ukuhlolisisa lesi siguli sabantu isiguli.
I-European Post-Marketing Study Surveillance Study
I-registry yasungulwa kuzo zonke izigulane ezithe zafumana isixhobo seCefaly phakathi kukaSeptemba 2009 noJuni 2012. Uninzi lwaba abathengi behlala eFransi naseBelgium. Emva kokusebenzisa ifowuni phakathi kweentsuku ezingama-40 no-80, ezi zigulane zacelwa ukuba zithathe inxaxheba kwiphulo lokuhlola ukwaneliseka nokukhathazeka malunga nemiphumo emibi.
Iziphumo zolu phando lwentengiso-ntengiso lubonise ukuba malunga neepesenti ezingama-53 zezigulane zaneliswe unyango kwaye zafuna ukuqhubeka zisebenzisa idivayisi. Phantse iipesenti ezi-4 zezigulane zazingenelisekanga kwisixhobo. Akukho namnye kwezi zikhalazo ezibandakanya iziphumo ezibi kakhulu. Ngokukodwa, aba bathengi bekhalaza ngoluvo olubangelwa yi sixhobo (oko kukuthi, "ukubetha"), ukulala ngexesha leseshoni, kunye nentloko emva kweseshoni.
Cefaly kwi-Attack ye-Migraine
Ngokusekelwe kwiziphumo zovavanyo lwe-placebo lwe-placebo olubizwa ngokuba yi-ACME (i-Acute Treatment of Migraine ne-External triggerinal nerve stimulation), ngo-Disemba 2017, i-FDA ibuye yavuma kwakhona i-Cefaly yokunyanga ukuhlaselwa kwe-migraine njengoko ivela. Ngolu hlobo lonyango lwezonyango, inani labantu abane-migraines abaya kuzuza kwiCefaly liye landa i-10. Kule sifundo, kukho ukunciphisa ama-65 ekhulwini kwintlungu ye-migraines, kwaye i-32 ekhulwini abathathi-ntliziyo babengenabuhlungu phakathi kweyure.
Iziphumo ezivela kwilingo evulekileyo yeebulayi ezihlola ukhuseleko kunye nokuphumelela kweCefaly kunyango lwe-migraine ekhutshiweyo kwanyatheliswa kwiphepha leNeromodulation ngo-Oktobha 2017. Kule sifundo, i-Chou kunye noogxa bavavanya ukusebenzisa i-Cefaly kwizigulane ezingama-30 ezazifumana imigraines nokuba kunye okanye ngaphandle. Ukuze kufakwe kwisifundo, ezi zi gulane kufuneka zihlaselwe i-migraine ukuhlala okungenani iiyure ezintathu. Ngaphezu koko, aba bantu bamele bangathathi naliphi na unyango lokuhlaselwa kwe-migraine.
Unyango kunye noCefaly wanikwa iyure enye. Kwimibini kunye neeyure ezimbini emva kokuqala kokonyango, abathathi-nxaxheba baceliwe ukuba bahlawule intlungu yabo ngokusebenzisa izikali zentlungu.
Ngokutsho kweCuu kunye nabalobi bezobambisene nabo, nantsi iziphumo zoFundo lwazo lweCefaly:
Ngokubhekiselele ekusebenzeni, intlungu yentlungu iyancitshiswa kakhulu ngamaphesenti angama-57.0 emva kweyure elilodwa kunye nama-52.8 ekhulwini kwiiyure ezimbini. Umlinganiselo ofanayo kumanqaku amabini kubonisa ukuba ukunciphisa intlungu kugcinwe kakuhle ubuncinane kwiyure emva kokuphela kwe-neurostimulation. Ipesenti yezigulane ezingasebenzisi imithi yokuhlangula yayingama-100 ekhulwini emva kweeyure ezimbini kunye ne-65.4 ekhulwini emva kweeyure ezingama-24. Isixa sezigulane ezingathathi unyango kumaxesha angama-24 kwiindawo ze-placebo ze-pharmacologic ezinzima zokwelapha izigulane zonyango ngokuqhelekileyo zixelwa ukuba zibe malunga neepesenti ezingama-32.
Ingqalelo, "imithi yokuhlangula" ibhekisela kumayeza athathwe xa unyango lweyeza lokuqala luhluleka ukunceda. Kule sifundo, ukuba iseshoni yeCefaly yahluleka, ngoko abathathi-nxaxheba babeza kuthatha imithi yokuhlangula. Ukungena kwamachiza okuhlangula kubhalwe kwiiyure ezimbini kunye neeyure ezingama-24.
Ukongezelela ekuhlaseleni ngokuphumelelayo ukuhlaselwa kwe-migraine, iChou kunye noogxa baqaphele akukho ziganeko ezimbi, kwaye akukho namnye wabathathi-nxaxheba okhalaza ngonyango.
Kunzima ukuthelekisa ukuphumelela kweCefaly ngamachiza asetyenziswe ukunyanga i-migraine ngenxa yokungafani koyilo lwezilingo phakathi kovavanyo. Nangona kunjalo, uvavanyo olulodwa lufumanisa ukuba iyure enye emva kokuthatha i-NSAID i-diclofenac (i-Voltaren), izigulane zaxela ukunciphisa i-26.8 ekhulwini kwiimpawu zentlungu xa kuthelekiswa nokunciphisa i-17.1 ekhulwini kwintlungu ye-migraine kulabo bathatha i-sumatriptan kunye ne-52.7 ukunciphisa ipesenti kulabo bafumana iseshoni yeCefaly.
Ngokumalunga nokuthatha imithi yokunceda, olunye uphando lubonisa ukuba phakathi kwama-20 eepesenti kunye nama-34 ekhulwini abantu kufuneka bathathe imithi yokuhlangula phakathi kweeyure ezimbini neye-24 emva kokuthatha i-triptan. Ngaphezu koko, ngokuqhelekileyo, ama-37 ekhulwini abantu abathatha i-NSAID kufuneka bathathe amachiza okuhlangula. Nangona, iipesenti ezingama-34.6 zezigulane ezithola iseshoni yeCefaly zifuna ukuthatha imithi yokuhlangula.
Ekugqibeleni, kubonakala ukuba uCefaly usebenza kunye nezinye iindlela zokwelapha iintsholongwane ezinjengeen-triptans kunye ne-NSAID. Ngokungafani nale miyeza, nangona kunjalo, uCefaly akanayo imiphumo emibi kakhulu. Ngaphezu koko, abaphandi bacetyisa ukuba isixhobo seCefaly sinokusebenza ngakumbi xa sisetyenziswe ngaphaya kweeyure ezintathu ukuhlaselwa.
Olunye ulwazi malunga neMigraines
Amaphesenti angama-12 aseMelika ahlakulela imigraines. Iimigraines ziphindwe kathathu ngokuqhelekileyo kubafazi. Ngokwe-Global Burden of Disease Study 2013, i-migraines yintetho yesithandathu ekhubaza kakhulu emhlabeni jikelele kwaye ibangela ukungonakali okukhulu kumgangatho wobomi.
Iimigraines zenzeka ekuhlaselweni kweentlungu ezidityanisiweyo. Ubungakanani bentlungu buya kuphazamiseka okanye ukuphosa-ngokuqhelekileyo kuthintela kwicala elinye lentloko. Ngethuba lokuhlaselwa kwe-migraine, abantu bava novelwano oluphakamileyo ukukhanya kunye nesandi. Abaxhamli be-Migraine banokuva nesicathulo kunye nokuhlanza.
Abanye abantu bafumana ukuphazamiseka kwengqondo ngaphambi okanye ngexesha lokuhlaselwa kwe-migraine. Ukuphazamiseka kwengqondo kuthiwa yi-aura. Ezi mphazamiso zingabonwa, njengezibane ezikhanyayo okanye iimpawu eziyimfama. Bakwazi ukubonakalisa nje ukubetha kwezandla okanye ubuso.
Iziphumo eziququzelelweyo zeMigraine ziquka:
- Ukuxinezeleka
- Ukuxhalabisa
- Ukungabikho kokulala
- Ukubonakalisa ukukhanya
- Iinguqu zeHormon
Ulawulo lwe-migraines lunokuba lukhulu okanye lukhuseleke. Ukunyangwa okuthe tye kusetyenziswa ukuyeka ukuhlaselwa kwe-migraine nokubuyisela ukusebenza okuqhelekileyo. Ulawulo lokukhusela lujolise ekutshintsheni ukuhlaselwa kwamanzi kunye nobuqili.
Izidakamizwa ezisetyenziselwa unyango olunzulu kwi-migraine ziquka:
- NSAID
- Uhlalutyo
- Triptans
Nazi iindlela zokuthintela ukuthintela i-migraine:
- Beta-blockers (umzekelo, metoprolol, propranolol, bisoprolol, kunye ne-candesartan)
- Abaqambi bee-calcium (umzekelo, i-flunarizine kunye ne-verapamil)
- Anticonvulsants (umz., Topiramate kunye ne-valproate)
I-Nutraceuticals, kubandakanye i-riboflavin, i-coenzyme Q10, kunye ne-magnesium, ine-efficiency ephantsi ekukhuseleni ukuhlaselwa kwe-migraine.
Ukubhala eCephalalgia , Dodick, kunye noMartin ukuphawula ngemiphumo emibi ye-triptans:
Nangona kubonakala ngathi liqela lezilwanyana ezidityaniswayo, iziphumo ezivela kuhlalutyo lweemeta zibonisa ukungafani okubalulekileyo ekusebenzeni kunye nokunyamezela phakathi kwama-triptans omlomo. Iziganeko zesistim se-central central nervous system (CNS) kunye nezinye i-triptans ziphakamileyo ezili-15 kwaye zingabandakanywa nokuphazamiseka komsebenzi kunye nokuveliswa kwemveliso. Ukuvela kweziganeko ezimbi ezinxulumene ne-triptans ngokubanzi, kunye nemiphumo ye-CNS ngokukodwa, kunokukhokelela ekulibazisekeni ekuqaliseni okanye ekukhuselweni kolunye unyango olululo.
> Imithombo:
> Iwebhusayithi yeCefaly. www.cefaly.us.
> Chou DE, et al. I-External Triginal Nerve stimulation for the Acute Treatment of Migraine: Uvavanyo lweLayibha evulekileyo kwiKhuseleko kunye neNtsebenzo. 2017; 20: 678-683.
> I- De Novo Ukufowunelwa Isicelo seCefaly Device . FDA.
> I-migraine. MedlinePlus.
> I-Riederer F, i-Penning S, i-Schoenen J. I-Supraorbital Nerv stimulation (T-SNS) kunye neCefaly [1] Idivayisi ye-Prevention Migraine: Ukuhlaziywa kweenkcukacha ezifumanekayo. Ubuhlungu kunye neNyango. 2015; 4: 135-137.