Chipangizo chatsopano chimayambira migraines atayamba
Migraines ndi ovuta kuchiza. Mankhwala oletsa anti-migraine amakhala ndi zotsatira zovuta ndipo nthawi zambiri sagwira ntchito bwino. Komanso, pakamwa nthawi zonse, mankhwala oletsa anti-migraine amatha kupweteka mutu, "kapena kupweteka mutu. Chifukwa chake, pakhala pali chidwi chachikulu popanga chithandizo chopanda mankhwala kwa migraine, kuphatikizapo kugwiritsira ntchito ubongo.
Chipangizo cha Cefaly ndi chithunzithunzi chapadera choteteza mitsempha (e-TNS) chomwe chimatumiza mitsinje kupyolera mu electrode yomwe ili pamphumi. Zimagwira ntchito polimbikitsa mitsempha ya ophthalmic, yomwe ndi nthambi ya mitsempha ya trigeminal. Chipangizo cha Cefaly chinavomerezedwa kale ndi FDA kwa kupewa migraine. Mu December 2017, anamasulidwa chifukwa cha mankhwala ovuta a migraines ndipo angagwiritsidwe ntchito pakatha migraine.
Kodi Cefaly Chipangizo N'chiyani?
Chida cha Cefaly ndi chigwirizano chomwe chimapanga nthawi zonse kugwiritsa ntchito mabatire AAA awiri. Zamakono zimagwiritsidwa ntchito kudutsa khungu la pamphumi, pogwiritsa ntchito electrode yokha. Cefaly imalimbikitsa nthambi zapamwamba ndi zapamwamba za mitsempha yotchedwa ophthalmic, yomwe ili nthambi ya mitsempha yotchedwa trigeminal nerve. Mitsempha yotchedwa trigeminal nerve imathandiza kwambiri pamutu wa mutu wa migraine.
Cefaly akubwera mu mitundu itatu: Cefaly Acute, Cefaly Prevent, ndi Cefaly Dual. Cefaly Acute amachitira mwamphamvu zowawa za migraine.
Cefaly Prevent imagwiritsidwa ntchito popewera migraines. Ndipo Cefaly Dual ali ndi zolemba zonse.
The Cefaly Acute imapereka gawo lapamwamba, mphindi 60 zolimbikitsa. Cefaly Prevent ndifupipafupi ndipo ingagwiritsidwe ntchito tsiku ndi tsiku.
Malinga ndi opanga makinawo, chipangizo cha Cefaly chimawonjezeka pang'onopang'ono mkati mwa mphindi 14 zoyambirira.
Panthawiyi, ngati pakalipano ikukulirakulira, mungathe kukanikiza batani kuti mutsimikizire kukula ndikukhazikitsa kuwonjezeka kwina kulikonse.
Wopanga amalemba zolemba pa webusaiti yathu, yomwe ikugwira ntchito kwa anthu omwe ali ndi:
- chipangizo chopangidwa ndi zitsulo kapena zamagetsi pamutu
- kuvutika ndi ululu wosadziwika
- chowombera mtima kapena chovala chovala chovala, chomwe chingayambitse kusokonezeka, kuthamanga kwa magetsi, kapena kufa
Njira zomwe TNS imagwira ntchito sizidziwika. Poyambirira, akatswiri amachititsa kuti kugwiritsira ntchito matendawa kukulepheretseni kukwera m'mayendedwe opweteka. Komabe, izi zongopeka sizidathandizidwa ndi kufufuza kafukufuku. Mofananamo, zakhala zikuperekedwa kuti e-TNS isinthe kulamulira kupweteka mu mafashoni apamwamba.
Chipangano cha FDA cha Cefaly monga chithandizo chowopsa chinachokera ku zotsatira za mayesero awiri a ku Ulaya: Mlandu wa PREMICE ndi Phunziro la Kufufuza Kwambiri pa European Post-Marketing.
Chiyeso cha PREMICE
Chiyeso cha PREMICE chinali kuyesedwa kosasinthika kwa Cefaly, komwe kunachitika pakati pa 2009 ndi 2011 ndi Belgian Headache Society. Phunziroli linali phunziro lapadera, lomwe linaphatikizapo odwala 67 omwe ali ndi ziwawa zosachepera ziwiri mwezi uliwonse.
Mu mayeserowa, pamakhala miyezi yodziyambira miyezi isanayambe isanayambe ophunzirawo atapatsidwa mwayi wokhazikika kapena wamwano (mwachitsanzo, zabodza). Nthawi yothandizira idatha miyezi itatu.
Nazi zotsatira za phunziro:
- Anthu amene amalandira chithandizo cha Cefaly anapeza kuchepa kwakukulu kwa masiku awiri a mutu wa mutu wa mutu komanso wa mutu ndi mwezi wachitatu wa chithandizo.
- Odwala amene analandira chithandizo cha Cefaly anapeza 29,7 peresenti yochepa masiku a migraine ndipo 32.3 peresenti amachepera masiku ammutu.
- Mu ulamuliro kapena sham, gulu, kuchepetsa masiku a migraine ndi masiku a mutu wa mutu ndi 4.9 peresenti ndi 3.4 peresenti, motsatira.
- Mu gulu loyesera, kapena omwe amalandira Cefaly mankhwala, 38.2 peresenti ya odwala anali ndi kuchepetsa kuchepa kwa 50 peresenti m'mwezi wamwezi wa migraine.
- Mu gulu lolamulira, 12.1 peresenti ya ophunzira adapeza kuchepetsa kuchepa kwa magawo 50 patsiku la mwezi wa migraine.
- Zonsezi, panali kuchepa kwa chiwerengero cha masiku a migraine mu gulu loyesera.
- Ngakhale kuti si ofunika kwambiri, omwe amalandira chithandizo cha Cefaly adalongosola kuchepa kwa migraines.
- Omwe amagwiritsa ntchito Cefaly anafunikira mankhwala osachepera 36.7 peresenti kuti athe kupweteka mutu.
- Kwa omwe analandira chithandizo chamankhwala, panali kuwonjezeka kwa 0.4 peresenti ya mankhwala oletsa anti-migraine.
- Panalibe zotsatira zoyipa mwa iwo ogwiritsa ntchito Cefaly.
- Cefaly ikhoza kukhala yopindulitsa kwambiri kwa anthu omwe amakhala ndi migraines, kapena oposa oposa mwezi (mwachitsanzo, masiku asanu ndi awiri a migraine). Mwachiwonekere, kafukufuku wambiri akuchitidwa kuti aunike anthu odwalawa.
Phunziro la Kufufuzidwa kwa European Post-Marketing
A registry anakhazikitsidwa kwa odwala onse omwe anapeza chipangizo cha Cefaly pakati pa September 2009 ndi June 2012. Ambiri mwa ogulawa ankakhala ku France ndi ku Belgium. Atagwiritsa ntchito chipangizochi pakati pa masiku 40 ndi 80, odwalawa anafunsidwa kutenga nawo mbali pa kafukufuku woyesa kukhutira ndi nkhawa za zotsatirapo zoipa.
Zotsatira za kafukufuku wotsatsa malondazi zasonyeza kuti pafupifupi 53 peresenti ya odwala adakhutitsidwa ndi chithandizo ndipo akufuna kupitiriza kugwiritsa ntchito chipangizocho. Pafupifupi 4 peresenti ya odwala sanakhudzidwe ndi chipangizochi. Palibe zodandaulazi zili ndi zotsatira zoyipa. Mwachindunji, ogula awa adandaula chifukwa cha chisokonezo chomwe chinapangidwa ndi chipangizo (mwachitsanzo, "kugwedeza"), kugona pa phunziro, ndi mutu pambuyo pa gawoli.
Cefaly for Migraine Attack
Malingana ndi zotsatira za mayesero opatsirana, omwe amachititsa kuti ACME (Acute Treatment Migraine ndi chiwonongeko cha m'mimba), mu December 2017, a FDA avomereze Cefaly kuti azitha kulandira matenda a migraine pamene akuchitika. Ndizimenezi zikuwonjezeka, chiŵerengero cha anthu omwe ali ndi migraines omwe angapindule ndi Cefaly chawonjezeka katatu. Mu phunziro ili, kudalipa 65 peresenti ya kupweteka kwa migraines, ndipo 32 peresenti ya ophunzira anali opanda ululu mkati mwa ola limodzi.
Zotsatira za mayesero otseguka pofufuza za chitetezo ndi chithandizo cha Cefaly pofuna kulandira mankhwala osokoneza bongo anafalitsidwa mu nyuzipepala ya Neuromodulation mu October 2017. Phunziro ili, Chou ndi anzake adayesa kugwiritsa ntchito Cefaly kwa odwala 30 omwe anali ndi migraines kaya ndi kapena opanda aura. Kuti akhale nawo mu phunziroli, odwalawa ayenera kuti anali ndi vuto la migraine losatha maola atatu. Kuwonjezera apo, anthuwa sayenera kumwa mankhwala alionse kuti asokonezeke.
Kuchiza ndi Cefaly kunaperekedwa kwa ola limodzi. Pa maola awiri ndi awiri chiyambireni chithandizo, ophunzirawo adafunsidwa kuti ayese kupweteka kwawo pogwiritsa ntchito masautso.
Malingana ndi Chou ndi olemba mabuku, apa pali zotsatira za phunziro lawo la Cefaly:
Pofuna kuthandizira, kupweteka kwambiri kunachepetsedwa ndi 57.0 peresenti pambuyo pa mankhwala ola limodzi ndi 52.8 peresenti pa maola awiri. Kufanana komweko pa mfundo ziwirizi kumasonyeza kuti kuchepetsa kupweteka kumasungidwa bwino kwa ola limodzi lokha pambuyo pa kutha kwa ubongo. Chiwerengero cha odwala osagwiritsira ntchito mankhwala opulumutsa anali 100 peresenti pambuyo pa maola awiri ndi 65.4 peresenti pambuyo pa maola 24. Chiwerengero cha odwala osalandira mankhwala opulumutsidwa mkati mwa maola 24 m'magulu a placebo chifukwa cha mankhwala osokoneza bongo omwe amachititsa kuti munthu asamalidwe bwino nthawi zambiri amadziwika kuti ali pafupi 32 peresenti.
Zindikirani, "mankhwala opulumutsa" akutanthauza mankhwala omwe atengedwa pamene mankhwala oyamba amalephera kuthandiza. Mu phunziro ili, ngati gawo la Cefaly lilephera, ndiye ophunzira angatenge mankhwala opulumutsa. Kufunika kwa mankhwala opulumutsawo kunalembedwa m'maola awiri ndi maola 24.
Kuwonjezera pa kulondolera matenda a migraine, Chou ndi anzake sanaganizire zochitika zovuta, ndipo palibe aliyense amene adadandaula za mankhwalawa.
N'zovuta kuyerekezera momwe Cefaly alili ndi mankhwala omwe amatha kulandira migraine chifukwa cha kusiyana kwa mayesero pakati pa maphunziro. Komabe, pogwiritsa ntchito kupweteka kofanana komweku, kafukufuku wosiyana anapeza kuti ola limodzi atatha kutenga NSAID diclofenac (Voltaren), odwala amalemba kuchepetsa 26,8 peresenti ya kupweteka poyerekeza ndi kuchepa kwa 17.1 peresenti ya kupweteka kwa migraine kwa omwe amatenga sumatriptan, ndi 52.7 kuchepetsa kuchepa kwa iwo omwe alandira gawo la Cefaly.
Ponena za kudya kwa mankhwala opulumutsa, kafukufuku wina akusonyeza kuti pakati pa 20 peresenti ndi 34 peresenti ya anthu amafunika kupulumutsa mankhwala pakati pa maola awiri ndi 24 mutatha triptan. Kuwonjezera apo, pafupifupi 37 peresenti ya anthu omwe amatenga NSAID kuti atenge mankhwala opulumutsa. Ngakhale kuti, 34.6 peresenti ya odwala omwe akulandira gawo la Cefaly ayenera kutenga mankhwala opulumutsa.
Pamapeto pake, zikuwoneka kuti Cefaly amagwira ntchito komanso njira zina zothandizira mutu wa mutu wa migraine kuphatikizapo triptans ndi NSAIDs. Mosiyana ndi mankhwala enawa, Cefaly alibe mavuto aakulu. Komanso, ochita kafukufuku akuganiza kuti chipangizo cha Cefaly chingakhale chogwira ntchito kwambiri ngati chinagwiritsidwa ntchito kale kuposa maola atatu.
Zambiri Zokhudza Migraines
Pafupifupi anthu 12 pa 100 aliwonse a ku America amapanga migraines. Migraines imakhala yofala katatu kwa amayi. Malinga ndi Global Burden of Disease Study 2013, migraines ndi matenda asanu ndi chimodzi olepheretsa anthu padziko lonse ndipo amachititsa kuwonongeka kwakukulu ku umoyo wa moyo.
Migraines zimachitika povutitsa ululu waukulu. Ubwino wa kupweteka ndiko kuthamanga kapena kupweteka-nthawi zambiri kumakhudza mbali imodzi yokha ya mutu. Panthawi ya ululu wa migraine, anthu amamva kukhudzidwa kwakukulu kwa kuwala ndi phokoso. Odwala matenda a Migraine angakhalenso ndi nseru ndi kusanza.
Anthu ena amakumana ndi mavuto osokonezeka kapena asanamwalire. Kusokonezeka kwachisokonezo chimenechi kumatchedwa aura. Kusokonezeka uku kungakhale kooneka, monga magetsi oyatsa kapena mawanga akhungu. Amatha kuwonetseranso ngati akugwira manja kapena nkhope.
Migraine oyambitsa ndi awa:
- Kusokonezeka maganizo
- Nkhawa
- Kupanda tulo
- Kuwonetsera kuwala
- Kusintha kwa mahomoni
Oyang'anira migraines akhoza kukhala ovuta kapena othawirako. Mankhwala ochiritsira amagwiritsidwa ntchito kuti athetse vuto la migraine ndi kubwezeretsa kugwira ntchito bwino. Kukonzekera kotetezera kumapangitsa kusintha maulendo oopsa ndi kuuma.
Mankhwala osokoneza bongo amagwiritsa ntchito:
- NSAIDs
- Analgesic
- Triptans
Nazi njira zothandizira matenda a migraine:
- Mabeta-blockers (mwachitsanzo, metoprolol, propranolol, bisoprolol, ndi candesartan)
- Amalonda a calcium (mwachitsanzo, flunarizine ndi verapamil)
- Anticonvulsants (mwachitsanzo, topiramate ndi valproate)
Nutraceuticals, kuphatikizapo riboflavin, coenzyme Q10, ndi magnesium, ali ndi mphamvu zochepa poletsa kuthamanga kwa migraine.
Kulemba ku Cephalalgia , Dodick, ndi Martin akunena za zotsatirapo zoipa za triptans:
Ngakhale zikuwoneka kuti ndi gulu la mankhwala osokoneza bongo, zotsatira za meta-analytical zimasonyeza kusiyana kwakukulu kwa mphamvu ndi kulekerera pakati pa katatu triptans. Zotsatira za zotsatira zoopsa za mankhwalawa (CNS) zokhudzana ndi mankhwala (CNS) ndi zina za triptan zimakhala zazikulu kwambiri kuposa 15 peresenti ndipo zingagwirizane ndi kuwonongeka kwa ntchito komanso kuchepetsa zokolola. Zomwe zimachitikira zovuta zomwe zimagwirizanitsidwa ndi triptans, ndipo zotsatira za CNS makamaka, zingayambitse kuchepetsa kapena kuteteza mankhwala osagwira ntchito.
> Zotsatira:
> Webusaiti ya Cefaly. www.cefaly.us.
> Chou DE, et al. Kuchokera Kwambiri kwa Nthendayi Yamakono Yogwira Ntchito Yachilendo cha Migraine: Mayeso Otseguka Otsatira pa Chitetezo ndi Efficacy. 2017; 20: 678-683.
> Kulemba kwa De Novo Kufunsira kwa Cefaly Device . FDA.
> Migraine. MedlinePlus.
> Wotchera F, Penning S, Schoenen J. Transcutaneous Supraorbital Mitsempha Yokhumudwitsa (t-SNS) ndi Cefaly [1] Chipangizo cha Migraine Prevention: A Review of Available Data. Ululu ndi Thandizo. 2015; 4: 135-137.