Pakhala pali zotsutsana zambiri ponena kuti mankhwala ochiritsira ndi odwala matenda a khunyu ndi omwe amatchedwa "mankhwala ofanana." Mwa kuyankhula kwina, pali funso linalake ngati mankhwala ochizira kapena ayi amagwira ntchito komanso omwe amakhala nawo pafupi kwambiri. Ngati mukuganiza kuti mutembenuke kuchoka ku mankhwala a mankhwala otchedwa antitic anvulonvulsant mankhwala, kapena ngati mukuganiza kuti mutembenuke kuchokera kuchipatala kwa wina, muyenera kudziwa bwino nkhaniyi kuti mupange chisankho chodziwika bwino.
Inde, mufunanso kukhala otsimikiza ndikukambirana chisankho ichi ndi dokotala wanu.
Momwe MaseĊµera Ochizira Amayambira
Kampani ikamagwiritsa ntchito mankhwala atsopano, nthawi zambiri imathira madola mamiliyoni ambiri kuti afufuze. Ndondomeko yamtengo wapatali imathandiza kutsimikizira kuti mankhwalawa amatsatira miyezo yoyenera yotetezera komanso yogwira ntchito. Kampani yosokoneza bongoyo ingagwiritse ntchito kulandira ndalama zambiri za mankhwala atsopano. Pafupifupi zaka 20 kuchokera pamene chilolezo choyambirira chimasungidwa, kampani ya mankhwala imatayika ufulu wopezeka kwa mankhwalawa. Mwa kuyankhula kwina, makampani ena angapereke mankhwala ochizira a mankhwala pamtengo wotsika.
Bungwe la United States Chakudya ndi Drug amayesa machitidwe onse a generic antiepileptics kuonetsetsa kuti mankhwala akusinthana ndi mankhwala. Ngakhale izi, kufufuza kwa madokotala ndi malipoti akusonyeza kuti pakhala pali mavuto aakulu pamene akusintha kuchokera ku dzina loti antiepileptic mankhwala kwa generics.
Ngati FDA ikuyesera kwambiri, kodi zingakhale bwanji kuti madokotala ndi odwala ambiri akufotokozera mavuto?
Kusamala pa Kusintha
A FDA amawona mankhwala omwe amachititsa kuti akhale "mankhwala ofanana ndi mankhwala" ngati ali ndi mankhwala omwe ali ndi mphamvu zofanana, ndipo amatsatira miyezo ya mphamvu, khalidwe, chiyero, ndi chidziwitso.
Zinthu ziwiri zimayang'aniridwa makamaka:
- Dera-pansi-la-curve (AUC)
- Mavuto aakulu a plasma (Cmax).
Zizindikiro izi zimayesa momwe mankhwala amathandizidwira m'magazi. The FDA imafuna kuti AUC ndi Cmax ya mankhwala ochiritsira olowa m'malo akhale 80 peresenti mpaka 125 peresenti ya dzina mayina ndi 90 peresenti chidaliro. Izi zimawoneka ngati malo okongola kwambiri, makamaka ngati mankhwalawa ali ndi "mawindo ochizira" - kusiyana kwa mlingo wa mankhwala omwe ndi othandiza komanso mankhwala omwe amachititsa zotsatira zosavomerezeka.
Kuonjezera apo, mayesero owonetsetsa kuti mankhwala ochiritsira omwe amagwiritsidwa ntchito pamtundu uwu amachitika pafupifupi anthu 35. Izi ndi zosiyana kwambiri kusiyana ndi nthawi zambiri anthu ambiri amayesa mankhwala osokoneza bongo.
Nchiyani FDA State About Switch to Generic Medication?
The FDA yanena kuti palibe umboni wamphamvu kuti pali ngozi yowonjezera yosintha kwa generics. Otsatira ena amasonyeza kuti zotsatira zothandizira zikhoza kuthandizira mavuto omwe odwala amatha atasintha. Pamene zotsatira za placebo zimakhudza zizindikiro za odwala atalandira mankhwala osagwira ntchito (monga mapiritsi a shuga) chifukwa wodwalayo amakhulupirira kuti mankhwalawa amawathandiza, zotsatira zake sizitsutsana ndi zizindikiro za odwala chifukwa akuganiza kuti mankhwala osagwira ntchito sangawathandize.
Zonse zimakhala zovuta kunena - mwinamwake kusokonezeka ndi nkhawa zomwe zimagwirizanitsidwa ndi kusintha kwa generic generator kugwidwa kwa anthu ena ali ndi khunyu.
Kupenyetsetsa kwambiri kwa Generic Anti-Epileptics
Komabe, ngati kusagwira ntchito kumangogwirizana ndi vuto la kusintha kwa mankhwala, si zachilendo kuti zofananazo siziwoneka mwa mankhwala ena monga mankhwala opweteka . Chifukwa chiyani izi ziyenera kukhala zovuta kwambiri kwa odwala omwe amamwa mankhwala a khunyu? Zingakhale zotsutsana ndi khunyu zomwe zimafuna kuti chidziwitso cha mlingo chikhale chokwanira kwambiri komanso kuti magawo omwe adaikidwa ndi FDA samagwiranso ntchito mankhwala omwe ali ndi mawindo ochepetsetsa.
Pachifukwa ichi, vuto silimodzi lokha kuchoka ku dzina lachidziwitso kupita ku mankhwala ochiritsira, koma lingakhalensopo pamene likusintha kuchokera ku chibadwa china kupita kuchilendo, monga momwe mankhwalawa angathenso kusiyana. Mwachitsanzo, ngati mankhwala amodzi amadziwika ndi 125 peresenti yomwe imapezeka mu dzina loti anti-epileptic, ndipo mumasintha mankhwala omwe ali ndi chiwerengero cha 80 peresenti, mlingo wanu wa mankhwala wagwera kwambiri.
Zowopsa
Kuopsa kwa kusinthika kuchoka ku dzina lachidziwitso kupita ku generic kapena pakati pa generics kumadalira pang'ono pa mankhwala omwe akutengedwa. Odwala omwe amagwiritsa ntchito Keppra (levetiracetam), Lamictal (lamotrigine) kapena Divalproex amatha kubwerera kuchokera ku generic kupita ku mankhwala, nthawi zambiri pofuna kuwonjezeka kapena kusintha kwa mankhwala osokoneza bongo. Chenjezo lodziwikanso limatchedwanso pamene kugwidwa kungakhale koopsa kwambiri, monga anthu omwe amayendetsa galimoto, ali ndi mimba, kapena amene avutika kwambiri chifukwa cha kugwidwa kwawo m'mbuyomo.
Pansi
Mavuto omwe akukumana nawo posintha dzina la antiepileptic mankhwala sizitanthauza kuti mankhwala onse okhudzana ndi khunyu ayenera kupewa. Mofanana ndi mankhwala ena alionse, pali zowopsa ndi zopindulitsa kusintha kwa zowonjezera. Zowopsya ndi zopindulitsazi ziyenera kumveka bwino musanapange chisankho chosintha. Ndalama idzapulumutsidwa, koma pangakhale mavuto ena omwe muyenera kudziwa kapena kusintha mazenera omwe angafunikire kupanga. Ndikofunika kuzindikira zomwe zingakhale zovuta ngakhale mutasintha pakati pa mankhwala ochiritsira ndikukambirana zomwe mukusankha ndi zodandaula zanu ndi dokotala wanu.
Zotsatira:
American Epilepsy Society (AES) Msonkhano Wapachaka wa 65: Msonkhanowu wa msonkhano wa tauni wa FDA. Inaperekedwa pa December 2, 2011.
Gidal, BE (2012). Mankhwala oletsa antiepileptic mankhwala: Ndi bwino bwanji pafupi? Matenda a Khunyu, 12 (1): 32-34.
Henney, JE. (1999). Kuchokera ku chakudya ndi mankhwala osokoneza bongo. JAMA, 282 1995.
Kramer, G., Steinhoff, BJ, Feucht, M., Pfafflin, M., & May, TW (2007). Zochitika ndi mankhwala ochiritsira odwala matenda a khunyu: kufufuza kwa magetsi kwa mamembala a nthambi za Germany, Austria ndi Switzerland za ILAE. Epilepsia , 48 (3): 609-611
Krauss, GJ, Caffo, B., Chang, Y.-T., Hendrix, CW, ndi Chuang, K. (2011). Kuwonetsa bioequivalence ya mankhwala oopsa antiepilepsy mankhwala. Annals of Neurology , 70: 221-228. lembani: 10.1002 / ana.22452
KUDZIZIRANI: Zomwe zili pa tsamba ili ndi zolinga za maphunziro okha. Sitiyenera kugwiritsidwa ntchito ngati choloweza m'malo mwa chisamaliro cha munthu wodwala wovomerezeka. Chonde funsani dokotala wanu kuti apeze matenda ndi chithandizo cha chilichonse chokhudza zizindikiro kapena matenda .