Kube nokuphikisana okuningi ngokuthi ngabe imithi yokwelapha negciwane lomuthi yilabo ababizwa ngokuthi "ukulingana ngokweqile." Ngamanye amazwi, kunombuzo othi noma ngabe imithi yokwelapha isebenza kanjani noma amanye ama-brand-brand ajwayelekile kakhulu. Uma ucabanga ukuthi ususelwa kumuthi wegama lomkhiqizo kuya emithini yama-generic anticonvulsant, noma ngisho noma ucabangela ukushintsha umuthi owodwa owenziwe komunye umuntu, udinga ukwazi kahle ngalolu daba ukuze wenze isinqumo esinolwazi.
Yiqiniso, uzophinde ufune ukuqinisekisa futhi uxoxe ngalesi sinqumo nodokotela wakho.
Ukuthi Imithi Ejwayelekile Yenziwa Kanjani
Lapho inkampani yokwelapha imithi iqala umuthi omusha, ivame ukuthululela izigidi zamaRandi ukucwaninga. Le nqubo ebiza kakhulu iyasiza ukuqinisekisa ukuthi imithi ihlangabezana nezindinganiso ezamukelekayo kokubili ukuphepha nokusebenza. Ikhamphani yezidakamizwa ingabe ivumelekile ukushaja imali eningi ngemithi emisha yegama lomkhiqizo. Eminyakeni engaba ngu-20 ngemuva kokuba i-patent yokuqala ifakwe, inkampani yezokwelapha ilahlekelwa ilungelo lokusabalalisa kuphela lalo mithi. Ngamanye amazwi, ezinye izinkampani zingahlinzeka ngohlobo olujwayelekile lomuthi ngamanani aphansi.
I-United States Yokudla Nezidakamizwa Ezokuphatha ihlola zonke izinhlobo zemithi ye-antiepileptics ukuqinisekisa ukuthi imithi iyashintshaniswa nemikhiqizo yomkhiqizo. Naphezu kwalokhu, ucwaningo lwezokwelapha kanye nemibiko yecala lisikisela ukuthi kuye kwaba nezinkinga eziphawulekayo lapho usuka emithini yegama elibizwa ngokuthi yi-brand antiepileptic imithi ekhiqiza.
Uma ngabe i-FDA idinga kakhulu ekuhlolweni, kungaba kanjani ukuthi odokotela abaningi neziguli babonisa ukukhathazeka?
Ukukhathazeka ekushintsheni
I-FDA ibona ukuthi izidakamizwa ezivamile "zilingana ngokweqile" kumuthi wegama lomkhiqizo uma unesisindo esifanayo sesithako esisebenzayo, futhi ihlangabezana nezindinganiso zamandla, ikhwalithi, ubumsulwa, nobunikazi.
Izici ezimbili zihlolwe ngokukhethekile:
- Indawo-ngaphansi kwe-curve (AUC)
- I-concentration enkulu ye-plasma (Cmax).
Lezi zici zilinganisela ukuthi imithi eminingana ithatha kanjani igazi. I-FDA idinga ukuthi i-AUC ne-Cmax yemithi ephindaphindiwe yemvelo ibe ngamaphesenti angama-80 kuya kuma-125 amaphesenti wegama lomkhiqizo ngamaphesenti angu-90 ukuzethemba. Lokhu kubonakala sengathi kunomkhawulo omuhle kakhulu, ikakhulukazi uma izidakamizwa ezinombuzo zine "encane" yokwelapha - umehluko phakathi komthamo wezokwelapha osebenzayo kanye nomthamo wezokwelapha owenza imiphumela emibi engamukeleki.
Ngaphezu kwalokho, izivivinyo zokwenza ukuthi izidakamizwa ezijwayelekile zihlangabezane nale nqubo ngokuvamile ziyenziwa kubantu abangaba ngu-35. Lokhu kuyindinganiso ehluke kakhulu kunaleyo kaningi abantu abaningi abavivinywa ngegama lomuthi.
Uyini Umbuso We-FDA Ngokushintshela Emidlalweni YamaGeneric?
I-FDA ithe akukho bufakazi obuqinile bokuthi kunezingozi ezikhudlwana zokushintshela kuma-generics. Abanye abasekeli balesi sikhundla basikisela ukuthi umphumela we-nocebo ungadlala indima ezinkingeni ezibikwe iziguli ngemuva kokushintsha. Nakuba umphumela we- placebo uhilela izimpawu zeziguli eziphuthumayo ngemva kokuthola into engasebenzi (njengephilisi le-sugar) ngoba isiguli siyakholelwa ukuthi izinto ezizozisiza, umphumela we-nocebo uhilela izimpawu zabagulayo ezimbi kakhulu ngoba becabanga ukuthi imithi esebenzayo ngeke isisize.
Konke kunzima kakhulu ukukusho - mhlawumbe ukucindezeleka nokukhathazeka okuhlobene nokushintshela kumuntu odala ukuthunjwa kwabanye abantu abanesifo sokuwa nesithuthwane.
Ukubheka ngokucophelela ama-Generic Anti-Epileptics
Kodwa-ke, uma ukungabi nokusebenza kuhlobene nje nokucindezeleka kokushintsha imithi, akuvamile ukuthi imiphumela efanayo ayibonakali kwezinye izinhlobo zezidakamizwa ezifana nemithi yobuhlungu . Kungani kufanele kube yinkinga enkulu kulabo abaphuza imithi yokuphuza? Kungenzeka nje ukuthi labo abahlukunyezwayo badinga ukulingana okuncane kakhulu kwezilwane nokuthi imingcele eyenziwe yi-FDA ayisebenzisi kahle ngemithi enefasitela elincane elithintekayo.
Kule nkinga, inkinga ayikho enye yokushintshela kusuka egameni lomkhiqizo kuya emithi yokwelapha, kepha ingase ibe khona lapho ishintsha kusuka komunye owodwa kuya komunye, njengoba lawo mazinga angase ahluke. Isibonelo, uma umuthi owodwa we-generic unamaphesenti angu-125 umthamo osebenzayo otholakala egameni legama eliphikisayo, futhi ushintshe kumuthi onamaphesenti angu-80 umthamo, umthamo wakho wezokwelapha weqiniso uwile kakhulu.
Izingozi ezingenzeka
Izingozi zokusuka egameni lomkhiqizo kuya kohlobo noma phakathi kwama generic zizoxhomekeka kancane ngokuthi yimiphi imithi ethathwa. Iziguli ezisebenzisa i-Keppra (levetiracetam), i-Lamictal (i-lamotrigine) noma i-Divalproex kungenzeka kakhulu ukubuyela emuva kusuka kumkhiqizo wemikhiqizo yamagama wegama lomkhiqizo, ngokuvamile ngenxa yokwenyuka kokuncipha noma ukuguquka kwezimpendulo ezimbi emithi. Ukuqapha okunye okubizwa nangokuthi ukuthunjwa kungaba yingozi kakhulu, njengabantu abashayelayo, abakhulelwe, noma abaye babhekana nemiphumela emibi yokwehluleka kwabo esikhathini esidlule.
Ngaphansi
Izinkinga ezibikiwe ngokushintsha umuthi wama-antiepileptic brand akusho ukuthi yonke imithi ejwayelekile yokulwa nesifo sofuba kufanele igwenywe. Njenganoma imuphi omunye umuthi, cishe kunezingozi nezinzuzo zokushintshela kuma-generics. Lezi zingozi nezinzuzo kudingeka ziqondwe kahle ngaphambi kokwenza isinqumo sokushintsha. Imali izosindiswa, kodwa kungase kube nezinye izinkinga okudingeka uziqaphele noma ukulungiswa kohlobo oluzodinga ukwenziwa. Kubalulekile ukuqaphela ukuthi kungenzeka yini izinkinga ngisho nalapho ushintsha phakathi kwemithi ejwayelekile futhi uxoxe ngakho konke okukhethayo nokukhathazeka nodokotela wakho.
Imithombo:
I-American Epilepsy Society (AES) Umhlangano Wonyaka Wengu-65: Umhlangano wehholo ledolobha lase-FDA. Ihanjiswe ngomhla kaDisemba 2, 2011.
I-Gidal, BE (2012). Izidakamizwa ezijwayelekile zokulwa nesibhamu: Kuhle kangakanani ngokushelela? Iziqu ze-Epilepsy, 12 (1): 32-34.
Henney, JE. (1999). Kusukela kokudla nokudla kwezidakamizwa. I-JAMA, 282 1995.
Kramer, G., Steinhoff, BJ, Feucht, M., Pfafflin, M., & May, TW (2007). Ukuhlangabezana nezidakamizwa ezijwayelekile ezigulini zesithuthwane: inhlolovo ye-elektroniki yamalungu aseGermany, Austrian naseSwitzerland amagatsha e-ILAE. I-Epilepsia , 48 (3): 609-611
Krauss, GJ, Caffo, B., Chang, Y.-T., uHendrix, CW, no-Chuang, K. (2011). Ukuhlola i-bioequivalence yezidakamizwa ezijwayelekile zokulwa nezifo. Ama- Annal of Neurology , 70: 221-228. i-doi: 10.1002 / ana.22452
QAPHELA: Ulwazi olukulesi sayithi lunguzinhloso zemfundo kuphela. Akufanele isetshenziswe njengengxenye yokunakekelwa ngumuntu udokotela olayisenisi. Sicela ubheke udokotela wakho ukuze ahlolwe futhi aphathwe noma yiziphi izimpawu noma isimo sezokwelapha .