Amiodarone (Cordarone, Pacerone) ndi yogwira mtima kwambiri, ndipo ndithudi mankhwala osokoneza bongo omwe ndi opambana kwambiri. (Pano pali ndondomeko yodabwitsa ndi zotsatira zosazolowereka za amiodarone .) Chimodzi mwa zinthu zazikulu kwambiri za mankhwala ndi mbiri yake. Ndi mbiri yomwe imalongosola zambiri za chifukwa chake, mpaka lero, zinthu zambiri zosadziwika bwino za mankhwalawa sizikumvetsetsedwa bwino ndi madokotala ambiri omwe amapereka izi.
Development
Amiodarone inakhazikitsidwa ndi kampani ya ku Belgium mu 1961 monga mankhwala ochizira angina (chifuwa chokhudzana ndi matenda a mitsempha) ndipo mwamsanga anayamba kukhala mankhwala odziwika ndi anti-angina ku Ulaya ndi South America. Komabe, posankha kampani ya mankhwala (mwinamwake kupeĊµa chikhalidwe chodziwika bwino cha ku America), amiodarone sanaperekedwe kuti amasulidwe ku United States.
Patatha zaka zingapo dokotala wina ku Argentina, Dr. Mauricio Rosenbaum, adazindikira kuti amiodarone zikuwoneka kuchepetsa mtima wamaganizo mwa odwala omwe ali ndi matenda a mtima. Anayamba kugwiritsa ntchito mankhwalawa mobwerezabwereza chifukwa cha kusokonezeka kwa mtima ndipo anayamba kufalitsa zotsatira zake, zomwe zinali zodabwitsa kwambiri. Madokotala ochokera padziko lonse lapansi (kupatula ku United States) mwamsanga anayamba kugwiritsa ntchito mankhwalawa kuti athetse matenda a mtima wa mitundu yonse. Mbiri ya amiodarone imafalikira kutali ndi-amiodarone, mawuwo anali, anali odabwitsa kwambiri mankhwala osokoneza bongo omwe nthawi zambiri ankagwira ntchito, ndipo analibe zotsatirapo.
Zonsezi, zowona, zinali zabodza.
Gwiritsani ntchito ku America
Kuchokera kumapeto kwa zaka za m'ma 1970, American electrophysiologists (akatswiri a mtima wamtima) anayamba kupeza amiodarone kuchokera ku Canada ndi ku Ulaya kuti agwiritse ntchito odwala awo omwe amatha kuika moyo wawo pachiopsezo chomwe sichimayankha mankhwala ena onse. (The FDA inavomereza ntchitoyi mwachifundo-ntchito.) Mawu oyambirira ochokera ku America ankawoneka kutsimikizira zomwe anali kunena padziko lonse-amiodarone anali otetezeka kwambiri ndi ogwira mtima.
M'zaka zingapo, odwala a ku America oposa 10,000 omwe ali ndi ziwalo zoopsa zowonongeka akuyembekezeredwa kulandira amiodarone. Inde, chifukwa cha momwe amiodarone inkagawidwira, palibe amene ankadziwa kuti odwala ambiri amalandira mankhwalawa. Chofunika kwambiri, chifukwa a FDA sanaphatikizidwe ndi china chirichonse (kupatula kuti avomereze kugwiritsa ntchito mankhwalawa chifukwa cha chifundo), palibe amene anali kulemba zambiri zokhudza mphamvu ya mankhwala kapena chitetezo.
Zotsatira Zotsatira Zinapezeka
Komabe, madokotala ambiri a ku America anaphunzira zotsatira za azimaodarone pa odwala awo molimbika kwambiri kuposa omwe anzathu a kunja kwa dziko lapansi adachita. Zotsatira zake, mkati mwa chaka chimodzi kapena ziwiri momwe timaonera amiodarone anayamba kusintha. Amiodarone inalidi yothandiza kwambiri kuthetsa arrhythmias kuposa mankhwala ena onse omwe tidawawonetsepo (ngakhale kuti sanagwiritse ntchito moyenera monga momwe adalengezedwera), koma izi zinabala zotsatira zovuta kwambiri kuphatikizapo mavuto a chithokomiro , kutuluka kwa khungu, kuopseza ziphuphu za m'mapapo zomwe madokotala padziko lonse akuwoneka kuti "asochera." Zotsatira zake zinali zitasoweka, chifukwa cha mbali zambiri, chifukwa zinali zosazolowereka komanso zosayembekezereka ndipo chifukwa chakuti ziyambi zawo zinkakhala zopusa komanso mochedwa.
Zotsatira za mankhwala a amiodarone atayamba kufotokozedwa m'mabuku a zachipatala, a FDA sanafune kuvomereza mankhwalawa. Komabe, a FDA posakhalitsa sanasankhe. Pakatikati mwa zaka za m'ma 1980, opanga alendo ochokera ku mayodarone adaopseza kuti adzalanditsa ku America (osati chifukwa chopanda nzeru, popeza adagwiritsa ntchito mankhwala osokoneza bongo kwa zikwi zikwi ndi mazana ambiri ku America kwa zaka zoposa zisanu). Kungodzipha Achimerika kuchoka ku mankhwala kungabweretse mankhwala (ndipo motero, mwinamwake ndale) tsoka. Kotero, mu 1985, mosiyana kwambiri ndi mankhwala ena alionse m'mbiri yamakono, amiodarone anakhala FDA -vomerezedwa popanda zovuta, FDA-zovomerezeka zovuta zowonongeka.
Fomu ya FDA
Polemekeza mankhwala omwe ali atangopeza kumene komanso oopsa kwambiri, a FDA amavomereza mankhwalawa chifukwa chowopsyeza kuti palibe mankhwala ena omwe angawathandize, ndipo amawachenjeza za bokosi lakuda za zotsatira zake zoopsa. Pozindikira kuti mankhwalawa anali othandiza kwambiri kuti asakhale ndi moyo woopsa, a FDA adalimbikitsa opanga kuchita mayesero amtundu wa randomzedwe kuti adzivomereze kuti adziwe ngati akudwala matenda oopsa , pozindikira kuti kuyambitsa ziyeso zoterezi kungatiphunzitse zambiri zokhudza zochitika zenizeni kuopsa kwa zotsatira za mankhwala. Mayesero amenewa sanayambe achitidwa (mwina chifukwa mayeserowa ndi okwera mtengo kwambiri, ndipo panthawiyi chivomerezo cha amiodarone chinali kutha, kutsegula chitseko cha opanga mavitamini kuti ayambe kuchigulitsa), ndipo malamulo oyambirira pa ntchito ya amiodarone apitirirabe tsiku.
Ndipo chifukwa chake, kugwiritsa ntchito amiodarone kwa mankhwala a atrial fibrillation (chifukwa chofala kwambiri chomwe chimayikidwa lero) sichikhala pambali.
Pansi
Mbiri yachilendo ya amiodarone ikhoza kufotokoza chifukwa chake madokotala ena omwe amapereka mankhwalawa akuwoneka kuti sakudziwa kukula kwake ndi zowonongeka za zotsatira zake zambiri ndi chifukwa chake ena mwa iwo samayang'anitsitsa mokwanira odwala awo omwe amachititsa amiodarone kapena kuwauza odwala awo zomwe muyenera kusamala. Aliyense amene akugwiritsa ntchito mankhwala osokoneza bongo ayenera kudzidziwitsa yekha zotsatira zake kuti athe kuthandiza madokotala awo kuzindikira ngati zotsatira zake zikhoza kuchitika. Malamulo onsewa ndi owonadi a amiodarone.
Zotsatira:
Rosenbaum MB, Chiale Pa, Halpren MS. Kuchepetsa mankhwala a amiodarone ngati wothandizira. Am J Cardiol. 38: 934; 1976
Mason JW. Amiodarone N Engl J Med 316: 455; 1987.