Amiodarone (Cordarone, Pacerone) ndiyo inonyanya kushanda, uye zvechokwadi inoshamisa, antiarrhythmic drug yakambotangwa. (Heino kuongororwa kwezvisiri izvo zvinobudirira uye zvisingasviki migumisiro yemamayodarone .) Chimwe chezvinhu zvinoshamisa zvechirwere ndezvezvakaitika. Iyo nhoroondo inotsanangura zvakawanda pamusoro pokuti sei, kusvika nhasi, dzakawanda zvezvinhu zvisingawanzove zvechirwere hazvina kunzwisiswa nevakawanda vanachiremba vanozvinyora.
Development
Amiodarone yakagadzirwa nekambani yeBelgium muna 1961 sechirwere chekurapa angina (kusagadzikana kwechifu chakaenderana nekodonary artery disease) uye nokukurumidza kwakave chirongwa chinorwisa anti-angina muEurope neSouth America. Zvisinei, nechisarudzo chekambani yezvinodhaka (zvichida kuti irege kuoma zvakanyanya kuAmerica kuronga nzvimbo), amiodarone haina kupiwa kuti ibudiswe muUnited States.
Mushure memakore mashomanana chiremba muArgentina, Dr. Mauricio Rosenbaum, akacherechedza kuti amiodarone yakaratidzika kuderedza mwoyo yemarimthmias muvarwere vake vane chirwere chemoyo. Akatanga kushandisa mushonga wacho zvakanyanya nokuda kwekuvhiringidzika kwemwoyo uye akabva atanga kuparidzira zvaakawana, izvo zvaive zvinoshamisa zvikuru. Vanachiremba vanobva kumativi ose epasi rose (kunze kweUnited States) vakakurumidza kushandiswa kushandisa chirwere ichi kuti vabate chirwere chemwoyo chemarudzi ose. Mukurumbira weAbhiodarone wakapararira kure uye yakazara-amiodarone, shoko rakanga riri, raive rakasiyana-siyana rinorwisa mishonga iro raive nguva dzose rakashanda, uye rakanga risina matambudziko.
Zvose izvi zvinotaurwa, zvechokwadi, zvakaratidzwa zvenhema.
Shandisa muAmerica
Kutanga pakupera kwema1970, American electrophysiologists (nyanzvi yemwoyo yakatanga) vakatanga kuwana amiodarone kubva kuCanada neEurope kuti vashandise mune varwere vavo vane zvirwere zvinopisa upenyu avo vasina kupindura kune mamwe mishonga. (FDA yakagadza basa iri pamusana pekushandisa-tsitsi.) Shoko rekutanga kubva kuAmerica raiita sechisimbisa izvo zvairehwa pasi rose-amiodarone yakachengeteka uye yakanyatsoshanda.
Mumakore mashomanana, vanopfuura 10 000 varwere veAmerica vane zvirwere zvinouraya vaifungidzirwa kuva kugamuchira amiodarone. Zvechokwadi, nekuda kwemaitiro amiodarone akanga ari kugoverwa, hapana ainyatsoziva kuti vangani varwere vaiwana mushonga uyu. Zvinonyanya kukosha, nokuti FDA haina kubatanidzwa mune chero ipi zvayo (kunze kwekubvuma kushandiswa kwechirwere nokuda kwezvikonzero zvetsitsi), hapana munhu aive nokuunganidza mashoko pamusoro pekushandisa kwezvinodhaka kana kuchengeteka.
Migumisiro Yechiratidzo Yakawanikwa
Zvisinei, vazhinji vanachiremba vokuAmerica vakaongorora migumisiro yeAmaiodarone kune vayo varwere zvimwe zvakanyanya zvakasimba kudarika vatinoshanda navo kunze kwenyika vakanga vaita. Somugumisiro, mukati megore rimwe chete kana maviri maonero atinoita amiodarone akatanga kuchinja. Amiodarone ainyatsobudirira pakupedza magythmias kupfuura chero mimwe mimwe mishonga yatakamboona (kunyange zvisingabatsiri sezvakange yakashambadzirwa), asi yakabudisa mhando dzakasiyana-siyana dzemigumisiro kusanganisira kuoma kwehutano hwehutachiona , kugadziriswa kweganda, kutyisa chirwere chemapapu icho vanachiremba pasi pose vakaita sevakange "vasisipo." Zvimwe zvikamu zvakavhiringidzika, nokuda kwechikamu chikuru, nokuti zvakanga zvisina kujairika uye zvisingatarisirwi uye nokuti kutanga kwavo kwaiwanzove kusina uye kwakapera.
Apo migumisiro yemaAmododarone yakatanga kurondedzerwa muzvinyorwa zvezvokurapa, FDA yakazozeza kubvuma chiremba. Zvisinei, FDA munguva pfupi yakanga isisina chakanaka. Mumakore ekuma1980, vatengesi vekune dzimwe nyika vaAmododarone vakatyisidzira kuparadza hurumende yeAmerica (kwete zvisinganzwisisiki, sezvo vakange vapa mishonga pasina zvezviuru kune zviuru nezviuru zveAmerica kwemakore anopfuura mashanu). Kungoparadza vanhu vokuAmerica kubva pamishonga inozobudisa chiremba (uye naizvozvo, zvichida mune zvematongerwe enyika) njodzi. Saka, muna 1985, zvakasiyana zvakasiyana nedzimwe mimwe mishonga munhoroondo yemazuva ano, amiodarone yakava FDA-yakagamuchirwa pasina kukanganisa, FDA-yakagadziriswa makiriniki emakiriniki.
FDA Chibvumirano
Kuremekedza chirwere ichi chachangobva kuwanikwa uye chinotyisa zvikuru, FDA yakabvumira mushonga chete nokuda kwehutano hwehupenyu husingatauriki, uye hunoda nyevero yebhokisi-bhokisi pamusoro pemigumisiro yaro ine ngozi. Achicherechedza kuti mishonga iyi yakanyatsobudirira zvikuru kwete yehupenyu hunotyisidzira zvirongwa, FDA yakakurudzira vaiti kuti vaite maitiro emakiriniki akasiyana-siyana kuti vawane chibvumirano chakanaka kwezviratidzo zvakadai sehutachiona hwehutachiona , tichicherechedza kuti kuitisa miedzo yakadai kunotidzidzisa zvakawanda pamusoro penyaya dzechokwadi uye kukanganisa kwemishonga yemigumisiro. Miedzo iyoyo yakanga isati yamboitwa (zvichida nokuti miedzo yakadaro inodhura, uye panguva ino patent ye amiodarone yakanga yava kupera, ichizarura mukova wezvigadzirwa zvemauto kutanga kutengesa iyo), uye mitsara yekutanga yekushandiswa kwemadiodarone yakaramba ichi zuva.
Uye somugumisiro, kushandiswa kwemadiodarone ye-atrial fibrillation (iyo inonyanya kukosha iyo inorayirwa nhasi) inoramba iri kunze-iyo.
Pasi Pasi
Nhoroondo isingazivikanwi yediodarone inogona kutsanangura kuti sei vamwe vanachiremba vanoronga kuti mishonga iyi inoratidzika sevasingazivi hukuru uye hunyengeri huzhinji hwemigumisiro yaro uye nei vamwe vavo vasina kunyatsotarisa varwere avo vanotora amiodarone kana kuudza varwere vavo sezvavanoda chii chokuchenjerera. Munhu wese anotora mishonga yemishonga inofanirwa kuzviita kuti azive zvinogona kuitika migumisiro kuitira kuti vabatsire vanachiremba vanoziva kana izvo zvigumisiro zvingave zvichiitika. Uyu mutemo mukuru ndeyechokwadi kune amiodarone.
Sources:
Rosenbaum MB, Chiale Pa, Halpren MS. Clinical efficacy ya amiodarone senhengo inopesana nemararamiro. Am J Cardiol. 38: 934; 1976
Mason JW. Amiodarone N Engl J Med 316: 455; 1987.