I-Amiodarone (iCordarone, i-Pacerone) iyona ndlela iphumelelayo, kwaye ngokuqinisekileyo iyona nto inqabileyo, izidakamizwa ezichasene nazo. (Nanku ukuhlaziywa kokusebenza okungaqhelekanga kunye nemiphumo engavumelekanga ye-amiodarone .) Enye yezinto ezintle kakhulu zeziyobisi yimbali yayo. Yimbali ecacisa kakhulu malunga nokuba kutheni, unamhlanje, ezininzi iimpawu ezingavumelekanga zesilwanyana aziqondi kakuhle oogqirha abaninzi abayalela.
Phuhliso
I-Amiodarone yasungulwa yinkampani yaseBelgium ngo-1961 njengesiza sokunyanga i-angina (ukungathandeki kwesifuba esifana ne-coronary artery disease) kwaye ngokukhawuleza yaba yinto eyaziwayo echasene ne-angina eYurophu naseMzantsi Melika. Nangona kunjalo, ngokukhethwa kwenkampani yeziyobisi (mhlawumbi ukukhusela imeko engummiselo engummiselo waseMerika), i-amiodarone ayinikelwanga ukukhululwa e-United States.
Emva kweminyaka embalwa ugqirha waseArgentina, uDkt. Mauricio Rosenbaum, waphawula ukuba i-amiodarone ibonakala iyanciphisa izigulane zengqondo kwizigulane zakhe ezinesifo senhliziyo. Waqala ukusebenzisa le nkunkuma ngokubanzi ngenxa yokuphazamiseka kwentliziyo kwaye ke waqala ukupapasha iziphumo zakhe, ezazingummangaliso kakhulu. Iintsholongwane ezivela kulo lonke ihlabathi (ngaphandle kwe-United States) ngokukhawuleza zaqalisa ukusebenzisa iziyobisi ukunyanga i-cardiac arrhythmias yazo zonke iintlobo. Idumela le-amiodarone lisabalalisa i-amiodarone elide nelibanzi, igama lalinjalo, liyi-drug antiarrhym eyingqayizivele eyayisoloko isebenza, kwaye yayingekho nemiphumo emibi.
Zomibini zezi zizwi, zinyani, zibuxoki.
Sebenzisa eMelika
Ukuqala ngasekupheleni kwee-1970, i-American electrophysiologists (iingcali zengqondo yenhliziyo) zaqala ukufumana i-amiodarone evela eCanada naseYurophu ukuba isebenzise kwizigulane zabo ezineempawu zokusongela ubomi abangaphenduliyo naziphi na ezinye iziyobisi. (I-FDA yalela lo msebenzi ngomsebenzi onobubele.) Ilizwi lokuqala ukusuka kumaMerika lalibonakala liqinisekisa ukuba oko kwakuthethwa kuwo wonke umhlaba-amiodarone wawukhuselekile kwaye usebenza kakuhle.
Kwiminyaka embalwa, abantu abangaphezu kwe-1000 baseMerika abaneempawu zokubulala ezicetywayo babalwa ukuba bafumana i-amiodarone. Ngokuqinisekileyo, ngenxa yendlela yokwenza i-amiodarone isasazwa, akukho mntu wayesazi ukuba ziphi izigulane ezifumana iziyobisi. Okubaluleke ngakumbi, ngenxa yokuba i-FDA ayibandakanyekanga nakweliphi na le (ngaphandle kokuba ivume ukusetyenziswa kweziyobisi ngezizathu zenceba), akukho mntu wayequlunqa ulwazi malunga nokusebenza kweziyobisi okanye ukhuseleko.
Iziphumo eziPhakathi zifunyenwe
Nangona kunjalo, abaninzi oogqirha baseMerika bafunde iiphumo le-amiodarone kwizigulane zabo ngokukodwa ngokugqithiseleyo kunokuba basebenzisana nabo base-overseas. Ngenxa yoko, ngaphaya konyaka okanye amabini umbono wethu we-amiodarone waqala ukutshintsha. I-Amiodarone yayiphumelele ngakumbi ekunqandeni i-arrhythmias kunezinye izilwanyana esazange zibonwe (nangona kungenakusebenza ngempumelelo njengoko kwaye kwapapashwa), kodwa ivelise uchungechunge olumangalisayo lwemiphumo emibi kubandakanya ukukhathazeka kwe-thyroid , ukukhutshwa kwesikhumba, esongela imiphunga yemiphunga ukuba odokotela behlabathi lonke babonakala "belahlekile." Iziphumo ezibekwe bucala zazingekho phantsi, ngenxa yeyona nto ininzi, ngenxa yokuba yayingavamile kwaye ingalindelekanga kwaye ngenxa yokuqala kwabo kwakulindelekile ukuba ingabonakaliyo kwaye ifike.
Xa iziphumo zecala le-amiodarone zaqala ukuchazwa kwiimpapasho zonyango, i-FDA yaba nekwenkqonkqo ukuvunywa kwesi sidakamizwa. Nangona kunjalo, i-FDA yayingenamkhethe. Phakathi koo-1980, abavelisi basekuhlaleni be-amiodarone babesongela ukunqumla ukunikezelwa kwe-Amerika (kungekhona ngokungaqondakaliyo, ekubeni babebonelele izidakamizwa zamahhala kumawaka kunye namawaka aseMelika iminyaka engaphezu kwe-5). Ukunciphisa abantu baseMerika besuka kwisibisi kunokuvelisa unyango (kwaye ke, mhlawumbi i-politike) ntlekele. Ngoko, ngo-1985, ngokungafani naliphi na isilwanyana kwimbali yanamhlanje, i-amiodarone yaba yi-FDA-yamkelwe ngaphandle kokuqineka, i-FDA-ityalwe izilingo ezinokwenziwa kweeklinikhi ezingenamsebenzi.
Ukuvunyelwa kwe-FDA
Ukuhlonela isicatshulwa esisandul 'ukufumanisa kunye neengxaki ezinobungozi kakhulu, i-FDA ivume le nkunkuma kuphela kwiimpawu zokusongela ubomi ezingekho nonyango olwenziweyo, kwaye zifuna isilumkiso sebhokisi emnyama ngokuphathelele kwimiphumo eyingozi yecala. Ukuqaphela ukuba le nkunkuma yayiphumelele kakhulu kwimigqaliselo engasongela ubomi, i-FDA yabanxusa abavelisi ukuba baqhube iimvavanyo zeklinikhi ezingenangqondo ukuze bafumane imvume ngokusemthethweni yezibonakaliso ezinjengefayili ye-fridaying , ekuboneni ukuba ukuqhuba izilingo ezinjalo kuya kusifundisa okuninzi ngeziganeko zinyani kunye ukunyaniseka kweziphumo zecala. Ezi zilingo azange zenziwe (mhlawumbi ngenxa yokuba ezinjalo izilingo zibiza kakhulu, kwaye ngeli xesha i-patent ye-amiodarone yayiphelelwa yisikhathi, ivula umnyango wabakhiqizi bezovelisa ukuqala ukuyithengisa), kwaye imimiselo yokuqala ekusebenziseni i-amiodarone iye yaqhubeka usuku.
Kwaye ngenxa yoko, ukusetyenziswa kwe-amiodarone kwi-fibrillation ye-atriyri (isizathu esivakalayo esinqunyiwe namhlanje) sihlala ngaphandle-ilebula.
Okukwintsusa
Imbali engaqhelekanga ye-amiodarone inokuthi ichaze ukuba kutheni abanye oogqirha abayalela ukuba le nkunkuma ibonakala bengakwazi ukuba nobubanzi kunye nobuqhetseba bemimandla yaso emibi kunye nokuba kutheni abanye babo bengaboni ngokwaneleyo izigulane zabo ezithatha i-amiodarone okanye bazise ngokupheleleyo izigulane zabo yintoni omele uyibukele. Wonke umntu othatha izidakamizwa zonyango kufuneka azenzele iziphumo ezichaphazelekayo ukwenzela ukuba ancede oogqirha baqaphele ukuba zeziphi iziphumo ezichaphazelekayo. Lo mgaqo jikelele uqinisile ukuba u-amiodarone.
Imithombo:
Rosenbaum MB, Chiale Pa, Halpren MS. Ukusebenza ngonyango lwe-amiodarone njenge-arrhythmic agent. InguJ Cardiol. 38: 934; 1976
Mason JW. Amiodarone N Engl J Med 316: 455; 1987.