I-Amiodarone (i-Cordarone, i-Pacerone) iphumelela kakhulu, futhi ngokuqinisekile imishanguzo emangalisayo kakhulu, i-antiarrhythm. (Nansi ukubuyekezwa kokusebenza okungavamile nemiphumela emibi engavamile ye-amiodarone .) Esinye sezici eziqakathekile kakhulu zezidakamizwa ngumlando wayo. Umlando ochaza okuningi ngokuthi kungani, kuze kube namuhla, izici eziningi ezingavamile zesidakamizwa aziqondakali kahle odokotela abaningi abakubekayo.
Ukuthuthukiswa
I-Amiodarone yasungulwa yinkampani yaseBelgium ngo-1961 njengesidakamizwa sokwelapha i-angina (ukuhluleka kwesifuba esihlobene nesifo somzimba we-coronary artery disease) futhi ngokushesha waba yisidakamizwa esivame ukulwa ne-angina eYurophu naseNingizimu Melika. Kodwa-ke, ngokukhetha inkampani yezidakamizwa (mhlawumbe ukugwema isimo esingavamile esingokomthetho saseMelika), i-amiodarone ayinikezwa ukukhululwa e-United States.
Ngemuva kweminyaka embalwa udokotela wase-Argentina, uDkt. Mauricio Rosenbaum, waphawula ukuthi i-amiodarone ibonakala iyancipha iziguli zesifo senhliziyo. Waqala ukusebenzisa lesi sidakamizwa kakhulu ukuphazamiseka kwenhliziyo futhi wabe eseqala ukushicilela imiphumela yakhe, eyayihlaba umxhwele kakhulu. Abahlengikazi abavela emhlabeni wonke (ngaphandle kwa-United States) baqala ukusebenzisa lesi sidakamizwa ukuphatha ama-arrhythmias enhliziyo yazo zonke izinhlobo. Idumela le-amiodarone lisakaze i-amiodarone elide nelibanzi, leli gama laliyi-drug antiarrhythm eliyingqayizivele elalihlala lisebenza njalo futhi lingabi namiphumela emibi.
Zombili lezi zizathu, empeleni, zazingamanga.
Sebenzisa eMelika
Kusukela ngasekupheleni kweminyaka yama-1970, ama-electrophysiologists aseMelika (ochwepheshe be-heart rhythm) baqala ukuthola i-amiodarone evela eCanada naseYurophu ukuze basebenzise iziguli zabo nge-arrhythmias esongela ukuphila abangazange baphendule kunoma yiziphi ezinye izidakamizwa. (I-FDA yavuma lo msebenzi ngomsebenzi onesihawu.) Izwi lokuqala kusuka kumaMelika lalibonakala liqinisekisa lokho okwakushiwo kuwo wonke umhlaba-amiodarone wawuphephile kakhulu futhi usebenza kahle kakhulu.
Phakathi neminyaka embalwa, iziguli ezingaphezu kuka-10 000 zaseMelika ezinama-arrhythmias angabulala cishe zathola ama-amiodarone. Yiqiniso, ngenxa yokuthi i-amiodarone yayisakazwa kanjani, akekho owazi ngempela ukuthi zingaki iziguli ezithola lesi sidakamizwa. Okubaluleke nakakhulu, ngoba i-FDA ayizange ihileleke kunoma yikuphi kwalokhu (ngaphandle kokuvuma ukusetshenziswa kwesidakamizwa ngezizathu zobubele), akekho owahlanganisa ulwazi ngokusebenza noma ukuphepha komuthi.
Imiphumela emibi itholakale
Kodwa-ke, odokotela abaningi baseMelika bafundela imiphumela ye-amiodarone ezigulini zabo ngokwedlulele kakhulu kunezakwethu osebenza ngaphandle kwezilwandle. Ngenxa yalokho, phakathi nonyaka noma kabili umbono wethu we-amiodarone waqala ukushintsha. I-Amiodarone yayiphumelela kakhulu ekunqandeni ama-arrhythmias kunanoma imuphi omunye umuthi esake wambona (nakuba wawungekho ophumelelayo njengoba wawushicilelwe), kodwa wakhiqiza uchungechunge olubi kakhulu lwemiphumela emibi okubandakanya ukukhathazeka kakhudlwana kwe-thyroid , ukukhishwa kwesikhumba, ukusongela amakhemikhali e-lungs ukuthi odokotela emhlabeni wonke babonakala sengathi "belahlekile." Imiphumela emibi yayingabanjwanga, ikakhulukazi, ngoba yayingavamile futhi ingalindelekile futhi ngoba ukuqala kwabo kwakulindelekile ukuba kube mnandi futhi kuphele.
Lapho imiphumela emibi ye-amiodarone yaqala ukuchazwa ezincwadini zezokwelapha, i-FDA yazama ukuvuma lesi sidakamizwa. Kodwa-ke, i-FDA maduze yayingenakukhetha. Maphakathi nawo-1980, abakhiqizi bamazwe angaphandle ba-amiodarone besongela ukunikezwa kweMelika (hhayi ngokungaqondakali ngokuphelele, ngoba babenikeze izidakamizwa mahhala ezinkulungwaneni nezinkulungwane zamaMelika iminyaka engaphezu kwemihlanu). Ukumisa abantu baseMelika ngokusuka kulesi sidakamizwa kungabangela ukwelashwa (ngakho-ke, mhlawumbe kwezepolotiki) inhlekelele. Ngakho-ke, ngo-1985, ngokuphambene kakhulu nanoma imuphi omunye umuthi emlandweni wanamuhla, i-amiodarone yaba i-FDA-ngaphandle kokuqineka, ukuhlolwa kwe-FDA-kwamukelwa ukuhlolwa kwamakhambi.
Ukugunyazwa kwe-FDA
Ehlonipha ukutholakala kwezidakamizwa ezisanda kutholakala futhi ezinzima kakhulu, i-FDA ivume lesi sidakamizwa kuphela ngenxa yezidakamizwa ezisongela ukuphila okungekho omunye ukwelashwa okufinyelelekayo, futhi idinga isixwayiso se-black box mayelana nemiphumela yaso emibi. Eqaphela ukuthi lesi sidakamizwa sasiphumelele kakhulu ekusebenziseni ama-arrhythmias asongela ukuphila, i-FDA yakhuthaza abakhiqizi ukuba bahlole ukuhlolwa kwemithi ukuze bazuze ukuvunyelwa ngokusemthethweni kwezinkomba ezinjenge -fibrillation ye-atrial , okuphawula ukuthi ukuqhuba ukulingwa okunjalo kungasifundisa okuningi mayelana nezigameko zangempela ukungathí sina kwemiphumela emibi yezidakamizwa. Lezo zivivinyo azikaze zenziwe (mhlawumbe ngoba lezi zilingo zibiza kakhulu, futhi ngalesi sikhathi i-patent yama-amiodarone yayiphelelwa yisikhathi, ivula umnyango wabakhiqizi abavamile ukuze baqale ukuyithengisa), futhi imingcele yokuqala yokusetshenziswa kwe-amiodarone iye yaqhubeka nalokhu usuku.
Futhi ngenxa yalokho, ukusetshenziswa kwe-amiodarone ye-fibrillation ye-atrial (isizathu esivame kakhulu esinqunyiwe namhlanje) sihlala ngaphandle kwelebuli.
Ngaphansi
Umlando ongaqondakali we-amiodarone ungase uchaze ukuthi kungani odokotela abathile abanikeza lo muthi babonakala bengaboni ukuthi ububanzi nobungani obuqili bemiphumela yaso emibi nokuthi kungani abanye babo bengaboni ngokwanele iziguli zabo ezithatha i-amiodarone noma zazise ngokugcwele iziguli zabo njengokuthi yini okufanele uyiqaphele. Wonke umuntu othatha izidakamizwa zemithi kufanele azenzele imiphumela emibi ukuze bakwazi ukusiza odokotela babo ukuthi baqaphele ukuthi lezo zimphumela zingase zenzeke. Lo mthetho jikelele uqinisile we-amiodarone.
Imithombo:
I-Rosenbaum MB, i-Chiale Pa, i-Halpren MS. Ukusebenza kahle kwemitholampilo ye-amiodarone njenge-agent e-antiarrhythmic. Am J Cardiol. 38: 934; 1976
Mason JW. Amiodarone N Engl J Med 316: 455; 1987.