I-VTE yinkxalabo yesithathu exhaphakileyo yesifo senhliziyo kwaye iyenzeka xa unesifo se-thrombosis esiswini (DVT) okanye i-pulmonary embolism (PE). I-thrombosis ye-vein isisiseko xa i-clot yegazi yenza i-vein deep in the body. I-DVT inokuvimba ukuhamba kwegazi kwiimvini. I-pulmonary embolism iyakwenzeka ngoko ukuba i-clot yegazi iphuma kwi-vein kwaye ihamba idlulele emzimbeni.
Oku kunokukhokelela ekufeni.
Uphando oludlulileyo lugqithise ukuba ukusetyenziswa kolawulo lokuzalwa kwe-hormonal lungakhuphula amathuba akho okufumana i-thromboembolism ene-venous-VTE (eyaziwa nangokuthi i-clots blood) okanye ezinye iintlobo zeengxaki ze-cardiovascular. Amaxabiso e-VTE kubasetyhini abasebenzisa i pilisi bahlula u-3-9 ngabasetyhini ngabama-10 ngonyaka ngelixa i-VTE rates malunga nabasebenzisi abangenayo ipilisi yobudala bokuzala okuba malunga no-1-5 kwabafazi abangama-10 000 ngonyaka. Iindaba ezilungileyo: Oku kuthetha umngcipheko ophantsi kakhulu kwiqela. Kodwa ngaba usenokukhathazeka?
Ucwaningo luye lwabonisa ukuba konke ukudibanisa kwe-hormonal ye-hormonal kungabangela uhlobo olunobungozi bokuphuhlisa i-VTE. Kucingelwa ukuba i-estrogen efumaneka kwi-hormonal birth control ingaba yinxalenye ebalulekileyo. Ngenxa yophando olutsha lwaseYurophu olupapashwe phakathi ko-2011 olubonisa umngcipheko ophezulu wokuphuhlisa i-VTE kubasetyhini basebenzise iipilisi zokulawula ukuzalwa ngokutsha kunye ne- progestin drospirenone, i-FDA e-United States inqume ukuqhuba uphando olunzulu ukuvavanya ubudlelwane phakathi kwe-VTE mngcipheko kunye nokuqhathaniswa kwe-hormonal contraception.
Kwakhona: Kubalulekile ukuba uqaphele, nangona kunjalo, ukuba nangona i-VTE mngcipheko ingaba phezulu kwabesetyhini abasebenzisa lolu hlobo lokukhulelwa komzimba, umngcipheko jikelele uphantsi kakhulu.
I-VTE ne-Hormonal Birth Control Usetyenziso
Iindlela ezintsha zokulawula ukuzalwa kwe-hormonal eziqulethe i-progestin drospirenone inokwandisa umngcipheko we-VTE, ngaphezu koko ukuba uthathe indlela yokulawula i-hormonal yokudala.
Uhlalutyo lwe-FDA, oluqulethe ulwazi olubanzi kakhulu olukhoyo, luqulethwe uphando oluye lwahlola ixabiso leemali eziyiminyaka esixhenxe ukusuka kwiindawo ezihlukeneyo zendawo. Ubuncinane aba-835,826 abasetyhini, abaneminyaka eyi-10 ukuya ku-55 ubudala, ababenomncinci omnye wemithi yokudibanisa kwe-hormonal contraception. Injongo yolu phando kwakukuhlolisisa imiqathango emithathu yokuvelisa i-hormone ye-hormone ukuze kuqinisekiswe ukuba umngcipheko we-VTE, i-DVT, i-PE kunye / okanye ukufa kwe-cardiovascular kuphezulu kunokuba bekuyimimiselo emine emininzi yokukhulelwa komlomo kunye namazinga aphantsi a- estrogen . Iindlela zokulawula ukuzalana ezilandelayo zihlolwe (ezi-3 zokuqala ziindlela ezintsha):
- 3.0 mg I-drospirenone / 30 mcg I-Ethinyl estradiol yokukhulelwa komlomo (Yasmin)
- 6 mg I-Norelgestromin / 750 mcg I-epitlli estradiol ipastidi ye-transdermal (i- Ortho Evra Patch )
- 11.7 mg I-Etonogestrel / 2700 mcg estradiol isondo lesisu ( NuvaRing )
- .10 mg Levonorgestrel / 20 mcg I-ethinyl estradiol (njenge-Alesse, Aviane-28)
- .15 mg Levonorgestrel / 30 mcg I-ethinyl estradiol ( njengeSeasonique , Nordette)
- 1 mg Norethindrone / 20 mcg I-ethinyl estradiol ( Loestrin 1/20 )
- .18-.25 iimigca I-Norgestimate / 35 mcg I-ethinyl estradiol (i-Ortho Tri-Cyclen)
Ukuqonda iziphumo
Xa uguqulela iziphumo ezivela kulolu cwaningo lwe-FDA, kubalulekile ukuqonda ukuba uphando, umphumo uthathwa njengesigxina (okanye kubaluleke) xa sele kuqinisekiswe ukuba umphumo unokubangela into ethile (kwimeko le ngxelo ye-FDA, iifom ezitsha).
Ngamanye amazwi, umphumo uthathwa njengento ebalulekileyo xa kunokwenzeka ukuba akuzange kwenzeke ngethuba.
Ezinye iziphumo eziphambili ezivela kwi-FDA Study
- Kubo bonke abasebenzisi, iipilisi ze-drospirenone / i-Ethinylestradiol, i-patch kunye ne-NuvaRing zidibaniswe nomngcipheko ophezulu kakhulu we-VTE (xa kuthelekiswa nama-4 asekudala). Oku kubaluleke kakhulu kubafazi abaneminyaka eyi-10-34.
- Abasebenzisi abatsha (abafazi abasebenzisa ulwalamano lwe-hormonal kokuqala ngethuba lokufunda) ukuthatha i-drospirenone / i-Ethinylestradiol iipilisi ibonise umngcipheko ophezulu kakhulu we-ATE (i-thrombosis yamagciwane - i-blood clot kwisitrifu esivame ukukhokelela ekuhlaselweni kwintliziyo okanye ngesifo sobomi) kunye neVTE.
- Iipilisi ze-Drospirenone / i-Ethinylestradiol zazidibene nomngcipheko ophezulu kakhulu we-VTE xa zisetyenziselwa iinyanga ezi-0-3 kunye neenyanga ezi-7-12 zokusetyenziswa.
- Kubasebenzisi abatsha, iqhosha lokukhusela i-contraceptive patch lidibene nokunyuka kwama-3 kwimiba yengozi ye-VTE xa isetyenziselwa iinyanga ezili-12 xa kuthelekiswa nobude obufanayo bokusetyenziswa kwamafomula amadala.
- Iipilisi ze-Drospirenone / i-Ethinylestradiol zibonise ingozi ebalulekileyo ye-VTE kwabasetyhini abaneminyaka eyi-10-34 ubudala kunye nengozi eyongeziweyo ye-ATE kuma-35 ubudala nangaphezulu.
- Nangona i -15 mg levonorgestrel / i-30 mcg i-ethyl estradiol iipilisi yayinexabiso elifanayo le-estrogen njenge-drospirenone / i-Ethinylestradiol iipilisi, iipilisi ze-drospirenone zibeka ingozi enkulu kubo bonke abasebenzisi.
- Xa iqhosha lalifaniswa nokuqulunqwa komdala .15 mg levonorgestrel / 30 mcg I-ethinyl estradiol iipilisi, kwakukho ingozi eyongeziweyo ye-VTE yabasetyhini abasetyenzisiweyo kwiinyanga ezi-0-3 kunye neenyanga ezili-12 okanye ngaphezulu (le mngcipheko ayizange ibonwe ngokuqulunqa ukufaniswa).
- Kukho umngcipheko okhulayo we-ATE kwabasetyhini abasebenzisa i-NuvaRing kwiinyanga ezili-12, kodwa le datha isekelwe kwimeko e-1, ngoko ke le mngcipheko kufuneka ukuba uhlolwe kwakhona.
Ngokubanzi, ngexesha lophando lwe-FDA, kwakukho izibetho ezingama-78, ii-405 ze-VTE, i-DVTs, i-60 DVTs, i-heart attack, ezingama-41 ngenxa yokugula kwesifo senhliziyo, kunye nokufa kwabangu-267 okubangelwa naziphi na iimeko ezi ngasentla.
Uphando olongezelelweyo
Ingxenye yale phando nayo iqukelelwe ngokuphonononga izifundo ezipapashwe ezithandathu eziye zahlalutya ingozi ye-VTE kunye neepilisi zokulawula ukuzalwa eziqukethe i-drospirenone. Iziphumo ezivela ezi zifundo zixutywe, kodwa ezine zazo zigqibile ukuba kukho ingozi eyongezelelweyo ye-VTE yabasetyhini abasebenzisa la mapilisi. Enyanisweni, ezi zimbini zifundo (ukususela ngo-Apreli 2011) zibonisa ukuba umngcipheko wokuphuhlisa i-blood clots kubasetyhini abasebenzisa i-drospirenone eneenkcukacha ezi- 1.5 ukuya kweyesi-2 eziphakamileyo kunabasetyhini abasebenzisa iipilisi zokulawula ukuzalwa eziqukethe i-progestin eyahlukileyo.
I-FDA iphinde iphinde ihlolisise uphando olusisigxina kwi-VTE mngcipheko kunye ne-Ortho Evra Patch. Ngokuqhelekileyo, ezi ngxelo zibonisa ukuba, xa kuthelekiswa nezinye iifom zokulawula iipilisi zokuzalwa , inqaku lokukhusela liyakwandisa umngcipheko we-VTE. Ngenxa yokuba amabhinqa avuleleke kumazinga aphakamileyo kakhulu e-estrogen kunye nekiti, kulinganiselwa ukuba amaxesha angama-2-3 anako ukufumana olunye uhlobo lwe-VTE uphawu.
Kuthetha ntoni Lonke Oku?
Ngokusekelwe kwiziphumo zophando lwazo, ngokubambisana neencwadi ezikhoyo, i-FDA igqibile ukuba ukusetyenziswa kokuhlanganiswa kokuvuthwa kwe-hormone ye-hormonal eqhubekayo, njenge-Ortho Evra Patch (ehlala emzimbeni iveki enye ngexesha) kunye I-NuvaRing (ehlala ifakwe emzimbeni iiveki ezintathu ngelo xesha), inokubangela ukuba kubekho ukugqithiswa okuphezulu kwe-estrogen-ekhokelela ekwandeni kwegazi okanye kwi-VTE mngcipheko. Ngaloo ndlela, i-FDA imele emva kwesigqibo sayo sokuqala (ukufaka isilumkiso esimnyama esicatshulwa ebhokisini ngoJanuwari 2008) - ukuba ukusetyenziswa kwe-patch ye-Ortho Evra kuhambelana nomngcipheko ophezulu we-VTEs xa kuthelekiswa neepilisi ezidibeneyo.
Iziphumo ezibonisa ingozi eyongezelelweyo ye-VTE kunye no-NuvaRing (xa kuthelekiswa neepilisi ezidibeneyo) iphakamisa inkxalabo ethile. Kodwa, i-FDA ikholelwa ukuba oku kufunwa kuyadingeka kuphinde kuphindwe kuphando olongezelelweyo phambi kokuba i-arhente ithathe isigqibo esiphezulu kuyo okanye ivakalise nasiphi na isilumkiso esisemthethweni kwi-NuvaRing.
I-FDA ibonisa ukuba ukusetyenziswa kweepilisi ezine-drospirenone nazo zidibaniswe kwi-1.5-fold-fold increase the risk of VTE / clots clots xa kuthelekiswa ne-standard dose-dose oral contraceptives. Oku kuthetha ukuba ukuba umngcipheko wokuphuhlisa i-blood clot yowesifazane usebenzisa olunye ulawulo lokuzalwa kwe-hormonal malunga ne-6 kwi-10 lamawaka, ngoko umngcipheko wokuphuhlisa i-blood clot phakathi kwabasetyhini basebenzisa iipilisi nge-drospirenone kuya kuba malunga ne-10 kwi-10 000. Ukongezelela, i-VTE mngcipheko ngezi pilisi zibonakala zikhule kakhulu kwiinyanga zokuqala ezintathu zokusetyenziswa kunye neenyanga ezi-7-12 zokusetyenziswa.
Kukho kwakhona kubonakala kunxibelelwano olubalulekileyo phakathi kweminyaka, i-pilspirenone ene-pilil usetyenziso kunye ne-VTE / ATE. Abasetyhini abangaphantsi kweminyaka engama-35 basengozini ephezulu ye-VTE kodwa banomngcipheko ophantsi we-ATE. I-FDA igxininisa ukuba i-progestin drospirenone ingaba nokwandisa iingxaki zeengqondo kunye nokufa ngokukhawuleza phakathi kwabasebenzisi kuba inezakhiwo ezithile ezichaphazela ityuwa namanqanaba okumanzi kwaye zinokunyusa amazinga e-potassium.
Ngeli xesha, i-FDA ayikhiphi isilumkiso esisemthethweni malunga nokusetyenziswa kweepilisi zokuzalwa eziqulethe i-drospirenone. I-arhente ibonise kuphela kwisaziso sayo sokugqibela senqabiseko ngo-Apreli 10, 2012,
"I-US Food Management and Drug Administration (i-FDA) igqibile ukuhlaziywa kwayo kwimiba yembonakalo yecandelo elijongene nomngcipheko wegazi lamabhinqa kubasetyhini abathabatha iipilisi zokulawula ukuzalwa kokuzalwa kwe-drospirenone. Ngokusekelwe kulo mbononongo, i-FDA iqukumbele ukuba iipilisi ze-drospirenone ezine-birth controls inokudityaniswa nomngcipheko ophezulu weengcambu zegazi kunezinye iipilisi ezineprogesine. "
Ukuhlaziywa kwe-FDA yeziphumo zolu cwaningo (ingakumbi i-data ephumela ekuhlolweni kweepilisi zokulawula ukuzalwa kokuzalisa i-drospirenone) yangeniswa kwaye ixutyushwa kwingqungquthela edibeneyo yeKomiti Yokucebisa Izidakamizwa ZezeMpilo kunye neKomiti yoLuleko loLawulo lweMingcipheko. Disemba 8, 2011. Iphaneli yokucebisa ivotele u-21-5 ukuba i-FDA ifanele i-labeling entsha kwiipilisi zeprospirenone eziqulethwe njenge- Yaz , Yasmin, Beyaz , iSafirral (kunye neenguqu zabo zendalo); Bavakalelwa ukuba iilebula zangoku ziyanelisekanga kuba ziquka kuphela ulwazi malunga nophando oluphikisayo kwiingozi ze-VTE. I-labeling kufuneka icetyiswe ukuba icacise ngokucacileyo ingozi ye-VTE kunye nokucacisa ukuba i-VTE (i-clots yegazi) ingaba yingozi. Ngomhla ka-Apreli 2012, i-FDA ikhishwe imfuneko yokubhalwa kwileyibhile. Nangona kunjalo, iimfuno zeelayile ezitsha azizange zilandele iingcebiso zeplanethi yeengcebiso. I-FDA igunyazisa ukuba iileyile zeepilisi zokulawulwa kokuzalwa kokuzaliswa kwe-drospirenone ngoku ziqulethe ulwazi malunga neengxelo zembonakalo ezandul 'i-FDA. Ukongezelela, iileyibhile zezabisi ezihlaziyiweyo ngoku kufuneka zichaze ukuba ezinye iiprogram zityhilelwe ukunyuka kwintathu emngciphekweni wecala legazi kwimveliso eline-drospirenone xa kuthelekiswa nemveliso equkethe i-levonorgestrel okanye enye i-progestins, kodwa ezinye iifundo azifumanekanga Umngcipheko wegazi lomngcipheko weemveliso ezine-drospirenone. Iibhile ezitsha ziza kubhekisela kwiziphumo zophando lwe-FDA lwengozi ye-VTE. Imithombo:
I-ofisi ye-FDA ye-Monitoring and Epidemiology. [10-27-2011] Ukukhulelwa kweHormonal (iiCCs) kunye neengozi yeeMpilo eziPhephayo zeMpilo .
Reid, R. "I-Contraceptive Oral and the Risk of Venous Thromboembolism: Uhlaziyo." I- JOGC 2010; No. 252: 1192-1197.