I-VTE iyinkimbinkimbi yesithathu evamile yezinhliziyo zenhliziyo futhi kwenzeka uma une-thrombosis ejulile ye-vein (DVT) noma i-pulmonary embolism (PE). I-thrombosis ejulile ye-vein yisimo lapho i-clot yegazi ikhiqiza emzimbeni ojulile emzimbeni. I-DVT ingavimbela ukugeleza kwegazi emithanjeni. I-embolism ye-pulmonary ingase ikwenzeke uma i-clot yegazi iphuma ephuma emthanjeni bese ihamba emzimbeni ibe emaphashini.
Lokhu kungaholela ekufeni.
Ucwaningo olwedlule luye lwafakazela ukuthi ukusetshenziswa kokulawulwa kokuzalwa kwama-hormonal kungandisa amathuba akho okubhekana ne-thromboembolism ene-venous-VTE (eyaziwa nangokuthi i-blood clots) noma ezinye izinhlobo zezinkinga zenhliziyo. Amanani we-VTE kwabesifazane abasebenzisa iphilisi aphakathi kuka-3-9 nabesifazane abayi-10 000 ngonyaka kanti ama-VTE amanani kubantu abangekho amapilisi enyaka yokuzala cishe ngo-1-5 ngabesifazane abangu-10 000 ngonyaka. Izindaba ezinhle: Lokhu kusho ingozi ephansi kakhulu yeqembu ngalinye. Kodwa kufanele usakhathazeke?
Ucwaningo luye lwabonisa ukuthi yonke inhlanganisela yokuvimbela i-hormonal ingabangela ingozi ethile yokuthuthukisa i-VTE. Kucatshangwa ukuthi i-estrogen etholakala ekulawulweni kokuzalwa kwama-hormone ingase ibe yimbangela enkulu. Ngenxa yocwaningo olusha lwaseYurophu olushicilelwe maphakathi no-2011 olubonisa ingozi ephakeme yokuthuthukisa i-VTE kubesifazane abasebenzisa amaphilisi okulawula ukuzalwa okuhlanganisa omusha okuqukethe i- progestin drospirenone, i-FDA e-United States yanquma ukwenza uphenyo olujulile ukuhlola ubuhlobo phakathi kwe-VTE nobungozi bokubeletha kwe-hormonal.
Nakulokhu: Kubalulekile ukuqaphela ukuthi noma ngabe i-VTE ingozi ingaba ngaphezulu kwabesifazane abasebenzisa lolu hlobo lokukhulelwa kwengculazi, ingozi enkulu isencane kakhulu.
I-VTE ne-Hormonal Birth Control Ukusetshenziswa
Izindlela zokulawula ukuzalwa kwe-hormonal ezintsha ezine-drospirenone ye-progestin zingakwandisa ingozi yakho ye-VTE, ngaphezu kwalokho uma uthatha indlela yokulawula i-hormonal yokudala.
Ukuhlaziywa kwe-FDA, okuqukethe idatha ephelele kakhulu etholakalayo, kwenzelwe isifundo esihlolisise idatha yonyaka eyisikhombisa kusukela ezindaweni ezine ezihlukahlukene. Okungenani abesifazane abangu-835.826, abaneminyaka engama-10-55 ubudala, ababengenani elilodwa lemithi yokuvimbela ukukhulelwa kwe-hormonal. Umgomo walolu cwaningo kwakuwukuhlola izindlela ezintathu ezintsha zokuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukuvimbela ukwelashwa. Izindlela zokulawula ukubeletha ezilandelayo zihlolwe (ezintathu zokuqala yizindlela ezintsha):
- I-3.0 mg I-drospirenone / 30 mcg I-Ethinyl estradiol isisu somlomo (Yasmin)
- 6 mg Norelgestromin / 750 mcg I-ethinyl estradiol transdermal patch (i- Ortho Evra Patch )
- 11.7 mg 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 amigrikhi Norgestimate / 35 mcg i-Ethinyl estradiol (i-Ortho Tri-Cyclen)
Ukuqonda Imiphumela
Lapho uhumusha imiphumela kulolu cwaningo lwe-FDA, kubalulekile ukuqonda ukuthi ocwaningweni, umphumela ubhekwa njengokubaluleka kwesibalo (noma okuphawulekayo) uma kunqume ukuthi umphumela kungenzeka ukuthi ubangelwa okuthile (uma kwenzeka lolu cwaningo lwe-FDA, amafomu amasha).
Ngamanye amazwi, umphumela ubhekwa njengabalulekile uma kungenzeka kakhulu ukuthi awuzange kwenzeke ngengozi.
Ezinye Imiphumela Eyisisekelo Ezivela Kulesi sifundo se-FDA
- Kuwo wonke abasebenzisi, amaphilisi e-drospirenone / e-Ethinylestradiol, i-patch, ne-NuvaRing baxhunyaniswe nengozi ephezulu kakhulu ye-VTE (uma kuqhathaniswa namafomu amane asebekhulile). Lokhu kwenzeka ikakhulukazi besifazane abaneminyaka eyi-10-34.
- Abasebenzisi abasha (abesifazane abasebenzisa inqubo yokukhulelwa kwe-hormonal okokuqala ngqa phakathi nalolu cwaningo) bathatha amaphilisi e-drospirenone / e-Ethinylestradiol abonisa ingozi ephezulu kakhulu ye-ATE (ukucindezeleka kwamagciwane - i-clot yegazi emthini ngokuvamile oholela ekuhlaselweni kwenhliziyo noma ngesifo sohlangothi) ne-VTE.
- Amaphilisi e-Drospirenone / Ethinylestradiol ayehlanganiswa nengozi ephezulu kakhulu ye-VTE uma isetshenziselwa izinyanga ezingu-0-3 kanye nezinyanga ezingu-7-12 zokusetshenziswa.
- Kubasebenzisi abasha, i-patch yokukhulelwa ixhunywe ngokunyuka kwama-3 kwengozi ye-VTE lapho isetshenziselwa izinyanga ezingaphezu kwezingu-12 uma kuqhathaniswa nobude obufanayo bokusetshenziswa kwamafomula amadala.
- Amaphilisi e-Drospirenone / Ethinylestradiol abonise ingozi ephawulekayo ye-VTE kubantu besifazane abaneminyaka engu-10-34 ubudala futhi ingozi eyengeziwe yokwenza i-ATE kwabesifazane eminyakeni engama-35 nangaphezulu.
- Ngisho noma i - .15 mg levonorgestrel / 30 mcg ethyl estradiol amaphilisi equkethe inani elifanayo le-estrogen njengamaphilisi e-drospirenone / e-Ethinylestradiol, amaphilisi e-drospirenone abeka ingozi enkulu ku-VTE kubasebenzisi bonke.
- Ngesikhathi isiqephu sasiqhathaniswa kuphela nokubunjwa okudala .15 mg levonorgestrel / 30 mcg i-ethinyl estradiol amaphilisi, kwaba khona ingozi eyengeziwe ye-VTE yabesifazane abasebenzisa le patch ngezinyanga ezingu-0-3 nezinyanga ezingu-12 noma ngaphezulu (lokhu kungabonakali kubonakala ekwenzeni ukufaniswa).
- Kungaba khona ingozi eyengeziwe yokwenza i-ATE kwabesifazane abasebenzisa i-NuvaRing izinyanga ezingaphezu kwezingu-12, kodwa le datha isekelwe ku-1 icala, ngakho-ke lokhu kubungozi okungenzeka kudingeke kuhlolwe ngokuqhubekayo.
Ngokuvamile, phakathi nalolu cwaningo lwe-FDA, kunezinhlungu ezingu-78, ama-405 ama-VTE, ama-DVTs angu-220, ama-60 okuhlaselwa yinhliziyo, ukufa kuka-41 ngenxa yesifo senhliziyo, kanye nokufa okungu-267 okubangelwa yiziphi izimo ezingenhla.
Ucwaningo olwengeziwe
Ingxenye yalolu uphenyo iphinde ibe nokubuyekezwa kwezifundo ezishicilelwe eziyisithupha eziye zahlaziya ingozi ye-VTE ngamaphilisi okulawula ukuzalwa okuqukethe i-drospirenone. Imiphumela evela kulezi zifundo ixutshwe, kodwa amane kubo baphetha ngokuthi kukhona ingozi enkulu ye-VTE yabesifazane abasebenzisa la maphilisi. Eqinisweni, izifundo ezimbili zakamuva (kusukela ngo-Ephreli 2011) zikhombisa ukuthi ingozi yokuthuthukisa ama-blood clots kubantu besifazane abasebenzisa i-drospirenone enezikhathi eziphakathi kuka-1.5 kuya kwezingu-2 eziphakeme kunabesifazane abasebenzisa amaphilisi okulawula ukubeletha aqukethe i-progestin ehlukile.
I-FDA iphinde ibuyekeze ucwaningo oluyisikhombisa olwenziwe ngengozi ye-VTE kanye ne-Ortho Evra Patch. Ngokuvamile, le mibiko ibonisa ukuthi, uma kuqhathaniswa namanye amafomu okulawula ukuvimbela amaphilisi okuzalwa , isisindo sokukhulelwa cishe sandisa ingozi ye-VTE. Ngenxa yokuthi abesifazane bavezwa emazingeni aphezulu kakhulu e-estrogen nge-patch, kulinganiselwa ukuthi bangama- 2-3 amathuba amaningi okuzwa uhlobo oluthile lwesifo se-VTE.
Kwenzekani Konke Lokhu?
Ngokusekelwe emiphumeleni yophenyo lwayo, kuhlangene nezincwadi ezikhona, i-FDA iphetha ukuthi ukusetshenziswa kwezinto zokuvimbela ukukhulelwa kwe-hormone, njenge-Ortho Evra Patch (esele emzimbeni ngesonto elilodwa ngesikhathi) I-NuvaRing (ehlala efakwe emzimbeni amasonto amathathu ngesikhathi), ingaholela ekuvezeni okuphakeme okuqhubekayo ku-estrogen - okuholela ekwandeni kwegazi noma i-VTE engozini. Ngakho-ke, i-FDA imele ngemuva kwesiphetho sayo sokuqala (ukufaka isixwayiso ebhokisini elimnyama olusetshenziswe ku-patch ngoJanuwari 2008) - ukuthi ukusetshenziswa kwe-Ortho Evra patch kuhlotshaniswa nengozi ephakeme ye-VTEs uma kuqhathaniswa namaphilisi okuhlanganiswa okujwayelekile.
Imiphumela ebonisa ingozi eyengeziwe yokwenza i-VTE ne-NuvaRing ukusetshenziswa (uma kuqhathaniswa namaphilisi okuhlanganiswa) yakhulisa ukukhathazeka okuthile. Kodwa, i-FDA ikholelwa ukuthi lokhu kutholwa kudinga ukuphindaphindiwe ocwaningweni olwengeziwe ngaphambi kokuba i-ejensi ithathe isinqumo esiqondile noma isimemezele noma yisiphi isixwayiso esisemthethweni ekusetshenzisweni kwe-NuvaRing.
I-FDA iphakamisa ukuthi ukusetshenziswa kwamaphilisi aqukethe i-drospirenone nayo ixhunywe cishe cishe ngo-1.5-kwandisa ingozi ye-VTE / iwashi legazi uma iqhathaniswa ne-standard-dose contraceptive oral dose. Lokhu kusho ukuthi uma ingozi yokwenza i-blood clot kumfazi osebenzisa olunye ukulawulwa kokuzalwa kwama-hormones cishe ngo-6 kuya ku-10 000, khona-ke ingozi yokuthuthukisa i-blood clot phakathi kwabesifazane abasebenzisa amaphilisi nge drospirenone ingaba ngu-10 ku-10 000. Ukwengeza, ingozi ye-VTE nalezi amaphilisi ibonakala inyuke kakhulu phakathi nezinyanga ezintathu zokuqala kanye nokusetshenziswa kwezinyanga ezingu-7-12.
Kukhona futhi kubonakala kunesixhumanisi esibalulekile phakathi kweminyaka yobudala, ukusetshenziswa kwephilisi ye-drospirenone ne-VTE / ATE okwenzekayo. Abesifazane abangaphansi kweminyaka engu-35 basengozini enkulu ye-VTE kodwa banengozi ephansi ye-ATE. I-FDA idinga ukuthi i-drogirenone ye-progestin ingase ibe nokwandisa izinkinga zenhliziyo kanye nokufa okungazelelwe phakathi kwabasebenzisi ngoba kunezakhiwo ezithile ezithinta usawoti namanzi okulinganisa futhi zingandisa amazinga e-potassium.
Ngalesi sikhathi, i-FDA ayikhiphi isixwayiso esisemthethweni ekusebenziseni amaphilisi okulawula ukuzalwa okuqukethe i-drospirenone. I-ejensi ibonise kuphela ekumemezelweni kwayo kwamuva kwezokuphepha ngo-Ephreli 10, 2012,
"I-US Food and Drug Administration (FDA) isiqedile ukubuyekezwa kwayo kokuhlolwa kwamuva kwamuva ngokuphathelene nokufaka ingxube yezindwangu zamagciwane kwabesifazane abasebenzisa amaphilisi okulawula ukuzalwa kokuzalwa kwe-drospirenone. Ngokusekelwe kulokhu kubuyekezwa, i-FDA inqume ukuthi amaphilisi okulawula ukuzalwa kwe-drospirenone kungase kuhlotshaniswe nengozi ephakeme yezindwangu zegazi kunamanye amaphilisi ane-progestin. "
Ukubuyekezwa kwe-FDA kwemiphumela yalolu cwaningo (ikakhulukazi idatha ephuma ekuhloleni kwamaphilisi okulawula ukuzalwa kokuzalwa kwe-drospirenone) yahanjiswa futhi yaxoxwa emhlanganweni ohlangene weKomiti Yokucebisa Imithi Yezokwelapha kanye neKomiti Yokucebisa Ukulawulwa Kwezidakamizwa kanye neKhomishana Yokulawulwa Kwengozi. NgoDisemba 8, 2011. Iphaneli lokucebisa livotele u-21-5 ukuthi i-FDA kumele idinga ukulayishwa okusha kwamaphilisi e- dropspirenone afana ne- Yaz , Yasmin, Beyaz , iSaferal (kanye nezinguqulo zabo ezijwayelekile); bezwa ukuthi amalebula wamanje akwanele ngoba nje afaka ulwazi mayelana nocwaningo oluphikisanayo ngezingozi ze-VTE. Ukubhalwa kufanele kuboniswe ukucacisa ngokucacile ukuthi ingozi ye-VTE ingaba yini kanye nokucacisa ukuthi i-VTE (i-clots yegazi) ingaba yingozi. Ngo-Ephreli 2012, i-FDA ikhiphe imfuneko yokubhalisa okubuyekeziwe. Noma kunjalo, izidingo zelebula ezintsha azilandelanga izincomo zephaneli lezeluleko. I-FDA inqume ukuthi amalebula weiphilisi zokulawula ukuzalwa kokuzalwa kwe-drospirenone manje aqukethe ulwazi mayelana nokuhlola okwakamuva okwenziwa yi-FDA. Ukwengeza, amalebuli wezokwelapha avuselelwe manje kufanele asho ukuthi ezinye izifundo ziveze ukukhuphuka kathathu engozini yezindwangu zegazi zemikhiqizo equkethe i-drospirenone uma kuqhathaniswa nemikhiqizo equkethe i-levonorgestrel noma amanye ama-progestin, kodwa ezinye izifundo azitholakalanga I-blood clot engozini yemikhiqizo ene-drospirenone. Amalebula amasha azophinde abhekisele emiphenyweni ka-FDA yophenyo lwe-VTE. Imithombo:
I-FDA Ihhovisi Lokuqapha Ne-Epidemiology. [10-27-2011] Ukuvimbela Ukuvimbela I-Hormonal (CHCs) kanye Nengozi Yokuphela Kwezifo Zezifo Zenhliziyo .
Reid, R. " Ukuvimbela Ngokwemlomo Nengozi Ye-Thromboembolism Yama-Venous : Isibuyekezo." I- JOGC 2010; No. 252: 1192-1197.