VTE ndi vuto lachitatu la matenda a mtima ndipo limapezeka pamene muli ndi mitsempha ya thrombosis (DVT) kapena pulmonary embolism (PE). Mimba yamkati imapangitsa kuti magazi asapangidwe mthupi mwathu. DVT ikhoza kuletsa magazi kudutsa m'mitsempha. Kuwombera kwapopysi kumatha kuchitika ngati magazi amatha kutuluka mumsana ndikuyenda kupyola thupi kupita m'mapapo.
Izi zingachititse imfa.
Kafukufuku wakale wanena kuti kugwiritsa ntchito mphamvu yobadwa ndi mahomoni kungakuthandizeni kuti mukhale ndi mwayi wotenga thromboembolism - VTE (yomwe imadziwikiranso kuti magazi) kapena mavuto ena a mtima. Madera a VTE azimayi omwe amagwiritsira ntchito mapiritsi ali pa 3-9 pa amayi 10,000 pa chaka pomwe ma ARV aliwonse omwe amagwiritsa ntchito mapiritsi osakwanitsa zaka za kubala pafupifupi 1-5 pa amayi 10,000 pa chaka. Uthenga wabwino: Izi zikutanthauza chiopsezo chochepa cha gulu lililonse. Koma kodi muyenera kukhalabe ndi nkhawa?
Kafukufuku wasonyeza kuti kuphatikiza kwa ma ARV kumayambitsa vuto linalake lokhazikitsa VTE. Zimaganiziridwa kuti estrogen yomwe imapezeka mu mphamvu ya kubadwa kwa mahomoni ikhoza kukhala chinthu chachikulu chothandizira. Chifukwa cha kufufuza kwatsopano kwa Ulaya komwe kunafalitsidwa pakati pa chaka cha 2011 chomwe chinasonyeza kuti pangakhale chiopsezo chachikulu chokhazikitsa VTE mwa amayi pogwiritsa ntchito mapiritsi atsopano ophatikizira odwala omwe ali ndi progesin drospirenone, a FDA ku United States adasankha kufufuza mozama kuti ayese ubalewo pakati pa VTE ngozi ndi kuphatikiza kwa ma ARV.
Kachiwiri: Ndikofunika kuzindikira kuti ngakhale kuti VTE ingawonongeke kwambiri mwa amayi omwe amagwiritsira ntchito njira iyi ya kulera, chiopsezo chonse chikuchepa.
VTE ndi Hormonal Birth Control Gwiritsani ntchito
Njira zatsopano zowonetsera mahomoni zomwe zili ndi progestin drospirenone zikhoza kuonjezera chiopsezo chanu cha VTE, kuposa momwe mungatengere njira yakuletsa kubereka.
Kufufuza kwa FDA, yomwe ili ndi deta yolondola kwambiri, ili ndi phunziro lomwe linafufuza deta ya zaka zisanu ndi ziwiri kuchokera kumalo osiyanasiyana osiyanasiyana. Akazi okwana 835,826, a zaka zapakati pa 10-55, omwe anali ndi mankhwala osachepera amodzi omwe anagwiritsidwa ntchito podziletsa kulumikizana kwa mahomoni. Cholinga cha kafukufukuyu chinali kuyesa njira zitatu zatsopano zogwiritsira ntchito njira zothandizira njira ya kulera kuti adziwe ngati chiopsezo cha VTE, DVT, PE ndi / kapena mtima wa imfa ndi chokwanira kuposa momwe zingakhazikitsire njira zowonjezera zazing'ono zamakono zovomerezeka za m'mimba ndi maselo otsika a estrogen . Njira zotsatirazi zothandizira kubereka zinayesedwa (zoyamba zitatu ndizo njira zatsopano):
- 3.0 mg Drospirenone / 30 mcg Ethinyl estradiol njira yothandizira pakamwa (Yasmin)
- 6 mg Norelgestromin / 750 mcg Ethinyl estradiol transdermal patch ( Ortho Evra Patch )
- 11.7 mg Etonogestrel / 2700 mcg estradiol vaginal ring ( NuvaRing )
- .10 mg Levonorgestrel / 20 mcg Ethinyl estradiol (monga Alesse, Aviane 28)
- .15 mg Levonorgestrel / 30 mcg Ethinyl estradiol (monga Seasonique , Nordette)
- 1 mg Norethindrone / 20 mcg Ethinyl estradiol ( Loestrin 1/20 )
- .18 -25 .magazi Zosasintha / 35 mcg Ethinyl estradiol (Ortho Tri-Cyclen)
Kumvetsa Zotsatira
Potanthauzira zotsatira kuchokera mukufufuza kwa FDA, nkofunika kumvetsetsa kuti mu kafukufuku, zotsatira zimatengedwa ngati statistically (kapena zofunikira) ngati zatsimikiziridwa kuti zotsatira zake ziyenera kuti zinayambitsidwa ndi chinachake (ngati phunziro la FDA, mawonekedwe atsopano).
Mwa kuyankhula kwina, zotsatira zimalingalidwa ngati ziri zotheka kwambiri kuti sizinachitike mwangozi.
Zotsatira Zowunika Zambiri Kuchokera Phunziro la FDA
- Kwa ogwiritsira ntchito onse, mankhwala a drospirenone / Ethinylestradiol, chigamba, ndi NuvaRing anagwirizanitsidwa ndi chiopsezo chachikulu cha VTE (poyerekezera ndi 4 akulu akulu). Izi ndizo makamaka kwa amayi a zaka zapakati pa 10-34.
- Ogwiritsa ntchito atsopano (amayi omwe adagwiritsa ntchito njira yothandizira kulumikizana kwa ma hormonal nthawi yoyamba panthawiyi ) kutenga mankhwala a drospirenone / Ethinylestradiol amasonyeza chiopsezo chachikulu kwambiri cha ATE (arterial thrombosis - magazi m'magazi omwe nthawi zambiri amachititsa kudwala mtima kapena kukwapulidwa) ndi VTE.
- Mapiritsi a Drospirenone / Ethinylestradiol ankagwiritsidwa ntchito ndi chiopsezo chachikulu cha VTE pamene agwiritsidwa ntchito kwa miyezi 0-3 komanso kwa miyezi 7-12 yogwiritsiridwa ntchito.
- Kwa ogwiritsa ntchito atsopano, chigwirizano cha kulera chinagwirizanitsidwa ndi kuwonjezeka kwa katatu pangozi ya VTE ikagwiritsidwa ntchito kwa miyezi 12 poyerekeza ndi nthawi yomweyi yogwiritsira ntchito mawonekedwe akale.
- Mapiritsi a Drospirenone / Ethinylestradiol anasonyeza chiopsezo chachikulu cha VTE mwa amayi a zaka 10-34 ndipo chiopsezo chowonjezereka cha ATE mwa amayi a zaka 35 kapena kuposerapo.
- Ngakhale kuti mapiritsi a .15 mg levonorgestrel / 30 mcg ethyl estradiol anali ndi ofanana ndi estrogen monga drospirenone / Ethinylestradiol mapiritsi, mapiritsi a drospirenone anali ndi vuto lalikulu la VTE kwa ogwiritsira ntchito onse.
- Pamene chigambacho chinkafanizidwa ndi kupangidwa kwachikulire .15 mg levonorgestrel / 30 mcg mapiritsi a Ethinyl estradiol, pangakhale chiopsezo chowonjezeka cha VTE kwa amayi omwe adagwiritsa ntchito chigambacho kwa miyezi 0-3 ndi miyezi 12 kapena yoposa (ngozi iyi sinkawoneke mu kufanizira kufanana).
- Pangakhale chiopsezo chowonjezereka kwa ATE mwa amayi omwe amagwiritsa ntchito NuvaRing kwa miyezi 12, koma deta iyi imachokera pa vuto limodzi, choncho chiopsezochi chiyenera kupitilizidwanso.
Pafupipafupi, panthawiyi a FDA adafufuza, panali mazunzo 78, 405 VTEs, 220 DVTs, 60 mtima wa mtima, 41 kufa chifukwa cha matenda a mtima, ndi 267 imfa chifukwa cha zilizonse zapamwambazi.
Kafukufuku Wowonjezera
Chimodzi mwa kafukufukuyu chinaphatikizanso ndi kuwonetsa maphunziro asanu ndi limodzi omwe adafalitsidwa kuti athetse vuto la VTE ndi mapiritsi oletsa kubereka omwe ali ndi drospirenone. Zotsatira za maphunzirowa zasokonezedwa, komabe anayi adatsimikiza kuti pali vuto lalikulu la VTE kwa amayi omwe amagwiritsira ntchito mapiritsiwa. Ndipotu, maphunziro awiri atsopano (kuchokera mu April 2011) akusonyeza kuti amayi omwe amagwiritsa ntchito mankhwala a drospirenone ali ndi mwayi wokhala ndi mazira a magazi omwe amatha kugwiritsa ntchito drospirenone ndi apakati pa 1.5 mpaka 2 kuposa amayi omwe amagwiritsa ntchito mapiritsi oletsa kubereka omwe ali ndi progesin yosiyana.
A FDA awonanso maphunziro asanu ndi awiri ofufuza pa VTE ngozi ndi Ortho Evra Patch. Kawirikawiri, mauthengawa amasonyeza kuti, poyerekeza ndi njira zina zothandizira kupiritsira mapiritsi , chidziwitso cha kulera chimawonjezera ngozi ya VTE. Chifukwa chakuti akazi amapezeka pamtunda wapamwamba kwambiri wa estrogen ndi chigamba, akuganiza kuti nthawi zambiri amatha kukhala ndi zizindikiro zina za VTE.
Kodi Zonsezi Zikutanthauzanji?
Malingana ndi zotsatira za kafukufuku wake, kuphatikizapo mabuku omwe alipo, a FDA atsimikiza kuti kugwiritsa ntchito njira zowonjezereka zowonongeka kwa mahomoni monga Ortho Evra Patch (yomwe yatsala pamtunda kwa sabata limodzi) NuvaRing (yomwe imayikidwa mu thupi kwa masabata atatu pa nthawi), ikhoza kubweretsa chiwopsezo chokwanira kwa estrogen - kutsogolo kwa kuwonjezeka kwa magazi kapena VTE ngozi. Momwemonso, a FDA amaimirira pamapeto pake (poyambitsa ma bokosi ofiira wakuda pa tsambali mu January 2008) - kuti ntchito ya Ortho Evra patch ikugwirizanitsidwa ndi chiopsezo chachikulu cha VTEs poyerekeza ndi mapiritsi ophatikizana.
Zotsatira zomwe zikuwonetsa chiopsezo chowonjezereka cha VTE ndi ntchito ya NuvaRing (poyerekeza ndi mapiritsi osakaniza) inadzutsa nkhawa. Koma, a FDA amakhulupirira kuti kupeza izi kuyenera kufotokozedwa mu kafukufuku wowonjezereka pamaso pa bungwe lidzayang'ana molondola pa izo kapena kulengeza chenjezo lililonse lovomerezeka pa ntchito ya NuvaRing.
A FDA akuwonetsa kuti kugwiritsa ntchito mapiritsi okhala ndi drospirenone akugwirizananso ndi pafupifupi pafupifupi 1.5-kuchulukitsa chiopsezo chowonjezeka cha VTE / mazira a magazi poyerekeza ndi njira zowonongeka za mlingo wochepa. Izi zikutanthauza kuti ngati chiopsezo chotenga magazi kwa mayi pogwiritsa ntchito njira ina yoletsa kubereka ndi pafupifupi 6 mwa 10,000, ndiye kuti pangakhale chiopsezo chokhala ndi magazi pakati pa akazi ogwiritsira ntchito mapiritsi a drospirenone angakhale 10 pa 10,000. Kuonjezerapo, vuto la VTE ndi mapiritsiwa akuwoneka kuti akuwonjezeka kwambiri m'miyezi itatu yoyamba yogwiritsiridwa ntchito komanso pakadutsa miyezi 7-12.
Kumeneko kumawoneka kuti ndikulumikizana kwakukulu pakati pa zaka, kugwiritsa ntchito mapiritsi a drospirenone ndi VTE / ATE. Azimayi osakwana zaka 35 ali pangozi yaikulu ya VTE koma ali ndi chiopsezo chochepa cha ATE. A FDA amaganiza kuti progesin drospirenone ingakhale yowonjezera mavuto a mtima ndi kuwonongeka mwadzidzidzi pakati pa ogwiritsa ntchito chifukwa ali ndi zinthu zomwe zimakhudza miyeso ya mchere ndi madzi ndipo zikhoza kuwonjezera ma potaziyamu.
Panthawiyi, a FDA sanapereke chenjezo pazogwiritsa ntchito mapiritsi oletsa kubereka omwe ali ndi drospirenone. Bungweli lawonetsa mwachidziwitso chaposachedwa cha chitetezo pa April 10, 2012,
"US Food and Drug Administration (FDA) yatsiriza kafukufuku wawo wamakono okhudza kuopsa kwa magazi m'magazi azimayi omwe akugwiritsa ntchito mapiritsi oletsa kubereka a drospirenone. Mogwirizana ndi ndemanga iyi, a FDA apeza kuti mapiritsi oletsa kubadwa kwa drospirenone akhoza kugwiriridwa ndi chiopsezo chapamwamba chokhalira magazi m'malo mwa mapiritsi ena a progestin. "
Kuwunika kwa FDA za zotsatira za phunziroli (makamaka chidziwitso chochokera ku kuyesa kwa mapiritsi oletsa kubereka ana) kunatumizidwa ndikukambidwa pamsonkhano wapadera wa Komiti Yopereka Malangizo Omwe Amawongolera Kugwiritsa Ntchito Mankhwala Osokoneza Bongo komanso Komiti Yowonongeka kwa Drug Management. December 8, 2011. Komiti yolangizira inavomerezera 21-5 kuti FDA iyenera kuitanitsa mankhwala atsopano a mapiritsi a drospirenone monga Yaz , Yasmin, Beyaz , Safyral (ndi ma generic awo); iwo amamva malemba omwe alipo tsopano alibe okwanira popeza akuphatikizapo zokhudzana ndi kafukufuku wotsutsana pa zoopsa za VTE. Kulembera kuyenera kulangizidwa kuti akufotokozere momveka bwino vuto la VTE komanso pofotokoza momveka bwino kuti VTE (magazi) amatha kupha. Mu April 2012, chipani cha FDA chinapereka lamulo lolemba malemba. Komabe, zofunikira zatsopanozi sizinatsatire malangizo a gulu la uphungu. A FDA akulamula kuti mayina a mapiritsi oletsa kubadwa a drospirenone tsopano ali ndi chidziwitso cha maphunziro omwe aposachedwapa omwe a FDA awonanso. Kuonjezera apo, malemba omwe akuwongosoledwa ndi mankhwalawa adzalongosola kuti kafukufuku wina adawonekera kuwonjezeka katatu pangozi yowonjezera mwazi kwa mankhwala omwe ali ndi drospirenone poyerekeza ndi mankhwala omwe ali ndi levonorgestrel kapena ma progestins ena, komabe maphunziro ena sanapezedwe magazi owopsa kwa mankhwala a drospirenone. Malemba atsopanowa adzafotokozanso zotsatira za kufufuza kwa FDA pa VTE ngozi. Zotsatira:
FDA Office of Surveillance and Epidemiology. [10-27-2011] Kuphatikizako Mankhwala Osakaniza a Mthupi (CHCs) ndi Kuopsa kwa Matenda a Maganizo a Mliri.
Reid, R. "Kulankhulana kwabwino ndi Kuopsa kwa Thromboembolism Yowopsya: Zosintha." JOGC 2010; Ayi. 252: 1192-1197.