VTE ndiyo yechitatu inowanzobatwa nehutano hwemwoyo uye inoitika kana iwe unenge wakadzika worwere (DVT) kana kuti pulmonary embolism (PE). Mvura yakadzika yepinein is a condition when blood clot forms in a deep vein in the body. DVT inogona kudzivirira ropa richiyerera mumumvuri. A pulmonary embolism inogona kuitika ipapo kana ropa rinoputika kubva mumupfu uye rinofamba nemuviri kuenda mumapapu.
Izvi zvinogona kutungamirira kurufu.
Ongororo yekare yakaratidza kuti kushandiswa kwekubatana kwemahomoni ekuberekwa kunogona kuwedzera mikana yako yekuwana thromboembolism inosangana -VTE (inozivikanwawo seyevha yegazi) kana mamwe mhando dzehutano hwemwoyo. Mitengo yeVTE mumadzimai anoshandisa mapiritsi ari mumakero matatu kubva ku3 kusvika ku10 000 vakadzi gore rimwe chete asi VTE mamiriyoni evanhu vasingashandisi mapiritsi emakore ekuberekesa anenge anenge 1-5 kusvika pavakadzi 10 000 pagore. Mashoko akanaka: Izvi zvinoreva dambudziko rakaderera kune rimwe boka. Asi iwe uchiri kungofunganya here?
Zvidzidzo zvakaratidza kuti zvose kusanganiswa kweHommonal contraception kunogona kukanganisa imwe mungozi yekuvandudza VTE. Inofungidzirwa kuti isrogen inowanika muhomoni yekuberekwa kwekuberekwa inogona kunge iri iyo inobatsira zvikuru. Pamusana pekutsvakurudza kweEuropeya yakabudiswa mukati megore ra2011 iyo yakaratidza dambudziko rakakura rekudzidzira VTE kuvakadzi vachishandisa mishonga inobatanidza kuberekwa kuzvironga mapiritsi ane progesin drospirenone, FDA muUnited States yakasarudza kuongorora zvakadzama kuongorora hukama pakati peVTE ngozi nekubatana kwemasimba ekudzivirira kubata pamuviri.
Zvakare: Zvakakosha kucherechedza, zvisinei, kuti kunyange zvazvo VTE ngozi ingave yakakwirira kune vakadzi vanoshandisa rudzi urwu rwekudzivirira kubata pamuviri, dambudziko rose rinenge richiri pasi.
VTE neHormonal Birth Control Shandisa
Nzira itsva dzekudzivirira kuberekwa kwemhomhoni dzine progesin drospirenone inogona kuwedzera kowani yako yeVTE, yakawanda kupfuura kana iwe wakatora imwe yakwegura yekuberekwa kwevana.
Kuongororwa kweDAA, iyo ine data yakazara yakakwana inowanika, yakave yedzidzo yakatsvaga dhigirii yemakore manomwe kubva kune dzimwe nzvimbo dzakasiyana-siyana. Vanenge 835 826 vakadzi, vane makore gumi kusvika ku55, avo vaive nemurairo mumwechete wekubatana kwemishonga inokonzerwa nehutoni yakaongororwa. Chinangwa chekutsvakurudza uku ndechekuongorora zvitatu zvitsva zvekudzivirira kubata pamuviri kuti zvione kana njodzi yeVTE, DVT, PE uye / kana kufa kwepfungwa yakakwirira kupfuura iyo yaizove yakagadzirwa nemakwenzi mana ekurerura kubvisa pamuviri uye zvakafanana nemazinga eestrogen . Iyi inotevera nzira yekudzivirira kuberekwa kwekuberekwa yakaongororwa (yekutanga 3 ndiyo nzira itsva):
- 3.0 mg Drospirenone / 30 mcg Ethinyl isradiol pamuviri wekurwa (Yasmin)
- 6 mg Norelgestromin / 750 mcg Ethinyl estradiol transdermal patch ( Ortho Evra Patch )
- 11.7 mg Etonogestrel / 2700 mcg isradiol vaginal ring ( NuvaRing )
- .10 mg Levonorgestrel / 20 mcg Ethinyl estradiol (kufanana naAlesse, Aviane-28)
- .15 mg Levonorgestrel / 30 mcg Ethinyl estradiol ( seSeasonique , Nordette)
- 1 mg Norethindrone / 20 mcg Ethinyl estradiol ( Loestrin 1/20 )
- .18-.25 mimwe Norgestimate / 35 mcg Ethinyl estradiol (Ortho Tri-Cyclen)
Kunzwisisa zvabuda
Kana uchiturudzira zvabuda kubva kuDDA yekuongorora, zvakakosha kunzwisisa kuti mukutsvakurudza, chigumisiro chinotaridzirwa kuti chinotaridzika (kana chinokosha) kana chave chagadziriswa kuti mugumisiro wacho unogona kunge wakakonzerwa nechimwe chinhu (kana iyi FDA yekudzidza, iyo itsva inogadzirwa).
Mune mamwe mazwi, mugumisiro unofungidzirwa zvikuru kana zvichida zvakanyanya kuti hauna kuitika pangozi.
Zvimwe Zvikamu Zvikuru Kubva KuChidzidzo cheD FDA
- Kune vese vashandisi, drospirenone / Ethinylestradiol mapiritsi, patch, uye NuvaRing zvakabatanidzwa nehuwandu hwepamusoro hweVTE (kana ichienzaniswa ne 4 yakakura formulation). Izvi zvinonyanya kuitika kune vakadzi vane makore 10-34.
- Vashandisi vatsva (vakadzi vakashandisa mushonga wokudzivirira mishonga inokonzerwa nehutachiona kwekutanga panguva ino muchidzidzo) kutora drospirenone / Ethinylestradiol mapiritsi akaratidza dambudziko guru kwazvo reATE (arterial thrombosis - ropa rinopisa muyiti iyo inowanzokonzera kushaya mwoyo kana kupora) uye VTE.
- Drospirenone / Ethinylestradiol mapiritsi aibatanidzwa nehuwandu hwepamusoro hweVTE kana yakashandiswa kwemwedzi 0-3 uye kwemwedzi 7-12 yekushandiswa.
- Kune vashandisi vatsva, chirongwa chekudzivirira pamuviri chakabatanidzwa pakuwedzera kwemazana matatu pangozi yeVTE iyo inoshandiswa kwemwedzi inopfuura 12 kana ichienzaniswa nenguva yakafanana yekushandiswa kwemafomu akare.
- Drospirenone / Ethinylestradiol mapiritsi akaratidza njodzi inowanikwa yakawanda yeVTE muvakadzi gumi nemakore makumi maviri nemashanu uye yakawedzera ngozi yeATE muvakadzi makore makumi matatu nekure.
- Kunyange zvazvo .15 mg levonorgestrel / 30 mcg ethyl estradiol mapiritsi aiva nemutengo wakafanana we estrogen se drospirenone / Ethinylestradiol mapiritsi, madhemirone emadokisi akaisa vTE ngozi kune vashandisi vose.
- Apo chigamba chaingoenzaniswa chete nekugadzirwa kwekare .15 mg levonorgestrel / 30 mcg Ethinyl estradiol mapiritsi, pakanga pane ngozi yakawanda yeVTE yevakadzi vakashandisa chigamba kwemwedzi 0-3 nemwedzi 12 kana kupfuura (iyi ngozi haina kuonekwa mukuenzanisa mukuenzanisa).
- Panogona kuva nehuwandu hwehuwandu hweATE kuvakadzi vanoshandisa NuvaRing kwemwedzi inopfuura 12, asi iyi dhesi inobva pane imwe nyaya, saka iyo ngozi inogona kuongororwa zvakare.
Pasi pose, panguva iyi yekuongorora FDA, paiva nemakororo makumi mana, 405 VTEs, 220 DVTs, 60 kushaya mwoyo, 41 kufa nekuda kwehutano hwehutano, uye 267 kufa zvichibva kune ipi zvayo pamusoro apa.
Ongororo Yokuwedzera
Chikamu chekutsvakurudza uku chaivewo chekuongorora zvidzidzo zvitanhatu zvakabudiswa izvo zvakanga zvichitsvaga njodzi yeVTE nemapiritsi ekuzvidzivirira ekuberekwa ane drospirenone. Zvigumisiro kubva pane zvidzidzo izvi zvakave zvakakanganiswa, asi vana vavo vakapedzisa kuti kune chokwadi chakawedzera VTE ngozi kunevakadzi vanoshandisa mapiritsi aya. Kutaura zvazviri, zvidzidzo zviviri zvekupedzisira (kubva munaEpril 2011) zvinoratidza kuti njodzi yekudzivirira ropa dzemadzimai kwevakadzi vanoshandisa drospirenone-ine yeka 1.5 kusvika kune 2 yakapamusoro kupfuura vakadzi vanoshandisa mapiritsi ekuberekwa ane zera reprogestin yakasiyana.
Iyo FDA yakaongorora zvakare zvidzidzo zvinomwe zvekutsvaga pamusoro peVTE ngozi uye yeOrtho Evra Patch. Pasi pose, mitsara iyi inoratidza kuti, kana ichienzaniswa nemamwe ekubatana kwekuberekwa kwepiritsi maitiro, chirongwa chekubata pamuviri chingangowedzera ngozi yeVTE. Nemhaka yokuti vakadzi vanoratidzwa kune yakakwirira kwazvo maestrogen nechigamba, zvinofungidzirwa kuti vanowanzoita 2-3 dzimwe nguva kuti vawane rumwe rudzi rwechiratidzo cheVTE.
Zvose Izvi Zvinorevei?
Kubva pamigumisiro yekutsvakurudza kwayo, pamwe chete nemabhuku akange aripo, FDA yakagumisa kuti kushandiswa kwekuenderera mberi kwekutsvaga kusanganiswa kwemahomoni inonzi hormonal contraceptive, yakadai seOrtho Evra Patch (inosara pamuviri kwevhiki imwe panguva imwe) uye NuvaRing (iyo inoramba ichiiswa mumuviri kwemavhiki matatu panguva imwe), inogona kuita kuti kuve nekusvika kwepamusoro kune esrogen-inotungamirira kuwedzerwa ropa clot kana VTE ngozi. Nokudaro, FDA inomira shure kwekupedzisa kwayo kwepakutanga (kukurudzira bhokisi rakasvibirirwa bhokisi rinoshandiswa pachikwata munaJanuary 2008) - kuti kushandiswa kweOrtho Evra patch kunobatanidza nehuwandu hwehuwandu hweVTEs kana zvichienzaniswa nemishonga yakakwana yekubatanidza.
Migumisiro inoratidza kuwedzera kwengozi yeVTE neNuvaRing kushandiswa (kana ichienzaniswa nemishonga inoshandiswa) yakasimudzira kunetseka. Asi, iyo FDA inofunga kuti kuwanikwa uku kunoda kudzokororwa mukutsvakurudza kwakawedzerwa pamberi pejisheni ichatora chimiro chaicho pamusoro payo kana kuzivisa chero nyevero yepamutemo paNuvaRing kushandiswa.
Iyo FDA inoratidza kuti kushandiswa kwepiritsi ine drospirenone inobatanidzawo inenge inenge 1.5-kuwedzerwa kuwedzera kowanda yakawanda yeVTE / blood clots kana ichienzaniswa nemirairo yakadzika inowanikwa mumuromo. Izvi zvinoreva kuti kana mukana wekudzidzira ropa rekuvhara mukadzi kune imwe sarudzo yekuberekwa kwehomoni inenge 6 mu10 mamiriyoni, ipapo njodzi yekudzidzira ropa clot pakati pevakadzi vanoshandisa mapiritsi ne drospirenone ingava anenge gumi mu10 000. Uyezve, iyo VTE ngozi nemapiritsi aya anoita seakawedzerwa mukati memwedzi mitatu yekutanga yekushandiswa pamwe chete nemwedzi 7-12 yekushandiswa.
Ikoko kunoratidzikawo sechibvumirano chinokosha pakati pezera, drospirenone-rine piritsi yekushandisa uye VTE / ATE zviitiko. Vakadzi vasati vava nemakore makumi matatu nevashanu vari pangozi yakanyanya yeVTE asi vane njodzi yakaderera yeATE. Iyo FDA inofungidzira kuti progestin drospirenone inogona kunge yakanyanya kuwedzera matambudziko emwoyo uye kushungurudzika kamwe kamwe pakati pevashandisi nokuti ine zvimwe zvinhu zvinokanganisa munyu nemari yemvura uye inogona kuwedzera pasiziyamu mazinga.
Panguva ino, FDA haina kubvisa nyevero yepamutemo pamusoro pekushandisa kwekuberekwa kwepiritsi inenge ine drospirenone. Iyo sangano inongoratidzira muhuwandu hwayo hwekuchengetedzwa kwekuchengeteka musi waApril 10, 2012,
"IU.S. Food and Drug Administration (FDA) yakapedza kubvunzurudzwa kwekuongorora kwemazuva ano pamusoro pehutano hwekuvhara ropa mumadzimai ekutora drospirenone-ine zvokurapa mapiritsi ekuberekwa.Kubva pakuongorora uku, FDA yakagumisa kuti drospirenone-ine vana yekuzvidzivirira mapiritsi inogona kusanganiswa nehuwandu hwehutachiona hwemagazi eropa kupfuura mamwe mapuropirini ane mapiritsi. "
Kuongororwa kweDAA yemigumisiro yeyikudzidza (zvikurukuru data inobva pakuongororwa kwe drospirenone-ine-birth control mapiritsi) yakatumirwa uye inokurukurwa pamusangano wekubatana weReproductive Health Drugs Advisory Committee uye Drug Safety uye Risk Management Advisory Committee pa December 8, 2011. Zano remakurukota rakaratidza 21-5 kuti FDA inofanira kutora mazita matsva emiromo ye drospirenone yakafanana naJaz , Yasmin, Beyaz , Safyral (uye maitiro avo evanhu); vakafunga kuti mavara emazuva ano haana kukwana sezvo achangosanganisira ruzivo rwekutsvakurudza kunopesana kwezviitiko zveVTE. Kunyora kwacho kunofanira kukurudzirwa kunyatsojekesa zvinogona kuitika VTE ngozi pamwe nekuita pachena kuti VTE (blood clots) inogona kuuraya. MunaMuvhuro 2012, FDA yakabudisa chidimbu chekunyora mabhuku. Zvisinei, izvo zvitsva zvinotarisirwa hazvo hazvina kutevera mazano ekugadzirisa mapurisa. Iyo FDA inorayira kuti mabhii e drospirenone-ane zvekuberekwa kwepiritsi yemapirisa iye zvino ane ruzivo pamusoro pekuchangobva kuongorora zvidzidzo izvo FDA ichangobva kuongororwa. Uyezve, iyo yakagadziridzwa mishonga yemishonga iye zvino inofanira kutaura kuti zvimwe zvidzidzo zvakaratidzwa kusvika katatu kuwedzerwa mudambudziko rekuvhara ropa kwezvinhu zvinokonzerwa ne drospirenone kana zvichienzaniswa nemiti yakange ine levonorgestrel kana zvimwewo progestin, asi zvimwe zvidzidzo zvakawanikwa pasinazve ropa clot ngozi ye drospirenone-ine zvigadzirwa. Zvinyorwa zvitsva zvicharevawo zvitsva zvekuongorora kweDefA yeVTE ngozi. Sources:
FDA Office of Surveillance uye Epidemiology. [10-27-2011] Mubatanidzwa weHormonal Contraceptives (CHCs) uye Dambudziko reMwoyo weAIDS Mazuva Ekupedzisira.
Reid, R. "Zvipfeko Zvimwe Zvimwe uye Dambudziko reVeast Thromboembolism: Chimwe Chinyorwa." JOGC 2010; Nha. 252: 1192-1197.