VTE ita ce karo na uku na nakasa na zuciya da na zuciya daya kuma yana faruwa yayin da kake da magunguna mai zurfi (DVT) ko kuma embolism na pulmonary (PE). Cikakke mai zurfi shine yanayin lokacin da jinin jini ya zama cikin jiki mai zurfi a jiki. DVT zai iya toshe jini ta hanyar daji. Hakanan zai iya faruwa idan wani jini ya kwance daga kwayar cutar kuma yana tafiya cikin jiki zuwa cikin huhu.
Wannan zai haifar da mutuwa.
Binciken da suka gabata ya rubuta cewa yin amfani da hadewar hawan hawan hawan hauka na iya kara yawan damar da kake fuskanta na cin zarafin thromboembolism - VTE (wanda aka fi sani da jini) ko wasu nau'o'in cututtukan zuciya. Hanyoyin VTE a cikin matan da suke amfani da kwaya suna cikin iyakar mata 3-9 da 10,000 a kowace shekara, yayin da VTE rates ga masu amfani da kwayoyin ba da haihuwa na kimanin shekara 1-5 zuwa 10,000 a kowace shekara. Bishara: Wannan yana nufin ƙananan hadarin ga ko dai kungiya. Amma idan har yanzu za ku damu?
Nazarin ya nuna cewa duk haɗuwa da maganin hana haihuwa na hormonal na iya haifar da wani haɗari don bunkasa VTE. Anyi zaton cewa estrogen da aka samu a cikin hawan haifa mai yiwuwa na iya zama babban abu mai ba da gudummawa. Saboda sababbin bincike na Turai da aka buga a tsakiyar shekara ta 2011 wanda ya nuna mummunan haɗarin bunkasa VTE a cikin mata ta amfani da sababbin kwayoyin maganin haifa da ke dauke da progestin drospirenone, FDA a Amurka ta yanke shawarar gudanar da bincike mai zurfi don kimanta dangantaka tsakanin haɗarin VTE da haɗuwa da maganin hana haihuwa.
Bugu da kari: Yana da muhimmanci a lura cewa duk da cewa VID yana iya zama mafi girma ga mata masu amfani da irin wannan maganin hana haihuwa, haɗarin haɗari har yanzu yana da ƙananan ƙananan.
Gyara da Hormonal Birth Control Yi amfani da shi
Sabbin hanyoyin hanyoyin haihuwa na haihuwa waɗanda ke dauke da progestin drospirenone na iya ƙara yawan haɗarin VTE, fiye da idan ka ɗauki hanyar kula da haihuwa ta haifa.
Binciken FDA, wanda ya ƙunshi mafi yawan bayanai da aka samo, ya ƙunshi nazarin da ya bincikar kimanin shekaru bakwai na bayanai daga wasu wurare daban-daban. Akalla mata 835,826, shekarun shekaru 10-55, waɗanda aka yi amfani da akalla takardun magani guda ɗaya don haɗin haɗar hormonal. Manufar wannan bincike shine bincikar sababbin sababbin maganin rigakafi na kwayoyin halitta don sanin idan hadarin VTE, DVT, PE da / ko mutuwa na zuciya da jijiyoyin jini ya fi girma fiye da yadda za'a iya yin maganin maganin rigakafi ta hudu da mahimmancin isrogen . Wadannan hanyoyin haɓaka haifuwar haihuwar sunyi nazarin (na farko 3 su ne sababbin hanyoyin):
- 3.0 MG Drospirenone / 30 mcg Ethinyl estradiol maganin jiyya (Yasmin)
- 6 MG Norelgestromin / 750 mcg Ethinyl estradiol transdermal patch ( Ortho Evra Patch )
- 11.7 MG Kwaro / 2700 mcg estradiol zobe na ciki ( NuvaRing )
- .10 MG Levonorgestrel / 20 mcg Ethinyl estradiol (kamar Alesse, Aviane-28)
- .15 MG Levonorgestrel / 30 mcg Ethinyl estradiol (kamar Seasonique , Nordette)
- 1 MG Norethindrone / 20 mcg Ethinyl estradiol ( Loestrin 1/20 )
- .18 -25 mgs Norgestimate / 35 mcg Ethinyl estradiol (Ortho Tri-Cyclen)
Fahimtar sakamakon
Yayin da aka fassara sakamakon daga wannan binciken na FDA, yana da muhimmanci a fahimci cewa a bincike, ana ganin sakamako ne a matsayin muhimmi (ko muhimmanci) idan aka ƙaddara cewa sakamakon zai iya haifar da wani abu (a game da wannan binciken FDA, sabon tsarin).
A wasu kalmomi, ana ganin sakamakon yana da muhimmanci idan yana da mahimmanci cewa ba ta faru ba.
Wasu Abubuwan Sakamako Daga Wannan Nazarin FDA
- Ga dukkan masu amfani, kwayoyin drospirenone / kwayoyin Ethinylestradiol, da takalma, da NuvaRing sun haɗu da wani mummunar haɗari na VTE (idan aka kwatanta da 4 tsofaffin samfurori). Wannan shi ne batun musamman ga mata masu shekaru 10-34.
- Sabbin masu amfani (matan da suka yi amfani da haɗin haɗar hormonal a karo na farko a wannan binciken) shan kwayoyin drospirenone / kwayoyin Ethinylestradiol sun nuna mummunar haɗari ga duka ATE (maganin kututturewa na jini - yatsun jini a cikin maganin da ke haifar da ciwon zuciya ko bugun jini) da kuma VTE.
- Drospirenone / kwayoyin Ethinylestradiol sun haɗu da haɗari mai tsanani na VTE a lokacin da aka yi amfani da watanni 0-3 har ma don watanni 7-12 na amfani.
- Don sababbin masu amfani, an danganta maƙalar ƙwayar cutar ta hanyar ninka sau uku a cikin haɗarin VTE lokacin da aka yi amfani da shi fiye da watanni 12 idan aka kwatanta da tsawon lokacin da ake amfani da su na tsofaffi.
- Drospirenone / kwayoyin Ethinylestradiol sun nuna mummunar haɗarin VTE a cikin mata masu shekaru 10-34 da kuma kara haɗari ga ATE a cikin mata 35 da shekaru da haihuwa.
- Ko da yake da .15 MG levonorgestrel / 30 mcg kwayoyin ethyl estradiol sun ƙunshi yawan isrogen kamar kwayoyin drospirenone / Ethinylestradiol, kwayoyin kwayar cutar kwayar cutar ta haifar da haɗarin VTE ga duk masu amfani.
- A lokacin da aka ba da takalma idan aka kwatanta da tsohuwar tsari .15 MG levonorgestrel / 30 mcg Dokokin Ethinyl estradiol, akwai ƙari mai yawa na VTE ga matan da suka yi amfani da patch don watanni 0-3 da watanni 12 ko fiye (ba a ganin wannan hadarin ba a cikin kwatanta tsarin).
- Akwai yiwuwar haɗari ga ATE a cikin mata da suke amfani da NuvaRing fiye da watanni 12, amma wannan bayanan ya dogara ne akan 1 akwati, saboda haka ana bukatar a kara nazarin wannan hadarin.
Yawanci, a wannan binciken na FDA, akwai raunuka 78, 405 VTEs, 220 DVTs, hare-haren zuciya na zuciya 60, mutuwar 41 saboda cututtuka na zuciya, da kuma mutuwar 267 daga duk wani yanayin da ya gabata.
Ƙarin Bincike
Sakamakon wannan bincike ya hada da yin nazarin binciken da aka buga a cikin bita shida wanda ya bincikar hadarin VTE tare da kwayoyin maganin haihuwa da ke dauke da drospirenone. Sakamakon wadannan nazarin sun haɗu, amma hudu daga cikinsu sun tabbatar da cewa akwai haɗarin VTE mai yawa ga matan da suke amfani da waɗannan kwayoyin. A gaskiya ma, binciken da aka yi a kwanan nan (daga Afrilu 2011) ya nuna cewa hadarin ƙaddamar da jini ga mata ta yin amfani da drospirenone yana dauke da 1.5- 2 sau mafi girma fiye da matan da suke amfani da kwayoyin maganin haihuwa da ke dauke da progestin daban-daban.
Har ila yau, FDA ta sake bincikar binciken bincike bakwai game da hadarin VTE da Ortho Evra Patch. Gaba ɗaya, waɗannan rahotanni sun nuna cewa, idan aka kwatanta da wasu nau'in kwayar cutar haihuwa , ƙwaƙwalwar ƙwayar cutar tana iya ƙara haɗarin VTE. Saboda mata suna da alamun yaduwar isrogen tare da alamar, an kiyasta cewa su sau 2-3 ne zasu iya samun irin alamar VTE.
Mene Ne Yake Ma'anar?
Bisa ga sakamakon bincikensa, a hade tare da wallafe-wallafe na yanzu, FDA ta ƙaddara cewa yin amfani da haɗarin haɗarin hormonal haɗuwa har abada, irin su Ortho Evra Patch (wanda ya rage a jiki har tsawon mako daya a lokaci) da kuma NuvaRing (wanda ya kasance a cikin jiki na tsawon makonni uku a lokaci daya), zai iya haifar da ci gaba mai girma ga estrogen - yana haifar da ƙarar jini ko VTE haɗari. Saboda haka, FDA tana tsayawa bayan ƙaddamarwa ta karshe (yana mai da hankali ga gargaɗin akwatin akwatin bango a kan faɗin cikin Janairu 2008) - cewa amfani da Ortho Evra patch yana haɗuwa da haɗarin VTE mafi girma idan aka kwatanta da daidaitattun haruffa.
Sakamakon yana nuna haɗarin VTE tare da amfani da NuvaRing (idan aka kwatanta da kwayoyin hade) ya damu da damuwa. Amma, FDA ta yi imanin cewa wannan binciken yana buƙata a sake gwadawa a ƙarin bincike a gaban hukumar zata dauki wani ra'ayi mai kyau akan shi ko kuma ya sanar da wani gargadi game da amfani da NuvaRing.
FDA ta nuna cewa amfani da kwayoyin kwayoyi dauke da drospirenone kuma an haɗa su da kimanin 1.5-ninka ƙara yawan haɗarin VTE / jini a lokacin da aka kwatanta da daidaitattun maganin maganin ƙwaƙwalwa. Wannan yana nufin cewa idan hadarin ƙaddamar da jinin jini ga mace ta yin amfani da wani haifa na haihuwar hormonal yana da kimanin 6 a cikin dubu 10, to, hadarin ƙaddamar da jini tsakanin matan da ke amfani da kwayoyi tare da drospirenone zai kasance kimanin 10 a cikin dubu 10. Bugu da ƙari, haɗarin VTE tare da waɗannan kwayoyin sunadaran ya karu da ƙaruwa a lokacin farkon watanni uku na amfani da kuma lokacin watanni 7-12 na amfani.
Har ila yau akwai alama mai mahimmanci tsakanin shekaru, amfani da kwayoyin drospirenone da VTE / ATE abin da ke faruwa. Mata a ƙarƙashin shekaru 35 suna fuskantar mummunar haɗari na VTE amma suna da ƙananan haɗarin ATE. FDA ta tabbatar da cewa progestin drospirenone na iya ƙara ƙãra matsalolin zuciya da kuma mutuwar kwatsam tsakanin masu amfani saboda yana da wasu kaddarorin da suka shafi gishiri da ruwan sha kuma zai iya ƙara matakan potassium.
A wannan lokacin, FDA ba ta bayar da gargadi game da amfani da kwayoyin maganin haihuwa ba wanda ya ƙunshi drospirenone. Hukumar ta bayyana kawai a cikin sanarwar lafiya ta kwanan nan a ranar 10 ga Afrilu, 2012,
"Cibiyar Abinci da Harkokin Kiwon Lafiyar Amurka (FDA) ta kammala nazarin binciken da aka yi a kwanan nan dangane da hadarin jini a cikin matan da ke dauke da kwayoyin maganin haihuwa. A bisa wannan bita, FDA ta kammala cewa kwayoyin kwayar cutar haihuwa ta ɗauke da kwayoyin haihuwa na iya haɗuwa da haɗari mafi girma ga jini fiye da sauran kwayoyin kwayar cutar. "
Binciken na FDA akan sakamakon binciken (musamman bayanan da aka samu daga kimantawa da kwayoyin maganin haihuwa) da aka gabatar da tattaunawar a taron haɗin gwiwar kwamitocin Shawarar Magungunan Kiwon Lafiyar Harkokin Kiwon Lafiyar da Kwamitin Shawarwari na Kariya da Kariya na Kwayoyi. 8 ga watan Disamba, 2011. Rukunin shawarwari sun amince da 21-5 cewa FDA ya buƙaci sabon lakabi don maganin kwayoyin drospirenone irin su Yaz , Yasmin, Beyaz , Safyral (da kuma jigilar su); sun ji cewa alamu na yanzu basu kasa ba tun lokacin da suka ƙunshi bayanai game da rikice-rikice akan bincike na VTE. Dole a rika lakafta lakabin ya bayyana a fili yadda za a iya ciwo VTE da kuma tabbatar da cewa VTE (jinin jini) zai iya zama m. A cikin Afrilu 2012, FDA ta ba da wata bukata don sabuntawa. Duk da haka, buƙatar sabon lakabi bai bi shawarar shawarwari na kwamitin ba. FDA tana buƙatar cewa lakabi na kwayoyin shan magani na haihuwa da ke dauke da kwayoyin haihuwa a yanzu sun ƙunshi bayanin game da binciken da aka yi a kwanan nan cewa FDA ta sake dubawa. Bugu da ƙari, ƙididdigar miyagun ƙwayoyi za su bayyana cewa wasu karatun sun nuna saurin sau uku a cikin hadarin ƙuƙwalwar jini don samfurori da ke dauke da kwayoyin drospirenone idan aka kwatanta da samfurori da ke dauke da levonorgestrel ko wasu magoya bayansa, duk da haka wasu binciken ba su sami ƙarin ba Jubar jini ya haddasa haɗari ga samfurori na drospirenone. Sabbin alamomi za su yi la'akari da sakamakon sakamakon binciken na FDA game da hadarin VTE. Sources:
FDA ofishin Kulawa da Lafiya. [10-27-2011] Ƙungiyar Harkokin Hormon Clan (CHCs) da Hadarin Kwayoyin cututtuka na zuciya da jijiyoyin jini.
Reid, R. " Shirye-shiryen maganganun maganganu da hadarin Thromboembolism Venous: Ɗaukakawa." JOGC 2010; A'a. 252: 1192-1197.