Isidakamizwa "Clayra": ukubuyekezwa kodokotela, pluses, minuses, imiyalo, nemiphumela emibi. Ukubuyekezwa kwama-gynecologists mayelana namathebhulethi ka-Claira ane-endometriosis, aphelelwa yisikhathi

Muva nje, kaningi odokotela zanamuhla izifo ezithize linqume izidakamizwa "Klayra". Uphenyo odokotela, buhle, bawo yaleli ithuluzi - konke lokhu kuzoxoxwa ngezansi.

Sisebenza kanjani?

Lesi sidakamizwa kuyinto elihlangene umuthi ngomlomo, ogxile nokuxhumana izici eziningana. Into ebaluleke kakhulu phakathi kwabo kukhona ukucindezelwa nge-ovulation, kanye ukulungiswa of property isikhwehlela wesibeletho - kule futhi kususelwe isenzo "Klayra" izidakamizwa. Uphenyo odokotela (elithola, nebubi ochwepheshe ngaso sonke isikhathi cabanga) ngokuvamile zithi iyithuluzi livelele umphumela wawo efanayo.

Ngaphezu ekuvimbeleni ukukhulelwa okungafunwa lokhu izidakamizwa kuyahluka lonke uchungechunge izindawo ezengeziwe ezuzisayo ukuthi, ngisho ikhumbula unezimfanelo negative akuvumela ukuba ukhethe best inzalo. Zonke contraindications izidakamizwa uchaza "Klayra" imfundiso. Izibuyekezo odokotela futhi zihlanganisa ulwazi mayelana nokuthi ubani ukuthatha leli imithi engathandeki.

Yini eyenza i-aphoyintimenti?

Ukunciphisa umfutho ubuhlungu futhi menstrualnopodobnoe ukopha, okwagcina kuholela ekuncipheni okuphawulekayo ingozi yensimbi ukuntula igazi. Lokho umphumela main, esihlinzeka "Klayra". Uphenyo odokotela (buhle / nebubi we cm izidakamizwa. Ngezansi) bathi konke lokhu inikezwe ngokugcwele, ngokuqondene lapho nomuthi futhi batusa ukusetshenziswa kaningi. Ngaphezu kwalokho, ngokuvamile baphawula nokuthi yokwamukela ithuluzi ihlinzeka ukunciphisa okuphawulekayo kungenzeka nomdlavuza endometrial. Futhi, izidakamizwa kunciphisa ingozi yomdlavuza wesibeletho.

Yini odokotela bathi?

Ngokuphathelene izidakamizwa "Klayra" impendulo evela lodokotela ngokuvamile ukugqamisa ukuthi it has nethonya elizuzisa kakhulu phezu endometrium, ngokuqondene esetshenziswe kuwo ekwelapheni eside noma ukopha engahlula kokuya esikhathini ngaphandle zokugula organic. Lezi zimpawu yilezi ngezikhathi enezinkinga lesizalo ukopha. Leli qiniso ukwaba etholakalayo mayelana izidakamizwa "Klayra" impendulo evela kodokotela. Ngo endometriosis ukusetshenziswa kwalo kungabuye kunikezelwe.

ucwaningo

Ukuphepha kanye nempumelelo besebenzisa amaphilisi estradiol valerate / dienogest ekwelapheni izimpawu enezinkinga lesizalo ukopha sezihlonziwe ngokuhamba izifundo ezimbili emtholampilo.

isembozo design kanye nokuhlaziywa ngomklamo ofanayo ayesetshenziswa kokubili izifundo. Ekugcineni, iziguli 269 abakhethelwa "Klayra" izidakamizwa. Uphenyo odokotela (buhle / nebubi zichazwe ngokuningiliziwe), ngekubamba lichaza kulolu cwaningo, wathi ukuthi ngaphezu kwale liye abathintekayo kulolu cwaningo iziguli 152, okuyinto ihlolwe umphumela placebo. Kulezi izifundo, kwatholakala ukuthi lesi sidakamizwa kwaba nemiphumela engcono kuqhathaniswa placebo ekwelapheni lezi zimpawu, futhi kuyafaneleka yokuthi impendulo yokugcina zezidakamizwa "Klayra" ingaphezu 40% ngayinye izifundo.

Ngaphezu kwalokho, ngamunye izifundo kwabonisa ngokucacile ukuncipha wezibalo futhi emtholampilo okuphawulekayo kokuya esikhathini igazi ukulahleka, futhi eminye ke kwakulandelwa nokwanda okuphawulekayo yensimbi umzimba nemingcele okwamanje ngokuvamile ukumaka esebenzisa "Izibuyekezo Klayra 'odokotela (ngokucophelela ngobuhle nangobubi bawo kwalo mkhiqizo sisuke sicabanga) .

Njengoba i-estrogen kule nokulungiselela ukhonza variat estradiol, okuyinto eyandulela engokwemvelo yomuntu 17β-estradiol. isakhi Estrogenic esetshenziswa lapha lisho esihluke kakhulu kusukela estrogens ezisetshenziswa e elihlangene zokuvimbela inzalo temlomo, okuyizinto ejwayelekile zokwenziwa i-estrogen, ezifana mestranol noma ethinyl, ngamunye equkethe iqembu methyl kule sikhundla 17α. Leli qembu kubangela ukuzinza okukhulu umzimba, kodwa ngesikhathi esifanayo kunomphumela evelele kwesibindi, okuyilona elisebenzayo futhi okubaluleke kakhulu.

Encazelweni yalokho ukulungiswa "Klayra" impendulo evela kodokotela ngokuvamile abhekisela yokuthi ukuthatha inikeza umphumela ingasaphathwa evelele kwesibindi kuqhathaniswa nezinye PDA ezintathu okhombisa, okuhlanganisa levonorgestrel futhi ethinyl estradiol. Phakathi nocwaningo kuphethwa ngokuthi umphumela lokuhlushwa globulin yakhelwe ukuhlanganisa uxhumano nomsebenzisi hormone, lingaphansi evelele. Lihambisana dienogest estradiol valerate libonisa nokwanda okuphawulekayo HDL, kuyilapho lokuhlushwa ingqikithi LDL cholesterol kuyehla.

Dienogest - a progestogen, ukusebenza esimweni ekuphathweni ngomlomo. It libhekene ezengeziwe ngokwengxenye imiphumela anti-androgenic, ngenkathi anti-estrogenic, izakhiwo zalo androgenic futhi estrogenic abangelutho. Ngenxa esiyingqayizivele isakhiwo sazo sekhemikhali ibangelwa lonke nomkhakha we isinyathelo kwemithi, esakhiwa Izinzuzo ebaluleke kakhulu 19-futhi-progestogen, kanye nemikhiqizo ezihlukahlukene progesterone, okuyinto kaningi ziphawula mayelana izindlela ezitholakalayo "Izibuyekezo Klayra '(buhle / nebubi Kamuva sizoxoxa ngokuthi).

Enye idatha pre-clinical ukuthi zazitholakala ngokuhamba abavamile izifundo ubuthi ngemva kokudla nokufakwa amaningi, kanye genotoxicity abangaba umdlavuza kwaleli thuluzi, ayiboniswa, ukuthi kukhona abanye abalulekile ingozi ethize ukuze abantu. Nokho, lapho echaza lesi sidakamizwa "Klayra" libuyekeza gynecologists ngokuvamile bathi akufanele sikhohlwe mayelana nokwenzeka inkanuko eziningi kwezicubu ama-hormone engaphansi izimila hormone ocansini. Endabeni ukusetshenziswa ngokufanele okubizwa ngokuthi Pearl Inkomba (isilinganiso ukuthi inquma ukuvama kwabakhulelwe abesifazane wayesevile eminyakeni eyikhulu kwesicelo isidakamizwa) inenani esingaphansi 1, kodwa angakhula esimweni amaphilisi ezingabanjwanga nobe kabi ngakho.

pharmacokinetics Okulandelayo "Klayra" isidakamizwa ezocatshangelwa. Izibuyekezo gynecologists uqinisekise cishe ngokuphelele ulwazi olushiwo ngumkhiqizi, ngokuqondene okuyinto ithuluzi futhi ngabelwa iziguli eziningi.

dienogest

• Absorption. Ukulandela ekuphathweni temlomo element ngokushesha futhi cishe egxile ngokuphelele. C _max ku serum igazi lifika kule inkomba 90,5 ng / ml emva cishe ihora ngemva ithebhulethi esithathwayo (iqukethe 3 mg dienogest futhi 2 mg estradiol variat). Bioavailability kulokhu ifinyelela izisulu 91%. Kufanele kuqashelwe ukuthi pharmacokinetics ka dienogest etinhlotjeni letibanti umthamo kusuka 1 mg kuya kwezingu-8 libhekene kwencika ngqo ku umthamo. Uma ukulungiselela isetshenziswa kanyekanye ngokudla, ke akubangi umphumela emtholampilo abalulekile kwi degree noma izinga lokukhula ukumuncwa kwalesi sakhi.

• Distribution. Ingxenye enkulu dienogest afundwa (10%) kuyinto ifomu itho olukhululekile, kuyilapho okusele liqinisekile non-ethize ukuze albumin. Dienogest ngokwalo ngqo ehambisana nanoma iyiphi globulin kortikosteroidsvyazyvayuschim, noma SHBG nge. Kungenxa yalesi sizathu ukuthi testosterone siqedwa ngokuphelele ingozi displacement we ngokuqondene SHBG noma cortisol kusukela zokuxhumana timphawu ne DRG. Ithonya ethize izinqubo ezihlukahlukene bokuphila ukuhambisa ama endogenous, ngokulandelana, kuyinto cishe engenakwenzeka. Lapho emakamu yakhoibrium kuyinto 46 V _d L ngenxa yokuphathwa emthanjeni of 85 mg dienogest anelebuli tritium.

• Umzimba. Dienogest isici is akheka cishe ngokuphelele nekuhambisana ezindleleni ezaziwayo okwamanje umzimba hormone steroid, kanye kumiswa metabolites ezisesandleni iningi amacala hormonally esingasebenzi. Lezi metabolites kuthiwa excreted ngokushesha okukhulu kangaka iqembu ovelele kule oketshezini olungenambala lwegazi imele dienogest zinjalo. imvume Ubude ngemva kokuphathwa emthanjeni of dienogest tritiated kuyinto 5.1 l / h.

• Ukuqedwa. Ngenxa yalokho ekutholeni isici lokhu umthamo ngemlomo ngaloko lokusandza kwenteka 0.1 mg / kg ngokuphelele dienogest njengoba metabolites ukuthi excreted ngu nezinso amathumbu ku isilinganiso silinganisiwe 3: 1. Ngemva kokuphathwa temlomo cishe 42% umthamo lususwe emini wokuqala, ngenkathi 63% - kwezinsuku ezingu-6 ngu excretion kwezinso. Ngaphezu kwalokho, ngemva kwezinsuku ezingu-6 kuya ku-emathunjini kanye izinso etholakala cishe 86% umthamo.

• Ubuningi zilingana. Kulokhu, lo pharmacokinetics ka dienogest akuyona kuncike lokuhlushwa SHBG. Inkomba C _ss kufinyelelwa ngemva cishe izinsuku ezintathu emva usebenzisa umthamo ofanayo, okuyinto 3 mg dienogest lihambisana 2 mg Estradiol valerate.

estradiol valerate

• Absorption. Ngenxa yalokho sokuthatha estradiol izidakamizwa amasampula engcono ngokushesha futhi ngokuphelele ugxile. Cleavage at valeric acid estradiol uqobo ngqo eyenziwa ngesikhathi ukuncela kwalesi sakhi we wokugaya ukudla ipheshana mucosa noma ngesikhathi ndima lokuqala ngokusebenzisa isibindi, avele estradiol futhi metabolites yayo kanjalo. Uma ejenti esithathwayo kanyekanye ukudla, ke akunamthelela emtholampilo abalulekile ngezinga noma izinga lokukhula ukumuncwa kwalesi sakhi.

• Umzimba. Valeric acid kuyahluka umzimba okusheshayo kakhulu. Ngemva kokuphathwa temlomo cishe 3% umthamo, kuba bioavailable ngokuphelele njengoba estradiol okumsulwa othola umphumela olunzulu kokuqala edabula isibindi, ukuze ingxenye enkulu ye-umthamo iqondiswa akheka kakade iqala le mucosa yokusetshenziswa pheshana emathunjini. Lihambisana umzimba presystemic esibindini ngqo mayelana 95% i umthamo temlomo ekugcineni akheka ngaphambi kokuba angene kwegazi. I metabolites main lapha isinyathelo estrone sulfate, estrone futhi estrone glucuronide.

• Distribution. Ngo serum 38% of estradiol kuhlobene SHBG, kuyilapho 60% - ne-albumin futhi% 2-3 kuphela ngokuqhubekayo lalikhona isimo olukhululekile. Kuyaphawuleka yokuthi estradiol kungase insignificantly ukwandisa lokuhlushwa ingqikithi SHBG egazini serum, futhi lokhu nomphumela encike ngqo kwi umthamo ukwamukelwa. Ngosuku 21 yokwamukela lokhu ukulungiselela emakamu ingqikithi SHBG kwaba cishe 146% koqobo, ngesikhathi usuku 28, okuyinto esigabeni ekupheleni isicelo amaphilisi ngasebenzi aye ancipha aze 141%.

• Ukuqedwa. Ngenxa ichibi ngokwanele enkulu afundwa glucuronides nama-sulfate, kanye ngenxa hepato-enteric recirculation T _1/2 estradiol emva ukusetshenziswa temlomo esigabeni ukuphela isici eziyinkimbinkimbi, encike ngqo kwi zonke lezi izinqubo.

• Ubuningi zilingana. Pharmacokinetics estradiol kuncike ngqo lokuhlushwa SHBG. Ngo abesifazane, lokuhlushwa estradiol e-plasma kuyinto eyinkimbinkimbi estradiol endogenous, nokuthi estradiol olunceleka inqubo Uthola le izidakamizwa. Phakathi amaphilisi reception isigaba, aqukethe 3 mg dienogest futhi 2 mg estradiol valerate, emakamu kusho estradiol ku serum igazi isimo ravnomestnom kuyinto 51,6 pg / ml.

Uma lokhu izidakamizwa isetshenziswa?

Okokuqala esimisiwe 'Klayra "phakathi kwabadala. Uphenyo odokotela bathi lokhu kuyisinqumo esingcono kakhulu ekwelapheni abesifazane abaphethwe kokuya esikhathini esindayo noma nokunwetshiwe ukopha nokungabi khona kwanoma yiliphi zokugula organic.

Futhi, lolu izidakamizwa esithathwayo ukusebenzisa zokuvimbela inzalo ngomlomo.

Izimo

On the ukulungiselela "Klayra" impendulo evela odokotela (side effects - okufanele asolwe) akuyona eyakhayo ngaso sonke isikhathi. Ngokwesibonelo, ukwaba ezinye Izimo. Phawula izimo ezimbalwa okuyiwona kumele kusetshenziswe leli thuluzi cha, futhi ngaleyo ndlela yokwamukela ihoxiswe ngokuphelele uma kungenzeka omunye wabo uqala ukuthuthukisa ngesikhathi yokwelapha:

• ukuzwela ngokweqile kunoma yiziphi izinto asebenzayo noma othile sub-ingxenye;
• embolism noma thrombosis manje noma emlandweni;
• lukahulumeni, pre-thrombosis kokubili umlando nasesikhathini samanje;
• uzwakalise nezici ezithile lezinceku noma bathenga ukuvela lwemithambo noma thrombosis emithambo yegazi, kuhlanganise futhi ukuntula antithrombin III, amaprotheni C no S ukuntula, amasosha omzimba phospholipids futhi gipergomotsistsinemiya;
• khona olwelwesini lwemithambo ephakeme noma thrombosis emithambo yegazi;
• khona migraine onezimpawu ebalulekile zezinzwa efana okwamanje, futhi umlando;
• isifo sikashukela, libhekene yezinkinga ezihlukahlukene semithambo;
• pancreatitis, hypertriglyceridemia ezinzima kokuba isikhathi esebenzayo noma umlando;
• isifo sesibindi ezinzima noma yokwehluleka kwesibindi ukutholakala;
• ama-hormone engaphansi zomdlavuza ukuboniswa noma izinsolo nesenzakalo yabo;
• izimila isibindi;
• sokukhulelwa noma izinsolo ke;
• ukopha lwesitho sangasese sowesifazane umsuka engaziwa;
• khona ukungezwani ne-lactose, klyukozo-galactose malabsorption noma lactase ukuntula.

Ngaphezu kwalokho, kuyafaneleka uma umuntu ngaphezulu okuyinto ayikwazi ukusetshenziswa zokuvimbela inzalo amaphilisi "Klayra". Uphenyo odokotela bathi akufanele kuthathwe ngesikhathi ibele.

izixwayiso ekhethekile

Uma ezifweni ezithile, izimo noma engcupheni okukhulunywe ngezansi ebonwe abantu ngesikhathi samanje, kuyodingeka kube ngokucophelela sokucabangela izingozi ezingaba khona futhi izinzuzo kokuthatha lesi izidakamizwa ngamunye icala ngabanye. Kahle kahle, lokhu kusebenza kwalezi zimo:

• engcupheni ukuthuthukiswa alandelayo thromboembolism futhi thrombosis;
• Ezinye izifo lapho kungabonwa ezahlukene neuropathy iziyaluyalu kwegazi;
• hypertriglyceridemia;
• khona lezinceku edema angioneurotic;
• izifo ezihlukahlukene, okuyinto uqala ukuvela noma saba sibi kakhulu ngesikhathi bekhulelwe noma ngesikhathi ukusetshenziswa odlule hormone ocansini.

akufanele kuthathwe "Klayra" amaphilisi kuzo zonke lezi zimo. Uphenyo odokotela kulesi simo ukusiza ulondoloze impilo.

Ukukhulelwa ibele

Ukusetshenziswa kwalesi sidakamizwa kuyaphikisana ngesikhathi sokukhulelwa. Kule nkinga, kunezimo lapho ukukhulelwa kwenzeka ngemuva kwesimiso sokwamukelwa, okubuye kukhulume ngemfundo yokulungiselela "Clayra" yokusetshenziswa. Odokotela bathi kuleli cala udinga ukumisa ngokushesha ukuqokwa okulandelayo. Kodwa-ke, lapho kuqhutshwa izifundo ezinkulu, kwakungekho ingozi eyengeziwe yokwenza noma yikuphi ukukhubazeka kokuzalwa kwabantwana ababelethwe abesifazane ababethathe i-CCP kokubili ngaphambi kokukhulelwa futhi ngokuvunyelwa ngengozi ekuqaleni kokukhulelwa.

I-CCP ngezinye izikhathi inomthelela ekutheni i-lactation, ngoba ingaphazamisa inani lobisi elikhiqizwa noma liguqule nokubunjwa kwalo, okuvame ukubhekisela ku-"Clayra" odokotela bezobuchwepheshe. Ngemuva kweminyaka engu-40 ngalesi sizathu, ukusetshenziswa kwayo akukhuthazwa ngokukhethekile.