IMifepristone: Indisebenza Ngayo, Ukusetshenziswa Kwayo, Ukuphepha & Imiphumela Eceleni

IMifepristone yimithi kadokotela eliye lafunyaniswa kakhulu kunayo yonke eminye imithi ezindabeni zempilo yokuzala, futhi isetshenziswe ngabantu abangaphezu kwezigidi ezingu-5 e-U.S. kusukela ivunyelwa yi-FDA ngonyaka ka-2000. Ukusetshenziswa kwayo okuvame kakhulu ukuqeda ukukhulelwa ngaphambi kwamaviki angu-10 (kanye nenye imithi), kodwa futhi isetshenziselwa ukwelapha ukukhipha isisu, i-Cushing syndrome, nezinye izifo ezihlobene namahomoni (off-label).

Lapha sihlinzeka ngokubuka konke ukuthi i-mifepristone isebenza kanjani, isetshenziselwa ini, inqubo egunyazwe yi-FDA, imiphumela engaba khona yecala kanye nomlando wayo wokuphepha iminyaka engaphezu kwengu-20. Lolu lwazi luvela kumalambuli e-FDA, ucwaningo olushicilelwe kanye neziqondiso zokuzijwayeza ezivela kuHlelo Lwezempilo Lomhlaba (WHO) kanye ne-American College of Obstetricians and Gynecologists. Akufanele isetshenziswe njengesikhundla seluleko lodokotela wakho.

Yini i-mifepristone?

IMifepristone yimithi kadokotela eyimisa ibhodi lokuvimbela ihomoni ye-progesterone, ebalulekile ekukhulelweni. Le mithi yadalwa eFrance ngeminyaka yama-1980 ngegama lekhodi elithi RU-486 (isabizwa ngale ndlela kwezinye izincwadi zezokwelapha ezindala). I-U.S. Food and Drug Administration (FDA) yayivumela ngonyaka ka-2000 ukuqeda ukukhulelwa kufika ezinsukwini ezingu-49, kodwa i-FDA yavumela umuthi izinsuku ezingu-70 ngonyaka ka-2016 ngemuva kokuba kutholwe idatha eyengeziwe yokuphepha nokusebenza kahle.

Ifakwe ohlwini lwe-World Health Organization's Model List of Essential Medicines, olubala imithi ebaluleke kakhulu ohlelweni lwezempilo oluyisisekelo. Inikezwa kuphela ngabahlinzeki abanamalayisensi e-U.S. futhi kusukela ngo-2023 inganikezwa ezitolo zemithi ezingezona ezikhethekile nezamakhaya kanye nemitholampilo.

Isebenza kanjani i-mifepristone?

IMifepristone iphazamisa izindlela ze-progesterone, ngakho-ke i-progesterone ayikwazi ukusebenza ukuze igcine ukukhulelwa kuhlale noma igcine umbungu womlomo wesibeletho. Lokhu kubangela ukuthi umbungu uze uwe, nokukhulelwa kuhlale kudabuke odongeni lwesibeletho. Ngokungezwa kwe-misoprostol emva kwamahora angu-24-48, isibeletho siyancipha futhi ukukhulelwa kuxoshwe.

IMifepristone ivela eqenjini lemidlalo eyaziwa ngokuthi ama-antiprogestins noma ama-progesterone receptor modulators. Lo muthi unamandla kuno-progesterone ekuhlanganiseni izindlela ze-progesterone kodwa awuzisebenzisi, ngakho-ke ziyayeka ukuthumela izimpawu. Lokhu kuyisisekelo sokuthi i-mifepristone ne-misoprostol zisetshenziselwa kanjani ukukhipha isisu ngemithi nokuphatha ukulahlekelwa ukukhulelwa kwasekuqaleni, ngokusho kokuqaliswa kabusha ngo-2020 ku-New England Journal of Medicine.

Iphinde ivimbele izindlela ze-progesterone kumazinga aphezulu, futhi yilokho okwenza uhlobo oluhlukile lungavunyelwa ukwelapha i-Cushing syndrome, okwenzeka lapho umuntu enokweqisa kwe-cortisol.

Izinsizakalo ze-mifepristone

IMifepristone inenye indawo evunyelwe yi-FDA yokukhulelwa nenye ye-Cushing syndrome, kanye nezinye izindawo ezisetshenziswa kakhulu ezibuyekezwa imiphakathi enkulu yezokwelapha.

Inhlanganisela ye-mifepristone ne-misoprostol yiyona esetshenziswa kakhulu ngezizathu eziningi. Isibindi sezokwelapha se-ACOG sibonisa ukuthi uhlelo olufanayo futhi luyinto yokwelashwa kokuqala kokulahlekelwa ukukhulelwa kwasekuqaleni, lapho kusiza khona umzimba ukuthi uqede ukukhipha isisu ekhaya kunokuba udinge inqubo.

Umuthi we-mifepristone nesilinganiso sawo

Isilinganiso esijwayelekile se-mifepristone sokukhipha isisu ngemithi noma ukuphatha ukukhipha isisu umuthi owodwa we-mg angu-200 womlomo, olandelwa emva kwamahora angu-24 kuya kwangu-48 yi-misoprostol, kusho ulwazi lokunikeza lwe-FDA. Ingxenye ye-misoprostol ithathwa ekhaya, emlonyeni noma ngasese (njengoba kuyalwe udokotela).

Isikhathi nesilinganiso sohlelo kunqunywa udokotela wakho, ngokuya ngegazi lokukhulelwa, umlando wakho wezempilo kanye nesizathu sokuthi kungani imithi inikeziwe. Bayophinde banikeze izidambisi zokubuhlungu kanye nemithi yokulwa nokuhlanza (evimbela isicanucanu) okufanele ithathwe kanye nomuthi. Akufanele uthathe imithi noma ushintshe isikhathi ngaphandle kokuxhumana nodokotela wakho, ngoba isilinganiso sisekelwe kulwazi kuphela udokotela wakho akwazi ngalo ukuthi ngempela, njengegazi lakho lokukhulelwa kanye nokuqeda ukukhulelwa okungaphandle.

Umuthi we-Cushing syndrome uhlukile kakhulu (umuthi okufanele uthathwe nsuku zonke isikhathi eside) futhi unikezwa yi-endocrinologist.

Uhlelo lokusebenza lwezempilo olufana no-August AI lungasiza ukulandela izimpawu, imiphumela yecala kanye nokopha nsuku zonke ukuze kuvezwe noma yiziphi izinguquko ezingajwayelekile ukuze wazi ukuthi nini kufanele uxhumane nodokotela wakho.

Imiphumela yecala ye-mifepristone

Imiphumela yecala ye-mifepristone ejwayelekile lapho isetshenziswa ne-misoprostol ekukhulelweni ihlanganisa ukukhumula, ukuphuma kwegazi esithweni sangasese, isicanucanu, ukuhlanza, uhudo, ikhanda elibuhlungu, isiyezi, umkhuhlane, nokuqhaqhazela. Iningi liyaduma phakathi namahora angu-24 ngemuva kokuthatha i-misoprostol. Ukukhumula nokopha yindlela imithi esebenza ngayo kunokuba yisibonakaliso sezinkinga.

Ukuphuma kwegazi okudlula isinye esijwayelekile kulindelekile, futhi ukudlula kwama-clots afika osayizi kalemon kuyinto evamile ngosuku lokuqala. Ukukhumula kuvame ukuchazwa njengokubuthaka kunama-cramps ajwayelekile enyanga futhi kuza ngokukhukhululeka. Ibhodi lokushisa, imithi edambisa ubuhlungu edumele, nokuphumula kusiza abantu abaningi.

Imiphumela yecala engavamile kodwa ebucayi kakhulu idinga ukunakekelwa kwezokwelapha ngokushesha:

• Ukudabula amapadi amabili ashubile kakhulu ngehora amahora amabili alandelana

• Umkhuhlane ongaphaya kuka-100.4°F ohlala amahora angaphezu kwangu-24 ngemuva kwe-misoprostol

• Ubuhlungu besisu obubalulekile obungadambisi ngemithi edambisa ubuhlungu edumele

• Akukho ukuphuma kwegazi ngaphakathi kwamahora angu-24 ngemuva kokuthatha i-misoprostol

• Izibonakaliso zokungezwani komzimba (izimbotshana, ukuvuvukala, ubunzima bokuphefumula)

Imiphumela yecala lapho i-mifepristone isetshenziswa kumazinga aphezulu e-Cushing syndrome ihlukile futhi ihlanganisa ukukhathala, i-potassium ephansi, ubuhlungu bamalunga, umfutho wegazi ophakeme, kanye nezinguquko ekusebenzeni kwe-thyroid, yingakho kudingeka ukuqhubeka kokuqhubeka kwe-endocrinology.

Ukuvunyelwa yi-FDA kanye nomlando we-mifepristone

Ulayini wesikhathi wokuvunyelwa yi-FDA we-mifepristone uhlanganisa iminyaka engaphezu kwamashumi amabili yokubuyekezwa kokuphepha. Lo muthi wavunyelwa ngoSepthemba 2000 ngemuva kwezifundo zezokwelapha e-U.S. naseYurophu ezibandakanye abesifazane abangaphezu kuka-2,100. Ilambuli yasekuqaleni yayidinga ukunikezwa mathupha ngabahlinzeki abanamalayisensi.

Izibuyekezo ezinkulu ezintathu ziye zalandela. Ngo-2016, i-FDA yandisa isikhathi esivunyelwe kusukela ezinsukwini ezingu-49 kuye kwezingama-70 zokukhulelwa futhi yanciphisa isilinganiso esidingekayo ngokuya ngedatha ekhombisa ukusebenza okufanayo nemiphumela yecala encane. Ngo-2021, i-FDA yanquma unomphela ukususwa kwesidingo sokunikezwa mathupha phakathi kwalolu bhubhane ngemuva kokuba idatha ibonise ukuthi ukwelashwa kwe-telehealth kwakuphephile ngokulinganayo. NgoJanuwari 2023, i-FDA yavumela izitolo zemithi ezikhethekile ukuthi zinikeze imithi okokuqala ngqa.

Wonke ushintsho lwalulandela iminyaka yokubuyekezwa kwedatha yokuphepha. Kuze kube ngo-2022, uhlelo lokuqapha lwangemuva kokumaketha lwe-FDA lubhalise ukufa okungaphansi kwe-1 ezigidini ezingama-200,000 okuhlobene nokusetshenziswa kwe-mifepristone, okungaphansi kunezinga lemidlalo eminingi ethengwa ngaphandle kwekhawunta, okuhlanganisa i-aspirin ne-acetaminophen.

Ukuphepha kwe-mifepristone: okukhombisa ucwaningo

Ukuphepha kwe-mifepristone kuye kwayafunyiswa ezifundweni ezinkulu eziningi kanye nasezibuyekezweni zangemva kokumaketha. Izinkinga ezibucayi, ezichazwa njengokuboshwa esibhedlela, ukudluliswa kwegazi, noma ukutheleleka okukhulu, zenzeka ezingaphansi kwe-1 kwabangu-300 abantu abathatha uhlelo lokukhulelwa kwasekuqaleni, ngokusho kokuqaliswa kabusha ngo-2022 ku-Obstetrics & Gynecology okuhlanganisa izigidi zabantu abangaphezu kuka-30,000.

Amaqembu ambalwa akufanele athathe i-mifepristone, noma kufanele ayisebenzise kuphela ngokuqhubeka ngokuqapha okungeziwe:

• Abantu abaqinisekisiwe noma abasolwa ngokukhulelwa okungaphandle komlomo (umuthi awuphathi ukukhulelwa okungaphandle komlomo futhi ungakufihla)

• Abantu abahlushwa ukuphazamiseka kwezinso okungapheli

• Abantu abathatha imishanguzo ye-corticosteroid yesikhathi eside

• Abantu abanezinkinga ezithile zokopha noma abasebenzisa ama-anticoagulants

• Abantu abane-IUD efakiwe (i-IUD kufanele isuswe kuqala)

• Abantu abaziwa ukuthi abathandi i-mifepristone noma i-misoprostol

I-WHO's 2022 abortion care guideline ichaza ukukhipha isisu ngemithi nge-mifepristone ne-misoprostol njengokuphephile kunezinqubo eziningi ezivamile zase-outpatient, okuhlanganisa ukukhipha izinyo elihlakaniphile kanye ne-tonsillectomy.

Nini ukubiza umhlinzeki wakho noma ukuya e-ER

Iningi labantu abathatha i-mifepristone baqedela inqubo ngokuphepha ngaphandle kokuxhumana kwezokwelapha ngaphezu kokulandelela abahlelelekile. Ezinye izimpawu zidinga ukunakwa ngokushesha.

Shayela umhlinzeki wakho kungakapheli amahora angu-24 uma une:

• Akukho ukuphuma kwegazi ngaphakathi kwamahora angu-24 ngemuva kokuthatha i-misoprostol

• Ukuphuma kwegazi okungaphansi kwesinye esijwayelekile (kungasho ukuthi ukukhulelwa kwaqhubeka)

• Umkhuhlane ongaphaya kuka-100.4°F ohlala amahora angaphezu kwangu-24 ngemuva kwe-misoprostol

• Ukuphuma kwesitho sangasese okunuka kabi

• Ukuphuma kwegazi okukhulu okuhlala amahora angaphezu kwangu-2 esikhathini esiphezulu

Hambela i-ER noma shayela u-911 ku:

• Ukudabula amapadi amabili noma ngaphezulu ashubile ngehora amahora amabili

• Ubuhlungu besisu obubalulekile obungadambisi ngemithi edambisa ubuhlungu edumele

• Ukuquleka noma isiyezi esibucayi

• Izibonakaliso zokungezwani komzimba (izimbotshana, ukuvuvukala, ubunzima bokuphefumula)

• Ukuphuma kwegazi okukhulu nobuhlungu obuphezulu bomhlane (isibonakaliso esingenzeka sokukhulelwa okungaphandle komlomo)

Kwezimpawu ezingezwakala zingajwayelekile kodwa zingeyona izimo eziphuthumayo, August AI ikuvumela ukuthi uchaze lokho okuzwayo ngolimi olulula futhi ikusize unqume ukuthi ulindele, ubize umhlinzeki wakho, noma uye e-ER. Igcina ingxoxo ukuze ukwazi ukuyihlanganyela nodokotela wakho kamuva.

Imibuzo Evame Ukubuzwa

Ngabe i-mifepristone iyafana ne-morning-after pill?

Cha. IMifepristone iphelisa ukukhulelwa kwangaphambi kwesikhathi, ngenkathi ukulawulwa kokukhulelwa okuphuthumayo (i-Plan B, i-ella) kuvimbela ukukhulelwa ukuba kuqale ngemuva kobulili obungavikelwanga. Lezi zisebenza ngezindlela ezihlukene futhi zisetshenziswa ngezikhathi ezihlukene. IMifepristone idinga umuthi kadokotela ovela kumhlinzeki onesitifiketi. Ukulawulwa kokukhulelwa okuphuthumayo kuyatholakala ngaphandle kwekhawunta noma ngomuthi kadokotela kuye ngohlobo.

Ngabe i-mifepristone ithinta ukuzala esikhathini esizayo?

Cha. Amashumi eminyaka ocwaningo abonisa ukuthi i-mifepristone ayithinti ukuzala esikhathini esizayo, imiphumela yokukhulelwa yesikhathi esizayo, noma ingozi yokukhishwa isisu ekukhulelweni kwesikhathi esizayo. Ukukhulelwa kungabuya kusebenze ngemuva kwezinsuku ezingu-8 kuphela ngemuva kokuthatha imithi. Uma ungathanda ukukhulelwa futhi ngokushesha, khuluma nomhlinzeki wakho ngezinketho zokulawula ukukhulelwa, ezingaqala nsuku zonke ngosuku lokuqala.

Kuchitheke isikhathi esingakanani i-mifepristone emzimbeni?

IMifepristone inesikhathi esingama-half-life samahora angu-18, okusho ukuthi umzimba ukhipha cishe ingxenye yomthamo njalo ngehora angu-18. Iningi lemithi liphelile emzimbeni wakho phakathi kwezinsuku ezingu-3 kuya kwezingu-5. Umphumela wezokwelapha (ukuqeda i-progesterone) uhlala isikhathi eside ngoba umuthi uhlanganisa kakhulu izindlela. Imiphumela yecala ivame ukuduma phakathi kwamahora angu-24.

Ngabe i-mifepristone ingachithwa uma ngiyithatha?

Ayikho indlela ethembekile ekhona. Amanye amatholampilo akhuthaza uhlelo "lokuchithwa" kusetshenziswa i-progesterone enkulu, kodwa i-American College of Obstetricians and Gynecologists ithi lokhu akusekelwa isayensi futhi isifundo sango-2020 esasizihlolwa naso siyeke ngaphambi kwesikhathi ngenxa yezinkinga zokuphepha. Uma ungabaza ngokuthatha i-mifepristone, khuluma nomhlinzeki wakho ngaphambi komthamo wokuqala.

Ngabe i-mifepristone ejeneriki iyafana nohlobo olukhiqiziwe?

Yebo. IMifepristone ejeneriki, eyavunywa yi-FDA ngonyaka ka-2019 futhi eyathengiswa yiGenBioPro, iyefana nohlobo lweMifeprex olukhiqiziwe. Zombili zinezingxenye ezifanayo ezisebenzayo kumthamo ofanayo futhi zihlangabezana namazinga afanayo e-FDA wokuba nekhwalithi nokusebenza kahle. Ejeneriki ivame ukubiza kancane. Udokotela wakho noma ikhemisi lichitha uhlobo olutholayo.

Okubalulekile Okubalulekile

IMifepristone yimithi kadokotela ekuvimbelayo i-progesterone, esetshenziswa kakhulu ne-misoprostol ukuze kuqedwe ukukhulelwa kwasekuqaleni noma ukuphatha ukukhipha isisu. Ivunyelwe yi-FDA kusukela ngo-2000, isetshenziswe ngabantu abangaphezu kwezigidi ezingu-5 e-U.S., futhi isohlwini lwezempilo lwe-WHO. Uhlelo olujwayelekile lunomthamo owodwa we-mg angu-200 olandelwa yi-misoprostol amahora angu-24 kuya kwangu-48 kamuva, unikezwe umhlinzeki onesitifiketi.

Imiphumela yecala ejwayelekile (ukukhumula, ukuphuma kwegazi, isicanucanu, ikhanda elibuhlungu) ivame ukuduma phakathi kosuku. Izinkinga ezibucayi zenzeka ezingaphansi kwe-1 ezigidini ezingama-300, okuyenza iphephe kunezinye izinqubo eziningi zase-outpatient. Ukuphuma kwegazi okukhulu okudabula amapadi amabili ngehora amahora amabili, umkhuhlane ongadluli amahora angu-24, noma ubuhlungu obubalulekile kudinga ukunakwa ngokushesha. Ukuzala esikhathini esizayo akuthintwa, futhi i-mifepristone ejeneriki isebenza ngendlela efanayo neyohlobo olukhiqiziwe. Umthetho wesifundazwe uthinta ukutholakala, ngakho-ke izindawo zokuhlola ziqinisekisa izinketho lapho uhlala khona.