Yini iPeginesatide: Ukusetshenziswa, Umthamo, Imiphumela Eceleni Nokunye

I-Peginesatide yimithi eyenziwe ngendlela yokwelapha i-anemia kubantu abanezifo ezingamahlalakhona zezinso abasebenzisa i-dialysis. Isebenza ngokukhuthaza umnkantsha wakho ukuthi ukhiqize amaseli abomvu egazi amaningi, okufana nendlela i-hormone yakho yemvelo i-erythropoietin esebenza ngayo. Kodwa-ke, le mithi yasuswa emakethe ngo-2013 ngenxa yokukhathazeka okukhulu ngokuphepha, okuhlanganisa ukusabela okukhulu komzimba okwaholela ekulalisweni esibhedlela nasekufeni.

Yini iPeginesatide?

I-Peginesatide yayiyimithi yamaprotheni eyenziwe ngabantu eyayilingisa isenzo se-erythropoietin emzimbeni wakho. I-Erythropoietin iyi-hormone izinso zakho ezizikhiqiza ngokwemvelo ukuze zitshele umnkantsha wakho ukuthi wakhe amaseli abomvu egazi. Uma izinso zakho zilimazwe yisifo esingamahlalakhona, azikwazi ukwenza le hormone eyanele, okuholela ku-anemia.

Le mithi yayenzelwe ngqo abantu abanezifo ezingamahlalakhona zezinso ababethola ukwelashwa nge-dialysis. Yayinikezwa njengesijovo kanye ngenyanga, okwakulula kunezinye izidakamizwa ezifanayo ezazidinga ukulinganiswa kaningi. Ngeshwa, i-peginesatide ayisatholakali ukuthi isetshenziswe ngenxa yezinkinga zokuphepha ezaqhamuka ngemva kokugunyazwa kwayo.

Yayisetshenziselwani iPeginesatide?

I-Peginesatide yayisetshenziselwa ukwelapha i-anemia kubantu abadala abanezifo ezingamahlalakhona zezinso ababesebenzisa i-dialysis. I-Anemia yenzeka uma ungenayo amaseli abomvu egazi anempilo eyanele yokuthwala umoya-mpilo emzimbeni wakho wonke, okukushiya uzizwa ukhathele, ubuthakathaka, futhi uphelelwa umoya.

Abantu abanezifo zezinso bavame ukuthuthukisa i-anemia ngoba izinso zabo ezilimele azikwazi ukukhiqiza i-erythropoietin eyanele. Lokhu kudala umjikelezo lapho umzimba wakho ulwela ukwenza amaseli abomvu egazi awadingayo. I-Peginesatide yayenzelwe ukungenelela futhi inikeze lowo mqondo olahlekile emnkantshini wakho.

Umuthi wawuvunyelwe kuphela iziguli ezithola ukwelashwa kwe-dialysis. Awuzange uhloselwe abantu abanezifo ezinzima zezinso noma labo abangakaqali ukwelashwa nge-dialysis. Udokotela wakho wayezobe ecabangele le nketho uma ezinye izindlela zokwelapha zazingasebenzi kahle ngokwanele ukuphatha izimpawu zakho ze-anemia.

Isebenza kanjani i-Peginesatide?

I-Peginesatide yayisebenza ngokubopha kuma-receptors afanayo emnkantshubeni wakho wamathambo aphendula i-erythropoietin yemvelo. Cabanga ngayo njengokusebenzisa ukhiye olungena kulokhiye ofanayo i-hormone yakho yemvelo engawusebenzisa. Uma isinamathele, yaqala umnkantshubeni wakho wamathambo ukuthi uqale ukukhiqiza amaseli amaningi abomvu egazi.

Umuthi wawubhekwa njengenketho yokwelapha eqinile ngoba wawungakwazi ukukhuphula kakhulu ukukhiqizwa kwamaseli abomvu egazi. Kodwa-ke, leli qiniso lalisho ukuthi lidinga ukuqashwa ngokucophelela ukuvimbela amazinga akho amaseli abomvu egazi ukuthi angakhuphuki ngokushesha kakhulu noma aphezulu kakhulu, okungadala izinkinga eziyingozi.

Umzimba wakho ngokuvamile wawuzoqala ukuphendula i-peginesatide phakathi namasonto ambalwa, nakuba kungathatha izinyanga ezintathu ukubona umphumela ogcwele. Umuthi wawuhlala usebenza ohlelweni lwakho cishe inyanga, yingakho kwakudingeka unikezwe kanye ngenyanga.

I-Peginesatide bekufanele ithathwe kanjani?

I-Peginesatide yayinikezwa njengomjovo emthanjeni (ngokungena emthanjeni) noma ngaphansi kwesikhumba (ngaphansi kwesikhumba) kanye ngenyanga. Umhlinzeki wakho wezempilo wayezobe enikeza lo muthi ngesikhathi seseshini yakho ye-dialysis noma esikhungweni sezokwelapha. Kwakungeyona into ongayithatha ekhaya wedwa.

Umjovo awuzange udinge noma yikuphi ukulungiswa okukhethekile mayelana nokudla noma isiphuzo. Ungadla ngokujwayelekile ngaphambi nangemva kokuthola umuthi. Udokotela wakho wayezobe enquma umthamo ofanele ngokuya ngesisindo sakho, amazinga akho wamanje amaseli abomvu egazi, nokuthi uphendula kahle kangakanani ekwelashweni.

Ngaphambi komjovo ngamunye, ithimba lakho lezempilo belizobe lihlole umfutho wegazi lakho futhi libuke imiphumela yakho yamuva yaselebhu. Futhi bebeyokubuka ngokucophelela nganoma yiziphi izimpawu zokungezwani komzimba, ikakhulukazi ngesikhathi semithamo yakho yokuqala lapho ukusabela kwakungenzeka kakhulu.

Kufanele ngabe i-Peginesatide yayithathwa isikhathi esingakanani?

Ubude bokwelashwa nge-peginesatide ngabe buhlukile kuye ngokuthi umzimba wakho usabela kanjani futhi ukubekezelela kanjani umuthi. Abantu abaningi ngabe baqhubeka nokwelashwa uma nje i-anemia yabo iqhubeka futhi umuthi usiza ngaphandle kokubangela imiphumela emibi ebalulekile.

Udokotela wakho ngabe uqaphele amazinga akho amangqamuzana abomvu egazi ngokucophelela, ngokuvamile ewahlole njalo emavikini ambalwa ekuqaleni, bese kuthi njalo ngenyanga uma amazinga akho esezinzile. Uma i-anemia yakho yathuthuka kakhulu noma uma uhlangabezane nemiphumela emibi ekhathazayo, udokotela wakho ngabe walungisa umthamo noma wacabangela ukushintshela ekwelashweni okuhlukile.

Njengoba i-peginesatide yasuswa emakethe, noma ubani owayeyithatha ngabe washintshela ekwelashweni okuhlukile kwe-anemia. Ithimba lakho lezempilo ngabe lasebenza nawe ukuthola ukwelashwa okungcono kakhulu esikhundleni sesimo sakho esithile.

Zaziyini imiphumela emibi ye-Peginesatide?

I-Peginesatide yayinezinhlangothi eziningana ezingaba khona, kusukela kokulula kuya kokusongela impilo. Okukhathaza kakhulu kwaba ukungezwani komzimba okukhulu, okwaholela ekususweni komuthi emakethe. Lokhu kusabela kungaba ngokushesha futhi kuyingozi, kudinga ukwelashwa okuphuthumayo kwezokwelapha.

Imiphumela emibi ejwayelekile abantu abayithola yayihlanganisa:

• Ukuqina kwemisipha nobuhlungu
• Ubuhlungu emhlane
• Ukukhwehlela
• Umfutho wegazi ophezulu
• Ukuqunjelwa
• Isicanucanu
• Ukuvuvukala ezingalweni noma emilenzeni

Le miphumela emibi yansuku zonke yayivame ukulawuleka futhi ivame ukuthuthuka njengoba umzimba wakho uzivumela emuthini. Kodwa-ke, kwakusadingeka ukuthi kubikwe ethimbeni lakho lezempilo.

Imiphumela emibi kakhulu eyaholela ekuhoxisweni kwe-peginesatide kwakuyizimpawu zokungezwani komzimba ezibizwa ngokuthi i-anaphylaxis. Lezi zimpawu zingabangela ubunzima bokuphefumula, ukwehla okukhulu kwengcindezi yegazi, ukuvuvukala kobuso nomphimbo, futhi kungabulala uma kungelashwa ngokushesha. Abanye abantu babenezinkinga ezinzima zenhliziyo nemithambo yegazi, okuhlanganisa ukuhlaselwa yinhliziyo nokushaywa unhlangothi.

Amaqhubu egazi kwakuyinye into ekhathazayo, ikakhulukazi ezindaweni zokufinyelela ezisetshenziselwa i-dialysis. Umuthi futhi wawungabangela ukuthi amazinga akho amaseli abomvu egazi anyuke ngokushesha kakhulu, okuholela engcindezi yegazi ephezulu ngokuyingozi nezinye izinkinga.

Obani okungafanele basebenzise i-Peginesatide?

Amaqembu amaningana abantu akufanele ngabe asebenzise i-peginesatide, ngisho nalapho yayitholakala. Noma ubani onokungezwani komzimba okwaziwayo ne-peginesatide noma yiziphi izingxenye zayo ngabe wagwema lo muthi ngokuphelele. Abantu abanengcindezi yegazi ephezulu engalawuleki nabo babengabona abaqokiwe abahle bokwelashwa.

Abesifazane abakhulelwe nabancelisayo babelulekwa ukuthi bangasebenzisi i-peginesatide ngenxa yokunganele kwedatha yokuphepha. Imiphumela yomuthi ezinganeni ezisakhulayo yayingaqondwa ngokugcwele, okwenza kube yingozi kakhulu ukusetshenziswa ngesikhathi sokukhulelwa noma ngenkathi bencelisa.

Abantu abanezinhlobo ezithile zomdlavuza, ikakhulukazi labo abathinta igazi noma umnkantsha wamathambo, akufanele ngabe basebenzise i-peginesatide. Umuthi wawungakhuthaza ukukhula kwamaseli omdlavuza ezimweni ezinjalo. Ngaphezu kwalokho, noma ubani onomlando wokungezwani komzimba okukhulu emithini efanayo ngabe esengozini enkulu.

Labo abanezifo ezithathelwanayo eziqhubekayo noma izimo zokuvuvukala kungenzeka badinga ukulinda kuze kube yilapho lezi zinkinga zixazululwe ngaphambi kokuqala ukwelashwa. Impendulo yomzimba wakho yokuzivikela ku-peginesatide ingaba engalindelekile lapho ubhekene nezinye izinselelo zempilo ngasikhathi sinye.

Igama lomkhiqizo le-Peginesatide

I-Peginesatide yayithengiswa ngaphansi kwegama lomkhiqizo elithi Omontys e-United States. Leli kwakuyigama lomkhiqizo elilodwa kuphela lapho umuthi wawuthengiswa ngaphambi kokuthi ususwe emakethe ngo-2013.

Lo muthi wathuthukiswa yi-Affymax futhi wathengiswa ngokubambisana ne-Takeda Pharmaceuticals. Wathola imvume ye-FDA ngoMashi 2012 kodwa wabuyiselwa ngokuzithandela ngabakhiqizi ngoFebhuwari 2013 ngenxa yokukhathazeka okukhulu ngokuphepha.

Ezinye izindlela zokwelapha i-Peginesatide

Ezinye izindlela zokwelapha i-peginesatide ziyatholakala zokwelapha i-anemia kubantu abanezifo ezingamahlalakhona zezinso. Le mithi isebenza ngendlela efanayo ngokukhuthaza ukukhiqizwa kwamaseli abomvu egazi, kodwa inezici zokuphepha ezihlukene kanye nezimiso zokulinganisa.

Ezinye izindlela zokwelapha ezisetshenziswa kakhulu zihlanganisa:

• I-Epoetin alfa (Epogen, Procrit) - inikezwa izikhathi eziyi-1-3 ngesonto
• I-Darbepoetin alfa (Aranesp) - inikezwa masonto onke noma ngemva kwamasonto amabili
• I-Methoxy polyethylene glycol-epoetin beta (Mircera) - inikezwa njalo ngenyanga

Le mithi isetshenziswe isikhathi eside kune-peginesatide futhi inezirekhodi zokuphepha ezisunguliwe. Udokotela wakho uzokhetha inketho engcono kakhulu ngokusekelwe ezidingweni zakho ezithile, ukuthi uvame kangakanani ukuza ngemijovo, nokuthi uyikwazi kangakanani ukubekezelela umuthi ngamunye.

Izithasiselo zensimbi zivame ukusetshenziswa kanye nale mithi ukuqinisekisa ukuthi umzimba wakho unensimbi eyanele yokwenza amaseli abomvu egazi anempilo. Abanye abantu bangase futhi bazuze ekumpontshweni kwegazi ezimweni ezithile, nakuba lokhu kuvame ukugcinwa ezimweni ezinzima.

Ingabe i-Peginesatide yayingcono kune-Epoetin alfa?

I-Peginesatide ne-epoetin alfa zombili zisebenza kahle ekwelapheni i-anemia kubantu abanezifo ezingamahlalakhona zezinso, kodwa zazinenzuzo kanye nobubi obuhlukene. Inzuzo enkulu ye-Peginesatide kwakuwuhlelo lwayo lokulinganisa kanye ngenyanga, uma kuqhathaniswa nesidingo se-epoetin alfa sokuthola imijovo eyi-1-3 ngesonto.

Ngokuqondene nokusebenza, ucwaningo lwabonisa ukuthi i-peginesatide yakwazi ukugcina amazinga e-hemoglobin kahle njenge-epoetin alfa. Yomibili le mithi yayingaphatha ngempumelelo i-anemia futhi inciphise isidingo sokumpontshelwa igazi ezigulini eziningi.

Kodwa-ke, iphrofayili yokuphepha ye-peginesatide yabonakala imbi kakhulu kune-epoetin alfa. Ukusabela okukhulu komzimba okwaholela ekuhoxisweni kwe-peginesatide kwakungabonakali kakhulu nge-epoetin alfa, esetshenziswe ngokuphepha iminyaka eminingi. Lokhu kwenza i-epoetin alfa ibe yindlela engcono iyonke, naphezu kokudinga imijovo evame kakhulu.

Namuhla, i-epoetin alfa isahlala iyindlela yokwelapha ejwayelekile enerekhodi elihle lokuphepha. Ngenkathi ukulula kokulinganisa kwanyanga zonke kwakukhanga, izingozi ezinkulu ezihambisana ne-peginesatide ekugcineni zayenza ingafaneleki ukuqhubeka nokusetshenziswa.

Imibuzo evame ukubuzwa nge-Peginesatide

Q1. Ingabe i-Peginesatide iphephile kubantu abanesifo sikashukela?

Ngesikhathi i-peginesatide itholakala, abantu abanesifo sikashukela ababenezifo ezingamahlalakhona zezinso babengase bakwazi ukusebenzisa lo muthi, kodwa kwakudingeka ukuqapha okwengeziwe. Isifo sikashukela sivame ukubangela isifo sezinso, futhi abantu abaningi abanezimo zombili bathuthukisa i-anemia edinga ukwelashwa.

Kodwa-ke, abantu abanesifo sikashukela bavame ukuba nengozi enkulu yezinkinga zenhliziyo nemithambo yegazi, ezingase zibe zimbi kakhulu yimiphumela emibi ye-peginesatide. Ukuthambekela komuthi lokhu ukunyusa umfutho wegazi nokwandisa ingozi yokuqina kwegazi kwakwenza kube ngokuqondile okukhathazayo ezigulini ezinomdlavuza. Udokotela wakho wayezolinganisisa lezi zingozi ngokucophelela ngaphambi kokunika umuntu onesifo sikashukela i-peginesatide.

Q2. Kufanele ngenzeni uma ngisebenzisa i-Peginesatide eningi ngengozi?

Ukweqisa kwe-peginesatide bekuyoba isimo esiphuthumayo sezokwelapha esidinga ukunakekelwa ngokushesha esibhedlela. Ukusebenzisa lo muthi omningi kakhulu kungabangela amazinga akho amaseli abomvu egazi ukuthi anyuke ngendlela eyingozi, okuholela kumfutho wegazi ophezulu kakhulu, amahlule egazi, izinkinga zenhliziyo, nesifo sohlangothi.

Njengoba i-peginesatide yayinikezwa kuphela abahlinzeki bezempilo ezindaweni zezokwelapha, ukweqisa ngengozi bekuyoba yinto engavamile. Kodwa-ke, uma kwenzeka ukweqisa, ukwelashwa bekuzogxila ekuphatheni izinkinga, njengokulawula umfutho wegazi nokuvimbela ukujiya kwegazi. Kwakungekho umuthi oqondile wokweqisa i-peginesatide.

Q3. Kufanele ngenzeni uma ngiphuthelwa umthamo we-Peginesatide?

Uma uphuthelwe umjovo we-peginesatide ohleliwe, bekuzodingeka ukuthi uthinte umhlinzeki wakho wezempilo ngokushesha ukuze uhlele kabusha. Ukuphuthelwa imithamo kungabangela ukuthi i-anemia yakho ibe yimbi, okuholela ekukhathaleni, ubuthakathaka, nezinye izimpawu zibuye.

Udokotela wakho ubeyonquma isikhathi esingcono kakhulu somthamo wakho wokwenza ngokuya ngokuthi uphuthelwe nini umjovo kanye namazinga akho amanje amaseli abomvu egazi. Bangase balungise imithamo yakho embalwa elandelayo ukuze ubuyele emkhondweni ohleliwe wokwelashwa kwakho. Kwakubalulekile ukungazami ukwenza imithamo ephuthelwe wedwa.

Q4. Ngingayeka nini ukuthatha i-Peginesatide?

Isinqumo sokuyeka i-peginesatide besizokwenziwa udokotela wakho ngokusekelwe ezintweni eziningana. Uma ukusebenza kwezinso zakho kuthuthuka kakhulu, umzimba wakho ungase uqale ukukhiqiza i-erythropoietin yemvelo eyanele futhi, okwenza umuthi ungadingeki.

Ubuzoyeka futhi ukuthatha i-peginesatide uma uhlangabezana nemiphumela emibi engathi sína noma ukusabela komzimba. Ezimweni eziningi, nokho, abantu abanesifo sezinso esingamahlalakhona abakwi-dialysis bebeyodingeka baqhubeke nohlobo oluthile lokwelashwa kwe-anemia isikhathi eside. Lapho i-peginesatide ikhishwa, iziguli zashintshwa zaya emithini ehlukile kunokuyeka ukwelashwa kwe-anemia ngokuphelele.

Q5. Kungani i-Peginesatide yakhishwa emakethe?

I-Peginesatide yasuswa emakethe ngoFebhuwari 2013 ngenxa yemibiko yokusabela okubi kakhulu nokwesathekisa ngamanye amathuba. Ngemuva kokuthi imithi igunyazwe futhi isetshenziswe kabanzi, abahlinzeki bezempilo baqala ukubika amacala e-anaphylaxis enzima eyadinga ukwelashwa okuphuthumayo.

I-FDA kanye nabakhiqizi banquma ukuthi ingozi yokusabela okusongela impilo yayiphezulu kakhulu ukuthi kuqhubeke ukuthengisa imithi. Isinqumo senziwa sokubuyisa ngamabomu yonke imikhiqizo ye-peginesatide futhi kuyekwe ukuyisebenzisa. Iziguli ezazithatha i-peginesatide zashintshwa zaya ekwelashweni okunye okuphephe kakhulu kwe-anemia yazo.