I-Viagra Yabesifazane: Isebenza Kanjani, Futhi Ingabe Iphephile?

-Delile

• I-Addyi vs. Viagra
• Inhloso nezinzuzo
• Isebenza kanjani i-flibanserin
• Ukusebenza ngempumelelo
• Kwabesifazane be-postmenopausal
• Okuqhamuka uma udla imishanguzo
• Izexwayiso ze-FDA: Esifo sesibindi, ama-enzyme inhibitors, notshwala
  
• Izexwayiso nokuxhumana
• I-Addyi notshwala
• Izinselelo zokuvunywa
• Ukuthatha

Ukubuka konke

UFlibanserin (Addyi), umuthi ofana ne-Viagra, wamukelwa yi-Food and Drug Administration (FDA) ngo-2015 ekwelapheni intshisekelo yezocansi yabesifazane / ukuvuswa kwesifo (i-FSIAD) kwabesifazane be-premenopausal.

I-FSIAD yaziwa nangokuthi i-hypoactive sex desire disorder (HSDD).

Njengamanje, i-Addyi itholakala kuphela kubanikazi abathile kanye nakumakhemisi. Inqunywe ngabahlinzeki abavunyelwe ngokuvumelana phakathi komkhiqizi ne-FDA. Ummeli kumele aqinisekiswe ngumenzi ukuhlangabezana nezimfuneko ezithile ze-FDA.

Kuthathwa kanye ngosuku, ngesikhathi sokulala.

U-Addyi wayeyisidakamizwa sokuqala se-HSDD ukuthola imvume ye-FDA. NgoJuni 2019, i-bremelanotide (Vyleesi) yaba eyesibili. I-Addyi yiphilisi lansuku zonke, kuyilapho iVyleesi ingumjovo oziphathela wona osetshenziswayo njengoba kudingeka.

I-Addyi vs. Viagra

I-FDA ayivumanga i-Viagra (sildenafil) uqobo ukuthi abesifazane bayisebenzise. Kodwa-ke, kunqunyelwe ukuthi kungabikho ilebula kwabesifazane abane-low drive drive.

Ukusetshenziswa kwezidakamizwa ezingekho kwelebula kusho ukuthi umuthi ovunyelwe yi-FDA ngenhloso eyodwa usetshenziselwa injongo ehlukile engakavunyelwa. Kodwa-ke, udokotela usengasisebenzisa lesi sidakamizwa ngaleyo njongo. Lokhu kungenxa yokuthi i-FDA ilawula ukuhlolwa nokuvunywa kwezidakamizwa, kodwa hhayi ukuthi odokotela bazisebenzisa kanjani izidakamizwa ukwelapha iziguli zabo. Ngakho-ke, udokotela wakho angakunikeza umuthi kodwa bacabanga ukuthi kungcono kakhulu ukunakekelwa kwakho.

Ubufakazi bokusebenza kwayo buxutshwe kakhulu. Ukuhlolwa kwe-Viagra kwabesifazane kucabanga ukuthi imiphumela emihle iyabonakala maqondana nokuvuka komzimba. Kodwa-ke, lokhu akunjalo ngemvelo eyinkimbinkimbi ye-FSIAD.

Isibonelo, ukubuyekezwa kuchaze kabanzi ucwaningo olunikeze i-Viagra kwabesifazane abangama-202 be-postmenopausal abane-FSIAD eyinhloko.

Abaphenyi babone inani elinyukile lemizwa yokuvuka, ukuthambisa kwesitho sangasese sowesifazane, kanye ne-orgasm kubahlanganyeli bokufunda. Kodwa-ke, abesifazane abanezinkinga ezihambisana ne-FSIAD (ezifana ne-multiple sclerosis (MS) nesifo sikashukela) ababikanga ukwanda kwesifiso noma ukujabula.

Ucwaningo lwesibili okuxoxwe ngalo ekubuyekezweni luthole ukuthi bobabili abesifazane be-premenopausal kanye ne-postmenopausal ababikanga zimpendulo ezinhle lapho besebenzisa iViagra.

Inhloso nezinzuzo

Kunezizathu eziningana zokuthi abesifazane bafune iphilisi elifana ne-Viagra. Njengoba besondela eminyakeni yobudala ephakathi nangaphezulu, akuyona into engavamile ngabesifazane ukuthi babone ukwehla kokushayela kwabo ucansi jikelele.

Ukwehla kwe-sex drive nakho kungavela ekucindezelekeni kwansuku zonke, imicimbi ebalulekile yempilo, noma izimo ezingalapheki njenge-MS noma isifo sikashukela.

Kodwa-ke, abanye besifazane babona ukwehla noma ukungabikho kokushayela ucansi ngenxa ye-FSIAD. Ngokuya ngephaneli elilodwa lochwepheshe nokubuyekezwa, i-FSIAD ilinganiselwa ukuthi ingathinta cishe amaphesenti ayi-10 abesifazane abadala.

Kubonakala ngalezi zimpawu ezilandelayo:

• imicabango noma amaphupho alinganiselwe noma angekho ocansini
• impendulo encishisiwe noma engekho yesifiso sezinkomba zocansi noma ukugqugquzela
• ukulahlekelwa yintshisekelo noma ukungakwazi ukugcina intshisekelo ezenzweni zocansi
• imizwa ebalulekile yokukhungatheka, ukungakwazi ukusebenza, noma ukukhathazeka ngokungabi nentshisekelo yezocansi noma ukuvuka

Isebenza kanjani i-flibanserin

IFlibanserin ekuqaleni yathuthukiswa njenge-anti-depressant, kepha yamukelwa yi-FDA yokwelashwa kwe-FSIAD ngo-2015.

Indlela yokusebenza kwayo maqondana ne-FSIAD ayiqondakali kahle. Kuyaziwa ukuthi ukuthatha i-flibanserin njalo kuphakamisa amazinga e-dopamine ne-norepinephrine emzimbeni. Ngasikhathi sinye, yehlisa amazinga e-serotonin.

Kokubili i-dopamine ne-norepinephrine kubalulekile ekuzijabuliseni ngocansi. I-Dopamine ineqhaza ekufukuleni isifiso sobulili. INorepinephrine inendima ekukhuthazeni ukuvuswa kocansi.

Ukusebenza ngempumelelo

Ukuvunyelwa kwe-FDA kwe-flibanserin kwakususelwa kwimiphumela yokuhlolwa kwemitholampilo yesigaba sesithathu. Isivivinyo ngasinye sithathe amasonto angama-24 futhi sahlola ukusebenza kwe-flibanserin ngokuqhathaniswa ne-placebo kwabesifazane be-premenopausal.

Abaphenyi kanye ne-FDA bahlaziya imiphumela yezilingo ezintathu. Lapho kulungiswa impendulo ye-placebo, ababambiqhaza babika isimo “esithuthukiswe kakhulu” noma “esithuthukiswe kakhulu” emavikini esivivinyo 8 kuya ku-24. Lokhu kungukuthuthuka okuncane uma kuqhathaniswa ne-Viagra.

Ukubuyekezwa okushicilelwe eminyakeni emithathu ngemuva kokuvunyelwa kwe-Viagra's FDA yokwelapha ukungasebenzi kahle kwe-erectile (ED) kufingqa izimpendulo zomhlaba wonke ekwelashweni. E-United States, isibonelo, ababambiqhaza basabela kahle. Lokhu kuqhathaniswa nempendulo enhle ngamaphesenti ayi-19 kulabo abathatha i-placebo.

Kwabesifazane be-postmenopausal

I-Flibanserin ayivunyelwe i-FDA ukuthi isetshenziswe kwabesifazane be-postmenopausal. Kodwa-ke, ukusebenza kwe-flibanserin kulesi sibalo kuhlolwe esivivinyweni esisodwa.

Lezi zibikwe ziyefana nalabo ababikwe kwabesifazane abangakayi esikhathini. Lokhu kuzodinga ukuphindwaphindwa ekuhlolweni okwengeziwe ukuze kuvunyelwe abesifazane besikhathi sokuya esikhathini.

Okuqhamuka uma udla imishanguzo

Imiphumela emibi kakhulu ye-flibanserin ifaka:

• isiyezi
• ubunzima bokulala noma ukulala
• isicanucanu
• umlomo owomile
• ukukhathala
• umfutho wegazi ophansi, owaziwa nangokuthi i-hypotension
• ukuquleka noma ukulahlekelwa ukwazi

Izexwayiso ze-FDA: Esifo sesibindi, ama-enzyme inhibitors, notshwala

• Lo muthi unezixwayiso zesibhakela. Lezi izexwayiso ezibucayi kakhulu ezivela ku-Food and Drug Administration (FDA). Isexwayiso sebhokisi sazisa odokotela neziguli ngemiphumela yezidakamizwa engaba yingozi.
• I-Flibanserin (i-Addyi) ingadala ukuquleka noma i-hypotension enamandla uma ithathwa ngabantu abanesifo sesibindi noma eceleni kwezidakamizwa ezithile, kufaka phakathi notshwala.
• Akufanele usebenzise i-Addyi uma uthatha ama-inhibitor athile alinganiselayo noma aqinile we-CYP3A4. Leli qembu lama-enzyme inhibitors lifaka ama-antibiotic akhethiwe, ama-antifungal, nemithi ye-HIV, kanye nezinye izinhlobo zemithi. Ijusi lamagilebhisi libuye libe i-inhibitor elinganiselayo ye-CYP3A4.
• Ukuvimbela le miphumela engemihle, kufanele futhi uyeke ukuphuza utshwala okungenani amahora amabili ngaphambi kokuthatha isilinganiso sakho sasebusuku se-Addyi. Ngemuva kokuthatha umthamo wakho, kufanele uyeke ukuphuza utshwala kuze kube ngakusasa ekuseni. Uma uphuze utshwala ngaphansi kwamahora amabili ngaphambi kwesikhathi sakho sokulala esilindelwe, kufanele weqe umthamo walobo busuku esikhundleni salokho.

Izexwayiso nokuxhumana

I-Flibanserin akufanele isetshenziswe kubantu abanezinkinga zesibindi.

Khuluma nodokotela wakho mayelana nokuthi imiphi imithi nezengezo ozithathayo ngaphambi kokuqala i-flibanserin. Akufanele futhi uthathe i-flibanserin uma uthatha noma imuphi umuthi noma izengezo ezilandelayo:

• imithi ethile esetshenziselwa ukwelapha izimo zenhliziyo, njenge-diltiazem (iCardizem CD) ne-verapamil (Verelan)
• ama-antibiotic athile, njenge-ciprofloxacin (Cipro) ne-erythromycin (i-Ery-Tab)
• imithi yokwelapha izifo ezikhunta, njenge-fluconazole (Diflucan) kanye ne-itraconazole (Sporanox)
• Imithi ye-HIV, efana ne-ritonavir (Norvir) ne-indinavir (Crixivan)
• nefazodone, i-antidepressant
• izithasiselo ezifana neSt

Eziningi zalezi zidakamizwa ziseqenjini lama-enzyme inhibitors elaziwa nge-CYP3A4 inhibitors.

Okokugcina, akufanele uphuze ijusi lamagilebhisi ngenkathi uthatha i-flibanserin. Iphinde ibe yi-CYP3A4 inhibitor.

I-Addyi notshwala

Lapho i-Addyi ivunywa okokuqala yi-FDA, i-FDA yaxwayisa labo abasebenzisa lesi sidakamizwa ukuba bayeke utshwala ngenxa yengozi yokuphelelwa amandla ne-hypotension enamandla. Kodwa-ke, i-FDA ngo-Ephreli 2019.

Uma unikezwe i-Addyi, akusadingeki ukuthi ugweme ngokuphelele utshwala. Kodwa-ke, ngemuva kokuthatha umthamo wakho wobusuku, kufanele uyeke ukuphuza utshwala kuze kube ngakusasa ekuseni.

Kufanele futhi uyeke ukuphuza utshwala okungenani amahora amabili ngaphambi ukuthatha umthamo wakho wobusuku. Uma uphuze utshwala ngaphansi kwamahora amabili ngaphambi kwesikhathi sakho sokulala esilindelwe, kufanele weqe umthamo walobo busuku we-Addyi esikhundleni salokho.

Uma uphuthelwa umthamo we-Addyi nganoma yisiphi isizathu, ungathathi umthamo ozokwenzela wona ngakusasa ekuseni. Linda kuze kube kusihlwa okulandelayo bese uqala kabusha uhlelo lwakho olujwayelekile lokulinganisa.

Izinselelo zokuvunywa

UFlibanserin wayenendlela eyinselele yokuvunyelwa yi-FDA.

I-FDA ibuyekeze umuthi kathathu ngaphambi kokukuvumela. Kube nokukhathazeka ngokusebenza kwayo uma kuqhathaniswa nemiphumela emibi emibi. Lokhu kukhathazeka bekuyizizathu eziyinhloko zokuthi kungani i-FDA income ukuphikisana nokuvunywa ngemuva kokubuyekezwa okubili kokuqala.

Kwakunemibuzo ebambezele maqondana nokuthi kufanele kuphathwe kanjani ukungasebenzi kahle ngokocansi kwabesifazane. Ukushayela ocansini kuyinkimbinkimbi impela. Kukhona kokubili ingxenye yomzimba nengokwengqondo.

I-Flibanserin ne-sildenafil isebenza ngezindlela ezihlukile. I-Sildenafil, isibonelo, ayikhulisi ukuvuswa kocansi emadodeni. Ngakolunye uhlangothi, i-flibanserin isebenza ukukhulisa amazinga e-dopamine ne-norepinephrine ukukhuthaza isifiso nokuvuka.

Ngakho-ke, iphilisi elilodwa lihlose isici somzimba sokukhubazeka ngokocansi. Okunye kuhlose imizwa yokuvuka nesifiso, inkinga eyinkimbinkimbi kakhulu.

Ngemuva kokubuyekezwa okwesithathu, i-FDA ivume lesi sidakamizwa ngenxa yezidingo zezokwelapha ezingagcwaliseki. Kodwa-ke, ukukhathazeka kusalokhu kuhlobene nemiphumela emibi. Okukhathazeka kakhulu yi-hypotension ebukhali ebonwa lapho i-flibanserin ithathwa notshwala.

Ukuthatha

Kunezimbangela eziningi zedrayivu yocansi ephansi, kusuka ezicindezelweni zansuku zonke kuye ku-FSIAD.

I-Viagra ibone imiphumela exubekile kwabesifazane ngokujwayelekile, futhi ayikatholakali isebenza kwabesifazane abane-FSIAD. Abesifazane be-Premenopausal abane-FSIAD bangabona ukuthuthuka okuncane kwesifiso nokuvuka ngemuva kokuthatha i-Addyi.

Khuluma nodokotela wakho uma unentshisekelo yokuthatha i-Addyi. Futhi qiniseka ukuthi uxoxa ngeminye imithi noma izithasiselo nodokotela wakho ngaphambi kokusebenzisa i-Addyi.