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Ushwankathelo

I-Flibanserin (i-Addyi), ichiza elinjenge-Viagra, lavunywa liCandelo loLawulo lokutya kunye neDrug (FDA) ngo-2015 kunyango lomdla wesini sabasetyhini / ukuphazamiseka kwengqondo (FSIAD) kubafazi abangaphambi kwexesha.

I-FSIAD ikwabizwa ngokuba kukungaziphathi kakuhle ngokwesini (HSDD).

Okwangoku, iAddyi ifumaneka kuphela ngabagqirha abathile nakwiikhemesti. Imiselwe ngababoneleli abavunyiweyo kwisivumelwano phakathi komenzi kunye ne-FDA. Ummeli kufuneka aqinisekiswe ngumenzi ukuba ahlangabezane neemfuno ezithile ze-FDA.

Ithathwa kanye ngemini, ngexesha lokulala.

U-Addyi wayelichiza lokuqala le-HSDD lokufumana imvume ye-FDA. NgoJuni 2019, i-bremelanotide (Vyleesi) yaba yeyesibini. I-Addyi yipilisi yemihla ngemihla, ngelixa iVyleesi iyinaliti yokuzilawula ngokwakho esetyenziswayo njengoko kufuneka.

Addyi vs Viagra

I-FDA ayivumanga iViagra (sildenafil) ngokwayo ukuba isetyenziswe ngabafazi. Nangona kunjalo, ikhutshelwe ngaphandle kwelebheli yabasetyhini abanesondo esisezantsi.

UKUSETYENZISWA KWEELAYIBRARI KWI-OFF-LABEL

Ukusetyenziswa kweziyobisi ngaphandle kwelebheli kuthetha ukuba ichiza elivunyiweyo yi-FDA ngenjongo enye lisetyenziselwa injongo eyahlukileyo engekavunywa. Nangona kunjalo, ugqirha usenokulisebenzisa iyeza ukulungiselela loo njongo. Kungenxa yokuba i-FDA ilawula ukuvavanywa kunye nokuvunywa kwamachiza, kodwa hayi indlela abagqirha abazisebenzisa ngayo iziyobisi ukunyanga izigulana zabo. Ke, ugqirha wakho unokuyalela ichiza kodwa bacinga ukuba kokona kulungileyo ukukhathalela kwakho.


Ubungqina bokusebenza kwayo buxutywe okona kulungileyo. Uvavanyo lweViagra kwabasetyhini lubonisa ukuba iziphumo ezilungileyo ziyajongwa ngokubhekisele ekuvuseleleni ngokwasemzimbeni. Nangona kunjalo, oku akunjalo kwimeko enobunzima be-FSIAD.

Umzekelo, uphononongo oluneenkcukacha zesifundo esinike iViagra kwabafazi abayi-202 abasemva kwemini kunye ne-FSIAD ephambili.

Abaphandi baqwalasele inani elonyukayo leemvakalelo zokuvuselelwa, ukuthanjiswa kwelungu lobufazi, kunye ne-orgasm kubathathi-nxaxheba. Nangona kunjalo, abasetyhini abanengxaki yokuphazamiseka okunxulumene ne-FSIAD (enjenge-multiple sclerosis (MS) kunye neswekile) baxele ukungabikho komnqweno okanye ukonwaba.

Isifundo sesibini ekuxoxwe ngaso kuvavanyo lufumanise ukuba omabini ama-premenopausal kunye ne-postmenopausal women baxele ukuba akukho mpendulo zibalulekileyo xa besebenzisa iViagra.

Injongo nezibonelelo

Kukho izizathu ezininzi zokuba abafazi bafune ipilisi efana neViagra. Njengoko besondela kubudala obuphakathi nangaphaya, akuqhelekanga kubafazi ukuba babone ukwehla kwi-sex drive yabo ngokubanzi.

Ukwehla kwesondo kuqhuba nako kunokuvela koxinzelelo lwemihla ngemihla, iziganeko zobomi ezibalulekileyo, okanye iimeko ezingapheliyo ezifana ne-MS okanye isifo seswekile.


Nangona kunjalo, abanye abantu basetyhini bajonga ukwehla okanye ukungabikho kwidrive drive ngenxa ye-FSIAD. Ngokwelinye ipaneli yengcali kunye nokuphononongwa, i-FSIAD iqikelelwa ukuba ichaphazele malunga neepesenti ezili-10 zabasetyhini abadala.

Lubonakala ngezi mpawu zilandelayo:

  • iingcinga zesondo ezinqunyelweyo okanye ezingekhoyo okanye iingcinga
  • Ukuphungulwa okanye ukungabikho kwempendulo yomnqweno kwizenzo zesondo okanye ukuvuselela
  • Ukuphulukana nomdla okanye ukungakwazi ukugcina umdla kwimisebenzi yesondo
  • iimvakalelo ezibalulekileyo zokudideka, ukungakwazi ukusebenza, okanye ukuxhalaba ngokungabikho komdla wesondo okanye ukuvuka

Isebenza njani i-flibanserin

IFlibanserin ekuqaleni yayiphuhliswa njenge-antidepressant, kodwa yamkelwa yi-FDA yonyango lwe-FSIAD ngo-2015.

Indlela yokusebenza yayo ngokokuhambelana ne-FSIAD ayiqondakali kakuhle. Kuyaziwa ukuba ukuthatha i-flibanserin rhoqo kuphakamisa amanqanaba e-dopamine kunye ne-norepinephrine emzimbeni. Kwangelo xesha, yehlisa amanqanaba e-serotonin.

Zombini i-dopamine kunye ne-norepinephrin zibalulekile kulonwabo lwesondo. I-Dopamine inendima yokukhuthaza umnqweno wesondo. INorepinephrine inendima ekukhuthazeni inkanuko yesini.


Ukusebenza ngempumelelo

Ukuvunywa kwe-FDA kwe-flibanserin kwakusekwe kwiziphumo zolingo lwesithathu lonyango. Uvavanyo ngalunye luye lwahlala iiveki ezingama-24 kwaye lwavavanya ukusebenza kwe-flibanserin ngokuthelekiswa ne-placebo kubafazi be-premenopausal.

Abaphandi kunye ne-FDA bahlalutye iziphumo zovavanyo olo. Xa kwahlengahlengiswa impendulo ye-placebo, abathathi-nxaxheba baxela imeko "ephuculwe kakhulu" okanye "ephuculwe kakhulu" kwiiveki zokuvavanya i-8 ukuya kwi-24. Olu luphuculo oluncinci xa kuthelekiswa neViagra.

Uphengululo olupapashwe kwiminyaka emithathu emva kokuvunywa kweViagra's FDA yokunyanga ukungasebenzi kakuhle kwe-erectile (ED) ishwankathela iimpendulo zehlabathi kunyango. EUnited States, umzekelo, abathathi-nxaxheba baphendule kakuhle. Oku kuthelekiswa nempendulo ye-19 yeepesenti kwabo bathatha indawo ye-placebo.

Kwabasetyhini abase-postmenopausal

I-Flibanserin ayivunyelwanga yi-FDA ukuba isetyenziswe kubafazi abasemva kokubeleka. Nangona kunjalo, ukusebenza kwe-flibanserin kwaba bantu kuvavanywe kuvavanyo olunye.

Zixelwe ngokufanayo nezo zixelwe kubafazi ababengaphambi kokuba baye exesheni. Oku kuyakufuneka ukuba kuphindwe kwenziwe ezinye izilingo ukuze kuvunyelwe abasetyhini abasele beyekile ukuya exesheni.

Imiphumela

Iziphumo eziqhelekileyo ezichaphazelekayo ze-flibanserin zibandakanya:

  • isiyezi
  • kunzima ukulala okanye ukuhlala ulele
  • isicaphucaphu
  • umlomo owomileyo
  • ukudinwa
  • uxinzelelo lwegazi oluphantsi, ekwabizwa ngokuba yi-hypotension
  • ukuphelelwa ngamandla okanye ukulahleka kwengqondo

Izilumkiso ze-FDA: Kwisifo sesibindi, ii-enzyme inhibitors kunye notywala

  • Eli chiza linezilumkiso zebhokisi. Ezi zezona zilumkiso zinzima ezivela kuLawulo lokutya kunye noLawulo lweziyobisi (FDA). Isilumkiso esinebhokisi silumkisa oogqirha kunye nezigulana malunga neziyobisi ezinokuba yingozi.
  • IFlibanserin (iAddyi) inokubangela ukuba utyhafe okanye uxinzelelo olunzulu xa usiwe ngabantu abanesifo sesibindi okanye ecaleni kwamachiza athile, kubandakanya notywala.
  • Akufanele usebenzise i-Addyi ukuba uthatha i-CYP3A4 inhibitors ezithile ezilinganiselweyo okanye ezinamandla. Eli qela le-enzyme inhibitors libandakanya i-antibiotics ekhethiweyo, i-antifungals, kunye neyeza ze-HIV, kunye nezinye iintlobo zamachiza. Ijusi yeziqhamo zeediliya ikwayimodareyitha eyi-CYP3A4 inhibitor.
  • Ukuthintela ezi ziphumo bezingalindelekanga, kuya kufuneka uyeke ukusela utywala ubuncinci iiyure ezimbini ngaphambi kokuba uthathe idosi yakho yasebusuku yeAddyi. Emva kokuba uthathe idosi yakho, kufuneka uyeke ukusela utywala kude kube ngentsasa elandelayo. Ukuba ubusele utywala ngaphantsi kweeyure ezimbini ngaphambi kwexesha lakho lokulala, kufuneka weqe idosi yobo busuku endaweni yoko.

Izilumkiso kunye nonxibelelwano

I-Flibanserin ayifanele isetyenziswe kubantu abaneengxaki zesibindi.

Thetha nogqirha wakho malunga nawaphi amayeza kunye nezongezelelo ozithathayo ngaphambi kokuqala kwe-flibanserin. Kananjalo akufuneki uthathe i-flibanserin ukuba uthatha nawaphi na amayeza okanye izongezo:

  • amayeza athile asetyenziselwa ukunyanga iimeko zentliziyo, ezinje nge-diltiazem (iCardizem CD) kunye neverapamil (Verelan)
  • ii-antibiotics ezithile, ezinje nge-ciprofloxacin (Cipro) kunye ne-erythromycin (Ery-Tab)
  • amayeza okunyanga usulelo lokungunda, njenge-fluconazole (Diflucan) kunye ne-itraconazole (Sporanox)
  • Amayeza e-HIV, anje nge-ritonavir (Norvir) kunye ne-indinavir (Crixivan)
  • nefazodone, ichiza lokudakumba
  • izongezo ezifana neSt

Uninzi lwala machiza ludweliso lwee-enzyme inhibitors ezaziwa njenge CYP3A4 inhibitors.

Okokugqibela, akufuneki usele ijusi ye grapefruit ngelixa uthatha i-flibanserin. Ikwayi-inhibitor ye-CYP3A4.

Addyi notywala

Xa i-Addyi yayisamkelwa okokuqala yi-FDA, i-FDA yalumkisa abo basebenzisa iziyobisi ukuba bayeke utywala ngenxa yomngcipheko wokuphelelwa ngamandla kunye noxinzelelo olukhulu. Nangona kunjalo, i-FDA ngo-Epreli 2019.

Ukuba umiselwe iAddyi, akusafuneki ukuba ubuphephe ngokupheleleyo utywala. Nangona kunjalo, emva kokuba uthathe idosi yakho yasebusuku, kuya kufuneka uyeke ukusela utywala kude kube ngentsasa elandelayo.

Kuya kufuneka uyeke ukusela utywala ubuncinci iiyure ezimbini ngaphambili ukuthatha idosi yakho yasebusuku. Ukuba ubusele utywala ngaphantsi kweeyure ezimbini ngaphambi kwexesha lakho lokulala, kufuneka weqe idosi yobo busuku yeAddyi endaweni yoko.

Ukuba uphosa idosi yeAddyi nangasiphi na isizathu, sukuthatha idosi ukuyenzela intsasa elandelayo. Lindela kude kube ngorhatya olulandelayo kwaye uqalise kwakhona ishedyuli yakho yesiqhelo yedosi.

Imingeni yokwamkelwa

UFlibanserin wayenendlela ecel'umngeni kulwamkelo lwe-FDA.

I-FDA iphonononge iziyobisi kathathu ngaphambi kokuyivuma. Kwakukho iinkxalabo malunga nokusebenza kwayo xa kuthelekiswa nemiphumo emibi. Ezi zinto zixhalabisayo zezona zizathu ziphambili zokuba kutheni i-FDA icebise ngokuchasene nokuvunywa emva kovavanyo ezimbini zokuqala.

Kwakukho nemibuzo emide malunga nokuba kufuneka uphathwe njani umntu osebenza ngokwesondo. Ukuqhuba ngesondo kunzima kakhulu. Kukho zombini icandelo lomzimba kunye nengqondo.

IFlibanserin kunye nesildenafil basebenza ngeendlela ezahlukeneyo. I-Sildenafil, umzekelo, ayonyusi ukuvuswa kwesondo emadodeni. Kwelinye icala, i-flibanserin isebenza ukunyusa amanqanaba e-dopamine kunye ne-norepinephrin yokukhuthaza umnqweno kunye nokuvuselela.

Ke, ipilisi enye ijolise kwimeko yomzimba yokungasebenzi ngokwesondo. Olunye ujolise kwiimvakalelo zokuvuka kunye nomnqweno, umba onzima ngakumbi.

Ukulandela uphononongo lwesithathu, i-FDA ilivumile iyeza ngenxa yeemfuno zonyango ezingafezekiswanga. Nangona kunjalo, iinkxalabo zihlala zikhona malunga neziphumo ebezingalindelekanga. Inkxalabo ethile yi-hypotension eqatha ebonwa xa i-flibanserin ithathwa ngotywala.

Ukuthatha

Zininzi izinto ezibangela ukuqhuba ngesondo okuphantsi, ukusukela koxinzelelo lwemihla ngemihla ukuya kwi-FSIAD.

I-Viagra ibone iziphumo ezixubileyo kwabasetyhini ngokubanzi, kwaye ayifumanekanga isebenza kwabasetyhini abane-FSIAD. Abafazi be-Premenopausal abane-FSIAD banokubona ukuphucuka okucothayo kwiminqweno kunye nokuvuka emva kokuthatha iAddyi.

Thetha nogqirha wakho ukuba unomdla wokuthatha iAddyi. Qiniseka ukuba uxoxa ngamanye amayeza okanye izongezo kunye nogqirha wakho ngaphambi kokusebenzisa iAddyi.

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