Inkomba (ukusetshenziswa okugunyaziwe): Ngo-2019, i-FDA yagunyaza ukwelashwa kwesifo sesifiso socansi esitholiwe, esivamile (i-HSDD) kwabesifazane abangaphambi kokuya esikhathini lapho isimo sibangela ukucindezeleka okuphawulekayo futhi asibangelwa ezinye izimo zezokwelapha/zengqondo noma imiphumela engemihle yezidakamizwa.
Indlela Yokwenza
I-PT-141 iyi-agonist ye-melanocortin receptor (ikakhulukazi i-MC4 receptor) ehlela isifiso socansi ngokusebenzisa izindlela zesistimu yezinzwa emaphakathi.
Ngokungafani ne-PDE5 inhibitors (isb, i-sildenafil), ethinta kakhulu imithambo yegazi, i-PT-141 isebenza phakathi nendawo ukuze ithinte isisusa socansi nokuvusa inkanuko.
I-Pharmacology & Dosing
Ukuphatha: Umjovo ongaphansi kwesikhumba, njengoba kudingeka (lapho kudingeka).
Umthamo ovunyelwe: 1.75 mg sc
I-Pharmacokinetics:
I-Tmax ≈ ~ 60 imizuzu
t½ ≈ amahora angu-2-3
Imiphumela ingahlala amahora ambalwa, kweminye imibiko kufika emahoreni angu-16.
Ukusebenza Komtholampilo (Izilingo zeSigaba III - RECONNECT, amaviki angama-24, ama-RCT)
Iziphetho eziyinhloko:
Female Sexual Function Index–Desire domain (FSFI-D)
Isikali sokucindezeleka ngokocansi kwabesifazane (FSDS-DAO)
Imiphumela engukhiye (izifundo ezihlanganisiwe 301 + 302):
Ukuthuthukiswa kwe-FSFI-D: +0.35 vs placebo (P<0.001)
Ukwehliswa kwesikolo se-FSDS-DAO: −0.33 vs placebo (P<0.001)
Ezinye iziphetho: Imiphumela esekelayo (amaphuzu okusebenza kocansi, ukwaneliseka okubikwe ngesiguli) ithambekele njengenhle, kodwa izehlakalo zocansi ezanelisayo (ama-SSE) azizange zibonise njalo umehluko obalulekile.
Imicimbi Emibi (evame ukubikwa ezivivinyweni)
Okujwayelekile (≥10%):
Isicanucanu (~30–40%; kufika ku-~40% okubikwe ezivivinyweni)
Ukuhlanza (≥10%)
Ikhanda elibuhlungu (≥10%)
Imiphumela yenhliziyo nemithambo yegazi:
Ukwenyuka kwesikhashana komfutho wegazi kanye nezinguquko ekushayeni kwenhliziyo kwabonwa, ngokuvamile kuxazululeka emahoreni ambalwa.
I-contraindicated noma isetshenziswe ngokuqapha ezigulini ezinomfutho wegazi ophakeme ongalawuleki noma isifo senhliziyo.
Isibindi: Imibiko engavamile yokuphakama kwe-enzyme yesibindi yesikhashana; Imibiko yezigameko ezingavamile kakhulu iphakamisa ukulimala kwesibindi okungaba khona, kodwa akuvamile.
Ukuphepha Kwesikhathi Eside (Ucwaningo Lwesandiso)
Ucwaningo lwamaviki angu-52 olunwetshiwe lwelebula evulekile luthole ukuthuthuka okuqhubekayo esifisweni esingenazo izimpawu ezintsha zokuphepha.
Iphrofayili yokuphepha yesikhathi eside ibhekwa njengebekezelelwa kahle ngokuvamile, nezinkinga eziyinhloko zokubekezelelana kuseyimiphumela emibi yesikhashana esifushane njengesicanucanu.
Amanothi Okusetshenziswa Abalulekile
Isibalo sabantu abagunyaziwe sinomkhawulo: Kwabesifazane abangaphambi kokuya esikhathini kuphela abane-HSDD etholiwe, eyejwayelekile.
Akuvunyelwe kabanzi kumadoda (i-ED noma isifiso esiphansi emadodeni sihlala siphenywa).
Ukuhlolwa kokuphepha kubalulekile: Umfutho wegazi ophakeme, isifo senhliziyo nemithambo yegazi, kanye nomlando wesibindi kufanele uhlolwe ngaphambi kokunikezwa kwencwadi.
Isifinyezo Sedatha Esheshayo
Imvume ye-FDA: 2019 (Vyleesi).
Umthamo: 1.75 mg umjovo ongaphansi kwesikhumba, lapho kudingeka.
PK: Tmax ~ 60 min; t½ 2–3 h; imiphumela kufika ku-~16 h.
Ukusebenza kahle (Isigaba III, sihlanganisiwe):
I-FSFI-D: +0.35 (P<.001)
I-FSDS-DAO: −0.33 (P<.001)
Izehlakalo ezimbi:
Isicanucanu: kufika ku-~40%
Ukushisa: ≥10%
Ikhanda elibuhlungu: ≥10%
Ukwenyuka kwe-BP edlulayo kuyaphawulwa.
Ithebula lokuqhathanisa negrafu (Isifinyezo)
| Uhlobo lokufunda / lwedatha | Iphoyinti lokugcina / Isilinganiso | Inani / Incazelo |
|---|---|---|
| Isigaba III (301+302 sihlanganisiwe) | I-FSFI-D (isizinda sesifiso) | +0.35 vs i-placebo (P<0.001); I-FSDS-DAO −0.33 |
| Izehlakalo Ezingezinhle | Isicanucanu, ukushaywa umoya, ikhanda elibuhlungu | Isicanucanu ~30–40% (ubukhulu ~40%); ukushisa ≥10%; ikhanda elibuhlungu ≥10% |
Isikhathi sokuthumela: Sep-30-2025