I-Vulva-vaginal atrophy (VVA) ingenye yemiphumela evamile yokuntuleka kwe-estrogen, ikakhulukazi ngemva kokunqamuka kokuya esikhathini.Ucwaningo oluningana luhlole imiphumela ye-hyaluronic acid (HA) ezimpawini ezingokomzimba nezocansi ezihlobene ne-VVA futhi zithole imiphumela ethembisayo.Kodwa-ke, iningi lalezi zifundo zigxile ekuhloleni okuzimele kwempendulo yezimpawu ekwakhiweni kwezihloko.Noma kunjalo, i-HA iyi-molecule engapheli, futhi kunengqondo ukuthi isebenza kangcono uma ijovwe ku-epithelium engaphezulu.I-Desirial® iyi-acid yokuqala ye-hyaluronic exhunywe ngokuphambana esetshenziswa ngomjovo we-mucosal ye-vaginal.Inhloso yalolu cwaningo bekuwukuphenya umthelela wemijovo eminingi ye-intravaginal intramucosal ye-hyaluronic acid ethize exhumene nesiphambano (DESIRIAL®, Laboratoires VIVACY) emiphumeleni eminingana ebalulekile yomtholampilo kanye nebikwe isiguli.
Iqoqo lokuhlola lokuhlola izikhungo ezimbili.Imiphumela ekhethiwe yayihlanganisa izinguquko ekugqitheni kwe-vaginal mucosal, ama-biomarker okwakhiwa kwe-collagen, i-flora yangasese, i-pH yesitho sangasese sowesifazane, inkomba yempilo ye-vaginal, izimpawu ze-vulvovaginal atrophy kanye nomsebenzi wocansi emavikini angu-8 ngemva komjovo we-Desirial®.Umbono ophelele wesiguli wokwenza ngcono (PGI-I) isikali siphinde sasetshenziswa ukuhlola ukwaneliseka kwesiguli.
Isamba sabahlanganyeli abangama-20 baqashwa kusukela ngomhlaka-19/06/2017 kuya ku-05/07/2018.Ekupheleni kocwaningo, awubanga khona mehluko ekujimeni kwe-mucosa ye-vaginal isiyonke emaphakathi noma i-procollagen I, III, noma i-Ki67 fluorescence.Nokho, ukusho kofuzo okuthi COL1A1 kanye ne-COL3A1 kunyuke kakhulu ngokwezibalo (p = 0.0002 kanye ne-p = 0.0010, ngokulandelana).I-dyspareunia ebikiwe, ukoma kwesitho sangasese sowesifazane, ukulunywa kwesitho sangasese sowesifazane, kanye nemihuzuko yesitho sangasese sowesifazane nakho kwehliswe kakhulu, futhi zonke izilinganiso zenkomba yokusebenza kocansi kwabesifazane zathuthukiswa kakhulu.Ngokusekelwe ku-PGI-I, iziguli ze-19 (95%) zibike amazinga ahlukene okuthuthukiswa, lapho i-4 (20%) yazizwa ingcono kancane;Abangu-7 (35%) babengcono, futhi abangu-8 (40%) babengcono.
I-Multi-point intravaginal injection ye-Desirial® (i-HA exhunywe esiphambanweni) yayihlotshaniswa kakhulu nokuvezwa kwe-CoL1A1 ne-CoL3A1, okubonisa ukuthi ukwakheka kwe-collagen kwakhuthazwa.Ukwengeza, izimpawu ze-VVA zancishiswa kakhulu, futhi ukwaneliseka kwesiguli kanye nezibalo zomsebenzi wocansi kwathuthukiswa kakhulu.Kodwa-ke, ukushuba okuphelele kwe-mucosa yangasese akuzange kushintshe kakhulu.
I-Vulva-vaginal atrophy (VVA) ingenye yemiphumela evamile yokuntuleka kwe-estrogen, ikakhulukazi ngemva kokuya esikhathini [1,2,3,4].Ama-syndromes amaningi emitholampilo ahlotshaniswa ne-VVA, okuhlanganisa ukoma, ukucasuka, ukulunywa, i-dyspareunia, kanye nezifo eziphindaphindayo zomgudu womchamo, ezingaba nomthelela omubi kakhulu izinga lokuphila labesifazane [5].Nokho, ukuqala kwalezi zimpawu kungase kube okucashile futhi kancane kancane, futhi kuqale ukubonakala ngemva kokudamba kwezinye izimpawu zokunqamuka kokuya esikhathini.Ngokwemibiko, kufika ku-55%, 41%, kanye ne-15% yabesifazane be-postmenopausal bahlushwa ukomisa kwesitho sangasese sowesifazane, i-dyspareunia, kanye nezifo eziphindaphindiwe zomchamo, ngokulandelana [6,7,8,9].Noma kunjalo, abanye abantu bakholelwa ukuthi ukusabalala kwangempela kwalezi zinkinga kuphezulu, kodwa iningi labesifazane alifuni usizo lwezokwelapha ngenxa yezimpawu [6].
Okuqukethwe okuyinhloko kokuphathwa kwe-VVA ukwelashwa okunezimpawu, okuhlanganisa izinguquko zendlela yokuphila, okungezona amahomoni (njengamafutha okugcoba esithweni sangasese sangasese noma izinto zokuthambisa kanye nokwelashwa nge-laser) nezinhlelo zokwelapha amahomoni.Izithambisi zangasese zisetshenziselwa kakhulu ukukhulula ukomisa kwesitho sangasese sowesifazane ngesikhathi sokuya ocansini, ngakho-ke azikwazi ukuhlinzeka ngesixazululo esisebenzayo sokuhlala isikhathi eside nokuba yinkimbinkimbi kwezimpawu ze-VVA.Ngokuphambene nalokho, kubikwa ukuthi i-moisturizer ye-vaginal iwuhlobo lomkhiqizo "we-bioadhesive" ongakhuthaza ukugcinwa kwamanzi, futhi ukusetshenziswa njalo kungathuthukisa ukucasuka kwe-vaginal kanye ne-dyspareunia [10].Noma kunjalo, lokhu akuhlangene nokuthuthukiswa kwenkomba yokuvuthwa kwe-vaginal epithelial maturity [11].Eminyakeni yamuva nje, kube nezimangalo eziningi zokusebenzisa i-radiofrequency kanye ne-laser ukwelapha izimpawu zokunqamuka kokuya esikhathini [12,13,14,15].Noma kunjalo, i-FDA ikhiphe izexwayiso ezigulini, igcizelela ukuthi ukusetshenziswa kwezinqubo ezinjalo kungaholela ezenzakalweni ezimbi kakhulu, futhi ayikanqumi ukuphepha nokusebenza kwemishini esekelwe amandla ekwelapheni lezi zifo [16].Ubufakazi obuvela ekuhlaziyweni kwe-meta yezifundo eziningana ezingahleliwe zisekela ukuphumelela kwe-topical and systemic hormone therapy ekunciphiseni izimpawu ezihlobene ne-VVA [17,18,19].Kodwa-ke, inani elilinganiselwe locwaningo lihlole imiphumela eqhubekayo yokwelashwa okunjalo ngemva kwezinyanga ezingu-6 zokwelashwa.Ngaphezu kwalokho, ukungqubuzana kwabo nokukhetha komuntu siqu kuyizici ezikhawulela ukusetshenziswa okubanzi nesikhathi eside kwalezi zinketho zokwelapha.Ngakho-ke, kusenesidingo sesixazululo esiphephile nesisebenzayo sokuphatha izimpawu ezihlobene ne-VVA.
I-Hyaluronic acid (HA) iyi-molecule eyinhloko ye-matrix engaphandle kwe-extracellular, etholakala ezicutshini ezihlukahlukene kuhlanganise ne-mucosa yangasese.I-polysaccharide evela emndenini we-glycosaminoglycan, edlala indima ebalulekile ekugcineni ibhalansi yamanzi nokulawula ukuvuvukala, ukuphendula kwamasosha omzimba, ukwakheka kwezibazi kanye ne-angiogenesis [20, 21].Amalungiselelo e-HA ye-synthetic anikezwa ngendlela yama-gel we-topical futhi anesimo "semishini yezokwelapha".Ucwaningo oluningana luye lwahlola umthelela we-HA ezimpawu zomzimba nezocansi ezihlobene ne-VVA futhi zithole imiphumela ethembisayo [22,23,24,25].Kodwa-ke, iningi lalezi zifundo zigxile ekuhloleni okuzimele kwempendulo yezimpawu ekwakhiweni kwezihloko.Noma kunjalo, i-HA iyi-molecule engapheli, futhi kunengqondo ukuthi isebenza kangcono uma ijovwe ku-epithelium engaphezulu.I-Desirial® iyi-acid yokuqala ye-hyaluronic exhunywe ngokuphambana esetshenziswa ngomjovo we-mucosal ye-vaginal.
Inhloso yalolu cwaningo lokuhlola oluzoba lwezindawo ezimbili ukuhlola umthelela wemijovo ye-intravaginal intramucosal enamaphuzu amaningi e-hyaluronic acid (DESIRIAL®, Laboratoires VIVACY) emiphumeleni eyinhloko yemibiko eminingana yomtholampilo neyesiguli, kanye nokuhlola. ukuba nokwenzeka kokuhlolwa kokuhlola Ubulili le miphumela.Imiphumela ebanzi ekhethelwe lolu cwaningo ihlanganisa izinguquko ekujikeni komucosa wesitho sangasese sowesifazane, izimpawu zezinto eziphilayo zokuvuselelwa kwezicubu, izimbali zesitho sangasese sowesifazane, i-pH yesitho sangasese sowesifazane kanye nenkomba yempilo yesitho sangasese sowesifazane sangasese emasontweni angu-8 ngemva komjovo we-Desirial®.Silinganise imiphumela ebikwe iziguli eziningana, okuhlanganisa izinguquko ekusebenzeni kocansi kanye nezinga lokubika lezimpawu ezihlobene ne-VVA ngesikhathi esifanayo.Ekupheleni kocwaningo, isikali sesiguli sokwenza ngcono (PGI-I) sisetshenziselwe ukuhlola ukwaneliseka kwesiguli.
Isibalo socwaningo sasihlanganisa abesifazane abangemva kokuya esikhathini (abaneminyaka emi-2 kuye kweyi-10 ubudala ngemva kokunqamuka kokuya esikhathini) abathunyelwa emtholampilo wokunqamuka kokuya esikhathini abanezimpawu zokungakhululeki kwesitho sangasese sowesifazane kanye/noma i-dyspareunia yesibili yokoma kwesitho sangasese sowesifazane.Abesifazane kufanele babe ≥ iminyaka engu-18 futhi <70 ubudala futhi babe ne-BMI <35.Ababambiqhaza baphuma kwenye yamayunithi angu-2 abambe iqhaza (Centre Hospitaler Régional Universitaire, Nîmes (CHRU), France and Karis Medical Centre (KMC), Perpignan, France).Abesifazane babhekwa njengabafanelekile uma beyingxenye yohlelo lomshwalense wezempilo noma bezuza ohlelweni lomshwalense wezempilo, futhi bayazi ukuthi bangabamba iqhaza esikhathini sokulandelela esihleliwe samaviki angu-8.Abesifazane ababehlanganyela kwezinye izifundo ngaleso sikhathi babengafanelekile ukuqashwa.≥ Isigaba 2 sokuvuvukala kwesitho se-apical pelvic, ingcindezi yokungakwazi ukuzibamba komchamo, i-vaginismus, i-vulvovaginal noma i-urinary tract infection, izilonda zokopha noma ze-neoplastic ezithweni zangasese, izimila ezincike ku-hormone, ukopha esithweni sangasese se-etiology engaziwa, i-porphyria ephindaphindayo, isithuthwane esingalawuleki, i-angina pectoral conduction , i-rheumatic fever, ukuhlinzwa kwangaphambili kwe-vulvovaginal noma urogynecological, ukuphazamiseka kwe-hemostatic, kanye nokuthambekela kokwenza izibazi ze-hypertrophic kwakubhekwa njengemibandela yokungabandakanyi.Abesifazane abathatha izidakamizwa ezilwa nokuvuvukala, i-steroidal kanye ne-non-steroidal eqeda ukuvuvukala, ama-anticoagulants, ama-antidepressants amakhulu noma i-aspirin, kanye nezibulala-zinzwa zasendaweni ezixhunywe ne-HA, mannitol, betadine, lidocaine, amide noma Abesifazane abangezwani nanoma yiziphi izithasiselo kulo muthi. ithathwa njengabangalufanelekeli lolu cwaningo.
Ekuqaleni, abesifazane bacelwe ukuthi bagcwalise i-Female Sexual Function Index (FSFI) [26] futhi basebenzise i-0-10 visual analog scale (VAS) ukuze baqoqe ulwazi oluhlobene nezimpawu ze-VA (dyspareunia, ukoma kwesitho sangasese sowesifazane, imihuzuko yesitho sangasese sowesifazane, nokuluma kwezitho zangasese. ) ulwazi.Ukuhlolwa kwangaphambi kokungenelela kwakuhlanganisa ukuhlola i-pH yesitho sangasese sowesifazane, kusetshenziswa i-Bachmann Vaginal Health Index (VHI) [27] ukuze kuhlolwe umtholampilo wesitho sangasese sowesifazane, i-Pap smear yokuhlola ukumila kwesitho sangasese sowesifazane, kanye ne-vaginal mucosal biopsy.Linganisa i-pH yesitho sangasese sowesifazane eduze kwendawo yomjovo ehleliwe kanye ne-fornix yangasese.Ngezitshalo zangasese, amaphuzu we-Nugent [28, 29] ahlinzeka ngethuluzi lokulinganisa i-ecosystem yangasese, lapho amaphuzu angu-0-3, 4-6 kanye ne-7-10 amelela isitshalo esivamile, i-flora ephakathi kanye ne-vaginosis, ngokulandelana.Konke ukuhlolwa kwezitshalo zesitho sangasese sowesifazane kwenziwa kumnyango we-Bacteriology we-CHRU e-Nimes.Sebenzisa izinqubo ezijwayelekile ze-vaginal mucosal biopsy.Yenza i-punch biopsy engu-6-8 mm endaweni ehleliwe yokujova.Ngokusho kokuqina kongqimba oluyisisekelo, ungqimba oluphakathi nendawo kanye nongqimba olungaphezulu, i-mucosal biopsy yahlolwa ngokomlando.I-Biopsy iphinde isetshenziselwe ukukala i-COL1A1 ne-COL3A1 mRNA, kusetshenziswa i-RT-PCR kanye ne-procollagen I kanye ne-III immunotissue fluorescence njenge-surrogate ye-collagen expression, kanye ne-fluorescence yomaka wokwanda kwe-Ki67 njenge-surrogate yomsebenzi we-mucosal mitotic.Ukuhlolwa kwezakhi zofuzo kwenziwa ilabhorethri ye-BioAlternatives, 1bis rue des Plantes, 86160 GENCAY, France (isivumelwano siyatholakala uma usicela).
Uma amasampula ayisisekelo nezilinganiso seziqediwe, i-HA (Desirial®) exhunywe ngokuphambano ijovwa omunye wochwepheshe abaqeqeshiwe be-2 ngokuvumelana nephrothokholi evamile.I-Desirial® [NaHa (sodium hyaluronate) i-IPN-Like 19 mg/g + mannitol (antioxidant)] iyijeli e-HA ejovwayo engeyona eyesilwane, ukuze isetshenziswe kanye futhi ipakishwe kusirinji esipakishwe ngaphambili (2 × 1 ml ).Kuyidivayisi yezokwelapha ye-Class III (CE 0499), esetshenziselwa umjovo we-intramucosal kwabesifazane, esetshenziselwa i-biostimulation kanye nokubuyisela amanzi emzimbeni we-mucosal surface yendawo yangasese (Laboratoires Vivacy, 252 rue Douglas Engelbart-Archamps Technopole, 74160 Archamps, France).Cishe imijovo eyi-10, ngayinye engu-70-100 µl (0.5-1 ml isiyonke), yenziwa emigqeni evundlile engu-3-4 endaweni engunxantathu yodonga lwangemuva lwesitho sangasese sowesifazane, isisekelo sayo esisezingeni le-posterior vaginal. udonga, kanye ne-apex ku-2 cm ngaphezulu (umdwebo 1).
Ukuhlolwa kokuphela kocwaningo kuhlelelwe amaviki angu-8 ngemva kokubhalisa.Imingcele yokuhlola yabesifazane iyafana neyasekuqaleni.Ngaphezu kwalokho, iziguli nazo zidingeka ukuthi zigcwalise I-Overall Improving Impression (PGI-I) Scale Satisfaction Scale [30].
Ngenxa yokuntuleka kwedatha yangaphambilini kanye nemvelo yokuhlola yocwaningo, akunakwenzeka ukwenza isibalo esisemthethweni sangaphambili sikasayizi wesampula.Ngakho-ke, usayizi wesampula olula wenani leziguli ze-20 ukhethiwe ngokusekelwe emandleni amayunithi amabili abambe iqhaza futhi wanele ukuthola isilinganiso esinengqondo senqubo yomphumela ehlongozwayo.Ukuhlaziywa kwezibalo kwenziwa kusetshenziswa isofthiwe ye-SAS (9.4; SAS Inc., Cary NC), futhi izinga lokubaluleka labekwa ku-5%.Ukuhlolwa kwezinga elisayinwe yi-Wilcoxon kwasetshenziselwa okuguquguqukayo okuqhubekayo futhi ukuhlolwa kwe-McNemar kwasetshenziselwa okuguquguqukayo kwezigaba ukuhlola izinguquko emavikini angu-8.
Ucwaningo lugunyazwe i-Comité d'ethique du CHU Carémeau de Nimes (ID-RCB: 2016-A00124-47, ikhodi yephrothokholi: LOCAL/2016/PM-001).Bonke ababambiqhaza bocwaningo basayine ifomu lemvume ebhaliwe elisemthethweni.Ngokuvakasha oku-2 kocwaningo kanye nama-biopsies angu-2, iziguli zingathola isinxephezelo esingafika kuma-Euro angu-200.
Isamba sabahlanganyeli abangama-20 baqashwa kusukela ngomhlaka-19/06/2017 kuya ku-05/07/2018 (iziguli eziyi-8 ezivela ku-CHRU kanye neziguli eziyi-12 ezivela e-KMC).Asikho isivumelwano esephula imibandela yokufakwa kuqala/yokukhipha eceleni.Zonke izinqubo zokujova zaziphephile futhi ziphilile futhi zaqedwa phakathi nemizuzu engama-20.Izici zenani labantu kanye nesisekelo sabahlanganyeli bocwaningo zikhonjiswe kuThebula 1. Ekuqaleni, abesifazane abangu-12 kwabangu-20 (60%) basebenzise ukwelashwa kwezimpawu zabo (ama-hormone angu-6 nabangu-6 okungewona ama-hormone), kuyilapho ngeviki 8 kuphela iziguli ezi-2. (10%) basaphathwa kanje (p = 0.002).
Imiphumela yemiphumela yemiphumela yomtholampilo neyesiguli ikhonjisiwe kuThebula lesi-2 kanye neThebula lesi-3. Isiguli esisodwa senqaba i-W8 biopsy yesitho sangasese sowesifazane;esinye isiguli senqaba i-W8 biopsy yesitho sangasese sowesifazane.Ngakho-ke, abahlanganyeli be-19/20 bangathola idatha ephelele yokuhlaziywa kwe-histological kanye nofuzo.Uma kuqhathaniswa ne-D0, kwakungekho umehluko ekugqileni okuphelele kwe-median ye-mucosa yangasese ngeviki 8. Kodwa-ke, ubukhulu bengqimba ye-basal ephakathi bukhuphuke busuka ku-70.28 kuya ku-83.25 microns, kodwa lokhu kwanda kwakungabalulekile ngezibalo (p = 0.8596).Awukho umehluko wezibalo ku-fluorescence ye-procollagen I, III noma i-Ki67 ngaphambi nangemuva kokwelashwa.Noma kunjalo, isisho sofuzo esithi COL1A1 kanye ne-COL3A1 sikhuphuke kakhulu ngokwezibalo (p = 0.0002 kanye ne-p = 0.0010, ngokulandelana).Alukho ushintsho olubalulekile ngokwezibalo, kodwa lusize ukuthuthukisa ukuthambekela kwezitshalo zesitho sangasese sowesifazane ngemuva komjovo we-Desirial® (n = 11, p = 0.1250).Ngokufanayo, eduze nendawo yomjovo (n = 17) kanye ne-fornix yangasese (n = 19), inani le-pH yesitho sangasese sowesifazane nalo lithande ukwehla, kodwa lo mehluko wawungabalulekile ngokwezibalo (p = p = 0.0574 no-0.0955) (Ithebula 2) .
Bonke ababambiqhaza bocwaningo banokufinyelela emiphumeleni ebikwe isiguli.Ngokusho kwe-PGI-I, umhlanganyeli oyedwa (5%) ubike ukuthi akukho shintsho ngemva kokujova, kuyilapho iziguli ezisele ze-19 (95%) zibike amazinga ahlukene okuthuthukiswa, okuthi i-4 (20%) izizwe ingcono kancane;U-7 (35%) ungcono, u-8 (40%) ungcono.I-dyspareunia ebikiwe, ukoma kwesitho sangasese sowesifazane, ukulunywa kwesitho sangasese sowesifazane, imihuzuko yesitho sangasese sowesifazane, kanye nenani eliphelele le-FSFI kanye nesifiso sabo, ukuthambisa, ukwaneliseka, nobukhulu bobuhlungu nakho kwehliswe kakhulu (Ithebula 3).
Inkolelo-mbono esekela lolu cwaningo iwukuthi imijovo eminingi ye-Desirial® odongeni olungemuva lwesitho sangasese sowesifazane izoshubisa umcosa wesitho sangasese sowesifazane, i-pH ephansi yesitho sangasese sowesifazane, ithuthukise ukumila kwesitho sangasese sowesifazane, yenze ukwakheka kwe-collagen futhi ithuthukise izimpawu ze-VA.Sikwazile ukukhombisa ukuthi zonke iziguli zibike ukuthuthuka okuphawulekayo, okuhlanganisa i-dyspareunia, ukoma kwesitho sangasese sowesifazane, imihuzuko yesitho sangasese sowesifazane, kanye nokulunywa kwezitho zangasese.I-VHI ne-FSFI nayo ithuthukiswe kakhulu, futhi nenani labesifazane abadinga ezinye izindlela zokwelapha ukulawula izimpawu zabo liye lehla kakhulu.Ngokuhlobene, kungenzeka ukuqoqa ulwazi mayelana nayo yonke imiphumela enqunywe ekuqaleni futhi ukwazi ukunikeza ukungenelela kwabo bonke ababambiqhaza bocwaningo.Ngaphezu kwalokho, i-75% yabahlanganyeli bocwaningo ibike ukuthi izimpawu zabo ziba ngcono noma zazingcono kakhulu ekupheleni kocwaningo.
Kodwa-ke, naphezu kokwenyuka okuncane kobukhulu obujwayelekile be-basal layer, asikwazanga ukufakazela umthelela obalulekile ekugqineni okuphelele kwe-mucosa yangasese.Nakuba ucwaningo lwethu alukwazanga ukuhlola ukusebenza kahle kwe-Desirial® ekuthuthukiseni ukushuba kwe-mucosal ye-vaginal, sikholelwa ukuthi imiphumela ibalulekile ngoba ukuvezwa kwezimpawu ze-CoL1A1 kanye ne-CoL3A1 kukhuphuke kakhulu ngokwezibalo ku-W8 uma kuqhathaniswa ne-D0.Kusho ukugqugquzelwa kwe-collagen.Nokho, kunezinto ezithile okufanele zicatshangelwe ngaphambi kokucabangela ukusetshenziswa kwayo ocwaningweni oluzayo.Okokuqala, ingabe isikhathi sokulandelela samasonto angu-8 sifushane kakhulu ukufakazela ukuthuthuka kokuqina kwe-mucosal isiyonke?Uma isikhathi sokulandelela siside, izinguquko ezikhonjwe kusendlalelo sesisekelo kungenzeka zisetshenziswe kwezinye izendlalelo.Okwesibili, ingabe ubukhulu be-histological bongqimba lwe-mucosal bubonisa ukuvuselelwa kwezicubu?Ukuhlolwa kwe-histological of the vaginal mucosal ukujiya akucabangi ngempela ungqimba oluyisisekelo, oluhlanganisa izicubu ezivuselelwe ezixhumene nezicubu ezixhumene ezingaphansi.
Siyaqonda ukuthi inani elincane labahlanganyeli kanye nokushoda kosayizi wesampula osemthethweni yimikhawulo yocwaningo lwethu;noma kunjalo, zombili izici ezijwayelekile zocwaningo lokuhlola.Kungalesi sizathu sigwema ukwelula esikutholile ezimangalweni zokufaneleka komtholampilo noma ukungasebenzi.Kodwa-ke, enye yezinzuzo eziyinhloko zomsebenzi wethu ukuthi isivumela ukuthi sikhiqize idatha yemiphumela eminingana, okuzosisiza ukuba sibale usayizi wesampula osemthethweni wocwaningo lwesikhathi esizayo olunqumayo.Ukwengeza, umshayeli wendiza usivumela ukuthi sihlole isu lethu lokuqasha, izinga le-churn, ukuthi kungenzeka yini ukuqoqwa kwesampula nokuhlaziywa kwemiphumela, okuzohlinzeka ngolwazi lwanoma yimuphi omunye umsebenzi ohlobene.Okokugcina, uchungechunge lwemiphumela esiyihlolile, okuhlanganisa imiphumela yomtholampilo eyinhloso, ama-biomarker, nemiphumela embikwe isiguli ehlolwe kusetshenziswa izinyathelo eziqinisekisiwe, ingamandla amakhulu ocwaningo lwethu.
I-Desirial® iyi-acid yokuqala ye-hyaluronic exhunywe ngokuphambana esetshenziswa ngomjovo we-mucosal ye-vaginal.Ukuze ulethe umkhiqizo ngalo mzila, umkhiqizo kufanele ube noketshezi olwanele ukuze ukwazi ukujovwa kalula kusicubu esixhumene esiminyene esikhethekile kuyilapho ugcina i-hygroscopicity yawo.Lokhu kufinyelelwa ngokuthuthukisa usayizi wama-molecule ejeli kanye nezinga le-gel cross-linking ukuze kuqinisekiswe ukuhlushwa kwejeli okuphezulu ngenkathi kugcinwa i-viscosity ephansi nokunwebeka.
Ucwaningo oluningi luye lwahlola imiphumela enenzuzo ye-HA, iningi lazo elingewona ama-RCT aphansi, liqhathanisa i-HA nezinye izinhlobo zokwelapha (ikakhulukazi ama-hormone) [22,23,24,25].I-HA kulezi zifundo yayiphathwa endaweni.I-HA iyi-molecule engapheli ebonakala ngekhono layo elibaluleke kakhulu lokulungisa nokuthutha amanzi.Ngokukhula, inani le-endogenous hyaluronic acid ku-mucosa yangasese liyancipha kakhulu, futhi ukushuba kwayo kanye ne-vascularization kuyancipha, ngaleyo ndlela kunciphisa ukukhishwa kwe-plasma nokugcoba.Kulolu cwaningo, sibonise ukuthi umjovo we-Desirial® uhlotshaniswa nokuthuthukiswa okuphawulekayo kuzo zonke izimpawu ezihlobene ne-VVA.Lokhu okutholakele kuhambisana nocwaningo lwangaphambilini olwenziwe nguBerni et al.Njengengxenye yemvume yokulawula ye-Desirial® (ulwazi olungadalulwanga-olwengeziwe) (Ifayela Elingeziwe 1).Nakuba kuwukuqagela kuphela, kunengqondo ukuthi lokhu kuthuthukiswa kungokwesibili kumathuba okubuyisela ukudluliswa kwe-plasma endaweni ye-epithelial yangasese.
Ijeli ye-HA exhunywe esiphambanweni nayo ikhonjiswe ukwandisa ukuhlanganiswa kohlobo lwe-collagen I-elastin ne-elastin, ngaleyo ndlela ikhulise ukushuba kwezicubu ezizungezile [31, 32].Esifundweni sethu, asizange sibonise ukuthi i-fluorescence ye-procollagen I no-III ihluke kakhulu ngemva kokwelashwa.Noma kunjalo, ukusho kofuzo kwe-COL1A1 ne-COL3A1 kwenyuke ngokwezibalo kakhulu.Ngakho-ke, i-Desirial® ingase ibe nomphumela ovuselelayo ekwakhekeni kwe-collagen esithweni sangasese, kodwa izifundo ezinkulu ezinokulandelela isikhathi eside ziyadingeka ukuze kuqinisekiswe noma kukuphikise lokhu kungenzeka.
Lolu cwaningo luhlinzeka ngedatha yesisekelo namasayizi omthelela angaba khona emiphumeleni embalwa, okuzosiza ukubalwa kosayizi wesampula esikhathini esizayo.Ngaphezu kwalokho, ucwaningo lwafakazela ukuthi kungenzeka ukuqoqa imiphumela ehlukene.Nokho, iphinde igqamise izindaba ezimbalwa okudingeka zibhekwe ngokucophelela lapho kuhlelwa ucwaningo lwangomuso kule ndawo.Nakuba i-Desirial® ibonakala ithuthukisa kakhulu izimpawu ze-VVA nomsebenzi wocansi, indlela yayo yokusebenza ayicacile.Njengoba kungabonakala ekukhulumeni okubalulekile kwe-CoL1A1 ne-CoL3A1, kubonakala kunobufakazi bokuqala bokuthi ivuselela ukwakheka kwe-collagen.Noma kunjalo, i-procollagen 1, i-procollagen 3 ne-Ki67 ayizange izuze imiphumela efanayo.Ngakho-ke, omaka abengeziwe be-histological kanye ne-biological kufanele bahlolwe ocwaningweni oluzayo.
I-Multi-point intravaginal injection ye-Desirial® (i-HA exhunywe esiphambanweni) yayihlotshaniswa kakhulu nenkulumo ye-CoL1A1 ne-CoL3A1, ebonisa ukuthi ivuselela ukwakheka kwe-collagen, inciphisa kakhulu izimpawu ze-VVA, futhi isebenzisa ezinye izindlela zokwelapha.Ngaphezu kwalokho, ngokusekelwe kumaphuzu we-PGI-I kanye ne-FSFI, ukwaneliseka kwesiguli kanye nomsebenzi wocansi kuthuthuke kakhulu.Kodwa-ke, ukushuba okuphelele kwe-mucosa yangasese akuzange kushintshe kakhulu.
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Isikhathi sokuthumela: Oct-26-2021