• Je něco špatně v tomto záznamu ?

Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial

AL. Major, V. Dvořák, J. Schwarzová, A. Skřivánek, T. Malík, M. Pluta, I. Mayboroda, EM. Grandjean

. 2021 ; 303 (2) : 501-511. [pub] 20201120

Jazyk angličtina Země Německo

Typ dokumentu časopisecké články, randomizované kontrolované studie, práce podpořená grantem

Perzistentní odkaz   https://www.medvik.cz/link/bmc21011516

PURPOSE: The effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated. METHODS: 216 women aged 25-60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3 months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16/Ki-67 test. At 6 months a further cytology and p16/Ki-67 test was performed. RESULTS: Regression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6 months the cytological regression in the treatment group and the highly significant effect on p16/Ki-67 was still present. CONCLUSION: SAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer. TRIAL REGISTRATION NUMBER: ISRCTN11009040, date of registration: 10/12/2019; https://doi.org/10.1186/ISRCTN11009040 ; retrospectively registered.

Citace poskytuje Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc21011516
003      
CZ-PrNML
005      
20240828142610.0
007      
ta
008      
210420s2021 gw f 000 0|eng||
009      
AR
024    7_
$a 10.1007/s00404-020-05816-8 $2 doi
035    __
$a (PubMed)33219482
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a gw
100    1_
$a Major, Attila Louis $u Femina Gynecology Center, Rue Emile-Yung 1, 1205, Geneva, Switzerland. majorattila@outlook.fr $u Department of Obstetrics and Gynecology, Cantonal Hospital, University of Fribourg, Fribourg, Switzerland. majorattila@outlook.fr
245    10
$a Efficacy and safety of an adsorbent and anti-oxidative vaginal gel on CIN1 and 2, on high-risk HPV, and on p16/Ki-67: a randomized controlled trial / $c AL. Major, V. Dvořák, J. Schwarzová, A. Skřivánek, T. Malík, M. Pluta, I. Mayboroda, EM. Grandjean
520    9_
$a PURPOSE: The effect of SAM vaginal gel, a medical device containing adsorptive silicon dioxide and antioxidative sodium selenite and citric acid, on histologically-proven cervical intraepithelial neoplasia type 2 (CIN2) as well as p16 positive CIN1, and on the presence of the onco-marker p16 was investigated. METHODS: 216 women aged 25-60 years were randomized to either receive an intravaginal daily dose of SAM gel for three 28-day periods, or be followed-up without intervention. The primary endpoint was efficacy, defined as a combined histological and cytological regression. At baseline and after 3 months participants had: a guided biopsy including p16 immunohistochemical (IHC) staining, only if a lesion was visible at colposcopy; a cervical smear for cytology, high-risk human papillomavirus (hr-HPV) and a p16/Ki-67 test. At 6 months a further cytology and p16/Ki-67 test was performed. RESULTS: Regression of CIN lesions was observed in 78 out of 108 patients (72.2%) in the SAM gel arm and in 27 out of 108 patients (25.0%) in the control arm. Similarly, the change in the p16/Ki-67 cytological test status was significantly in favor of the treatment arm. The prevalence of hr-HPV decreased significantly (p < 0.001) in the treatment arm, from 87.0% to 39.8%, while it slightly increased in the control arm, from 78.7% to 83.3%. At 6 months the cytological regression in the treatment group and the highly significant effect on p16/Ki-67 was still present. CONCLUSION: SAM vaginal gel enhances the regression of cervical lesions and clears hr-HPV and p16/Ki-67 in smears significantly, thus offering an active non-destructive management to prevent cervical cancer. TRIAL REGISTRATION NUMBER: ISRCTN11009040, date of registration: 10/12/2019; https://doi.org/10.1186/ISRCTN11009040 ; retrospectively registered.
650    _2
$a aplikace intravaginální $7 D000282
650    _2
$a dospělí $7 D000328
650    _2
$a antioxidancia $x aplikace a dávkování $7 D000975
650    _2
$a nádorové biomarkery $x analýza $7 D014408
650    _2
$a dysplazie děložního hrdla $x patologie $x terapie $7 D002578
650    _2
$a kyselina citronová $x aplikace a dávkování $7 D019343
650    _2
$a kolposkopie $7 D003127
650    _2
$a inhibitor p16 cyklin-dependentní kinasy $x účinky léků $7 D019941
650    _2
$a cytodiagnostika $7 D003581
650    _2
$a ženské pohlaví $7 D005260
650    _2
$a geny p16 $7 D019942
650    _2
$a lidé $7 D006801
650    _2
$a antigen Ki-67 $x účinky léků $7 D019394
650    _2
$a lidé středního věku $7 D008875
650    _2
$a infekce papilomavirem $x terapie $x virologie $7 D030361
650    _2
$a těhotenství $7 D011247
650    _2
$a oxid křemičitý $x aplikace a dávkování $7 D012822
650    _2
$a seleničitan sodný $x aplikace a dávkování $7 D018038
650    _2
$a výsledek terapie $7 D016896
650    _2
$a nádory děložního čípku $x prevence a kontrola $7 D002583
650    12
$a vaginální krémy, pěny a želé $7 D014622
650    _2
$a vaginální stěr $7 D014626
655    _2
$a časopisecké články $7 D016428
655    _2
$a randomizované kontrolované studie $7 D016449
655    _2
$a práce podpořená grantem $7 D013485
700    1_
$a Dvořák, Vladimír, $d 1961- $7 xx0062700 $u Centrum ambulantní Gynekologie a primární péče, s.r.o., Brno, Czech Republic
700    1_
$a Schwarzová, Jana $u Smetanova 388, 252 64 Velké Prilepy, Prague-West, Czech Republic
700    1_
$a Skřivánek, Aleš $u G-CENTRUM Olomouc, s.r.o., Olomouc, Czech Republic
700    1_
$a Malík, Tomáš $u Gyneko spol. s.r.o., Vsetin, Czech Republic
700    1_
$a Pluta, Marek $u Fakultní Nemocnice v Motole (University Hospital Motol), Onkogynekologická a kolposkopická Ambulance, Praha, Czech Republic
700    1_
$a Mayboroda, Ivanna $u Department of Obstetrics and Gynecology, University Hospital of Geneva, Geneva, Switzerland
700    1_
$a Grandjean, Etienne Marc $u Phidalsa Pharma-Consultants, Petit-Lancy/Geneva, Switzerland $u Camara-Partners, Consultant, Nyon, Switzerland
773    0_
$w MED00009249 $t Archives of gynecology and obstetrics $x 1432-0711 $g Roč. 303, č. 2 (2021), s. 501-511
856    41
$u https://pubmed.ncbi.nlm.nih.gov/33219482 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y p $z 0
990    __
$a 20210420 $b ABA008
991    __
$a 20240828142605 $b ABA008
999    __
$a ok $b bmc $g 1650021 $s 1131895
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2021 $b 303 $c 2 $d 501-511 $e 20201120 $i 1432-0711 $m Archives of gynecology and obstetrics $n Arch Gynecol Obstet $x MED00009249
LZP    __
$a Pubmed-20210420

Najít záznam

Citační ukazatele

Možnosti archivace