Effect of a Multi-Ingredient <i>Coriolus-versicolor</i>-Based Vaginal Gel in Women with HPV–Dependent Cervical Lesions: The Papilobs Real-Life Prospective Study
Human papillomavirus (HPV) is responsible for virtually all cervical cancers in women. HPV infection and persistency may lead to different-grade squamous intraepithelial lesions that can result in high-grade lesions and cancer. The objective was to prospectively evaluate the results of using a <i...
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| Format: | Article |
| Language: | English |
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MDPI AG
2023-07-01
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| Series: | Cancers |
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| Online Access: | https://www.mdpi.com/2072-6694/15/15/3863 |
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| author | Javier Cortés Bordoy Javier de Santiago García Marta Agenjo González Damián Dexeus Carter Gabriel Fiol Ruiz Carmen García Ferreiro Silvia P. González Rodríguez Marta Gurrea Soteras Ester Martínez Lamela Santiago Palacios Gil-Antuñano José María Romo de los Reyes María del Pilar Sanjuán Cárdenas Luis Serrano Cogollor Ana E. del Villar Vázquez |
| author_facet | Javier Cortés Bordoy Javier de Santiago García Marta Agenjo González Damián Dexeus Carter Gabriel Fiol Ruiz Carmen García Ferreiro Silvia P. González Rodríguez Marta Gurrea Soteras Ester Martínez Lamela Santiago Palacios Gil-Antuñano José María Romo de los Reyes María del Pilar Sanjuán Cárdenas Luis Serrano Cogollor Ana E. del Villar Vázquez |
| author_sort | Javier Cortés Bordoy |
| collection | DOAJ |
| description | Human papillomavirus (HPV) is responsible for virtually all cervical cancers in women. HPV infection and persistency may lead to different-grade squamous intraepithelial lesions that can result in high-grade lesions and cancer. The objective was to prospectively evaluate the results of using a <i>Coriolus-versicolor</i>-based vaginal gel (Papilocare<sup>®</sup>) on HPV-dependent low-grade cervical lesion repair in a real-life scenario. HPV-positive women ≥ 25 years with ASCUS/LSIL cervical cytology results and concordant colposcopy images were included, receiving the vaginal gel one cannula/day for 21 days (first month) + one cannula/alternate days (five months). A 6-month second treatment cycle was prescribed when needed. Repair of the cervical low-grade lesions through cytology and colposcopy, HPV clearance, and level of satisfaction, and tolerability were evaluated. In total, 192 and 201 patients accounted for the total and safety analyses, respectively, and 77.1% repaired cervical lesions at 6 or 12 months (76.0% for high-risk HPV). Additionally, 71.6% achieved HPV clearance throughout the study’s duration (70.6% for high-risk HPV). Satisfaction level was rated 7.9 and 7.5 out of 10 at 6 and 12 months, respectively. Only three mild–moderate product-related adverse events were reported, and all of them were resolved by the end of the study. In our study, we observed higher regression rates of low-grade cervical lesions in women treated with Papilocare<sup>®</sup> vaginal gel than spontaneous regression rates reported in the literature. |
| first_indexed | 2024-03-11T00:29:59Z |
| format | Article |
| id | doaj.art-0972e41f375a47f8ab16d25386c57002 |
| institution | Directory Open Access Journal |
| issn | 2072-6694 |
| language | English |
| last_indexed | 2024-03-11T00:29:59Z |
| publishDate | 2023-07-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Cancers |
| spelling | doaj.art-0972e41f375a47f8ab16d25386c570022023-11-18T22:42:25ZengMDPI AGCancers2072-66942023-07-011515386310.3390/cancers15153863Effect of a Multi-Ingredient <i>Coriolus-versicolor</i>-Based Vaginal Gel in Women with HPV–Dependent Cervical Lesions: The Papilobs Real-Life Prospective StudyJavier Cortés Bordoy0Javier de Santiago García1Marta Agenjo González2Damián Dexeus Carter3Gabriel Fiol Ruiz4Carmen García Ferreiro5Silvia P. González Rodríguez6Marta Gurrea Soteras7Ester Martínez Lamela8Santiago Palacios Gil-Antuñano9José María Romo de los Reyes10María del Pilar Sanjuán Cárdenas11Luis Serrano Cogollor12Ana E. del Villar Vázquez13Gynecologic Oncology, Private Practice (Laboratorio citología Dr. Cortés), 07004 Palma, SpainMD Anderson Cancer Center, 28033 Madrid, SpainCervical Pathology Unit, Gynaecology Department, Hospital Sanitas La Zarzuela (Madrid), 28006 Madrid, SpainClínica Ginecológica Women’s CD, 08017 Barcelona, SpainClínica Alborán CMM, 04001 Almería, SpainCentro Ginecológico de León, 24004 León, SpainHM Gabinete Velázquez, 28001 Madrid, SpainOncologic Gynecology, Lower Genital Tract Unit, Women’s Health Area, Hospital Universitari i Politécnic La Fe Valencia, 46026 Valencia, SpainLower Genital Tract & Endoscopic Gyneacology Unit, Hospital Universitario Infanta Leonor, 28031 Madrid, SpainInstituto Palacios de Salud de la Mujer, 28009 Madrid, SpainObstretrics and Gynaecology Unit, Hospital Universitario Virgen de Valme, 41014 Sevilla, SpainClínica GINEMED, 41010 Sevilla, SpainHM Gabinete Velázquez, 28001 Madrid, SpainClínica Millenium-Dent, 28005 Madrid, SpainHuman papillomavirus (HPV) is responsible for virtually all cervical cancers in women. HPV infection and persistency may lead to different-grade squamous intraepithelial lesions that can result in high-grade lesions and cancer. The objective was to prospectively evaluate the results of using a <i>Coriolus-versicolor</i>-based vaginal gel (Papilocare<sup>®</sup>) on HPV-dependent low-grade cervical lesion repair in a real-life scenario. HPV-positive women ≥ 25 years with ASCUS/LSIL cervical cytology results and concordant colposcopy images were included, receiving the vaginal gel one cannula/day for 21 days (first month) + one cannula/alternate days (five months). A 6-month second treatment cycle was prescribed when needed. Repair of the cervical low-grade lesions through cytology and colposcopy, HPV clearance, and level of satisfaction, and tolerability were evaluated. In total, 192 and 201 patients accounted for the total and safety analyses, respectively, and 77.1% repaired cervical lesions at 6 or 12 months (76.0% for high-risk HPV). Additionally, 71.6% achieved HPV clearance throughout the study’s duration (70.6% for high-risk HPV). Satisfaction level was rated 7.9 and 7.5 out of 10 at 6 and 12 months, respectively. Only three mild–moderate product-related adverse events were reported, and all of them were resolved by the end of the study. In our study, we observed higher regression rates of low-grade cervical lesions in women treated with Papilocare<sup>®</sup> vaginal gel than spontaneous regression rates reported in the literature.https://www.mdpi.com/2072-6694/15/15/3863cervical lesions<i>Coriolus versicolor</i>human papillomavirusreal lifevaginal gel |
| spellingShingle | Javier Cortés Bordoy Javier de Santiago García Marta Agenjo González Damián Dexeus Carter Gabriel Fiol Ruiz Carmen García Ferreiro Silvia P. González Rodríguez Marta Gurrea Soteras Ester Martínez Lamela Santiago Palacios Gil-Antuñano José María Romo de los Reyes María del Pilar Sanjuán Cárdenas Luis Serrano Cogollor Ana E. del Villar Vázquez Effect of a Multi-Ingredient <i>Coriolus-versicolor</i>-Based Vaginal Gel in Women with HPV–Dependent Cervical Lesions: The Papilobs Real-Life Prospective Study Cancers cervical lesions <i>Coriolus versicolor</i> human papillomavirus real life vaginal gel |
| title | Effect of a Multi-Ingredient <i>Coriolus-versicolor</i>-Based Vaginal Gel in Women with HPV–Dependent Cervical Lesions: The Papilobs Real-Life Prospective Study |
| title_full | Effect of a Multi-Ingredient <i>Coriolus-versicolor</i>-Based Vaginal Gel in Women with HPV–Dependent Cervical Lesions: The Papilobs Real-Life Prospective Study |
| title_fullStr | Effect of a Multi-Ingredient <i>Coriolus-versicolor</i>-Based Vaginal Gel in Women with HPV–Dependent Cervical Lesions: The Papilobs Real-Life Prospective Study |
| title_full_unstemmed | Effect of a Multi-Ingredient <i>Coriolus-versicolor</i>-Based Vaginal Gel in Women with HPV–Dependent Cervical Lesions: The Papilobs Real-Life Prospective Study |
| title_short | Effect of a Multi-Ingredient <i>Coriolus-versicolor</i>-Based Vaginal Gel in Women with HPV–Dependent Cervical Lesions: The Papilobs Real-Life Prospective Study |
| title_sort | effect of a multi ingredient i coriolus versicolor i based vaginal gel in women with hpv dependent cervical lesions the papilobs real life prospective study |
| topic | cervical lesions <i>Coriolus versicolor</i> human papillomavirus real life vaginal gel |
| url | https://www.mdpi.com/2072-6694/15/15/3863 |
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