Kolesnikova EV, Zharov AV, Mingaleva NV, Penzhoyan MA. Complex anti-relapse therapy of various variants of the course of the vulvar lichen sclerosus: A randomized prospective study. Gynecology. 2024;26(2):176–184.
DOI: 10.26442/20795696.2024.2.202663
Комплексная противорецидивная терапия различных вариантов течения склеротического лихена вульвы
Колесникова Е.В., Жаров А.В., Мингалева Н.В., Пенжоян М.А. Комплексная противорецидивная терапия различных вариантов течения склеротического лихена вульвы. Гинекология. 2024;26(2):176–184.
DOI: 10.26442/20795696.2024.2.202663
Kolesnikova EV, Zharov AV, Mingaleva NV, Penzhoyan MA. Complex anti-relapse therapy of various variants of the course of the vulvar lichen sclerosus: A randomized prospective study. Gynecology. 2024;26(2):176–184.
DOI: 10.26442/20795696.2024.2.202663
Цель. Разработать и оценить эффективность комплексной терапии склеротического лихена вульвы (СЛВ), учитывающей клинико-иммунологический вариант (КИВ) заболевания. Материалы и методы. В рандомизированном проспективном исследовании приняли участие 292 пациентки 20–70 лет с различными КИВ течения СЛВ: атрофическим (n=101), склерозирующим (n=154), склероатрофическим (n=37), а также 35 женщин с СЛВ из группы сравнения той же возрастной категории. На основе клинико-иммунологических и морфологических особенностей течения СЛВ разработана комплексная противорецидивная терапия, эффективность которой оценивали через год наблюдения в сравнении со стандартной терапией (СТ) пациенток (из группы сравнения) в виде анализа количества рецидивов заболевания и результатов опроса о качестве жизни (КЖ) женщин с заболеваниями вульвы (Vulvar Quality of Life Index Questionnaire – VQLI). Результаты. У больных со склерозирующим вариантом СЛВ обосновано применение топических глюкокортикоидов короткими курсами в периоды обострения заболевания, у пациенток со склероатрофическим вариантом – топических ингибиторов кальциневрина, при атрофическом варианте – белково-пептидного комплекса из лейкоцитов крови свиней, содержащего интерлейкин-1, 6, фактор некроза опухоли α, трансформирующий фактор роста, фактор, угнетающий миграцию макрофагов (в виде вагинальных суппозиториев и крема-бальзама с ланолином). Пациенткам с любым вариантом СЛВ назначено выполнять бытовые и гигиенические рекомендации, ежедневно применять эмоленты, профилактические дозы витаминов А и Е, а также витамин D для коррекции его дефицита или недостаточности, проводить по показаниям локальную ферментотерапию, направленную на профилактику или борьбу с рубцовыми изменениями. Локальные эстрогены назначали только женщинам с генитоуринарным менопаузальным синдромом в период пери- и постменопаузы. Разработанная комплексная противорецидивная терапия СЛВ показала большую клиническую эффективность относительно СТ в виде уменьшения эпизодов обострения заболевания в 3,7 раза, а также достоверного (р=0,001) снижения в 1,3 раза негативного влияния СЛВ на КЖ пациенток основной клинической группы (15,4 балла по оценке VQLI – слабое влияние на КЖ) в сравнении с СТ, где средний балл составил 27,6, что соответствовало сильному негативному влиянию заболевания на КЖ. Заключение. Полученные результаты исследования подтверждают рациональность выделения КИВ СЛВ и необходимость учета их особенностей при выборе эффективной терапии заболевания. Правильно подобранная комплексная, поддерживающая терапия СЛВ позволяет значительно повысить КЖ пациенток, свести к минимуму количество рецидивов, предотвратить развитие осложнений заболевания, в том числе, вероятно, и риск злокачественной трансформации.
Ключевые слова: патология вульвы, склеротический лихен, иммунопатогенез, глюкокортикоиды, цитокинотерапия, ингибиторы кальциневрина, качество жизни
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Aim. To develop and evaluate the effectiveness of complex therapy of vulvar lichen sclerosus (VLS), considering the clinical and immunological variant (CIV) of the disease. Materials and methods. A randomized prospective study included 292 patients 20-70 years old with different CIVs of the VLS course: atrophic (n=101), sclerosing (n=154), scleroatrophic (n=37), as well as 35 females with VLS in the comparison group of the same age category. Based on the clinical, immunological, and morphological features of the VLS course, a complex anti-relapse therapy was developed, the effectiveness of which was evaluated after a year of follow-up in comparison with the standard of care (SoC) of patients (from the comparison group) based on the number of disease relapses and the results of the Vulvar Quality of Life Index Questionnaire (VQLI) survey of women with vulvar diseases. Results. In patients with the sclerosing variant of VLS, short courses of topical glucocorticoids during exacerbations are justified; in patients with the scleroatrophic variant – topical calcineurin inhibitors, in the atrophic variant – a protein-peptide complex from porcine blood leukocytes (vaginal suppositories and cream-balsam with lanolin) containing interleukin-1, 6, tumor necrosis factor α, transforming growth factor, macrophage migration inhibitory factor. Patients with any variant of VLS are instructed to follow household and hygienic recommendations, use emollients daily, take prophylactic doses of vitamins A, E, and D to correct its deficiency or insufficiency, as well as use local enzyme therapy, as indicated, aimed at preventing or treatment of cicatricial changes. Local estrogens were prescribed only to women with genitourinary menopausal syndrome in the peri- and postmenopausal period. The developed complex anti-relapse therapy of VLS showed greater clinical efficacy compared to SoC: 3.7-fold decrease in episodes of disease exacerbation, as well as a significant (p=0.001) 1.3-fold decrease in the negative effect of VLS on the QoL of patients in the main clinical group (15.4 points according to the VQLI assessment – a mild effect on QoL) compared to SoC with the average score of 27.6, which corresponded to a strong negative effect of the disease on QoL. Conclusion. The results of the study support the distinction of VLS CIVs and the need to consider their features when choosing an effective therapy for the disease. Properly selected complex, supportive therapy of VLS can significantly increase the QoL of patients, minimize the number of relapses, and prevent the development of complications, including, probably, the risk of malignant transformation.
Keywords: vulvar diseases, lichen sclerosus, immunopathogenesis, glucocorticoids, cytokine therapy, calcineurin inhibitors, quality of life
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56. De Giorgi V, Scarfì F, Silvestri F, et al. Genital piercing: A warning for the risk of vulvar lichen sclerosus. Dermatol Ther. 2021;34(1):e14703. DOI:10.1111/dth.14703
57. Lyons ME, Goldman JJ. Vulvar-Vaginal Reconstruction. StatPearls. 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK568772. Accessed: 06.05.2023.
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55. Vishwanath T, Ghate S, Shinde G, et al. Koebnerization of Lichen Sclerosus Et Atrophicus at Insulin Injection Sites – A Rare Case with Dermoscopic Features. Indian J Dermatol. 2021;66(2):224. DOI:10.4103/ijd.IJD_634_18
56. De Giorgi V, Scarfì F, Silvestri F, et al. Genital piercing: A warning for the risk of vulvar lichen sclerosus. Dermatol Ther. 2021;34(1):e14703. DOI:10.1111/dth.14703
57. Lyons ME, Goldman JJ. Vulvar-Vaginal Reconstruction. StatPearls. 2023. Available at: https://www.ncbi.nlm.nih.gov/books/NBK568772. Accessed: 06.05.2023.