medsovetМедицинский СоветMeditsinskiy sovet = Medical Council2079-701X2658-5790REMEDIUM GROUP Ltd.10.21518/2079-701X-2014-17-140-143medsovet-790Research ArticleДИССЕРТАНТDISSERTANTКонсервативная терапия CIN I-II вагинальными суппозиториями цервикон-дим (промежуточные результаты клинического исследования)Conservative therapy with CIN I-II vaginal suppositories Cervicon-Dim (intermediate results of a clinical study)КиселевВ. И.KiselyovV. I.noemail@neicon.ruДрухВ. М.DrukhV. M.noemail@neicon.ruКузнецовИ. Н.KuznetsovI. N.noemail@neicon.ruМуйжнекЕ. Л.MuyahnekE. L.noemail@neicon.ruАполихинаИ. А.ApolikhinaI. A.noemail@neicon.ruГорбуноваЕ. А.GorbunovaE. A.noemail@neicon.ruПчелинцеваО. И.PchelintsevaO. I.noemail@neicon.ruРоссийский университет дружбы народов, МоскваРоссияPeople's Friendship University of Russia, MoscowRussian FederationМосковский государственный медико-стоматологический университет им. А.И. ЕвдокимоваРоссияMoscow State University of Medicine and Dentistry named after A.I. EvdokimovRussian FederationЗАО «МираксБиоФарма», Московская обл.РоссияMiraksBioFarma CJSC, Moscow regionRussian FederationНаучный центр акушерства, гинекологии и перинатологии им. академика В.И. Кулакова, МоскваРоссияScientific center for obstetrics, gynecology and perinatology named after V.I. Kulakov, MoscowRussian FederationНаучный центр акушерства, гинекологии и перинатологии им. академика В.И. Кулакова, МоскваРоссияScientific center for obstetrics, gynecology and perinatology named after V.I. Kulakov, MoscowRussian Federation201430122014017140143Copyright © Киселев В.И., Друх В.М., Кузнецов И.Н., Муйжнек Е.Л., Аполихина И.А., Горбунова Е.А., Пчелинцева О.И., 20142014Киселев В.И., Друх В.М., Кузнецов И.Н., Муйжнек Е.Л., Аполихина И.А., Горбунова Е.А., Пчелинцева О.И.Kiselyov V.I., Drukh V.M., Kuznetsov I.N., Muyahnek E.L., Apolikhina I.A., Gorbunova E.A., Pchelintseva O.I.Данная работа распространяется под лицензией Creative Commons Attribution 4.0.This work is licensed under a Creative Commons Attribution 4.0 License.https://www.med-sovet.pro/jour/article/view/790

CIN наиболее распространена у женщин репродуктивного возраста. Существующие стандарты лечения CIN I и/или CIN II инвазивны и агрессивны, что порой приводит к нарушению репродуктивной функции. В то же время длительное динамическое наблюдение и тактика невмешательства могут повлечь за собой дальнейшее прогрессирование процесса. Поэтому поиск консервативного метода лечения CIN I--II остается актуальным. Проведенное нами многоцентровое рандомизированное плацебо-контролируемое двойное слепое исследование в параллельных группах показало, что применение вагинальных суппозиториев Цервикон-ДИМ в течение 90 дней в дозе как 200 мг/сут, так и 100 мг/сут сопровождается улучшением гистологической картины течения CIN I-II и даже ее излеченностью.

CIN is most common in women of reproductive age. The current treatment standards for CIN I and/or CIN II are invasive and aggressive, which sometimes leads to a disruption of reproductive function. At the same time, long-term follow-up and non-intervention can result in further progression of the process. Therefore the search for conservative treatment of CIN I-II remains a challenging task. We conducted a multicenter, randomized, placebo-controlled, double-blind, parallel group study which showed that administration of Cervicon-DIM vaginal suppositories for 90 days at a dose of 200 mg/day or 100 mg/day is associated with improved histological condition of CIN I-II and even leads to cure.

цервикальная интраэпителиальная неоплазияCIN ICIN IIВПЧдииндолилметанДИМЦервикон-ДИМклиническое исследованиеcervical intraepithelial neoplasiaHPVDiindolylmethaneDIMCervicon-DIMclinical studyReferencesДмитриева Г.А., Биткина О.А. Папилломавирусная инфекция. М.: Медицинская книга, 2006: 76.Дмитриева Г.А., Биткина О.А. Папилломавирусная инфекция. М.: Медицинская книга, 2006: 76.Маянский А.Н. Патогенетическая микробиология: Руководство. Н. Новгород: Изд-во Нижегородской государственной медицинской академии, 2006: 520.Маянский А.Н. Патогенетическая микробиология: Руководство. Н. Новгород: Изд-во Нижегородской государственной медицинской академии, 2006: 520.Апгар Б.С., Броцман Г.Л., Шпицер М. Клиническая кольпоскопия. М.: Практическая медицина, 2012: 496.Апгар Б.С., Броцман Г.Л., Шпицер М. Клиническая кольпоскопия. М.: Практическая медицина, 2012: 496.Маянский А.Н. Папилломавирусы человека: Возбудители доброкачественных и злокачественных неоплазий. Вопросы диагностики в педиатрии, 2010, 2 (2): 5-11.Маянский А.Н. Папилломавирусы человека: Возбудители доброкачественных и злокачественных неоплазий. Вопросы диагностики в педиатрии, 2010, 2 (2): 5-11.Schneider J et al. Abnormal oxidative metabolism of estradiol in women with breast cancer. Proc Natl acad Sci USA, 1982, 79 (9): 3047-51.Schneider J et al. Abnormal oxidative metabolism of estradiol in women with breast cancer. Proc Natl acad Sci USA, 1982, 79 (9): 3047-51.Chung SH, Wiedmeyer K, Shai A et al. Requirement for estrogen receptor a in a mouse model for human papillomavirus-associated cervical cancer. Cancer Res., 2008, 68 (23): 9928-9934.Chung SH, Wiedmeyer K, Shai A et al. Requirement for estrogen receptor a in a mouse model for human papillomavirus-associated cervical cancer. Cancer Res., 2008, 68 (23): 9928-9934.Morimoto Y et al. Urinary estrogen metabolites during a randomized soy trial. Nutr Cancer, 2012, 64 (2): 307-14.Morimoto Y et al. Urinary estrogen metabolites during a randomized soy trial. Nutr Cancer, 2012, 64 (2): 307-14.Киселев В.И. Вирусы папилломы человека в развитии рака шейки матки. М.: ДГГ, 2004: 184.Киселев В.И. Вирусы папилломы человека в развитии рака шейки матки. М.: ДГГ, 2004: 184.Banerjee S. Attenuation of multi-targeted proliferation-linked signaling by 3,3'-diindolylmethane (DIM): from bench to clinic. Banerjee S, Kong D, Wang Z. Mutat Res, 2011, 728: 47-66.Banerjee S. Attenuation of multi-targeted proliferation-linked signaling by 3,3'-diindolylmethane (DIM): from bench to clinic. Banerjee S, Kong D, Wang Z. Mutat Res, 2011, 728: 47-66.Zhu J, Li Y, Guan C, Chen Z. Anti-proliferative and pro-apoptotic effects of 3,3'-diindolylmethane in human cervical cancer cells. Oncol Rep, 2012, 28 (3): 1063-8.Zhu J, Li Y, Guan C, Chen Z. Anti-proliferative and pro-apoptotic effects of 3,3'-diindolylmethane in human cervical cancer cells. Oncol Rep, 2012, 28 (3): 1063-8.Chen DZ, Qi M, Auborn KJ, Carter TH. Indole-3-carbinol and diindolylmethane induce apoptosis of human cervical cancer cells and in murine HPV16-transgenic preneoplastic cervical epithelium.J. Nutr., 2001, 131 (12): 3294-3302.Chen DZ, Qi M, Auborn KJ, Carter TH. Indole-3-carbinol and diindolylmethane induce apoptosis of human cervical cancer cells and in murine HPV16-transgenic preneoplastic cervical epithelium.J. Nutr., 2001, 131 (12): 3294-3302.Sepkovic DW, Stein J, Carlisle AD et al. Diindolylmethane inhibits cervical dysplasia, alters estrogen metabolism, and enhances immune response in the K14-HPV16 transgenic mouse model. Cancer Epidemiol. Biomarkers Prev, 2009, 18 (11), 2957-2964.Sepkovic DW, Stein J, Carlisle AD et al. Diindolylmethane inhibits cervical dysplasia, alters estrogen metabolism, and enhances immune response in the K14-HPV16 transgenic mouse model. Cancer Epidemiol. Biomarkers Prev, 2009, 18 (11), 2957-2964.Dalessandri KM, Firestone GL, Fitch MD, Bradlow HL, Bjeldanes LF. Pilot study: effect of 3,3'-diindolylmethane supplements on urinary hormone metabolites in postmenopausal women with a history of early-stage breast cancer. Nutr Cancer, 2004, 50 (2): 161-7.Dalessandri KM, Firestone GL, Fitch MD, Bradlow HL, Bjeldanes LF. Pilot study: effect of 3,3'-diindolylmethane supplements on urinary hormone metabolites in postmenopausal women with a history of early-stage breast cancer. Nutr Cancer, 2004, 50 (2): 161-7.Chang, X et al. 3,3'-Diindolylmethane inhibits angiogenesis and the growth of transplantable human breast carcinoma in athymic mice. Carcinogenesis, 2005, 26 (4): 771-8.Chang, X et al. 3,3'-Diindolylmethane inhibits angiogenesis and the growth of transplantable human breast carcinoma in athymic mice. Carcinogenesis, 2005, 26 (4): 771-8.Kim EJ, Shin M, Park H, Hong JE, Shin HK, Kim J et al. Oral administration of 3,3'-diindolylmethane inhibits lung metastasis of 4T1 murine mammary carcinoma cells in BALB/c mice.J.Nutr., 2009, 139 (12): 2373-9.Kim EJ, Shin M, Park H, Hong JE, Shin HK, Kim J et al. Oral administration of 3,3'-diindolylmethane inhibits lung metastasis of 4T1 murine mammary carcinoma cells in BALB/c mice.J.Nutr., 2009, 139 (12): 2373-9.Semov A, Iourtchenko L, Liu LF, Li S, Xu Y, Su X et al. Diindolylmethane (DIM) selectively inhibits cancer stem cells. Biochem. Biophys. Res. Commun., 2012; 424 (1): 45-51.Semov A, Iourtchenko L, Liu LF, Li S, Xu Y, Su X et al. Diindolylmethane (DIM) selectively inhibits cancer stem cells. Biochem. Biophys. Res. Commun., 2012; 424 (1): 45-51.Zeligs MA et al. US patent 6.416.793, Formulation and use of controlled-release indole alkaloids.Zeligs MA et al. US patent 6.416.793, Formulation and use of controlled-release indole alkaloids.Kiselev VI. Diindolylmethane-based drug for the treatment of hyperplastic and inflammatory diseases. WO 2011/136691 A1. 2011.Kiselev VI. Diindolylmethane-based drug for the treatment of hyperplastic and inflammatory diseases. WO 2011/136691 A1. 2011.Киселев В.И. Суппозитории вагинальные на основе 3,3'-дииндолилметана (метиндола) (RU 2318510).Киселев В.И. Суппозитории вагинальные на основе 3,3'-дииндолилметана (метиндола) (RU 2318510).Bell MC et al. Placebo-controlled trial of indole-3-carbinol in the treatment of CIN. Gynecol Oncol., 2000, 78(2): 123-9.Bell MC et al. Placebo-controlled trial of indole-3-carbinol in the treatment of CIN. Gynecol Oncol., 2000, 78(2): 123-9.Giuseppe Del Priore, Deleep Kumar Gudipudi, Nadine Montemarano, Antonella M Restivo, Jeanetta Malanowska-Stega, Alan A Arslan. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol, 2010, 116 (3): 464-7.Giuseppe Del Priore, Deleep Kumar Gudipudi, Nadine Montemarano, Antonella M Restivo, Jeanetta Malanowska-Stega, Alan A Arslan. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol, 2010, 116 (3): 464-7.Zeligs MA, Sepkovic DW, Manrique C. Absorption-enhanced 3,3'-diindolylmethane: human use in HPV-related, benign and pre-cancerous conditions. Proc Am. Assoc. Cancer Res, 2003, 44.Zeligs MA, Sepkovic DW, Manrique C. Absorption-enhanced 3,3'-diindolylmethane: human use in HPV-related, benign and pre-cancerous conditions. Proc Am. Assoc. Cancer Res, 2003, 44.Carter TH, Liu K, Ralph W et al. Diindolylmethane alters gene expression in human keratinocytes in vitro.J. Nutr, 2002, 132 (11): 3314-3324.Carter TH, Liu K, Ralph W et al. Diindolylmethane alters gene expression in human keratinocytes in vitro.J. Nutr, 2002, 132 (11): 3314-3324.Savino JA, Evans JF, Rabinowitz D, Auborn KJ, Carter TH. Multiple, disparate roles for calcium signaling in apoptosis of human prostate and cervical cancer cells exposed to diindolylmethane. Mol Cancer Ther, 2006, 5 (3): 556-63.Savino JA, Evans JF, Rabinowitz D, Auborn KJ, Carter TH. Multiple, disparate roles for calcium signaling in apoptosis of human prostate and cervical cancer cells exposed to diindolylmethane. Mol Cancer Ther, 2006, 5 (3): 556-63.

The authors declare that there are no conflicts of interest present.