Investigation of the efficacy and safety of a diindolylmethane-based drug in patients with cervical intraepithelial neoplasia grades 1-2 (CIN 1-2)
Objective. To investigate the efficacy and safety of the vaginal suppositories Cervicon-DIM (diindolylmethane) in patients with histologically confirmed neoplastic processes of the cervix uteri – cervical intraepithelial neoplasia grades 1-2 (CIN 1-2).Sukhikh G.T., Ashrafyan L.A., Kiselev V.I., Apolikhina I.A., Maltseva L.I., Suturina L.V., Selivanov S.P., Leonidova T.N., Tskhai V.B., Radzinsky V.E., Ordiyants I.M., Bebneva T.N., Evtushenko I.D., Udut V.V., Kulagina N.V., Baranov A.N., Khasanov R.Sh., Guryeva V.A., Shamina I.V., Karakhalis L.Yu., Muyzhnek E.L.
Subject and methods. The randomized study enrolled 160 patients aged 18 to 45 years; the follow-up period was 3 months. The investigators analyzed clinical and laboratory data and evaluated the efficacy and safety of treatment with Cervicon-DIM versus placebo.
Results. Cervicon-DIM was shown to contribute to the elimination of human papillomavirus infection and to the regression of mild and moderate neoplastic processes of the cervix uteri (CIN 1-2).
Conclusion. It is appropriate to prescribe Cervicon-DIM as one suppository (100 mg) twice daily for 3 months to patients with human papillomavirus infection and those with CIN 1-2.
Keywords
human papillomavirus
cervical intraepithelial neoplasia
cervix uteri
Cervicon-DIM
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Received 06.09.2018
Accepted 21.09.2018
About the Authors
Sukhikh, Gennady T., MD, PhD, Professor, Academician of Russian Academy of Sciences, Director of National Medical Research Center of Obstetrics,Gynecology and Perinatology, Ministry of Health of Russia. 117997, Russia Moscow, Ac. Oparina str. 4. Tel.: +74954381800. E-mail: gtsukhikh@mail.ru
Ashrafyan, Lev A., MD, Academician of RAS, Professor, Director of the Institute of Oncogynecology and Mammology, National Medical Research Center of Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia. 117997, Russia Moscow, Ac. Oparina str. 4. Tel.: +74955314444. E-mail: levaa2004@yahoo.com
Kiselev, Vsevolod I., doctor of biological sciences, Deputy Director for Science, Head of the laboratory of epigenetics of the Institute of Oncogynecology and Mammology, National Medical Research Center of Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia.
117997, Russia Moscow, Ac. Oparina str. 4. Tel.: +79857763116. E-mail: vkis10@mail.ru
Apolikhina, Inna A., MD, Professor of the Department of Obstetrics, Gynecology, Perinatology and Reproductology, I.M. Sechenov First Moscow State Medical University, a doctor of the highest category, head of the Department of Aesthetic Gynecology and Rehabilitation and a day hospital, National Medical Research Center of Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia. 117997, Russia Moscow, Ac. Oparina str. 4. Tel.: +74955314444
Maltseva, Larisa I., MD, professor, head of the Obstetrics and Gynecology Department № 1, Kazan State Medical Academy, Branch, Russian Medical Academy
of Continuing Postgraduate Education, Ministry of Health of Russia. 422012, Russia, Kazan, Mushtari str. 11. Tel.: +79053144051. E-mail: laramalc@mail.ru
Suturina, Larisa V., MD, Professor of the Department of Endocrinology, State Medical University of Irkutsk State Medical Academy of Postgraduate Education of the Ministry of Health of Russia, Head of the Department of Reproductive Health, Research Center for Family Health and Human Reproduction Problems,
Siberian Branch of the Russian Academy of Medical Sciences. Russia, Irkutsk, Timiryazeva str. 16. Tel.: +73952292207. E-mail: lsuturina@mail.ru
Selivanov, Sergey P., MD, assistant of the Department of Urology, Siberian State Medical University, member of the Russian Society of Urology, member of the European Society of Urology, chief medical officer of the NMU Medical diagnostic center. Russia, Tomsk, Moscow highway, 2. Tel.: +73822417578. E-mail: health@ldc.tom.ru
Leonidova T.N., MD, doctor of the highest category, gynecologist-endocrinologist, chief oncogynecologist of the Ministry of Health of the Perm Krai.
Russia, Perm, Sedova str. 8. Tel.: +79223015212. E-mail: drleonidova@mail.ru
Tskhay, Vitaly B., MD., prof., Head of Department of Perinatology, Obstetrics and Gynecology, Medical Faculty, Krasnoyarsk State Medical University named
after V.F. Voyno-Yasenetsky. 660022, Russia, Krasnoyarsk, P. Zheleznyaka str. 1. Tel.: +79232872134. E-mail: tchai@yandex.ru
Radzinskiy, Viktor E., Doctor of Medicine, professor, Honored Researcher of the Russian Federation, corresponding member of the Russian Academy of Sciences, vice-president of the Russian Society of Obstetricians and Gynecologists; Head of the Department of Obstetrics and Gynecology with a Perinatology Course of the Medical Institute of the Peoples’ Friendship University of Russia, subdivision of the Ministry of Education and Science of Russia; Head of the Department of Obstetrics, Gynecology and Reproductive Medicine of the Advanced Medical Training Faculty of the Peoples’ Friendship University of Russia.
117198, Russia, Moscow, Miklukho-Maklaya str. 6. Tel.: +79037232212. E-mail: radzinsky@mail.ru
Ordiyants, Irina M., Professor of the Department of Obstetrics and Gynecology with the course of Perinatology, Peoples’ Friendship University of Russia.
117198, Russia, Moscow, Miklukho-Maklaya str. 6. Tel.: +79268005036. E-mail: ordiyantc@mail.ru
Bebneva, Tamara N., Candidate of Medical Sciences, Associate Professor of the Department of Obstetrics, Gynecology and Reproductive Medicine, Faculty of Advanced Training for Medical Professionals, Peoples’ Friendship University of Russia, Ministry of Education and Science.
117198, Russia, Moscow, Miklukho-Maklaya str. 21, bld. 3. Tel.: +79165181964. E-mail: bebn@mail.ru. ORCID.org 0000-0001-9524-8962
Evtushenko I.D., MD, professor, head of Department of Obstetrics and Gynecology of the State Medical University of the Siberian Federal University of Health Care
of the Ministry of Health of Russia. Russia, Tomsk, Moscow highway, 2. Tel.: +73822905338. E-mail: evtushenko_id@mail.ru
Udut V.V., MD, Professor, Corresponding Member of RAS, Deputy director for scientific and medical work, head of the laboratory of physiology, molecular and clinical pharmacology E.D. Goldberg NIIFiRM. Russia, Tomsk, Lenin Ave. 3. Tel.: +73822418892. E-mail: udutv@mail.ru
Kulagina N.V., MD, Professor of the Department of Obstetrics and Gynecology I.I. Mechnikov Northwestern State Medical University, Ministry of Health of Russia.
191015, Russia, St. Petersburg, Kirochnaya str. 41. Tel.: +78123035000. E-mail: dr.kulagina@mail.ru
Baranov A.N., Doctor of Medicine, Head of Department of Obstetrics and Gynecology, Northern State Medical University.
163000, Russia, Arkhangelsk, Troitskiy Ave. 5. Tel.: +7182275631. E-mail: albar@atnet.ru
Hasanov R.Sh., MD, Corresponding Member of RAS, Professor, Director of Kazan State Medical Academy, Head of the Department of Oncology, Radiology and Palliative Medicine, Honored Doctor of the Russian Federation and the Republic of Tatarstan, Chief Oncologist of the Privolzhsky Federal District and the Republic of Tatarstan. Russia, Kazan, Butlerova str. 36. Tel.: +78432676151. E-mail: kgma.rf@tatar.ru
Guryeva V.A., MD, Professor, Honored Doctor of the Russian Federation, full member of the Russian Academy of Natural Sciences, twice winner
of the Altai Territory Award in the region. science and technology. Russia, Barnaul, Lyapidevskogo str. 1. Tel.: +73852689622. E-mail: ag.fpk@mail.ru
Shamina I.V., Ph.D., Associate Professor of the Department of Obstetrics and Gynecology No. 2, Omsk State Medical University, Ministry of Health of Russia.
644043, Russia, Omsk, Lenina str. 12. Tel.: +73821240658. E-mail: innadocsever@rambler.ru
Karakhalis, Lyudmila Yu., Doctor of Medicine, Professor of the Department of Obstetrics, Gynecology, and Perinatology, Kuban State Medical University,
Ministry of Health of Russia. 350007, Russia, Krasnodar, Sedina str. 4. Tel.: +79882444044. E-mail: lomela@mail.ru
Muyzhnek E.L., Ph.D., Director for Science, MiraxBioPharma JSC. Russia, Moscow, Valovaya str. 21, bld. 125. Tel.: +74957212058. E-mail: MuyzhnekEL@ilmixgroup.ru
For citations: Sukhikh G.T., Ashrafyan L.A., Kiselev V.I., Apolikhina I.A., Maltseva L.I., Suturina L.V., Selivanov S.P., Leonidova T.N., Tskhai V.B., Radzinsky V.E., Ordiyants I.M., Bebneva T.N., Evtushenko I.D., Udut V.V., Kulagina N.V., Baranov A.N., Khasanov R.Sh., Guryeva V.A., Shamina I.V., Karakhalis L.Yu., Muyzhnek E.L. Investigation of the efficacy and safety of a diindolylmethane-based drug in patients with cervical intraepithelial neoplasia grades 1-2 (CIN 1-2). Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2018; (9): 91-8. (in Russian)
https://dx.doi.org/10.18565/aig.2018.9.91-98
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