Безопасность фармацевтической композиции на основе дииндолилметана в виде суппозиториев у пациенток с CIN 1-2 (II фаза)
Автор: Киселев В.И., Ашрафян Л.А., Друх В.М., Муйжнек Е.Л., Кузнецов И.Н., Андрианова Е.А., Барановский П.М.
Журнал: Вестник Российского научного центра рентгенорадиологии Минздрава России @vestnik-rncrr
Рубрика: Гинекология
Статья в выпуске: 2 т.15, 2015 года.
Бесплатный доступ
Цель исследования. Проведено изучение безопасности нового препарата Цервикон-ДИМ на основе дииндолилметана (ДИМ), представленного в лекарственной форме «суппозитории вагинальные». Материалы и методы. В исследование безопасности было включено 78 пациенток с верифицированным диагнозом цервикальная интраэпителиальная неоплазия 1-2 степени (CIN 1-2). Первая и вторая экспериментальные группы получали препарат Цервикон-ДИМ в дозах 100 мг ДИМ в сутки и 200 мг ДИМ в сутки, соответственно, в течение 180 дней. Третья группа получала плацебо. Оценка безопасности и переносимости терапии проводилась в результате регистрации нежелательных явлений (НЯ) клинически и с помощью инструментально-лабораторных методов исследования и их последующего анализа. Результаты. В ходе исследования во всех трех группах в общей сложности было зафиксировано 34 нежелательных явления (НЯ): 13 в группе Цервикон-ДИМ 100 мг/сут, 14 в группе Цервикон-ДИМ 200 мг/сут, 7 в группе плацебо. Для четырех случаев была выявлена связь НЯ с приемом препарата. В остальных случаях связь НЯ с приемом исследуемого препарата была в основном оценена как маловероятная. Все зарегистрированные НЯ имели незначительную выраженность. Серьезных НЯ ни в одной группе отмечено не было. Выводы. Препарат Цервикон-ДИМ обладает благоприятным профилем безопасности и переносимости.
3'-дииндолилметан (дим), суппозитории, клиническое исследование, безопасность
Короткий адрес: https://sciup.org/14955485
IDR: 14955485
Safety of the pharmaceutical composition comprising dim in suppository form in patients with CIN 1-2 (phase II)
Abstract Purpose of the study: To evaluate safety of the novel pharmaceutical composition «Cervicon-DIM» in suppository form containing 3,3’-diindolylmethane (DIM) substance in patients with cervical intraepithelial neoplasia grade 1-2 (CIN 1-2). Materials and methods: 78 patients with CIN 1-2 were included and randomized to three groups. The patients in the first study group received 100 mg DIM intravaginally per day. In the second study group patients received 200 mg DIM intravaginally per day. In the control group patients received placebo. Patients were followed for six months. Safety was evaluated by adverse events (AEs), laboratory tests and physical examinations. Results: We noted total 34 AEs: 13 in group 100 mg DIM per day, 14 in group 200 mg DIM per day, 7 in placebo group. An association between treatment and AEs was registered for 4 cases. In other cases, the relationship of AEs with study drug was assessed as unlikely. All registered AEs had non-severe form. Serious adverse events haven’t been observed. Conclusions: We confirmed safety and good tolerability of novel DIM-based formulation.
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