PharmatecaPharmatecaФарматека2073-40342414-9128Bionika Media286690ArticlesСтатьиResearch ArticleMeta-analiz priema 200 ili 600 mg mifepristona v sochetanii s dvumya vidami prostaglandinov dlya preryvaniya beremennosti na rannikh srokakh (original'naya nauchnaya stat'ya)Мета-анализ приема 200 или 600 мг мифепристона в сочетании с двумя видами простагландинов для прерывания беременности на ранних сроках (оригинальная научная статья)L'evreMishel'ЛьевреМишель

Кафедра фармакологии

Sitruk-VareRegineСитрук-ВареРегине

Совет по проблемам народонаселения и Университет Рокфеллера

Лионский университет 1Университет Рокфеллера20022014214NO4 (2014)№4 (2014)465326022023Copyright ©; 2014, Bionika MediaCopyright ©; 2014, ООО «Бионика Медиа»2014Bionika MediaООО «Бионика Медиа»https://journals.eco-vector.com/2073-4034/article/view/286690

There is unsettled controversy about the respective efficacy and safety of 200 and 600 mg mifepristone in combination with two prostaglandins for the termination of pregnancy up to 63 days’ gestation. We performed a meta-analysis of randomized controlled trials (RCTs) of direct comparisons between the two dose regimens. End points were complete abortion, continuing pregnancy and side effects. Four RCTs (3482 patients) were found. Noninferiority of 200 mg mifepristone compared with 600 mg was proven for complete abortion (difference, 0.4 %; 95 % confidence interval [CI] = -1.4 % to 2.3 %). Noninferiority was not proven for continuing pregnancy (difference, 0.4 %; 95 % CI = -0.3 % to 1.0 %). Two hundred milligrams may therefore result in 1 % more continuing pregnancies than 600 mg when used with the approved prostaglandin regimens. Sensitivity analyses confirmed the findings. There was no difference in adverse events between both doses of mifepristone. Although 200 or 600 mg of mifepristone with two prostaglandins probably results in similar rates of complete abortion, the substitution of 200 mg for 600 mg may lead to an increased continuing pregnancy rate.

Существуют различные мнения относительно эффективности и безопасности приема доз мифепристона 200 и 600 мг в сочетании с двумя видами простагландинов для прерывания беременности сроком до 63 дней. Нами был проведен мета-анализ рандомизированных контролируемых испытаний (РКИ) по прямому сравнению двух схем дозировок. Конечными точками исследования считались полный аборт, сохранение беременности и побочные эффекты. Было обнаружено 4 РКИ (3482 пациента).Не меньшая эффективность дозы мифепристона 200 мг по сравнению с дозой 600 мг была доказана в отношении полных абортов (разница - 0,4 %; доверительный интервал [ДИ] 95 % - от -1,4 до 2,3 %). Не меньшая эффективность с точки зрения сохранения беременности (разница - 0,4 %; ДИ 95 % - от-0,3 до 1,0 %) не была доказана. Это означает, что доля сохранившихся беременностей при дозе мифепристона 200 мг может быть на 1 % выше, чем при дозе 600 мг, в случае сочетания с разрешенными схемами приема простагландинов. Анализы на чувствительность подтвердили данные выводы. Существенной разницы в побочных эффектах между двумя дозами мифепристона не выявлено. Таким образом, несмотря на то что дозы 200 или 600 мг мифепристона в сочетании с двумя простагландинами, вероятно, обусловливают одинаковые показатели полного аборта, замена 600 на 200 мг может приводить к увеличению процента сохранившихся беременностей.

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