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Новые возможности патогенетической терапии миомы матки
Новые возможности патогенетической терапии миомы матки
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Аннотация
В статье приведены результаты изучения эффективности применения селективного модулятора прогестероновых рецепторов – препарата Эсмия (улипристала ацетат) в лечении миомы матки.
Ключевые слова: миома матки, селективные модуляторы рецепторов прогестерона, улипристала ацетат.
Key words: uterine myoma (fibroid), selective progesterone-receptor modulator (SMRP), ulipristal acetate.
Ключевые слова: миома матки, селективные модуляторы рецепторов прогестерона, улипристала ацетат.
________________________________________________
Key words: uterine myoma (fibroid), selective progesterone-receptor modulator (SMRP), ulipristal acetate.
Полный текст
Список литературы
1. Тихомиров А.Л. Миома, патогенетическое обоснование органосохраняющего лечения. Монография, М., 2013.
2. Chabbert-Buffet N, Meduri G, Bouchard P et al. Selective progesterone receptor modulators and progesterone antagonists: mechanisms of action and clinical applications. Hum Reprod Update 2005; 11: 293–307.
3. Chwalisz K, Perez MC, Demanno D et al. Selective progesterone receptor modulator development and use in the treatment of leiomyomata and endometriosis. Endocr Rev 2005; 26: 423–38.
4. Donnez J, Tatarchuk TF, Bouchard P et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. TV Engl J Med 2012; 366: 409–20.
5. Donnez J, Tomaszewski J, Vazquez F et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. TV Engl J Med 2012; 366: 421–32.
6. Mutter GL, Bergeron C, Deligdisch L et al. The spectrum of endometrial pathology induced by progesterone receptor modulators. Mod Pathol 2008; 21: 591–8.
7. Home FM, Blithe DL. Progesterone receptor modulators and the endometrium: changes and consequences. Hum Reprod Update 2007; 13: 567–80.
8. Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990; 97: 734–9.
9. Janssen CA, Scholten PC, Heintz AP. A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss. Obstet Gynecol 1995; 85: 977–82.
10. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Estrogen and Estrogen/Progestin Drug: Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation. Rockville, MD: Center for Drug Evaluation and Research (CDER) 2013. Available at: http://www.fda.gov/cder/guidance/index.htm
11. Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab 2007; 92: 3582–9.
12. Williams ARW, Bergeron C, Chabbert-Buffet N et al. Progesterone receptor modulator associated endometrial changes: a pilot histological dose escalation study of ulipristal acetate. Facts, Views and Vision in ObGyn. EBCOG. Sci J Flemish Soc Obstet Gynecol 2010; (abstr 163): 99.
13. Kelly RW, King AE, Critchley HOD. Inflammatory mediators and endometrial function – focus on the perivascular cell. Reprod Immunol 2002; 57: 81–93.
14. Baird DT, Brown A, Critchley HOD et al. Effect of long-term treatment with low-dose mifepristone on the endometrium. Hum Reprod 2003; 18: 61–8.
15. Williams ARW, Critchley HOD, Osei J et al. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod 2007; 22: 1696–704.
16. Hodgen GD, van Uem JF, Chillik CF et al. Non-competitive anti-oestrogenic activity of progesterone antagonists in primate models. Hum Reprod 1994; 9 (Suppl. 1): 77–81.
17. Chwalisz K, Brenner RM, Fuhrmann UU et al. Antiproliferative effects of progesterone antagonists and progesterone receptor modulators on the endometrium. Steroids 2000; 65: 741–51.
18. Brenner RM, Slayden OD, Nath A et al. Intrauterine administration of CDB-2914 (ulipristal) suppresses the endometrium of rhesus macaques. Contraception 2010; 81: 336–42.
19. Croxatto HB, Kovacs L, Massai R et al. Effects of long-term low-dose mifepristone on reproductive function in women. Hum Reprod 1998; 13: 793–8.
20. Lakha F, Ho PC, Van der Spuy ZM et al. A novel estrogen-free oral contraceptive pill for women: multicentre, double-blind, randomized controlled trial of mifepristone and progestogen-only pill (levonorgestrel). Hum Reprod 2007; 22: 2428–36.
21. Fiscella J, Bonfiglio T, Winters P et al. Distinguishing features of endometrial pathology after exposure to the progesterone receptor modulator mifepristone. Hum Pathol 2011; 42: 947–53.
22. Heikinheimo O, Vani S, Carpen O et al. Intrauterine release of progesterone antagonist ZK230211 is feasible and results in novel endometrial effects: a pilot study. Hum Reprod 2007; 22: 2515–22.
23. Mutter GL, Olga B, Loffe R et al. Proellex effects on the endometrium. Gynecol Endocrinol 2008; 24 (Suppl. 1): 75.
24. Loffe OB, Zaino RJ, Mutter GL. Endometrial changes from short-term therapy with CDB-4124, a selective progesterone receptor modulator. Mod Pathol 2009; 22: 450–9.
25. Slayden OD, Nayak NR, Burton KA et al. Progesterone antagonists increase androgen receptor expression in the rhesus macaque and human endometrium. Clin Endocrinol Metab 2001; 86: 2668–79.
26. Heikinheimo O, Hsiu JG, Gordon K et al. Endometrial effects of RU486 in primates – antiproliferative action despite signs of estrogen action and increased cyclin-B expression. Steroid Biochem Mol Biol 1996; 59: 179–90.
27. Eisinger SH, Bonfiglio T, Fiscella K et al. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol 2005; 12: 227–33.
28. Donnez J, Tatarchuk TF, Bouchard P et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 2012; 366: 409–20.
29. Donnez J, Tomaszewski J, Vazquez F et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med 2012; 366: 421–32.
30. Stovall TG, Muneyyirci-Delale O, Summitt RL Jr, Scialli AR. GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: a randomized controlled trial. Obstet Gynecol 1995; 86: 65–71.
31. Mutter GL, Bergeron C, Deligdisch L et al. The spectrum of endometrial pathology induced by progesterone receptor modulators. Mod Pathol 2008; 21: 591–8.
32. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 1998; 17: 873–90 (Erratum, Stat Med 1999; 18: 1293J).
33. Hollander M, Wolfe DA. Nonparamet-ric statistical methods. New York: John Wiley, 1973; р. 75–82.
34. Viswanathan M, Hartmann K, McKoy N et al. Management of uterine fibroids: an update of the evidence. Evid Rep Technol Assess (Full Rep) 2007; 154: 1–122.
35. Hoffman R, Benz E, Shattil S et al. Disorders of iron metabolism: iron deficiency and iron overload. Hematology: basic principles and practice. 5th ed. New York: Churchill Livingstone, 2008; р. 453–68.
36. Spitz IM, Grunberg SM, Chabbert-Buffet N et al. Management of patients receiving long-term treatment with mifepristone. Fertil Steril 2005; 84: 1719–26.
2. Chabbert-Buffet N, Meduri G, Bouchard P et al. Selective progesterone receptor modulators and progesterone antagonists: mechanisms of action and clinical applications. Hum Reprod Update 2005; 11: 293–307.
3. Chwalisz K, Perez MC, Demanno D et al. Selective progesterone receptor modulator development and use in the treatment of leiomyomata and endometriosis. Endocr Rev 2005; 26: 423–38.
4. Donnez J, Tatarchuk TF, Bouchard P et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. TV Engl J Med 2012; 366: 409–20.
5. Donnez J, Tomaszewski J, Vazquez F et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. TV Engl J Med 2012; 366: 421–32.
6. Mutter GL, Bergeron C, Deligdisch L et al. The spectrum of endometrial pathology induced by progesterone receptor modulators. Mod Pathol 2008; 21: 591–8.
7. Home FM, Blithe DL. Progesterone receptor modulators and the endometrium: changes and consequences. Hum Reprod Update 2007; 13: 567–80.
8. Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990; 97: 734–9.
9. Janssen CA, Scholten PC, Heintz AP. A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss. Obstet Gynecol 1995; 85: 977–82.
10. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Estrogen and Estrogen/Progestin Drug: Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation. Rockville, MD: Center for Drug Evaluation and Research (CDER) 2013. Available at: http://www.fda.gov/cder/guidance/index.htm
11. Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab 2007; 92: 3582–9.
12. Williams ARW, Bergeron C, Chabbert-Buffet N et al. Progesterone receptor modulator associated endometrial changes: a pilot histological dose escalation study of ulipristal acetate. Facts, Views and Vision in ObGyn. EBCOG. Sci J Flemish Soc Obstet Gynecol 2010; (abstr 163): 99.
13. Kelly RW, King AE, Critchley HOD. Inflammatory mediators and endometrial function – focus on the perivascular cell. Reprod Immunol 2002; 57: 81–93.
14. Baird DT, Brown A, Critchley HOD et al. Effect of long-term treatment with low-dose mifepristone on the endometrium. Hum Reprod 2003; 18: 61–8.
15. Williams ARW, Critchley HOD, Osei J et al. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod 2007; 22: 1696–704.
16. Hodgen GD, van Uem JF, Chillik CF et al. Non-competitive anti-oestrogenic activity of progesterone antagonists in primate models. Hum Reprod 1994; 9 (Suppl. 1): 77–81.
17. Chwalisz K, Brenner RM, Fuhrmann UU et al. Antiproliferative effects of progesterone antagonists and progesterone receptor modulators on the endometrium. Steroids 2000; 65: 741–51.
18. Brenner RM, Slayden OD, Nath A et al. Intrauterine administration of CDB-2914 (ulipristal) suppresses the endometrium of rhesus macaques. Contraception 2010; 81: 336–42.
19. Croxatto HB, Kovacs L, Massai R et al. Effects of long-term low-dose mifepristone on reproductive function in women. Hum Reprod 1998; 13: 793–8.
20. Lakha F, Ho PC, Van der Spuy ZM et al. A novel estrogen-free oral contraceptive pill for women: multicentre, double-blind, randomized controlled trial of mifepristone and progestogen-only pill (levonorgestrel). Hum Reprod 2007; 22: 2428–36.
21. Fiscella J, Bonfiglio T, Winters P et al. Distinguishing features of endometrial pathology after exposure to the progesterone receptor modulator mifepristone. Hum Pathol 2011; 42: 947–53.
22. Heikinheimo O, Vani S, Carpen O et al. Intrauterine release of progesterone antagonist ZK230211 is feasible and results in novel endometrial effects: a pilot study. Hum Reprod 2007; 22: 2515–22.
23. Mutter GL, Olga B, Loffe R et al. Proellex effects on the endometrium. Gynecol Endocrinol 2008; 24 (Suppl. 1): 75.
24. Loffe OB, Zaino RJ, Mutter GL. Endometrial changes from short-term therapy with CDB-4124, a selective progesterone receptor modulator. Mod Pathol 2009; 22: 450–9.
25. Slayden OD, Nayak NR, Burton KA et al. Progesterone antagonists increase androgen receptor expression in the rhesus macaque and human endometrium. Clin Endocrinol Metab 2001; 86: 2668–79.
26. Heikinheimo O, Hsiu JG, Gordon K et al. Endometrial effects of RU486 in primates – antiproliferative action despite signs of estrogen action and increased cyclin-B expression. Steroid Biochem Mol Biol 1996; 59: 179–90.
27. Eisinger SH, Bonfiglio T, Fiscella K et al. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol 2005; 12: 227–33.
28. Donnez J, Tatarchuk TF, Bouchard P et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 2012; 366: 409–20.
29. Donnez J, Tomaszewski J, Vazquez F et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med 2012; 366: 421–32.
30. Stovall TG, Muneyyirci-Delale O, Summitt RL Jr, Scialli AR. GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: a randomized controlled trial. Obstet Gynecol 1995; 86: 65–71.
31. Mutter GL, Bergeron C, Deligdisch L et al. The spectrum of endometrial pathology induced by progesterone receptor modulators. Mod Pathol 2008; 21: 591–8.
32. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 1998; 17: 873–90 (Erratum, Stat Med 1999; 18: 1293J).
33. Hollander M, Wolfe DA. Nonparamet-ric statistical methods. New York: John Wiley, 1973; р. 75–82.
34. Viswanathan M, Hartmann K, McKoy N et al. Management of uterine fibroids: an update of the evidence. Evid Rep Technol Assess (Full Rep) 2007; 154: 1–122.
35. Hoffman R, Benz E, Shattil S et al. Disorders of iron metabolism: iron deficiency and iron overload. Hematology: basic principles and practice. 5th ed. New York: Churchill Livingstone, 2008; р. 453–68.
36. Spitz IM, Grunberg SM, Chabbert-Buffet N et al. Management of patients receiving long-term treatment with mifepristone. Fertil Steril 2005; 84: 1719–26.
2. Chabbert-Buffet N, Meduri G, Bouchard P et al. Selective progesterone receptor modulators and progesterone antagonists: mechanisms of action and clinical applications. Hum Reprod Update 2005; 11: 293–307.
3. Chwalisz K, Perez MC, Demanno D et al. Selective progesterone receptor modulator development and use in the treatment of leiomyomata and endometriosis. Endocr Rev 2005; 26: 423–38.
4. Donnez J, Tatarchuk TF, Bouchard P et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. TV Engl J Med 2012; 366: 409–20.
5. Donnez J, Tomaszewski J, Vazquez F et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. TV Engl J Med 2012; 366: 421–32.
6. Mutter GL, Bergeron C, Deligdisch L et al. The spectrum of endometrial pathology induced by progesterone receptor modulators. Mod Pathol 2008; 21: 591–8.
7. Home FM, Blithe DL. Progesterone receptor modulators and the endometrium: changes and consequences. Hum Reprod Update 2007; 13: 567–80.
8. Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990; 97: 734–9.
9. Janssen CA, Scholten PC, Heintz AP. A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss. Obstet Gynecol 1995; 85: 977–82.
10. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Estrogen and Estrogen/Progestin Drug: Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation. Rockville, MD: Center for Drug Evaluation and Research (CDER) 2013. Available at: http://www.fda.gov/cder/guidance/index.htm
11. Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab 2007; 92: 3582–9.
12. Williams ARW, Bergeron C, Chabbert-Buffet N et al. Progesterone receptor modulator associated endometrial changes: a pilot histological dose escalation study of ulipristal acetate. Facts, Views and Vision in ObGyn. EBCOG. Sci J Flemish Soc Obstet Gynecol 2010; (abstr 163): 99.
13. Kelly RW, King AE, Critchley HOD. Inflammatory mediators and endometrial function – focus on the perivascular cell. Reprod Immunol 2002; 57: 81–93.
14. Baird DT, Brown A, Critchley HOD et al. Effect of long-term treatment with low-dose mifepristone on the endometrium. Hum Reprod 2003; 18: 61–8.
15. Williams ARW, Critchley HOD, Osei J et al. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod 2007; 22: 1696–704.
16. Hodgen GD, van Uem JF, Chillik CF et al. Non-competitive anti-oestrogenic activity of progesterone antagonists in primate models. Hum Reprod 1994; 9 (Suppl. 1): 77–81.
17. Chwalisz K, Brenner RM, Fuhrmann UU et al. Antiproliferative effects of progesterone antagonists and progesterone receptor modulators on the endometrium. Steroids 2000; 65: 741–51.
18. Brenner RM, Slayden OD, Nath A et al. Intrauterine administration of CDB-2914 (ulipristal) suppresses the endometrium of rhesus macaques. Contraception 2010; 81: 336–42.
19. Croxatto HB, Kovacs L, Massai R et al. Effects of long-term low-dose mifepristone on reproductive function in women. Hum Reprod 1998; 13: 793–8.
20. Lakha F, Ho PC, Van der Spuy ZM et al. A novel estrogen-free oral contraceptive pill for women: multicentre, double-blind, randomized controlled trial of mifepristone and progestogen-only pill (levonorgestrel). Hum Reprod 2007; 22: 2428–36.
21. Fiscella J, Bonfiglio T, Winters P et al. Distinguishing features of endometrial pathology after exposure to the progesterone receptor modulator mifepristone. Hum Pathol 2011; 42: 947–53.
22. Heikinheimo O, Vani S, Carpen O et al. Intrauterine release of progesterone antagonist ZK230211 is feasible and results in novel endometrial effects: a pilot study. Hum Reprod 2007; 22: 2515–22.
23. Mutter GL, Olga B, Loffe R et al. Proellex effects on the endometrium. Gynecol Endocrinol 2008; 24 (Suppl. 1): 75.
24. Loffe OB, Zaino RJ, Mutter GL. Endometrial changes from short-term therapy with CDB-4124, a selective progesterone receptor modulator. Mod Pathol 2009; 22: 450–9.
25. Slayden OD, Nayak NR, Burton KA et al. Progesterone antagonists increase androgen receptor expression in the rhesus macaque and human endometrium. Clin Endocrinol Metab 2001; 86: 2668–79.
26. Heikinheimo O, Hsiu JG, Gordon K et al. Endometrial effects of RU486 in primates – antiproliferative action despite signs of estrogen action and increased cyclin-B expression. Steroid Biochem Mol Biol 1996; 59: 179–90.
27. Eisinger SH, Bonfiglio T, Fiscella K et al. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol 2005; 12: 227–33.
28. Donnez J, Tatarchuk TF, Bouchard P et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 2012; 366: 409–20.
29. Donnez J, Tomaszewski J, Vazquez F et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med 2012; 366: 421–32.
30. Stovall TG, Muneyyirci-Delale O, Summitt RL Jr, Scialli AR. GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: a randomized controlled trial. Obstet Gynecol 1995; 86: 65–71.
31. Mutter GL, Bergeron C, Deligdisch L et al. The spectrum of endometrial pathology induced by progesterone receptor modulators. Mod Pathol 2008; 21: 591–8.
32. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 1998; 17: 873–90 (Erratum, Stat Med 1999; 18: 1293J).
33. Hollander M, Wolfe DA. Nonparamet-ric statistical methods. New York: John Wiley, 1973; р. 75–82.
34. Viswanathan M, Hartmann K, McKoy N et al. Management of uterine fibroids: an update of the evidence. Evid Rep Technol Assess (Full Rep) 2007; 154: 1–122.
35. Hoffman R, Benz E, Shattil S et al. Disorders of iron metabolism: iron deficiency and iron overload. Hematology: basic principles and practice. 5th ed. New York: Churchill Livingstone, 2008; р. 453–68.
36. Spitz IM, Grunberg SM, Chabbert-Buffet N et al. Management of patients receiving long-term treatment with mifepristone. Fertil Steril 2005; 84: 1719–26.
________________________________________________
2. Chabbert-Buffet N, Meduri G, Bouchard P et al. Selective progesterone receptor modulators and progesterone antagonists: mechanisms of action and clinical applications. Hum Reprod Update 2005; 11: 293–307.
3. Chwalisz K, Perez MC, Demanno D et al. Selective progesterone receptor modulator development and use in the treatment of leiomyomata and endometriosis. Endocr Rev 2005; 26: 423–38.
4. Donnez J, Tatarchuk TF, Bouchard P et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. TV Engl J Med 2012; 366: 409–20.
5. Donnez J, Tomaszewski J, Vazquez F et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. TV Engl J Med 2012; 366: 421–32.
6. Mutter GL, Bergeron C, Deligdisch L et al. The spectrum of endometrial pathology induced by progesterone receptor modulators. Mod Pathol 2008; 21: 591–8.
7. Home FM, Blithe DL. Progesterone receptor modulators and the endometrium: changes and consequences. Hum Reprod Update 2007; 13: 567–80.
8. Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol 1990; 97: 734–9.
9. Janssen CA, Scholten PC, Heintz AP. A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss. Obstet Gynecol 1995; 85: 977–82.
10. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER). Guidance for Industry: Estrogen and Estrogen/Progestin Drug: Products to Treat Vasomotor Symptoms and Vulvar and Vaginal Atrophy Symptoms – Recommendations for Clinical Evaluation. Rockville, MD: Center for Drug Evaluation and Research (CDER) 2013. Available at: http://www.fda.gov/cder/guidance/index.htm
11. Chabbert-Buffet N, Pintiaux-Kairis A, Bouchard P. Effects of the progesterone receptor modulator VA2914 in a continuous low dose on the hypothalamic-pituitary-ovarian axis and endometrium in normal women: a prospective, randomized, placebo-controlled trial. J Clin Endocrinol Metab 2007; 92: 3582–9.
12. Williams ARW, Bergeron C, Chabbert-Buffet N et al. Progesterone receptor modulator associated endometrial changes: a pilot histological dose escalation study of ulipristal acetate. Facts, Views and Vision in ObGyn. EBCOG. Sci J Flemish Soc Obstet Gynecol 2010; (abstr 163): 99.
13. Kelly RW, King AE, Critchley HOD. Inflammatory mediators and endometrial function – focus on the perivascular cell. Reprod Immunol 2002; 57: 81–93.
14. Baird DT, Brown A, Critchley HOD et al. Effect of long-term treatment with low-dose mifepristone on the endometrium. Hum Reprod 2003; 18: 61–8.
15. Williams ARW, Critchley HOD, Osei J et al. The effects of the selective progesterone receptor modulator asoprisnil on the morphology of uterine tissues after 3 months treatment in patients with symptomatic uterine leiomyomata. Hum Reprod 2007; 22: 1696–704.
16. Hodgen GD, van Uem JF, Chillik CF et al. Non-competitive anti-oestrogenic activity of progesterone antagonists in primate models. Hum Reprod 1994; 9 (Suppl. 1): 77–81.
17. Chwalisz K, Brenner RM, Fuhrmann UU et al. Antiproliferative effects of progesterone antagonists and progesterone receptor modulators on the endometrium. Steroids 2000; 65: 741–51.
18. Brenner RM, Slayden OD, Nath A et al. Intrauterine administration of CDB-2914 (ulipristal) suppresses the endometrium of rhesus macaques. Contraception 2010; 81: 336–42.
19. Croxatto HB, Kovacs L, Massai R et al. Effects of long-term low-dose mifepristone on reproductive function in women. Hum Reprod 1998; 13: 793–8.
20. Lakha F, Ho PC, Van der Spuy ZM et al. A novel estrogen-free oral contraceptive pill for women: multicentre, double-blind, randomized controlled trial of mifepristone and progestogen-only pill (levonorgestrel). Hum Reprod 2007; 22: 2428–36.
21. Fiscella J, Bonfiglio T, Winters P et al. Distinguishing features of endometrial pathology after exposure to the progesterone receptor modulator mifepristone. Hum Pathol 2011; 42: 947–53.
22. Heikinheimo O, Vani S, Carpen O et al. Intrauterine release of progesterone antagonist ZK230211 is feasible and results in novel endometrial effects: a pilot study. Hum Reprod 2007; 22: 2515–22.
23. Mutter GL, Olga B, Loffe R et al. Proellex effects on the endometrium. Gynecol Endocrinol 2008; 24 (Suppl. 1): 75.
24. Loffe OB, Zaino RJ, Mutter GL. Endometrial changes from short-term therapy with CDB-4124, a selective progesterone receptor modulator. Mod Pathol 2009; 22: 450–9.
25. Slayden OD, Nayak NR, Burton KA et al. Progesterone antagonists increase androgen receptor expression in the rhesus macaque and human endometrium. Clin Endocrinol Metab 2001; 86: 2668–79.
26. Heikinheimo O, Hsiu JG, Gordon K et al. Endometrial effects of RU486 in primates – antiproliferative action despite signs of estrogen action and increased cyclin-B expression. Steroid Biochem Mol Biol 1996; 59: 179–90.
27. Eisinger SH, Bonfiglio T, Fiscella K et al. Twelve-month safety and efficacy of low-dose mifepristone for uterine myomas. J Minim Invasive Gynecol 2005; 12: 227–33.
28. Donnez J, Tatarchuk TF, Bouchard P et al. Ulipristal acetate versus placebo for fibroid treatment before surgery. N Engl J Med 2012; 366: 409–20.
29. Donnez J, Tomaszewski J, Vazquez F et al. Ulipristal acetate versus leuprolide acetate for uterine fibroids. N Engl J Med 2012; 366: 421–32.
30. Stovall TG, Muneyyirci-Delale O, Summitt RL Jr, Scialli AR. GnRH agonist and iron versus placebo and iron in the anemic patient before surgery for leiomyomas: a randomized controlled trial. Obstet Gynecol 1995; 86: 65–71.
31. Mutter GL, Bergeron C, Deligdisch L et al. The spectrum of endometrial pathology induced by progesterone receptor modulators. Mod Pathol 2008; 21: 591–8.
32. Newcombe RG. Interval estimation for the difference between independent proportions: comparison of eleven methods. Stat Med 1998; 17: 873–90 (Erratum, Stat Med 1999; 18: 1293J).
33. Hollander M, Wolfe DA. Nonparamet-ric statistical methods. New York: John Wiley, 1973; р. 75–82.
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Авторы
А.Л.Тихомиров
ГБОУ ВПО Московский государственный медико-стоматологический университет им. А.И.Евдокимова Минздрава РФ
ГБОУ ВПО Московский государственный медико-стоматологический университет им. А.И.Евдокимова Минздрава РФ
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