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Инновации в контрацепции. Новый комбинированный оральный контрацептив (обзор литературы)
Инновации в контрацепции. Новый комбинированный оральный контрацептив (обзор литературы)
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Аннотация
В статье рассматриваются предпосылки создания нового комбинированного орального контрацептива, фармакокинетика и фармакодинамика номегестрола ацетата и 17b-эстрадиола, отличительные особенности, обусловленные комбинацией компонентов препарата, описание эффективности, безопасности и некоторых ключевых характеристик препарата.
Ключевые слова: гормональная контрацепция, инновации, комбинированный оральный контрацептив, номегестрола ацетат, 17b-эстрадиол, эстрадиол, режим применения 24/4.
Ключевые слова: гормональная контрацепция, инновации, комбинированный оральный контрацептив, номегестрола ацетат, 17b-эстрадиол, эстрадиол, режим применения 24/4.
Полный текст
Список литературы
1. НоваРинг и Чарозетта в гинекологической практике: контрацептивы и их дополнительные лечебные свойства. Эффективная фармакотерапия. Акушерство и гинекология. 2011.
2. Прилепская В.Н. Руководство по контрацепции. М.: МЕДпресс-информ, 2010.
3. Gaussem P, Alhenc-Gelas M et al. Haemostatic effects of a new combined oral contraceptive, nomegestrol acetate/17b-estradiol, compared with those of levonorgestrel/ethinyl estradiol. A double-blind, randomised study. Schattauer 2011: 560–7.
4. Agren UM et al. Eur J Contracept Reprod Health Care 2011.
5. Gallo MF, Lopez LM, Grimes DA et al. Combination contraceptives: effects on weight. Cochrane Database Syst Rev 2008; 1: CD003987. oi:10.1002/14651858. CD003987. pub 2.
6. Speroff L, Fritz MA. Oral contraception. In: Clinical Gynecologic Endocrinology and Infertility; Philadelphia: Lippincott Williams & Wilkins, 2005: 861–942.
7. Sitruk-Ware R. Pharmacological profile of progestins. Maturitas 2008; 61: 151–7.
8 Martin, K, Barbieri R. Overview of the use of estrogen-progestogen contraceptives.
9. Ouzounian S, Verstraete L, Chabbert-Buffet N. Third-generation oral contraceptives: future implications of current use. Exp Rev Obstet Gynecol 2008; 3 (2): 189–201.
10. Westhoff C, Andrew M et al. Efficacy, Safety, and Tolerability of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate and 17-Estradiol. A Randomized Controlled Trial. Obstet Gynecol 2012; 119 (5).
11. Schindler A. Classification and pharmacology of progestins. Maturitas 2008; 61: 171–180.
12. Alfred O. Mueck, Regine Sitruk-Ware. Nomegestrolacetate, a novelprogestogen for oral contraception. Steroids 76 2011; 531–9.
13. Couzinet B et al. J Clin Endocrin Metab 1999; 84: 4191–6.
14. Van Diepen HA et al. Contraception 2011; 84: 199–204.
15. Mansour D et al. Eur J Contracept Reprod Health Care 2011.
16. Fotherby K. Contraception 1996; 54: 59–69.
17. Lobo RA et al. Am J Obstet Gynecol 1994; 170: 1499–507.
18. Зоэли® summary of product characteristics. London, England: Merck Serono Europe Limited, 2011.
19. Mansour D, Verhoeven C, Sommer W et al. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17b-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care 2011.
20. Wiegratz I, Hommel HH et al. Attitude of German women and gynecologists towards long-cycle treatment with oral contraceptives. Contraception 2004; 69 (1): 37–42.
21. Coney P, Washenik K, Langley RGB et al. Weight change and adverse event incidence with a low-dose oral contraceptive: two randomized, placebo-controlled trials. Contraception 2001; 63 (6): 297–302.
22. Thiboutot D, Archer DF, Lemay A et al. A randomized, controlled trial of a low-dose contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel for acne treatment. Fertil Steril 2001; 76 (3): 461–8.
23. Sibai BM, Odlind V, Meador ML et al. A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho EvraTM/EvraTM). Fertil Steril 2002; 77 (suppl. 2): S19–S26.
24. Maloney JM, Dietze P, Watson D et al. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol 2008; 112 (4): 773–81.
25. Oelkers W, Foidart JM, Dombrovicz N et al. Effects of a new oral contraceptive containing an antimineralocorticoid progestogen, drospirenone, on the renin-aldosterone system, body weight, blood pressure, glucose tolerance, and lipid metabolism. J Clin Endocrinol Metab 1995; 80 (6): 1816–21.
26. Endrikat J, Sandri M, Gerlinger C et al. A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 μg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weight. Eur J Contracept Reprod Health Care 2007; 12 (3): 220–8.
27. Agren UM et al. Eur J Contracept Reprod Health Care 2011.
28. Xiangyan Ruan, Helen Schneck et al. Nomegestrol acetate sequentially or continuously combined to estradiol did not negatively affect membrane-receptor associated progestogenic effects in human breast cancer cells. Gynecol Endocrinol. 2012 Apr 12 [Epub]
2. Прилепская В.Н. Руководство по контрацепции. М.: МЕДпресс-информ, 2010.
3. Gaussem P, Alhenc-Gelas M et al. Haemostatic effects of a new combined oral contraceptive, nomegestrol acetate/17b-estradiol, compared with those of levonorgestrel/ethinyl estradiol. A double-blind, randomised study. Schattauer 2011: 560–7.
4. Agren UM et al. Eur J Contracept Reprod Health Care 2011.
5. Gallo MF, Lopez LM, Grimes DA et al. Combination contraceptives: effects on weight. Cochrane Database Syst Rev 2008; 1: CD003987. oi:10.1002/14651858. CD003987. pub 2.
6. Speroff L, Fritz MA. Oral contraception. In: Clinical Gynecologic Endocrinology and Infertility; Philadelphia: Lippincott Williams & Wilkins, 2005: 861–942.
7. Sitruk-Ware R. Pharmacological profile of progestins. Maturitas 2008; 61: 151–7.
8 Martin, K, Barbieri R. Overview of the use of estrogen-progestogen contraceptives.
9. Ouzounian S, Verstraete L, Chabbert-Buffet N. Third-generation oral contraceptives: future implications of current use. Exp Rev Obstet Gynecol 2008; 3 (2): 189–201.
10. Westhoff C, Andrew M et al. Efficacy, Safety, and Tolerability of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate and 17-Estradiol. A Randomized Controlled Trial. Obstet Gynecol 2012; 119 (5).
11. Schindler A. Classification and pharmacology of progestins. Maturitas 2008; 61: 171–180.
12. Alfred O. Mueck, Regine Sitruk-Ware. Nomegestrolacetate, a novelprogestogen for oral contraception. Steroids 76 2011; 531–9.
13. Couzinet B et al. J Clin Endocrin Metab 1999; 84: 4191–6.
14. Van Diepen HA et al. Contraception 2011; 84: 199–204.
15. Mansour D et al. Eur J Contracept Reprod Health Care 2011.
16. Fotherby K. Contraception 1996; 54: 59–69.
17. Lobo RA et al. Am J Obstet Gynecol 1994; 170: 1499–507.
18. Зоэли® summary of product characteristics. London, England: Merck Serono Europe Limited, 2011.
19. Mansour D, Verhoeven C, Sommer W et al. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17b-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care 2011.
20. Wiegratz I, Hommel HH et al. Attitude of German women and gynecologists towards long-cycle treatment with oral contraceptives. Contraception 2004; 69 (1): 37–42.
21. Coney P, Washenik K, Langley RGB et al. Weight change and adverse event incidence with a low-dose oral contraceptive: two randomized, placebo-controlled trials. Contraception 2001; 63 (6): 297–302.
22. Thiboutot D, Archer DF, Lemay A et al. A randomized, controlled trial of a low-dose contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel for acne treatment. Fertil Steril 2001; 76 (3): 461–8.
23. Sibai BM, Odlind V, Meador ML et al. A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho EvraTM/EvraTM). Fertil Steril 2002; 77 (suppl. 2): S19–S26.
24. Maloney JM, Dietze P, Watson D et al. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol 2008; 112 (4): 773–81.
25. Oelkers W, Foidart JM, Dombrovicz N et al. Effects of a new oral contraceptive containing an antimineralocorticoid progestogen, drospirenone, on the renin-aldosterone system, body weight, blood pressure, glucose tolerance, and lipid metabolism. J Clin Endocrinol Metab 1995; 80 (6): 1816–21.
26. Endrikat J, Sandri M, Gerlinger C et al. A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 μg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weight. Eur J Contracept Reprod Health Care 2007; 12 (3): 220–8.
27. Agren UM et al. Eur J Contracept Reprod Health Care 2011.
28. Xiangyan Ruan, Helen Schneck et al. Nomegestrol acetate sequentially or continuously combined to estradiol did not negatively affect membrane-receptor associated progestogenic effects in human breast cancer cells. Gynecol Endocrinol. 2012 Apr 12 [Epub]
2. Прилепская В.Н. Руководство по контрацепции. М.: МЕДпресс-информ, 2010.
3. Gaussem P, Alhenc-Gelas M et al. Haemostatic effects of a new combined oral contraceptive, nomegestrol acetate/17b-estradiol, compared with those of levonorgestrel/ethinyl estradiol. A double-blind, randomised study. Schattauer 2011: 560–7.
4. Agren UM et al. Eur J Contracept Reprod Health Care 2011.
5. Gallo MF, Lopez LM, Grimes DA et al. Combination contraceptives: effects on weight. Cochrane Database Syst Rev 2008; 1: CD003987. oi:10.1002/14651858. CD003987. pub 2.
6. Speroff L, Fritz MA. Oral contraception. In: Clinical Gynecologic Endocrinology and Infertility; Philadelphia: Lippincott Williams & Wilkins, 2005: 861–942.
7. Sitruk-Ware R. Pharmacological profile of progestins. Maturitas 2008; 61: 151–7.
8 Martin, K, Barbieri R. Overview of the use of estrogen-progestogen contraceptives.
9. Ouzounian S, Verstraete L, Chabbert-Buffet N. Third-generation oral contraceptives: future implications of current use. Exp Rev Obstet Gynecol 2008; 3 (2): 189–201.
10. Westhoff C, Andrew M et al. Efficacy, Safety, and Tolerability of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate and 17-Estradiol. A Randomized Controlled Trial. Obstet Gynecol 2012; 119 (5).
11. Schindler A. Classification and pharmacology of progestins. Maturitas 2008; 61: 171–180.
12. Alfred O. Mueck, Regine Sitruk-Ware. Nomegestrolacetate, a novelprogestogen for oral contraception. Steroids 76 2011; 531–9.
13. Couzinet B et al. J Clin Endocrin Metab 1999; 84: 4191–6.
14. Van Diepen HA et al. Contraception 2011; 84: 199–204.
15. Mansour D et al. Eur J Contracept Reprod Health Care 2011.
16. Fotherby K. Contraception 1996; 54: 59–69.
17. Lobo RA et al. Am J Obstet Gynecol 1994; 170: 1499–507.
18. Зоэли® summary of product characteristics. London, England: Merck Serono Europe Limited, 2011.
19. Mansour D, Verhoeven C, Sommer W et al. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17b-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care 2011.
20. Wiegratz I, Hommel HH et al. Attitude of German women and gynecologists towards long-cycle treatment with oral contraceptives. Contraception 2004; 69 (1): 37–42.
21. Coney P, Washenik K, Langley RGB et al. Weight change and adverse event incidence with a low-dose oral contraceptive: two randomized, placebo-controlled trials. Contraception 2001; 63 (6): 297–302.
22. Thiboutot D, Archer DF, Lemay A et al. A randomized, controlled trial of a low-dose contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel for acne treatment. Fertil Steril 2001; 76 (3): 461–8.
23. Sibai BM, Odlind V, Meador ML et al. A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho EvraTM/EvraTM). Fertil Steril 2002; 77 (suppl. 2): S19–S26.
24. Maloney JM, Dietze P, Watson D et al. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol 2008; 112 (4): 773–81.
25. Oelkers W, Foidart JM, Dombrovicz N et al. Effects of a new oral contraceptive containing an antimineralocorticoid progestogen, drospirenone, on the renin-aldosterone system, body weight, blood pressure, glucose tolerance, and lipid metabolism. J Clin Endocrinol Metab 1995; 80 (6): 1816–21.
26. Endrikat J, Sandri M, Gerlinger C et al. A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 μg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weight. Eur J Contracept Reprod Health Care 2007; 12 (3): 220–8.
27. Agren UM et al. Eur J Contracept Reprod Health Care 2011.
28. Xiangyan Ruan, Helen Schneck et al. Nomegestrol acetate sequentially or continuously combined to estradiol did not negatively affect membrane-receptor associated progestogenic effects in human breast cancer cells. Gynecol Endocrinol. 2012 Apr 12 [Epub]
________________________________________________
2. Прилепская В.Н. Руководство по контрацепции. М.: МЕДпресс-информ, 2010.
3. Gaussem P, Alhenc-Gelas M et al. Haemostatic effects of a new combined oral contraceptive, nomegestrol acetate/17b-estradiol, compared with those of levonorgestrel/ethinyl estradiol. A double-blind, randomised study. Schattauer 2011: 560–7.
4. Agren UM et al. Eur J Contracept Reprod Health Care 2011.
5. Gallo MF, Lopez LM, Grimes DA et al. Combination contraceptives: effects on weight. Cochrane Database Syst Rev 2008; 1: CD003987. oi:10.1002/14651858. CD003987. pub 2.
6. Speroff L, Fritz MA. Oral contraception. In: Clinical Gynecologic Endocrinology and Infertility; Philadelphia: Lippincott Williams & Wilkins, 2005: 861–942.
7. Sitruk-Ware R. Pharmacological profile of progestins. Maturitas 2008; 61: 151–7.
8 Martin, K, Barbieri R. Overview of the use of estrogen-progestogen contraceptives.
9. Ouzounian S, Verstraete L, Chabbert-Buffet N. Third-generation oral contraceptives: future implications of current use. Exp Rev Obstet Gynecol 2008; 3 (2): 189–201.
10. Westhoff C, Andrew M et al. Efficacy, Safety, and Tolerability of a Monophasic Oral Contraceptive Containing Nomegestrol Acetate and 17-Estradiol. A Randomized Controlled Trial. Obstet Gynecol 2012; 119 (5).
11. Schindler A. Classification and pharmacology of progestins. Maturitas 2008; 61: 171–180.
12. Alfred O. Mueck, Regine Sitruk-Ware. Nomegestrolacetate, a novelprogestogen for oral contraception. Steroids 76 2011; 531–9.
13. Couzinet B et al. J Clin Endocrin Metab 1999; 84: 4191–6.
14. Van Diepen HA et al. Contraception 2011; 84: 199–204.
15. Mansour D et al. Eur J Contracept Reprod Health Care 2011.
16. Fotherby K. Contraception 1996; 54: 59–69.
17. Lobo RA et al. Am J Obstet Gynecol 1994; 170: 1499–507.
18. Зоэли® summary of product characteristics. London, England: Merck Serono Europe Limited, 2011.
19. Mansour D, Verhoeven C, Sommer W et al. Efficacy and tolerability of a monophasic combined oral contraceptive containing nomegestrol acetate and 17b-oestradiol in a 24/4 regimen, in comparison to an oral contraceptive containing ethinylestradiol and drospirenone in a 21/7 regimen. Eur J Contracept Reprod Health Care 2011.
20. Wiegratz I, Hommel HH et al. Attitude of German women and gynecologists towards long-cycle treatment with oral contraceptives. Contraception 2004; 69 (1): 37–42.
21. Coney P, Washenik K, Langley RGB et al. Weight change and adverse event incidence with a low-dose oral contraceptive: two randomized, placebo-controlled trials. Contraception 2001; 63 (6): 297–302.
22. Thiboutot D, Archer DF, Lemay A et al. A randomized, controlled trial of a low-dose contraceptive containing 20 μg of ethinyl estradiol and 100 μg of levonorgestrel for acne treatment. Fertil Steril 2001; 76 (3): 461–8.
23. Sibai BM, Odlind V, Meador ML et al. A comparative and pooled analysis of the safety and tolerability of the contraceptive patch (Ortho EvraTM/EvraTM). Fertil Steril 2002; 77 (suppl. 2): S19–S26.
24. Maloney JM, Dietze P, Watson D et al. Treatment of acne using a 3-milligram drospirenone/20-microgram ethinyl estradiol oral contraceptive administered in a 24/4 regimen: a randomized controlled trial. Obstet Gynecol 2008; 112 (4): 773–81.
25. Oelkers W, Foidart JM, Dombrovicz N et al. Effects of a new oral contraceptive containing an antimineralocorticoid progestogen, drospirenone, on the renin-aldosterone system, body weight, blood pressure, glucose tolerance, and lipid metabolism. J Clin Endocrinol Metab 1995; 80 (6): 1816–21.
26. Endrikat J, Sandri M, Gerlinger C et al. A Canadian multicentre prospective study on the effects of an oral contraceptive containing 3 mg drospirenone and 30 μg ethinyl oestradiol on somatic and psychological symptoms related to water retention and on body weight. Eur J Contracept Reprod Health Care 2007; 12 (3): 220–8.
27. Agren UM et al. Eur J Contracept Reprod Health Care 2011.
28. Xiangyan Ruan, Helen Schneck et al. Nomegestrol acetate sequentially or continuously combined to estradiol did not negatively affect membrane-receptor associated progestogenic effects in human breast cancer cells. Gynecol Endocrinol. 2012 Apr 12 [Epub]
Авторы
В.Н.Прилепская
ФГБУ Научный центр акушерства, гинекологии и перинатологии им. акад. В.И.Кулакова Минздравсоцразвития РФ
ФГБУ Научный центр акушерства, гинекологии и перинатологии им. акад. В.И.Кулакова Минздравсоцразвития РФ
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