Проблемы безопасности применения лекарственных средств при инфекциях у беременных женщин

1. Brent RL. Environmental Causes of Human Congenital Malformations: The Pediatrician’s Role in Dealing With These Complex Clinical Problems Caused by a Multiplicity of Environmental and Genetic Factors. PEDIATRICS 2004; 113 (4): 957–68.
2. Wilson JG. Current status of teratology. In: Wilson JG, Fraser FC, eds. Handbook of teratology. New York: Plenum, 1977; 47.
3. Mortensen ME, Sever LE, Oakley GP. Teratology and the epidemiology of birth defects. In: Gabbe SG, Niebyl JR, Simpson JL (eds): Obstetrics: Normal and Problem Pregnancies. New York, Churchill Livingstone, 1991; 233–68.
4. Стриженок Е.А., Гудков И.В., Страчунский Л.С. Применение лекарственных средств при беременности: результаты многоцентрового фармакоэпидемиологического исследования. КМАХ. 2007; 9 (2): 162–75.
5. Amann U, Egen-Lappe V, Strunz-Lehner C, Hasford J. Antibiotics in pregnancy: analysis of potential risks and determinants in a large German statutory sickness fund population. Pharmacoepidemiol Drug Saf 2006; 15: 327–37.
6. Miller EM. Changes in serum immunity during pregnancy. Am J Hum Biol 2009; 2.
7. Cartin-Ceba R, Gajic O, Iyer VN, Vlahakis NE. Fetal outcomes of critically ill pregnant women admitted to the intensive care unit for nonobstetric causes. Crit Care Med 2008; 36 (10): 2746–51.
8. Mann JR, McDermott S, Bao H, Bersabe A. Maternal genitourinary infection and risk of cerebral palsy. Dev Med Child Neurol 2009 Jan 26.
9. Herr?iz MA, Hern?ndez A, Asenjo E, Herr?iz I [Urinary tract infection in pregnancy]. Enferm Infecc Microbiol Clin 2005;23 (Suppl. 4): 40–6.
10. Никонов А.П., Асцатурова О.Р., Шулутко П.А., Каптильный В.А. Инфекции мочевыводящих путей и беременность: диагностика и антибактериальная терапия. Consilium Medicum 2006; 6.
11. Conde-Agudelo A, Villar J, Lindheimer M. Maternal infection and risk of preeclampsia: systematic review and metaanalysis. Am J Obstet Gyn 2008; 198 (1): 7–2.
12. Kirkham C, Harris S, Grzybowski S. Evidence-based prenatal care: part II. Third-trimester care and prevention of infectious diseases. Am Fam Physician 2005; 71 (8): 1555–60.
13. Swadpanich U, Lumbiganon P, Prasertcharoensook W, Laopaiboon M. Antenatal lower genital tract infection screening and treatment programs for preventing preterm delivery. Cochrane Database Syst Rev. 2008; 2: CD00617.
14. Amann U, Egen-Lappe V, Strunz-Lehner C, Hasford J. Antibiotics in pregnancy: analysis of potential risks and determinants in a large German statutory sickness fund population. Pharmacoepidemiol Drug Saf 2006; 15: 327–37.
15. Рафальский В.В. Обоснование выбора антимикробных препаратов при амбулаторных инфекциях  мочевыводящих путей. Дис. ... докт. мед. наук. Смоленск, 2004.
16. Gagne JJ, Maio V, Berghella V et al. Prescription drug use during pregnancy: a population-based study in Regione Emilia-Romagna, Italy. Eur J Clin Pharmacol 2008; 64 (11): 1125–32.
17. Morency AM, Bujold E. The effect of second-trimester antibiotic therapy on the rate of preterm birth. J Obstet Gyn Can 2007; 29 (1): 35–44.
18. Rosental M. How safe is that antimicrobial you are writing for the female patient? Infectious disease news. September 2003.
19. Haas A, Maschmeyer G. [Antibiotic therapy in pregnancy]. Dtsch Med Wochenschr 2008; 133 (11): 511–5.
20. Nahum GG, Uhl K, Kennedy DL. Antibiotic use in pregnancy and lactation: what is and is not known about teratogenic and toxic risks. Obstet Gyn 2006; 107 (5): 1120–38.
21. Jepsen P, Skriver MV, Floyd A et al. A population-based study of maternal use of amoxicillin and pregnancy outcome in Denmark. Br J Clin Pharmacol 2003; 55 (2): 216–21.
22. Berkovitch M, Diav-Citrin O, Greenberg RC et al. First-trimester exposure to amoxycillin/clavulanic acid: a prospective, controlled study. Br J Clin Pharmacol 2004; 58 (3): 298–302.
23. Kenyon S, Pike K, Jones DR et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet 2008; 372 (9646): 1319–27.
24. K?ll?n BA, Otterblad Olausson P, Danielsson BR. Is erythromycin therapy teratogenic in humans? Reprod Toxicol 2005; 20 (2): 209–14.
25. Czeizel AE, Rockenbauer M, Olsen J, Sоrensen HT. A case-control teratological study of spiramycin, roxithromycin, oleandomycin and josamycin. Acta Obstet Gyn Scand 2000; 79 (3): 234–7.
26. Pitsouni E, Iavazzo C, Athanasiou S, Falagas ME. Single-dose azithromycin versus erythromycin or amoxicillin for Chlamydia trachomatis infection during pregnancy: a meta-analysis of randomised controlled trials. Int J Antimicrob Agents 2007; 30 (3): 213–21.
27. European STD Guidelines, International J of STD AIDS 2001; 12 (Suppl. 3).
28. Российское общество акушеров-гинекологов. Информационное письмо. М., Январь 2005.
29. Sarkar M, Woodland C, Koren G, Einarson AR. Pregnancy outcome following gestational exposure to azithromycin. BMC Pregnancy Childbirth 2006; 6: 18.
30. Einarson A, Phillips E, Mawji F et al. A prospective controlled multicentre study of clarithromycin in pregnancy. Am J Perinatol 1998; 15 (9): 523–5.
31. Guay DR. Contemporary management of uncomplicated urinary tract infections. Drugs 2008; 68 (9): 1169–205.
32. Garau J. Other antimicrobials of interest in the era of extended-spectrum beta-lactamases: fosfomycin, nitrofurantoin and tigecycline. Clin Microbiol Infect 2008; 14 (Suppl. 1): 198–202.
33. Bayrak O, Cimentepe E, Inegоl I et al. Is single-dose fosfomycin trometamol a good alternative for asymptomatic bacteriuria in the second trimesterof pregnancy? Int Urogynecol J Pelvic Floor Dysfunct 2007; 18 (5): 525–9.
34. Naber KG, Schito G, Botto H et al. Surveillance study in Europe and Brazil on clinical aspects and Antimicrobial Resistance Epidemiology in Females with Cystitis (ARESC): implications for empiric therapy. Eur Urol 2008; 54 (5): 1164–75.
35. Синякова Л.А., Косова И.В. Применение фосфомицина трометамола в лечении инфекций нижних отделов мочевыводящих путей. Клин. микробиол. и антимикроб. xимиотер. 2005; 7 (2).
36. Reeves DS. Treatment of bacteriuria in pregnancy with single dose fosfomycin trometamol: a review. Infection 1992; 20 (Suppl. 4): S313–6.
37. Smet PA. Clinical risk management of herb-drug interactions. Br J Clin Pharmacol 2007; 63 (3): 258–67.
38. Boullata JI, Nace А. Safety Issues with Herbal Medicine. Pharmacotherapy 2000; 20 (3): 257–69.
39. Low Dog T. The use of botanicals during pregnancy and lactation. Altern Ther Health Med 2009; 15 (1): 54–8.
40. Monitoring of herbal medicines http://www.whoumc.org/DynPage.aspx?id=13120&mn=1510#herbal
41. Gabardi S, Munz K, Ulbricht C. A review of dietary supplement-induced renal dysfunction. Clin J Am Soc Nephrol 2007; 2 (4): 757–65.
42. Lai RS, Chiang AA, Wu MT et al. Outbreak of bronchiolitis obliterans associated with consumption of Sauropus androgynus in Taiwan. Lancet 1996; 348: 83–5.

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1. Brent RL. Environmental Causes of Human Congenital Malformations: The Pediatrician’s Role in Dealing With These Complex Clinical Problems Caused by a Multiplicity of Environmental and Genetic Factors. PEDIATRICS 2004; 113 (4): 957–68.
2. Wilson JG. Current status of teratology. In: Wilson JG, Fraser FC, eds. Handbook of teratology. New York: Plenum, 1977; 47.
3. Mortensen ME, Sever LE, Oakley GP. Teratology and the epidemiology of birth defects. In: Gabbe SG, Niebyl JR, Simpson JL (eds): Obstetrics: Normal and Problem Pregnancies. New York, Churchill Livingstone, 1991; 233–68.
4. Стриженок Е.А., Гудков И.В., Страчунский Л.С. Применение лекарственных средств при беременности: результаты многоцентрового фармакоэпидемиологического исследования. КМАХ. 2007; 9 (2): 162–75.
5. Amann U, Egen-Lappe V, Strunz-Lehner C, Hasford J. Antibiotics in pregnancy: analysis of potential risks and determinants in a large German statutory sickness fund population. Pharmacoepidemiol Drug Saf 2006; 15: 327–37.
6. Miller EM. Changes in serum immunity during pregnancy. Am J Hum Biol 2009; 2.
7. Cartin-Ceba R, Gajic O, Iyer VN, Vlahakis NE. Fetal outcomes of critically ill pregnant women admitted to the intensive care unit for nonobstetric causes. Crit Care Med 2008; 36 (10): 2746–51.
8. Mann JR, McDermott S, Bao H, Bersabe A. Maternal genitourinary infection and risk of cerebral palsy. Dev Med Child Neurol 2009 Jan 26.
9. Herr?iz MA, Hern?ndez A, Asenjo E, Herr?iz I [Urinary tract infection in pregnancy]. Enferm Infecc Microbiol Clin 2005;23 (Suppl. 4): 40–6.
10. Никонов А.П., Асцатурова О.Р., Шулутко П.А., Каптильный В.А. Инфекции мочевыводящих путей и беременность: диагностика и антибактериальная терапия. Consilium Medicum 2006; 6.
11. Conde-Agudelo A, Villar J, Lindheimer M. Maternal infection and risk of preeclampsia: systematic review and metaanalysis. Am J Obstet Gyn 2008; 198 (1): 7–2.
12. Kirkham C, Harris S, Grzybowski S. Evidence-based prenatal care: part II. Third-trimester care and prevention of infectious diseases. Am Fam Physician 2005; 71 (8): 1555–60.
13. Swadpanich U, Lumbiganon P, Prasertcharoensook W, Laopaiboon M. Antenatal lower genital tract infection screening and treatment programs for preventing preterm delivery. Cochrane Database Syst Rev. 2008; 2: CD00617.
14. Amann U, Egen-Lappe V, Strunz-Lehner C, Hasford J. Antibiotics in pregnancy: analysis of potential risks and determinants in a large German statutory sickness fund population. Pharmacoepidemiol Drug Saf 2006; 15: 327–37.
15. Рафальский В.В. Обоснование выбора антимикробных препаратов при амбулаторных инфекциях  мочевыводящих путей. Дис. ... докт. мед. наук. Смоленск, 2004.
16. Gagne JJ, Maio V, Berghella V et al. Prescription drug use during pregnancy: a population-based study in Regione Emilia-Romagna, Italy. Eur J Clin Pharmacol 2008; 64 (11): 1125–32.
17. Morency AM, Bujold E. The effect of second-trimester antibiotic therapy on the rate of preterm birth. J Obstet Gyn Can 2007; 29 (1): 35–44.
18. Rosental M. How safe is that antimicrobial you are writing for the female patient? Infectious disease news. September 2003.
19. Haas A, Maschmeyer G. [Antibiotic therapy in pregnancy]. Dtsch Med Wochenschr 2008; 133 (11): 511–5.
20. Nahum GG, Uhl K, Kennedy DL. Antibiotic use in pregnancy and lactation: what is and is not known about teratogenic and toxic risks. Obstet Gyn 2006; 107 (5): 1120–38.
21. Jepsen P, Skriver MV, Floyd A et al. A population-based study of maternal use of amoxicillin and pregnancy outcome in Denmark. Br J Clin Pharmacol 2003; 55 (2): 216–21.
22. Berkovitch M, Diav-Citrin O, Greenberg RC et al. First-trimester exposure to amoxycillin/clavulanic acid: a prospective, controlled study. Br J Clin Pharmacol 2004; 58 (3): 298–302.
23. Kenyon S, Pike K, Jones DR et al. Childhood outcomes after prescription of antibiotics to pregnant women with spontaneous preterm labour: 7-year follow-up of the ORACLE II trial. Lancet 2008; 372 (9646): 1319–27.
24. K?ll?n BA, Otterblad Olausson P, Danielsson BR. Is erythromycin therapy teratogenic in humans? Reprod Toxicol 2005; 20 (2): 209–14.
25. Czeizel AE, Rockenbauer M, Olsen J, Sоrensen HT. A case-control teratological study of spiramycin, roxithromycin, oleandomycin and josamycin. Acta Obstet Gyn Scand 2000; 79 (3): 234–7.
26. Pitsouni E, Iavazzo C, Athanasiou S, Falagas ME. Single-dose azithromycin versus erythromycin or amoxicillin for Chlamydia trachomatis infection during pregnancy: a meta-analysis of randomised controlled trials. Int J Antimicrob Agents 2007; 30 (3): 213–21.
27. European STD Guidelines, International J of STD AIDS 2001; 12 (Suppl. 3).
28. Российское общество акушеров-гинекологов. Информационное письмо. М., Январь 2005.
29. Sarkar M, Woodland C, Koren G, Einarson AR. Pregnancy outcome following gestational exposure to azithromycin. BMC Pregnancy Childbirth 2006; 6: 18.
30. Einarson A, Phillips E, Mawji F et al. A prospective controlled multicentre study of clarithromycin in pregnancy. Am J Perinatol 1998; 15 (9): 523–5.
31. Guay DR. Contemporary management of uncomplicated urinary tract infections. Drugs 2008; 68 (9): 1169–205.
32. Garau J. Other antimicrobials of interest in the era of extended-spectrum beta-lactamases: fosfomycin, nitrofurantoin and tigecycline. Clin Microbiol Infect 2008; 14 (Suppl. 1): 198–202.
33. Bayrak O, Cimentepe E, Inegоl I et al. Is single-dose fosfomycin trometamol a good alternative for asymptomatic bacteriuria in the second trimesterof pregnancy? Int Urogynecol J Pelvic Floor Dysfunct 2007; 18 (5): 525–9.
34. Naber KG, Schito G, Botto H et al. Surveillance study in Europe and Brazil on clinical aspects and Antimicrobial Resistance Epidemiology in Females with Cystitis (ARESC): implications for empiric therapy. Eur Urol 2008; 54 (5): 1164–75.
35. Синякова Л.А., Косова И.В. Применение фосфомицина трометамола в лечении инфекций нижних отделов мочевыводящих путей. Клин. микробиол. и антимикроб. xимиотер. 2005; 7 (2).
36. Reeves DS. Treatment of bacteriuria in pregnancy with single dose fosfomycin trometamol: a review. Infection 1992; 20 (Suppl. 4): S313–6.
37. Smet PA. Clinical risk management of herb-drug interactions. Br J Clin Pharmacol 2007; 63 (3): 258–67.
38. Boullata JI, Nace А. Safety Issues with Herbal Medicine. Pharmacotherapy 2000; 20 (3): 257–69.
39. Low Dog T. The use of botanicals during pregnancy and lactation. Altern Ther Health Med 2009; 15 (1): 54–8.
40. Monitoring of herbal medicines http://www.whoumc.org/DynPage.aspx?id=13120&mn=1510#herbal
41. Gabardi S, Munz K, Ulbricht C. A review of dietary supplement-induced renal dysfunction. Clin J Am Soc Nephrol 2007; 2 (4): 757–65.
42. Lai RS, Chiang AA, Wu MT et al. Outbreak of bronchiolitis obliterans associated with consumption of Sauropus androgynus in Taiwan. Lancet 1996; 348: 83–5.

Е.А.Ушкалова,

Кафедра общей и клинической фармакологии РУДН, научно-аналитический отдел (руководитель – проф. Е.А.Ушкалова) Федерального центра мониторинга безопасности лекарственных средств, Москва