Лекарственные средства и беременность


Е.А. Ушкалова

Применение ЛС при беременности является одной из наименее изученных проблем клинической фармакологии. Предполагают, что ЛС определяют около 1% всех врожденных аномалий. Обсуждаются проблемы регулирования ЛС при беременности. Подробно рассматриваются и сопоставляются классификации потенциального риска ЛС для плода (FDA, ADEC, FASS). Приводятся данные о влиянии беременности на фармакокинетику ЛС, рассматриваются механизмы и сроки неблагоприятного воздействия фармакотерапии на плод. Формулируются общие правила назначения ЛС беременным женщинам.

Литература






  1. [Syndromes 8. The diagnosis of congenital anomalies and syndromes] Ned Tijdschr Tandheelkd 1999;106:51-3.
  2. Kalter H, Warkany J. Congenital malformations: etiologic factors and their role in prevention. N Engl J Med 1983;308:424-31.
  3. Anderson RN. Deaths: leading causes for 2000. Natl Vital Stat Rep 2002;50:1-85.
  4. 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, pp 233-268.
  5. Brent RL, Beckman DA. The contribution of environmental teratogens to embryonic and fetal loss. Clin Obstet Gynecol 1994;37:646-70.
  6. Epidemiology 2001;12:497-501.
  7. Mengue SS, Schenkel EP, Duncan BB, Schmidt MI. Drug use by pregnant women in six Brazilian cities. Rev Saude Publica 2001;35:415-20.
  8. Brucker MC. Top ten pharmacologic considerations in pregnancy. Program and abstracts of the 5th Annual Conference of the National Association of Nurse Practitioners in Women's Health; September 27-29, 2002; Scottsdale, Arizona
  9. National Center for Health Statistics, CDC. 1997 National Ambulatory Medical Care Survey (public use data files). Available at: http://www.cdc.gov/nchs/datawh/ftpserv/ftpdata/ftpdata.htm.
  10. Weiss SR, McFarland BE, Corelle C, et al. Patterns of drug use in pregnancy [abstract]. Pharmacoepidemiol Drug Saf 1997;6(suppl. 2):S69.
  11. Weiss SR. Prescription Medication Use in Pregnancy. Medscape Pharmacotherapy 2000;2(2).
  12. Olesen C, Sorensen HT, de Jong-van den Berg L, et al. Prescribing during pregnancy and lactation with reference to the Swedisр classification system. A population-based study among Danish women. The Euromap Group. Acta Obstet Gynecol Scand 1999;78:686-92.
  13. FASS. Classification of medical products for use during pregnancy and lactation. The Swedish system. Stockholm: LINFO, Drug Information Ltd, 1993.
  14. Briggs CG, Freeman RK, Yaffe SJ, editors. Drugs in pregnancy and lactation. Williams & Wilkins, 1994.
  15. Australian Drug Evaluation Committee. Medicines in pregnancy. An Australian Categorization of Risk, 1992.
  16. Addis A, Sharabi S, Bonati M. Risk classification systems for drug use during pregnancy: are they a reliable source of information? Drug Saf 2000;23:245-53.
  17. Summary of labelling changes by FDA, 17 Apr 2002. Available from URL: http://www.fda.gov.
  18. U.S. Food and Drug Administration Center for Drug Evaluation and Research. Reviewer guidance: evaluation of human pregnancy outcome data. Draft Guidance. June 1999. Available at: http://www.fda.gov/cder/guidance/2377dft.htm.
  19. U.S. Food and Drug Administration Center for Drug Evaluation and Research. Guidance to industry: establishing pregnancy registries. Draft Guidance. June 1999. Available at: http://www.fda.gov/cder/guidance/2381dft.pdf
  20. National Institutes of Health. Agenda for research on women's health for the 21st Century. A report of the task force on the NIH Women's Health Research Agenda for the 21st Century, Volume 1, Executive Summary. Bethesda, Maryland. NIH 99-4395. Available at: http://www4.od.nih.gov/orwh/report.pdf.
  21. Loebstein R, Lalkin A, Koren G. Pharmacokinetic changes during pregnancy and their clinical relevance. Clin Pharmacokinet 1997;33:328-43.
  22. Frederiksen MC. Physiologic changes in pregnancy and their effect on drug disposition. Semin Perinatol 2001;25:120-3.
  23. Ballabh P, Lo ES, Kumari J, et al. Pharmacokinetics of Betamethasone in Twin and Singleton Pregnancy. Clin Pharmacol Ther 2002;71:39-45.
  24. Little BB. Pharmacokinetics during pregnancy: evidence-based maternal dose formulation. Obstet Gynecol 1999;93(5 Pt 2):858-68.
  25. Tomson T, Lindbom U, Ekqvist B, Sundqvist A. Epilepsy and pregnancy: a prospective study of seizure control in relation to free and total plasma concentrations of carbamazepine and phenytoin. Epilepsia 1994;35:122-30.
  26. Rubin PC. General principles. In: Rubin PC, ed. Prescribing in pregnancy. 2nd ed. London: BMJ Publishing, 1995:1-8.
  27. Карпов О.И., Зайцев А.А. Риск применения лекарств при беременности и лактации. БХВ – Санкт-Петербург, 1998 – 352 с.
  28. Moore KL, Persaud TVN. The Developing Human: Clinically Oriented Embryology. 6th ed. Philadelphia, Pa: WB Saunders Co; 1998:183.
  29. Lammer EJ, Chen DT, Hoar RM, et al. Retinoic acid embryopathy. N Engl J Med 1985;313:837-84.
  30. Schmitz KJ, Matos MI, Lopez D, et al. Folate supplementation and neural tube defects: a review of a public health issue. P R Health Sci J 1997;16:387-393.
  31. Lewis DP, Van Dyke DC, Stumbo PJ, Berg MJ. .Drug and environmental factors associated with adverse pregnancy outcomes. Part I: Antiepileptic drugs, contraceptives, smoking, and folate. Ann Pharmacother 1998;32:802-17.
  32. Crawford P. CPD-Education and self-assessment: Epilepsy and pregnancy. Seizure 2001;10:212-9.
  33. Centers for Disease Control and Prevention (CDC). Neural Tube Defect Surveillance and Folic Acid Intervention – Texas-Mexico Border, 1993-1998 MMWR 49(1), 2000.
  34. Fitzgerald M. Sick and pregnant: treatment of common episodic illness. Program and abstracts of the National Conference for Nurse Practitioners 2001; November 7-10, 2001; Washington, DC.
  35. Edmunds MW, Mayhew MS. Pharmacology for the Primary Care Provider. Baltimore, Md: Mosby; 2000;115.
  36. Drugs in pregnancy and lactation (4-th edition). Ed.: Gerald G. Biggs, Roger K. Freeman, Summer J. Yaffe – Williams & Wilkins. – 1994. – 975 p.
  37. Rubin P. Drug treatment during pregnancy BMJ 1998;317:1503-6



Бионика Медиа