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Лекарственные поражения печени и регуляторные решения (стр. 4 из 4)

2 Нежелательное явление (НЯ) – любое выявленное у пациента или субъекта клинического исследования после применения ЛС/ исследуемого продукта неблагоприятное с медицинской точки зрения событие, которое может и не иметь причинно–следственной связи с его применением.

Список литературы

1. Mengoli M., Parmeggiani D., Mengoli M.C., et al. Drug–induced hepatotoxicity: clinical and biochemical features of 26 patients and a review of the literature. // Recenti Prog. Med. – 2011. Vol. Jun;102(6):.– P. 253–260.

2. Giri S., Nieber K., Bader A. Hepatotoxicity and hepatic metabolism of available drugs: current problems and possible solutions in preclinical stages. // Expert. Opin. Drug. Metab. Toxicol. –2010.– Aug;Vol. 6(8):.– P. 895–917.

3. Ghabril M., Chalasani N., Bjornsson E. Drug–induced liver injury: a clinical update. // Curr. Opin. Gastroenterol.– 2010.– May;Vol. 26(3):.– P. 222–226.

4. Bell L.N., Chalasani N. Epidemiology of Idiosyncratic Drug–Induced Liver Injury. // Semin. Liver. Dis. – 2009;.– Vol. 29(4):.– P. 337–347.

5. Robles M., Toscano E., Cotta J, . et al. Antibiotic–induced liver toxicity: mechanisms, clinical features and causality assessment. // Curr. Drug. Saf. – 2010. Jul– Vol. 2;5(3):.– P.212–222.

6. Petronijevic M., Ilic K., Suzuki A. Drug induced hepatotoxicity: data from the Serbian pharmacovigilance database. // Pharmacoepidemiol. Drug. Saf. – 2011.– Apr;Vol. 20(4):.– P. 416–423.

7. Larrey D. Epidemiology and individual susceptibility to adverse drug reactions affecting the liver. // Semin. Liver. Dis. – 2002;.– Vol. 22:.– P.145–155.

8. Bjornsson E., Olsson R. Outcome and prognostic markers in severe drug–induced liver disease. // Hepatology. – 2005;.– Vol. 42:.– P. 481–489.

9. Andrade R.J., Lucena M.I., Fernandez M.C., et al. Drug–induced liver injury: an analysis of 461 incidences submitted to the Spanish registry over a 10–year period. // Gastroenterology. –2005;.Vol. 129:.– P. 512–521.

10. Chalasani N., Fontana R.J., Bonkovsky H.L., et al. Causes, clinical features, and outcomes from a prospective study of drug–induced liver injury in the United States. // Gastroenterology.– 2008.– Vol. ;135:1924–1934.– P. e1921–1924.

11. Ostapowicz G., Fontana R.J., Schiodt F.V., et al. Results of a prospective study of acute liver failure at 17 tertiary care centers in the United States. // Ann. Intern. Med.– 2002;.– Vol. 137:.– P. 947–954.

12. Lee W.M., Senior J.R. Recognizing drug–induced liver injury: current problems, possible solutions. // Toxicol. Pathol.– 2005;.– Vol. 33(1):.– P.155–164.

13. Sgro C., Clinard F., Ouazir K, . et al. Incidence of drug–induced hepatic injuries: a French population–based study //. Hepatology.– 2002;.– Vol. 36:.– P. 451–455.

14. Hussaini S.H., Farrington E.A. Idiosyncratic drug–induced liver injury: an overview. // Expert. Opin. Drug. Saf.– 2007.– Nov;Vol. 6(6):.– P. 673–684.

15. Lee W.M. Drug–Induced Hepatotoxicity. // N. Engl. J. Med. – 2003;.– Vol. 349:.– P. 474–485.

16. Navarro V.J., Senior J.R. Drug–related hepatotoxicity. // N. Engl. J. Med.– 2006;.– Vol. 354(7):.– P. 731–739.

17. Li B., Wang Z., Fang J.J., Xu CY, Chen WX. et al. Evaluation of prognostic markers in severe drug–induced liver disease// . World. J. Gastroenterol. – 2007;.– Vol. 13:.– P. 628–632.

18. Юргель Н.В. и др. Руководство по организации системы мониторинга безопасности лекарственных средств в компаниях– производителях лекарственных средств или держателях регистрационных удостоверений. – Москва., 2009. http://www.roszdravnadzor.ru/i/upload/files/1297630679.43081–2828.pdf

19. Scott H.D., Rosenbaum S.E., Waters W.J., et al. Rhode Island physicians’ recognition and reporting of adverse drug reactions //. R. I. Med J.– 1987;.– Vol. 70:.– P.311–316.

20. Rogers A.S., Israel E., Smith C.R. Physician knowledge, attitudes, and behavior related to reporting adverse drug events //. Arch. Intern. Med.– 1988;.–Vol. 148:.– P.1589–1592.

21. Smith C.C., Bennett P.M., Pearce H.M., Harrison PI, Reynolds DJ, Aronson JK, Grahame–Smith et al. DG. Adverse drug reactions in a hospital general medical unit meriting notifi cation to the Committee on Safety of Medicines //. Br. J. Clin. Pharmacol. – 1996;.– Vol. 42:.– P. 423–429.

22. Aithal G.P., Rawlins M.D., Day Ch.–P. Accuracy of hepatic adverse drug reaction reporting in one English health region. // BMJ.– 1999;.– Vol. 319:.– P.1541.

23. Danan G., Benichou C. Causality assessment of adverse reactions to drugs. I. A novel method based on the conclusions of international consensus meetings: application to drug–induced liver injuries. // J. Clin. Epidemiol. – 1993;.– Vol. 46:.– P.1323–1330.

24. Rochon J., Protiva P., Seeff L.B., et al. Reliability of the Roussel Uclaf Causality Assessment Method for assessing causality in drug–induced liver injury. // Hepatology. – 2008.– Vol. Oct;48(4):.– P. 1175–1183.

25. Daly A.K., Donaldson P.T., Bhatnagar P, . et al. HLA–B*5701 genotype is a major determinant of drug–induced liver injury due to flucloxacillin. // Nat. Genet.– 2009;.– Vol. 41:.– P. 816–821.

26. Fontana R.J., Watkins P.B., Bonkovsky H.L., et al. Drug–Induced Liver Injury Network (DILIN) prospective study: rationale, design and conduct. // Drug. Saf.– 2009;. – Vol. 32(1):.– P. 55–68.

27. Leitner J.M., Graninger W., Thalhammer F. Hepatotoxicity of antibacterials: Pathomechanisms and clinical. // Infection.– 2010;.– Vol. 38:.– P. 3–11.

28. Dore D.D., DiBello J.R., Lapane K.L. Telithromycin use and spontaneous reports of hepatotoxicity // . Drug. Saf. – 2007;.– Vol. 30:.– P. 697–703.

29. Garcia Rodriguez L.A., Stricker B.H., Zimmerman H.J. Risk of acute liver injury associated with the combination of amoxicillin and clavulanic acid. //Arch. Intern. Med. – 1996;.– Vol. 156:.– P. 1327–1332.

30. Hussaini S.H., O’Brien C.S., Despott E.J., et al. Antibiotic therapy: a major cause of drug–induced jaundice in southwest England. // Eur. J. Gastroenterol. Hepatol.– 2007;.– Vol. 19:.– P.15–20.

31. O’Connor N.R. FDA boxed warnings: how to prescribe drugs safely. // Am. Fam. Physician.– 2010.– FebVol. 1;81(3).– P. :298–303.

32. Амоксициллин/клавуланат. ТКФС. www.regmed.ru.

33. Lowes R. 13 Drugs on Latest FDA List for Safety Monitoring. http://www.medscape.com/viewarticle/724545.

34. Ответ директора НИИ антимикробной химиотерапии Р.С.Козлова на публикацию новости от 7 июня 2011 года. http://www.rlsnet.ru/news_1060.htm

35. Periti P., Mazzei T., Mini E., et al. Adverse effects of macrolide antibacterials. // Drug. Saf., –1993, .– Vol. 9.– P.: 346–364.

36. Leung L., Kalgutkar A.S., Obach R.S. Metabolic activation in drug–induced liver injury. // Drug. Metab. Rev. – 2012.– Feb;Vol. 44(1):.– P.18–33.

37. Lammert C., Einarsson S., Saha C., et al. Relationship between daily dose of oral medications and idiosyncratic drug–induced liver injury: search for signals. // Hepatology. – 2008;.– Vol. 47:. –P. 2003–2009.

38. Lammert C., Niklasson A., Bjornsson E, . et al. Oral medications with significant hepatic metabolism are at higher risk for hepatic adverse events. // Hepatology.– 2010;.– Vol. 51:.– P. 615–620.

39. Ballet F. Back to basics for idiosyncratic drug–induced liver injury: dose and metabolism make the poison. // Gastroenterol. Clin. Biol. – 2010. – Aug–Sep;Vol. 34(6–7):.– P. 348–350.

40. Zhou Q., Yan X.F., et al. Rational prescription of drugs within similar therapeutic or structural class for gastrointestinal disease treatment: drug metabolism and its related interactions. // World. J. Gastroenterol. – 2007.– NovVol. 14;13(42):.– P.5618–5628.

41. Chang C.Y., Schiano T.D. Review article: drug hepatotoxicity. // Aliment. Pharmacol. Ther. –2007.– MayVol. 15;25(10):.– P.1135–1151.

42. Longo G., Valenti C., Gandini G., et al. Azithromycin–induced intrahepatic cholestasis. // Am. J. Med. – 1997;.– Vol. 102:.– P. 217–218.

43. Cascaval R.I., Lancaster D.J. Hypersensitivity syndrome associated with azithromycin. // Am. J. Med. – 2001;.– Vol.110:.– P.330–331.

44. Chandrupatla S., Demetris A.J., Rabinovitz M. Azithromycin–induced intrahepatic cholestasis .// Dig Dis Sci. – 2002;.– Vol. 47:.– P. 2186–2188.

45. Lockwood A.M., Cole S., Rabinovich M. Azithromycin–induced liver injury. // Am. J. Health Syst. Pharm. – 2010;.– Vol. 67:.– P.810–814.

46. Principi N., Esposito S. Comparative tolerability of erythromycin and newer macrolide antibacterials in paediatric patients. // Drug. Saf.– 1999;.– Vol. 20:.– P. 25–41.

47. FDA, July, 8, 2000. PID# D000539. Drug: Azithromycin. Reaction: Hepatic necrosis/hepatic failure. http://www.docstoc.com/docs/76282324/Date–January–To–Lisa–Mathis–MD–Associate– Director/.

48. Ferrajolo C., Capuano A., Verhamme K.M., et al. Drug–induced hepatic injury in children: a case/non–case study of suspected adverse drug reactions in VigiBase. // Br. J. Clin. Pharmacol. –2010.– Nov;Vol. 70(5):.– P.721–728.

49. Белоусов Ю.Б. Лекарственные поражения печени, ассоциируемые с макролидами. Очевидна ли связь? // РМЖ.– 2011 г, .– тТ.ом 19, № 18, .– с.С. 1118–1121.

50. Brown B.A., Wallace R.J., Jr, Griffith D.E., et al. Clarithromycin–induced hepatotoxicity. .// Clin. Infect. Dis.– 1995.– Vol. ;20:.– P.1073–1074.

51. Christopher K., Hyatt P.A., Horkan C., Yodice P.C. Clarithromycin use preceding fulminant hepatic failure. // Am. J. Gastroenterol.– 2002;.– Vol. 97:.– P.489–490

52. de Abajo F.J., Montero D., Madurga M., et al. Acute and clinically relevant drug–induced liver injury: a population based case–control study. // Br. J. Clin. Pharmacol.– 2004;.– Vol. 58:.– P.71–80.

53. 54. Masia M., Gutierrez F., Jimeno A, . et al. Fulminant hepatitis and fatal toxic epidermal necrolysis (Lyell disease) coincident with clarithromycin administration in an alcoholic patient receiving disulfiram therapy. // Arch. Intern. Med. – 2002. Feb– Vol. 25;162(4):.– P.474–476.

54. Tarantino G., Conca P., Basile V., et al. A prospective study of acute drug–induced liver injury in patients suffering from nonalcoholic fatty liver disease. // Hepatol. Res.– 2007;.– Vol. 37:.– P. 410–415.

55. Thevenot T., Mathurin P., Martinez F, . et al. Acute hepatitis during hypersensitivity syndrome due to midecamycin //. Eur. J. Gastroenterol. Hepatol.– 1997.– Dec;Vol. 9(12):.– P. 1249–1250.

56. 57. See A., Weiffenbach E., Bouvry M. [Cholestasis during josamycin treatment]. // Rev. Med. Interne. –1986.– May;Vol. 7(3):.– P.309–310.

57. Hussein R., El–Halabi M., Ghaith O., Severe hepatotoxicity associated with the combination of spiramycin plus metronidazole//. Arab. J. Gastroenterol.– 2011.– Mar;Vol. 12(1):.– P.44–47.