DOI QR코드

DOI QR Code

한약 복용 후 발생한 유해사례에 대한 연구 - 소아·청소년을 중심으로

A Study of Adverse Events that Occurred after Taking Herbal Medicine - Focused on Children and Adolescents

  • 이지홍 (동의대학교 한의과대학 소아과학교실) ;
  • 유선애 (동의대학교 한의과대학 소아과학교실) ;
  • 이승연 (동의대학교 한의과대학 소아과학교실)
  • Lee, Ji Hong (Dept. of Pediatrics, College of Oriental Medicine, Dongeui University) ;
  • Yu, Sun Ae (Dept. of Pediatrics, College of Oriental Medicine, Dongeui University) ;
  • Lee, Seung Yeon (Dept. of Pediatrics, College of Oriental Medicine, Dongeui University)
  • 투고 : 2014.07.24
  • 심사 : 2014.08.08
  • 발행 : 2014.08.31

초록

Objectives The purpose of this study is to investigate the incidence and clinical features of adverse events associated with herbal medicine, and to analyze their causality and severity. Methods This study was carried out from 159 children and adolescents who took herbal medicine in the Department of Pediatrics, ${\bigcirc}{\bigcirc}$ Korean Medical Hospital from december, 2013 to april, 2014. The data was collected by survey in person or telephone. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to analyze causality for each adverse events. Results 1. 207 cases were surveyed from 159 children and adolescents who took one or more kinds of herbal medicine. 2. A total of 12 general adverse events (5.8%) were reported from the study. Among these adverse events, 8 cases (3.9%) were associated with herbal medicine. 3. Gastro-intestinal system disorders were most frequently reported (70%) as adverse events, which is followed by psychiatric disorders (15%), skin and appendages disorders (10%), urinary system disorders (5%). 4. The most common clinical symptom was abdominal pain (20%), followed by diarrhea (15%), loose stools (10%), vomiting (10%) and borborygmus (10%). 5. The severity of adverse drug reactions was mostly mild (87.5%), and moderate (12.5%). There was no severe case. Conclusions The adverse events from herbal medicine on children and adolescents were mostly minor, most of them could continue herbal medicines.

키워드

참고문헌

  1. Lee SD, Park YC. Toxicology for herbal medicine I. Paju: Korean Studies Information. 2012:42-5.
  2. Edwards IR, Aronson JK. Adverse drug reaction: definitions, diagnosis, and management. Lancet. 2000;356:1255-9. https://doi.org/10.1016/S0140-6736(00)02799-9
  3. Lee SD. The study for activation and development of herbal adverse reaction reporting system. Ministry Food Drug Saf. 2007.
  4. Kwon YJ, Cho WK, Han CH. Status of herbal-drug-associated adverse drug reactions voluntarily reported by EMR. Korean J Orient Int Med. 2012;33(4):485-97.
  5. Jung SK, Gok SY, Yu SA, Lee SY. A study of side effects from korean herb medicine on children. J Pediatr Korean Med. 2010;24(3):33-42.
  6. You HJ, Lee JY, Kim DG. A survey on parent's recognition and retrospective study on effect of herbal medication. J Pediatr Korean Med. 2005;19(2):243-53.
  7. Korea Institute of Drug Safety & Risk Management. Available from: https://www.drugsafe.or.kr/
  8. Korea Institute of Drug Safety & Risk Management. Available from: https://www.drugsafe.or.kr/iwt/ds/ko/bbs/EgovBbs.do? bbsId=BBSMSTR_000000000041&nttId=273&pageIndex=1&searchCnd=&searchWrd=
  9. Chee DH, Kim HK, Bae JW, Sohn DR, Kim IB, Chun YK, Park HY. Guidelines on adverse drug reaction reporting. Kor J Clin Pharmacol Ther. 1998;6(2):109-18.
  10. Rhew KY, Lee SH. Analysis of the korea food and drug administration adverse drug reaction reports. Kor J Clin Pharm. 2011;21(2):138-44.
  11. Kyung EJ, Rew JH, Oh MN, Kim EK. A survey on attitude and awareness of health-care professionals regarding pharmacovigilance system and experience for Adverse Drug Reaction (ADR) from a single university hospital. Kor J Clin Pharm. 2013;23(3):256-7.
  12. Kim MH, Jung HY, Sohn MK, Kim SE, Lee YW, Park JW, Hong CS. Clinical features of adverse drug reactions in a tertiary care hospital in korea. Kor J Asthma Allergy Clin Immunol. 2008;28(1):35-9.
  13. Kim MG, Kang HR, Kim JH, Ju YS, Park SH, Hwang YI, Jang SH, Kim DG, Jung KS. Analysis of adverse drug reactions collected by an electronic reporting system in a single hospital. Kor J Med. 2009;77(5):601-9.
  14. Shin HK, Jeong SJ, Lee MS, Ernst E. Adverse events attributed to traditional korean medical practices: 1999-2010. Bull World Health Organ. 2013;91:569-75. https://doi.org/10.2471/BLT.12.111609
  15. Barnes J. Pharmacovigilance of herbal medicines : a UK perspectives. Drug Saf. 2003;26(12):829-51. https://doi.org/10.2165/00002018-200326120-00001
  16. Firenzuoli F, Gori L, Menniti-Ippolito F. Symposium on pharmacovigilance of herbal medicines. London, March 28, 2006. eCAM. 2008;5(1):117-8.
  17. Yun YJ, Shin BC, Lee MS, Cho SI, Shin WJ, Park HJ, Lee HJ. Korean herbal medicine on liver function : a systematic review in korean literature. Korean J Orient Int Med. 2009:30(1)153-72.
  18. Yun YJ, Shin BC, Lee MS, Cho SI, Park JH, Lee HJ. Systematic review of the cause of drug-induced liver injuries in korean literature. J Korean Orient Med. 2009;30(2):30-45.
  19. Jung JM, Son CG. Consideration of adverse effects of herbal drug : focussing on hepatic damage. J Daejeon Orient Med. 2008;17(1):53-7.
  20. Ko SG, Jang BE, Choi JS. ADR of herbal medicines. Kor J Orient Physiol Pathol. 2004;18(4):957-64.
  21. Kang HJ, Kim HD, Park HJ, Lee BK, Park SH, Lee JC. Analysis study of articles about 'side effect' published in the japanese journal of oriental medicine. Kor J Orient Med. 2011;17(2):47-56.
  22. Lee E, Park BW, Hea GJ, Ko H. A study on the side effects and toxicity of herbal medicine. Korean J Orient Int Med. 2002;23(2):222-7.
  23. Kim MK, Jung JH, Ahn JS, Yim JH, Lee HJ, Park EJ. A study on the state of health functional foods & herbal medicine consumed by elementary school students. J Pediatr Korean Med. 2009;23(3):143-53.
  24. Ahn YJ. A study of elementary school pupils using traditional herbal medicines. Korean J Pediatr. 2007;50(4):381-5. https://doi.org/10.3345/kjp.2007.50.4.381
  25. Ministry of Health & Welfare. A survey of the medical use of korean medicine and the consumption of herbal medicine. December 2011:143-62.
  26. Choi YH, Sohn UD. The surveillance of Adverse Drug Reaction(ADR) reported. Kor J Clin Pharm. 2003;13(2):72-81.
  27. Zopf Y, Rabe C, Neubert A, Janson C, Brune K, Hahn EC. Gender-based differences in drug prescription: relation to adverse drug reactions. Pharmacology. 2009;84(6):333-9. https://doi.org/10.1159/000248311
  28. Aagaard L, Christensen A, Hansen EH. Information about adverse drug reactions reported in children: a qualitative review of empirical studies. Br J Clin Pharmacol. 2010;70(4):481-91. https://doi.org/10.1111/j.1365-2125.2010.03682.x
  29. Rashed AN, Wong IC, Cranswick N, Hefele B, Tomlin S, Jackman J, Lee K, Hon KE, Ong J, Ghaleb M, Chua SS, Hui TM, Rascher W, Neubert A. Adverse drug reactions in children - international surveillance and evaluation (ADVISE), a multicentre cohort study. Drug Saf. 2012;35(6):481-94. https://doi.org/10.2165/11597920-000000000-00000
  30. The pharmaceutical affairs law, section 2, subsection 5. Avialable form : http://www.law.go.kr/%EB%B2%95%EB%A0%B9/%EC%95%BD%EC%82%AC%EB%B2%95
  31. Kim YK. The standardization of herbal medicine preparations in Korea. KFDA. January 2012.
  32. Kim KB, Kim DG, Kim YH, Kim JH, Baek JH, Min SY, Park EJ, Yu SA, Lee SY, Lee JY, Chae JW, Jang GT, Han YJ, Han JK. Hanbangsoacheongsonyeonuihak. Seoul: Ui Seoung Dang Publishing Co. 2010:347, 449-54.
  33. Shin MK. Clinical Traditional Herbology. Seoul: Yeong Lim's Publisher. 2002:457, 464, 466, 469, 477.
  34. Lee SJ, Lee SY, Yu SA. A Survey of actual guides for children to take the oriental medicine in the oriental clinics & the oriental hospitals. J Pediatr Korean Med. 2013;27(3):12-9. https://doi.org/10.7778/jpkm.2013.27.3.012
  35. Son MK, Lee YW, Jung HY, Yi SW, Lee KH, Kim SU, Jeong JH, Park JJ, Park JW, Hong CS. Comparison of the naranjo and WHO-uppsala monitoring centre criteria for causality assessment of adverse drug reactions. Kor J Med. 2008;74(2):181-7.
  36. Yoon CH. A study of reports about dizziness reaction - focus on the china academic journal -. J Korean Orient Med. 2009;30(5):635-49.