대한한의학회지 (The Journal of Korean Medicine)

  • 제36권1호
  • /
  • Pages.45-60
  • /
  • 2015
  • /
  • 1010-0695(pISSN)
  • /
  • 2288-3339(eISSN)
대한한의학회 (The Society of Korean Medicine)
권호 표지
DOI QR코드

DOI QR Code

EMR의 자발적 약물부작용보고 시스템을 이용한 한약약물유해반응 분석

Analysis of Herbal-drug-associated Adverse Drug Reactions Using Data from Spontaneous Reporting System in Electronic Medical Records

  • Kim, Mikyung (Research Institute of Oriental Medicine, Dongguk University) ;
  • Han, Chang-Ho (Research Institute of Oriental Medicine, Dongguk University)
  • 투고 : 2015.03.19
  • 심사 : 2015.03.25
  • 발행 : 2015.03.31
PDF 다운로드
⟨ 이전 논문 다음 논문 ⟩

초록

Objectives: The purpose of this study was to understand the status of reporting and characteristics of adverse drug reactions (ADRs) induced by herbal drugs and to make a suggestion for the domestic pharmacovigilance system on herbal medicine. Methods: We carried out a hospital-based observational study at Dongguk University Ilsan Oriental Hospital from April 2012 to December 2014. We reviewed all the herbal-drug-associated ADRs reports registered to the spontaneous ADR reporting system in electronic medical records of the hospital in the period. Results: We found out 101 reports including 163 herbal-drug-associated ADRs from 97 patients. Females (69.3%) outnumbered males and the most frequent age group was the 50s (44, 27.0%). No serious adverse event was observed. The most commonly reported ADR was gastro-intestinal system disorders (68, 41.5%) followed by skin-related disorders (42, 25.8%). Diarrhea (29, 17.8%) was the most frequently referred clinical manifestation. Most ADRs were induced by internal medicines (160, 98.2%) including manufactured (36, 22.1%) and self-prepared decoction (160, 76.1%). The pairs of Igi-hwan-diarrhea, gamiboa-tang-vomiting, and Magnoliae Flos-gastro-intestinal-system-related ADRs were observed twice each and the others appeared only once. Conclusions: We propose Korean government to take an initiative in national pharmacovigilance system for herbal medicine. To perform the surveillance on herbal drugs, the Association of Korean Medicine (AKOM) should set up a nationwide network by designating centers connecting the Korean medical hospitals, local Korean medicine clinics, and the public health centers. The government and AKOM should also educate and encourage them to understand the pharmacovigilance system and report the ADRs actively.

키워드

참고문헌

  1. Cheon C, Park JS, Park S, Kweon KT, Shin Y, Ko SG. Necessity of Adverse Event Reporting System through the Trend of Internet News about Safety of Herbal Medicine. Kor. J. Oriental Preventive Medical Society. 2011;15(2):131-43.
  2. Jang IS, Yang CS, Lee SD, Han CH. A Review of Herbal Medicinal Products Associated with Toxic Events in Korea. J Korean Oriental Med. 2007;28(1):1-10.
  3. Heinrich M, Chan J, Wanke S, Neinhuis C, Simmonds MS. Local uses of Aristolochia species and content of nephrotoxic aristolochic acid 1 and 2--a global assessment based on bibliographic sources. Journal of ethnopharmacology, 2009;125(1):108-44. https://doi.org/10.1016/j.jep.2009.05.028
  4. Haller CA, Benowitz NL. Adverse Cardiovascular and Central Nervous System Events Associated with Dietary Supplements Containing Ephedra Alkaloids. New England Journal of Medicine. 2000;343(25):1833-8. https://doi.org/10.1056/NEJM200012213432502
  5. Sato A, Toyoshima M, Kondo A, Ohta K, Sato H, Ohsumi A. [Pneumonitis induced by the herbal medicine Sho-saiko-to in Japan]. Nihon Kyobu Shikkan Gakkai zasshi. 1997;35(4):391-5.
  6. Suk KT, Kim DJ, Kim CH, Park SH, Yoon JH, Kim YS, et al. A Prospective Nationwide Study of Drug-Induced Liver Injury in Korea. Am J Gastroenterol. 2012;107(9):1380-7. https://doi.org/10.1038/ajg.2012.138
  7. Lee J, Son C, Lee JA, Choi J, Lee MS. Do herbal medicines negatively affect liver tests? A systematic review of Korean clinical studies on safety. European Journal of Integrative Medicine. 2014;6(4):441-50. https://doi.org/10.1016/j.eujim.2014.06.006
  8. Shin HK, Jeong SJ, Lee MS, Ernst E. Adverse events attributed to traditional Korean medical practices: 1999-2010. Bull World Health Organ. 2013;91(8):569-75. https://doi.org/10.2471/BLT.12.111609
  9. Korea Institute of Drug Safety & Risk Management. Pharmacovigilance. 2014. Available at: URL:https://www.drugsafe.or.kr/iwt/ds/ko/information/EgovDrugWatchTerm.do. Accessed February 21, 2014.
  10. Korean Society for Pharmacoepidemiology & Risk Management. Pharmacoepidemiology. 2 ed. SNU Book. 2012:1-9, 33, 74-82, 108-121.
  11. Kwon YJ, Cho WK, Han CH. Status of Herbal-drug-associated Adverse Drug Reactions Voluntarily Reported by EMR. J. Int. Korean Med. 2012;33(4):485-97.
  12. Korea Institute of Drug Safety & Risk Management. Adverse Drug Reaction Assessment Report. 1 ed. Korea Institute of Drug Safety & Risk Management. 2013:60-63.
  13. Herbology Textbook Compilation Commitee for College of Korean Medicine, Herbology. Yeonglim. 2011.
  14. WHO. WHO Monographs on Selected Medicinal Plants. WHO 2009.
  15. Ryu JH. Analysis of Spontaneously Reported Adverse Drug Reactions(ADRs) and a Survey Regarding ADR from a Single Hospital. Chungnam National University. 2013.
  16. Kyung EJ, Ryu JH, Kim EY. Evaluation of adverse reactions to contrast media in the hospital. 2013;86(1032):20130418. https://doi.org/10.1259/bjr.20130418
  17. Korea Institute of Drug Safety & Risk Management. Terminology Guide for Reporting Adverse Drug Reactions. Korea Institute of Drug Safety & Risk Management. 2014:1-6.
  18. Shaw D, Graeme L, Pierre D, Elizabeth W, Kelvin C. Pharmacovigilance of herbal medicine. Journal of ethnopharmacology. 2012;140(3): 513-8. https://doi.org/10.1016/j.jep.2012.01.051
  19. Park JW. Spontaneous Adverse Drug Reaction Reporting Program in Korea JPERM. 2008; 1:20-4.
  20. Woo YJ, Chung SY, Park BJ. Current Status of Spontaneous Adverse Reactions Reporting System on Herbal Medicine in China, Japan, Korea and WHO. J. Int. Korean Med. 2014; 35(2):111-8.
  21. Kim MG, Kang HR, Kim JH, Ju YS, Park SH, Hwang YI, et al. Analysis of adverse drug reactions collected by an electronic reporting system in a single hospital. The Korean Journal of Medicine. 2009;77(5):601-9.
  22. Rhew KY, Lee S. Analysis of the Korea Food and Drug Administration Adverse Drug Reaction Reports. Kor. J. Clin. Pharm. 2011;21(2):138-44.
  23. Korean Institute for Health & Social Affairs. The Domestic Survey on the Usage and Awareness Level of Korean Medicine. Health & Welfare Issue & Focus. 2012;140(2012-21):1-8.

피인용 문헌

  1. Korean Multidimensional Assessment of Interoceptive Awareness (K-MAIA): Development and Validation vol.24, pp.3, 2015, https://doi.org/10.17547/kjsr.2016.24.3.177
  2. Characteristics of Herbal Medicine Users and Adverse Events Experienced in South Korea: A Survey Study vol.2017, pp.None, 2015, https://doi.org/10.1155/2017/4089019
  3. Cervical Spondylotic Myelopathy 환자에게 소시호탕(小柴胡湯) 투여 후 발생한 약물유해반응에 관한 임상 보고 vol.9, pp.1, 2017, https://doi.org/10.22891/kmedia.2017.9.1.47
  4. Retrospective Study of Reported Adverse Events Due to Complementary Health Products in Singapore From 2010 to 2016 vol.5, pp.None, 2015, https://doi.org/10.3389/fmed.2018.00167
  5. 가미 태음조위탕과 저열량 식이를 병행한 체중 감량 프로그램에서 발생한 이상 반응 분석 vol.18, pp.1, 2015, https://doi.org/10.15429/jkomor.2018.18.1.1
  6. 약물역학분야의 한약연구동향 vol.22, pp.3, 2015, https://doi.org/10.25153/spkom.2018.22.3.002
  7. 약물감시 실습 교육이 한의과대학 학부생의 지식, 태도 및 자가 효능감에 미치는 효과 vol.41, pp.1, 2015, https://doi.org/10.13048/jkm.20003