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Introduction of evidence-based practical medicine through safety classification for herbal medicine(1)

한약의 안전성 등급화를 통한 근거중심실용의학적 연구(1) - Aristolochic acid 함유 한약재를 중심으로 -

  • Park, Yeong-Chul (GLP Center, Catholic University of Daegu) ;
  • Lee, Sundong (Dept. of Preventive Korean Medicine, School of Korean Medicine, Sangji University)
  • 박영철 (대구가톨릭대학교 GLP센터) ;
  • 이선동 (상지대학교 한의과대학 예방의학교실)
  • Received : 2014.02.21
  • Accepted : 2014.03.25
  • Published : 2014.03.31

Abstract

Objectives: Evidence-based medicine(EBM) advocates the use of up-to-date "best" scientific evidence from health care research as the basis for making medical decisions. EBM also has been applied to traditional Korean medicine(TKM), especially in the field of safety. Recently, the standard prescription for TKM by Korea Institute of Oriental Medicine was published based on toxic index from various toxicity tests. However, there are some limitations when the results from the study based on EBM are applied in clinics. To overcome these imitations, the term "evidence-based practical medicine" was developed and defined as clinically applicable results from the study based on EBM. And safety classification for TKM was suggested as an example of evidence-based practical medicine. Methods: For safety classification for TKM, the data for $LD_{50}$(50% lethal dose), which was transformed to theoretical $LD_1$(1% lethal dose), was analyzed as one of tools for EMB study and divided by maximum dose used in clinics. Results and Conclusions: As a result, human equivalent dose(HED)-based MOS(margin of safety) for korean traditional medicine was calculated and used for safety classification with 5 categories. These categories would be helpful for oriental medicine clinicians to decide the increase and decrease of dosage according to various factors such as patient's sensitivity, potential toxicity of herbal medicines, clinician's experience for better cure. Thus, this safety classification provides some evidences enough that evidence-based practical medicine should be not the same with EBM and defined differently from EBM.

Keywords

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