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한약의 안전성 등급화를 위한 evidence-based approach

Evidence-based approach for herbal medicine-safety classification : Human equivalent dose-based the margin of safety

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초록

This study was aimed to develop a new formula for herbal medicine-safety classification in terms of evidence-based medicine. Recently, human equivalent dose(HED)-based therapeutic index was developed for herbal medicine-safety classification by transforming LD50 to HED. However, the use of the ED50 and LD50 to derive the therapeutic index may be misleading as to safety, depending on the slope of the dose-response curves for therapeutic and lethal effects. To overcome this deficiency, HED-based MOS( Margin of Safety) was developed and suggested in this study. The HED-based MOS developed by using LD1, changing to ALD(approximate lethal dose), and ED99. The HED-based MOS seems to be more useful and safer than HED-based therapeutic index since its values for several herbal medicines are basically two times less than the values from HED-based therapeutic index. Thus, HED-based MOS can be a good example of Evidence-based approach for herbal medicine-safety classification.

Abstract

This study was aimed to develop a new formula for herbal medicine-safety classification in terms of evidence-based medicine. Recently, human equivalent dose(HED)-based therapeutic index was developed for herbal medicine-safety classification by transforming LD50 to HED. However, the use of the ED50 and LD50 to derive the therapeutic index may be misleading as to safety, depending on the slope of the dose-response curves for therapeutic and lethal effects. To overcome this deficiency, HED-based MOS( Margin of Safety) was developed and suggested in this study. The HED-based MOS developed by using LD1, changing to ALD(approximate lethal dose), and ED99. The HED-based MOS seems to be more useful and safer than HED-based therapeutic index since its values for several herbal medicines are basically two times less than the values from HED-based therapeutic index. Thus, HED-based MOS can be a good example of Evidence-based approach for herbal medicine-safety classification.

참고문헌 (9)

  1. 이선동, "한약독성학I" (2012), 한국학술정보(주)
  2. Bensoussan A, "Development of a Chinese herbal medicine toxicology database", Journal of Toxicology-Clinical Toxicology, 40, pp.159~167 (2002)
  3. Kim, Ellie JY, "Evidence- based toxicity evaluation and scheduling of Chinese herbal medicines", Journal of Ethno- pharmacology, 146, pp.40~61 (2013)
  4. Reagan-Shaw S, "Dose translation from animal to human studies revisited", Journal of the Federation of Ame- rican Societies for Experimental Biology, 22, pp.659~661 (2008)
  5. Esti- mating the safe starting dose in clinical trials for therapeutics in adult healthy volunteers, "U.S. Food and Drug Administration", U.S. Food and Drug Administration, ~ (2002)
  6. Peter J. Vit, "Approximate lethal dose versus median lethal dose in acute toxicity testing of pharmaceuticals. A retrospective study", Arch Toxicol, 63(4), pp.343~344 (1989)
  7. Duke JA, "Handbook of Medicinal Herbs" (2002), CRC Press
  8. McGuffin M, "Botanical Safety Handbook: Guidelines for the Safe Use and Labeling for Herbs in Commerce" (1997), CRC Press
  9. 중화인민공화국, "의료용 독성약품관리법", ~ (1988)

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