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The Journal of Internal Korean Medicine > Volume 30(1); 2009 > Article
The Journal of Internal Korean Medicine 2009;30(1): 181-190.
간손상 관련 한약 안전성 연구의 개선을 위한 한약인성 간손상 조사표 제안
윤영주1, 신병철2, 신우진3, 장인수4
1경희대학교 동서의학대학원 동서의학과
2부산대학교 한의학전문대학원 한방재활의학과
3삼세한방병원 한방내과
4우석대학교 한의과대학 한방내과
Suggestion of Herbal Medicine-Induced Liver Injury Investigation Forms for Improving the Research Quality of Herbal Safety
Young-ju Yun1, Byung-cheul Shin2, Woo-jin Shin3, In-soo Jang4
1Dept. of East-West Medicine, Graduate School of East-West Medical Science, Kyung-hee University
2Dept. of Oriental Rehabilitation Medicine, School of Oriental Medicine, Pu-san National University
3Dept. of Internal Medicine, Sam-se Traditional Korean Hospital
4Dept. of Internal Medicine, College of Korean Medicine, Woo-suk University
Correspondence  In-soo Jang ,Tel: 063-220-8608, Fax: 063-220-8616, Email: mackayj@naver.com
  Published online: March 30, 2009.
It is important to establish the safety of herbal medicine because of its frequent and widespread use in Korea. Several studies on the safety of herbal medicine have been performed and there have been rare serious adverse drug reactions from those reports in Korea. However, the results are not strongly supported because of not adopting appropriate enough research methodology as to make the safety issue clear. For improving the quality of the safety research on herbal medicine, including investigations of drug induced liver injury (DILI), the aim of this study was to suggest herbal medicine-induced liver injury investigation forms for performing reasonable safety research. After a systematic review of the preceding studies regarding herbal safety in Korea was performed in 2008, we assessed the quality and the limitations of the primary studies. Two investigation forms for herbal safety research were made as a following step, one a basic investigation form for herbal safety research and the other an advanced investigation form for suspected DILI cases. Those forms include the essential informations and data needed to make an appropriate assessment of whether DILI occurred during or after the use of herbal medicine. Guidelines for using those forms and other recommendations were also suggested. More rigorous studies are required for answering the safety issue of herbal medicine as well as the efficacy issue. We hope for wide use and improvement of those investigation forms in the study of herbal safety by many researchers for establishing better evidences in Korea.
Key words: herbal medicine, drug induced liver injury, investigation form, causality assessment, safety, adverse drug reaction
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