간손상 관련 한약 안전성 연구의 개선을 위한 한약인성 간손상 조사표 제안
Suggestion of Herbal Medicine Induced Liver Injury Investigation Forms for Improving The Research Quality of Herbal Safety
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초록
It is important to establish the safety of herbal medicine, because of its frequent and wide spreading use in Korea. Several studies on the safety of herbal medicine were performed and there had been rare serious adverse drug reaction from those reports in Korea. However the results are not strongly supported because of adopting inappropriate research methodology as enough 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 is to suggest herbal medicine induced liver injury investigation forms for performing reasonable safety research. After systematic review on the preceding studies regarding herbal safety in Korea were performed in 2008, we assessed the quality and the limitations of the primary studies. Two investigation forms for herbal safety research were made as following step, one is basic investigation form for herbal safety research and the other is advanced investigation form for suspected DILI cases. Those forms include the essential informations and data needed to make an appropriate assessment of DILI occurred during or after the use of herbal medicine. The guideline 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 widely use and improvement of those investigation forms in the study of herbal safety by many researchers for establishing better evidences in Korea.
Abstract
It is important to establish the safety of herbal medicine, because of its frequent and wide spreading use in Korea. Several studies on the safety of herbal medicine were performed and there had been rare serious adverse drug reaction from those reports in Korea. However the results are not strongly supported because of adopting inappropriate research methodology as enough 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 is to suggest herbal medicine induced liver injury investigation forms for performing reasonable safety research. After systematic review on the preceding studies regarding herbal safety in Korea were performed in 2008, we assessed the quality and the limitations of the primary studies. Two investigation forms for herbal safety research were made as following step, one is basic investigation form for herbal safety research and the other is advanced investigation form for suspected DILI cases. Those forms include the essential informations and data needed to make an appropriate assessment of DILI occurred during or after the use of herbal medicine. The guideline 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 widely use and improvement of those investigation forms in the study of herbal safety by many researchers for establishing better evidences in Korea.
참고문헌 (21)
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