지원사업
학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
커뮤니티
연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
초록· 키워드
오류제보하기
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.
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.
목차
서론
연구대상과 방법
결과
고찰 및 제언
참고문헌
참고문헌 (23)
참고문헌 신청
1. [학술지(정기간행물)] - 전천후 / 2011 / 한약의 안전성에 대한 인터넷 보도의 특성을 통해 본 한약 부작용 관리 체계 확립의 필요성 / 대한예방한의학회지 15 (2) : 131 ~ 143
2. [학술지(정기간행물)] - 장인수 / 2007 / 최근 독성 문제가 제기된 한약재에 대한 고찰 / 대한한의학회지 28 (1) : 1 ~ 10
3. [학술지(정기간행물)] - Heinrich M / 2009 / Local uses of Aristolochia species and content of nephrotoxic aristolochic acid 1 and 2--a global assessment based on bibliographic sources / Journal of ethnopharmacology 125 (1) : 108 ~ 144
4. [학술지(정기간행물)] - Haller CA / 2000 / Adverse Cardiovascular and Central Nervous System Events Associated with Dietary Supplements Containing Ephedra Alkaloids / New England Journal of Medicine 343 (25) : 1833 ~ 1838
5. [학술지(정기간행물)] - Sato A / 1997 / [Pneumonitis induced by the herbal medicine Sho-saiko-to in Japan] / Nihon Kyobu Shikkan Gakkai zasshi 35 (4) : 391 ~ 395
2. [학술지(정기간행물)] - 장인수 / 2007 / 최근 독성 문제가 제기된 한약재에 대한 고찰 / 대한한의학회지 28 (1) : 1 ~ 10
3. [학술지(정기간행물)] - Heinrich M / 2009 / Local uses of Aristolochia species and content of nephrotoxic aristolochic acid 1 and 2--a global assessment based on bibliographic sources / Journal of ethnopharmacology 125 (1) : 108 ~ 144
4. [학술지(정기간행물)] - Haller CA / 2000 / Adverse Cardiovascular and Central Nervous System Events Associated with Dietary Supplements Containing Ephedra Alkaloids / New England Journal of Medicine 343 (25) : 1833 ~ 1838
5. [학술지(정기간행물)] - Sato A / 1997 / [Pneumonitis induced by the herbal medicine Sho-saiko-to in Japan] / Nihon Kyobu Shikkan Gakkai zasshi 35 (4) : 391 ~ 395
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UCI(KEPA) : I410-ECN-0101-2016-519-001392155