한방병원 입원환자의 한⋅양방 약물 병용에 따른 간 기능 안전성 평가 : 전향적 관찰연구
Safety of Korean Herbal Medicine Used with Western Medicine on Liver Function : Prospective Observational Study
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참고문헌
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초록
Objectives : To investigate the incidence of drug-induced liver injury (DILI) by combined-prescription of Korean herbal medicine (KHM; prescribed herbal medicine by doctors of traditional Korean medicine) and Western medicine on liver function. Methods : Sixty-nine in-patients who took KHM and Western medicine for various conditions were enrolled for prospective observational study. All subjects were given liver and renal function tests at the start of hospitalization to establish a baseline. After taking KHM and Western medicine, tests were done at approximately 4-week intervals afterwards. Results : Fifty-three subjects showed normal liver function test (LFT) at baseline, 50 subjects (72.5%) remained within the normal range at the second test, while 3 subjects (4.3%) tests revealed slight increase of LFT. However not a single patient had a high enough raised LFT to indicate liver injury. Sixteen of 69 subjects had abnormal baseline, 11 subjects recovered to normal levels and 5 subjects remained at abnormal level. Among all subjects, there was no statistically significant increase in LFT level between the first and second tests. Conclusions : This study shows that the combined-prescription of KHM and Western medicine did not cause any DILI. In some cases, combined treatment increased LFT levels but those increases were not high enough to have statistical significance. Additional large scale and systematical studies are required for more conclusive proof and results.
Abstract
Objectives : To investigate the incidence of drug-induced liver injury (DILI) by combined-prescription of Korean herbal medicine (KHM; prescribed herbal medicine by doctors of traditional Korean medicine) and Western medicine on liver function. Methods : Sixty-nine in-patients who took KHM and Western medicine for various conditions were enrolled for prospective observational study. All subjects were given liver and renal function tests at the start of hospitalization to establish a baseline. After taking KHM and Western medicine, tests were done at approximately 4-week intervals afterwards. Results : Fifty-three subjects showed normal liver function test (LFT) at baseline, 50 subjects (72.5%) remained within the normal range at the second test, while 3 subjects (4.3%) tests revealed slight increase of LFT. However not a single patient had a high enough raised LFT to indicate liver injury. Sixteen of 69 subjects had abnormal baseline, 11 subjects recovered to normal levels and 5 subjects remained at abnormal level. Among all subjects, there was no statistically significant increase in LFT level between the first and second tests. Conclusions : This study shows that the combined-prescription of KHM and Western medicine did not cause any DILI. In some cases, combined treatment increased LFT levels but those increases were not high enough to have statistical significance. Additional large scale and systematical studies are required for more conclusive proof and results.
참고문헌 (18)
- Cullen JM, "Mechanistic classification of liver injury", Toxicol Pathol, 33(1), pp.6~8 (2005)
- Nadir A, "Acute hepatitis associated with the use of a Chinese herbal product, ma-huang", Am J Gastroenterol, 91(7), pp.1436~1438 (1996)
- Itoh S, "Liver injuries induced by herbal medicine, syo-saiko-to(xiao-chai-hu-tang)", Dig Dis Sci, 40(8), pp.1845~1848 (1995)
- Li B, "Evaluation of prognostic markers in severe drug-induced liver disease", World J Gastroenterol, 13(4), pp.628~632 (2007)
- Wai CT, "Drug-induced liver Injury at an Asian center: a prospective study", Liver Int, 27(4), pp.465~474 (2007)
- Melchart D, "Monitoring of liver enzymes in patients treated with traditional Chinese drugs", Complement Ther Med, 7, pp.208~216 (1999)
- Al-Khafaji M, "Monitoring of liver enzymes in patients on Chinese Medicine", J Chinese Med, 62, pp.6~10 (2000)
- Mantani M, "Incidence and clinical features of liver injury related to Kampo (Japanese herbal) medicine in 2,496 cases between 1979 and 1999: Problems of the Lymphocyte transformation test as a diagnostic method", Phytomedicine, 9, pp.280~287 (2002)
- Jeong TY, "A prospective study on the safety of herbal medicines, used alone or with conventional medicines", Journal of Ethnopharmacology, 143(3), pp.884~888 (2012)
- 김진배, "급성 독성 간손상의 임상적 양상", Clinical and Molecular Hepatology, 10(2), pp.125~134 (2004), 대한간학회
- Benichou C, "Criteria of drug-induced liver disorders : Report of an international consensus meeting", J Hepatol, 11, pp.272~276 (1990)
- Bussieres JF, "Application of International Consensus Meeting : Criteria for classifying drug-induced liver disorders", Ann Pharmacother, 29, pp.875~878 (1995)
- Andrade RJ, "Drug- induced Liver injury; an analysis of 461 Incidences Submitted to the Spainish Registry over a 10-year perioid", J Clin Gastroenterol, 129(2), pp.512~521 (2005)
- Reuben A, "Drug-induced acute liver failure: results of a U.S. multicenter, prospective study", Hepatology, 52(6), pp.2065~2076 (2010)
- 한국인의 한약재 복용실태 조사 연구, "이종태", 식품의약품안전청, ~ (2006)
- 윤영주, "한약이 간손상을 유발할 가능성이 있는가 : 한약 관련 간손상에 관한 국내 연구의 체계적 고찰", 박사, 동서의학, pp.2009
- 윤영주, "한약 복용이 간기능에 미치는 영향 : 전향적 다기관 예비연구", 동의생리병리학회지, 23(3), pp.715~722 (2009), 대한동의병리학회
- Kim NH, "Liver enzyme abnormalities during concurrent use of herbal and conventional medicines in Korea: A retrospective study", Phytomedicine, 18, pp.1208~1213 (2011)