• 대한한방소아과학회지
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• 제22권3호
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• pp.83-94
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• 2008

Objectives : The purpose of this study is to confirm severe problem caused by using a modified RUCAM scale than that officially recognized to diagnose liver injury induced by herbal medicine. Materials and Methods : Cases with liver injury induced by herbal medicine received to a related institute from January 2004 to December 2007 were collected and evaluated by the original scale and modified scale. Results : 1. Based on this study, we couldn't clinicaly confirm that the case was not excluded by the relieved first item basis of modified RUCAM scale which has to be excluded by the first item basis of orginal RUCAM scale. 2. By modified 6th item, one score was added to the total score. 3. By adding 8th item, it gaind one point to the whole the total score. Conclusions : In this study, we can clinically confirm that the modified RUCAM　application to case with liver injury induced by herbal medicine is a severe problem.

• 대한한방내과학회지
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• 제36권1호
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• pp.69-75
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• 2015

본 증례보고는 퇴행성 관절염으로 양방병원에서 치료를 받던 중에 발생한 약인성 간손상으로 한방병원에서 진단 및 치료 받은 73세의 여성 환자의 증례를 소개하고자 한다. 환자는 약 3개월 동안 양방병원에서 비스테로이드성 소염제와 근육이완제 등을 처방 받아 오던 중 점차적으로 피로감과 오심 구역감 등의 위장장애를 호소하였다. 양방 의원에서 수 차례 약물치료를 하였으나 호전되지 않고 점차 극심한 피로감과 무기력감 및 위장증상으로 한방병원을 찾게 되었다. 한방병원에서 혈액검사상에 급성감염(AST 90 IU/L, ALT 100 IU/L, ALP 191 IU/L, GGT 614 IU/L) 소견을 보였다. 초음파 검사상 정상적 소견과 다른 기저질환의 배제 및 RUCAM score가 9로서 약인성 간손상으로 진단이 되었다. 15일간의 뜸치료와 침치료 및 한약물 (청간플러스시럽)의 복용으로 주관적 증상은 완전히 소실되었으며 GGT를 제외한 간기능 검사도 정상으로 회복되었다. 그동안 한약물과 관련된 약인성 간손상에 대한 연구가 주로 양의학계에서 이루어지다보니 한약물의 안전성에 대한 부정적 평가가 많았었다. 그러한 의미에서 본 증례보고는 양약에 의한 약인성 간손상에 대한 전형적인 증상의 특성을 보여주고 약인성 간손상에 대한 한의학적 관리 및 치료의 향후 연구에 대한 의미있는 증례를 제시한다고 하겠다.

• 대한한방내과학회지
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• 제40권6호
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• pp.1035-1042
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• 2019

Background: Herbal medication is widely used in the Korean Medicine Hospital, and drug-induced liver injury (DILI) in Korea has increased proportionally. Herb-induced liver injury now accounts for approximately 40% of cases of hepatotoxicity in Korea, according to research data. Currently, however, the component responsible for the toxicity is usually unknown or can only be suspected. Objective: To study the hepatotoxicity of Cheongsimyeonja-tang in DILI. Methods: A retrospective review was conducted of 82 inpatients between April 2010 and March 2017 with suspected drug-induced liver injury (n=5). The standard criteria (RUCAM scale) for drug-induced liver injury (DILI) were applied. The electronic medical records (EMRs) were retrospectively reviewed to identify the relevant database. Aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase (ALP), and total bilirubin (T. Bili) were analyzed in blood samples before and after the administration of Cheongsimyeonja-tang. Results: Five cases out of 82 patients had a criterion-referenced probable (RUCAM) score ranging from 6 to 8 points DILI. However, statistical analysis of the liver function parameters results of the 82 patients did not show a statistically meaningful elevation after taking Cheongsimyeonja-tang. Conclusions: These data suggest a relationship between Cheongsimyeonja-tang and DILI. More studies are needed to validate these observations and to explore their implications.

• 한방재활의학과학회지
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• 제26권3호
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• pp.183-189
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• 2016

A 84 year old male patient with amyotrophic lateral sclerosis (ALS) was treated by Jeungsonbaekchulsan and Gakbyeongyeonsu-tang for ten days. In the course of treatments, this patient was evaluated with Roussel Uclaf Casusality Assessment Method (RUCAM), showing results of drug induced liver injury. Herb medicine was immediately discontinued, followed by therapeutic laser treatments once a day for one week combined with 2 weeks of GODEX$^{(R)}$ administration. Transaminase results were lowered and changes in blood test results were time-effective changes. Therapeutic laser therapy could be considered effective on drug induced liver injury with further studies.

• 동의생리병리학회지
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• 제32권5호
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• pp.347-353
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• 2018

There are some controversies about the safety of herbal medicine. In order to examine the safety of herbal medicine, this study investigated the level of liver function test(AST/ALT) in patients taking herbal medicine for more than 6 months We checked liver function in 121 patients who took herbal medicine for more than 6 months. AST/ALT were measured before treatment and every 3 months (from 3 month to 9 month). In 121 patients taking herbal medicine for more than 6 months, mean AST level after 6 months was lower than before treatment and mean ALT level after 6 months was lower than before treatment. In 20 patients with abnormal AST/ALT before herbal treatment, 18 patients's AST/ALT changed to normal after 6 month herbal treatment. 2 patients's AST/ALT was slightly higher than normal. One woman patient met the criteria for herb-induced liver injury(HILI) with RUCAM scores 4 after taking herbal medicine for 6 months. Although her RUCAM score decreased to zero after taking herbal medicine for 9 months. This study suggests that long-term herbal medicine for 6 months or longer is very unlikely to injury liver function. Individual-specific liver damage may occur, it can be recovered.

• 사상체질의학회지
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• 제21권3호
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• pp.209-215
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• 2009

1. Objects: This case study reports a liver injury in treatment of constipation with Yeoldahanso-tang plus Rheum rhabarbarum. 2. Methods: The patient's subjective symptoms and the laboratory data including aspartate transaminase(AST), alanine transaminase(ALT), alkaline phosphatase(ALP), and gamma($\gamma$)-glutamyl transpeptidase(GGT) were observed before and after liver injury. We used the Roussel Uclaf Causality Assessment Method(RUCAM) scale in order to find out whether if Yeoldahanso-tang plus Rheum rhabarbarum was related with the liver injury. 3. Results: The patient's AST and ALT were elevated more than twice after a 3week administration period of herbal medicine. After discontinuation of the herbal medicine and administration of hepatic protective medication, AST and ALT decreased. The patient's general condition improved during hospitalization. The RUCAM score was estimated at 8. 4. Conclusions: This case is presented to bring more attention to the toxicity of herbal medicine.

• 대한한의학회지
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• 제37권2호
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• pp.119-124
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• 2016

Objectives: To demonstrate a clinical course and feature of a female patient with a severe liver injury (DILI) during antituberculosis treatment for her intestinal tuberculosis, whom traditional Korean medicine completely recovered. Methods: A female patient with diagnosed as DILI by antituberculosis drugs had been treated with herbal drugs; and then the clinical outcome and biochemical parameters had been monitored. Result: A 45-year old female had taken antituberculosis drugs for about 2 months, and complained severe abdominal discomfort and dyspepsia. The RUCAM score was 10, which met the criteria for DILI (AST 584 IU/L, ALT 1212 IU/L, ALP 100 IU/L, and GGT 161 IU/L, total bilirubin 0.9 mg/dL). She had been treated with herbal drugs and acupuncture as inpatient and outpatient, and then her symptoms had been completely recovered with normalization of hepatic enzymes. Conclusion: This report provides a clinical characteristic for a severe hepatotoxicity induced by antituberculosis drugs, and showed an example of TKM-based application.

• 대한한방내과학회지
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• 제44권4호
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• pp.751-756
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• 2023

목적: 본 연구는 임상에서 많은 빈도로 사용되고 있는 향정신성 약물이 간독성을 발생시킬 수 있음을 임상 예를 통해 보여줌으로써, 한의진료현장에서 이에 대한 경각심과 더불어 약인성간손상에 대한 최신 정보를 제공하고자 한다. 방법: 본 임상 예의 논문은 향정신성 약물을 사용한 후 약인성간독성의 의심과 진단 및 약물의 중단 후 증상과 간손상 효소의 개선과정을 자세히 제시하였다. 결과: 평소 혼합결합조직병으로 한방병원에서 수년 동안 침과 뜸 치료 등으로 잘 유지되고 있던 56세의 여성 환자가, 어느날부터 갑자기 심한 피로감과 전신적 불편편함을 호소하였다. 혈액검사를 시행한 결과, 혈청 AST, ALT가 정상 경계의 2.5-배 이상 증가하였고, 촤근 복용한 향정신성약물에 대한 RUCAM score가 9점으로 약인성간손상 진단에 부합하였다. 이 의심 약물들을 중지한 뒤에 주관적 불편함이 빠르게 개선되었으며, 혈청 간손상 효소 수치 또한 2주 안에 정상화되었다. 결론: 본 증례는 향정신성약물로 생길 수 있는 간손상의 전형적인 임상 예로서, 향정신성약물의 일반화된 상황에 비추어 한의원에서 환자의 진료 과정에서 하나의 중요한 고려사항을 암시한다.

• 대한한방내과학회지
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• 제40권6호
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• pp.1219-1224
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• 2019

Objective: To investigate the possibility of hepatotoxicity by supplemental foods or folk herbs such as Salvia Plebeia R. Br. Methods: A hospitalized male patient with alcoholic liver disease and electrolyte imbalance had recovered, and then followed by rapid hepatic serum enzymes after taking S. Plebeia. This study monitored the clinical outcome and biochemical parameters. Result: A 58-year male had drunk frequently, which led to alcoholic steatohepatitis and hospitalization. Two weeks after his discharge from hospital, he felt nausea, dizziness, and mild difficulties in speech and walking, resulting in re-hospitalization at the Korean Medical Hospital. The symptoms disappeared on correction of the electrolyte imbalance suspected to have been caused by severe sweating while working in the outdoors, and the patient was discharged. During treatment and monitoring of his health as an outpatient, the serum hepatic enzyme rapidly elevated approximately 10-fold in hepatic enzymes; the enzyme levels fluctuated according to whether or not he was taking the boiled water of S. Plebeia. The RUCAM score was 12, which met the criteria for toxic hepatitis by S. Plebeia. His general condition and abnormal hepatic enzymes recovered with cessation of S. Plebeia and administration of Chungganplus syrup (CGX). Conclusion: This study reports the hepatotoxic risk of Salvia Plebeia, which is commonly used as a folk remedy in Korea.

• 한국식품위생안전성학회지
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• 제26권4호
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• pp.302-307
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• 2011

One of the most important objectives of post-marketing monitoring of dietary supplements is the early detection of unknown and unexpected adverse events (AEs). Several causality algorithms, such as the Naranjo scale, the RUCAM scale, and the M & V scale are available for the estimation of the likelihood of causation between a product and an AE. Based on the existing algorithms, the Korea Food & Drug Administration has developed a new algorithm tool to reflect the characteristics of dietary supplements in the causality analysis. However, additional work will be required to confirm if the newly developed algorithm tool has reasonable sensitivity and not to generate an unacceptable number of false positives signals.