임상시험심사위원회(Institutional Review Board)의 임상시험에 대한 위험평가 분류조사연구

이선주,강수진,맹치훈,신유진,유소영,Lee, Sun Ju,Kang, Su Jin,Maeng, Chi Hoon,Shin, Yoo Jin,Yoo, Soyoung 대한기관윤리심의기구협의회 2022 대한기관윤리심의기구협의회지(JKIRB) Vol.4 No.2

Purpose: The purpose of this study is to evaluate how university hospital Institutional Review Boards (IRBs) in Korea classify risk when reviewing clinical trial protocols. Methods: IRB experts (IRB chairman, vice chairman, IRB administrator) in the university hospitals obtaining a Human research protection program (HRPP) or IRB accreditation in Korea were asked to fill out the Google Survey from September 1, 2020 to October 10, 2020. Result: Among the 23 responder hospitals, 8 were accredited by the American Association for Human Research Protection Program (AAHRPP) and 8 were accredited by the HRPP of Ministry of Food and Drug Safety (MFDS). Seven were accredited by Forum for Ethical Review Committees in Asia and the Western Pacific or Korea National Institution for Bioethics Policy. Thirteen of 23 hospitals (56.5%) had 4 levels (less than minimal, low, moderate, high risk), 4 hospitals had 3 levels (less than, slightly over, over than minimal risk), 1 hospital had 5 levels (4 levels plus required data safety monitoring board), and 1 hospital had 2 levels (less than, over than minimal risk) risk classification system. Thirteen of 23 hospitals (56.5%) had difficulty classifying the risk levels of research protocols. Fourteen hospitals (60.9%) responded that different standards among hospitals for risk level determination associated with clinical trials will affect the subject protection. Six hospitals (26.1%) responded that it will not. Three hospitals (13.0%) responded that it will affect the beginning of the clinical trial. To resolve differences in standards between hospitals, 14 hospitals (60.9%) responded that either the Korean Association of IRB or MFDS needs to provide a guideline for risk level determination in clinical trials: 5 hospitals (21.7%) responded education for IRB members and researchers is needed; 3 hospitals (13.0%) responded that difference among institutions needs to be acknowledged; and 1 hospital (4.3%) responded that there needs to be communication among IRB, investigator, and sponsor. Conclusion: After conducting a nationwide survey on how IRB in university hospital determines risk during review of clinical trials, it is reasonable to use 4-level risk classification (less than minimal, low, moderate, high risk); the most utilized method among hospitals. Moreover, personal information and conflict of interest associated with clinical trials have to be considered when reviewing clinical trial protocols.

증례 : 치은으로 전이된 비소세포폐암 1예

우종신 ( Jong Shin Woo ),맹치훈 ( Chi Hoon Maeng ),이재진 ( Jae Jin Lee ) 대한내과학회 2007 대한내과학회지 Vol.73 No.6

구강 종양은 대부분 원발성으로 발생하며, 구강 종양의 1~4%만이 전이성 암이다. 폐암의 치은으로의 전이는 뒤늦게 발생하며, 매우 드물게 보고되고 있다. 저자들은 56세 남자 환자가 비소세포폐암을 진단받은 후 1차와 2차 항암화학요법을 시행 받았으나, 원발암이 진행으로 다발성 전이와 함께 우연히 상악 치은에서 종양이 발견되어 절개 조직검사 시행 후 전이성 폐암이 진단된 증례를 경험하였기에 문헌고찰과 함께 보고하는 바이다. About 5% of all malignancies involve the oral cavity. Metastatic cancers to the oral cavity from distant sites are very rare, and only a few cases have been reported in the clinical literature. The most common tumors that metastasize to the oral cavity originate in the breast, lung, and kidney. We recently experienced a patient who had a non-small cell lung cancer that metastasized to the gingiva. The patient was 56-year-old man. The disease status was a progressive condition, although the patient had received third-line chemotherapy. The patient had multiple bony metastases including vertebral bodies, femurs, and clivus as well as the gingival metastasis. The gingival tumor was histopathologically diagnosed as a poorly differentiated adenocarcinoma. The metastatic gingival tumor had the same pathology as the primary lung cancer. (Korean J Med 73:661-665, 2007)

슈퍼와파린(Superwarfarin) 중독으로 진단된 원인미상의 응고장애 2례

변종규 ( Jong Kyu Byun ),맹치훈 ( Chi Hoon Maeng ),변자민 ( Ja Min Byun ),엄유진 ( Yu Jin Um ),김진숙 ( Jin Sug Kim ),이철현 ( Cheol Hyun Lee ),이태인 ( Tae In Lee ),윤휘중 ( Hwi Joong Yoon ),조경삼 ( Kyung Sam Cho ),김시영 ( Si Y 전북대학교 의과학연구소 2014 全北醫大論文集 Vol.38 No.1

브로디파쿰은 강력한 항응고억제작용을하여 장기간 지속되는 응고장애를 유발하는 살서제로 이로 인한 중독은 비교적 흔히 보고되나 원인이 밝혀지지 않은 중독은 드물게 보고 되고 있다. 본 증례에서는 와파린이나 살서제의 복용력이 없었으나 무통성 혈뇨를 주소로 내원한 환자에서 후천성 비타민 K 의존성 혈액응고인자의 결핍을 보여 브로디파쿰 중독을 의심하였고 혈청 브로디파쿰 농도 측정 결과 이로 인한 중독에 의한 응고장애로 진단되어 비타민 k로 혈액응고 장애를 교정하고 치료하였다. 본 사례에서와 같이 임상적으로 유의한 응고장애를 보이는 환자에서 노출 병력이 명확하지 않은 경우에도 살서제 중독을 원인으로 고려하여 혈청 농도 측정을 하고 진단시 장기간의 비타민 K 투여를 통한 치료를 통하여 치료 중단으로 인한 재출혈이 없도록 주의해야 한다. superwarfarins are popular and are readily accessible, they are associated with intoxication, leading to prolonged and sometimes life-threatening coagulopathies. We report our experience managing 2 patients who had clinical evidence of superwarfarin intoxication at Kyung Hee Medical Center in Seoul, Korea. Superwarfarin exposure or poisoning is an important public health concern in South Korea, affecting those of all ages. The diagnosis of superwarfarin poisoning is usually straightforward in cases of acute poisoning, but because many cases present with obscure history of exposure, clinical suspicion is the key to early diagnosis and timely intervention. Prolonged treatment with large doses of vitamin K is needed for superwarfarin intoxication.

Olanzapine과 Lithisum 복용 후 나타난 Neuroleptic Malignant Syndrome에 동반된 급성신부전과 Lithium 중독

오원택 ( Won Taek Oh ),맹치훈 ( Chi Hoon Maeng ),박미나 ( Mi Na Park ),최선영 ( Sun Young Choi ),정경환 ( Kyung Hwan Jeong ),문주영 ( Ju Young Moon ),이태원 ( Tae Won Lee ),임천규 ( Cheon Gyu Ihm ),이상호 ( Sang Ho Lee ) 대한신장학회 2006 Kidney Research and Clinical Practice Vol.25 No.5

We report a patient developed neuroleptic malignant syndrome (NMS) with myoglobulinemic acute renal failure and lithium intoxication due to lithium-olanzapine combination, who was successfully treated by hemodiafiltration. A 34-year-old woman with a 14-year history of bipolar disorder had been treated with lithium-olanzapine during last four days. She was admitted to our hospital for muscular rigidity, hyperthermia and altered consciousness. On admission, rhabdomyolsis was demonstratd by biochemical methods and serum level of lithium was 3.78 mEq/L which was far above toxic level. After the diagnosis of NMS with acute renal failure and lithium intoxication, olanzapine and lithium were discontinued and conservative measures and continuous venovenous hemodiafiltration were instituted. She recovered without any neurologic sequelae. (Korean J Nephrol 2006;25(5):835-839)

암환자와 비-암환자의 임종기 치료 강도 비교: 단일 연구기관 자료

김재민,백선경,김시영,맹치훈,한재준,박소영,박재훈,Kim, Jae Min,Baek, Sun Kyung,Kim, Si-Young,Maeng, Chi Hoon,Han, Jae Joon,Park, Soyoung,Park, Jae Hun 한국호스피스완화의료학회 2015 한국호스피스.완화의료학회지 Vol.18 No.4

목적: 의학의 발달로 인구가 고령화됨에 따라, 사망의 원인이 되는 질환 및 동반질환의 유병기간은 함께 증가하고 있으며, 고령환자의 임종기 관리에 대한 연구의 필요성도 더욱 증가하고 있다. 그러나 임종기 치료 강도에 대한 국내연구는 암환자에 국한되어 있으며, 비-암환자의 임종기 치료 강도에 대한 국내 연구는 없었다. 그래서 본 연구는 암환자와 비-암환자의 임종기 치료 강도에 대해 연구하였다. 방법: 경희대학교병원에서 2014년 12월 1일부터 2015년 3월 31일까지 4개월간 사망자의 의무기록을 조사하여 암환자와 비-암환자의 기본 인구학적 정보, 임종기 치료 강도, 심폐소생술 금지 요청서 경향 등에 대해 비교 연구하였다. 결과: 비-암환자가 암환자에 비해 나이가 많았음에도 불구하고(73.7 vs. 67.4, P=0.001), 중환자실 치료(87.4% vs. 36.0%, P<0.001), 기도 삽관 및 기계 호흡(63.2% vs. 24%, P<0.001), 응급 투석(28.7% vs. 8.0%, P=0.001)을 더 많이 받은 것으로 나타났으며, 나이(P=0.038), 암의 유병 여부(P<0.001)가 임종기 침습적 치료에 영향을 미치는 인자로 나타났다. 결론: 임종기 치료 강도는 비-암환자에서 더 높은 것으로 나타났으며, 나이와 암의 유병여부가 임종기 치료 강도를 결정하는 중요한 인자였다. Purpose: The aging of society has rapidly progressed, especially in Korea. Therefore, the necessity of research on end-of-life (EOL) care in elderly patients has increased. However, there are few studies on EOL care intensity for non-cancer patients. This study was designed to compare the EOL care intensity between cancer and non-cancer patients. Methods: We retrospectively analyzed the EOL care intensity based on medical records of decedents of Kyung Hee University Medical Center, a tertiary referral hospital from December 2014 through March 2015. And we compared EOL care intensity between cancer patients and non-cancer patients using statistical analysis of the frequency of invasive procedures and logistic regression analysis for factors that affect the EOL care intensity. Results: Statistical analysis showed invasive procedures, such as intensive care unit admission, endotracheal intubation followed by mechanical ventilation and emergency dialysis, were performed more frequently in non-cancer patients than cancer patients (29.3% vs. 72.4%, P<0.001). And age (P=0.038) and morbidity of cancer (P<0.001) influenced the invasive procedural decision when analyzed by logistic regression analysis. Conclusion: The EOL care was more intensive in non-cancer patients, and age and morbidity of cancer were major factors for the treatment intensity.

원발성 간내 종괴가 없는 간외담관 간세포암 1예

박철기 ( Choul Ki Park ),주광로 ( Kwang Ro Joo ),김경엽 ( Kyung Yup Kim ),오원택 ( Won Taek Oh ),맹치훈 ( Chi Hoon Maeng ),임성직 ( Sung Jig Lim ),이정일 ( Joung Il Lee ) 대한내과학회 2008 대한내과학회지 Vol.75 No.5

간내 원발성 종괴가 없는 간외담관 간세포암은 간세포암의 매우 드문 형태로 진단함에 있어 간외담관암과 감별이 매우 힘든 질환이다. 저자들은 황달을 주소로 내원한 69세 여자 환자에서 수 차례의 ERCP를 통한 조직 검사로 상기 질환을 진단하였기에 문헌고찰과 함께 보고한다. Obstructive jaundice associated with hepatocellular carcinoma (HCC) is an uncommon symptom caused by intraductal tumor growth, the migration of tumor necrosis, blood clots within the biliary tract, or compression of the biliary tract by the tumor. Most cases of icteric-type HCC involve a main tumor in the liver parenchyma. Bile duct HCC without a primary hepatic tumor is extremely rare, but because it shows similar clinical manifestations and imaging results to extrahepatic bile duct cancer, it is possible to misdiagnose this condition as a primary bile duct tumor or choldocholithiasis. Recently, we experienced a case of obstructive jaundice associated with an extrahepatic bile duct tumor in a 69-year-old woman. Upon radiologic studies and endoscopic cholangiography, the cause of obstructive jaundice was initially attributed to the bile duct tumor itself. However, subsequent analysis indicated that the condition was, in fact, due to bile duct thrombi associated with extrahepatic bile duct HCC. (Korean J Med 75:559-563, 2008)

A Case of Streptococcus pyogenes Pneumonia with Rhabdomyolysis

Shin, Joonbeom,Moon, Soo-youn,Maeng, Chi Hoon,Lee, Mi Suk,Lee, Sangho,Lee, Hee Joo,Lee, Sang Oh 대한감염학회 2007 감염과 화학요법 Vol.39 No.5

We describe a case of Streptococcus pyogenes pneumonia in a 63-year-old man presenting with rhabdomyolysis and acute renal failure. The patient completely recovered following treatment with mechanical ventilation, continuous venovenous hemodiafiltration, and intravenous antimicrobial agents. 저자들은 제2형 당뇨병으로 진단 받고 인슐린으로 당뇨조절 중이던 68세 남자에서 횡문근융해증이 동반된 Streptococcus pyogenes에 의한 지역사회폐렴 1예를 경험하였기에 문헌고찰과 함께 보고하는 바이다.