[이달의 설교] 매력 있는 영의 사람 예수!

신재국 새가정사 2005 새가정 Vol.- No.-

활성산소에 의한 조직손상에 미치는 인삼성분의 보호효과 ( Protective Effects of a Ginseng Component , Maltol ( 2-Methyl-3-Hydroxy-4-Pyrone ) against Tissue Damages Induced by Oxygen Radicals )

신재국,박종완,표장근,김명석,정명희 고려인삼학회 1990 Journal of Ginseng Research Vol.14 No.2

임상시험의 개요

신재국,차인준 인제대학교 백병원 2002 仁濟醫學 Vol.23 No.5

Clinical trial has been extensively applied not only in drug development but for the academic researches in biomedical field. Since this is an experimental research in human subjects, the highest level of ethical and scientific requirements should be asked to the investigators and their processing. Therefore, it is not surprising that clinical trial in drug development is strictly controlled by the ethical committee(institutional review board, IRB) and governmental regulations. Good clinical practice(GCP) has been developed as a guideline to keep the ethical and scientific requirements of clinica??trial. Unreliable data obtained from non-scientific approach can not be used for the best application of drugs or medical devices in to patients, which is not ethical in terms of their unnecessary exposure in human subjects. The most ideal type of clinical trial includes prospective, randomized. controlled and double-blinded approach. This short review introduces some of the important concepts in clinical trial, especially in the design and preparation of protocol.

한국의 임상약리학: 小考

신재국 대한임상약리학회 2010 Translational and Clinical Pharmacology Vol.18 No.2

The Disposition of Reduced Haloperidol and HPP,+ Metabolites of Haloperidol, is Not Influenced by P-Glycoprotein

신재국 대한임상약리학회 2006 Translational and Clinical Pharmacology Vol.14 No.1

임상시험의 개요

신재국,차인준 인제대학교 백병원 2002 仁濟醫學 Vol.23 No.1

Clinical trial has been extensively applied not only in drug development but for the academic researches in biomedical field. Since this is an experimental research in human subjects, the highest level of ethical and scientific requirements should be asked to the investigators and their processing. Therefore, it is not surprising that clinical trial in drug development is strictly controlled by the ethical committee (institutional review board, IRB) and governmental regulations. Good clinical practice (GCP) has been developed as a guideline to keep the ethical and scientific requirements of clinical trial. Unreliable data obtained from non-scientific approach can not be used for the bess application of drugs or medical devices in to patients, which is not ethical in terms of their unnecessary exposure in human subjects. The most ideal type of clinical trial includes prospective, randomized, controlled and double-blinded approach. This short review introduces some of the important concepts in clinical trial, especially in the design and preparation of protocol.

Predictive Capability of Anorectal Physiologic Tests for Unfavorable Outcomes Following Biofeedback Therapy in Dyssynergic Defecation

신재국,천재희,김은숙,윤진영,이진하,전성민,복현정,박재준,문창모,홍성필,이용찬,김원호 대한의학회 2010 Journal of Korean medical science Vol.25 No.7

The purpose of this study is to evaluate the predictive capability of anorectal physiologic tests for unfavorable outcomes prior to the initiation of biofeedback therapy in patients with dyssynergic defecation. We analyzed a total of 80 consecutive patients who received biofeedback therapy for chronic idiopathic functional constipation with dyssynergic defecation. After classifying the patients into two groups (responders and non-responders),univariate and multivariate analyses were performed to determine the predictors associated with the responsiveness to biofeedback therapy. Of the 80 patients, 63 (78.7%) responded to biofeedback therapy and 17 (21.3%) did not. On univariate analysis, the inability to evacuate an intrarectal balloon (P=0.028), higher rectal volume for first, urgent, and maximal sensation (P=0.023, P=0.008, P=0.007, respectively), and increased anorectal angle during squeeze (P=0.020) were associated with poor outcomes. On multivariate analysis,the inability to evacuate an intrarectal balloon (P=0.018) and increased anorectal angle during squeeze (P=0.029) were both found to be independently associated with a lack of response to biofeedback therapy. Our data show that the two anorectal physiologic test factors are associated with poor response to biofeedback therapy for patients with dyssynergic defecation. These findings may assist physicians in predicting the responsiveness to therapy for this patient population.

혈액 종양환자에서 Tobramycin의 임상약동학

신재국,신완균,장인진,신상구,김성민,배현주,최강원,김진규 대한화학요법학회 1990 대한화학요법학회지 Vol.8 No.1

항암화학요법을 받고 있던 중 감염으로 tobramycin을 투여받은 36명의 혈액종양 환자에서 tobramycin의 약동학적 특성을 비종양환자군에서의 population 값과 비교 검토하였다. 이들은 모두 정상 신기능을 가진 16세 이상의 성인남녀(21:15)백혈병 환자들이었다. 36명의 혈액종양 환자에서 산출된 tobramycin의 청소율 및 체내분포용적은 각각 120.3± 27.2ml/lg/hr 및 0.386± 0.11 L/㎏로 population 추정 치보다 유의하게 큰 값을 보였다.(P. <0.05).청소율과 체내분포용적을 해당 population 추정치로 나눈 비율치(ratio)의 평균값은 각각 1.47± 0.34 및 1.20± 0.34였다. 연령, hematocrit치, 혈청albumin치, 발열 및 항암화학요법기간과 tobramycin의 청소율 및 체내분포용적 사이에 유의한 상관관계는 발견할 수 없었다. 본 연구결과 혈액종양 환자에서 tobramycin 투여시는 적정혈장농도를 유지하기 위해 일반 환자군에 비해 용량의 증가 및 투여간격의 조정이 필요하며 지속적인 혈장농도 monitoring을 통하여 용법의 재적정화가 필요할 것으로 사료된다. The pharmacokinetics of tobramycin were evaluated in 36 hematologic malignancy patients undergoing anticancer chemotherapy and compared to the expected values from the population parameters. Total body clearance(mean : 12.3±27.2㎖/㎏/hr) and volume of distribution (mean : 0.386±0.11 L/㎏) in hematologic malignancy patients with normal renal function were significantly greater than those of estimated from population parameter distribution(P<0.05). The ratios of total body clearance and volume of distribution to the population estimates were 1.44±0.37 and 1.20±.034, respectively. No relationships were found between age, hematocrit, serum albumin, fever or duration of anticancer chemotherapy and pharmacokinetic parameters. It is suggested that the increment of tobramycin dose regimen wold be considered in patients with hematologic malignancy, and dose readjustment followed by close monitoring of plasma drug concentration would be required.

약물유전학과 개인별 맞춤약물요법

신재국 대한임상약리학회 2002 Translational and Clinical Pharmacology Vol.10 No.1

Individual variation in drug response is one of major issues in clinical practice and of a drug development. These variation can range from therapeutic failure to adverse or even fatal effects of drugs in some patients. The incidence of serious and fatal adverse drug reactions (ADRs) has been reported to be 6.7% and 0.32% of hospitalized patients in USA, respectively. The risk for therapeutic failure or toxicity of a drug in an individual patient is determined by the interaction of genes and environment. Environmental factors include drug-drug interactions, patient's age, weight, renal and liver dysfunction, or other disease factors or clinical variables such as smoking and alcohol consumption. Many of these environmental factors have long been considered in determining the individualized dose regimen in conventional pharmacotherapeutics. However, inherited individual variability of drug responses has been left as a so called “idiosyncrasy” that are not predictable by physicians. Recently, the rapid development of pharmacogenetics/pharmacogenomics provide us extensive informations regarding on the genetic background on the wide inter-individual variation of drug responses, which is expected to lead to the era of personalized pharmacotherapy. Pharmacogenetics is a science that is interesting to the inherited variants of genes related to pharmacokinetics (drug metabolizing enzymes, drug transporters etc.) and pharmacodynamics (receptor, ion channel, target enzyme etc.), which are associated to the susceptibility of an individual to the higher risk of ADR or therapeutic failure. This review addresses the role of pharmacogenetics/pharmacogenomics in relation to wide interindividual variation of drug responses and to the possible contribution to the prediction of personalized pharmacotherapy.

미래의 의약품

신재국,Sin, Jae-Guk 한국과학기술단체총연합회 2004 과학과 기술 Vol.37 No.11