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Effect of Cimetidine on Theophylline Disposition and Metabolic Pathways
장인진,이선희,신재국,신상구,박찬웅,Jang, In-Jin,Lee, Sun-Hee,Shin, Jae-Gook,Shin, Sang-Goo,Park, Chan-Woong The Korean Society of Pharmacology 1990 대한약리학잡지 Vol.26 No.1
Cimetidine이 theophylline의 약동학적 특성과 대사과정에 미치는 효과를 검토코자 6마리의 개를 대상으로 일주일간 정맥내 cimetidine(30mg/kg/day)투여 전후에 단일 용량의 정맥투여에 따른 theophylline의 약동학적 parameter 및 뇨중 theophylline 대사물 배설의 변화를 교차 실험을 통하여 관찰하였다. 대조실험에 비해 cimetidine투여후 theophylline의 청소율은 평균 31%(P<0.05)감소하였고 혈장반감기는 29%(P<0.01)연장되었다. 그러나 steady-state의 분포용적 및 혈장 단백 결합의 변화는 관찰할 수 없었다. Theophylline의 주 대사물인 3-methylxanthine, 1-methyluric acid 및 1,3-dimethyluric acid의 24시간 뇨증 배설량은 cimetidine투여후 모두 감소 하였으나 통계적으로 유의한 변화는 아니었으며 개별대사물의 배설 분획은 변화가 없었다. 이상의 결과로 부터 cimetidine이 theophylline의 demethylation과 8-hydroxylation대사과정 모두를 비선택적으로 억제함으로써 청소율을 감소시키고 반감기를 증가시킬 것으로 추정되었다. The effect of cimetidine on theophylline metabolism was examined in dogs. Single dose intravenous theophylline kinetic studies were performed in cross-over manner before and after one week intravenous cimetidine (30 mg/kg/day) treatment. Cimetidine decreased theophylline clearance by an average of 31% (p<0.05) and prolonged theophylline half-li fe by an average of 29% (p<0.01) compared to those in control peirods. However, steady-state volume of distribution and protein binding of theophylline were not changed significantly. Twenty-four hours urinary excretion of 3-methylxanthine, 1-methyluric acid and 1,3-dimethyluric acid, which are the major metabolites of theophylline, were all decreased after cimetidine treatment, whereas the excreted fractions of individual metabolites were unchanged by cimetidine. From the above data, it could be susggested that cimetidine decreases theophylline clearance and prolongs the half-life by non-specific inhibition of the demethylations and 8-hydroxylation pathways.
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장인진 대한의사협회 2010 대한의사협회지 Vol.53 No.9
The reported failure rates in phase 2A and 2B for drugs completing phase 1 and proof of concept (POC) and those in phase 3 for drugs completing phase 2B are as high as 40% and 50%, respectively. These attrition rates are often due to poor design and analysis of data, such as insufficient size and duration for safety, insufficient dose range, neglected time course of drug response, poor analysis of categorical data, and neglected subgroups. Collaborations among industry, academia, and government are becoming more important in developing new clinical trial technology and bridging the gap between the discoveries in basic science and product development for public health. The benefit of using new science are emphasized in a white paper “Critical Path Initiatives” and following reports by United States Food and Drug Administration (US FDA) and consortium activities such as the Critical Path Institute of the US. When properly analyzed, biomarkers of pharmacodynamics (PD), disease progress, or toxicity can reduce failure rates in phase 2 or 3 by providing tools for an early decision of GO or NO-GO, optimal dose range,etc. Eventually this can lead to monitoring tools for outcomes of disease, better and safer therapy,and tailored medicine. In the past, traditional biomarkers were single measures of physiological or biochemical processes such as HIV burden, cancer markers, blood glucose, blood pressure, etc. Now multiple or clusters of omics measures and in vivo imaging are being added to the list. These biomarkers are best utilized when more quantitative model based drug development tools such as modeling and simulation of pharmacokinetics/PD and disease model are implemented in the overall drug development processes. New clinical trial designs such as microdosing and adaptive designs are also useful for the application of biomarkers for efficient clinical trials. Bioinformatics can also facilitate clinical trials with electronic data capturing, data transfer, and so on.
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기관지천식 환자에서 salbutamol의 분무치료에 의한 혈청 칼륨 농도의 변화
장인진,지영구,권숙회,이계영 대한알레르기학회 1998 천식 및 알레르기 Vol.18 No.4
Background and objective: The knowledge about the effects of the nebulized β₂-agonist on serum potassium is limited. We aimed to assess the possible hypokalemia following nebulization of salbutamol. Methods: Seven patients(mean age 60 ±7.1years) with acute exacerbated asthma were treated with salbutamol nebulization(5mg nebulization at 1 hour interval, 3 times) without concomitant use of steroid or other bronchodilator such as theophylline. Results: There was a significant increase in FEV1, from 46.41 ±25.91% at baseline to 62.86 ±22.38% at 3 hours after treatment. Serum potassium concentration was significantly decreased, from 3.93 ±0.58mEq/L at baseline to 3.41 ±0.62mEq/L and 3.46 ±0.53mEq/L at 1 hour and 3 hours after third nebulization, repectively. There was a significant prolongation of the QTc interval in EKG from 454.36 ±27.07msec at baseline to 479.41 ±35.64msec and 505.09 ±58. 69msec at 1 hour and 3 hours after third nebulization, respectively. Serum salbutamol concentration was 4.18 ±3.39ng/ml at baseline, and increased to 7.69 ±6.94ng/ml and 9.84 ±10.34ng/ ml at 1 hour and 3 hours after treatment, respectively. Magnitude of the hypokalemia and the degree of prolongation of the electrocardiographic QTc interval were significantly correlated with the level of serum salbutamol concenturation. Conclusion: The results suggest that cardiac complication could develop due to hypokalemia during repeated salbutamol nebulization. Caution should be done in monitoring of serum potassium concentration when using nebulized salbutamol repeatedly for the treatment of acute exacerbated bronchial asthma.
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