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정인범,오재성,이승환,장인진,이영조,정재용 대한임상약리학회 2017 Translational and Clinical Pharmacology Vol.25 No.4
Because bioequivalence studies are performed using a crossover design, information on the intrasubjectcoefficient of variation (intra-CV) for pharmacokinetic measures is needed when determiningthe sample size. However, calculated intra-CVs based on bioequivalence results of identicalgeneric drugs produce different estimates. In this study, we collected bioequivalence results usingpublic resources from the Ministry of Food and Drug Safety (MFDS) and calculated the intra-CVs of various generics. For the generics with multiple bioequivalence results, pooled intra-CVswere calculated. The estimated intra-CVs of 142 bioequivalence studies were 14.7±8.2% for AUCand 21.7±8.8% for Cmax. Intra-CVs of Cmax were larger than those of area under the concentrationtimecurve (AUC) in 129 studies (90.8%). For the 26 generics with multiple bioequivalence results,the coefficients of variation of intra-CVs between identical generics (mean±sd (min ~ max)) were38.0±24.4% (1.9 ~ 105.3%) for AUC and 27.9±18.2 % (4.0 ~ 70.1%) for Cmax. These results suggestthat substantial variation exists among the bioequivalence results of identical generics. In this study,we presented the intra-CVs of various generics with their pooled intra-CVs. The estimated intra-CVs calculated in this study will provide useful information for planning future bioequivalencestudies.
정인범,배장호,김기영,현대우,김완호,류기현,윤세희,이희정 대한심장학회 2005 Korean Circulation Journal Vol.35 No.6
Background and Objectives:This study was performed to evaluate the clinical usefulness of the carotid intimamediathickness (IMT) as a screening test for coronary artery disease (CAD), and evaluate the differences in thecarotid IMT in CAD patients with age- and sex-matched healthy subjects and hyperlipidemic hypertensive patients.Subjects and Methods:The study was conducted on a total of 609 subjects; 229 patients with CAD (mean age;53 yrs, 148 males), 207 age- and sex-matched hyperlipidemic hypertensive patients (mean age; 52 yrs, 115 males)and 173 age and sex matched healthy subjects (mean age; 52 yrs, 100 males). The carotid IMT was semi-automaticallymeasured using high-resolution ultrasound. The clinical variables and carotid IMT in the study subjects werecompared, and the data analyzed. Results:The mean carotid IMT in patients with CAD (0.87±0.19 mm) wassignificantly higher than that in hyperlipidemic hypertensive patients (0.72±0.14 mm, p<0.001) and the healthysubjects (0.66±0.11 mm, p<0.001). Also, the carotid IMT in the hyperlipidemic hypertensive patients was significantlyhigher than that in the healthy subjects (p=0.001). The prevalence of carotid plaques was also significantlydifferent between the CAD, hyperlipidemic hypertensive and healthy groups; 29.3, 18.4 and 8.7%, respectively(p<0.001). The cutoff values for differentiating CAD patients from healthy subjects and hyperlipidemic hypertensivepatients were both 0.754 mm, with sensitivities and specificities of 72 and 80% and 72 and 66%, respectively,inform an ROC curve analysis. Conclusion:The carotid IMT was more increased in patients with coronaryartery disease than in the hyperlipidemic hypertensive patients and healthy subjects. Therefore, the cutoff value(0.754 mm) of the carotid IMT could be a clinically useful screening test for predicting significant CAD and fordifferentiating high risk patients. 배경 및 목적: 본 연구는 관상동맥 질환에 대한 선별검사로서의 경동맥내중막 두께 측정의 임상적 유용성을 알아보고, 연령과 성비가 일치하는 건강한 대상들과 고지혈증을 가진 고혈압 환자군에서의 경동맥 내중막 두께의 차이를 알아보고자 하였다. 방 법: 관상동맥 조영술을 시행 받은 609명의 환자를 대상으로하여, 관상동맥 질환자군 229명(평균 53세, 남성 148명), 연령과 성비가 일치하는 고지혈증이 동반된 고혈압 환자군 207 명(평균 52세, 남성 115명) 연령과 성비가 일치하는 건강인군173명(평균 52세, 남성 100명)으로 나누었다. 경동맥 내중막두께는 고해상도 초음파와 M´ATH 소프트웨어를 이용하여반자동화 측정법을 이용해서 측정하였다. 결 과: 경동맥 내중막 두께는 관상동맥 질환자군이 고지혈증을 가진 고혈압 환자군에 비해서 두꺼웠고(0.87±0.19 mm vs. 0.72±0.14 mm p<0.001) 건강인군(0.66±0.11 mm, p< 0.001)에 비해서도 두꺼웠다. 또한 위험인자군의 경동맥 내중막 두께도 건강인 군에 비해서 두꺼웠다(p=0.001). 동맥경화반의 유무도 세 군간에서 의미 있는 차이를 보였다(29.3%, 18.4%, 8.7%, p<0.001). 건강인군과 관상동맥 질환자군을 구별은 경동맥 내중막 두께가 0.754 mm에서 72%의 민감도와 80%의 특이도를 보였고, 위험인자군과 관상동맥질 환자군의 구별은 0.754 mm에서 72%의 민감도와 66%의 특이도를 보였다. 결 론: 경동맥 내중막 두께는 건강인에 비해 위험인자군, 그리고관상동맥 질환군에서 유의하게 증가되었다. 경동맥 내중막두께는 0.754 mm에서 유의한 관상동맥 질환의 유무를 파악할 수 있는 선별 검사 뿐 만 아니라, 위험인자군과의 감별에도 도움이 되는 유용한 비침습적 검사로 생각된다.