Ciprofloxacin 제제의 생물학적 동등성에 관한 연구

최철희,신재국,신완균,유호진,이경훈,정원석,장인진,신상구 대한화학요법학회 1991 대한화학요법학회지 Vol.9 No.1

국내 시판중인 ciprofloxacin 제제인 Citopcin®(250㎎ tablet)의 동등성을 검토하기 위해 제조원인 Bayer사의 Citopcin®(250㎎ tablet)를 기준제제로 하여 18명의 건강한 남성 피험자를 대상으로 500㎎ 1회 교차 경구 투여후 약동학적 성상을 분석비교한 결과는 다음과 같다. 시험제제의 생체 이용율의 지표인 AUC, C_(mao), T_(max) 및 MRT들의 평균치는 백분율차이에 있어 모든 기준제제 지표의 ± 20% 이내였으며, 이들 생체 이용율 지표들은 분산분석 검정에서 차이를 인지할 수 없었다.생체 이용율 지표들의 기준제제에 대한 백분율 90% 대칭 신뢰구간 검토시 모든 경수들에서 ± 20% 이내의 조건을 만족하였으며 AUC의 경우에는 대칭형 신뢰구간으로 변환시 95% 신뢰구간에서도 동등성의 조건을 만족하였다, 이상의 시험결과로 시험제제인 Citopcin®은 기준제제인 Ciprobay®와 생물학적 동등한 제제로 판단되었다. The pharmacokinetics of ciprofloxacin was studied for the evaluation of the bioequivalence of the generic ciproflocacin products. Two single doses of 500㎎ each of ciprofloxacin(Ciprobay® 250㎎ tablet as a reference compound and Citopcin® 250㎎ tablet s a test compound) were administered orally to ighteen male volunteers in a balanced, randomized crossover design. Pek plasma levels of ciprofloxacin were observed about 1 hour after the doses and the peak concentrations of both products were similar(Ciprobay®, 3.18㎍/㎖; Citopcin®, 2.89㎍/㎖). The values of other pharmacokinetic parameter of ciprofloxacin computed for Ciprobay® are presented in that order: AUC=13.53:12.47㎍·h/㎖, T_(max)=1.28:1.14 hours; MRT=5.30:5.08 hours; t_(1/2)β=3.65:3.47 hours. No satistically significant, differences were detected when AUC and the other parameters were compared with the method of ANOVA. Using the criteria of 90% confidence interval for the assessment of bioequivalence al the parameters were acceptable. The products were found to be equivalent on the premise that no significant difference was detected when the relevant pharmacokinetic parameters were compared, and the confidence limit analysis showed acceptable results.

비디오시스템과의 일체형 지면반력 Windows 프로그램 개발

신인식,문영진,정철수,이기청 서울대학교 체육연구소 2000 서울大學校 體育硏究所論集 Vol.21 No.2

The study was designed to develop the window version force platform from the former program operated in DOS version. The window version program was developed utilizing a visual-basic program of Microsoft Inc. The characteristics of the program are as follows: 1.The compatibility among the board was enhanced so that all AD board of Data Translation Inc. can be utilized. 2.The program can be operated with the connection to the image analysis system which consists of force platform and D-5100 Panasonic Video Camera. 3.The automation of analysis was achieved so that the variable can be analyzed immediately after the button on the force platform was pressed. 4.Multi-file processing was adopted so that several files can be performed simultaneously for the analysis. 5.The program was designed in user-friendly mode. The program can be operated by even novice because the main menu was composed in flowchart format. There were not significant differences between the values obtained utilizing the program developed in the present study and the former program. The present results suggest that the program developed in this study may have advantage with regard to conveniency and economical efficiency over the expensive programs imported from the foreign countries.

정신분열병에 대한 Risperidone의 효과 및 안전성에 관하여

신석철,왕성근,지익성,이선우,이규광,이봉희,이진영,황선희,신용재,배경도,김정란 충남대학교 의과대학 지역사회의학연구소 1997 충남의대잡지 Vol.24 No.1

In order to evaluate the efficacy and safety of risperidone, 10 patients with chronic schizophrenia were examined for 8 weeks in a silgle-open study. After the wash-out period of 1 week, risperidone was administered. Efficacy was evaluated by means of Positive and Negative syndrome Scale for Schizophernia(PANSS) and Clinical Global Impression(CGI). Safety assessment included the Extrapyramidal Symptom Rating Scale(ESRS), vital signs, body weight, ECG, and laboratory tests. The results were as follows 1) On the PANSS total score, there was significant improvement of total score after 1 week (P<.05) of administratiom. 2) On the PANSS positive and negative subscal, there were significant improvement of posotive and negative scores after 2 weeks (P<.05) of administration. 3) On the PANSS general psychopatholgy subscals, there were significant improvement of general psychopathologyscores after 1 week (P<.05) of administratiom. 4) On the CGI, there was significant decreasement of clinical impression of severity of schizophrenia score after 2 week (P<.05) of administration. 5) A statistically significant increase in body weight (P<.05) was observed after 8 weeks of administration. 6) EPS reached the peak at the end of the 1st week of administration of risperidone (11.8± 24.25) but they were easily relieved by addition of benztropine and clonazepam. There was not significant change in laboratory tests, vital sign, ECG after 8 weeks of administration. These results suggest that Risperidone is an effective antipsychotics and clinically safe except for increased body weight in chronic schizophrenia.

우수방사성의약품 생산시설 개발

신병철,정원명,박상현,이규일,박경배,박진호 한국약제학회 2003 Journal of Pharmaceutical Investigation Vol.33 No.2

Manufacturing facilities of the pharmaceuticals must meet certain level of the cleanness required so that foreign substances such as dust, moisture, heat, microorganism, or virus do not contaminate the product. In case of radiopharmaceuticals for medical treatment and diagnosis, not only should the operators and environment be protected from radiation but also need to be isolated from the foreign contaminant. Therefore, manufacturing facilities for radiopharmaceuticals must satisfy the design standards of both hot cell and clean room which are specified by GNP. However, standards of maintaining negative pressure for preventing spread of radioactive contaminant in isolated facilities conflict with the standards of maintaining positive pressure for keeping cleanness. To solve this problem, are pressure of hot cell was designed lower than in the adjacent area to meet standards of the radiation safety. To keep higher cleanness in certain part of the hot cell for filling, minimal relative positive pressure allows. In order to effectively maintain the cleanness that is required for production of Tc-99m generator, which takes 70% of whole demand of radiopharmaceuticals, the rooms placed in each side of production room are used as a buffer area and three lead hot cells are installed in production room. In this research, we established the appropriate engineered design concept for Tc-99m generator manufacturing facility, which satisfies both GMP cleanness standard for preventing particles, bacteria, other contaminants and the regulations of radiation safety for supervising and controlling the amount of radiation exposure and exhausted radioactivity. And the concept of multi-buffer zones is introduced to apply negative air pressure for hot cell with first priority and to continue relative positive air pressure for clean room.

C형 간염 바이러스 core 단백의 대장균내 발현

신현진,김철중,신광순 충남대학교 수의과대학 동물의과학연구소 1995 動物醫科學硏究誌 Vol.3 No.-

C형 간염 바이러스(HCV)의 구조 유존자중 core 유전자를 fusion protein vector인 pGEX-2T vector에 cloning하여 core단백질을 발현시켜서 항원성을 증가시키고자 하였다. HCV의 core gene을 PCR (polymerase chain reaction) 기법을 이용하여 증폭한 후, 약 0.57kb 정도의 증폭된 core gene을 TA cloning vector에 cloning 한 후, restriction exzyme BamH I으로 잘라, gel elution method로 elution하여 pGEX-2T vector의 BamH I site에 cloning 시켰다. Cloning된 plasmid를 E coli cell인 JM105에 transformation시킨 후, IPTG에의해 protein induction 하였다. pGEX-2T에서 발현된 HCV core 단백질은 SDSPAGE및 Western-blotting 분석 결과, 양성 C형 간염 환자의 serum및 monoclonal antibody와 특이적으로 반응하였다.

TV媒體가 兒童의 攻擊性 發達에 미치는 影響

申允澈,裵珍洙 진주교육대학교 1986 論文集 Vol.30 No.1

Few tropics have attracted as much theoretical and empirical attention over the past score as the development and regulation of aggressive behavior permeated by the TV viloence viewing. In this pacer we intended to overview the ambivalent effects of TV-media, the relationship between TV violence viewing and aggressive behavior development of the children through the literatures according to the types of research, and after that suggest some implipications to decrease and prevention of aggression. In light of the review we draw the following conclusions. 1) Research has demonstrated that TV plays a role in the positive effect and negative effect as well according to the TV programs, 2) Although multiple theories have been explored to explain the development of aggression derived from the TV violence viewing, only one theory can't be done it completely. 3) Though the results gained from the laboratory experiments about the effects of TV violence viewing and the viewer's aggression are inconsistent, they have helped to identify the range of circumstamces under which it is possible to find an effect on viewer aggression. 4) While field experiments haute found either no effect or awn effect of less aggression in the group that viewed violence compared to a group that viewed neutral films, the remaining majority of these studies has provided qualified evidence that viewing of violence leads to an increase in viewer aggression. 5) Most of the correlational study have not reached the conclusion that there is a consistent or, small positive correlation between viewing TV violence and aggression. But there is little evidence that in natural settings viewing TV violence cause people to be more aggressive. 6) There are many intervening variables in determining the TV violence viewing and aggressive behavior, that is, age, sex-typing, identification and fantasy wish the TV characters, viewer's predisposition, parents influence, etc.

하악 매복 지치의 외과적 발거시 Methylprednisolone의 안면 부종 감소 효과에 대한 임상적 연구

신지훈,박진배,한지용,윤혜경,김우형,이희철 인제대학교 백병원 2002 仁濟醫學 Vol.23 No.4

Objective : The third molars, expecially mandibular wisdom teeth, are commonly obliquely impacted, and surgical procedure with odontomy and osteotomy is necessary for their extraction. The surgical extracion of impacted wisdom teeth occasionally in duces variable discomfort. Especially, postoperative swelling, pain and limitation of mouth opening determine the degree of discomfort. For the reduction of these complicaions, drug therapy(antihistamine, enzyme, steroid), cole pack and pressure technique have been studied. It is known that the steroids are the most effective. Methods and Meterial : We selected fifty patients in their twenties, who visited Department of Dentistry, Pusan Paik Hospital from March to August in 1998. All of 50 patients has no other medical problems. Total 50 patients were randomly divided to 30 of experimental group and 20 of control group. The experimental group had orally administration of methyprednisolone 5㎎ every 8 hours 2 times preoperatively and 7 times postoperatively. Five points were marked on the patients' face, and the distances between the points were measured just before operation and 48 hours after operation. Results : Methyprednisolone reduces swelling about 50% after surgical extraction of obliquely impacted mandibular third molars with osteotomy and odontomy. The difference in the amount of tissue edema between experimental and control group was significant(p<0.01). However, there was no significant difference according to the operation time. Conclusion : It seems that the use of methylprednisolone is effective to reduce postoperative swelling following surgical extraction of third molars.

정신분열병 환자의 항정신병 약물치료 전후의 뇌파소견의 변화 : 3차원적 신호부위 추적분석

신철진 충북대학교 의과대학 충북대학교 의학연구소 2008 忠北醫大學術誌 Vol.18 No.1

연구목적: 정신분열병 환자들을 대상으로 한 구조적 또는 기능적인 뇌영상 소견들이 결정적인 성과는 아직 없지만 지속적으로 보고되고 있으며, 최근에는 역문제가 있음에도 불구하고 뇌파를 사용하여 뇌내의 병리적인 부위를 3차원적으로 국소화하려는 시도도 이루어지고 있다. 정신분열병의 전기생리학적인 이해를 넓히고자 항정신병 약물의 치료 초기와 치료 후의 표면뇌파를 이용하여 어떠한 변화가 있는지를 살펴보고 이러한 변화를 일으키는 부위를 sLORETA를 이용하여 국소화하기 위하여 연구를 시행하였다. 대상 및 방법: 정신분열병의 급성 악화로 대학병원에 입원한 20명의 환자를 대상으로 시행되었으며, 모든 대상자는 뇌외상, 알코올 의존, 또는 간질의 과거력이 없는 환자들이었다. 입원 첫 주 및 넷째 주에 뇌파를 측정하였고 동시에 양성 및 음성증상척도(Positive and Negative Syndrome Scale, PANSS)를 사용하여 정신병리를 측정하였다. 13개의 전극에서 12비트 해상도를 가지고 125 Hz로 추출하여 디지탈화된 자료를 얻어 분석하였으며 눈을 감고 편안한 상태에서 얻은 512개의 자료를 이용하여 sLORETA 소프트웨어를 사용하여 치료 전후를 비교하였다. 결과: 정신병리척도 상에 나타난 증상의 호전은 유의하였으며(p<0.01), 양성, 음성, 및 일반 증상군에서 모두 유의하게 호전되었다. 입원 첫 주와 넷째 주의 뇌파의 비교에서는 알파 2파의 파워가 우측 연상회(supramarginal gyrus)에서 치료 후 유의하게 감소하였다. 다른 대역폭이나 부위에서는 유의한 차이를 나타내지 않았다. 결론: 이전의 연구들은 정신분열병 환자에서의 두정엽의 이상은 사회적인 인지의 손상과 관련이 있을 것으로 보고하였으며, 또한 환청의 정도와 연상회의 부피 감소가 상관관계를 보인다고 하였다. 본 연구결과는 정신분열병에서 연상회의 전기생리학적인 역동 이상을 시사하며, 두정엽의 부피감소나 기능이상, 또는 알파파의 파워 감소 등을 보고한 이전연구 결과와 일치한다. Purpose: The studies using structural or functional imaging have continuously reported localized abnormalities of schizophrenic brains but those findings are still inconclusive. In spite of the inverse problem, there have been also many efforts to localize the pathology in the brain from the surface electroencephalography. To expand the understandings of electrophysiological characteristics of schizophrenia, we tried to see any changes of the power spectrum of surface EEG during the antipsychotic treatment and to find out the localized brain area which is responsible for those changes using sLORETA software. Materials and Methods: Twenty one schizophrenic patients with acute exacerbation diagnosed by DSM-III-R were recruited from the university hospital. All the patients did not have any history of head trauma, alcohol dependence or epilepsy. The electroencephalography was checked twice, the first and the forth week of the antipsychotic treatment during admission, and the psychopathology was measured by the Positive and Negative Syndrome Scale (PANSS). The EEG signals from thirteen leads were digitalized with 125 Hz sampling rate and 12 bit resolution. The epochs of 512 points in eyes closed condition at rest were analyzed for the comparison of the two different times during the antipsychotic treatment. Three dimensional source localization and statistical comparisons were performed by sLORETA software. Results: The severity of psychopathology on PANSS scale was reduced after the treatment (p<0.01), and positive, negative and general psychopathology subscale score were all significantly reduced. In the comparison between the electroencephalogram of the first and the fourth week, sLORETA revealed that the power of alpha 2 band was significantly decreased on right supramarginal gyrus after the treatment (p<0.05). However, other cortical areas and other frequency bands have failed to show any significant differences. Conclusion: Previous studies reported that parietal lobe abnormalities in the schizophrenic patients can be considered to have a relation with their impaired social cognition, or that the severity of auditory hallucination had a correlation with the volume loss of supramarginal gyrus. The change of alpha spectral power on the supramargical gyrus in this study also suggests that schizophrenia may have a abnormal electrophysiological dynamics of supramarginal gyrus which is a part of inferior parietal lobe, and this finding is compatible with prior imaging studies that reported a reduced volume or impaired functions of parietal lobe, and with other electroencephalographic studies that reported the reduced alpha wave power during the antipsychotic treatment in schizophrenia.

정신분열병 환자의 뇌파를 대상으로 한 혼도의 정량화

신철진 용인정신의학연구소 1995 용인정신의학보 Vol.2 No.2

한국어판 일상적 스트레스 평가서의 신뢰도 및 타당도

신철진,김재진,정인원 大韓神經精神醫學會 1998 신경정신의학 Vol.37 No.2

연구목적 : 일상 생활에서 흔히 경험되는 사소한 스트레스 요인들의 상대적 강도를 전향적으로 측정하는 Daily Stress Inventory(DSI)의 한국어 판을 개발할 목적으로. 이를 번역하여 한국의 정상 성인들에게 적용하여 봄으로써 신뢰도 및 타당도를 검증하고자 하였다. 방 법 : 사소한 생활 사건 58문항이 기술된 DSI에 대하여 번역, 역번역, 재번역 과정을 통해 최종번역 안을 작성한 후. '주요 생활사건 측정도구'와 함께 대학생 200명과 직장인 150명에게 배포하였다. 최종적으로 120명(대학생 82명 직장인 38명)으로부터 결과를 회수하여 DSI의 세 가지의 기초 점수(사건점수. 강도 점수. 강도/사건비)를 산출한 후. 사회인구학적 변인의 차이에 따른 DSI 기초 점수의 차이, 내적 일치도, 동시타당도 등을 조사하였다. 결 과: 1) 일일 사건 및 강도점수, 주간 사건 및 강도점수 등은 모두 양의 왜도로 오른쪽 긴 꼬리를 하는 비정규분포를 하였으나, 일일 및 주간 강도/사건비늘 비교적 정규분포의 형태를 보였다. 2) 일일 및 주간 DSI 기초점수들은 성별에 따라 유의한 차이를 보이지 않았다. 연령과 교육수준의 차이에 따라서는 일일 및 주간 사건점수와 강도점수는 유의한 차이를 보였으나 강도/사건비늘 유의한 차이를 보이지 않았다. 직업별의 경우에는 일일 강도/사건비를 제외하면 모든 일일 및 주간 DSI 기초점수에서 유의한 차이를 보였다. 3) 대학생인 경우가 직장인인 경우에 비해 모든 일일 및 주간 DSI 기초점수들이 높은 것으로 나타났고, 특히 '개인적 능력' 부분에서 그 차이가 현저하였다. 4) 사건점수와 강도점수의 Cronbach 알파값은 0.98과 0.97로 산출되어 높은 내적 일치도를 보이는 것으로 나타났다. 5) 주요 생활사건 측정도구와의 Spearman 상관계수 조사 결과 모들 DSI 기초점수들은 부정적 생활사건과는 통계적으로 유의한 상관성을 보였으나, 긍정적 생활사건과는 유의성을 보이지 않았다. 결 론 : 이러한 결과를 통해 저자들은 한국어판 일상적 스트레스 평가서가 일상생활 수준에서 흔히 경험되는 사소한 생활사건들을 평가하는데 신뢰성과 타당성을 갖춘 도구로 이용될 수 있음을 알 수 있었다. 또한 평가과정에서 대상자의 대학생 유무에 따라 해석에 유의해야 함을 알 수 있었다. Objectives: To develope Korean version of Daily Stress Inventory(DSI) designed to assess prospectively the sources and magnitude of minor stressful events, the authors translated it into Korean and examined its reliability and validity. Methods : The translated DSI was distributed to] 200 collegians and 150 clericals. In order to test the validity, the previously qualified 'Major Life Event(MLE)' questionnaire was given concurrently. The materials were collected from 120 persons, and were analyzed by application of simple statistics of DSI scores, Wilcoxon's rank- sum test for differences of those according to demographic valiables, internal consistency for reliability, and Spearma's correlation coefficient for concurrent validity. Results : 1) The distributions of scores of daily event, daily impact, weekly event and weekly impact were all showed as having a positive skew. But the distributions of daily and weekly I/E ratio were approximately normal. 2) All daily and weekly DSI scores showed no significant differences by sex. There were significant differences in daily or weekly event and impact scores but insignificant differences in daily or weekly I/E ratio according to age and education level. By occupation, all daily and weekly DSI scores except daily I/E ratio showed significant differences. 3) Daily and weekly DSI scores were significanty higher in collegians than in clericals, and the cluster showing the most marked difference between the two group was 'personal competency'. 4) In the reliability test by internal consistancy, the Cronbach's alpha coefficients of the event score and the impact score were respectively 0.98 and 0.97. 5) In the concurrent validity between DSI and MLE, DSI scores were more highly correlated with negative life events with positive life events. Conclusions : With the above results, the authors concluded that Korean version of DSI was a reliable and valid tool for assessing minor stress experienced frequently in daily life level. But its scores should be interpreted differently according to collegian or not.