• 제목/요약/키워드: treatment criteria

검색결과 2,100건 처리시간 0.034초

레바미피드 100 mg 정제의 새울학적동등성 (Bioequivalence Test of Rebamipide 100 mg Tablets)

  • 김세미;조혜영;강현아;이용복
    • 한국임상약학회지
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    • 제18권1호
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    • pp.38-44
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    • 2008
  • Rebamipide, ($\pm$)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl] propionic acid, is used for mucosal protection, healing of gastroduodenal ulcers, and treatment of gastritis. It works by enhancing mucosal defense, scavenging free radicals and temporarily activating genes encoding cyclooxygenase-2. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{(R)}$ (Korea Otsuca Pharmaceuticals Co., Ltd.) and Mustar (Korean Drug Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of rebamipide from the two rebamipide formulations in vitro was tested using KP VIII Apparatus II method with pH 6.8 dissolution medium. Twenty six healthy male subjects, $23.46{\pm}2.63$ years in age and $66.62{\pm}8.97\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 100 mg as rebamipide was orally administered, blood samples were taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution medium. The pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated, and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the reference drug, $Mucosta^{(R)}$ were -5.08, 3.52 and -9.71 % for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.84$\sim$log 1.07 and log 0.90$\sim$log 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Mustar tablet was bioequivalent to $Mucosta^{(R)}$ tablet.

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Midazolam을 구강 점막 하로 병용 투여한 진정법의 안정성과 Houpt Scale을 이용한 진정효과에 대한 연구 (Safety and Efficacy of Submucosal Midazolam When Combined with Oral Chloral Hydrate, Hydroxyzine and Nitrous Oxide Sedation by using Houpt's Scale)

  • 박미경;김윤희;정상혁;백광우
    • 대한치과마취과학회지
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    • 제6권2호
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    • pp.103-112
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    • 2006
  • Background: The purpose of this study was to compare the clinical safety and effect with and without additional submucosal midazolam to oral chloral hydrate and hydroxyzine when used for pediatric conscious sedation in a clinical dental environment. Methods: Thirty one cases of pediatric conscious sedations were performed in this study. Selection criteria included good health (ASA I), under 6 years old, 20 kg of body weight, uncooperative behavior and the need for sedation to receive dental treatment including anesthesia and restorative or surgical procedure for at least two teeth. In each visit, patients were randomly assigned into one of two groups; CH group: chloral hydrate (60 mg/kg), hydroxyzine (1 mg/kg), CH-M group: chloral hydrate (60 mg/kg). hydroxyzine (1 mg/kg) and submucoal midazolam (0.1 mg/kg). 50% nitrous oxide-oxygen was maintained during the sedation period Sedations were monitored using a pulse oximeter for estimating pulse rate (PR) and percutaneous oxygen saturation ($SpO_2$). Behavior response rated using Houpt's scale and need of restraint was assessed every 2 minutes through 30 minutes of operative procedure reviewing the videotape recording. Evaluation of overall behavior success was performed using modified overall behavior rate of Houpt's scale. Data was analyzed using t-test. Results: PR and $SpO_2$ for both groups remained within the normal values. The mean scores for sleep and movement of CH-M group were higher than those of CH group (P < 0.05). There were no significant difference in mean score for crying between two groups. The mean scores of overall behavior of CH-M group was higher than those of CH group (P < 0.01). Reinstraint of CH-M group was less required than that of CH group (P < 0.05). Conclusions: Oral chloral hydrate (60 mg/kg) and hydroxyzine (1 mg/kg) combined with submucosal injection of midazolam was safer and showed more improved sedation effect than oral chloral hydrate (60 mg/kg) and hydroxyzine (1 mg/kg) without midazolam for sedation of pediatric dental patients.

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개방교합 경향을 갖는 성인 여성 환자들의 보상양상에 관한 연구 (Compensation of female adults with openbite tendency)

  • 김동언;유임학
    • 대한치과교정학회지
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    • 제32권1호통권90호
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    • pp.1-7
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    • 2002
  • 개방교합 경향을 갖고 있으나 보상작용 등에 의해 전치부 개방교합을 보이지 않는 성인 여성환자들의 보상양태를 관찰하여 진단 및 치료계획 수립에 도움을 주고자 본 연구를 시행하였다. 피개교합 심도지수(ODI)가 66이하이며 전치부 개방교합을 나타내는 증례(50명)를 대조군으로, 피개교합 심도지수(ODI)가 66이하이나 보상작용에 의하여 전치부 개방교합을 보이지 않는 증례(55명)를 실험군으로 하였다. 대조군과 실험군의 평균연령은 각각 23.88 ${\pm}$ 4.53세와 24.7 ${\pm}$ 6.20세이었다. 측모두부방사선 사진을 촬영하였으며 두 군간의 형태학적 차이를 비교하기 위해 41개 항목에 대한계측 및 통계학적인 분석을 시행하였다. 계측항목 중 lower face height, N-Me, ANS-Me, ANS-Me/N-Me ratio, Mx1-SN, Mx1-FH, Mx1-NA(mm), Mx1-APo, PP to Mx6, Mn1-NB(degree), Mn1-NB(mm)에서 통계학적인 유의차가 나타났다. 실험군에서는 감소된 lower face height N-Me, ANS-Me, ANS-Me/N-Me ratio와 상하악전치의 설측 경사 및 후퇴, 대조군에서는 상악 구치의 과맹출이 관찰되었다.

Cyclosporin A가 치은섬유아세포의 세포주기조절에 미치는 영향 (Effects of Cyclosporin A on the Cell Cycle Regulation of Human Gingival Fibroblasts)

  • 피성희;김대겸;김탁;유용욱;유형근;신형식
    • Journal of Periodontal and Implant Science
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    • 제31권3호
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    • pp.611-623
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    • 2001
  • Cyclosporin A is a cyclic polypeptide produced by the metabolism of fungi. It is widely used at present as immunosuppressive treatment following organ transplants. It is also used to deal with autoimmune diseases such as rheumatoid arthritis or type II diabetes. Gingival hyperplasia is one of the most frequent side-effects associated with the prescription of Cyclosporin A. The mechanisms involved in Cyclosporin A induced gingival hyperplasia are not yet clear. In vitro Cyclosporin A promotes proliferation of gingival fibroblasts, that Cyclosporin A act as a mitogen. Its action is based on mitosis of gingival fibroblasts regulated by cell cycle regulatory proteins. It was the purpose of the present study to examine the effects of Cyclosporin A on human gingival fibroblasts by means of biological and biochemical criteria. In this present study, we examined change of cell proliferation, cell activity, cell viability and cell cycle progression after application of Cyclosporin A. We also examined expression of cell cycle regulatory proteins by western blot analysis. Human gingival fibroblasts were cultured for 48 hours with application of Cyclosporin A at concentrations of 0.01, 0.1, 1, and 10 ng/ml. Cyclosporin A(1 ng/ml) significantly increased the cell activity of gingival fibroblast. Proliferation and viability of gingival fibroblasts were also increased in group treated with 1 ng/ml of Cyclosporin A compared to control group. In the cell cycle analysis, S phase was increased and G1 phase was decreased in the group treated with 1 ng/ml of Cyclosporin A. Cyclosporin A increased the expression of cdk4 and inhibited the expression of pRB and p21. These results suggest that 1 ng/ml of Cyclosporin A may increase the cell cycle progression of human gingival fibroblasts, and its mechanisms may increase the expression of cdk4 and decrease the expression of pRB and p21.

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뇌졸중 환자를 위한 팀접근 재활프로그램의 효과 (The Effect of a Multidisciplinary Team Approach on the Rehabilitation of Stroke Survivors)

  • 조복희
    • 재활간호학회지
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    • 제6권2호
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    • pp.137-151
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    • 2003
  • The purpose of this study was to develop a multidisciplinary team approach program for stroke survivors, and to identify its effects on their rehabilitation. The team was composed of 7 members: a rehabilitation nurse, a physician, a physical therapist, an occupational therapist, a therapeutic recreational therapist, a nutritionist, and a researcher. A quasi-experimental study was performed with 36 subjects: 18 in the experimental group and 18 in the control group, using a noneqivalent control group pretest-posttest design. The experimental group participated 4 times in rehabilitation programsfocused on information and emotional support provided by the rehabilation team-and received telephone counseling from the researcher. The control group did not receive any treatment. The selection criteria for the subjects in this study were: (a) patients who were diagnosed as having had an ischemic stroke within the last year, (b) patients free of any communication disorder, (c) and those having a primary caregiver who could assist in filling out the form assessing the level of ADL. The data were collected from patients who had been discharged from a tertiary hospital, between October 1st, 1999 and September 30th, 2000. The data were analysed by $X^2$ test, Fisher's exact test, ANCOVA, Wilcoxon's rank sum test, and Wilcoxon's signed rank test using an SAS program. The results were as follows: 1. In terms of physical variables (blood pressure, grasp power, and ADL) 1) There was a significant difference in blood pressure between the two groups (systolic pressure P= .012, diastolic pressure P= .050). 2) There was also a significant difference in grasp power between the two groups (affected side : P= .012, unaffected side : P= .010). 3) There was no significant change in the level of ADL between the two groups. 2. In terms of psychosocial variables (depression, self-efficacy, self-esteem, and social activities) 1) There were no significant differences between the two groups. However, all four psychosocial variables showed a tendency to improve in the experimental group, while only two variables (depression and self-efficacy) showed a simalar tendency in the control group. 2) The level of social activities in the control group decreased significantly after a month (P= .050). 3. The level of life satisfaction improved in both groups, but no significant difference was found. Stroke has high recurrence rate and requires considerable follow-up care. The program used in this study was developed and designed for stimulting the rehabilitation process of stroke survivors. Through the program period of one month (meetings were held weekly), a positive effect was detected in physical variables, although the psychosocial variables did not improve significantly. In retrospect, a one month period may not be an adequate length of time to improve the psychosocial variables, as the stroke survivors were complicated cases, and most of them were elderly. Further research is therefore recommended by increasing the length of program, so that its effect can be more noticeable.

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국내 경제활동 인구의 직업유형별 적정수면과의 연관성 (Association between job types of economically active population and sleep appropriateness among South Koreans)

  • 김선정;김동준;김은나;유태규
    • 한국병원경영학회지
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    • 제25권3호
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    • pp.67-77
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    • 2020
  • Background: As of 2016, average Koreans sleep 7 hours and 42 minutes, the lowest figure among Organization for Economic Cooperation and Development(OECD) countries, and the number of people with sleep disorders reached 561,000. Accordingly, the government has promoted the provision of 'Multiple Sleep Test' to strengthen the diagnosis service for patients with 'sleep disorder' in july 2018. As a result, healthcare costs for patients with sleep disorder is on the rise every year. In this study, we utilized 'Appropriate Sleep' criteria of United States's National Sleep Foundation(NSF) then investigated Korean's sleep pertinence using 「7th National Health and Nutrition Survey for 2016-2018」 by different occupational type, demographic characteristics, socio-economic characteristics, and health behaviors. Methods: We performed descriptive analysis to examine differences of sleep appropriateness by various sample characteristics. Multivariate logistic regression models were used to examine sleep appropriateness by occupational type and other variables. We also analyzed subgroup models to investigate. Results: As a result, a total of 1,948 (18.37%) study subjects experienced in-appropriate sleep. Results of the Multivariate logistic regression analysis revealed that blue color group had a higher odds ratio (OR) for experiencing in-appropriate sleep (OR=1.179). In addition, the odds ratio of experienced in-appropriate sleep among the elderly aged 70 and over was 2.698, and the odds ratio of the overstressed group was 1.299. Furthermore, sub-group analysis showed that blue color job of female(Or=1.334), high school or below(OR=1.404), divorce/death/separation(OR=2.039), 25%ile-50%lie income group(OR=1.411) more likely experienced in-appropriate sleep. Conclusion: Growing sleep disorder patients and related health care costs are expected. Government should apply detailed 'total periodic sleep disorder management policy' including pre-consultation, examination, diagnosis, treatment, post-consultation, self-management especially to vulnerable population that this study found.

양어사료의 어분대체품 개발의 경제성 분석 (Economic Evaluation of The Newly Developed Fish Meal Analog (BAIFA-M))

  • 김기수;배승철;최재영;김우경
    • 수산경영론집
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    • 제29권1호
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    • pp.121-137
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    • 1998
  • This study was conducted to examine the economic evaluation of the newly developed fish meal analog (BAIFA-M) in Korean rockfish feed. A raw fish feed (MP) and two commercially formulated diets (EP) were employed to compare weight gain (WG), feed conversion ratio (FCR) and survival rate (SR) from the sea cage culture system. By using the economic model in the practical sea cage culture system, feed cost, production cost and gross profit per kg production, rate of profit to gross revenue (RPGR), and internal rate of return (IRR) were calculated based upon the results of the experiment and the information of the private aquaculture farm (Young Chang) in Tong young, Korean. IRR criteria is one of the popular economic feasibility analysis methods applicable far aquaculture industry. This is an economic evaluation method to compare the given interest rate or the discount rate with IRR which can be calculated by the difference between the present value of the benefit stream and of the cost stream. The benefits of using EP on WG, FCR, SR, and production cost will be emphasized in this study. Fish averaging 20$\pm$3.6g (Mean$\pm$SD) were randomly distributed in each small cage (6m$\times$6m) as groups of 2,000 fish. By using 3 large size cages (12m$\times$12m), 12 small cages were constructed, and only 9 small cages were employed for three replicates of each diet treatment. To compare with MP diet, two sinking EP diets were designed by our laboratory and produced by the local feed company who wanted to promote these EP diets for the mass cage culture of Korean rockfish in the future. Two EP diets contain white fish meal and/or BAIFA-M as the main animal protein sources : WFM diet, maximum 43% of white fish meal : BAIEA- M diet, 30% of white fish meal nab replaced by BAIFA- M from WFM diet. Results are summarized in Table 1. Fish fed MP diet showed significantly lower SR than does fish fed two EP diets(P<0.05). However, there Were no significant difference on FCR among fish fed three practical diets. Table 1. Average feed conversion ratio (FCR), accumulative average survival rate (SR) and economic evaluation data far three practical diets. As we expected, BAIFA-M diet is more economical than WFM diet as well as MP diet. Feed cost and production cost per kg production from BAIEA - M diet were lower than those from WFM and MP diets. Moreover, gross profit per Kg production, RPGR and IRR from BAIFA- M diet were higher than those from WFM and MP diets. This economic evaluation study clearly indicated that MP diet should be replaced by the commerical formulated EP diets as soon as possible in the near future because MP diet is not economical in the practical sea cage culture system.

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생물학적제제의 치메로살 함량 정량을 위한 가열기화 아말감 흡광도법의 확립 및 검증 (Establishment and Validation of Gold Amalgamation Method for the Quantitation of Thimerosal in Biological Products)

  • 김병철;김도근;홍성화;김연희;임종미;원윤정;김석환;홍지영;윤영민;김재옥
    • 약학회지
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    • 제55권4호
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    • pp.284-288
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    • 2011
  • The test method for biologics of lot release system is based on 'Test procedure and specification for biological products,' generally, thimerosal content is measured by chemical analysis using O.D. In this study, the comparative analysis was carried out using the gold amalgamation method for thimerosal content was compared to the existing methods, which are described above. The gold amalgamation method, which uses atomic absorption spectrophotometry, was meets all the method validation acceptance criteria. It is considered to be proper as the assay and identification test for thimerosal. In this study, the comparative analysis was performed three times. As a result, gold amalgamation method is more convenient and easy to perform as this assay doesn't have pre-treatment procedure. Also this assay showed good precision and reproducibility compared to the conventional method. Therefore, it is appropriate to alternate the assay method of thimerosal from the conventional chemical analysis to gold amalgamation method to improve the credibility of lot release system and the quality control of biologics, by standardizing test method.

대사증후군에 대한 사상체질별 허리둘레 및 체질량지수의 절단값에 대한 연구 (Cut-off Values of Waist Circumference and Body Mass Index for Metabolic Syndrome according to Sasang Constitution)

  • 최재완;유준상
    • 사상체질의학회지
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    • 제26권4호
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    • pp.365-378
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    • 2014
  • Objectives This study was performed to investigate the cut-off values of abdominal circumference and Body Mass Index(BMI) according to Sasang Constitution. Methods A total of 1,773 persons, namely 440 male people and 1,333 female people, in ages from 40 to 69 years old, participated in this research. They are all included in the community based Genomic cohort in Wonju in years from 2006 to 2013. The diagnostic criteria of metabolic syndrome was used followed by the National Cholesterol Education Program in Adult Treatment Panel III (NCEP ATP III) and Asian pacific guideline for only abdominal obesity. Results The prevalence of metabolic syndrome was 34.8% for men and 37.6% for women in this research. Taeeumin was the highly significant risk type for the metabolic syndrome in both sexes. Cut-off values of abdominal circumference were 88.3 cm in men, 80.3 cm in women, and cut-off values of BMI were $24.2kg/m^2$ in men and $25.3kg/m^2$ in women. For men, cut-off values of abdominal circumference were 79.5cm in Soyangin, 88.8 cm in Taeeumin and 79.5 cm in Soeumin, and cut-off values of BMI were $23.2kg/m^2$ in Soyangin, $25.6kg/m^2$ in Taeeumin and $20.6kg/m^2$ in Soeumin. For women, cut-off values of abdominal circumference were 76.3 cm in Soyangin, 80.3 cm in Taeeumin and 76.8 cm in Soeumin, and cut-off values of BMI were $22.4kg/m^2$ in Soyangin, $24.9kg/m^2$ in Taeeumin and $21.3kg/m^2$ in Soeumin. Conclusions Although 90 cm in men, 80 cm in women as an Asian pacific guideline were regarded as quite approximate to the mean value of abdominal circumference and $25kg/m^2$ to BMI. But if the results could be allocated in terms of the Sasang constitutional method, the cut-off values for Soyangin and Soeumin should be lowered than now.

보류관장의 표준화된 방법을 위한 고찰: 임상논문을 중심으로 (The Review of a Standardized Method in Retention-Enema: a Clinical Study)

  • 송은영;이의주;부영민;신승원;채광민;유정희;김효진;백종헌;이준희;고병희
    • 사상체질의학회지
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    • 제25권2호
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    • pp.108-114
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    • 2013
  • Objectives This study was aimed to review a standardized method of retention enema by extracting elements associated with methods of retention enema from papers involved. Methods 1) Data sources : Retrieval was made, using 'Enema' or 'Retention Enema' as search words in MEDLINE, The Cochrane Library, KISS, RISS, and NDSL DB. 2) Study selection : Two authors excluded irrelevant papers and chose qualified abstracts in the rest of the papers. The chosen studies were reviewed fully by the authors so that they could screen the significant papers based on the exclusion criteria. 3) Data extraction : Data on the total number of subjects, the target disease, the type, quality, length, diameter of catheter, the insertion length of catheter, the sample, the sample volume, the process of retention enema and the number of performing retention enema were extracted from the selected studies. Results & Conclusions The retention enema can be applied to gastrointestinal diseases, genitourinary diseases, metabolic diseases such as hypertension and diabetes, headaches and neurological disorders. The standardized treatment method is as following: 1) inserting a rental tube of 18-28 Fr that measures 20 to 30 cm into the patient's anus, 2) injecting herbal medicines which have purgative action or benefit on stomach and intestinal tract at the rate of 4 ml/min, and 3) holding them for 10 to 15 minutes.