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

  • Kim, Se-Mi;Cho, Hea-Young;Kang, Hyun-Ah;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.18 no.1
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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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The Fatigue Experience of Shift Work Nurses (교대근무간호사의 피로경험)

  • Kho Hyo Jung;Kim Myung Ye;Kwon Young Sook;Kim Chung Nam;Park Kyung Min;Park Jung Sook;Park Young Suk;Park Cheong Ja;Shin Young Hee;Lee Kyung Hee;Lee Byung Sook;Lee Eun Joo
    • Journal of Korean Public Health Nursing
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    • v.18 no.1
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    • pp.103-118
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    • 2004
  • The purpose of this study was to understand the process and investigate basic theory of fatigue experience of shift work nurses. The present study adopted grounded theory methodology on fatigue of shift work nurses. The participants for this study were 15 shift work nurses who were in the age of 25 to 35, the clinical experience of 2 to 14 years and the work department of ICU. ER. ward and delivery room. The data were collected from 2000 to 2003 by using interviews and observations. The contents of the interviews were tape-recorded and were drawn through repeated method. And then were analyzed into the concept, subcategories, and categories with the open coding process and axial coding was done to identify the relationships of the concepts and categories according to the paradigm models. The core category generated, which was a central phenomena of the exhaustion process. The causal condition is change events. The central condition of exhaustion were sorted as physical discomfort, decreasing vigor, psychological instability, feeling of sleeping desire, changing face impression and being heavy body. The intervening condition were discovered as social$\cdot$ psychology$\cdot$physical resist and positive$\cdot$negative interaction strategies. The consequences of the fatigue process is the short term exhaustion relief and long term residual exhaustion. The fatigue process of this study was 'break through exhaustion' of change event-exhaustion-resist-resolve intervention-adaptation. This study offers better understanding on fatigue process of shift work nurses and may facilitate more appropriate interventive strategies to support, information and knowledges according to fatigue process.

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Clinical data analysis in retrospective study through equality adjustment between groups (후향적연구의 집단 간 동등성확보를 통한 임상자료분석)

  • Kwak, Sang Gyu;Shin, Im Hee
    • Journal of the Korean Data and Information Science Society
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    • v.26 no.6
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    • pp.1317-1325
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    • 2015
  • There are two types of clinical research to figure out risk factor for disease using collected data. One is prospective study to approach the subjects from the present time and the other is retrospective study to find the risk factor using the subject's information in the past. Both approached and study design are different but the purpose of the two studies is to identify a significant difference between two groups and to find out what the variables to influence groups. Especially when comparing the two groups in clinical research, we have to look at the difference between the impact clinical variables by group while controlling the influence of the baseline characteristics variables such as age and sex. However, in the retrospective study, the difference of baseline characteristic variables can occur more frequently because the past records did not randomly assign subjects into two groups. In clinical data analysis use covariates to solve this problem. Typically, the analysis method using the analysis of covariance of variance, adjusted model, and propensity score matching method. This study is introduce the way of equality adjustment between groups data analysis using covariates in retrospective clinical studies and apply it to the recurrence of gastric cancer data.

A Study on the Consciousness of Economic Ethics in Nursing Students (간호대학생의 경제의식에 관한 연구)

  • Hong, Yoon-Mi
    • Journal of Korean Academy of Nursing Administration
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    • v.9 no.3
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    • pp.429-445
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    • 2003
  • Purpose : The present study attempted to consider the degree of consciousness of economic ethics in nursing students and the factors affecting these perceptions. Method : A survey was conducted to a total of 874 nursing students from the freshmen and seniors of 11 depts of nursing science nationwide selected by convenience sampling (one for each province, and as for Gangwon-do, two schools were selected from Yeongdong area and Yeongseo area ; 13 male students were excluded). A structured questionnaire was used to collect data on their demographic characteristics and economic ethical perceptions. Collected data were analyzed using the SAS V8.1 statistical package. Result : (1) The score for the economic ethical consciousness of the subjects was $36.76{\pm}10.20$. As for each sub-categories, the score for industry was $7.67{\pm}2.77$; thrift, $7.42{\pm}2.37$; cooperation, $7.41{\pm}2.21$; occupational consciousness, $7.18{\pm}2.20$; and, for consumption, $7.02{\pm}1.90$. The score for the consciousness of consumption was the lowest. (2) Among the demographic characteristics of the subjects, age was found to have a statistically significant positive relation to the consciousness of economic ethics(r=.13, p<.001). The next significant factor was grade: seniors seemed to have a higher economic consciousness in all the sub-categories than freshmen(t=-4.32, p<.001). The number of in-home family has a statistically significant negative correlation with economic attitudes(r=-.15, p<.001). In addition, their economic ethical perceptions were significantly higher with no religion (t=2.14, p<.05); have an unemployed father (t=2.78, p<.05); have credit cards under their own names (t=3.04, p<.05); have ever had overdue card bills (t=4.25, p<.001); have ever had part time job(t=1.74, p<.1) and when they don't live with their parents (t=-2.01, p<.05). 3) A multiple regression analysis was conducted to examine the influential power of the factors affecting the consciousness of economic ethics of the subjects. The factors had more influence on the economic attitudes of the seniors than those of freshmen; in those who having credit cards under their own names than under others; and, in those who have ever experienced credit default than those haven't. Though these factors raised average 3.0 points of economic consciousness, their expository power for the consciousness were low. Conclusion : The nursing students had medium-high consciousness of economic ethics and they seemed to have low consciousness of the proper consumption practices. Their actual life experiences had an influence on their economic attitudes. Therefore, practical programs on economic knowledge should be developed and taught to students systematically at school so that they could have sound consciousness of economic ethics and appropriate knowledge closely related with their real life.

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AN EVALUATION OF TREATMENT EFFECTS OF BIONATOR IN CLASS II DIVISION 1 MALOCCLUSION BY FINITE ELEMENT METHOD (II급 1류 부정교합에서 bionator의 치료효과에 관한 유한요소법적 연구)

  • Ahn, Sug-Joon;Suhr, Cheong-Hoon
    • The korean journal of orthodontics
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    • v.26 no.2 s.55
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    • pp.219-232
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    • 1996
  • The purpose of this study was to evaluate treatment effects of bionator in Class II division 1 malocclusion by FEM(Finite Element Method). The 73 subjects were classified into good result group and poor result group in reference to posttreatment molar relation, posttreatment overbite and overjet, posttreatment profile, and relapse. Pretreatment and posttreatment lateral cephalograms were taken and FEM was performed. The results were as follow; 1. There was no statistical significance in treatment changes between the sexes, and between the treatment result groups. 2. Treatment changes were not significantly different among the age groups. 3. The effect of treatment period groups on skeletal and dentoalveolar changes were analyzed using ANOVA. Body of maxilla, upper incisor, anterior face, ramus, upper anterior face, lower anterior face and treatment effect were correlated with the treatment period, but correlation coefficients were low. 4. The results of present investigation confirm that Class II bionator can assist in the correction of Class II division 1 malocclusion, mainly due to dentoalveolar changes. 5. There is significant difference in skeletal and dentoalveolar pattern between good result group and poor result group. In poor result group, maxilla was relatively downward and backward rotated, mandible was relatively backward rotated, upper incisor was in relatively lingual position, lower incisor was in relatively labial position.

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Research on plaque removal by sonic toothbrush for patients with a fixed orthodontic appliance (고정식 교정장치 부착환자에서 음파칫솔의 치면세균막 제거 효과에 관한 연구)

  • Cha, Kyung-Suk
    • The korean journal of orthodontics
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    • v.34 no.2 s.103
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    • pp.189-195
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    • 2004
  • The purpose of this research is to evaluate and compare the plaque removal ability of sonic brushing and manual brushing in order to present a method for continuous and effective oral hygiene control during orthodontic treatment. Nonextracted adolescent patients (male: 23 persons, female: 37 persons) and adult patients (male: 15 persons, female: 45 persons) outfitted with a fixed orthodontic appliance from their incisors to second molar, in both the maxilla and mandible, were divided into manual brushing and sonic brushing groups. A Philips oral healthcare HX-4401 sonic toothbrush was used, and the application of brushing for the two groups was standardized at two minutes. After brushing, the plaque score was measured with a modified Wilkin's PHP. The following results were achieved after comparing each group's plaque score. 1. In patients with a fixed orthodontic appliance when age was not accounted for, the application of sonic brushing exerted a beneficially decreased effect on the plaque score. (adolescents : p<0.01, adults: p<0.05) 2. When comparing the adolescent and adult groups in regard to plaque score, the adolescent group showed a more decreased effect. 3. When using the same toothbrush type, there was no difference between the adolescent and adult groups.

Lateral Cephalometic Assessment in Patients with Condylar Resorption (과두흡수가 있는 환자의 측방 두부방사선 계측)

  • Hur, Yun-Kyung;Park, Hyo-Sang;Choi, Jae-Kap
    • Journal of Oral Medicine and Pain
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    • v.31 no.4
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    • pp.337-346
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    • 2006
  • Aims: The present study investigated the relationship between condylar resorption and craniofacial skeleton types(especially vertical relationships), the differences of craniofacial skeleton types between with open bite group and without open bite group, and the associations of anterior disc dislocation with or without reduction to condylar resorption with MRI. Patients selection and methods: Clinical examination, magnetic resonance imaging (MRI), panorama, lateral transcranial and lateral cephalometric radiographs in 34 patients with condylar resorption were used to investigate this relationship. Results and Conclusions: Patients with the following specific facial morphologic characteristics appear to be most susceptible to condylar resorption: (1) females were predominant, (2) patients' age ranged from 12 to 50 years old with a strong predominance for 2nd and 3rd decades, (3) patients had high mandibular plane angle and high gonial angle, (4) patients had decreased vertical height of the ramus, (5) patients had generally significant antegonial notch, (6) patients had predominance of Class I occlusal relationship with or without open bite but mandible was retruded as mean ANB 5.54 degrees, (7) condylar resorption rarely occurs in lower mandibular plane angle facial types, (8) although no statistically significant difference was found, the open bite group had a tendency more hyperdivergent skeletal pattern than the non open bite group, and (9) imaging demonstrates from small resorbing condyles to idiopathic condylar resorption and TMJ articular disc dislocations. Thus, morphologic features of patients with vertical discrepancies may represent a risk factor for the development of condylar resorption.

The Thickness Measurement of Masticatory Mucosa on the Hard Palate and Maxillary Tuberosity in Healthy Korean Adults (건강한 한국 성인에서 경구개와 상악결절 부위 저작점막의 두께 측정)

  • Cho, Ik-Hyun;Park, Jung-Mi;Chang, Moon-Taek;Kim, Hyung-Seop;Kim, Hyun-Chul
    • Journal of Periodontal and Implant Science
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    • v.31 no.3
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    • pp.641-649
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    • 2001
  • The aim of present study was to assess the thickness of masticatory mucosa on the hard palate and tuberosity as a potential donor site for mucogingival surgery. Thickness measurement was performed in 30 dental college students who are periodontally healthy, with a recently developed, ultrasonic device(SDM). The mean age of study subjects was 23.7(range 21-29) years old and the subjects were composed of 18 males and 12 females. Eighteen standard measurement points were defined on the hard palate, located on 3 lines which ran at different distances parallel to the gingival margin. Six positions were designated on each of these 3 lines between the level of the canine and the second molar. On the tuberosity, 6 standard measurement points were defined, located on 2 lines running parallel to the gingival margin at different distances. Data were analyzed to determine differences in gender, between different positions, and between lines, by an analysis of variance. The results showed that the mucosa of the tuberosity was significantly thicker than that of the hard palate region. Gender did not influence the thickness of masticatory mucosa, either on the hard palate or the tuberosity. On the hard palate, mucosa thickness increased as the distance from the marginal gingiva increased. The mucosa over the palatal root of the maxillary first molar was significantly thinner than that at all other positions on the hard palate. Measurement error at palate was 0.25mm, at tuberosity 0.51mm. No difference in the thickness of masticatory mucosa on palate and tuberosity was found between men and women. On the hard palate, soft tissue thickness progressively increased in sites further from the gingival margin. Therefore, we may harvest more thicker graft on the tuberosity that has more masticatory mucosa thickness than hard palate, however the width may not be sufficient for using.

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Necrotizing Enterocolitis in Term Infants (만삭아에 발생한 괴사성 장염)

  • Kim, Dae-Yeon;Kim, Seong-Chul;Kim, Kyung-Mo;Kim, Ellen Ai-Rhan;Kim, Ki-Soo;Pi, Soo-Young;Kim, In-Koo
    • Advances in pediatric surgery
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    • v.9 no.1
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    • pp.19-23
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    • 2003
  • Necrotizing Enterocolitis (NEC) is usually a disease of premature infants, but occasionally it affects the term neonate. Twenty-five infants with NEC were treated at Asan Medical Center between January 2000 and December 2002, and 13 of them were term infants. In each case, the diagnosis of NEC was established by a clinical illness fulfilling the Bell's stage II or III NEC as modified by Walsh or by surgical findings. There were six males and seven females. The birth weight was from 1,960 to 3,700 g. The age at diagnosis was from 1 to 40 days. Four patients had congenital heart disease: one of who had hypothyroidism and cleft palate. Abdominal distension was present in all, and bloody stools in four. One patient had history of hypoglycemia, three had Rota viral infection. Eight patients had leucopoenia (<$5.0{\times}10^9/L$), seven had thrombocytopenia (<$100{\times}10^9/L$), and three severe thrombocytopenia (<$50{\times}10^9/L$). Laparotomy was required in 10 of the 13 patients. Indications for operation in the acute phase were failure to respond to aggressive medical therapy in five, and perforation in three patients. There were two late phase operations for intestinal stricture and fistula. There were no operative complications. Ten of thirteen patients survived (76.9%). Two patients died of septic complication. There was a delayed death due to heart failure. There was a significant difference in survival according to platelet count ($50{\times}10^9/L$) (p<0.05). Congenital heart disease and Rota viral infection are associated with NEC in term infants and thrombocytopenia and leucopoenia may be surgical indications.

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Complications of Meckel's Diverticulum in Children (소아 멕켈씨 게실의 합병증)

  • Jun, Heung-Man;Nam, So-Hyun;Kim, Dae-Yeon;Kim, Seong-Chul;Kim, In-Koo
    • Advances in pediatric surgery
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    • v.13 no.2
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    • pp.127-134
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    • 2007
  • Meckel's diverticulum is the most common congenital anomaly of gastrointestinal tract in children. The incidence of complicated Meckel's diverticulum is about 4 %. The major complications of Meckel's diverticulum are bleeding, intussusception, obstruction and perforation. The aim of this study was to investigate the clinical manifestations and the role of laparoscopic surgery in complicated Meckel's diverticulum in children. We retrospectively reviewed the medical records of 19 patients with complicated Meckel's diverticulum who underwent operation at Asan Medical Center between Jan. 1990 and Apr. 2007. Male to female ratio was 11:8, and median age was 1 year (1 day-13 years). The most frequent symptom was hematochezia (68%), followed by irritability or abdominal pain (16%), vomiting (11%), and abdominal distension (5%). Two operative procedures were performed; small bowel resection with anastomosis (68%) and diverticulectomy (32%). The operation proven complications of the Meckel's diverticulum were bleeding (68%), intussusception (16%), perforation (11%) and obstruction (5%). Ectopic tissues found by postoperative pathologic examination were gastric (84%) and pancreatic (11%). Hospital stay after laparoscopic operation for bleeding Meckel's was 5 days (median) and average first postoperative feeding was 1.5 days. On the contrary, hospital stay for open surgery was 7 days and first feed was 3 days. In summary, the most common compliation of Meckel's diverticulum in children was bleeding and ectopic gastric tissues were present in 84%. Laparoscopic procedure seemed to be useful for diagnosis as well as for definitive treatment.

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