• 대한한방내과학회지
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• 제34권4호
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• pp.349-361
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• 2013

Objectives : This study aimed to evaluate the single oral dose toxicity and four weeks repeated dose determination of Gamisasangja-tang (GST) in male and female Sprague-Dawley rats. Methods : In the single oral toxicity study, rats were orally administered a single dose of 0 and 5,000 mg/kg GST. There were 5 rats in each group. After single administration, mortality, clinical signs, body weight changes and gross pathological finding were observed for 14 days. In the 4-weeks repeated oral dose determination study, rats were orally administered a single dose of 0, 1,250, 2,500 or 5,000 mg/kg GST. There were 5 rats in each group. Mortality, clinical signs, body weight changes, food consumption and gross pathological finding were observed for 28 days. Organ weight, clinical chemistry and hematology were tested after 28 days. Results : There was no mortality in either of the two studies. There were also no significant differences in clinical sign, body weight, organ weights, hematological or serum chemical parameters between the GST and control groups. Conclusions : The results obtained in this study suggest that the 50% lethal dose of GST is over 5,000 mg/kg, so this finding would be expected to provide scientific evidence for the safety of GST.

• 대한한의학방제학회지
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• 제20권2호
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• pp.55-63
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• 2012

Objectives : This study was conducted to investigate the safety of Bangpungtongsung-san in rats. Methods : The safety of this prescription on acute toxicity was evaluated by single dose toxicity study. Rats were orally administrated in a single dose of 0 and 2,000 mg/kg(limited dose) Bangpungtongsung-san. There were 7 rats in each groups. All animals were sacrificed after 14 days of treatment. After single administration, mortality, clinical signs, and body weight changes were observed for 14 days. Three parameters(autopsy finding, clinical chemistry, and hematology) were tested on the last day. Results : In this study with rats, Bangpungtongsung-san treatment did not show any acute toxicity. No mortality was noted for 14 days of treatment. There were no adverse effects on clinical signs, body weight changes, and autopsy finding at all treatment groups. The clinical chemistry parameters attesting to liver and kidney functions as well as the hematological parameters were within the normal ranges. Conclusions : It is considered that $LD_{50}$ of Bangpungtongsung-san is over 2,000 mg/kg in oral administration by rats. This finding of the safety of Bangpungtongsung-san is expected to strengthen the position of this prescription as nontoxic medicine.

• 응용통계연구
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• 제33권2호
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• pp.137-145
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• 2020

'투약용량 발견 시험(Dose Finding Study)'라고도 불리는 제 1상 임상시험은 동물 실험 혹은 시험관 실험을 통하여 개발된 신약물질을 사람에게 실시하는 첫 단계이다. 제1상 임상시험의 가장 주요한 목적은 환자에게 허용할 수 있고 최대의 효능을 가진 복용량을 결정하는 것이다. 본 논문에서는 이를 고려하여 최대허용용량(MTD)를 결정할 수 있는 적절한 추정방법을 제안하였다. 이 방법은 Biased coin design과 멈춤규칙을 이용하여 MTD를 추정한다. 제안하는 방법은 모의실험을 통해 기존의 방법들과 비교하였다.

• Communications for Statistical Applications and Methods
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• 제29권4호
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• pp.421-439
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• 2022

Phase I dose-finding trials are essential in drug development. By finding the maximum tolerated dose (MTD) of a new drug or treatment, a Phase I trial establishes the recommended doses for later-phase testing. The primary toxicity endpoint of interest is often a binary variable, which describes an event of a patient who experiences dose-limiting toxicity. However, there is a growing interest in dose-finding studies regarding non-binary outcomes, defined by either the weighted sum of rates of various toxicity grades or a continuous outcome. Although several novel methods have been proposed in the literature, accessible software is still lacking to implement these methods. This study introduces a newly developed R package, UnifiedDoseFinding, which implements three phase I dose-finding methods with non-binary outcomes (Quasi- and Robust Quasi-CRM designs by Yuan et al. (2007) and Pan et al. (2014), gBOIN design by Mu et al. (2019), and by a method by Ivanova and Kim (2009)). For each of the methods, UnifiedDoseFinding provides corresponding functions that begin with next that determines the dose for the next cohort of patients, select, which selects the MTD defined by the non-binary toxicity endpoint when the trial is completed, and get oc, which obtains the operating characteristics. Three real examples are provided to help practitioners use these methods. The R package UnifiedDoseFinding, which is accessible in R CRAN, provides a user-friendly tool to facilitate the implementation of innovative dose-finding studies with nonbinary outcomes.

• Journal of Chest Surgery
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• 제20권2호
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• pp.300-308
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• 1987

Clinical and pathologic data were reviewed in 20 patients who had have surgery for isolated aortic valvular heart disease between April 1978 and April, 1987. Hospital mortality was 10%, with no additional late mortality during a mean follow-up period of 24.1 months. Prosthetic valve failure developed in 3 patients and two had reoperation. Niety four percent of the survivors who were in NYHA Funtional class III or IV before operation are now in class I or II. Ninety percent of all patients are still alive at a maximum follow up of 9 years. The clinical histories, gross and histologic examination of valves estabilished the causes for isolated aortic valve disease: 3 rheumatic, 2 congenital bicuspid, 2 hypertention, 2 aortitis and each one case of floppy valve, medial cystic necrosis of aorta, bacterial endocarditis. But etiology was unknown in 8 cases. Sixteen patietns had myxoid degeneration, defined as significant disruption of the valve fibrosa and its replacement by acid mucosaccharides and cystic changes. Myxoid degeneration was also the primary pathologic abnormality in the patients with 2 hypertention, 2 rheumatic, 1 aortitis, 1 bacterial endocarditis, 1 floppy valve, 1 congenital bicuspid. The patients with myxoid degeneration of uncertain origin were 8. Histologic finding of all of them revealed nonspecific patients with myxoid degeneration of uncertain orgin were 8. Histologic finding of all of them revealed nonspecific chronic valvulitis with myxoid degeneration. This finding may indicate that the etiology w uld be infectious.

• Biomolecules & Therapeutics
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• 제5권2호
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• pp.158-164
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• 1997

To investigate the effects of trypsin inhibitors, aprotinin and urinary trypsin inhibitor (UTI), on the cute pancreatitis, this study was carried out in dogs of acute pancreatitis induced by oleic acid (0.28 mg/kg). Administration with aprotinin and UTI seemed to have a therapeutic effect on the clinical sign, ultrasonographic finding, histopathologic finding. But in amylase and lipase activity, there were no significant differences among three groups.

• 한국간호교육학회지
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• 제8권1호
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• pp.95-107
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• 2002

The purpose of this study is to determine the clinical nurses' knowledge of DM and diabetes patient education aptitude so as to provide a basis for clinical nurse training with respect to diabetes patient education program. The data has been collected through the questionnaires of 42 items from the Knowledge on DM and each 16 item from the Importance on the elements of diabetes patient and the Recognition for clinical nurses, respectfully. 166 nurses from a general hospital who had participated in clinical nurse training in Sep. 28 and Oct. 4, 2001 were subject to respond the questionnaires. Analysis has been done by using statistical method such as percentage, average, standard deviation, t-test, ANOVA, Duncan test and Pearson correlation coefficients. The findings are as follows: 1. Clinical nurses' knowledge levels of diabetes 1) The average level of nurses' knowledge about diabetes is 29.37 (right answer- finding rate: 70%), which is intermediate. 2) Amongst the nurses classified by their knowledge levels about diabetes, the group with less than one year career and that with more than 5 year careers are found to have higher knowledge levels. The item with the highest right answer-finding rate was 'Please find the wrong out of the following examples about foot care'. Meanwhile, the item with highest incorrect answer-finding rate was 'what does blood sugar control aims for amongst gestational diabetes?'. 2. Clinical nurses' importance and perception levels of educational training about diabetes 1) There were no differences amongst nurses' importance level about diabetes. 2) Nurses usually had high scores(4.30) in terms of the items related to the importances about educational training. 3) There were quite high recognitions of general characteristics and symptoms about diabetes, amongst the nurse cohorts working more than one year and less than 5 years, and over 5 years, the group belonging to the internal department, that having the previous experiences of dealing with diabetes, and that having their diabetic relatives and other close people. Meanwhile, strangely, the group who identified themselves as 'not good at treating diabetes' had a high recognition level of educational training about diabetes. 3. Relationship between knowledge levels and importance & perception levels of diabetes 1) The higher knowledge about diabetes nurses had, the more importance they recognized. 2) It is found that there was no relationship between knowledge and perception of diabetes. 3) The more importance about diabetes nurses had, the higher perception they obtained. In conclusion, there is an urgent need for systematic educational programs about diabetes including technical aspects, in order to upgrade and improve nurses knowledge levels. In addition, re-educational training should be provided at regular intervals. Further, we believe the nurses with high knowledge about diabetes and interests in the provision of educations for patients can be far more confident, and in return, patients can have better self-management about diabetes obtained through educations. Based on the above-mentioned findings, we would like to make the suggestion: re-evaluation about nurses' knowledge and cognition levels should be carried out after job training programs about diabetes.

• 치과방사선
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• 제21권2호
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• pp.327-336
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• 1991

The purpose of this study was to evaluate the validity among the clinical, transcraial radiographic and MRI diagnosis in internal derangement of the temporomandibular joint. Fourty two temporomandibular joints were assessed in twenty one patients who visited the dental department of Chonnam National University Hospital with the complaint of temporomandibular disorder from Oct. 1990 to Oct. 1991. The results were as follows: 1. In the clinically symptomatic 29 TMJs, 26 (89.7%) joints reveal disc displacement and 3 (10.3%) joints reveal normal disc position on MRI. The sensitivity of clinical diagnosis was 0.77, and the specificity was 0.63. 2. In the normal 22 TMJs on the trans cranial radiographic finding, 16 (72.7%) joints reveal disc displacement, and 6 (27.3%) joints reveal normal disc position on MRI. In the abnormal 20 TMJs on the transcranial radiographic finding, 18 (90%) joints reveal disc displacement, and 2 (10%) joints reveal normal disc position on MRI. The sensitivity of trans cranial radio- graph was 0.53, and the specificity was 0.75.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• 제17권3호
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• pp.186-190
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• 2014

Lymphocytic gastritis (LG) is a rare subtype of chronic gastritis. It is defined as dense proliferation of intraepithelial lymphocytes (IELs) more than 25 lymphocytes per 100 epithelial cells. The known major causes of LG are celiac disease and Helicobacter pylori infection. H. pylori associated LG (HpLG) has more enhanced cytotoxic and apoptotic tendencies than chronic H. pylori gastritis. A 12-year-old girl with postprandial epigastric pain was diagnosed HpLG on endoscopic biopsy. After the 1st eradication therapy, H. pylori bacilli were still found, and urea breathing test was positive. Although the endoscopic finding was partially improved, clinical symptoms and histologic finding were persisted. We could achieve the improvement of clinical symptoms and disappearance of IELs after the 2nd eradication. The discordant of histopathologic and endoscopic improvement occurred after the 1st eradication therapy of HpLG. Therefore the clinical and histopathologic evaluation should be considered as well as endoscopic findings.

• Journal of Korean Neurosurgical Society
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• 제30권1호
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• pp.47-53
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• 2001

Objective : This study was undertaken to evaluate operative results and prognosis according to preoperative clinical status and histopathological finding of spinal cord tumor. Methods : We analyzed of clinical feature, tumor location, histopathologic finding, operative results and prognosis in 55 patients with spinal cord tumor during last 10 years. Results : 1) The incidence of spinal cord tumors varies with the age of affected patients who are 2 to 75 years of age. Peak incidences were in the 5th & 7th decade of life, and the ratio of male to female was 1.2:1. 2) The most common histopathologic type was neurinoma(41.9%). 3) The tumors were located most frequently in the thoracic area(22 cases, 40.0%) and in the intradural extramedullary space(30 cases, 54.5%). 4) The most common initial clinical feature was pain in 20 cases(36.4%). For neurologic status on admission, 30 cases(54.5%) showed motor disturbance. 5) In radiologic studies, there were abnormal finding in 21 cases from plain X-rays among 37 cases. The entire 20 cases in when myelography was done showed subarachnoid blockade, either complete or incomplete. The magnetic resonance imaging, regard as the most accurate diagnostic method, revealed the exact location of the tumor and the relationship of the tumor with the adjacent anatomical structure. 6) The total removal was possible in 36 cases(65.5%), subtotal removal in 17 cases(30.9%) and biopsy in 2 cases (3.6%). Nineteen cases(90.5%) among 21 cases with preoperative radiculopathy group showed recovery or improvement, where as only 11 cases(36.7%) among 30 cases with preoperative motor weakness group showed recovery or improvement, with statistically significant difference(p<0.01). Pathologically, 26 cases(83.9%) among 31 cases of neurinoma and meningioma showed postoperative recovery or improved, but only 1 case(6.3%) among 16 cases of metastatic tumor, astrocytoma and ependymoma recovered. Postoperative complication noted in 5 cases(9.1%), and were noted postoperative hematoma, pneumonia, pulmonary edema and spinal cord infarction. Conclusion : Preoperative neurologic status and histopathologic finding are considered important factors of Postoperative outcome in patients with spinal cord tumor.