• Title/Summary/Keyword: trial records

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The Ability of Anti-tumor Necrosis Factor Alpha(TNF-${\alpha}$) Antibodies Produced in Sheep Colostrums

  • Yun, Sung-Seob
    • 한국유가공학회:학술대회논문집
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    • 2007.09a
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    • pp.49-58
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    • 2007
  • Inflammatory process leads to the well-known mucosal damage and therefore a further disturbance of the epithelial barrier function, resulting abnormal intestinal wall function, even further accelerating the inflammatory process[1]. Despite of the records, etiology and pathogenesis of IBD remain rather unclear. There are many studies over the past couple of years have led to great advanced in understanding the inflammatory bowel disease(IBD) and their underlying pathophysiologic mechanisms. From the current understanding, it is likely that chronic inflammation in IBD is due to aggressive cellular immune responses including increased serum concentrations of different cytokines. Therefore, targeted molecules can be specifically eliminated in their expression directly on the transcriptional level. Interesting therapeutic trials are expected against adhesion molecules and pro-inflammatory cytokines such as TNF-${\alpha}$. The future development of immune therapies in IBD therefore holds great promises for better treatment modalities of IBD but will also open important new insights into a further understanding of inflammation pathophysiology. Treatment of cytokine inhibitors such as Immunex(Enbrel) and J&J/Centocor(Remicade) which are mouse-derived monoclonal antibodies have been shown in several studies to modulate the symptoms of patients, however, theses TNF inhibitors also have an adverse effect immune-related problems and also are costly and must be administered by injection. Because of the eventual development of unwanted side effects, these two products are used in only a select patient population. The present study was performed to elucidate the ability of TNF-${\alpha}$ antibodies produced in sheep colostrums to neutralize TNF-${\alpha}$ action in a cell-based bioassay and in a small animal model of intestinal inflammation. In vitro study, inhibitory effect of anti-TNF-${\alpha}$ antibody from the sheep was determined by cell bioassay. The antibody from the sheep at 1 in 10,000 dilution was able to completely inhibit TNF-${\alpha}$ activity in the cell bioassay. The antibodies from the same sheep, but different milkings, exhibited some variability in inhibition of TNF-${\alpha}$ activity, but were all greater than the control sample. In vivo study, the degree of inflammation was severe to experiment, despite of the initial pilot trial, main trial 1 was unable to figure out of any effect of antibody to reduce the impact of PAF and LPS. Main rat trial 2 resulted no significant symptoms like characteristic acute diarrhea and weight loss of colitis. This study suggested that colostrums from sheep immunized against TNF-${\alpha}$ significantly inhibited TNF-${\alpha}$ bioactivity in the cell based assay. And the higher than anticipated variability in the two animal models precluded assessment of the ability of antibody to prevent TNF-${\alpha}$ induced intestinal damage in the intact animal. Further study will require to find out an alternative animal model, which is more acceptable to test anti-TNF-${\alpha}$ IgA therapy for reducing the impact of inflammation on gut dysfunction. And subsequent pre-clinical and clinical testing also need generation of more antibody as current supplies are low.

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Clinical Study of the Patients, in Whom Pulmonary Embolism was Suspected by Lung Perfusion Scan (폐 관류주사검사상 폐동맥 색전증 소견을 보인 환자의 임상적 고찰)

  • Lee, Gwi-Lae;Kim, Jae-Yeol;Park, Jae-Suk;Yoo, Chul-Gyu;Kim, Young-Whan;Shim, Young-Soo;Han, Sung-Koo
    • Tuberculosis and Respiratory Diseases
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    • v.44 no.4
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    • pp.889-898
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    • 1997
  • Pulmonary Embolism can develop in variable conditions, and presents with nonspecific symptoms and signs. If diagnosis is delayed, it can be resulted in catastrophic results. Therefore, early diagnosis and adequate treatment is crucial in Pulmonary Embolism. Lung Perfusion Scan is useful screening test. Negative result can exclude pulmonary embolism. But, perfusion defects don't always mean pulmonary embolism. To find the better methods of interpretation of lung perfusion scan and To evaluate the clinical course and outcomes of the patients, in whom pulmonary embolism was suspected by lung perfusion scan, we reviewed the clinical records of 49 cases suspected by lung perfusion scan at Seoul National University Hospital during the period of January, 1995 to July, 1996. The results are as follows. First impression of cases in which PE was present at time of admission were pulmonary embolism (63%), heart diseases (26%), and pneumonia (11%) in orders. Underlying diseases of cases in which PE developed during admission were malignancy (36.5%), ICH (22.7%), sepsis (13.7%), and SLE (9.1%) in orders. The predisposing factors were operation (20%), cancer (16%), immobility (16%), connective tissue disease (16%), heart dis. (10%), old age (10%), and preg/pelvic dis. (8%) The results, of lung perfusion scan were HPPE 40 cases(26.8 %), IPPE 21 cases(14.1%), LPPE 88 cases (59.1%), and cases(%) of treatment in these cases were HPPE 34 cases(85%), IPPE 9 cases(42.9%), LPPE 0 case(0.0%). Treatments were heparin and warfarin (69.5%), heparin alone (8.2%), warfarin alone (2.0%), embolectomy (4.1%), thrombolytics (2.0%), IVC filter (2.0%), and no treatment (12.2%) In 34 cases (69.4%), follow up could be done, and 5 cases were recurred (10.2%). The causes of recurrence was incomplete anticoagulant therapy (3 cases) and recurrence of predisposing factor (2 cases). Expired case due to pulmonary embolism was one who was expired just before trial of thrombolytic therapy. Conclusion : Efforts should be made to shorten the interval from onset of Sx to Dx, ie, high index of suspision.

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A Trial of Aerosolized Colistin for the Treatment of Nosocomial Pneumonia due to Multidrug-resistant Acinetobacter baumannii (다제내성 A. baumannii에 의한 병원획득폐렴에서 Colistin 분무치료의 시도)

  • Kim, Changhwan;Kim, Dong-Gyu;Kang, Hye-Ryun;Choi, Jeong-Hee;Lee, Chang Youl;Hwang, Yong Il;Shin, Tae Rim;Park, Sang Myeon;Park, Yong Bum;Lee, Jae Young;Jang, Seung Hun;Kim, Cheol Hong;Mo, Eun Kyung;Lee, Myung Goo;Hyun, In-Gyu;Jung, Ki-Suck;Choi, Young-Jin;Lee, Jae Woong
    • Tuberculosis and Respiratory Diseases
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    • v.64 no.2
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    • pp.102-108
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    • 2008
  • Background: Recently, multidrug-resistant (MDR) A. baumannii has been implicated for a significant proportion of nosocominal pneumonia in many intensive care units (ICUs), and its acquisition may increase mortality and the length of stay in the ICU. Aerosolized colistin has been successfully used in patients with cystic fibrosis, but there is a lack of data regarding the use of aerosolized colistin in patients with nosocomial pneumonia. Methods: We conducted the present study to assess the effectiveness of aerosolized colistin for the treatment of MDR A. baumannii nosocomial pneumonia. We retrospectively reviewed the medical records of 10 patients who had been hospitalized in the medical ICU and had received aerosolized colistin as a therapy for MDR A. baumannii pneumonia. Results: The mean duration of aerosolized colistin therapy was $12.7{\pm}2.4$ days. Nine (90%) of 10 patients showed a favorable response to the therapy. Follow-up cultures were available for all patients, and the responsible pathogen was completely eradicated. One patient suffered from bronchospasm, which resolved after treatment with nebulized salbutamol. Conclusion: Our results corroborate previous reports that aerosolized colistin may be an effective and safe choice for the treatment of nosocomial pneumonia caused by MDR A. baumannii. Larger prospective controlled clinical studies are warranted to validate further the effectiveness and safety of aerosolized colistin therapy.

Risk Factors Related to Uterine Leiomyoma in Korean Women - A Retrospective Study - (한국인 여성에서 자궁근종 발생에 관여하는 인자들에 대한 연구 - 후향적 연구 -)

  • Hong, D.G.;Chung, M.J.;Kim, B.S.;Lee, J.M.;Cho, Y.L.;Lee, T.H.;Chun, S.S.
    • Clinical and Experimental Reproductive Medicine
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    • v.33 no.3
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    • pp.159-170
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    • 2006
  • Objective: The purpose of this study is to find out risk factors related to uterine leiomyoma in Korean women and to compare with the results of previous western studies. Methods: A retrospective analysis was carried out. All the cases of uterine leiomyoma (n=244) were diagnosed surgically or sonographically between Jannuary 1998 and December 2004. Total of 269 controls not having uterine leiomyoma were collected from patients who visited Kyungpook national university hospital for routine gynecologic check-up or treatment of their gynecologic or obstetric diseases other than uterine leiomyoma. Data were collected through review of medical records and interviews and analyzed with $x^2$ and logistic regression model. Results: In multivariate analysis, patient's age (OR 1.070; 95% CI 1.041~1.099), number of artificial abortion (OR 1.182; 95% CI 1.018~1.374) and alcohol drinking (OR 1.865; 95% CI 1.231~2.824) had significantly positive correlation with uterine leiomyoma. The duration of lactation was the only factor which had negative correlation (OR 0.985; 95% CI 0.972~0.998). BMI, parity, age at menarche, the duration and interval of menstruation, caffeine consumption and marital status did not show any correlations. Conclusion: In this study, patient's age, number of artificial abortion, and alcohol drinking were the risk factors of uterine leiomyoma in Korean women and the result was similar to that of western studies. Though we couldn't find out the specific risk factors related to the development of uterine leiomyoma in this study, but it has a great meaning to be the first trial in Korean women. The role of information bias should be carefully evaluated and further multicentered, randomized, controlled prospective studies will be needed to know the possible risk factors among Korean women.

Effect of surfactant lavage in severe meconium aspiration syndrome (중증 태변 흡인 증후군에서 인공 폐표면활성제 세정요법의 효과에 관한 비교 연구)

  • Lee, Soon Min;Kim, He Min;Jeon, Ji Hyun;Park, Min Soo;Park, Kook In;Namgung, Ran;Lee, Chul
    • Clinical and Experimental Pediatrics
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    • v.51 no.4
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    • pp.367-371
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    • 2008
  • Purpose : The surfactant dysfunction may play an important role in meconium aspiration syndrome (MAS). We aim to evaluate the effect of surfactant lavage in the treatment of term infants with MAS. Methods : The medical records of 15 neonates with severe MAS admitted at Yongdong Severance Hospital from 2005 to 2007 were reviewed and analyzed. Seven infants with severe MAS necessitating mechanical ventilation underwent tracheobronchial lavage with 20 mL/kg of diluted (5.3 mg phospholipid/mL) surfactant saline suspension ($Newfactan^{(R)}$). Data regarding clinical outcomes was assessed by comparison with 8 control infants with equally severe MAS retrospectively. Results : In the lavage group, radiological improvement was evident after 6 hours of treatment. The duration of artificial ventilation and duration of hospital day were also significantly shorten in the lavage group compared with the control group. The mean oxygen index, mean ventilation index improved significantly within the first 6 hours after treatment. No differences were found in the incidence of major complications and mortality between the two groups. Conclusion : The surfactant lavage seems to be an effective and safe method for treatment of severe MAS. A multicenter, large scaled randomized controlled trial is needed for further study.

Prospective Randomized Trial for Postoperative Adjuvant Chemotherapy in Gastric Cancer without Serosal Invasion -Final Report- (장막침윤이 없는 위암환자에서 수술 후 보조적 화학 요법에 대한 전향적 연구 -최종보고-)

  • Kim Yong Jin;Kim Byung Sik;Kim Yong Ho;Yook Jung Hwan;Oh Sung Tae;Park Kun Choon
    • Journal of Gastric Cancer
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    • v.4 no.4
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    • pp.257-262
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    • 2004
  • Purpose: We reported our preliminary result in 2001. At that time, the follow-up period was too short to evaluate the survival benefit of adjuvant chemotherapy in gastric cancer without serosal invasion. Therefore, we followed those patients for 66 months to determine the long-term effects of adjuvant chemotherapy. Materials and Methods: We analyzed the recurrence pattern, the survival rate, and the disease-specific survival of 135 patients by reviewing their medical records and calling the patients or their relatives. All enrolled patients were included in the intention-to-treat analysis of efficacy. Results: The follow-up rate was $89.6\%$ (121/135), and the median follow-up duration was 66 months. Among the 135 patients, 4 relapsed in group 1 (5-FU+cisplatin), 7 in group 2 (mitomycin C+oral 5-FU), and 6 in group 3 (oral 5-FU only). The overall survival rate was $89\%$ in group 1, $84\%$ in group 2, and $82\%$ in group 3. There were no differences in the overall survival rates and the disease-specific survival rates among the three groups. Conclusion: Oral chemotherapeutic agents have an acceptable effect for adjuvant chemotherapy compared with intravenous agent. However, a large-scale, prospective, randomized study, including a control group, is needed for an exact evaluation.

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Predictability of Impending Events for Death within 48 Hours in Terminal Cancer Patients (말기암환자에서 임박사건 간 48시간 임종예측도 비교)

  • Hwang, In-Cheol;Choi, Chung-Hyun;Kim, Kyoung-Kon;Lee, Kyoung-Shik;Suh, Heuy-Sun;Shim, Jae-Yong
    • Journal of Hospice and Palliative Care
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    • v.14 no.1
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    • pp.28-33
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    • 2011
  • Purpose: Recognition of impending death is crucial not only for efficient communication with the caregiver of the patient, but also determination of the time to refer to a separate room. Current studies simply list the events 'that have already occurred' around 48 hours before the death. This study is to analyze the predictability of each event by comparing the time length from 'change' to death. Methods: Subjects included 160 patients who passed away in a palliative care unit in Incheon. The analysis was limited to 80 patients who had medical records for the last week of their lives. We determined 9 symptoms and 8 signs, and established the standard of 'significant change' of each event before death. Results: The most common symptom was increased sleeping (53.8%) and the most common sign was decreased blood pressure (BP) (87.5%). The mean time to death within 48 hours was 46.8% in the case of resting dyspnea, 13.6% in the ease of low oxygen saturation, and 36.9% in the case of decreased BP. The symptom(s) which had the highest positive predictive value (PV) for death within 48 hours was shown to be resting dyspnea (83%), whereas the combination of resting dyspnea and confusion/delirium (65%) had the highest negative PV. As for the most common signs before death within 48 hours, the positive PVs were more than 95%, and the negative PV was the highest when decreased BP and low oxygen saturation were combined. The difference in survival patterns between symptoms and signs was significant. Conclusion: The most reliable symptoms to predict the impending death are resting dyspnea and confusion/delirium, and decline of oxygen saturation and BP are the reliable signs to predict the event.

Etiology and Analysis of Severity in Childhood Pancreatitis (소아 췌장염의 원인과 중증도 분석)

  • Park, Jun-Eun;Kim, Kyong-Mo
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.2 no.2
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    • pp.194-203
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    • 1999
  • Purpose: Childhood pancreatitis has more various and somewhat different etiology than adult. Until now the analysis of severity in childhood pancreatitis were not well-known, although several studies have been made. Therefore, we studied the etiology and complications in childhood pancreatitis and analyzed whether Ranson and CT criteria could be applicated to evaluate the severity of childhood pancreatitis patients. Methods: The records of 30 patients with pancreatitis under 15 years of ages who were diagnosed in Asan medical center were reviewed. Age, sex, history, etiology, clinical features and treatment was reviewed in all patients but complications, Ranson and CT criteria were available in only 12 patients. Correlation between the number of complications and both Ranson and CT criteria were calculated with Spearman correlation coefficient. Results: 1. Median age at diagnosis was 7.3 years of age. 28 cases were acute pancreatitis and 2 cases were chronic pancreatitis. 2. Etiology: choledochal cyst(8 cases), drug (7 cases), trauma (4 cases), infection (3 cases), biliary stone or bile sludge (3 cases), idiopathic (2 cases) Hemolytic uremic syndrome, pancreatic duct obstruction, iatrogenic (1 case). 3. Local complications were ascites (5 cases), pseudocyts (4 cases) and systemic complications were hyperglycemia (4 cases), hypocalcemia (3 cases), pleural effusion (3 cases), etc. 4. Positive correlation was found between the number of complication and Ranson creteria (r=0.78, P=0.0016) and between the number of complication and CT criteria (r=0.65, P=0.015) in 13 cases. Conclusion: A trial to search the biliary duct anomaly may help to find the causes of childhood idiopathic pancreatitis, and both Ranson and CT criteria can be applicated to pediatric patients to evaluate the severity of childhood pancreatitis.

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Clinical Characteristics in Panic Disorder Patients in Emergency Department (공황발작으로 응급실에 내원한 공황장애 환자들의 임상 특징)

  • Lee, Chang-Ju;Nam, Beom-Woo;Sohn, In-Ki
    • Korean Journal of Psychosomatic Medicine
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    • v.29 no.1
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    • pp.26-33
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    • 2021
  • Objectives : This study was designed to investigate datas related to panic attack and treatment in emergency room of panic disorder patients who visited emergency room for panic attack. Methods : A retrospective analysis of medical records was conducted on 92 patients with panic disorder who visited Chungju Konkuk university hospital emergency department due to panic attack and had bodily symptoms from 1st January 2010 to 31th December 2019. In addition to demographic characteristics and comorbid disorders, triggering stressors and alcohol consumption were corrected as pre-panic attack datas, bodily symptoms at the time of panic attack were corrected as datas during attack, electrocardiogram trial, consultation with psychiatrist, admission and information of used psychotropic drugs were corrected as post-attack data. Depending on size of data, Chi-square test or Fisher's exact test was used. Collected data was analyzed using R 4.03. Results : Cardiovascular disease was accompanied by 5.4% and depressive disorder was the most common coexisting mental disorder. Among triggering stressors, economic problem/work-related stress was significantly higher in men than women (𝛘2=4.322, p<0.005). The most common physical symptom during attack was circulatory (65.2%), followed by respiratory (57.6%), numbness-paralysis (33.7%), dizziness (19.6%), gastro-intestinal (14.1%) and autonomic symptom (12.0%). Electrocardiogram was taken at higher rate when patients complained circulatory symptom (𝛘2=8.46, p<0.005). The psychotropic drug most commonly used in emergency room was lorazepam, used in 92.1%. Conclusions : The most common bodily symptom during panic attack was circulatory symptom and the most common triggering stressor in men was economic problem/work-related stress. The most commonly used psychotropic for panic attack was lorazepam.