• Radiation Oncology Journal
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• v.27 no.4
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• pp.210-217
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• 2009

Purpose: To assess the influence of cyclooxygenase-2 (COX-2) expression on the survival of patients with a combination of rectal cancer and lymph node metastasis. Materials and Methods: The study included rectal cancer patients treated by radical surgery and postoperative radiotherapy at the Dong-A university hospital from 1998 to 2004. A retrospective analysis was performed on a subset of patients that also had lymph node metastasis. After excluding eight of 86 patients, due to missing tissue samples in three, malignant melanoma in one, treatment of gastric cancer around one year before diagnosis in one, detection of lung cancer after one year of diagnosis in one, liver metastasis in one, and refusal of radiotherapy after 720 cGy in one, 78 patients were analyzed. The immunohistochemistry for COX-2 was conducted with an autostainer (BenchMark; Ventana, Tucson, AZ, USA). An image analyzer (TissueMine; Bioimagene, Cupertino, CA, USA) was used for analysis after scanning (ScanScope; Aperio, Vista, CA, USA). A survival analysis was performed using the Kaplan Meier method and significance was evaluated using the log rank test. Results: COX-2 was stained positively in 62 patients (79.5%) and negatively in 16 (20.5%). A total of 6 (7.7%), 15 (19.2%), and 41 (52.6%) patients were of grades 1, 2, and 3, respectively for COX-2 expression. No correlation was found between being positive of COX-2 patient characteristics, which include age (<60-year old vs. $\geq$60), sex, operation methods (abdominoperineal resection vs. lower anterior resection), degrees of differentiation, tumor size (<5 cm vs. $\geq$5 cm), T stages, N stages, and stages (IIIa, IIIb, IIIc). The 5-year overall and 5-year disease free survival rates for the entire patient population were 57.0% and 51.6%, respectively. The 5-year overall survival rates for the COX-2 positive and negative patients were 53.0% and 72.9%, respectively (p=0.146). Further, the 5-year disease free survival rates for the COX-2 positive and negative patients were 46.3% and 72.7%, respectively (p=0.118). The 5-year overall survival rates were significantly different (p<0.05) for the degree of differentiation, N stage, and stage, whereas the 5-year disease free survival rates were significant for N stage and stage. Conclusion: Being positive for and the degree of COX-2 expression did not have a significant influence on the survival of rectal cancer patients with lymph node metastasis. However, N stage and stage did significantly influence the rateof survival. Further analysis of a greater sample size is necessary for the verification of the effect of COX-2 expression on the survival of rectal cancer patients with lymph node involvement.

• The korean journal of orthodontics
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• v.36 no.5
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• pp.339-348
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• 2006

Objective: With development of the skeletal anchorage system, orthodontic mini-implant (OMI) assisted on masse sliding retraction has become part of general orthodontic treatment. But compared to the emphasis on successful anchorage preparation, the control of anterior teeth axis has not been emphasized enough. Methods: A 3-D finite element Base model of maxillary dental arch and a Lingual tipping model with lingually inclined anterior teeth were constructed. To evaluate factors influencing the axis of anterior teeth when OMI was used as anchorage, models were simulated with 2 mm or 5 mm retraction hooks and/or by the addition of 4 mm of compensating curve (CC) on the main archwire. The stress distribution on the roots and a 25000 times enlarged axis graph were evaluated. Results: Intrusive component of retraction force directed postero-superiorly from the 2 mm height hook did not reduce the lingual tipping of anterior teeth. When hook height was increased to 5 mm, lateral incisor showed crown-labial and root-lingual torque and uncontrolled tipping of the canine was increased.4 mm of CC added to the main archwire also induced crown-labial and root-lingual torque of the lateral incisor but uncontrolled tipping of the canine was decreased. Lingual tipping model showed very similar results compared with the Base model. Conclusion: The results of this study showed that height of the hook and compensating curve on the main archwire can influence the axis of anterior teeth. These data can be used as guidelines for clinical application.

• Radiation Oncology Journal
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• v.15 no.2
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• pp.145-151
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• 1997

Purpose : To evaluate the loss of bone mineral contents(BMC) in lumbar spine within the radiation field for cervical cancer treatment, BMC in the irradiated patient group was compared with that of a normal control group. Method and materials : Measurements of BMC in the trabecular bone in lumbar spines(L3-L5) were performed in the both patient and normal control groups. Investigators used dual-energy quantitative computerized tomography(DEQCT) using Photon energy of 120 and 80kVp, The numbers of Patient and control groups were 43 in each with age distribution of fifth to seventh decade of women. The numbers of control group were 22 in fifth, 10 in sixth and 11 in seventh decade, those of patient group were 14 in filth, 14 in sixth, and 15 in seventh decade of women. The radiation field was extended to L5 spine for Pelvic irrdiation with 45-54Gy of external radiation dose and 30Gy of high dose rate brachytherapy in cervical cancer, Results : The BMC is decreased as increasing age in both control and patient groups. BMC in lumbar spine of patient group was decreased by about $13\%\;to\;40\%$ maximally. The BMC of L3 and L4 a region that is out of a radiation field for the Patient group demonstrated $119.5\pm30.6,\;117.0\pm31.7\;for\;fifth,\;83.3\pm37.8,\;88.3\pm46.8\;for\;sixth\;and\;61.5\pm18.3,\;56.2\pm26.6mg/cc$ for seventh, Contrasted by the normal control group has shown $148.0\pm19.9,\;153.2\pm23.2\;for\;fifth,\;96.1\pm30.2,\;105.6\pm26.5\;for\;sixth\;and\;73.9\pm27.9,\;77.2\pm27.2mg/cc$ for seventh decade, respectively The BMG of patient group was decreased as near the radiation field, while the lower lumbar spine has shown more large amounts of BMC in the normal control group. In Particular, the BMC of L5 within the radiation field was significantly decresed to $33\%,\;31\%,\;40\%$ compared with the control group of the fifth, sixth and seventh decades, respectively. Conclusion : The pelvic irradiation in cervical cancer has much effected on the loss of bone mineral content of lumbar spine within the radiation field, as the lower lumbar spine has shown a smaller BMC in Patient group with Pelvic irradiation in contrast to that of the normal control groups.

• The Journal of Dong Guk Oriental Medicine
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• v.8 no.2
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• pp.115-129
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• 2000

The cause that the increase of animality fat intakes, under exercise, fatness, adding the stress, advanced age etc., the occurrence rate of the circulation system disease has been increased. And the thrombosis importantly came to the front as the risk factor of these circulation system's disease. Nowadays, the ischemic disease has especially discussed, for example the angina or myocardial infarction, originated in thrombosis that came from the platelet aggregation. In the western medicine, as the cure and prevention, using the aspirin or ticlopidine for platelet aggregation suppressant. But in the , the curing method must be used properly according to the pectoralgia or heartache's kind, state, grade. The platelet do not attache to the normal hemangioendothelial cell. But when it stimulated by endothelium peronia and so on, it attache to the injury endothelium or rise aggregation between the platelet. On this time, it secrete the platelet aggregation inducer as like ADP, thromboxane A2 from the inside of platelet. So it has first defensive function through the aggregation augment that prevent the celerity consumption of blood. But the activation of abnormal platelet occur the platelet grume and thrombogenesis. So it bring up the occlusive angiosis, so to speak, cardiovascular disease, cerebrovascular disease, arterial sclerosis. In oriental medicine, the thrombosis in the category of blood stasis and this blood stasis present the generalise or local blood circulation disturbance that generated by all kinds of pathological fact or blood stream retention accompanying with a series of syndrome. As the syndrome, stabbing pain fixed at certain region, squamous and dry skin, fullness and pain of the chest and hypochondrium, firmness and fullness of the lower abdomen, black stool, dark purple tongue or with ecchymoses and petechiae etc.. has been created. And it becomes the pathopoiesis cause that the convulsion and palpitation, severe palpitatiion, tympanites, the symtom complex with a mass or swelling in the abdomen, insanity, stricken by wind etc.. Moreover, it used the drugs for invigorating blood circulation and eliminating blood stasis or drugs for removing blood stasis for all kinds of syndrome through the blood stasis. And the drugs for activating the blood circulation, such as Salviae Radix, Angelicae Sinensis Radix, Persicae Semen, Achyranthis Radix, Cnidii Rhizoma, Carthami Flos are used for that. And it is used to the herbs of insects that has strong effect about the disintergrating blood stasis such as Hirudo, Scolopendrae Corpus, Buthus, Lumbricus etc.. On this study, It used Geijibokryunghwan(GBH) and the consisting herbs to investigate the influence of platelet aggregation about drugs that used to improvement various symptoms created by the thrombosis in oriental medicine. GBH formula has as formula recorded in the , action of 'eleminating the evil and not impairment of healthy energy' and 'promoting the flow of QI and cold and heat, so used for the expel blood stasis herbs from the ancient. Therefore we investigated the restraint effect of GBH and the consisting herbs about the platelet agregation induced to the ADP, AA or collagen. The conclusion is following. 1. When it added the aggregation inducer after that it added GBH and individual consisting herbs in the PRP, GBH showed the (+) inhibition effect on the platelet aggregation and it showed the (+) inhibition effect in the individual consisting herbs as like Paeoniae Radix and Moutan Cortex Radicis. 2. It showed the (+), (+,++) inhibition effect on the platelet aggregation in Paeoniae Radix Hoelen, Paeoniae Radix Moutan Cortex Radicis, Hoelen Moutan Cortex Radicis etc. 3. In the aggregation inhibition activating on the difference of density, GBH showed strong inhibition effect to the aggregation state induced to collagen, and it showed the inhibition effect in the individual consisting herbs as like Paeoniae Radix and Moutan Cortex Radicis about the aggregation induced by the collagen. 4. It showed the strong inhibition effect about the aggregation induced by the collagen in Paeoniae Radix Hoelen, Paeoniae Radix Moutan Cortex Radicis, Hoelen Moutan Cortex Radicis etc Like this, as confirm GBH and the individual consisting herb's inhibition effect of platelet aggregation, We considerated that GBH and the individual consisting herbs have practical applicational value of clinical trial in the thrombosis caused by platelet aggregation.

• Tuberculosis and Respiratory Diseases
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• v.49 no.3
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• pp.323-331
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• 2000

Purpose: Brain metastases are present in approximately 10-16% of small cell lung cancer patients at diagnosis. Brain metastasis is an important clinical problem associated with increasing the survival rate, with a cumulative incidence of up to 80% in patients surviving 2 years. Prophylactic cranial irradiation(PCI) reduces the incidence of brain matastasis and may prolong survival in patients with limited small-cell lung cancer who achieved complete remission. This study was performed to analyze the incidence of brain metastasis, survival and clinical aspects after PCI in patients with limited small-cell lung cancer who achieved complete remission. Methods : Between 1989 and 1999, forty-two patients with limited small-cell lung cancer who achived achieved complete remission after therapy were enrolled into this study retrospectively. All patients received etoposide and cisplatin(VPP) alternating with cytoxan, adriamycin, and vincristine(CAV) every 3 weeks for at least 6 cycles initially. All patients received thoracic radiotherapy: concurrent(38.1%) and sequential(61.9%). All patients received late PCI. Results : Most patients(88.1%) were men, and the median age was 58 years. The median follow-up duration was 18.1 months. During the follow-up period, 57.1% of the patients developed relapse. The most frequent site of relapse was chest(35.7%), followed by brain(14.3%), liver(11.9%), adrenal gland(44%), and bone(2.2%). With the Kaplan-Meier method, the average disease-free interval was 1,090 days(median 305 days). The average time to development of brain relapse after PCI and other sites relapse(except brain) were 2,548 days and 1,395 days(median 460 days), respectively. The average overall survival was 1,233 days(median 634 days, 21.1 months), and 2-year survival rates was 41.7%. The average overall survival in the relapse group was 642 days(median 489 days) and in the no relapse group was 2,622 days(p<0.001). The average overall survival in the brain relapse group was 928 days(median 822 days) and in the no brain relapse group was 1,308 days(median 634 days)(p=0.772). In most patients(85.7%), relapse(except brain) or systemic disease was the usual cause of death. Brain matastasis was the cause of death in 14.3% of the cases. Conclusions : We may conclude that PCI reduces and delays brain metastasis in patients with limited small cell lung cancer who achieved complete remission. We found decreased survival in relapse group but, no significant survival difference was noted according to brain matastasis. And relapse(except brain) or systemic disease was the usual cause of death. In order to increase survival, new treatment strategies for control methods for relapse and systemic disease are required.

• Tuberculosis and Respiratory Diseases
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• v.46 no.6
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• pp.795-802
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• 1999

Objective : Cardiopulmonary exercise test is a useful tool to evaluate the operative risk and to plan exercise treatment for the patients with chronic obstructive pulmonary disease(COPD). In cardiopulmonary exercise test, most of the measured parameters are recorded at the time of peak exercise, which are hard to attain in COPD patients. So we evaluated the usefulness of the parameter, breathing reserve index(BRI=minute ventilation [$V_E$]/maximal voluntary ventilation[MVV]) at the time of anaerobic threshold($BRI_{AT}$) for the differentiation of COPD patients with normal controls. Methods : Thirty-six COPD patients and forty-two healthy subjects underwent progressive, incremental exercise test with bicycle ergometer upto possible maximal exercise. All the parameters was measured by breath by breath method. Results : The maximal oxygen uptake in COPD patients (mean$\pm$SE) was $1061.2{\pm}65.6ml/min$ which was significantly lower than $2137.6{\pm}91.4ml/min$ of normal subjects(p<0.01). Percent predicted maximal oxygen uptake was 54.3% in COPD patients and 86.0% in normal subjects(p<0.01). Maximal exercise(respiratory quotient; $VCO_2/VO_2{\geq}1.09$) was accomplished in 7 of 36 COPD patients(19.4%) and in 18 of 42 normal subjects(42.9%). The $BRI_{AT}$ of COPD patients was higher($0.50{\pm}0.03$) than that of control subject($028{\pm}0.02$, p<0.01), reflecting early hyperventilation in COPD patient during exercise. The correlation between $BRI_{AT}$ and BRI at maximal exercise in COPD patients was good(r=0.9687, p<0.01). Conclusion : The $BRI_{AT}$ could be a useful parameter for the differentiation of COPD patients with normal controls in the submaximal cardiopulmonary exercise test.

• Journal of Chest Surgery
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• v.35 no.7
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• pp.523-529
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• 2002

Background: Previous reports present that the early results of coronary artery bypass grafting (CABG) has been improving with the accumulation of surgical experience. We conducted a retrospective analysis of the patients who received CABG to evaluate the recent results of CABG. Material and Method: Between January 1996 and August 2001, 154 patients underwent CABG at Hanyang University Hospital. There were 47 patients(group I) who were operated between 1996 and 1998, and 107 patients(group II) who were operated thereafter. The preoperative diagnosis, operative procedure, mortality, and complications were analyzed retrospectively. Result: There were 35 males and 12 females in group I, and 78 males and 29 females in group II, which shows similar ratio of sexes between the two groups. The average age of patients for group I and group II was $55.9{\pm}6.2$ years and $61.0{\pm}8.0$ years, respectively, showing a significant increase in group II(p<0.05). The average left ventricular ejection fraction(LVEF) for group I and group II was $54.6{\pm}11.8$% and $56.9{\pm}13.0$%, respectively. The number of patients who had previous MI in group I and group II were 13 patients(27.7%) and 14 patients(13.1%), respectively, which shows a significant difference (p<0.05). All procedures were performed using the cardiopulmonary bypass(CPB) and moderate systemic hypothermia. Myocardial protection was achieved using intermittent hypothermic ischemia under ventricular fibrillation state or cold crystalloid cardioplegic solution for most of group I patients, whereas cold blood cardioplegic solution was used for group II patients. The mean CPB times for group I and group II were $149.2{\pm}48.7$ minutes and $113.1{\pm}30.6$ minutes, respectively. The mean aortic cross clamp times for group I and group II were $81.3{\pm}26.5$ minutes $72.2{\pm}23.9$ minutes, respectively. These figures show that CPB and aortic cross clamp times were significantly reduced in group II(p<0.05). The use of the left internal thoracic artery(LITA) was increased from 42%(20/47) for group I to 81% (87/107) for group II. The mean number of grafts also significantly increased from $2.5{\pm}0.6$ for group I to $3.0{\pm}1.1$ for group II(p<0.05). Intra-aortic balloon pump(IABP) was applied in 7 cases in group I and 17 cases in group II. Of these, 28.6%(2/7) and 52.9%(9/17) were broadly applied preoperatively in patients with LVEF<40% or congestive heart failure. The operative mortalities for group I and II were 10.6%(5/47) and 0.9%(1/107), respectively, which shows significant decrease for group II(p.0.05). Conclusion: This report suggest that CABG using CPB can recently be performed more safely in virtue of the accumulation of surgical experience with reduction in CPB and aortic cross clamp times and improved surgical techniques and myocardial protection. And we think that the optimal treatment of patients with left ventricular dysfunction associated with congestive heart failure and the extended application of IABP, especially have contributed to the reduction of operative mortality and morbidity.

• Tuberculosis and Respiratory Diseases
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• v.44 no.4
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• pp.853-860
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• 1997

Background : Chronic cough, defined as a cough persisting for three weeks or longer, is a common symptom for which outpatient care is sought. The most common etiologies of chronic cough are postnasal drip, asthma, and gastroesophageal reflux. Methacholine challenge is a useful diagnostic study in the evaulation of chronic cough, particularly useful in chronic cough patients with asthmatic symptom. Patients with chronic cough may have dysfunction of bronchial and extrathoracic airways. To evaluate if dysfunction of the bronchial and extrathoracic airways causes chronic cough, we assessed bronchial (BHR) and extrathoracic airway (EAHR) responsiveness to inhaled methacholine in patients with chronic cough. Method : 111 patients with chronic cough were enrolled in our study. Enrolled patients had no recorded diagnosis of asthma, bronchopulmonary disease, hypertension, heart disease or systemic disease and no current treatment with bronchodilator or corticosteroid. Enrolled patients consisted of 46 patients with cough alone, 24 patients with wheeze, 22 patients with dyspnea, 19 patients with wheeze and dyspnea. The inhaled methacholine concentrations causing a 20% fall in forced expiratory volume in 1s($PC_{20}FEV_1$) and 25% fall in maximal mid-inspiratory flow ($PC_{25}MIF_{50}$) were used as bronchial and extra thoracic hyperresponsiveness. Results : There were four response patterns to methacholine challenge study : BHR in 27 patients, EAHR in 16 patients, combined BHR and EAHR in 8 patients, and no hyperresponsiveness in 60 patients. In patients with cough alone, there were BHR in 3 patients, EAHR in 9 patients, and combined BHR and EAHR in 2 patients. In patients with wheeze and/or dyspnea, there were BHR in 24 patients, EAHR in 7 patients, and BHR and EAHR in 6 patients. Compared with patients with wheeze and/or dyspnea, patients with cough alone had more common EAHR than BHR. In patients with wheeze and/or dyspnea, BHR was more common than EAHR. Conclusion : These results show that among patients with hyperresponsiveness to methacholine, those with dyspnea and/or wheezing had mainly bronchial hyperresponsiveness, whereas those with chronic cough alone had mainly extrathoracic airway hyperresponsiveness.

• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.99-116
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• 2016

We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.

• Journal of Chest Surgery
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• v.41 no.3
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• pp.329-334
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• 2008

Background: Percutaneous cardiopulmonary support. (PCPS) has the potential to rescue patients in cardiogenic shock who might otherwise die. PCPS has been a therapeutic option in a variety of the clinical settings such as for patients with myocardial Infarction, high-risk coronary intervention and postcardiotomy cardiogenic shock, and the PCPS device is easy to install. We report our early experience with PCPS as a life saving procedure in cardiogenic shock patients due to acute myocardial infarction. Material and Method: From January 2005 to December 2006, eight patients in cardiogenic shock with acute myocardial infarction underwent PCPS using the CAPIOX emergency bypass system($EBS^{(R)}$, Terumo, Tokyo, Japan). Uptake cannulae were inserted deep into the femoral vein up to the right atrium and return cannulae were inserted into the femoral artery with Seldinger techniques using 20 and 16-French cannulae, respectively. Simultaneously, autopriming was performed at the $EBS^{(R)}$ circuit. The $EBS^{(R)}$ flow rate was maintained between $2.5{\sim}3.0L/min/m^2$ and anticoagulation was performed using intravenous heparin with an ACT level above 200 seconds. Result: The mean age of patients was $61.1{\pm}14.2$ years (range, 39 to 77 years). Three patients were under control of the $EBS^{(R)}$ before percutaneous coronary intervention (PCI), three patients were under control of the $EBS^{(R)}$ during PCI, one patient was under control of the $EBS^{(R)}$ after PCI, and one patient was under control of the $EBS^{(R)}$ after coronary bypass surgery. The mean support time was $47.5{\pm}27.9$ hours (range, 8 to 76 hours). Five patients (62.5%) could be weaned from the $EBS^{(R)}$ after $53.6{\pm}27.2$ hours. (range, 12 to 68 hours) of support. All of the patients who could successfully be weaned from support were discharged from the hospital. There were three complications: one case of gastrointestinal bleeding and two cases of acute renal failure. Two of the three mortality cases were under cardiac arrest before $EBS^{(R)}$ support, and one patient had an intractable ventricular arrhythmia during the support. All of the discharged patients are still surviving at $16.8{\pm}3.1$ months (range, 12 to 20 months) of follow-up. Conclusion: The use of $EBS^{(R)}$ for cardiogenic shock caused by an acute myocardial infarction could rescue patients who might otherwise have died. Successfully recovered patients after $EBS^{(R)}$ treatment have survived without severe complications. More experience and additional clinical investigations are necessary to elucidate the proper installation timing and management protocol of the $EBS^{(R)}$ in the future.