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Expression of Oncogene Product in the Colorectal Carcinoma (결장암 및 직장암에서 암유전자 산물의 발현)

  • Shim, Young-Ran;Jang, Woo-Young;Choi, Kyoung-Chan;Choi, Joon-Hyuk;Choi, Won-Hee;Shim, Min-Chul
    • Journal of Yeungnam Medical Science
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    • v.12 no.2
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    • pp.210-225
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    • 1995
  • The expression of $p62^{c-myc}$ and $p21^{ras}$ can be seen in many solid tumor, but the pattern and incidence of expression were different according to organ, countries, and examiners, thus it is not definitely defined. Total 67 colorectal carcinoma in paraffin sections are analysed by immunohistochemically for evaluation of the $p62^{c-myc}$ and $p21^{ras}$ expression according to the age, sex, chief complaints, location, differentiation, modified Dukes stage, using the specific monoclonal antibodies. The results were summarized as follows : The age of patients ranged from 32 years to 82 years. The mean age was 57.6 years. The expression of $p62^{c-myc}$ and $p21^{ras}$ was not correlated with age. Male was 29 cases(43.3%) and female was 38 cases(56.7%). The male to female ratio was 1:1.31. The expression of $p21^{ras}$ was increased in female(p<0.05). Abdominal pain(43.7%) was the most frequent chief complaint. The most frequent tumor location was rectum(44.8%). The expression of $p62^{c-myc}$ was increased in the rectum(p<0.05). The 65 cases(97.0%) out of 67 cases showed positive reaction of $p62^{c-myc}$ in the nucleus, cytoplasmic membrane, and cytoplasm. The 62 cases(92.5%) out of 67 cases showed positive reaction of $p21^{ras}$ in the cytoplasmic membrane and cytoplasm. The positive rate of $p62^{c-myc}$ and $p21^{ras}$ was 97.0% and 91.4% in well differentiated adenocarcinoma, 100.0% and 95.0% in moderately differentiated adenocarcinoma, 90.0% and 90.0% in poorly differentiated adenocarcinoma, 100.0% and 100.0% in mucinous carcinoma. The positive rate of $p62^{c-myc}$ and $p21^{ras}$ was 94.1% and 88.2% in Dukes stage $B_1$, 96.0% and 96.0% in Dukes stage $B_2$, 100.0% and 100.0% in Dukes stage $C_1$, 100.0% and 88.9% in Dukes stage $C_2$, and 100.0% and 100.0% in Dukes stage D. The expression of $p62^{c-myc}$ in metastatic colorectal carcinoma showed diffuse and strongly positive reaction than primary colorectal carcinoma. The expression of $p21^{ras}$ in primary colorectal carcinoma showed diffuse and strongly positive reaction than metastatic colorectal carcinoma.

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Epidemiological investigation on the outbreak of foodborne and waterborne disease due to Norovirus with delayed notification (노로바이러스에 기인한 수인성·식품매개감염병 집단발생의 지연신고에 대한 역학조사)

  • Ha, Mikyung;Kim, Hyeongsu;Kim, Yong Ho;Na, Min Sun;Yu, Mi Jung
    • Journal of agricultural medicine and community health
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    • v.43 no.4
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    • pp.258-269
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    • 2018
  • Objectives: There was an outbreak of foodborne and waterborne disease among high school students at Okcheon in June, 2018. First attack occurred June $5^{th}$ but seven days later it was notified. The purpose of this investigation was to evaluate the pathogen of outbreak and cause of delayed notification. Methods: First, we did a questionnaire survey for 61 cases and 122 controls to find what symptoms they had and whether they ate foods or drank water from June $2^{nd}$ to June $12^{th}$. Second, we investigated the environment of cafeteria and drinking water. Third, we examined specimen of cases and environment to identify bacteria or virus. Results: Attack rate of this outbreak was 7.8%. Drinking water was strongly suspected as a source of infection in questionnaire survey but we could not find the exact time of exposure. Norovirus was identified in specimen of cases (2 students), drinking water (at main building and dormitory) and cafeteria (knife, dishtowel, hand of chef) Conclusions: We decided norovirus as the pathogen of this outbreak based on the clinical features of cases with diarrhea vomiting, abdominal pain and recovery within 2 or 3 days after onset, outbreak due to drinking water and microbiologic examination, And the cause of delayed notification might be the non-existence of the nurse teacher at that time and the lack of understanding of teachers on immediate notification under the outbreak. To prevent the delayed notification, notification system about outbreak of foodborne and waterborne disease in school is needed to be improved.

Incidence and Characteristics of Clostridioides difficile Infection in Children (소아 Clostridioides difficile 감염의 발생률 및 임상양상)

  • Jeong, Heera;Kang, Ji-Man;Ahn, Jong Gyun
    • Pediatric Infection and Vaccine
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    • v.27 no.3
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    • pp.158-170
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    • 2020
  • Purpose: We evaluated the incidence and characteristics of Clostridioides difficile infection (CDI) in Korean children. Methods: Medical records of patients aged 2-18 years and diagnosed with CDI at a tertiary hospital between 2009 and 2018 were analyzed. The patients were classified into three CDI groups: community-acquired (CA), community onset-health care facility-associated (CO-HCFA), and healthcare facility onset (HO). Results: The incidence of CDI increased from 1.00 to 10.01 cases per 10,000 admissions from 2009 to 2018 (P<0.001). As compared to the CA group, the HO group had a higher frequency of operation and malignancy as predisposing factors (40.4% vs. 0.0%, P=0.001; and 27.7% vs. 0.0%, P=0.027, respectively), frequency and number of previous antibiotic use (97.9% vs. 31.3%, P<0.001; and 2 vs. 0, P<0.001, respectively), and median postdiagnosis hospital stay (13 vs. 5 days, P=0.008). The CO-HCFA group had a lower median age and higher frequency of malignancy than the CA group (5 vs. 13 years, P=0.012; and 30.8% vs. 0.0%, P=0.030, respectively). As compared to the HO group, the CA group had a higher frequency of abdominal pain and hematochezia (56.3% vs. 10.6%, P=0.001; and 50.0% vs. 10.6%, P=0.002, respectively), inflammatory bowel disease (68.8% vs. 2.1%, P=0.001), and intravenous metronidazole treatment (37.5% vs. 2.1%, P=0.001). Conclusions: With the increasing incidence of pediatric CDI, awareness regarding its epidemiology and clinical characteristics is important to manage nosocomial infections.

Studies on Ancylostomiasis I. An Experimental Study on Hookworm Infection and Anemia (구충증(鉤蟲症)에 관(關)한 연구(硏究) 제1편(第1篇) 구충(鉤蟲)의 감염(感染) 및 구충성빈혈(鉤蟲性貧血)에 관(關)한 고찰(考奈))

  • Lee, Mun-Ho;Kim, Dong-Jip;Lee, Jang-Kyu;Seo, Byong-Sul;Lee, Soon-Hyung
    • The Korean Journal of Nuclear Medicine
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    • v.1 no.1
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    • pp.55-66
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    • 1967
  • In view of its prevalence in the Far East area, a more detailed knowledge on the hookworm infection is one of the very important medical problems. The present study was aimed to; determine the infectivity of the artificially hatched ancylostoma duodenale larvae in man after its oral administration, evaluate the clinical symptomatology of such infection, determine the date of first appearance of the ova in the stool, calculate the blood loss per worm per day, assess the relation-ships between the ova count, infectivity(worm load), blood loss and severity of anemia. An erythrokinetic study was also done to analyse the characteristics of hookworm anemia by means of $^{59}Fe\;and\;^{51}Cr$. Materials and Methods Ten healthy male volunteers(doctors, medical students and laboratory technicians) with the ages ranging from 21 to 40 years were selected as the experimental materials. They had no history of hookworm infection for preceding several years, and care was taken not to be exposed to reinfection. A baseline study including a through physical examinations and laboratory investigations such as complete blood counts, stool examination and estimation of the serum iron levels was done, and a vermifuge, bephenium hydroxynaphoate, was given 10 days prior to the main experiment. The ancylostoma duodenale filariform larvae were obtained in the following manner; The pure ancylostoma duodenale ova were obtained from the hookworm anemia patients and a modified filter paper method was adopted to harvest larger number of infective larvae, which were washed several times with saline. The actively moving mature larvae were put into the gelatine capsules, 150 in each, and were given to the volunteers in the fasting state with 300ml. of water. The volunteers were previously treated with intramuscular injection of 15mg. of chlorpromazine in order to prevent the eventual nausea and vomiting after the larvae intake. The clinical symptoms and signs mainly of the respiratory and gastrointestinal tracts, appearance of the ova and occult blood in the stool etc. were checked every day for the first 20 days and then twice weekly until the end of the experiment, which usually lasted for about 3 months. Roentgenological survey of the lungs was also done. The hematological changes such as the red blood cell, white blood cell and eosinophil cell counts, hemoglobin content and serum iron levels were studied. The appearance of the ova in the stool was examined by the formalin ether method and the ova were counted in triplicate on two successive days using the Stoll's dilution method. The ferrokinetic data were calculated by the modified Huff's method and the apparent half survival time of the red blood cells by the modified Gray's method. The isotopes were simultaneously tagged and injected intravenously, and then the stool and blood samples were collected as was described by Roche et al., namely, three separate 4-day stool samples with the blood sample drawing before each 4-day stool collection. The radio-activities of the stools ashfied and the blood were separately measured by the pulse-height analyser. The daily blood loss was calculated with the following formula; daily blood loss in $ml.=\frac{cpm/g\;stool{\times}weight\;in\;g\;of\;4-day\;stool}{cpm/ml\;blood{\times}4}$ The average of these three 4-day periods was given as the daily blood loss in each patient. The blood loss per day per worm was calculated by simply dividing the daily blood loss by the number of the hookworm recovered after the vermifuge given twice a week at the termination of the experiment. The iron loss in mg. through the gastrointestinal tract was estimated with the daily iron loss in $mg=\frac{g\;Hgb/100ml{\times}ml\;daily\;blood\;loss{\times}3.40}{100}$ 3.40=mg of iron per g Hgb following formula; Results 1. The respiratory symptoms such as cough and sputum were noted in almost all cases within a week after the infection, which lasted about 2 weeks. The roentgenological findings of the chest were essentially normal. A moderate degree of febril reaction appeared within 2 weeks with a duration of 3 or 4 days. 2. The gastrointestinal symptoms such as nausea, epigastric fullness, abdominal pain and loose bowel appeared in all cases immediately after the larvae intake. 3. The reduction of the red blood cell count was not remarkable, however, the hemoglobin content and especially the serum iron level showed the steady decreases until the end of the experiment. 4. The white blood cells and eosinophil cells, on the contrary, showed increases in parallel and reached peaks in 20 to 30 days after the infection. A small secondary rise was noted in 2 months. 5. The ova first appeared in the stool in 40. 1 days after the infection, ranging from 29 to 51 days, during which the occult blood reaction of the stool became also positive in almost cases. 6. The number of ova recovered per day was 164, 320 on the average, ranging from 89,500 to 253,800. The number of the worm evacuated by vermifuge was in rough correlation with the number of ova recovered. 7. The infectivity of ancylostoma duodenale was 14% on the average, ranging from 7.3 to 20.0%, which is relatively lower than those reported by other workers. 8. The mean fecal blood loss was 5.78ml. per day, with a range of from 2.6 to 11.7ml., and the mean blood loss per worm per day was 0.30ml., with a range of from 0.13 to 0.73ml., which is in rough coincidence with those reported by other authors. There appeared to exist, however, no correlation between the blood loss and the number of ova recovered. 9. The mean fecal iron loss was 2.02mg. per day, with a range of from 1.20 to 3.89mg., which is less than those appeared in the literature. 10. The mean plasma iron disappearance rate was 0.80hr., with a range of from 0.62 to 0.95hr., namely, a slight accerelation. 11. The hookworm anemia appeared to be iron deficiency in origin caused by continuous intestinal blood loss.

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Clinical Study of Tuberculous Meningitis in Children (소아 결핵성 뇌막염의 임상적 고찰)

  • Kim, Woo Sik;Kim, Jong Hyun;Kim, Dong Un;Lee, Won Bae;Kang, Jin Han
    • Pediatric Infection and Vaccine
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    • v.4 no.1
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    • pp.64-72
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    • 1997
  • Purpose : The incidence of tuberculous meningitis in Korean children has been markedly decreased after 1980s, but this disease has still occurred with low rate. Therefore, it may be suspected that delayed diagnosis and treatment will be happened because of lacking of clinical experiences and indistinguishable other meningitis, so it is important to make early diagnosis and treatment of tuberculous meningitis concerning with the prognosis. In this aspect, we conducted study to concern and investigate sustainly about the diagnostic criteria, clinical characteristics, radiological findings, complications, and prognosis of typical or atypical tuberculous meningitis in children. Methods : Forty four children who were hospitalized and treated due to tuberculous meningitis in pediatric wards of Our Lady of Mercy Hospital, St. Holy Hospital, St. Vincent Hospital and Uijungbu St. Mary Hospital from January 1985 to June 1996 were included in this study. We reviewed medical records of these patients retrospectively. Results : 1) The tuberculous meningitis has occured continuosly since mid-1980s. The highest 2) The diagnosis was made by contact history of active tuberculous patients, positive tuberculin test, responses of antituberculous antibiotics and discovery of Mycobacterium tuberculosis from CSF or other specimens. Among patients, 7 children(16%) were not vaccinated with BCG, and only 18 children(40%) were positive in tuberculin test. 3) The symptoms and signs of our patients on initial examinations were fever, vomiting, headache, lethargy, poor feeding, weight loss, neck stiffness, convulsion, abdominal pain and motor deficits. 4) The findings of initial CSF samples revealed leukocyte $239.5/mm^3$(mean) with lymphocyte predominant, elevated protein levels(mean;259.5mg%) and low sugar level(mean;40.7mg%). And the ratio of CSF/blood sugar was 0.407. But, atypical CSF findings were seen in 31.8% patients. 5) On brain imaging study, 34 out of 39 children had findings of hydrocephalus, basilar meningeal enhancement, infarction and subarachnoidal inflammations etc. On chest X-ray, the findings of miliary tuberculosis(34.1%), normal finding(29.5%), parenchymal infiltrations (11.4%) and calcifications(9.1%) were showed. 6) In neurological clinical stage, there were twenty-six children(59%) in stage 1, fourteen children(32%) in stage 2 and four children(9%) in stage 3. The late sequeles were encountered by 29.5% with mild and 4.6% with severe neurological injury. The most common neurological injury was quadriplegia and the mortality rate was 6.8%. 7) The SIADH was developed in 20 children(45.5%) after the 4th hospital day. Half of all SIADH patients were symptomatic. Conclusion : Tuberculosis meningitis is still an important extrapulmonary disease with high morbidity and mortality. Early diagnosis with clinical contact history of active tuberculosis and radiological imaging examinations and early treatments are essential in order to prevent and decrase the rate of late sequeles and death.

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Hepatitis Complicated with Mycoplasma pneumoniae Infection in Children (소아의 Mycoplasma pneumoniae 폐렴에 합병된 간염)

  • Lee, Seung Min;Lee, Sung Moon;Tchah, Hann;Jeon, In Sang;Ryoo, Eell;Cho, Kang Ho;Seon, Yong Han;Son, Dong Woo;Hong, Hee Joo
    • Clinical and Experimental Pediatrics
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    • v.48 no.8
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    • pp.832-838
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    • 2005
  • Purpose : Mycoplasma pneumoniae infection is relatively common in childhood. Its extrapulmonary manifestations have been reported so much, but hepatitis associated with it has been reported rarely in Korea. Methods : A clinical study was performed on 556 patients of M. pneumoniae pneumonia diagnosed serologically at Gil hospital from January 2001 to December 2004. We reviewed 65 cases among these patients, who had elevated level of serum AST and ALT greater than 50 IU/L respectively without evidence of hepatitis A, B, C, Cytomegalovirus and Ebstein-Barr virus infections. Results : Hepatitis occurred in 11.7% of Mycoplasma pneumoniae pneumonia, especially in fall and winter times. Male to female ratio was 1.2 : 1 and the mean age was 4 years and 3 months. Besides hepatitis, cough(95.4%), sputum(52.3%) and dyspnea(12.3%) were common as pulmonary manifestations. And among gastrointestinal manifestations, nausea/vomiting(26.2%) was the most common symptom, followed by poor oral intake(12.3%), diarrhea(12.3%) and abdominal pain(6.2%). In addition to hepatomegaly(4.6%) and splenomegaly(4.6%), coarse breathing sound was the most common physical manifestation, followed by rale(63.1%), pharyngeal injection(26.2%), and rash(10.8%). Anemia was noted in 20.0%, neutrophilia in 10.8%, eosinphilia in 38.5% and thrombocytosis in 6.2%, respectively. Mean level of ESR and CRP was 32.02 mm/hr and 6.69 mg/dL, respectively. Mean level of AST and ALT was 293.80 IU/L and 181.48 IU/L, respectively. Hyperbilirubinemia was noted in 7.7% and hypoalbuminemia was noted in 58.5%. Lobar or lobular pneumonia(78.5%) was the most common finding in chest X-ray and left lower lobe(39.2%) was most commonly affected. Pleural effusion was noted in 26.2%. Mean duration of hospitalization was 9.91 days. Serum AST/ALT level was normalized within 9.94 days and pulmonary consolidation resolved within 14.29 days. Conclusion : The prognosis of M. pneumoniae hepatitis is good. However, liver function should be considerately checked in M. pneumoniae infection because its incidence is not so low.

Epidemiological Changes and Clinical Features of Hepatitis A in Children, Living in Kyung-gi Province, Since 1988 to 1998 (최근 10년간(1988~1998) 경기지역 소아에서 A형 간염의 역학적 변화 및 임상에 관한 연구)

  • Kim, Hyun;Kim, Jong Hyun;Kim, Dong Un;Hur, Je Kyun;Lee, Won Bae;Seo, Byung Kyeu;Kang, Jin-Han
    • Pediatric Infection and Vaccine
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    • v.5 no.2
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    • pp.230-238
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    • 1998
  • Purpose : Worldwidely, the incidence of the hepatitis A has been markedly decreased in the past years. Also in Korea, there has been only a few sporadic cases without evidence of epidemics since the mid 1980s. However, the incidence of the hepatitis A in young adults and childen has been in trends of increasing since 1996. So, we retrospectively performed the study on the epidemiolgical changes and the clinical feature of hepatitis A in childen, living in Kyung-gi province, since 1988 to 1998. Methods : The four affiliated hospitals of the Catholic University of Korea, Our lady of Mercy's hospital, Holy family hospital, Eui-Jung-bu St. Mary's hospital, and St. Vincent hospital, were enrolled in this study. We conducted statistical analysis on the incidence of hepatitis A since 1988 to 1998, concerning with the period (monthly, annually), age, sex and related epidemiological property, by reviewing the hospital records of the patients with hepatitis A. We simultaneously performed the study concerning with the clinical characteristics of hepatitis A. Results : 1) During the study period, 46 children was diagnosed as hepatitis A, and among them 28 children (60.1%) developed sporadically in the 1998. And sex ratio was 1.2(male):1(female). 2) Most of the patients developed between March and July, and hepatitits A were mainly developed in the patients above the 10 year old ages(37 patients; 80.4%). 3) The socioeconomic and educational status of the patient's parents was almostly below the middle and low class. Although, we could not find the etiological factors in most cases, but we found the evidence of interfamilial transmission in one family. 4) The patients complained the symptoms of nausea and vomiting, jaundice, poor appetite, mild fever, fatigueness, abdominal pain, URI symptom, dyspepsia, dark urine, headache and diarrhea in order, and findings of jaundice, hepatomegaly, RUQ tenderness, splenomegaly and LLQ tenderness in order were seen. 5) All patients showed abnormal findings of the liver function tests, and the pattern of cholestatic hepatitis were seen in most cases, but these findings were normalized within the 2~4 weeks. The findings of the gall bladder wall thickening, hepatomegaly, splenomegaly and ascites were seen on abodominal sonogram. 6) The prognosis of all patients were good without complications, except in one case who had the episode of transient recuurence. And the mean hospitalization dates were 11.1 days. Conclusion : We found that the incidence of hepatitis A showed the increasing trend, and peaked in the 1998 in Kyung-gi province children. And hepatitis A mainly developed in children above the 10 year old ages. The scioeconomic and educational status of patient's family was almostly below the middle class. All of them showed abnormal liver function, and clinically cholestatic hepatitis features were seen in most cases. But, the prognosis was excellent without complication in all cases.

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The Study about 「The Discourse on the Constitutional Symptoms and Diseases」 of Sasangin on the 『Dongyi Suse Bowon』 (『동의수세보원(東醫壽世保元)』 태소음양인(太少陰陽人)의 「병증론(病證論)」에 관(關)한 연구(硏究))

  • Lee, Su-kyung;Song, Il-byung
    • Journal of Sasang Constitutional Medicine
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    • v.11 no.2
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    • pp.1-26
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    • 1999
  • This paper was written in order to understand each constitutional symptoms and diseases with two aspects. The first was to trace the courses to accomplish constitutional symptoms and diseases from that of oriented medicine through "Dongyi Bogam" and the original writing such as "Shanghanlun". The second was to analyze the constitutional diseases with Lee Je-ma's own recognition on human being and the society which was based on the "Dongyi Suse Bowon". The original concepts of 'The Interior Disease' and 'The Exterior Disease' were based on the Nature and the Emotion, the Environmental Frames and the Human Affairs, the Ears Eyes Nose Mouth and the Lung Spleen Liver Kidney. The exterior disease were caused by the abilities of ears to listen, eyes to see, nose to smell, and mouth to taste on the environmental frames which were related one's recognition to society. The interior diseases were caused by the abilities of lung to study, spleen to ask, liver to think, kidney to judge on human affairs which were related the relationship between me and others. So the titles of constitutional diseases were named by these views on his first writing of "Dongyi Suse Bowon" in 1894. So the titles of Taeyangin diseases, 'The lumbar Vertebae Disease Induced by Exopathogen' and 'The Small Intestine Disease Induced by Endopathogen' were still remained as the first writing. But the titles of constitutional diseases were rewritten such as present titles in 1900. In order to express pathology and mechanism of constitutional diseases exactly, he rewrote titles which contained the manifestation sites of diseases, and the symptoms of febrile and cold, and the different congenital formations of organs. The exterior diseases and interior diseases had three characteristics. The first was that the exterior disease injured by the nature which had a tendency to progress slowly and the interior disease injured by the emotion which had a tendency to progress rapidly. The second was not that the interior disease and the exterior disease were separated, but that one influenced the other and these were revealed as a disease together when the diseases continued for a long time. The third was that even though the disease caught together it was included the beginning disease. The symptoms in ordinary times was the origin and clue to recognize the constitutional symptoms and diseases. It enabled to establish the constitutional medicine which treated by different ways according to constitution. It had two characteristics which were different from the Traditional Chinese Medicine in appearance of diseases. The first was that the disease was progressed to the next step from the symptoms in ordinary times. The second was that each constitution had different symptoms which were due to symptoms in ordinary times under the same disease, The third was the manifestation of disease were different from symptoms in ordinary times in the same constitution. But the most important thing was that Lee Je-ma recognized these symptoms in ordinary times as four categories and he presented constitutional symptoms and constitutional disease. The four categories were the method to recognize the human being and the diseases for him As the symptoms and diseases of Sasang Constitutional Medicine were compared to Traditional Chinese Medicine, the constitutional diseases of "Dongyi Suse Bowon" could be classified into two groups. The first group was the unique diseases and symptoms, which were not in the Traditional Chinese Medicine, and which were established by the Lee Je-ma. These contained the diseases of taeyangin, the exterior disease of taeumin, the exterior disease of soyangin. The second group used the unique methods to treat disease, which were not in Traditional Chinese Medicine, and which were established by Lee Je-ma. This contained the interior disease of taeumin, the delirium diseases from the MangYin of soyangin, the treatment to help the Yang-Qi ascend and to supplement the ql In the exterior disease of soeumin. Especially, the diseases of taeyangin and taeumin which were caused by the metabolism disorders of Qi-Yack(氣液) were the great achievement to establish constitutional symptoms and diseases. The discourse of taeyangin diseases presented his original thought to recognize the symptoms and diseases through the Shin Gi Hyul Jeong(神氣血精) and the Qi-Yack, the discourse of taeumin diseases presented the disperse of Qi-Yack through the forward and backward of sweat, the discourse of soyangin disease presented the sweat of hand and feet which was manifested that yin-qi of spleen descended to yin qi of kidney, and the bowel movement which was manifested that yang qi of large intestine ascend to head, face and four extremities, the discourse of soeumin disease presented the Jueyin syndrome without the abdominal pain and diarrhea as the exterior disease and made importance to the nervous mind And the classification of exterior diseases and interior diseases were not due to the pharmacology but due to the symptoms and diseases according to the constitution.

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A Randomized, Double-Blind Study to Assess the Efficacy and Safety of Oral LB20304 (Gemifloxacin) at Doses of 160mg or 320mg (Equivalent to 200mg or 400mg of the Mesylate Salt) Once Daily for 7 Days for the Treatment of Acute Exacerbations of Chronic Bronchitis (AECB) in Korean Adult Population (한국인에서 만성기관지염의 급성악화를 치료하기 위한 LB20304(Gemifloxacin) 160mg 또는 320mg 1일 1회 7일간 투여의 유효성과 안전성에 대한 연구)

  • Kim, Young Whan;Shim, Young-Soo;Kim, Won Dong;Shim, Tae Sun;Kang, Hong Mo;Choi, ByoungWhui;Kim, Jae-Yeol;Kwon, O Jung;Kim, Hojoong;Kim, Ju Ock;Jung, Ki-Suck;Hyeon, In Gyou;Mo, Eun Kyung;Lee, Seung-Joon;Nam, Gui Hyun;Lee, Kye Young;Park, Jae Seuk
    • Tuberculosis and Respiratory Diseases
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    • v.55 no.1
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    • pp.69-87
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    • 2003
  • Background : LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. Methods : This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. Results : The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(${\leq}0.03$ ug/mL) than those for other quinolones, beta-lactams and macrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. Conclusion : The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.