• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.91-124
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• 2021

In May 2019, the Ministry of Food and Drug Safety revised the "Pharmaceutical Determination and Adjustment Criteria" with the content of differentially calculating the price of generic drugs according to the registration of the drug substance and meeting the requirements for their own bioequivalence test. According to this revised rule, if their own bioequivalence test is not conducted, even the generic drugs that have already been approved would be lowered in price. I wondered whether this system was introduced with sufficient public legal considerations regarding its legislative purposes and means. Therefore, I reviewed the contents of the revised notice based on whether or not it is valid to determine and adjust the price of generic drugs in terms of the legitimacy of legislative purposes and the proportionality principle after introducing the history and background of the rule. First, I raised a question as to whether the purpose of preventing the overrun of generic drugs is indeed legitimate in terms of the legitimacy of the purpose. In order for the revised notice of "reduction of drug prices when the test requirements are not met," to meet the conformity principle, the premise that it is difficult to recognize safety and effectiveness through consignment (joint) bioequivalence test or that these tests are insufficient in safety and efficacy verification than their own test must be established. Nevertheless, it seems that suffficient review has not been carried out. In order to achieve the purpose of securing safety and effectiveness, the focus should be on 'reinforcement of the standards for bioequivalence test and the management of the bioequivalence test itself' rather than whether it is a their own test or a consignment (joint) test. Third, it is contrary to the necessity and substantiality principle that strict standards are uniformly applied to the products that can be considered to have been sufficiently verified for safety and effectiveness after a considerable period of time has passed after the product approval. In many cases, revised administrative legislations quickly enacted and amended in the state of lack of legal review or consensus, while the regulatory effects resulting from it are quite direct and specific to the regulated person. In this respect, I emphasized that the administrative legislative process also requires substantial review and prior control of the regulatory purposes and means, and that the participation of stakeholders in the legislative procedure is to be strengthened.

• The Korean Journal of Pharmacology
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• v.11 no.1 s.17
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• pp.33-38
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• 1975

The clinical efficacy of Ethaverine, a peripheral vasodilator, was studied according to a double-blind, non-cross over method in 29 diabetic patients with peripheral arterial diseases. The clinical improvement was assessed from the history of patients including the incidence and frequency of intermitten claudication. Ethaverine, after 4 weeks of therapy, was not effective in improving clinical symptoms compared to placebo. Ethaverine, however, was an efective vasodilator than placebo. The quality of vasodilation induced by Ethaverine, was similar to that of alcohol. A new clinical method of studying peripheral vasodilator was presented. The clinical symptoms of peripheral vascular arterial disease in the lower extrimities include reduced intensity of palpable pulses, coldness, and discoloration of the skin. Intermittent claudication may be present. Pathologic changes in vessel architecture precede the symptoms, and recognition of impending vascular insufficiency is a determining factor in selecting vasodilating therapy or surgical management. Also, post-operative patients who have chronic peripheral vascular arterial disease may be candidates for subsequent vasodilating therapy. Peripheral vasodilators, according to the series of reports, may be indicated in vasospastic peripheral vascular condition rather than an occlusive vascular disease and the vessel responds best when a relatively large vascular beds are involved rather than a small, capillary beds. Recently, the clinical efficacy of peripheral vasodilators have been challanged by many clinical investigators and clinicians. In this study, we have re-evaluated the efficacy of Ethaverine HCl as peripheral vasodilator in patients with vasospastic peripheral arterial disease. Ethaverine is claimed to be two to four times as potent a spasmolytic agent as papaverine in a variety of laboratory and clinical work.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• v.7 no.1
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• pp.92-109
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• 1996

The objectives of the present study were to provide comprehensive assessment of the impact of epilepsy on the psychological well-being of children with epilepsy and to identify the neurological factors associated with the psychopathology. The participant patients were recruited from the population of children and adolescent aged 7 to 16 attending the OPD of department of pediatric neurology in Seoul National University Hospital in Korea. We exclude mental retardation, pervasive developmental disorder and brain organic pathology. As control group, formal students were chosen and their sex, age, achievement, socioeconomic status were matched to patients. The first author interviewed the children and their family members and obtained the developmental history and family information. We used the following 10 scales for assessing psychological and behavioral problems in patients and their family member. The scales were standardized and their validity and reliability were confirmed before. Parent rating scales : Yale children's inventory, Disruptive behavior disorder scale, Parent's attitude to epilepsy questionnaire, Family environment scale, Symptom check-list-90 revision, Children behavior check-list. Children's self rating scales : Children's depression inventory, Spielberger's state-trait anxiety anxiety, Piers-Harris self-concept inventory and Self-administered Dependency questionnaire for Mother. The result showed the risk factors associated depression were early onset, complex partial seizure, lateralized temporal focal abnormality on EEG, Drug polypharmacy, high seizure frequency and sick factors associated anxiety were old age of patient, lateralized temporal focal abnormality EEG, Drug polypharmacy, high seizure frequency. Also the result of this present study indicated that risk factors associated oppositional defiant disorder, conduct disorder and attention deficit hyperactivity disorder were young age, male, early onset, lateral temporal EEG abnormality and high seizure frequency. According to these results, common risk factors associated psychological and behavioral problems were lateralized EEG temporal abnormality, high seizure frequency in neurological factors.

• Korean Journal of Biological Psychiatry
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• v.6 no.2
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• pp.209-218
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• 1999

Objectives : The aims of this study were to discriminate the clinical differences, to measure the estrogen and homovanillic acid levels, to evaluate a correlation between estrogen and homovanillic acid, and to identify an association of cognitive deficit with estrogen and homovanillic acid among male and female schizophrenics. Methods : In addition to the structured interviews, the plasma estrogen levels by radioimmunoassay and the homovanillic acid levels by HPLC were measured in 20 male and 21 female schizophrenics as well as 10 healthy male and 9 female controls. Results : 1) The plasma estrogen levels were higher in females than males, and significantly higher in female schizophenics than female controls. The homovanillic acid levels were higher in female schizophrenics than female controls, and were lower in male schizophrenics than male controls. 2) The onset age seemed to be earlier in male schizophrenics, and the frequency of admission, duration of antipsychotic drug administration, dosage of antipsychotics and duration of illnesses were more in males. The estrogen and homovanillic acid levels were significantly higher in female schizophrenics. 3) The estrogen levels had a significant positive correlation with sex, age and onset age, while the homovanillic acid levels did with sex. However, estrogen were not correlated with homovanillic acid levels. 4) The estrogen and homovanillic acid levels were not significantly different between male and female schizophrenics with cognitive deficits. In the schizophrenic patients without cognitive deficits, the estrogen levels were significantly higher in females, while there were no significant sex differences in homovanillic acid. 5) In the male and female schizophrenics predominantly with negative symptoms, there were no significant differences in estrogen and homovanillic acid levels. In those predominantly with positive symptoms, the estrogen levels were significantly higher in females, while there were no sex differences in homovanillic acid levels. 6) In schizophrenics with undifferentiated subtype, the estrogen and homovanillic acid levels were significantly higher in females. In those with paranoid or disorganized subtypes, the estrogen levels were significantly higher in females, while there were no sex differences in the homovanillic acid levels. 7) The mean values of PANSS-negative, PANSS-total, PANSS-CF, MMSE-K and estrogen levels were significantly higher in male schizophrenics with cognitive deficits. The mean values of illness duration, CGI, PANSS-positive, PANSS-negative, PANSS-total, PANSS-CF and MMSE-K were significantly higher in female schizophrenics with cognitive deficits. 8) The variables which showed significant correlation with cognitive deficits were PANSS-negative, PANSS-total, PANSS-CF, MMSE-K and estrogen levels in male schizophrenics. The variables which showed significant correlation with cognitive deficits were subtypes, onset age, illness durataion, CGI, PANSS-positive, PANSS-negative, PANSS-total, PANMSS-CF and MMSE-K in female schizophrenics. The estrogen levels were significantly correlated with admission frequencies, history of antipsychotic administration, duration of antipsychotic administration and cognitive deficits in male schizophrenics, while age were not correlated with in females. The homovanillic acid levels had a significant correlation with subtypes and onset age in male schizophrenics, while there were no correlation among variables in females. Conclusions : Although the plasma concentrations of estrogen and homovanillic acid in female schizophrenics were significantly higher than males, we could not find an association between them. Furthermore, the various factors affecting on the cognitive deficits, estrogen and homovanillic acid levels seemed to be somewhat different according to sex.

• Journal of the Korean Arthroscopy Society
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• v.5 no.1
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• pp.22-26
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• 2001

Purpose : To confirm the efficacy of arthroscopic synovectomy fur the pigmented villonodular synovitis in the knee. Materials and Methods : Between October 1996 and February 2000, the arthroscopic synovectomy had been performed in six patients(six knee joints), whose diagnoses were confirmed by pathologist. All patients complained of painful swelling in involved knee and four of the six patients had trauma history. There were three male and three female patients. Average age was 35.8 years ranging from 16 to 67 years. Follow up period was average 22.7 months(range, $13\~53$ months). Results : According to arthroscopic findings, there were three localized forms and three diffuse forms. At their last follow-up examinations, all patients had improvement in pain, swelling and range of motion and there was no evidence of recurrence. Conclusion : Complete arthroscopic excision is the definitive treatment for localized pigmented villonodular synovitis and meticulous arthroscopic excision through all portals including posterior portal can be considered as a valid alternative to traditional open synovectomy for the patients with diffuse pigmented villonodular synovitis.

• Clinical and Experimental Pediatrics
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• v.52 no.2
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• pp.205-212
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• 2009

Purpose : Chronic urticaria is a disorder characterized by the appearance of wheals for more than 6 weeks; in most cases, the etiology is unknown. This study was aimed to discover the clinical aspects, the etiologic factors, and the course of chronic urticaria. Methods : 51 children who were diagnosed with chronic urticaria in the past 4 years, and who had had follow-ups more than 6 months after diagnosis in the pediatric department of Soonchunhyang University Hospital in Bucheon, were enrolled in the study. The laboratory findings, clinical aspects, and courses were retrospectively investigated by medical record review and telephone interview. Results : The median age of children with chronic urticaria was 4 years (8 months to 16 years) and the ratio of male to female was 1.4:1. Of the total, 39.2% of patients had a history of atopy. Angioedema occurred concurrently with urticaria in 11.8% of patients, and dermographism was seen in 41.2%. Results of thyroid function tests were normal and thyroid autoantibodies were absent in all cases. Regarding etiology, most cases (74.5%) were forms of idiopathic urticaria. Urticaria was induced by physical factors in 19.6% of patients. Open challenge tests revealed that 3 patients were allergic to food additives (glutamate 2, glutamate, and sulfite 1). In this study, most of the patients reported good response after medication of 1st- or 2nd-generation antihistamines alone. Follow-up at 6 months revealed that 70.6% of patients had experienced remission, and 84.8% of children who had follow-up at 1 year presented remission. Conclusion : Chronic urticaria in most patients was idiopathic. Remission occurred within 1 year of diagnosis, in most cases so chronic urticaria in children seems to have good prognosis.

• Clinical and Experimental Pediatrics
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• v.45 no.8
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• pp.980-986
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• 2002

Purpose : Although the number of patients with measles have dramatically decreased since the introduction of measles vaccines in 1965, measles outbreaks have occurred periodically every 4-6 years during the 1990s(1989-1990 and 1993-1994). During 2000-2001, measles prevailed all over the country again. A characteristic of current epidemics is that the majority of affected population was infants and school-aged children. This study was designed to analyze the epidemic and clinical features of measles prevalence during 2000-2001 and to find ways to overcome vaccination failure. Methods : We reviewed the records of 59 patients with mealses admitted in the Pediatric Department of Pusan National University Hospital from January 2000 to October 2001 for patient's age, month of admission, history of vaccination, clinical features and complications. Antibody titers of measles-specific IgM and IgG were measured by enzyme immunoassay. Results : The epidemic show two peaks in the age distribution. Forty three patients(72.9%) were under 2-years of age and 14 patients(23.7%) were over 5-years of age. Outbreaks had high incidence in July to August, 2000 and March to April, 2001, then faded away after July, 2001. Vaccinated group comprised 30.5% and unvaccinated group comprised 69.5% and their mean age was $9.25{\pm}4.27$ years old and $0.95{\pm}0.30$ years old respectively. Positive rate of IgM was 86.7% in vaccinated group and 90.3% in unvaccinated group. This means there was primary vaccine failure; 13 cases of 15 vaccinated patients were positive in IgM antibody. During the prevalence, two patients died with mealses complication. One of them was immunocompromised. Conclusion : To prevent another prevalence of measles in the future, we must enhance revaccination at ages 4-6 and check vaccination status when children enter elementary school. These will produce over 95% of herd immunity, with catch-up MMR vaccination which has been completed already.

• Korean Journal of Heritage: History & Science
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• v.56 no.2
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• pp.12-26
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• 2023

Recently, 『Gyeongja(庚子)/Daetongryeok(大統曆)』(1600), a memorandum record of Yu Seong-ryong during the reign of King Seonjo(宣祖) of the Joseon Dynasty, was returned to Korea from Japan, and about 4,000 letters in cursive characters have been interpreted by Ro Seung-suk. The contents for 203 days written in the margin of 『Gyeongja(庚子)/Daetongryeok(大統曆)』 are mostly new, and are meaningful in understanding Yu's life and social association circumstances. There are daily routines of each day, contemporary figures, diseases and oriental medicine prescriptions. In particular, the combat record of Admiral Yi Sun-shin in 83 letters on the cover is very important to understand the situation in those days. It seems that the reason for writing the combat situations a year and a few months after Admiral Yi died in war was to honor his distinguished military service for a long time by King Seonjo's order according to the public opinion of the royal court. The record can be classified into two categories. First, Admiral Yi sighed when he heard about Yu's dismissal from the office in Gogeumdo, and was always alert with clear water on the boat after the Battle of Waekyo Castle. Second, he was killed by bullets shot by the enemy while directly encouraging battle, not listening to his men who tried to dissuade him from leading the naval battle at Noryang. This only contained contents of devoting his life desperately, which is an important proof of the theory of his death in war. It also contains nine methods for making liquor and another method that wasn't known to the public, and seems to include popular alcohol brewing methods or newly devised ones. In addition, there is a detail that Heo Jun, the author of 『Donguibogam』, introduced medicine to Yu, along with being unable to attend ancestral rites and relieving the poor written in red. There are also stories about Kang Hang(姜沆) returning to Korea after being captured by Japan and Lee Deok-hong(李德弘)'s son, who introduced Gugapseondo(龜甲船圖, the first picture of the Turtle Ship in Korea) to King Seonjo. In the light of the above, 『Gyeongja(庚子)/Daetongryeok(大統曆)』is an important historical record to empirically research not only figures related to Yu but also the circumstances of those days since it contains new facts that are not in the existing literature. In particular, the big accomplishment of this study is to correct the mistakenly known theory of Admiral Yi's suicide and to find out the new fact that Heo Jun provided medical information. In this respect, this book is expected to serve as a testament to the future study of the history and characters related to Yu in the mid-Joseon period.

• Clinical and Experimental Pediatrics
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• v.46 no.10
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• pp.977-982
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• 2003

Purpose : This study aimed to examine the excretion of various urinary proteins in children with a history of urinary tract infection(UTI), with or without vesicoureteral reflux(VUR) or reflux nephropathy, and to identify means of predicting the severity of VUR or the presence of reflux nephropathy as indicated by these markers, and to know how these markers are changed after resolution of VUR. Methods : We studied 30 children with previous UTI, without VUR and renal scarring(group I), 12 children with VUR, without evidence of renal scarring(group II), and 34 children with VUR and renal scarring(group III). 24-hour or 12-hour urine ${\beta}_2$ microglobulin(${\beta}_2$ MG), microalbumin and N-acetyl-${\beta}$-D-glucosaminidase(NAG) were measured in each child. Urinary protein excretions were analyzed according to the degree of VUR(mild VUR : a grade reflux I-III, severe VUR : a grade reflux IV-V). Cases of bilateral VUR were graded by the higher grade of reflux detected. A total of 46 children with primary VUR were followed. Among these patients, VUR was completely resolved in 16 children. Voiding cystourethrography(VCUG) and DMSA scan were performed every year. Values for urinary markers were estimated every year. Results : 24 or 12 hour urine microalbumin and NAG excretions were significantly increased in group III compared to group I(microalbumin : $27.7{\pm}26.0mg/gCr$ vs $15.0{\pm}10.7mg/gCr$, P<0.05, NAG : $15.2{\pm}18.7U/gCr$ vs $3.4{\pm}2.2U/gCr$, P<0.05). Urinary ${\beta}_2$ MG excretions were not significantly different between groups. Urinary NAG excretions were elevated in the group of children with severe VUR compared to mild VUR($26.8{\pm}27.1U/gCr$ vs $7.6{\pm}3.8U/gCr$, P<0.05). After resolution of VUR, urinary microalbumin and NAG excretions were decreased(P<0.05). Conclusion : Urinary microalbumin and NAG may be useful clinical indicators to predict the presence of reflux nephropathy and the resolution of VUR. Especially, urinary NAG excretions may be used as a possible method to predict the severity of VUR.

• Journal of Nutrition and Health
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• v.41 no.8
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• pp.742-753
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• 2008

The purpose of this study is to investigate risk factors of pre-hypertension and hypertension in rural residents. Nine hundred and ninety four subjects aged 40-70 yrs in Chungnam-do participated in this study. The subjects (n = 824) were classified into three groups of hypertensive, pre-hypertensive, and normotensive according to the Joint National Committee (JNC)-7 criteria. The weight, body mass index (BMI), waist-hip ratio (WHR), and serum total protein, albumin, BUN, and triglyceride (TG) were positively correlated with SBP and DBP. After adjusted by age, sex and BMI, the total protein, albumin and TG were significantly correlated with SBP and DBP (p < 0.01). There was no significant difference in eating habits according to the level of blood pressure. The serum albumin, creatinine, Glu-FBS, Glu-PP l20, and triglyceride were higher in both prehypertensive and hypertensive group than in the normotensive group. However, mean serum cholesterol was not different among three blood pressure groups. In this study, the common risk factors of pre-hypertension and hyper-tension were male, age of fifties, lower education level, ex-smoking, higher drinking frequency, higher BMI, body fat %, waist circumference, WHR, serum albumin and diabetes, even though the degree of risks in these variables were higher in the hypertensive group. The higher BUN was a risk factor of prehypertension, while the family history, prediabetes, serum total protein, Glu-PP l20 and higher alcohol drinking amount were the risk factors of hypertension. This result suggests that maintaining good health habit and normal range of blood parameters as well as controlling body weight have to be paid attention in order to prevent hypertention, and further reseasch on the relationship of blood pressure and BUN are needed.