• Radiation Oncology Journal
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• v.25 no.4
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• pp.206-212
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• 2007

Purpose: Heterotopic ossification is a well-known postoperative and post-traumatic complication of the elbow. We reviewed the treatment outcome for the use of low-dose radiation after surgical intervention of the elbow to prevent recurrence of heterotopic ossification (HO). Materials and Methods: Forty-five patients with HO underwent surgical intervention and postoperative radiotherapy of the elbow. The median age of the patients was 29 years ($16{\sim}75$ years), and 27 of the patients were men and 18 were women. The occurrence of HO was mainly due to surgery after fracture (24/45) and traumatic injury (21/45). Limitation of the range of motion (ROM) was the most common symptom of the patients. Thirty-four patients received postoperative radiotherapy with a dose of 8 Gy in 2 fractions; 5 patients received a dose of 10 Gy in 5 fractions and 6 patients received a dose of 7 Gy in 1 fraction. Postoperative radiotherapy was given on the first two postoperative days for most of the patients. Sixteen patients were not given anti-inflammatory medication and 29 patients were given NSAIDs for $1{\sim}8$ months. Results: After a median follow-up period of 18 months (range $6{\sim}72$ months), 41 patients showed clinical improvement and two patients did not show improvement. Assessment of the ROM showed a mean improvement from $0{\sim}135^{\circ}$ to $60{\sim}145^{\circ}$ (p=0.028), and assessment of the functional outcome according to MEPI was from ($15{\sim}95$) to ($80{\sim}100$) (p<0.0001). Two of the 34 patients that were followed-up with radiography had mild radiological recurrence of heterotopic ossification. No complications were observed after the radiotherapy. Conclusion: These results suggested that low-dose radiation administered after surgical intervention is safe and effective to prevent the recurrence of HO in the elbow.

• The Korean Society of Law and Medicine
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• v.21 no.1
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• pp.223-259
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• 2020

With COVID-19 spreading rapidly around the world, research and development issues on treatments and vaccines for the virus are of high interest. Among them, Remdesivir was the first to show noticeable therapeutic effects and began clinical trials, with each country authorizing the use of the drug through emergency approval. However, Gilead Co., Ltd., the developer of Remdesivir, received a lot of criticism from civic groups for submitting the application for the marketing authorization as an orphan drug. This is because when a new drug got a marketing authorization as an orphan drug could be granted an exclusive status for seven year. The long-term exclusive status of an orphan drug comes from the policy purpose of motivating pharmaceutical companies to develop treatment opportunities for patients suffering from rare diseases, which was not appropriate to apply to infectious disease treatments. This paper provides a review of the problems and improvement directions of the domestic system through comparative legal consideration against the United States, Europe and Japan for the statutes which give exclusive status to medicines. The domestic system has a fundamental problem that it does not have explicit provisions in the statute in the manner of granting exclusive status, and that it uses the review system to give it exclusive status indirectly. In addition, in the case of orphan drugs, the "Rare Diseases Management Act" and the "Regulations on Examination of Items Permission and Reporting of Drugs" provide overlapping review periods, and despite the relatively long monopoly period, there seems to be no check clause to recover exclusive status in the event of a change in circumstances. Given that biopharmaceuticals are difficult to obtain patents, the lack of such provisions is a pity of domestic legislation, although granting exclusive rights may be a great motivation to induce drug development. In the United States, given that the first biosimilar also has a one-year monopoly period, it can be interpreted that domestic legislation is quite strictly limited to granting exclusive status to biopharmaceuticals. The need for improvement of the domestic system will be recognized in that it could undermine local pharmaceutical companies' willingness to develop biopharmaceuticals in the future, and in that it is also necessary to harmonize international regulations. Taking advantage of the emergence of COVID-19 as an opportunity, we look again at the problems of the domestic system that grants exclusive rights to medicines and hope that an overall revision of the relevant legislation will be made to establish a unified legal basis.

• Pediatric Infection and Vaccine
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• v.11 no.1
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• pp.73-80
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• 2004

Purpose : The serial clinical findings, biochemical results, and serological hepatitis B virus(HBV) markers in Korean children with chronic HBV infection were analyzed to determine the relationships among these factors. Methods : Ninety children have been chosen from those who have visited to the Department of Pediatrics at St. Vincent's Hospital in The Catholic University of Korea from July 1st, 1995 to June 30th, 2000. The sample patients were followed up for over six months. HBV markers and liver function tests were all performed. Results : All children were asymptomatic at presentation. Eighty-three percent of the children had a history of chronic HBV infection in their families. Eighty-one percent were HBeAg positive, 16% were anti-HBe positive, while 3% were all HBeAg and anti-HBe negative. The prevalence of HBeAg among three age groups : 0~5; 6~10; and 11~15 year-old was 90%, 96% and 61% respectively. The prevalence of HBeAg in less than 10 year-old group was significantly higher than 11~15 year-old group(P=0.001). Serum ALT levels were within 40 IU/L in 64% children, 41~80 IU/L in 17%, 81~200 IU/L in 10%, and beyond 201 IU/L in 9%. The percentage of abnormality of ALT levels in HBeAg positive patients was significantly higher than that of HBeAg negative(P=0.036). Eleven of the 73 HBeAg positive children lost their HBeAg and seroconverted to anti-HBe. In these cases, all had transient elevations in ALT levels before HBeAg seroconversions. The annual rates of spontaneous seroconversion of HBeAg and HBsAg were 9.7% and 0.6%, respectively. Conclusion : Recognition of the dynamics of these changes in viral markers and biochemical findings is needed in the selection and evaluation of therapeutic regimens, establishment of treatment, and calling for controlled trials with adequate follow-up. The hepatitis B carrier state may be asymptomatic in children however, continued surveillance of carriers is important to determine the individual adverse prognostic factors of chronic HBV infections.

• Childhood Kidney Diseases
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• v.4 no.2
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• pp.111-119
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• 2000

Purpose : Henoch-$Sch{\ddot{o}}nlein$ purpura(HSP) is a common pediatric discase presenting most frequently with skin, gastrointestinal, joint and renal manifestations. The prognosis of HSP is mainly determined by the involvement of the kidney, but prognostic markers have not been established. We evaluated the patients who have HSP nephritis with nephrotic syndrome. Method : Clinical manifestations and laboratory findings were observed and analyzed in 34 cases with HSP which were manifested by nephrotic syndrome hospitalized at Kyung Hee university Hospital during the period from Jan. 1990 to Dec. 1998. Results : 1) Male to female ratio was 1.3:1, and mean age at onset was 8.3 year. 2) Mean duration from symptom onset to renal biopsy was 10.5 weeks. 3) Proportion of patients presenting with acute nephritis was 32.4$\%$, gross hematuria 17.6$\%$, microscopic hematuria 50$\%$. 4) The findings of renal biopsy were 20 cases of grade II, 11 cases of grade III, 2 cases of grade I, 1 case of grade IV according to classification by ISKDC. 5) Patients with grade I were recovered with no residual defect, but patients with grade IV shows active renal disease(states C). Conclusion : Among the 디le patients with Henoch-$Sch{\ddot{o}}nlein$ purpura accompanying nephrotic syndrome, more aggressive treatment might be needed in patients showing crescents formation on renal biopsy. A prospective study will be needed to explore the progression of this disease.

• Childhood Kidney Diseases
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• v.18 no.2
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• pp.77-84
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• 2014

Purpose: The purpose of this study was to compare the validity of Onen's alternative grading system (AGS) with that of the APDRP and SFU grading systems in patients with isolated and complicated congenital hydronephrosis. Methods: We retrospectively reviewed the medical records of 153 patients (204 renal units) diagnosed with congenital hydronephrosis between January 2002 and December 2011. We classified patients into 2 groups; isolated or complicated hydronephrosis. All renal units were graded according to anterior-posterior diameter of renal pelvis (APDRP), Society for Fetus Urology (SFU) and Onen's grading systems. We analyzed the prognosis of hydronephrosis, according to each grading system, at 2 years of age. Results: There were 152 renal units with isolated hydronephrosis and 52 renal units with complicated hydronephrosis. The isolated hydronephrosis group had a lower grade according to Onen's AGS, and showed more frequent spontaneous remission by 2 years of age. There was more frequent obstruction (P =0.000) and surgical treatment (P =0.000) of units with high-grade hydronephrosis according to Onen's AGS. In the complicated hydronephrosis group the frequencies of spontaneous remission (P =0.015) and renal dysfunction (P =0.013) were significantly higher than those in high-grade hydronephrosis, as indicated by Onen's AGS. There were no significant differences in clinical outcomes among the highest grade groups, according to the 3 systems, in either isolated or complicated hydronephrosis. Conclusion: Onen's AGS reflects the prognosis of hydronephrosis as well as other grading systems in those with isolated hydronephrosis. It was better predictor of renal dysfunction in those with complicated hydronephrosis. However, Onen's AGS was not superior to the other grading systems in terms of predicting prognosis, especially in high-grade hydronephrosis.

• Childhood Kidney Diseases
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• v.18 no.1
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• pp.24-28
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• 2014

Purpose: The purpose of this study was to assess the therapeutic efficacy of methylprednisolone pulse therapy in children with IgA nephropathy and Henoch- Sch$\ddot{o}$nlein Purpura (HSP) nephritis combined with proteinuria. Methods: We retrospectively reviewed the clinical records of 21 patients who were diagnosed with IgA nephropathy and HSP nephritis based on percutaneous renal biopsy. Of the 21 patients, 15 were diagnosed with IgA nephropathy and 6 were diagnosed with HSP nephritis. They had mild to severe proteinuria at the time of diagnosis or during follow-up. Group 1 (n=7) received methylprednisolone pulse therapy three times every couple of months, and Group 2 (n=14) received oral steroid therapy. The follow-up periods for Group 1 and 2 were 14.0 (9-54) months and 26.5 (14-34) months, respectively. There was no significant difference in the follow-up duration between the two groups. Results: The average age at diagnosis and biopsy was lower in Group 1 compared to Group 2, but it was not significantly different. At admission, all patients in both groups had hematuria and 5 patients (71.4%) of Group 1 and 14 patients (100 %) of Group 2 had proteinuria. Before treatment, there was no significant difference of spot urine protein/creatinine ratio between the two groups. During followup, 7 patients of Group 1 (100%) and 10 patients of Group 2 (71.4%) showed complete improvement of proteinuria and the spot urine protein/creatinine ratio in Group 1 was significantly lower than Group 2. Conclusion: In patients with IgA nephropathy and HSP nephritis with proteinuria, methylprednisolone pulse therapy was more effective than oral steroid therapy in the reduction of proteinuria. To investigate the effects on long-term prognosis, large-scale prospective studies are needed.

• Journal of Chest Surgery
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• v.36 no.4
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• pp.261-266
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• 2003

Background: Surgery of abdominal aortic aneurysm revealed high operative mortality. We reviewed our 11-years' experiences of abdominal aortic aneurysm operation and wish to obtain information on the treatment. Material and Method: From Jan. 1990 to Dec. 2000, 48 patients were operated due to abdominal aortic aneurysm in Yonsei Cardiovascular Center Mean age was $62.8{\pm}12.7$ and there were 40 males and 8 females. Among 48 patients, nine patients had ruptured abdominal aortic aneurysm, and mean aneurysm diameter of non-ruptured cases was $8.8{\pm}2.4$cm. Result: There were 6 early deaths, and early mortality was 12.5%. Among 9 patients of preoperative aneurysm rupture, three patients died (33.3%), and among 39 patients of non-ruptured cases, 3 patients died (7.7%). Among preoperative variables, age (p<0.05), preoperative BUN level (p<0.05), and DM (p<0.05) were risk factors of early mortality. Among discharged 42 patients, 40 patients were followed up (f/u rate=95.2%) and mean follow up was $3.6{\pm}0.2$ years. During follow up periods, five patients died (late mortality=11.9%), and Kaplan-Meier survival analysis revealed $81.7{\pm}7.6$% survival rate at five and ten year. Linealized incidence of graft related event was 3.53% per patient-year. Conclusion: Surgical mortality of ruptured abdominal aortic aneurysm was higher than non-ruptured cases; therefore, early resection of the aneurysm can decrease the surgical mortality.

• The Korean Journal of Nuclear Medicine
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• v.38 no.1
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• pp.99-108
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• 2004

Purpose: The ability to noninvasively track the migration of neural progenitor cells would have significant clinical and research implications. We generated stably transfected F3 human neural progenitor cells with human sodium/iodide symporter (hNIS) for noninvasively tracking F3. In this study, the expression patterns of hNIS gene in F3-NIS were examined according to the cultured time and the epigenetic modulation. Materials and Methods: F3 human neural stem cells had been obtained from Dr. Seung U. Kim (Ajou University, Suwon, Korea). hNIS and hygromycin resistance gene were linked with IRES (Internal Ribosome Entry Site) under control of CMV promoter. This construct was transfected to F3 with Liposome. To investigate the restoration of hNIS gene expression in F3-NIS, cells were treated with demethylating agent (5-Azacytidine) and Histone deacetylase inhibitor (Trichostatin A: TSA). The expression of hNIS was measured by I-125 uptake assay and RT-PCR analysis. Results: The iodide uptake of the F3-NIS was higher 12.86 times than F3 cell line. According to the cell passage number, hNIS expression in F3-NIS gradually diminished. After treatment of 5-Azacytidine and TSA with serial doses (up to $20{\mu}M$, up to 62.5nM, respectively) for 24 hours, I-125 uptake and mRNA of hNIS in F3-NIS were increased. Conclusion: These results suggest that hNIS transfected F3 might undergo a change in its biological characters by cell passage. Therefore, the gene ex[ressopm of exogenous gene transferred human stem cell might be affected to the epigenetic modulation such as promoter methylation and Histone deacetylation and to the cell culture conditions.

• Nuclear Medicine and Molecular Imaging
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• v.41 no.5
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• pp.350-358
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• 2007

Purpose: Localizing and differentiating a metastatic lesion of differentiated thyroid cancer (DTC) by using radio iodine whole body scan could be difficult because a whole body scan (WBS) lacks anatomic information. This study was performed to evaluate the usefulness of radio-iodine SPECT/CT for differentiating equivocal lesions. Materials & Methods: Among 253 patients with DTC who had undergone radio-iodine scan between February and July 2006, 26 patients were enrolled (M:F = 8:18, Age $50.7{\pm}12.5$ years) in this study. The patients had abnormal uptakes in the WBSs that necessitated precise anatomical localization for differentiating between a metastatic lesion and a false-positive lesion. SPECT/CT was performed for the region with abnormal uptake in the WBS. WBS and SPECT/CT were evaluated visually. Metastases were diagnosed based on the results of the radio-iodine scan along with the results of other radiological examinations and serological tests. Results: Based on the WBS images, 13 were suspected with cervical lymph node (LN) metastases in 16 patients with abnormal neck uptake, and in the 11 patients with abnormal extra-cervical uptakes, extra-cervical metastases were doubtful in all. After SPECT/CT was performed, the diagnostic results were altered for 16 patients (62%). SPECT/CT revealed that only 5 patients had cervical LN metastases, while 3 patients had extra-cervical (mediastinal) LN metastases. Overall, there was a 58% (15/26) change in diagnoses and plans for treatment due to SPECT/CT. Among 8 patients suspected with metastases on SPECT/CT, 6 patients underwent another radio-iodine therapy. In 96% (24/25) of the patients, the results of SPECT/CT corresponded with those of further radiological examinations and with other clinical information. Conclusion: Radio-iodine SPECT/CT images permitted the differentiation of abnormal radio-iodine uptake and improved anatomical interpretation in DTC.

• The Korean Journal of Nuclear Medicine Technology
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• v.15 no.1
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• pp.3-9
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• 2011

Purpose: Generally dual energy X-ray absorptiometry has been used for the purpose of evaluation of osteoporosis and treatment. Recently the interest of obesity came to be high and body percent fat test is increasing. Existing measure of body fat have to scan the whole body can be evaluated, but only lumbar spine and hip measurements was assumed to be whole body fat as well as improving the software. It tries to check whether the part measured value not being whole body measurement has the validity or not compared with the value calculated with the method that it is different, it forgives through a correlation with a (BIA) and (BMI). Materials and Methods: In 2010, the body percent fat was measured among the examinee coming to the Asan Medical Center public health care center from March till August against 90 females more than 40 years old through (DXA) and BIA. BMI utilized the value which wrote an hight and weight measured through the body measuring instrument in the examinee information and is automatically calculated. In addition, it classified as the low weight ($13-18.5kg/m^2$), normal ($18.5-25kg/m^2$), and corpulence ($25-30kg/m^2$) based on BMI and so that it could check whether there was the difference according to the weight or not BMI and BIA and correlation between DXA were analyzed in each group. The statistical program for the analysis used SPSS 12.0. Results: The comparison of DXA at 3 which it divides into the low weight and normal and corpulence groups and BIA did not show the difference noted statistically in all groups and the between group comparison was exposed to do not have a meaning. The body percent fat measured by the correlation analysis result DXA at the state that it doesn't divide into the group showed the high correlation (r=0.908, p0.01) noted statistically compared with BMI and showed the high correlation noted statistically in a comparison with BIA (r=0.927, p0.01). Conclusion: It confirmed that the whole body percent fat presumed from the part bone density measurement showed the excel correlation compared with BIA and BMI and information is high. There is still no clear standard about the presumed whole body percent fat and it is difficult to evaluate the fat evaluation by the bone mineral density measurement. However, it is determined that the information offering which is more objective through the comparative study with the body percent fat which is very efficient and in that it can obtain till the information about a fat as well as diagnosis of the osteoporosis through the bone density checkup is measured by the afterward telegraph bone density checkup and is clinically useful is possible.