• Progress in Medical Physics
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• v.18 no.2
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• pp.87-92
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• 2007

A thermal neutron beam facility utilizing a typical tangential beam port for Neutron Capture Therapy was installed at the HANARO, 30 MW multi-purpose research reactor. Mixed beams with different physical characteristics and relative biological effectiveness would be emitted from the BNCT irradiation facility, so a quantitative analysis of each component of the mixed beams should be performed to determine the accurate delivered dose. Thus, various techniques were applied including the use of activation foils, TLDs and ionization chambers. All the dose measurements were perform ed with the water phantom filled with distilled water. The results of the measurement were compared with MCNP4B calculation. The thermal neutron fluxes were $1.02E9n/cm^2{\cdot}s\;and\;6.07E8n/cm^2{\cdot}s$ at 10 and 20 mm depth respectively, and the fast neutron dose rate was insignificant as 0.11 Gy/hr at 10 mm depth in water The gamma-ray dose rate was 5.10 Gy/hr at 20 mm depth in water Good agreement within 5%, has been obtained between the measured dose and the calculated dose using MCNP for neutron and gamma component and discrepancy with 14% for fast neutron flux Considering the difficulty of neutron detection, the current study support the reliability of these results and confirmed the suitability of the thermal neutron beam as a dosimetric data for BNCT clinical trials.

• Progress in Medical Physics
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• v.22 no.1
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• pp.52-58
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• 2011

Our goal is to assess the suitability of a glass dosimeter on detection of high-energy electron beams for clinical use, especially for radiation therapy. We examined the dosimetric characteristics of glass dosimeters including dose linearity, reproducibility, angular dependence, dose rate dependence, and energy dependence of 5 different electron energy qualities. The GD was irradiated with high-energy electron beams from the medical linear accelerator andgamma rays from a cobalt-60 teletherapy unit. All irradiations were performed in a water phantom. The result of the dose linearity for high-energy electron beams showed well fitted regression line with the coefficient of determination; $R^2$ of 0.999 between 6 and 20 MeV. The reproducibility of GDs exposed to the nominal electron energies 6, 9, 12, 16, and 20 MeV was ${\pm}1.2%$. In terms of the angular dependence to electron beams,GD response differences to the electron beam were within 1.5% for angles ranging from $0^{\circ}$ to $90^{\circ}$ and GD's maximum response differencewas 14% lower at 180o. In the dose rate dependence, measured dose values were normalized to the value obtained from 500 MU/min. The uncertainties of dose rate were measured within ${\pm}1.5%$ except for the value from 100 MU/min. In the evaluation of the energy dependence of the GD at nominal electron energies between 6 and 20 MeV, we obtained lower responses between 1.1% and 4.5% based on cobalt-60 beam. Our results show that GDs have a considerable potentiality for measuring doses delivered by high-energy electron beams.

• The Journal of the Korea Contents Association
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• v.8 no.11
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• pp.210-216
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• 2008

In this study, image comparisons were carried out using a MRI contrast medium which was derived by mixing a polyaminocarboxylic ligand and a gadolinium (III) transition metal which is paramagnetic and has good neutron absorbing capabilities with Gd-DTPA which is currently being used widely in the clinical setting. By using a 1.0T (Harmony, SIEMENS) MR equipment, phantoms of which 100cc of saline was diluted with a diethylenetriaminetriacetic acid derivative and Gd-DTPA were imaged. The amount of diethylenetriaminetriacetic acid and Gd-DTPA which was diluted into the 100cc of saline was 0.05mmol/L, 0.1mmol/L, 0.15mmol/L, 0.2mmol/L, 0.3mmol/L, 0.5mmol/L, 1.0mmol/L, 2.0mmol/L, 3.0mmol/L and 4.9mmol/L respectively. Head coils were used and while fixing the SE pulse sequence and image variable (as TE is 14ms, 1NEX with a 256x201 matrix), the signal intensity and simple contrast ratios according to changing concentrations and TR were compared with various TR at 300ms, 400ms, 500ms, 600ms, 700ms, 800ms, 900ms, 1000ms, 1200ms, 1400ms and 1600ms. According to the comparison results of the signal intensity of the image based on changes in contrast medium concentrations and TR, the differences in signal intensity between the two contrast mediums were found to be small at $1.0{\sim}2.0mmol/L$ when the highest signal intensity was achieved. However, at concentrations of 1.0mmol/L or less, the signal intensity was markedly higher in the Diethylenetriaminetriacetic acid derivative than in the Gd-DTPA complex. It was also found that the differences in the signal intensities demonstrated by the concentrations of the contrast mediums were affected by the TR. Accordingly, the efficacy of the Diethylenetriaminetriacetic acid derivative was shown to be better than the Gd-DTPA and also possible to get the optimum image quality by the use of an appropriate TR with appropriate concentrations of contrast medium.

• Clinical and Experimental Pediatrics
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• v.48 no.2
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• pp.178-185
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• 2005

Purpose : The purpose of this study was to evaluate the outcome of children with juvenile myelomonocytic leukemia(JMML) treated with allogeneic hematopoietic stem cell transplantation(allo-HSCT). Methods : Eleven JMML patients aged 8-39 months underwent allo-HSCT. The sources of grafts were unrelated donors(n=7), HLA-matched siblings(n=3) and an HLA 1-antigen mismatched familial donor. All patients had received chemotherapy ${\pm}13$-cis-retinoic acid(CRA) before transplant, and CRA was used, posttransplant, in six patients. Results : Only three patients were in complete remission(CR) at the time of transplantation. Initial chimeric status revealed complete donor chimerism(CC) in five patients, mixed chimerism(MC) in five and autologous recovery(AR) in one. One patient with MC having persistent splenomegaly eventually turned to CC and CR after rapid tapering of cyclosporine, combined with daily use of CRA. An AR case relapsed shortly after transplant but was rescued with second, unrelated cord blood transplantation. Ultimately, six patients are alive, event-free, with a median follow-up of 15.5 months posttransplant. All three deaths occurred in patients who failed to achieve CC, leading to disease progression. Conclusion : We suggest that graft-versus-leukemia effect play an important role and CRA a possible role in posttransplant leukemic involution in JMML. In patients whose leukemic burden is still high with MC after transplant, early tapering of immunosuppressants and introduction of CRA might provide a chance of a cure for some patients.

• Clinical and Experimental Pediatrics
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• v.45 no.11
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• pp.1325-1331
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• 2002

Purpose : We tried to check the accuracy of references in the Journal of the Korean Pediatric Society and Journals of the Korean Pediatric Subspecialty Societies. We also wanted to know the citation patterns of authors by analyzing the frequency of cited materials. Methods : Three journals were randomly selected from the 2000 issues of Journal of the Korean Pediatric Society and nine journals were selected mainly from the second half of 2000 issues of each Journal of the Korean Pediatric Subspecialty Societies for the study. Then the accuracy of references was checked with Medline. Journals before 1964, books, and journals which were not written in English were used only in the citation pattern analysis. Results : Author errors were the most common(21.3%) among the reference elements. The next was title errors, followed by page errors, journal errors, volume errors and year errors. Total average error rate was 34.7% and we were unable to find journals in 89 cases(2.2%). The journal of the Korean Society of Neonatology had the lowest error rate(17.4%) and the journal of the Korean Pediatric Cardiology Society had the highest error rate(53.2%). The reference journals which were published and quoted in the most recent three years were only 612 cases(15%). Foreign journals were selected as reference(78.4%) more than domestic journals; The Journal of the Korean Pediatric Society was the most frequently cited reference(43.3%) among domestic journals. Conclusion : Authors are ultimately responsible for the accuracy of references and they should check the reference list with responsibility. Hopefully, authors also will have to use more domestic journals and recent journals.

• Journal of Periodontal and Implant Science
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• v.32 no.3
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• pp.565-576
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• 2002

The ultimate goal of periodontal therapy is the regeneration of periodontal tissue which has been lost due to destructive periodontal disease. To achieve periodontal regeneration, various kinds of methods have been investigated and developed, including guided tissue regeneration and bone graft. Bone graft can be catagorized into autografts, allografts, xenografts, bone substitutes. And materials of all types have different biological activity and the capacity for periodontal regeneration, but ideal graft material has not been developed that fits all the requirement of ideal bone graft material. Intensive research is underway to identity, purify, synthesize a variety biologic modulators that may enhance wound healing and regeneration of lost tissues in periodontal therapy. The present study evaluates the effects of ABM/P-15 on the periodontal regeneration in intrabony defects of human. We used thirty four 2-wall or 3-wall osseous defects in premolars and molars of chronic peridontitis patient that have more than 5mm pockets and more than 3mm in intrabony defect. 12 negative control group underwent flap procedure only, 11 positive control group received DFDBA graft with flap procedure, and 11 experimental group received ABM/P-15 graft with flap procedure. The changes of probing pocket depth, loss of attachment and bone probing depth following 6months after treatment revealed the following results: 1. The changes of probing pocket depth showed a statistically significant decrease between after scaling and 6months after treatment in negative control(2.0${\pm}$0.9mm), positive control(3.0${\pm}$0.9mm), and experimental group (3.4${\pm}$1.5mm) (P<0.01). Significantly more reduction was seen in experimental group compared to negative control group (P<0.05). 2. The changes of loss of attachment showed a statistically significant decrease between after scaling and 6months after treatment in positive control(2.0${\pm}$0.6mm), and experimental group (2.2${\pm}$l.0mm) except negative control group(0.1${\pm}$0.7mm) (P<0.01). Significantly more reduction was seen in both experimental and positive control group compared to negative control group(P<0.05). 3. The changes of bone probing depth showed a statistically significant decrease between after scaling and 6months after treatment in positive control(2.7${\pm}$l.0mm), and experimental group (3.4${\pm}$1.3mm) except negative control(0.l${\pm}$0.9mm) (9<0.01). Significantly more reduction was seen in both experimental and positive control group compared to negative control group (P<0.05). The results suggest that the use of ABM/P-15 in the treatment of periodontal intrabony defects can reduce loss of attachment and bone probing depth more than flap operation only. It suggests that ABM/P-15 may be an effective bone graft material for the regeneration of periodontal tissue in intrabony defects.

• Clinical and Experimental Pediatrics
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• v.50 no.2
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• pp.198-204
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• 2007

Purpose : The hope that arresting pubertal developement might increase final adult height has led to an attempt to use GnRH agonist (GnRHa) in children with early puberty and poor growth prognosis. We investigated the growth-promoting effect of GnRH agonists with or without growth hormone (GH) in girls with early puberty and decreased predicted adult height (PAH). Methods : Thirty five girls with advanced bone age and early pubertal signs were randomized for treatment for about 1 year with monthly GnRHa in group 1 (n=18), or with a combination of GH and GnRHa in group 2 (n=17). The following growth parameters were compared between groups, and the difference ($\Delta$) before and after treatment : chronological age (CA), bone age (BA), $\Delta$(BA-CA), height (HT), target height (TH), predicted adult height (PAH), $\Delta$ (TH-PAH), serum insulin-like growth factor (IGF-1) and insulin-like growth factor binding protein (IGFBP-3). Results : Before treatment, BA, TH, PAH Standard deviation scores (SDS), $\Delta$(TH-PAH) were not different between the two groups, but CA was higher in group 2 and $\Delta$(BA-CA) were higher in group 1 (P<0.05). After $1.06{\pm}0.93$ year of treatment, $\Delta$ (BA-CA) decreased and there were significant changes in PAH and $\Delta$ (TH-PAH), especially in group 2 (P<0.05 in group 1, and P<0.001 in group 2). In both groups, IGF-1 and IGFBP-3 were not different before and after treatment, but after treatment, IGF-1 level in group 2 was marginally higher than IGF-1 in group 1 (P<0.1). Conclusion : Compromised predicted adult height in girls with early puberty and advanced bone age was significantly improved with GnRH with/without GH treatment in the short-term period. The addition of GH to GnRHa results in a significant increase in PAH compared to GnRHa alone because GnRHa suppressed growth hormone-IGF-1 axis. For comparison of final adult height, further longitudinal follow-up will be needed.

• 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.

• Radiation Oncology Journal
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• v.26 no.1
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• pp.17-23
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• 2008

Purpose: The best treatment for advanced esophageal cancer is chemoradiotherapy followed by surgery. In spite of the advance of multimodality therapy, most patients with esophageal cancer are treated with radiation therapy alone. This study reports the outcome of the use of conventional external beam radiotherapy alone for the treatment of esophageal cancer. Materials and Methods: Between January 1998 and December 2005, 30 patients with squamous cell carcinoma of the esophagus were treated with external beam radiotherapy using a total dose exceeding 40 Gy. Radiotherapy was delivered with a total dose of 44-60 Gy(median dose, 57.2 Gy) over $36{\sim}115$ days(median time, 45 days). Thirteen patients(43.3%) had a history of disorders such as diabetes, hypertension, tuberculosis, lye stricture, asthma, cerebral infarct, and cancers. Four patients metachronously had double primary cancers. The most common location of a tumor was the mid-thoracic portion of the esophagus(56.7%). Tumor lengths ranged from 2 cm to 11 cm, with a median length of 6 cm. For AJCC staging, stage III was the most common (63.3%). Five patients had metastases at diagnosis. Results: The median overall survival was 8.3 months. The survival rates at 1-year and 2-years were 33.3% and 18.7%, respectively. The complete response rate $1{\sim}3$ months after radiotherapy was 20%(6/30) and the partial response rate was 70%(21/30). Sixteen patients(53.3%) had an improved symptom of dysphagia. Significant prognostic factors were age, tumor length, stage, degree of dysphagia at the time of diagnosis and tumor response. Cox regression analysis revealed the aim of treatment, clinical tumor response and tumor length as independent prognostic factors for overall survival. Twenty-eight patients had local failure and another four patients had metastases. Three patients were detected with double primary cancers in this analysis. A complication of esophageal stricture was observed in three patients(10%), and radiation pneumonitis occurred in two patients(6.7%). Conclusion: The prognosis of esophageal cancer remains poor, in spite of advances in radiotherapy techniques. Radiotherapy is one of the main treatment modalities for the relief of dysphagia and treatment related complications are minimal. It is expected that the addition of chemotherapy or another systemic modality to radiotherapy will improve tumor control and increase the survival rate in advanced esophageal cancer.

• 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.