• Journal of Pharmaceutical Investigation
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• v.28 no.3
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• pp.185-191
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• 1998

A bioequivalence study of the Loxipen tablets (Dae Wha Pharmaceutical Co., Korea) to the Loxonin tablets (Dong Hwa Pharmaceutical Co., Korea), formulations of sodium loxoprofen anhydrous 60 mg, was conducted. Sixteen healthy Korean male subjects received each formulation at the dose of 60 mg as sodium loxoprofen anhydrous in a $2{\times}2$ crossover study. There was a 2-week washout period between the dose. Plasma concentrations of loxoprofen were monitored by an HPLC method for over a period of 6 h after each administration. AUC (area under the plasma concentration-time curve from time zero to infinity) was calculated by the linear trapezoidal and extrapolation method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ $(time\;to\;reach\;C_{max})$ were compiled from the plasma drug concentration-time data. Analysis of variance (ANOVA) revealed that there are no differences in AUC, $C_{max}$ and $T_{max}$ between the formulations. The apparent differences between the formulations in these parameters were all far less than 20% (i.e., 5.88, 7.81 and 6.09% for AUC, $C_{max}$ and $T_{max}$, respectively). Minimum detectable differences (%) at ${\alpha}=0.1$ and $1-{\beta}=0.8$ were all less than 20% difference in these parameters between the formulations were all over 0.8 (i.e., 15.81, 13.13 and 19.85 for AUC, $C_{max}$ and $T_{max}$, respectively). The 90% confidence intervals for these parameters were also within ${\pm}20%$ (i.e., $-16.52{\sim}4.77$, $-16.65{\sim}1,02$ and $-19.45{\sim}7.28%$ for AUC, $C_{max}$ and $T_{max}$, respectively). These results satisfy the bioequivalence criteria of the Korea Food and Drug Administration (KFDA) guidelines (No. 98-51). Therefore, these results indicate that the 2 formulations of loxoprofen are bioequivalent and, thus, may be prescribed interchangeably.

• YAKHAK HOEJI
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• v.54 no.4
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• pp.258-269
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• 2010

As people are easy to access the National Health Insurance, medical health service has been increased. It contributed to extend human's average life expectancy and to get better health care. But also increased unnecessary health service or inappropriate drug use. Therefore, DUR (Drug Use Review) is needed to induce appropriate drug use. The purpose of this study is to evaluate outpatient prescriptions by General Practitioner (GP) and Specialized Practitioner, especially indication for ENT referral including common cold which is the frequent indications that have patient see doctor. This study was reviewed retrospectively prescriptions for ENT referral collected at the A pharmacy for ENT Clinic in Cheong-Ju, B pharmacy for GP Clinic in BoEun from Feb 2nd, 2009 to Feb 28th, 2009. Each pharmacy located closed to the each enrolled clinic. The numbers of collected prescriptions were each A pharmacy (n=2501), B pharmacy (n=1343). This study was classified Drug Related Problems (DRPs) those prescriptions had as total 6 groups according to following 6 categories; 1) Unnecessary Drug, 2) Wrong Drug, 3) Low Dose, 4) Overdose, 5) Wrong Instruction, 6) Wrong Combination. In results, Specialized Practitioner's prescriptions had more DRPs than General Practitioner's prescriptions (ENT 155.34% vs GP 130.01%). In detail, Specialized Practitioner's prescriptions had more DRPs in Low Dose (ENT 16.95% vs GP 4.77%), Overdose (ENT 6.72% vs G.P 5.51%), Wrong Instruction (ENT 7.91% vs GP 5.81%), Wrong Combination (ENT 29.31% vs GP 25.09%). These DRPs would be caused from lack of consideration for dosage and drug interaction. General Practitioner's prescriptions had more DRPs in Unnecessary Drug (ENT 70.37% vs GP 78.85%), Wrong drug (ENT 4.12% vs GP 9.98%). These DRPs would be associated with drug selection. This study was assumed that Specialized Practitioner is better prescriber than General Practitioner because Specialized Practitioner complete additional intern and residency training. But, Specialized Practitioner is not always better prescriber than General Practitioner. Furthermore, prescriptions of both Specialized Practitioner and General Practitioner had many problems. In conclusion, It could be cut down the excessive medical expense and expected more efficient medical care by reducing DRPs, thus contributing to the improvement of national health. In order to pharmacist must have good professional ability of pharmacotherapy to help the physician for the drug selection.

• Journal of Oriental Neuropsychiatry
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• v.22 no.1
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• pp.53-67
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• 2011

Objectives : Dahuanghuanglianxiexin-tang(DHXT) has been prescribed for patients with anxiety disorder and has been believed to treat Haw-Byung. The present study was carried out to investigate whether Da-Huang, Huang-Lian and DHXT have beneficial effects on ability to recover from the stressful conditions. Methods : The mice were divided into normal group, control group, positive control group and experimental groups. The experimental groups were divided into Da-Huang, Hwan-gryun and DHXT group. In the positive control group, imiprimine at $500{\mu}g$/g/day of dose were applied to mice and in the experimental groups, Da-Huang, Huang-Lian and DHXT at $50{\mu}$/g/day of dose were applied to mice. After 1 hour, the mice in the rest of groups except normal group were exposed to immobilization stress. Their body weights, phagocytosis, nitric oxide in macrophage, iNOS in hippocampus, serum levels of corticosterone and adrenocorticotropic-hormone(ACTH) were observed. Results : Da-Huang, Huang-Lian and DHXT didn't increase the body weights of immobilization stressed mice but they improved phagocytosis in immobilization stressed mice. Also they worked on reducing the amount of nitric oxide in macrophages in immobilization stressed mice. Although Da-Huang, Huang-Lian and DHXT didn't affect the serum level of ACTH in immobilization stressed mice, they reduced the serum level of corticosterone in immobilization stressd mice. Conclusions : The present study suggests that Da-Huang, Huang-Lian and DHXT have beneficial effects on ability to recover from the stressful conditions.

• Journal of Energy Engineering
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• v.29 no.1
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• pp.63-74
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• 2020

The Kori-Unit 1 nuclear power plant, which is scheduled for decommissioning after permanent shutdown, is expected to generate a large amount of various types of radioactive waste during decommissioning process. For concrete radioactive waste, which is expected to occupy the most amount, it is important to analyze the current waste disposal status and legal limitations and to prepare an appropriate and efficient disposal method. Concrete radioactive waste is waste of various levels, of which the clearance level is bioshield concrete. In this paper, clearance radioactive waste safety evaluation was performed using the RESRAD code, which is a safety evaluation code, based on the activation evaluation results for the wastes with the clearance level. The clearance scenario of the target radioactive waste was selected and the individual's exposure dose was calculated at the time of clearance to determine whether the clearance criteria limit prescribed by the Nuclear Safety Act was satisfied. As a result of the evaluation, the results showed significantly lower results and satisfied the criteria value. Based on the results of this clearance safety assessment, the appropriate disposal method for bioshield concrete, which are the clearance wastes of subject of deregulation, was suggested.

• Progress in Medical Physics
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• v.12 no.2
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• pp.177-184
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• 2001

The goal of radiation treatment is to deliver a prescribed radiation dose to the target volume accurately while minimizing dose to normal tissues. Due to inaccurate placement of field and shielding block and patient's movement, there could be displacement errors between the planed and treatment regions. In order to verify the location of radiation treatment, we in this study developed the registration algorithm of the x-ray simulator images and portal images and quantified the inaccuracy in terms of shift, scale and rotation. The algorithm for registration of pairs of radiation fields consists of the alignment of pairs of radiation images by points matching and field displacement analysis by field boundary matching. In the first step, paired surface landmarks are matched to calculate the transformation parameters (scale, rotation and shift) using the corresponding line pairs which are created by connecting two landmarks of each image. In the next step, portal field boundary is extracted and then the two field boundaries are matched by the $\rho$-$\theta$ technique. Applying the phantom portal images, detection errors were calculated to be less than 2mm in translation, 1$^{\circ}$ in rotation and 1% in scale. In conclusion, we quantitatively analyzed the displacement error of x-ray simulator images and portal images. The present results could contribute to the study of the radiation treatment verification.

• The Korean Journal of Physiology and Pharmacology
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• v.16 no.3
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• pp.181-186
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• 2012

Fenofibrate is a selective peroxisome proliferator-activated receptor ${\alpha}$ ($PPAR{\alpha}$) activator and is prescribed to treat hyperlipidemia. The mechanism through which $PPAR{\alpha}$ agonists reduce food intake, body weight, and adiposity remains unclear. One explanation for the reduction of food intake is that fenofibrate promotes fatty acid oxidation and increases the production of ketone bodies upon a standard experimental dose of the drug (100~300 mg/kg/day). We observed that low-dose treatment of fenofibrate (30 mg/kg/day), which does not cause significant changes in ketone body synthesis, reduced food intake in Long-Evans Tokushima (LETO) rats. LETO rats are the physiologically normal controls for Otsuka Long-Evans Tokushima Fatty (OLETF) rats, which are obese and cholecystokinin (CCK)-A receptor deficient. We hypothesized that the reduced food intake by fenofibrate-treated LETO rats may be associated with CCK production. To investigate the anorexic effects of fenofibrate in vivo and to determine whether CCK production may be involved, we examined the amount of food intake and CCK production. Fenofibrate-treated OLETF rats did not significantly change their food intake while LETO rats decreased their food intake. Treatment of fenofibrate increased CCK synthesis in the duodenal epithelial cells of both LETO and OLETF rats. The absence of a change in the food intake of OLETF rats, despite the increase in CCK production, may be explained by the absence of CCK-A receptors. Contrary to the OLETF rats, LETO rats, which have normal CCK receptors, presented a decrease in food intake and an increase in CCK production. These results suggest that reduced food intake by fenofibrate treatment may be associated with CCK production.

• Radiation Oncology Journal
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• v.38 no.2
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• pp.109-118
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• 2020

Purpose: Hypofractionated radiotherapy (RT) is becoming a new standard in postoperative treatment of patients with early stage breast cancer after breast conservation surgery. However, data on hypofractionation in patients with advanced stage disease who undergo mastectomy followed by local and regional nodal irradiation (RNI) is lacking. In this retrospective study, we report late-term effects of 3 weeks post-mastectomy hypofractionated local and RNI with two-dimensional (2D) technique in patients with stage II and III breast cancer. Methods: Between January 1990 and December 2007, 1,770 women with breast cancer who were given radical treatment with mastectomy, systemic therapy and RT at least 10 years ago were included. RT dose was 35 Gy/15 fractions/3 weeks to chest wall by two tangential fields and 40 Gy in same fractions to supraclavicular fossa (SCF) and internal mammary nodes (IMNs). SCF and IMNs dose was prescribed at d_max and 3 cm depth, respectively. Chemotherapy and hormonal therapy was given in 64% and 74% patients, respectively. Late-term toxicities were assessed with the Radiation Therapy Oncology Group (RTOG) scores and LENT-SOMA scales (the Late Effects Normal Tissue Task Force-Subjective, Objective, Management, Analytic scales). Results: Mean age was 48 years (range, 19 to 75 years). Median follow-up was 12 years (range, 10 to 27 years). Moderate/marked arm/shoulder pain was reported by 254 (14.3%) patients. Moderate/marked shoulder stiffness was reported by 219 (12.3%) patients. Moderate/marked arm edema was seen in 131 (7.4%) patients. Brachial plexopathy was not seen in any patient. Rib fractures were noted in 6 (0.3%) patients. Late cardiac and lung toxicity was seen in 29 (1.6%) and 23 (1.3%) patients, respectively. Second malignancy developed in 105 (5.9%) patients. Conclusion: RNI with 40 Gy/15 fractions/3 weeks hypofractionation with 2D technique seems safe and comparable to historical data of conventional fractionation (ClinicalTrial.gov Registration No. NCT04175821).

• Progress in Medical Physics
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• v.30 no.1
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• pp.7-13
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• 2019

Purpose: To compare the dosimetrical and radiobiological parameters among various volumetric modulated arc therapy (VMAT) techniques using restricted and continuous arc beams for left-sided breast cancer. Materials and Methods: Ten patients with left-sided breast cancer without regional nodes were retrospectively selected and prescribed the dose of 42.6 Gy in 16 fractions on the planning target volume (PTV). For each patient, three plans were generated using the $Eclipse^{TM}$ system (Varian Medical System, Palo Alto, CA) with one partial arc 1pVMAT, two partial arcs 2pVMAT, and two tangential arcs 2tVMAT. All plans were calculated through anisotropic analytic algorithm and photon optimizer with 6 MV photon beam of $VitalBEAM^{TM}$. The same dose objectives for each plan were used to achieve a fair comparison during optimization. Results: For PTV, dosimetrical parameters such as Homogeneity index, conformity index, and conformal number were superior in 2pVMAT than those in both techniques. $V_{95%}$, which indicates PTV coverage, was 91.86%, 96.60%, and 96.65% for 1pVMAT, 2pVMAT, and 2tVMAT, respectively. In most organs at risk (OARs), 2pVMAT significantly reduced the delivered doses compared with the other techniques, excluding the doses to contralateral lung. For the analysis of radiobiological parameters, a significant difference in normal tissue complication probability was observed in ipsilateral lung while no difference was observed in the other OARs. Conclusions: Our study showed that 2pVMAT had better plan quality and normal tissue sparing than 1pVMAT and 2tVMAT but not for all parameters. Therefore, 2pVMAT could be considered the priority choice for the treatment planning for left breast cancer.

• Journal of Korean Medicine for Obesity Research
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• v.24 no.1
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• pp.94-101
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• 2024

Herbal medicine (HM)-containing Ephedra Sinica (ES) has been associated with false-positive amphetamine immunoassay (FP IA) results. This study retrospectively evaluated the effects of dose, duration, and withdrawal instructions on FP IA and the safety of HM-containing ES at a clinic in Seoul from 2022 to 2023. The study included 6 patients in the FP IA group and 5 patients in the withdrawal instruction negative (Neg) group. The pre-test ephedrine alkaloids dose in the FP IA group was 95.17±31.90 mg, compared with 88.6±20.43 mg in the Neg group. The FP IA group had taken HM for 226.67±152.87 days before testing, and testing was performed while taking HM. In contrast, the Neg group had taken HM for 147.6±23.49 days and had 5.4±1.50 days of withdrawal period before the test following instructions of Korean medicine doctors. All adverse events (AEs) were moderate in severity, and the number of occurrences was similar: 5 in the FP IA group and 7 in the Neg group. AEs included constipation, insomnia (3 cases each), and palpitations (2 cases). The results of this study show that ES-induced FP IA can be resolved with withdrawal instructions and ES can be safely prescribed and administered by Korean medicine doctors. Further studies are needed to determine how to prevent FP IA after taking ES.

• The Journal of Korean Society for Radiation Therapy
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• v.34
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• pp.21-30
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• 2022

Purpose: The purpose of this study is to evaluate the effectiveness of oral positioning stent, the BinkieRT^TM in radiation treatment for head and neck cancer patients in terms of tongue positions reproducibility, tongue doses and material properties. Materials and Methods: 24 cases using BinkieRT^TM during radiation treatments were enrolled. The tongue was contoured on planning CT and CBCT images taken every 3 days during treatment, and then the DSC and center of tongue shift values were analyzed to evaluate the reproducibility of the tongue. The tongue dose was compared in terms of dose distribution when using BinkieRT^TM and different type of oral stents (mouthpiece, paraffin wax). Randomly selected respective 10 patients were measured tongue doses of initial treatment plan for nasal cavity and unilateral parotid cancer. Finally, In terms of material evaluation, HU and relative electron density were identified in RTPS. Results: As a result of DSC analysis, it was 0.8 ± 0.07, skewness -0.8, kurtosis 0.61, and 95% CI was 0.79~0.82. To analyze the deviation of the central tongue shift during the treatment period, a 95% confidence interval for shift in the LR, SI, and AP directions were indicated, and a one-sample t-test for 0, which is an ideal value in the deviation(n=144). As a result of the t-test, the mean and SD in the LR and SI directions were 0.01 ± 0.14 cm (p→.05), 0.03 ± 0.25 cm (p→.05), and -0.08 ± 0.25 cm (p ←.05) in the AP direction. In the case of unilateral parotid cancer patients, the Dmean to the tongue of patients using BinkieRT^TM was 16.92% ± 3.58% compared to the prescribed dose, and 23.99% ± 10.86% of patients with Paraffin Wax, indicating that the tongue dose was relatively lower when using BinkieRT^TM (p←.05). On the other hand, among nasal cavity cancer patients, the Dmean of tongue dose for patients who used BinkieRT^TM was 4.4% ± 5.6%, and for those who used mouthpiece, 5.9% ± 6.8%, but it was not statistically significant (p→.05). The relative electron density of Paraffin Wax, BinkieRT^TM and Putty is 0.94, 0.99, 1.26 and the mass density is 0.95, 0.99 and 1.32 (g/cc), Transmission Factor is 0.99, 0.98, 0.96 respectively. Conclusion: The result of the tongue DSC analysis over the treatment period was about 0.8 and Deviation of the center of tongue shifts were within 0.2 cm, the reproducibility was more likely excellent. In the case of unilateral head and neck cancer patients, it was found that the use of BinkieRT^TM rather than Paraffin Wax or Putty can reduce the unnecessary dose irradiated to the tongue. This study might be useful to understand of BinkieRT^TM's properties and advantages. And also it could be another considered option as oral stent to keep the reproducibility of tongue and reducing dose during head and neck radiation treatments.