UI14SDF100CW is a chewable tablet of sildenafil citrate, which was developed to improve compliance through convenience of administration. The purpose of this study was to compare the pharmacokinetic (PK) properties of sildenafil citrate chewable tablets (UI14SDF100CW) and conventional sildenafil citrate film-coated tablets ($Viagra^{(R)}$, Pfizer). A randomized, open-label, single dose, two-treatment, two-period, two-way crossover study was conducted in 60 healthy male volunteers. In each period, the subjects received a single oral dose of UI14SDF100CW or $Viagra^{(R)}$ (both tablets contain 140.45 mg of sildenafil citrate, which is equivalent to 100 mg of sildenafil). Serial blood samples were collected up to 24 h post-dose for PK analysis. The plasma concentration of sildenafil was determined using a validated HPLC-MS/MS assay. PK parameters of sildenafil were calculated using non-compartmental methods. The plasma concentration-time profiles of sildenafil in both formulations were similar. For UI14SDF100CW, the $C_{max}$ and $AUC_{last}$ of sildenafil were $1068.69{\pm}458.25$ (mean${\pm}$standard deviation) mg/L and $3580.59{\pm}1680.29h{\cdot}mg/L$, and the corresponding values for $Viagra^{(R)}$ were $1146.84{\pm}501.70mg/L$ and $3406.35{\pm}1452.31h{\cdot}mg/L$, respectively. The geometric mean ratios (90% confidence intervals) of UI14SDF100CW to $Viagra^{(R)}$ for $C_{max}$ and $AUC_{last}$ were 0.933 (0.853-1.021) and 1.034 (0.969-1.108), respectively, which met the bioequivalence criteria of Korean regulatory agency. In conclusion, UI14SDF100CW and $Viagra^{(R)}$ showed similar PK properties. Therefore, UI14SDF100CW can be an alternative to sildenafil for the treatment of erectile dysfunction, providing better compliance.
Nam, Ji Won;Jung, Na Young;Park, Eun Suk;Kwon, Soon Chan
Journal of Korean Neurosurgical Society
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v.64
no.5
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pp.732-739
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2021
Objective : Early successful reperfusion is associated with favorable outcomes in acute ischemic stroke (AIS). The purpose of this study was to achieve successful recanalization by a combined mechanical thrombectomy technique, the Aspiration-Retriever Technique for Stroke (ARTS), which is composed of a flexible large lumen distal access catheter and a retrievable stent as the first-line strategy of mechanical thrombectomy. Methods : We retrospectively reviewed 62 patients with AIS who underwent mechanical thrombectomy from 2018 to 2019 at our institute by a senior neurointerventionalist. Among them, patients who were treated using the ARTS technique with the soft torqueable catheter optimized for intracranial access (SOFIA®; MicroVention-Terumo, Tustin, CA, USA) as the first-line treatment were included. Patients who had tandem occlusions or underlying intracranial artery stenosis were excluded. The angiographic and clinical outcomes were evaluated. The angiographic outcome was analyzed by the rate of successful recanalization, defined as a Thrombolysis in Cerebral Infarction score of 2b or 3 at the end of all procedures and the rate of successfully achieving the first pass effect (FPE), defined as complete recanalization with a single pass of the device. The clinical outcomes included the National Institutes of Health Stroke Scale (NIHSS) score, modified Rankin Scale (mRS), and mortality. Results : A total of 27 patients (mean age, 59.3 years) fulfilled the inclusion criteria. The successful recanalization rate was 96% (n=26) while the FPE rate was 41% (n=11). The mean post-procedural NIHSS change was -3.0. Thirteen patients (48%) showed good clinical outcomes after thrombectomy with the ARTS technique (mRS at 90 days ≤2). Postoperative complications occurred in seven of 25 patients : hemorrhagic transformation in six patients (22%) and distal embolization in one patient (4%). Mortality was 15% (n=4). Conclusion : Although the clinical outcomes using the ARTS technique with a flexible large lumen distal access catheter performed as the frontline thrombectomy in patients with AIS were not significantly superior than those of other studies, this study showed a high rate of successful endovascular recanalization which was comparable to that of other studies. Therefore, ARTS using the SOFIA® catheter can be considered as the first choice of treatment for AIS due to large vessel occlusion.
Woo Kyoung Jeong;Hyo-Jin Kang;Sang Hyun Choi;Mi-Suk Park;Mi Hye Yu;Bohyun Kim;Myung-Won You;Sanghyeok Lim;Young Seo Cho;Min Woo Lee;Jeong Ah Hwang;Jae Young Lee;Jung Hoon Kim;Ijin Joo;Jae Seok Bae;So Yeon Kim;Yong Eun Chung;Dong Hwan Kim;Jeong Min Lee
Korean Journal of Radiology
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v.24
no.6
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pp.482-497
/
2023
Sonazoid, a second-generation ultrasound contrast agent, was introduced for the diagnosis of hepatic nodules. To clarify the issues with Sonazoid contrast-enhanced ultrasonography for the diagnosis of hepatocellular carcinoma (HCC), the Korean Society of Radiology and Korean Society of Abdominal Radiology collaborated on the guidelines. The guidelines are de novo, evidence-based, and selected using an electronic voting system for consensus. These include imaging protocols, diagnostic criteria for HCC, diagnostic value for lesions that are inconclusive on other imaging results, differentiation from non-HCC malignancies, surveillance of HCC, and treatment response after locoregional and systemic treatment for HCC.
Objective: Laser ablation is a therapeutic modality used to reduce the volume of large benign thyroid nodules. Unsatisfactory reduction and regrowth are observed in some treated nodules. The aim of the study was to evaluate the long-term outcomes of laser treatment for solid nodules during a 5-year follow-up period, the regrowth rate, and the predictive risk factors of nodule regrowth. Materials and Methods: We retrospectively evaluated patients with benign, solid, cold thyroid nodules who underwent laser ablation and were followed-up for 5 years. According to the selection criteria, 104 patients were included (median baseline nodule volume, 12.5 mL [25.0-75.0%, 8-18 mL]; median energy delivered, 481.5 J/mL [25.0-75.0%, 370-620 J/mL]). Nodule volume, thyroid function test results, and ultrasound were evaluated at baseline and then annually after the procedure. Results: Of 104 patients, 31 patients (29.8%) had a 12-month volume reduction ratio (VRR) < 50.0% and 39 (37.5%) experienced nodule regrowth. Of these 39 patients, 17 (43.6%) underwent surgery and 14 (35.9%) underwent a second laser treatment. The rate of nodule regrowth was inversely related to the 12-month VRR, i.e., the lower the 12-month VRR, the higher the risk of regrowth (p < 0.001). The mean time for nodule regrowth was 33.5 ± 16.6 months. The 12-month VRR was directly related to time to regrowth, i.e., the lower the 12-month VRR, the shorter the time to regrowth (p < 0.001; R2 = 0.3516). Non-spongiform composition increased the risk of regrowth with an odds ratio of 4.3 (95% confidence interval [CI] 1.8-10.2; p < 0.001); 12-month VRR < 50.0% increased the risk of regrowth with an odds ratio of 11.7 (95% CI 4.2-32.2; p < 0.001). Conclusion: The VRR of thyroid nodules subjected to similar amounts of laser energy varies widely and depends on the nodule composition; non-spongiform nodules are reduced to a lesser extent and regrow more frequently than spongiform nodules. A 12-month VRR < 50.0% is a predictive risk factor for regrowth and correlates with the time to regrowth.
Multiple myeloma (MM) is a malignant hematologic disease caused by the proliferation of clonal plasma cells in the bone marrow, and its incidence is increasing in Korea. With the development of treatments for MM, the need for early diagnosis and treatment has emerged. In recent years, the International Myeloma Working Group (IMWG) has been constantly revising the laboratory and radiological diagnostic criteria for MM. In addition, as whole-body MRI (WBMR) has been increasing used in the diagnosis and treatment response evaluation of patients with MM, the Myeloma Response Assessment and Diagnosis System (MY-RADS) was created to standardize WBMR image acquisition techniques, image interpretation, and response evaluation methods. Radiologists need to have a detailed knowledge of the features of MM for accurate diagnosis. Thus, in this review article, we describe the imaging method for MM according to the latest IMWG guidelines as well as the image acquisition and response evaluation technique for WBMR according to MY-RADS.
Lee, Chang Yeol;Kim, Woo Chul;Kim, Hun Jeong;Park, Jeong Hoon;Min, Chul Kee;Shin, Dong Oh;Choi, Sang Hyoun;Park, Seungwoo;Huh, Hyun Do
Progress in Medical Physics
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v.26
no.3
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pp.127-136
/
2015
The purpose of this study is to perform a dosimetric evaluation of amplitude-based respiratory gating for the delivery of volumetric modulated arc therapy (VMAT). We selected two types of breathing patterns, subjectively among patients with respiratory-gated treatment log files. For patients that showed consistent breathing patterns (CBP) relative to the 4D CT respiration patterns, the variability of the breath-holding position during treatment was observed within the thresholds. However, patients with inconsistent breathing patterns (IBP) show differences relative to those with CBP. The relative isodose distribution was evaluated using an EBT3 film by comparing gated delivery to static delivery, and an absolute dose measurement was performed with a $0.6cm^3$ Farmer-type ion chamber. The passing rate percentages under the 3%/3 mm gamma analysis for Patients 1, 2 and 3 were respectively 93.18%, 91.16%, and 95.46% for CBP, and 66.77%, 48.79%, and 40.36% for IBP. Under the more stringent criteria of 2%/2 mm, passing rates for Patients 1, 2 and 3 were respectively 73.05%, 67.14%, and 86.85% for CBP, and 46.53%, 32.73%, and 36.51% for IBP. The ion chamber measurements were within 3.5%, on average, of those calculated by the TPS and within 2.0%, on average, when compared to the static-point dose measurements for all cases of CBP. Inconsistent breathing patterns between 4D CT simulation and treatment may cause considerable dosimetric differences. Therefore, patient training is important to maintain consistent breathing amplitude during CT scan acquisition and treatment delivery.
Background : This study aimed to estimate the clinical outcome and identify the characteristics of a group of patients with pulmonary tuberculosis who completed anti-tuberculosis therapy with the First-line drugs in spite of having positive smear results with negative sputum culture results over the previous six months. Method : A retrospective chart review of 21 patients who fulfilled the above criteria between 1995 and 1999 was performed. The laboratory data as well as the clinical data of the patients with positive smear results and negative culture results over a six months period were reviewed. Results : The negative conversion of sputum culture results was achieved within $1.3{\pm}1.2$ months and the negative conversion of the sputum smear results was accomplished during $9.5{\pm}3.3$ months. Chest X-rays at 5 months following the institution of anti-tuberculosis therapy from all patients revealed improvements. Four out of 21 patients(19%) relapsed during the follow up, $15.2{\pm}13.4$ months after administering anti-tuberculosis therapy for $13.3{\pm}3.1$ months. Relapses were confirmed from between 3 months and 4 months after the treatment completion. Only one of the four relapses had no past history of anti-tuberculosis therapy and the others had prior treatment twice (p<0.01). The period of anti-tuberculosis treatment was extended to a mean of $4.6{\pm}2.6$ months in 12 patients. However, prolongation of anti-tuberculosis therapy had no affect on the relapse rate (odds ratio, 95% CI 0.18, 2.15). Conclusion : Prolongation of therapy with the First-line drugs is not necessary for patients with persistently positive smear results over 6 months and negative culture results. A patient who has had prior anti-tuberculosis therapy more than twice should be paid the closest attention.
Purpose: SLE (systemic lupus erythematosus) is an inflammatory autoimmune disease, characterized by various autoantibody. The detection of Anti double-stranded DNA (Anti-ds DNA) is important in the diagnostics of SLE, and include the American College of Rheumatology (ACR) diagnostic criteria for SLE. Also SLE disease activity and correlativity with the level Anti-ds DNA antibody have been reported and Anti-ds DNA antibody quantitative test is very useful for tracing before and after SLE treatment. When These Anti-ds DNA antibody test (Farr assay: $^{125}I$ labeled ds-DNA and bound Anti-ds DNA antibodies complex in serum is precipitated by ammonium sulfate and used to centrifugation, measured it) inhaled supernatant after centrifugation, a lipemic specimen does not facilitate the formation of precipitate and also occurs situation was inhaled with precipitate. To solve these problems, The Influence of the degree of lipemic specimen was evaluated. Materials and Methods: September 2012 to February 2013, We selected lipemic samples (n=81) of specimen commissioned by Anti-ds DNA antibody test. Lipemic samples were done pre-treatment (high-speed centrifugation: 14,000 rpm 5 mins) used a micro-centrifuge (Eppendorf Model 5415D). At the same time lipemic specimen and pre-treatment samples were performed Anti-ds DNA antibody test (Anti-ds DNA kit, Trinity Biotech, Ireland). Statistical analysis were analyzed Pearson's correlation coefficients and regression and paired t-test, and Difference (%). Results: Experimental group 1 (Lipemic Specimen Anti-ds DNA Ab concentration ${\leq}7IU/mL$) at y=0.368X+4.732, $R^2=0.023$, Pearson's correlation coefficient was 0.154, paired t-test (P=0.003), Difference (%) mean 65.7 and showed a statistically significant difference. Experimental group 2 (Lipemic Specimen Anti-ds DNA Ab concentration ${\geq}8IU/mL$) at y=0.983X+0.298, $R^2=0.994$, Pearson's correlation coefficient showed 0.997, paired t-test (P=0.181), Difference (%) mean -5.53 made no statistically significant difference. Conclusion: Lipemic sample of low Anti-ds DNA Ab concentration (2.5-7 IU/mL) and the result is obtained pre-treatment (high-speed centrifugation: 14,000 rpm 5 mins) were made a significant difference statistically. Anti-ds DNA is one of the primary auto-antibodies present in patients with SLE, and remain an important diagnostic test for SLE. Therefore, we recommend preprocessing (high-speed centrifugation: 14,000 rpm 5 mins) in order to exclude the influence of lipemic specimen.
Journal of the Korea Academia-Industrial cooperation Society
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v.17
no.4
/
pp.34-42
/
2016
In order to prepare for the type approval test for the United States Coast Guard (USCG) Phase-II of Ballast Water Treatment System (BWTS), a phytoplankton mass culture was conducted in a mesocosm enclosure. We evaluated the response of the phytoplankton community after nutrient addition (+N, +P, and +NP) and investigated the development of the species with increasing culture time. After nutrient dosing, the phytoplankton population significantly (p < 0.05) increased from day 1 to day 3, depending on the nutrient treatments In particular, the specific growth rate of the phytoplankton community in the case of +NP treatment and + N treatment were estimated to be $2.47d^{-1}$ and $1.98d^{-1}$, respectively. The phytoplankton population density in the case of + NP treatment was approximately 50 times higher than that of the control group, suggesting that these treatments could be useful for mass culturing phytoplankton (> 75% of natural community) for the approval regulation of USCG Phase-II. In the phytoplankton community of the mesocosm, Pseudo-nitzchia spp. dominated in the logarithmic growth phase. The cell density decreased significantly (p < 0.05) with increasing time, coinciding with the nutrient limitation. At that time, the dominance of Pseudo-nitzchia spp. shifted to that of Cylindrotheca closterium. Therefore, the optimum nutrient concentration ($N:30{\mu}M$, $P:3{\mu}M$) and reasonable harvesting time (after 3 days in summer) found in this study for the mass culturing of phytoplankton may be helpful to meet the USCG Phase-II biological criteria to be used in BWTS.
Shin, Hyun Suk;Kim, Mi Eun;Kim, Jae Moon;Jang, Jong Kyung
Journal of Korea Water Resources Association
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v.46
no.12
/
pp.1193-1207
/
2013
Increase of impervious area caused by overdevelopment has led to increase of runoff and then the problem of flooding and NPS were brought up. In addition, as decrease of base flow made groundwater level to decline, a stream that dries up is issued. low impact development (LID) method which is possible to mimic hydrological water cycle, minimize the effect of development, and improve water cycle structure is proposed as an alternative. As introduction of LID in domestic increases, the study on small watershed is in process mainly. Also, analysis of property of hydrological runoff and load on midsize watershed, like sewage treatment district, is required, the study on it is still insufficient. So, area applying LID practices from watershed of Dongrae stream is pinpointed and made the ratio and then expand it to watershed of Oncheon stream. Among low impact development practices, Green Roof, Porous Pavement, and Bio- retention are selected for the application considering domestic situations and simulated with SWMM-LID model of each watershed and improvement of water cycle and reduction of non-point pollution loads was analysed. Improvement of water cycle and reduction of non-point pollution loads were analyzed including the property of rainfall and soil over long term simulation. The model was executed according to scenario based on combination of LID as changing conductivity in accordance with soil type of the watershed. Also, this study evaluated area of LID application that meets the efficiency of conventional management as a criteria for area of LID practices applying to sewer treatment district by comparing the efficiency of LID application with that of conventional method.
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