• Journal of Gastric Cancer
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• v.24 no.3
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• pp.327-340
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• 2024

Purpose: Results of initial endoscopic biopsy of gastric lesions often differ from those of the final pathological diagnosis. We evaluated whether an artificial intelligence-based gastric lesion detection and diagnostic system, ENdoscopy as AI-powered Device Computer Aided Diagnosis for Gastroscopy (ENAD CAD-G), could reduce this discrepancy. Materials and Methods: We retrospectively collected 24,948 endoscopic images of early gastric cancers (EGCs), dysplasia, and benign lesions from 9,892 patients who underwent esophagogastroduodenoscopy between 2011 and 2021. The diagnostic performance of ENAD CAD-G was evaluated using the following real-world datasets: patients referred from community clinics with initial biopsy results of atypia (n=154), participants who underwent endoscopic resection for neoplasms (Internal video set, n=140), and participants who underwent endoscopy for screening or suspicion of gastric neoplasm referred from community clinics (External video set, n=296). Results: ENAD CAD-G classified the referred gastric lesions of atypia into EGC (accuracy, 82.47%; 95% confidence interval [CI], 76.46%-88.47%), dysplasia (88.31%; 83.24%-93.39%), and benign lesions (83.12%; 77.20%-89.03%). In the Internal video set, ENAD CAD-G identified dysplasia and EGC with diagnostic accuracies of 88.57% (95% CI, 83.30%-93.84%) and 91.43% (86.79%-96.07%), respectively, compared with an accuracy of 60.71% (52.62%-68.80%) for the initial biopsy results (P<0.001). In the External video set, ENAD CAD-G classified EGC, dysplasia, and benign lesions with diagnostic accuracies of 87.50% (83.73%-91.27%), 90.54% (87.21%-93.87%), and 88.85% (85.27%-92.44%), respectively. Conclusions: ENAD CAD-G is superior to initial biopsy for the detection and diagnosis of gastric lesions that require endoscopic resection. ENAD CAD-G can assist community endoscopists in identifying gastric lesions that require endoscopic resection.

• Journal of Distribution Science
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• v.12 no.4
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• pp.23-30
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• 2014

Purpose - The purpose of this study is to analyze the efficiency of retail businesses by dividing domestic retailers into discount stores, super supermarkets (SSMs), and department stores. It suggests retail-business investment strategies by using data environment analysis (DEA) to analyze how input elements such as store area, parking lot area, number of employees, and sales management expenses for the convenience of customers positively affect business performance measurements such as sales and visiting customers per day. Research Design, Data, and Methodology - The DEA model calculates a ratio of the weighted mean of various inputs to the weighted mean of various outputs and measures the efficiency of a specific decision making unit (DMU). The study included 19 companies (five discount store DMUs, ten SSM DMUs, and four department store DMUs). Because the business elements and sizes of retail store DMUs used in this analysis are different, average per-store input and output variables were used. Data were collected from "The Yearbook of Retail Industry in Korea (2012)." DEA analysis was used to determine differences in efficiency among discount stores, SSMs, and department stores in terms of the business elements of each retail business. It was also used to determine what business elements were excessively invested in by comparing and analyzing efficiency by business elements using SPSS software's ANOVA (Analysis of Variance). Results - The CCR and BCC efficiency analysis found that the efficiency of discount stores is low. We believe that the saturation state of discount stores is a major factor. The ANOVA analysis confirms the VRS hypothesis with a statistically significant difference among the three groups, based on an analysis confidence interval of 95%. CRS and SE were not found to be significantly different among the three groups. As for the post hoc test, which concretely shows differences by group, the Scheffe's multiple comparison analysis test found the average differences between group 1 (discount stores) and group 2 (SSM) to be statistically significant. Conclusions - The DEA efficiency analysis implies that investment in input elements, including store area, parking lot area, and sales management expenses, were excessive in the case of discount stores, while SSMs need to invest more in promotion activities such as gifts, events, and coupons for customer management. Department stores have found that small companies invest excessively in input elements. Department stores need to invest in differentiated shopping mall complexes. This study was limited in acquiring statistical data; various input variables which might have shown more secure customer management and promotional expenses could not be applied. As the study was limited in various aspects of the efficiency analyses because financial analyses of the companies and of causal relationships, including satisfaction and loyalty of visiting customers, were not done, these aspects will be examined in the next study.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.11
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• pp.5427-5432
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• 2012

Background and Purpose: Ovarian cancer is the leading cause of death among gynecologic cancers because of the lack of effective early detection methods. Accuracies of the human epididymis protein 4 (HE4) and mesothelin in detecting ovarian cancer have never been systematically assessed. The current systematic review aimed to tackle this issue. Methods: MEDLINE, EMBASE, and Cochrane databases were searched (September 1995-November 2011) for studies on the diagnostic performances of HE4 and mesothelin in differentiating ovarian cancer from other benign gynecologic diseases. QUADAS items were used to evaluate the qualities of the studies. Meta-DiSc software was used to handle data from the included studies and to examine heterogeneity. All included studies for diagnostic performance were combined with sensitivity, specificity, positive likelihood ratio (PLR), negative likelihood ratio (NLR), diagnostic odds ratios (DORs) with 95% confidence intervals (CIs), summary receiver operating characteristic (SROC) curves, and areas under the SROC curves (AUC). Results: A total of 18 studies and 3,865 patients were eligible for the final analysis. The pooled sensitivity estimates for HE4 (74.4%) were significantly higher than those for mesothelin (49.3%). The pooled specificity estimates for mesothelin (94.5%) were higher than those for HE4 (85.8%). The pooled DOR estimates for HE4 (26.22) were higher than those for mesothelin (24.01). The SROC curve for HE4 showed better diagnostic accuracy than that for mesothelin. The PLR and NLR of HE4 were 6.33 (95% CI: 3.58 to 11.18) and 0.27 (95% CI: 0.21 to 0.34), respectively. The PLR and NLR for mesothelin were 11.0 (95% CI: 6.21 to 19.59) and 0.51 (95% CI: 0.42 to 0.62), respectively. The combination of the two tumor markers or their combination with CA-125 increased sensitivity and specificity to different extents. Conclusion: The diagnostic accuracy of HE4 in differentiating ovarian cancer from other benign gynecologic diseases is better than that of soluble mesothelin-related protein. Combinations of two or more tumor markers show more sensitivity and specificity.

• Journal of Pharmaceutical Investigation
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• v.36 no.2
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• pp.137-142
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• 2006

A bioequivalence of Daewoong $Alendronate^{TM}$ (Daewoong Pharmaceutical Co., Ltd., Korea) and $Fosamax^{TM}$ tablets (MSD Korea) was evaluated according to the guideline of Korea Food and Drug Administration (KFDA). A single 70 mg dose of sodium alendronate of each medicine was administered orally to 56 healthy male volunteers. This study was performed in a $2\;{\time}\;2$ crossover design. Concentrations of alendronate in the urine were monitored by a high-performance liquid chromatography (HPLC). $A_{et}$ (cumulative urinary excreted amount from time 0 to last sampling interval) was calculated by the accumulation of the urinary excreted alendronate. $U_{max}$ (maximum urinary excretion rate) and $T_{max}$ (time to reach $U_{max}$) were compiled from the urinary excretion rate - time data. Analysis of variance was performed using logarithmically transformed $A_{et}$ and $U_{max}$. No significant sequence effect was found for all of the bioavailability parameters. The 90% confidence intervals of the $A_{et}$ and $U_{max}$ for Daewoong $Alendronate^{TM}/Fosamax^{TM}$ were 0.89-1.12 and 0.82-1.02, respectively. This study demonstrated the bioequivalence of Daewoong $Alendronate^{TM}$ and $Fosamax^{TM}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.34 no.3
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• pp.209-214
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• 2004

A bioequivalence study of $Roxithrin^{TM}$ tablet (Kukje Pharma. Ind. Co., Ltd.) to $Rulid^{TM}$ tablet (Han Dok Pharma. Ind. Co., Ltd.) was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the roxithromycin dose of 300 mg in a $2{\times}2$ crossover study. There was a one-week wash-out period between the doses. Plasma concentrations of roxithromycin were monitored by a high-performance liquid chromatography for over a period of 36 hours after drug administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 36 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the cross-over design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Roxithrin^{TM}/Rulid^{TM}$ were 1.00 - 1.13 and 0.98 - 1.10, respectively. These values were within the acceptable bioequivalence intervals of 0.80 - 1.25. Thus, our study demonstrated the bioequivalence of $Roxithrin^{TM}$ and $Rulid^{TM}$ with respect to the rate and extent of absorption.

• Journal of Pharmaceutical Investigation
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• v.34 no.6
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• pp.505-511
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• 2004

A bioequivalence study of $Bestidine^{TM}$ tablets (Choong Wae Pharma. Corp., Korea) to Dong-A $Gaster^{TM}$ (Dong-A Pharmaceutical Co., Ltd., Korea) tablets was conducted according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty four healthy male Korean volunteers received each medicine at the famotidine dose of 40 mg in a $2{\times}2$ crossover study. There was a one-week wash out period between the doses. Plasma concentrations of famotidine were monitored by a high-performance liquid chromatography for over a period of 12 hours after the administration. $AUC_t$ (the area under the plasma concentration-time curve from time zero to 12 hr) was calculated by the linear trapezoidal rule method. $C_{max}$ (maximum plasma drug concentration) and $T_{max}$ (time to reach $C_{max}$) were compiled from the plasma concentration-time data. Analysis of variance was carried out using logarithmically transformed $AUC_t$ and $C_{max}$. No significant sequence effect was found for all of the bioavailability parameters indicating that the crossover design was properly performed. The 90% confidence intervals of the $AUC_t$ ratio and the Cmax ratio for $Bestidine^{TM}/Gaster^{TM}$ were log 0.90-log 1.06 and log 0.98-log 1.20, respectively. These values were within the acceptable bioequivalence intervals of 0.80-1.25. Thus, our study demonstrated the bioequivalence of $Bestidine^{TM}$ and $Gaster^{TM}$ with respect to the rate and extent of absorption.

• Journal of Korean Neurosurgical Society
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• v.65 no.2
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• pp.287-296
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• 2022

Objective : Although radiotherapy (RT) is recommended for multiple myeloma (MM) involving spine, the treatment of choice between reconstructive surgery with RT and RT alone for pathologic vertebral fractures (PVFs) associated with structural instability or neurologic compromises remains controversial. The purpose of this study was to evaluate the clinical efficacies of reconstructive surgery with adjuvant RT for treatment of MM with PVFs by comparing with matched cohorts treated with RT alone. Methods : Twenty-eight patients underwent reconstructive surgery followed by RT between 2008 and 2015 in a single institution, for management of PVFs associated with structural instability of the spine and/or neurologic compromises (group I). Twenty-eight patients were treated with RT alone (group II) after propensity score matching in a 1-to-1 format based on instability of the spine, as well as age and performance. Clinical outcomes including the overall survival rates, duration of independent ambulation, neurological status, and numeric rating scale (NRS) for back pain were compared. Results : Clinical and radiological features before treatment were similar in both groups. The median survival period was similar between the two groups. However, the mean duration of independent ambulation was significantly longer in group I (88.8 months; 95% confidence interval [CI], 66.0-111.5) than in group II (39.4 months; 95% CI, 25.2-53.6) (log rank test; p=0.022). Deterioration of Frankel grade (21.4% vs. 60.7%, p=0.024) and NRS for back pain (2.7±2.2 vs. 5.0±2.7, p=0.000) at the last follow-up were higher in the group II. Treatment-related complications were similar in both groups. Conclusion : In patients with unstable PVFs due to MM, reconstructive surgery may yield superior clinical outcomes compared with RT alone in maintaining independent ambulation and neurological status, as well as pain control despite similar median survival and complications.

• Korean Journal of Radiology
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• v.22 no.6
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• pp.867-879
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• 2021

Objective: To compare the screening performance of diffusion-weighted (DW) MRI and combined mammography and ultrasound (US) in detecting clinically occult contralateral breast cancer in women with newly diagnosed breast cancer. Materials and Methods: Between January 2017 and July 2018, 1148 women (mean age ± standard deviation, 53.2 ± 10.8 years) with unilateral breast cancer and no clinical abnormalities in the contralateral breast underwent 3T MRI, digital mammography, and radiologist-performed whole-breast US. In this retrospective study, three radiologists independently and blindly reviewed all DW MR images (b = 1000 s/mm² and apparent diffusion coefficient map) of the contralateral breast and assigned a Breast Imaging Reporting and Data System category. For combined mammography and US evaluation, prospectively assessed results were used. Using histopathology or 1-year follow-up as the reference standard, cancer detection rate and the patient percentage with cancers detected among all women recommended for tissue diagnosis (positive predictive value; PPV2) were compared. Results: Of the 30 cases of clinically occult contralateral cancers (13 invasive and 17 ductal carcinoma in situ [DCIS]), DW MRI detected 23 (76.7%) cases (11 invasive and 12 DCIS), whereas combined mammography and US detected 12 (40.0%, five invasive and seven DCIS) cases. All cancers detected by combined mammography and US, except two DCIS cases, were detected by DW MRI. The cancer detection rate of DW MRI (2.0%; 95% confidence interval [CI]: 1.3%, 3.0%) was higher than that of combined mammography and US (1.0%; 95% CI: 0.5%, 1.8%; p = 0.009). DW MRI showed higher PPV2 (42.1%; 95% CI: 26.3%, 59.2%) than combined mammography and US (18.5%; 95% CI: 9.9%, 30.0%; p = 0.001). Conclusion: In women with newly diagnosed breast cancer, DW MRI detected significantly more contralateral breast cancers with fewer biopsy recommendations than combined mammography and US.

• Korean Journal of Radiology
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• v.24 no.11
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• pp.1142-1150
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• 2023

Objective: To evaluate ^99mtechnetium-three polyethylene glycol spacers-arginine-glycine-aspartic acid (^99mTc-3PRGD₂) single-photon emission computed tomography (SPECT)/computed tomography (CT) imaging for diagnosing lymph node metastasis of primary malignant lung neoplasms. Materials and Methods: We prospectively enrolled 26 patients with primary malignant lung tumors who underwent ^99mTc-3PRGD₂ SPECT/CT and ¹⁸F-fluorodeoxyglucose (¹⁸F-FDG) positron emission tomography (PET)/CT imaging. Both imaging methods were analyzed in qualitative (visual dichotomous and 5-point grades for lymph nodes and lung tumors, respectively) and semiquantitative (maximum tissue-to-background radioactive count) manners for the lymph nodes and lung tumors. The performance of the differentiation of lymph nodes with and without metastasis was determined at the per-lymph node station and per-patient levels using histopathological results as the reference standard. Results: Total 42 stations had metastatic lymph nodes and 136 stations had benign lymph nodes. The differences between metastatic and benign lymph nodes in the visual qualitative and semiquantitative analyses of ^99mTc-3PRGD₂ SPECT/CT and ¹⁸F-FDG PET/CT were statistically significant (all P < 0.001). The area under the receiver operating characteristic curve (AUC) in the semi-quantitative analysis of ^99mTc-3PRGD₂ SPECT/CT was 0.908 (95% confidence interval [CI], 0.851-0.966), and the sensitivity, specificity, positive predictive value, and negative predictive value were 0.86 (36/42), 0.88 (120/136), 0.69 (36/52), and 0.95 (120/126), respectively. Among the 26 patients (including two patients each with two lung tumors), 15 had pathologically confirmed lymph node metastasis. The difference between primary lung lesions in patients with and without lymph node metastasis was statistically significant only in the semi-quantitative analysis of ^99mTc-3PRGD₂ SPECT/CT (P = 0.007), with an AUC of 0.807 (95% CI, 0.641-0.974). Conclusion: ^99mTc-3PRGD₂ SPECT/CT imaging may notably perform in the direct diagnosis of lymph node metastasis of primary malignant lung tumors and indirectly predict the presence of lymph node metastasis through uptake in the primary lesions.

• Journal of Pharmaceutical Investigation
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• v.38 no.4
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• pp.269-275
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• 2008

The purpose of the present study was to evaluate the bioequivalence of two levofloxacin tablets, Jeil $Cravit^{TM}$ tablet (Jeil Pharm. Co., Ltd., Korea, reference drug) and $Lesacin^{TM}$ tablet (Ilhwa. Co., Ltd., Korea, test drug), according to the guidelines of Korea Food and Drug Administration (KFDA). Twenty-four healthy male Korean volunteers received two tablets containing levofloxacin 200 mg in a $2{\times}2$ crossover study. There was a one-week washout period between the doses. Plasma concentrations of levofloxacin were monitored for over a period of 24 hr after administration by using a high performance liquid chromatography-tandem mass spectrometry (LC-MS/MS). The area under the plasma concentration-time curve from time zero to 24 hr ($AUC_t$), maximum plasma drug concentration ($C_{max}$) and time to reach $C_{max}\;(T_{max})$ were complied from the plasma concentration-time data. Analysis of variance (ANOVA) test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals of the $AUC_t$ ratio and the $C_{max}$ ratio for $Lesacin^{TM}$/Jeil $Cravit^{TM}$ were $\log\;0.9527{\sim}\log\;0.9981$ and $\log\;0.8712{\sim}\log\;1.0556$, respectively. These values were within the acceptable bioequivalence intervals of $\log\;0.80{\sim}\log\;1.25$, recommended by KFDA. In all of these results, we concluded that $Lesacin^{TM}$ tablet was bioequivalent to Jeil $Cravit^{TM}$ tablet, in terms of rate and extent of absorption.