• Journal of Gastric Cancer
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• v.19 no.4
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• pp.427-437
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• 2019

Purpose: We aimed to evaluate the clinical characteristics of microsatellite instability in early gastric cancer. Materials and Methods: The microsatellite instability status of resected early gastric tumors was evaluated using two mononucleotide repeat markers (BAT25 and BAT26) and three dinucleotide repeat markers (D5S346, D2S123, and D17S250). Tumors with instability in two or more markers were defined as microsatellite instability-high (MSI-H) and others were classified as microsatellite stable (MSS). Results: Overall, 1,156 tumors were included in the analysis, with 85 (7.4%) classified as MSI-H compared with MSS tumors. For MSI-H tumors, there was a significant correlation with the female sex, older age, tumor location in the lower gastric body, intestinal histology, lymphovascular invasion (LVI), and submucosal invasion (P<0.05). There was also a trend toward an association with lymph node (LN) metastasis (P=0.056). In mucosal gastric cancer, there was no significant difference in MSI status in tumors with LN metastasis or tumors with LVI. In submucosal gastric cancer, LVI was more frequently observed in MSI-H than in MSS tumors (38.9% vs. 25.0%, P=0.027), but there was no difference in the presence of LN metastases. The prognosis of MSI-H tumors was similar to that of MSS tumors (log-rank test, P=0.797, the hazard ratio for MSI-H was adjusted by age, sex, pT stage, and the number of metastatic LNs, 0.932; 95% confidence interval, 0.423-2.054; P=0.861). Conclusions: MSI status was not useful in predicting prognosis in early gastric cancer. However, the frequent presence of LVI in early MSI-H gastric cancer may help guide the appropriate treatment for patients, such as endoscopic treatment or limited LN surgical dissection.

• Journal of Pharmaceutical Investigation
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• v.32 no.1
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• pp.47-54
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• 2002

Cimetropium bromide, a quaternary ammonium compound which is chemically related to scopolamine, exhibits its antispasmodic activity by competing with acetylcholine for the muscarinic receptors of the smooth muscle of gastrointestinal tract. The drug has been used for the treatment of various disorders involving spasms of the musculature of the gastrointestinal, biliary and genitourinary tracts. The purpose of the present study was to evaluate the bioequivalence of two cimetropium bromide tablets, $Algiron^{TM}$ (Boehringer Ingelheim Korea Ltd.) and $Alpit^{TM}$ (Hana Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The cimetropium bromide release from the two cimetropium bromide tablets in vitro was tested using KP VII Apparatus II method with various different kinds of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty normal male volunteers, $25.25{\pm}2.10$ years in age and $65.76{\pm}6.39$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After three tablets containing 50 mg of cimetropium bromide per tablet were orally administered, blood was taken at predetermined time intervals and the concentrations of cimetropium bromide in serum were determined using HPLC method with UV detector. The dissolution profiles of two cimetropium bromide tablets were very similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t,\;C_{max}\;and\;T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using non-transformed and logarithmically transformed $AUC_t\;and\;C_{max}$. The results showed that the differences in $AUC_t,\;C_{max}\;and\;T_{max}$ between two tablets based on the $Algiron^{TM}$ were 2.19%, -5.97% and 3.49%, respectively. Minimum detectable differences $({\Delta})\;at \;{\alpha}=0.05\;and\;1-{\beta}=0.8$ were less than 20% (e.g., 13.71 %, 19.05% and 15.11% for $AUC_t,\;C_{max}\;and\;T_{max}$, respectively). The powers $(1-{\beta})\;at\;{\alpha}=0.05,\;{\Delta}=0.2\;for\;AUC_t$, $C_{max}\;and\;T_{max}$ were 97.79%, 83.22% and 95.60%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-5.84{\sim}10.21,\;-17.11{\sim}5.18\;and\;-5.35{\sim}12.33\;for\;AUC_t,\;C_{max}\;and\;T_{max}$, respectively). There were no sequence effect between two tablets in logarithmically transformed $AUC_t\;and\;C_{max}$. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., $0.94{\sim}1.10\;and\;0.85{\sim}1.05\;for\;AUC_t\;and\;C_{max}$, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that $Alpit^{TM}$ tablet is bioequivalent to $Algiron^{TM}$ tablet.

• Journal of Pharmaceutical Investigation
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• v.34 no.2
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• pp.139-145
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• 2004

The purpose of the present study was to evaluate the bioequivalence of two risperidone tablets, Risperdal (Janssen Korea Co., Ltd.) and Rispen (Myung In Pharm. Co., Ltd), according to the guidelines of Korea Food and Drug Administration (KFDA). The risperidone release from the two risperidone formulations in vitro was tested using KP VIII Apparatus II method with various of dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty four healthy male subjects, $23.33\;{\pm}2.10$ years in age and $69.24{\pm}8.05\;kg$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross over study was employed. After one tablet containing 2 mg as risperidone was orally administered, blood was taken at predetermined time intervals and the concentrations of risperidone in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$,$C_{max},\;and\;T_{max}$ were calculated and ANOVA test was utilized for the analysis of the parameters using logarithmically transformed $AUC_t$,$C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Risperdal were 0.20, -1.29 and -11-09% for $AUC_t$,$C_{max},\;and\;T_{max}$, respectively There were no sequence effects two formulations in parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g.,$log(0.90){\sim}log(1.30)$ and $log(0.84){\sim}log(1.09)$ for$AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Rispen tablet and Risperdal tablet were bioequivalent.

• Journal of Pharmaceutical Investigation
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• v.34 no.2
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• pp.147-153
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• 2004

The purpose of the present study was to evaluate the bioequivalence of two glimepiride tablets, $Amaryl^{\circledR}$ (Handok/Aventis Pharm. Co., Ltd.) and Glimed (Kuhn II Pharm. Co., Ltd.), according to the guidelines of Korea Food and Drug Administration (KFDA). The glimepiride release from the two glimepiride formulations in vitro was tested using KP VIII Apparatus II method with a variety of dissolution media (pH 1.2, 4.0, 6.8 buffer solution, water and blend of PSB 80 into each dissolution medium). Twenty six healthy male subjects, $22.65{\pm}2.19$ years in age and $66.55{\pm}8.85$ kg in body weight, were divided into two groups and a randomized $2\;{\times}\;2$ cross-over study was employed. After one tablet containing 2 mg as glimepiride was orally administered, blood was taken at predetermined time intervals and the concentrations of glimepiride in serum were determined using HPLC method with UV detector. The dissolution profiles of two formulations were similar at all dissolution media. Besides, the pharmacokinetic parameters such as $AUC_t$, $C_{max}$ and $T_{max}$ were calculated and ANOVA test was utilized for the statistical analysis of the parameters using logarithmically transformed $AUC_t$, $C_{max}$ and untransformed $T_{max}$. The results showed that the differences between two formulations based on the Amaryl were -3.70, -8.28 and 0.61% for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log(0.8) to log(1.25) (e.g., $log(0.84){\sim}log(1.04)$ for $log(0.82){\sim}log(1.03)$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA guideline for the bioequivalence were satisfied, indicating Glimed tablet and Amaryl tablet were bioequivalent.

• Development and Reproduction
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• v.14 no.3
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• pp.199-205
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• 2010

A neurotoxin, 6-hydroxydopamine (6-OHDA) has been widely used to create animal model for Parkinson's disease (PD). The present study was undertaken to examine whether depletion of brain dopamine (DA) stores with 6-OHDA can make alteration in the activities of the testicular steroidogenesis in adult rats. Young adult male rats (3 months old) were received a single dose of 6-OHDA (200 ${\mu}g$ in 10 ${\mu}{\ell}$/animal) by intracerebroventricular (icv) injection, and sacrificed after two weeks. The mRNA levels of steroidogenesis-related enzymes were measured by qRT-PCRs. Serum testosterone levels were measured by radioimmunoassay. Single icv infusion of 6-OHDA significantly decreased the mRNA levels of CYP11A1 (control:6-OHDA group=$1:0.68{\pm}0.14$ AU, p<0.05), CYP17 (control:6-OHDA group=$1:0.72{\pm}0.13$ AU, p<0.05). There were no changes in the mRNA levels of $3{\beta}$-HSD (control:6-OHDA group=$1:0.84{\pm}0.08$ AU) and $17{\beta}$-HSD (control: 6-OHDA group=$1:0.63{\pm}0.20$ AU), though the levels tended to be decreased in the 6-OHDA treated group. Administration of 6-OHDA decreased significantly the mRNA level of StAR when compared to the level of saline-injected control animals (control:6-OHDA group=$1:0.72{\pm}0.08$ AU, p<0.05). Treatment with single dose of 6-OHDA remarkably lowered serum testosterone levels compared to the levels of control group (control:6-OHDA group=$0.72{\pm}0.24:0.13{\pm}0.03ng/m{\ell}$, p<0.05). Taken together with our previous study, the present study demonstrated that the activities of hypothalamus-pituitary-testis hormonal axis could be negatively affected by blockade of brain DA biosynthesis, and suggested the reduced reproductive potential might be resulted in the animals. More precise information on the testicular steroidogenic activities in PD patients and PD-like animals should be required prior to the generalization of the sex steroid hormone therapy to meet the highest standards for safety and efficacy.

• Restorative Dentistry and Endodontics
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• v.35 no.2
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• pp.106-115
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• 2010

The purpose of this study was to evaluate the microtensile bond strength (${\mu}TBS$), failure modes and bonding interfaces of self-etching and three self-adhesive resin cements to dentin and indirect composite resin. Cylindrical composite blocks (Tescera, Bisco Inc.) were luted with resin cements (PA: Panavia F 2.0, Kuraray Medical Inc., RE: RelyX Unicem Clicker, 3M ESPE., MA: Maxem, Kerr Co., BI: BisCem, Bisco Inc.) on the prepared occlusal dentin surfaces of 20 extracted molars. After storage in distilled water for 24 h, $1.0\;mm\;{\times}\;1.0\;mm$ composite-dentin beams were prepared. ${\mu}TBS$ was tested at a cross-head speed of 0.5 mm/min. Data were analyzed with one-way ANOVA and Tukey's HSD test. Dentin sides of all fractured specimens and interfaces of resin cements-dentin or resin cements-composite were examined at FESEM (Field Emission-Scanning Electron Microscope). In conclusion, PA and RE showed higher bond strength and closer adaptation than MA and BI when indirect composite blocks were luted to dentin using a self-etching and three self-adhesive resin cements.

• Journal of Sericultural and Entomological Science
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• v.49 no.2
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• pp.67-70
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• 2007

This study was done for the dietary effect of silk protein, molecular controlled silk sericin and silk fibroin, on colon cancer of animal. The ICR mice were given weekly injections of 1,2-dimethylhydrazine (DMZ) for the initial 10 mg/kg with four weeks, and fed a diets supplemented with 3% (v/v) molecular controlled sericin and fibroin for 6 weeks, respectively. Then, the body weight, efficiency of dietary, typical histologic appearance of animal colon tissue and COX-2 effect were studied, too. Molecular controlled sericin protein are shown more higher dietary effect on animal colon cancer than fibroin supplemental case. The results suggest a potential usefulness of sericin as a chemopreventive for colon carcinogenesis and the development functional food.

• Parasites, Hosts and Diseases
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• v.58 no.2
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• pp.195-200
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• 2020

Soil-transmitted helminths, including Ascaris lumbricoides and Trichuris trichiura, are important intestinal parasites mostly affecting younger people in developing countries. In 2014-2015, we performed mass fecal examinations targeting a total of 2,227 schoolchildren in 3 districts (South Dagon, North Dagon, and Hlaing-thar-yar) of Yangon Region, Myanmar, using the Kato-Katz thick smear technique. The egg positive children were subjected to a mass drug administration (MDA) using a single oral dose of 400 mg albendazole. The pre-treatment egg positive rate (EPG/person) of A. lumbricoides averaged 17.2% (15,532); it was 25.2% (21,796), 14.2% (11,816), and 12.8% (12,983) in 3 districts, respectively, and that of T. trichiura averaged 19.4% (1,074), and was 24.1% (1,040), 12.3% (852), and 21.2% (1,330) in 3 districts, respectively. Follow-up fecal examinations performed 4 months post-MDA revealed considerable decreases of A. lumbricoides prevalence (EPG/person) to av. 8.3% (12,429), and 13.7% (17,640), 8.0% (7,797), and 4.5% (11,849) in 3 districts, respectively. However, T. trichiura did not show any recognizable decrease in the prevalence (EPG/person) remaining at av. 18.2% (862), and 18.5% (888), 11.5% (812), and 23.3% (887) in 3 districts, respectively. The results demonstrated difficulty in short-term control of T. trichiura by MDA using albendazole and suggested necessity of either a long-term MDA (>10 years) or changing the albendazole regimen into 2~3-day course (total 800 or 1,200 mg), or using an alternative drug/drug combination.

• Parasites, Hosts and Diseases
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• v.58 no.4
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• pp.421-430
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• 2020

This study aimed to investigate whether mass drug administration (MDA) intervention has an equivalent effect on reducing the prevalence and intensity of Schistosoma haematobium infection regardless of the baseline values. A repeated cross-sectional survey was performed targeting students of 12 primary schools in Al Jabalain and El Salam districts of White Nile State, Sudan, at both 1 week before and 8 months after the MDA. Prior to the baseline survey, schoolaged children in Al Jabalain had received MDA interventions twice in 4 years, while those in El Salam had not. The baseline prevalence was 9.1% in Al Jabalain and 35.2% in El Salam, which were reduced to 1.8% and 5.5% at 8 months after the MDA, respectively. The corresponding reduction rates were 80.3% and 84.4%, not significant difference between both districts. However, changes in the geometric mean intensity (GMI) of egg counts were significantly different between both districts. The baseline GMIs were 14.5 eggs per 10 ml of urine (EP10) in Al Jabalain and 18.5 EP10 in El Salam, which were reduced to 7.1 and 11.2 EP10 after treatment, respectively. The corresponding reduction rates were 51.0% and 39.5%. In conclusion, MDA interventions were found to bring about similar relative reduction in prevalence regardless of the baseline value; however, the relative reduction in infection intensity was more salient in the district with a low baseline value for both prevalence and intensity. This clearly points to the importance of repeated MDA interventions in endemic areas, which will eventually contribute to schistosomiasis elimination.

• Journal of Life Science
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• v.23 no.2
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• pp.249-258
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• 2013

The antioxidative activity and bioactivity of water, ethanol, and methanol extracts from Paecilomyces japonica (PJ), Cordyceps militaris (CM), and cordycepin-enriched C. militaris JLM0636 ($CM{\alpha}$) were tested in in vitro experimental models. The PJ water extract showed the highest extraction yield (42.53%). The highest content of phenolic compounds and flavonoids were found in the water extract of PJ, 2.72% and 1.73%, respectively. The major minerals were K, Mg, and Ca. The water extracts of PJ also showed the highest DPPH free radical scavenging activity and reducing power. Linoleic acid peroxidation and antioxidative activities were strong in $CM{\alpha}$. The methanol extracts of PJ showed the highest inhibition activity against tyrosinase. Fibriolytic activity was higher in $CM{\alpha}$ than in CM. These results may provide basic data to understand the biological activities of bioactive materials derived from $CM{\alpha}$ for the development of functional foods, cosmetics, and antithrombotics.