• Title/Summary/Keyword: Beta prior

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Hormonal Profiles during Periparturient Period in Single and Twin Fetus Bearing Goats

  • Khan, J.R.;Ludri, R.S.
    • Asian-Australasian Journal of Animal Sciences
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    • v.15 no.3
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    • pp.346-351
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    • 2002
  • The effect of fetal number (single or twin) on plasma concentrations of progesterone, estradiol $17{\beta}$, cortisol, prolactin, growth hormone, triiodothyronine, thyroxine and insulin around parturition (periparturient period) were studied on ten $Alpine{\times}Beetle$ crossbred goats in their first to third lactation. The hormone profiles were studied on days -20, -15, -10, -5, -4, -3, -2, -1 prior to kidding and on day 0 and +1, +2, +3, +4, +5, +10, +15, +20 days postkidding. Plasma progesterone levels were significantly (p<0.01) higher in twin bearing goats comparison to single bearing goats during all the days of sampling. The decline in progesterone concentration from day 20 to day 1 before kidding was 56% in twin and 42% in single bearing goats. In single bearing goats plasma estradiol $17{\beta}$ was significantly (p<0.01) higher during prekidding days compared to twin bearing goats. The level of estradiol $17{\beta}$ was highest on the day of kidding in both the groups. The plasma prolactin level in twin bearing goats from day 10 to day 1 prepartum was higher as compared to single fetus bearing goats. However there was abrupt increase in prolactin level on the day of kidding in both the groups. The plasma growth hormone levels were significantly (p<0.01) higher in twin compared to single bearing goats. On the day of kidding growth hormone levels were significantly (p<0.01) higher in twin as compared to single bearing goats (1.40 vs. 0.95 ng/ml). In twin bearing goats plasma cortisol values from day 5 till the day of kidding remained elevated and the levels on the day of kidding was significantly highest in both the groups. The levels of triiodothyronine ($T_3$) were significantly higher (p<0.01) during all the periods of sampling in single compared to twin bearing goats. Plasma thyroxine ($T_4$) was significantly (p<0.01) lower in twin compared to single bearing goats. In single bearing goats plasma insulin levels were significantly (p<0.01) higher than twin bearing goats during prepartum period however during post partum period the levels in both the groups remained similar. It can be concluded that number of fetuses is having significant influence on the hormone profile during periparturient period.

Effect of Dietary Antioxidant and Energy Density on Performance and Anti-oxidative Status of Transition Cows

  • Wang, Y.M.;Wang, J.H.;Wang, C.;Wang, J.K.;Chen, B.;Liu, J.X.;Cao, H.;Guo, F.C.
    • Asian-Australasian Journal of Animal Sciences
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    • v.23 no.10
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    • pp.1299-1307
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    • 2010
  • This study was conducted to evaluate the effect of dietary antioxidant and energy density on performance and antioxidative status in transition cows. Forty cows were randomly allocated to 4 dietary treatments in a $2{\times}2$ factorial design. High or low energy density diets (1.43 or 1.28 Mcal $NE_L$/kg DM, respectively) were formulated with or without antioxidant (AOX, a dry granular blend of ethoxyquin and tertiary-butylhydroquinone; 0 or 5 g/cow per d). These diets were fed to cows for 21 days pre-partum. During the post-partum period, all cows were fed the same lactation diets, and AOX treatment followed as for the pre-partum period. Feeding a high energy diet depressed the DMI, milk yield, and 4% fat-corrected milk (FCM) of cows. However, AOX inclusion in the diet improved the milk and 4% FCM yields. There was an interaction of energy density by AOX on milk protein, milk fat and total solids contents. Feeding a high energy diet pre-partum increased plasma glucose and ${\beta}$-hydroxybutyrate, whereas dietary AOX decreased plasma ${\beta}$-hydroxybutyrate value during the transition period. There were also interactions between time and treatment for plasma glutathione peroxidase activity and malondialdehyde content during the study. Cows fed high energy diets pre-partum had higher plasma glutathione peroxidase activity 3 days prior to parturition, compared with those on low energy diets. Inclusion of AOX in diets decreased plasma glutathione peroxidase activity in cows 3 and 10 days pre-partum. Addition of AOX significantly decreased malondialdehyde values at calving. Energy density induced marginal changes in fatty acid composition in the erythrocyte membrane 3 days post-partum, while AOX only significantly increased cis-9, trans-11 conjugated linoleic acid composition. The increase in fluidity of the erythrocyte membrane was only observed in the high energy treatment. It is suggested that a diet containing high energy density pre-partum may negatively affect the anti-oxidative status, DMI and subsequent performance. Addition of AOX may improve the anti-oxidative status and reduce plasma ${\beta}$-hydroxybutyrate, eventually resulting in improved lactation performance; the response to AOX addition was more pronounced on the high energy diet.

Factors Influencing the Intention of Admission into a Charged Nursing Home for the Elderly (유료노인전문요양원 입주의사 결정요인에 관한 연구)

  • Yoo, Young-Soon;Cho, Eun-Hi;Yu, Byung-Chul;Jeong, Ki-Won;Urm, Sang-Hwa;Kim, Sung-Jun;Chun, Jin-Ho
    • Journal of Preventive Medicine and Public Health
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    • v.34 no.1
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    • pp.1-8
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    • 2001
  • Objectives : To gather information about the factors which influence the interest and intention of admission into charging nursing hones for the elderly(CNH), as these homes represent an important method for resolving the problems related to the rapid population aging occurring in Korea. Methods : A face-to-face interview survey was carried out with 320(men 159, women 165) patients over 60 years old who were admitted at 2 university hospitals and 5 general hospitals in the Busan area between December 1998 and March 1999. Data were analyzed through t-test, ANOVA, correlation and multiple regression analysis. Results : The mean age and years of education of the study population was 67.0 and 7.7 years, and the types of chronic degenerative disease included musculoskeletal disorders(20.1%), cerebrovascular disease(17.1%), and diabetes(14.3%). The major forms of household living arrangement prior to admission were elderly alone(22.6%), and elderly couple(33.5%), while about half of them(55.5%) didn't want to live with their children id the future. Almost half were paying medication fees by themselves(46.6%). The level of actual intention of admission$(3.07{\pm}1.39)$ into a CNH was lower than that of interest$(3.22{\pm}1.33)$(p<0.01). Multiple analysis revealed that the intention of admission increased with decreasing number of future supportive persons$(\beta=-0.107)$, lower level of activity in daily life$(\beta=-0.447)$, and longer years of education$(\beta=-0.447)$ with 32.7% of $R^2$. As for the factors which determined the admission into a CNH, the fee and facilities were considered to be most important, and professional nursing and physician's care were the most desired services. In nomenclature, they preferred 'elderly hospital' or 'elderly health center' to CNH. Conclusions : Interest in CNH is increasing recently, but existing studies about patient experiences in CHN are still limited. This study may form a basis for future examinations of the needs and uses for CNH. Active financial support and public information are considered by the authors to be important factors for the induction of welfare services for the elderly, though CNH.

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Effects of three-dimensionally printed polycaprolactone/β-tricalcium phosphate scaffold on osteogenic differentiation of adipose tissue- and bone marrow-derived stem cells

  • Park, Hannara;Kim, Jin Soo;Oh, Eun Jung;Kim, Tae Jung;Kim, Hyun Mi;Shim, Jin Hyung;Yoon, Won Soo;Huh, Jung Bo;Moon, Sung Hwan;Kang, Seong Soo;Chung, Ho Yun
    • Archives of Craniofacial Surgery
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    • v.19 no.3
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    • pp.181-189
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    • 2018
  • Background: Autogenous bone grafts have several limitations including donor-site problems and insufficient bone volume. To address these limitations, research on bone regeneration is being conducted actively. In this study, we investigate the effects of a three-dimensionally (3D) printed polycaprolactone (PCL)/tricalcium phosphate (TCP) scaffold on the osteogenic differentiation potential of adipose tissue-derived stem cells (ADSCs) and bone marrow-derived stem cells (BMSCs). Methods: We investigated the extent of osteogenic differentiation on the first and tenth day and fourth week after cell culture. Cytotoxicity of the 3D printed $PCL/{\beta}-TCP$ scaffold was evaluated by 3-(4,5-dimethylthiazol-2-yl)-5-(3-carboxymethoxyphenyl)-2-(4-sulfophenyl)-2H-tetrazolium assay, prior to osteogenic differentiation analysis. ADSCs and BMSCs were divided into three groups: C, only cultured cells; M, cells cultured in the 3D printed $PCL/{\beta}-TCP$ scaffold; D, cells cultured in the 3D printed $PCL/{\beta}-TCP$ scaffold with a bone differentiation medium. Alkaline phosphatase (ALP) activity assay, von Kossa staining, reverse transcription-polymerase chain reaction (RT-PCR), and Western blotting were performed for comparative analysis. Results: ALP assay and von Kossa staining revealed that group M had higher levels of osteogenic differentiation compared to group C. RT-PCR showed that gene expression was higher in group M than in group C, indicating that, compared to group C, osteogenic differentiation was more extensive in group M. Expression levels of proteins involved in ossification were higher in group M, as per the Western blotting results. Conclusion: Osteogenic differentiation was increased in mesenchymal stromal cells (MSCs) cultured in the 3D printed PCL/TCP scaffold compared to the control group. Osteogenic differentiation activity of MSCs cultured in the 3D printed PCL/TCP scaffold was lower than that of cells cultured on the scaffold in bone differentiation medium. Collectively, these results indicate that the 3D printed PCL/TCP scaffold promoted osteogenic differentiation of MSCs and may be widely used for bone tissue engineering.

The Signal Transduciton of Ginsenosides, Active Ingredients of Panax ginseng, in Xenopus oocyte: A Model System for Ginseng Study

  • Nah Seung-Yeol;Lee Sang-Mok
    • Proceedings of the Ginseng society Conference
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    • 2002.10a
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    • pp.66-83
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    • 2002
  • Recently, we have provided evidence that ginsenosides, the active components of Panax ginseng, utilize pertussis toxin (PTX)-insensitive $G{\alpha}_{q/11}-phospholipase\;C-{\beta}3(PLC-{\beta}3)$ signal transduction pathway for the enhancement of $Ca^{2+}-activated\;Cl^{-}$ current in the Xenopus oocyte (British J. Pharmacol. 132, 641-647, 2001; JBC 276, 48797-48802, 2001). Other investigators have shown that stimulation of receptors linked to $G{\alpha}-PLC$ pathway inhibits the activity of G proteincoupled inwardly rectifying $K^+$ (GIRK) channel. In the present study, we sought to determine whether ginsenosides influenced the activity of GIRK 1 and GIRK 4 (GIRK 1/4) channels expressed in the Xenopus oocyte, and if so, the underlying signal transduction mechanism. In oocyte injected with GIRK 1/4 channel cRNAs, bath-applied ginsenosides inhibited high potassium (HK) solution-elicited GIRK current $(EC_{50}:4.9{\pm}4.3\;{\mu}g/ml).$ Pretreatment of the oocyte with PTX reduced the HK solution-elicited GIRK current by $49\%,$ but it did not alter the inhibitory ginsenoside effect on GIRK current. Prior intraoocyte injection of cRNA(s) coding $G{\alpha}_q,\;G{\alpha}_{11}\;or\;G{\alpha}_q/G{\alpha}_{11},\;but\;not\;G{\alpha}_{i2}\;or\;G{\alpha}_{oA}$ attenuated the inhibitory ginsenoside effect. Injection of cRNAs coding $G{\beta}_{1{\gamma}2}$ also attenuated the ginsenoside effect. Similarly, injection of the cRNAs coding regulators of G protein signaling 1, 2 and 4 (RGS1, RGS2 and RGS4), which interact with $G{\alpha}_i\;and/or\;G{\alpha}_{q/11}$ and stimulates the hydrolysis of GTP to GDP in active GTP-bound $G{\alpha}$ subunit, resulted in a significant reduction of ginsenoside effect on GIRK current. Preincubation of GIRK channel-expressing oocyte in PLC inhibitor (U73122) or protein kinase C (PKC) inhibitor (staurosporine or chelerythrine) blocked the inhibitory ginsenoside effect on GIRK current. On the other hand, intraoocyte injection of BAPTA, a free $Ca^{2+}$ chelator, had no significant effect on the ginsenoside action. Taken together, these results suggest that ginsenosides inhibit the activity of GIRK 1/4 channel expressed in the Xenopus oocyte through a PTX-insensitive and $G{\alpha}_{q/11}$-,PLC-and PKC-mediated signal transduction pathway.

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Factors Affecting the Productivity of Germ-line Chimeras from Jl Embryonic Stem Cells (Jl 배아주세포를 이용한 효율적인 생식선 이행 카이미라의 생산)

  • Kim, S.U.;Koo, B.S.;Jeong, S.;Lee, T.H.;Yu, S.L.;Nam, Y.I.;Kim, J.L.;Hyun, B.H.;Shin, H.S.;Lee, K.K.;Sang, B.C.;Yu, D.Y.
    • Korean Journal of Animal Reproduction
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    • v.25 no.1
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    • pp.71-77
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    • 2001
  • This experiment was designed to improve the production efficiency of germ-line chimeric mice from phospholipase C (PLC)-$\beta$3 or peroxiredoxin (Prx) E -targeted ($\Delta$) ES cells by the investigating the manipulation conditions and characteristics of Jl ES cells. Four targeting clones were isolated to investigate the karyotypical and morphological stability prior to injection. All clones ($\Delta$PLC$\beta$-3 C3, $\Delta$Prx II C3, C10 and I5) showed more than 80% euploidism, however, most of $\Delta$PLC$\beta$-3 C3 clones were extensively differentiated compared to the other clones. Nine of 13 $\Delta$Prx II chimeras appeared to have at least 80% chimerism, whereas $\Delta$PLC$\beta$-3 C3 chimeras had 20% chimerism at most. Therefore, the morphological stability of ES cells under stable euploidism might mainly affect the production rate of high-coat chimeric mice. To increase the collection rate of injectable blastocysts (IBs), 5 to 10 week -aged C57BL/6J female mice were sacrificed at 3.5 days post-coitum. Ten week-aged mice were the most optimal IB donors by showing the highest collection rate (2.94/mouse) of injectable blastocysts without increase of non-injectable embryos (0.29/mouse). Foster mothers might be another factor because ICR x C57BL/6J F1 foster mother showed more increased productivity in litter size (2.8 vs. 5.6) and chimera (0 vs. 35.3%) than those of ICR foster mothers. In conclusion, the efficient production of germ-line chimeras mainly depends on the maintenance of ES cell morphology during targeting procedure, and the establishment of manipulation conditions might be a key point to maximize it.

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The Role of c-Jun N-terminal Kinase in the Radiation-Induced Lung Fibrosis (방사선에 의한 폐 섬유화증에서 c-Jun N-terminal Kinase(JNK)의 역할)

  • Uh, Soo-Taek;Hong, Ki-Young;Lee, Young-Mok;Kim, Ki-Up;Kim, Do-Jin;Moon, Seung-Hyuk;Kim, Yong-Hoon;Park, Choon-Sik;Yeom, Uk;Kim, Eun-Suk;Choi, Doo-Ho
    • Tuberculosis and Respiratory Diseases
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    • v.50 no.4
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    • pp.450-461
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    • 2001
  • Background : The underlying pathogenesis of radiation-induced lung fibrosis (RTLF) has not been very well defined. However, the role of TGF-$\beta$ in the generation of RTLF has been a major focus because there is an increase in the expression of both the TGF-${\beta}m$-RNA and its protein preceding RTLF lesions. The down stream signal after a TGF-$\beta$ stimulated lung fibrosis includes the activation of many mediators such as Smad and c-Jun N-terminal kinase (JNK) through TAK1. It is we hypothesized that JNK activation may play a pivotal role in RTLF pathogenesis through increased transcription of the fibrogenic cytokines. The present study evaluates JNK activity in alveolar macrophages after irradiation and the relationship between JNK activity and the amount of collagen in the lung tissues. Methods : C57BL/6 mice(20-25 gr, males) received chlorotetracycline(2g/L) in their drinking water 1 week prior to irradiation and continuously there after. The mice were irradiated once with 1400 cGy of $60CO{\gamma}$-ray over the whole chest. The cellular composition of the whole lung bronchoalveoalr lavage fluids(BALF), elastin expression in the lung tissues, the level of hydroxyproline in lung tissues, and an in vitro JNK assay was measured before irradiation and one, four, and eight weeks after irradiation (RT). Results : The volumes of BALF retrieved from instilled 4 mL of saline with 2% heparin were 3.7-3.8 mL for each group. The cell numbers were similar before($4.1{\times}10^4{\pm}0.5{\times}10^4/mL$) and 1 week($3.1{\times}10^4{\pm}0.5{\times}10^4/mL$) after RT. At four and eight weeks after RT, the cell number reached to $14.0{\times}10^4{\pm}1.5{\times}10^4mL$ and $10.0{\times}10^4{\pm}1.3{\times}10^4/mL$, respectively. There we no changes in the lymphocytes and neutrophils population observed in the BALF after RT. The H-E stain of the lung tissues did not show any structural and fibrotic change in the lung tissues at 4 and 8 weeks after RT. In addition, the amount of elastin and collagen were not different on Verhoeff staining of the lung tissues before RT to eight weeks after RT. The hydroxyproine content was measured with the left lung dissected from the left main bronchus. The lung were homogenized and hydrolyzed with 6 N Hel for 12 hours at $110^{\circ}C$ then measured as previously described. The content of hydroxyproline, standardized with a lung protein concentration, reached a peak 4 weeks after RT, and thereafter showed a plateau. AnIn vitro JNK assay using c-$Jun_{1-79}$-GST sepharose beads were performed with the alveolar macrophages obtained from the BAL. JNK activity was not detected prior to RT, However, the JNK activity increased from one week after RT and reached a peak four weeks after RT. Conclusion : JNK may be involved in the pathogenesis because the JNK activity showed similar pattern observed with the hydroxyproine content. However, it is necessary to clarify that the JNK increases the transcription of fibrogenic cyiokines through the transcription factor.

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Structural Properties of Social Network and Diffusion of Product WOM: A Sociocultural Approach (사회적 네트워크 구조특성과 제품구전의 확산: 사회문화적 접근)

  • Yoon, Sung-Joon;Han, Hee-Eun
    • Journal of Distribution Research
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    • v.16 no.1
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    • pp.141-177
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    • 2011
  • I. Research Objectives: Most of the previous studies on diffusion have concentrated on efficacy of WOM communication with the use of variables at individual level (Iacobucci 1996; Midgley et al. 1992). However, there is a paucity of studies which investigated network's structural properties as antecedents of WOM from the perspective of consumers' sociocultural propensities. Against this research backbone, this study attempted to link the network's structural properties and consumer' WOM behavior on cross-national basis. The major research objective of this study was to examine the relationship between network properties and WOM by comparing Korean and Chinese consumers. Specific objectives of this research are threefold; firstly, it sought to examine whether network properties (i.e., tie strength, centrality, range) affect WOM (WOM intention and quality of WOM). Secondly, it aimed to explore the moderating effects of cutural orientation (uncertainty avoidance and individuality) on the relationship between network properties and WOM. Thirdly, it substantiates the role of innovativeness as antecedents to both network properties and WOM. II. Research Hypotheses: Based on the above research objectives, the study put forth the following research hypotheses to validate. ${\cdot}$ H 1-1 : The Strength of tie between two counterparts within network will positively influence WOM effectivenes ${\cdot}$ H 1-2 : The network centrality will positively influence the WOM effectiveness ${\cdot}$ H 1-3 : The network range will positively influence the WOM effectiveness ${\cdot}$ H 2-1 : The consumer's uncertainty avoidance tendency will moderate the relationship between network properties and WOM effectiveness ${\cdot}$ H 2-2 : The consumer's individualism tendency will moderate the relationship between network properties and WOM effectiveness ${\cdot}$ H 3-1 : The consumer's innovativeness will positively influence the social network properties ${\cdot}$ H 3-2 : The consumer's innovativeness will positively influence WOM effectiveness III. Methodology: Through a pilot study and back-translation, two versions of questionnaire were prepared, one in Korean and the other in Chinese. The chinese data were collected from the chinese students enrolled in language schools in Suwon city in Korea, while Korean data were collected from students taking classes in a major university in Seoul. A total of 277 questionnaire were used for analysis of Korean data and 212 for Chinese data. The reason why Chinese students living in Korea rather than in China were selected was based on two factors: one was to neutralize the differences (ie, retail channel availability) that may arise from living in separate countries and the second was to minimize the difference in communication venues such as internet accessibility and cell phone usability. SPSS 12.0 and AMOS 7.0 were used for analysis. IV. Results: Prior to hypothesis verification, mean differences between the two countries in terms of major constructs were performed with the following result; As for network properties (tie strength, centrality and range), Koreans showed higher scores in all three constructs. For cultural orientation traits, Koreans scored higher only on uncertainty avoidance trait than Chinese. As a result of verifying the first research objective, confirming the relationship between network properties and WOM effectiveness, on Korean side, tie strength(Beta=.116; t=1.785) and centrality (Beta=.499; t=6.776) significantly influenced on WOM intention, and similar finding was obtained for Chinese side, with tie strength (Beta=.246; t=3.544) and centrality (Beta=.247; t=3.538) being significant. However, with regard to WOM argument quality, Korean data yielded only centrality (Beta=.82; t=7.600) having a significant impact on WOM, whereas China showed both tie strength(Beat=.142; t=2.052) and centrality(Beta=.348; t=5.031) being influential. To answer for the second research objective addressing the moderating role of cultural orientation, moderated regression anaylsis was performed and the result showed that uncertainty avoidance moderated between network range and WOM intention for both Korea and China, But for Korea, the uncertainty avoidance moderated between tie strength and WOM quality, while for China it moderated between network range and WOM intention. And innovativeness moderated between tie strength and WOM intention for Korea but it moderated between network range and WOM intention for China. As a result of analysing for third research objective, we found that for Korea, innovativeness positively influenced centrality only (Beta=.546; t=10.808), while for China it influenced both tie strength (Beta=.203; t=2.998) and centrality(Beta=.518; t=8.782). But for both countries alike, the innovativeness influenced positively on WOM (WOM intention and WOM quality). V. Implications: The study yields the two practical implications. Firstly, the result suggests that companies targeting multinational customers need to identify segments which are susceptible to the positive WOM and WOM information based on individual traits such as uncertainty avoidance and individualism and based on that, develop marketing communication strategy. Secondly, the companies need to divide the market on Roger's five innovation stages and based on this information, enforce marketing strategy which utilizes social networking tools such as public media and WOM. For instance, innovator and early adopters, if provided with new product information, will be able to capitalize upon the network advantages and thus add informational value to network operations using SNS or corporate blog.

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Causative Organisms of Community Acquired Urinary Tract Infection and Their Antibiotic Susceptibility at a Secondary hospital in Korea (2차 병원에서의 지역 사회 획득 요로 감염의 원인균 및 항생제 감수성 분석)

  • Jo, Yun Ju;Lee, Eun Jeong;Choi, Kyong Min;Eun, Young Min;Yoo, Hwang Jae;Kim, Cheol Hong;Lee, Hyun Hee;Kim, Pyung Kil
    • Pediatric Infection and Vaccine
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    • v.17 no.1
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    • pp.30-35
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    • 2010
  • Purpose : We investigated the causative organism and its antibiotic susceptibility of community acquired urinary tract infection (UTI) in children at a secondary hospital to test the adequacy of the current guidelines. Methods : Children diagnosed with UTI at the Department of Pediatrics, Kwandong University MyMyongji Hospital by pyuria and bacterial growth of greater than $1.0{\times}10^5CFU/mL$ on clean catch midstream urine from January 2005 to December 2008 were studied retrospectively. The epidemiologic data, causative organism, and the antibiotic susceptibility were analyzed. Results : Sixty two children were diagnosed with sixty four cases of UTI's. Two bacteria were isolated in one case and thus data on 65 urine cultures were analyzed. The male:female ratio was 1.6:1 and 78.1% were less than 12 months of age. Escherichia coli was the predominant cause consisting of 53 cases (82.8%) of the cases. K. pneumoniae (5), Enterobacter (4), Enterococcus (1), $\beta$-streptococcus (1), Diphtheroides (1) were isolated. The antibiotic resistance of E. coli were as follows; ampicillin 69.8%, cefotaxime 1.9%, gentamicin 15.1%, amikacin 0.0%, levofloxacin 1.9%, and trimethoprim/sulfamethoxazole 26.4 %. Only one case of the E. coli was extended spectrum $\beta$-lactamase (ESBL) positive. Conclusion : Compared to prior reports from other tertiary hospitals in Korea, E. coli was the predominant cause in childhood UTI and the rate of ESBL positivity was low. The antibiotic resistance was also different compared to prior reports. We conclude that a difference in the cause and antibiotic resistance of childhood UTI exists between centers and this should be taken into consideration when prescribing antibiotics for childhood UTIs.

Bioequivalence of Carvelol Tablet to Dilatrend Tablet (Carvedilol 25 mg) (딜라트렌 정(카르베딜롤 25 mg)에 대한 카베롤 정의 생물학적 동등성)

  • Cho, Hea-Young;Lee, Moon-Seok;Park, Soon-Cheol;Lim, Dong-Koo;Moon, Jai-Dong;Lee, Yong-Bok
    • Journal of Pharmaceutical Investigation
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    • v.31 no.4
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    • pp.289-295
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    • 2001
  • Carvedilol is an antihypertensive and antianginal compound that combines nonselective beta-adrenoceptor blocking and vasodilation properties and is devoid of intrinsic sympathomimetic activity. The purpose of the present study was to evaluate the bioequivalence of two carvedilol tablets, $Dilatrend^{TM}$ (Chong Kun Dang Pharmaceutical Co., Ltd.) and $Carvelol^{TM}$ (Dae Won Pharmaceutical Co., Ltd.), according to the prior and revised guidelines of Korea Food and Drug Administration (KFDA). The carvedilol release from the two carvedilol 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, water and blend of PSB80 into water). Eighteen normal male volunteers, $24.22{\pm}1.86$ years in age and $64.81{\pm}4.56\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After one tablet containing 25 mg of carvedilol was orally administered, blood was taken at predetermined time intervals and the concentrations of carvedilol in serum were determined using HPLC method with fluorescence detector. The dissolution profiles of two carvedilol 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 $Dilatrend^{TM}$ were 2.23%, -2.00% and 0.00%, respectively. Minimum detectable differences $({\Delta})$ at ${\alpha}=0.05$ and $1-{\beta}=0.8$ were less than 20% (e.g., 13.55% and 17.61% for $AUC_t$ and $C_{max}$, respectively). The powers $(l-{\beta})$ at ${\alpha}=0.05$, ${\Delta}=0.2$ for $AUC_t$ and $C_{max}$ were 98.08% and 88.81%, respectively. The 90% confidence intervals were within ${\pm}20%$ (e.g., $-5.69{\sim}10.16$ and $-12.30{\sim}8.30$ for $AUC_t$ and $C_{max}$, respectively). There were no sequence effect between two tablets in logarithmically transformed $AUC_t$ and $C_{max}$. The 90% confidence intervals using logarithmically transformed were within the acceptance range of log(0.8) to log(1.25) (e.g., $0.95{\sim}1.11$ and $0.89{\sim}1.09$ for $AUC_t$ and $C_{max}$, respectively). Two parameters met the criteria of prior and revised KFDA guideline for bioequivalence, indicating that $Carvelol^{TM}$ tablet is bioequivalent to $Dilatrend^{TM}$ tablet.

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