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TEMPOROSPATIAL PATTERNS OF PROGRAMMED CELL DEATH DURING EARLY DEVELOPMENT OF THE MOUSE EMBRYOS (생쥐 배자발생초기의 세포자기사 발현 양상에 관한 연구)

  • Baik, Byeong-Ju;Lee, Seung-Ik;Kim, Jae-Gon;Park, Byung-Yong;Park, Byung-Keon
    • Journal of the korean academy of Pediatric Dentistry
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    • v.28 no.4
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    • pp.709-727
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    • 2001
  • The pattern of programmed cell death(PCD) has been examined during the early developmental period of development in mouse embryos, from embryonic day 4.5(E4.5) to E11.5 Embryos from Balb/c breedings were harvested at various embryonic stages between E4.5 and El1.5. Cell death was analysed by in situ terminal deoxynucleotidyl transferase mediated dUTP nick end labeling(TUNEL) staining in tissue sections and whole embryos. At the blastocyst stage(E4.5), a very few apoptotic cells were found in the inner cell mass of the blastocyst. In the early egg cylinder stage(35.0-5.5), a few apoptotic cells were detected in the embryonic ectoderm, the embryonic endoerm and the proamniotic cavity. In the advanced egg cylinder stage(E5.5-6.5), TUNEL-posifive cells were observed in the extra-embryonic ectoderm and extra-embryonic endoderm as well as in the embryonic ectoderm, embryonic visceral endoderm and proamniotic cavity. In the streak stage(E6.75-7.75), many TUNEL-positive cells were found in the ectoplacental cone. In contrast, only very few apoptotic cells were found in the chorion and extra-embryonic endoderm in extra-embryonic regions. In intra-embryonic region, a few apoptotic cells were randomly found in the embryonic ectoderm, mesoderm and visceral endoderm. At the early somitogenesis stage(E8.0-8.5), most apoptotic cells were observed in the most cranial portion of neural fold (neural ectoderm and adjacent ectoderm). At the mid somitogenesis stage(39.0-9.5), the otic placode first showed TUNEL-positive at this stage. Small number of TUNEL-positive cells were also first seen around optic placode and branchial arches. Three streams of TUNEL-positive cells were clearly seen in the cranial region at 59.5-9.75. At E10.5, apoptotic cells were localized in the developing eye, the junctional portion of medial nasal, lateral nasal and maxillary processes, the lateral portion of branchial arches, the junction of bilateral mandibular processes, and apical ectodermal ridges of limb buds. At E11.5, apoptotic cells were noticeably decreased in most area, except the developing limbs and several somites in the tail region. In this study, the global temporospatial pattern of PCD throughout early development of mouse embryos was discussed. It may provide the basis for further studies on its role in the morphogenesis of the embryo.

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A Survey on Child Battering among Elementary School Children and Related Factors in Urban and Rural Areas (도시 및 농어촌 아동의 가정내 구타발생률 및 관련요인 조사)

  • Jeon, Kae-Soon;Park, Jung-Han
    • Journal of Preventive Medicine and Public Health
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    • v.24 no.2 s.34
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    • pp.232-242
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    • 1991
  • To determine the incidence rate of child battering and related factors, a questionnaire survey was Conducted on 1,255 children in 4th and 5th grades of two elementary schools (one in the upper economic class area with 519 students and the other in the lower economic class area with 504 students) in Taegu and two schools in rural areas of Kyungpook province (120 and 112 students, respectively) from 1st May to 10th May 1990. Total number of children who were battered during one-month period (1-30 April 1990) prior to the survey was 918 (73.1%). Among the battered children 87 (6.9%) were severely battered (twice or more in a month by kicking or more severe method) and 831 children (66.2%) were moderately battered (all other battering than severe battering). The percentage of battered children and degree of battering were not significantly different between two schools in Taegu and between urban and rural areas. Common reasons for battering were disobediance (61.9%), making troubles (34.9%), and poor school performance (33.3%). However, 16.1% of severely battered children responded that the perpetrators battered them to wreak their anger and 5.7% of them did not know the reason why they were battered. A majority of the battered children (65%) regretted their fault after being battered but 20.7% of the severely battered children wanted to run away and 9.2% of them had an urge to commit suicide. While most of the physical injuries due to battering were minor as bruise (52.7%) but some of them were severe, e.g., bone fracture (2.5%), skin laceration (1.5%), and loss of consciousness. (0.2%). The common psycho-behavioral complaints of the severely battered children were unwillingness to study (31%), unwillingness to live (17.2%), and reluctance to go home (13.8%). The incidence rate of severe battering was significantly higher (p=0.018) among the children living in a quarter attached to a store (14.0%) than the children living in an apartment (6.6%) and individual house (6.2%). The incidence rate of severe battering was higher among children living in a rental house (8.4%) than children living in their own house 6.3%) (p=0.005). The children of father only working (5.1%) and mother only working (4.5%) had a lower incidence rate of severe battering than the children of both parents working (9.1%) and both parents unemployed (20.7%) (p=0.006). More children were battered when there was a sick family member (80.8%) compared with the children without a sick family member (71.4%) (p=0.001). The incidence rates of severe and moderate battering increased as the frequency of quarreling between mother and father increased (P=0.000). The percentage of unbattered children was higher among children whose father's occupation was professional (39.4%) than that of the total study subjects (26.9%) (p<0.001).

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Development of Formulas for the Estimation of Renal Depth and Application in the Measurement of Glomerular Filtration Rate in Koreans (사구체 여과율 측정을 위한 한국인의 신장 깊이에 관한 방정식 도출과 이용)

  • Yoo, Ie-Ryung;Kim, Sung-Hoon;Chung, Yong-An;Jung, Hyun-Seok;Lee, Hae-Giu;Park, Young-Ha;Lee, Sung-Yong;Sohn, Hyung-Seon;Chung, Soo-Kyo;Kim, Hyun-Mi;Lee, Hyung-Goo
    • The Korean Journal of Nuclear Medicine
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    • v.34 no.5
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    • pp.418-425
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    • 2000
  • Purpose: There is no established formula for estimating renal depths in Korean. As a result, we undertook this study to develop a new formula, and to apply this formula in the calculation of glomerular filtration rate (GFR). Materials and Methods: We measured the renal depth (RD) on the abdominal CT obtained in 300 adults (M:F: 167:133, mean age 50.9 years) without known renal diseases. The RDs measured by CT were compared with the estimated RDs based on the Tonnesen and Taylor equations. New formulas were derived from the measured RDs in 200 out of 300 patients based on several variables such as sex, age, weight, and height by multiple regression analysis. The RDs estimated from the new formulas were compared with the measured RDs in the remaining 100 patients as a control. In 48 patients who underwent Tc-99m DTPA renal scintigraphy, GFR was measured with three equations (new formula, Tonnesen and Taylor equations), respectively, and compared with each other. Results: The mean values of the RDs measured from CT were 6.9 cm for right kidney of the men (MRK), 6.7 cm for left kidney of the men (MLK), 6.7 cm for right kidney of the women (WRK), and 6.6 cm for left kidney of the women (WLK). The RDs estimated from Tonnesen equation were shorter than the ones measured from CT significantly. The newly derived formulas were 12.813 (weight/height)+0.002 (age)+ 2.264 for MRK, 15.344 (weight/height)+0.011 (age)+0.557 for MLK, 12.936 (weight/height)+ 0.014 (age)+1.462 for WRK and 13.488 (weight/height)+0.019 (age)+0.762 for WLK. The correlation coefficients of the RD measured from CT and estimated from the new formula were 0.529 in MRK, 0.729 in MLK, 0.601 in WRK, and 0.724 in WLK, respectively. The GFRs from the new formula were significantly higher than those from the Tonnesen equation significantly, which was the most similar to normal GFR values. Conclusion: We generated new formulas for estimating RD in Korean from the data by CT. By adopting these formulas, we expect that GFR can be measured by the Gates method accurately in Korean.

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Studies on the Directivity of Gokjungkyeong(Kyung Overlapped with Gok) which was specified in Byeokgye-ri, Yangpyeong-gun and the Hwaseo Lee, Hang-ro's Management in Byeokwon Garden (양평 벽계리에 설정된 곡중경(曲中景)의 지향성과 화서(華西) 이항로(李恒老)의 벽원(蘗園) 경영)

  • Jung, Woo-Jin;Rho, Jae-Hyun
    • Journal of the Korean Institute of Traditional Landscape Architecture
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    • v.34 no.3
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    • pp.78-97
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    • 2016
  • The objectives of this study are to examine the context of the establishment of Suhoe Gugok, Byeokgye Gugok Vally, and Nosan Palkyung, which have been established in Seojong-myeon of Yangpyeong-gun, by literature review and site investigations, and to determine the sceneries of Byeokgye scenic site as enjoyed and managed during the period of Hwaseo Lee, Hang-ro(華西 李恒老). The results of the study are as follows. First, Byeokgye Gugok Vally(黃蘗九曲) and Nosan Palkyung(蘆山八景), which have been established after the period of Hwaseo and theorized to have been established around key scenic areas associated with Hwaseo's activities, the analysis results showed that they were collecting sceneries of modern times. The extensive overlap between Byeokgye Gugok Vally and concentrated scenic elements of Suhoe Gugok(水回九曲), and the artificial configuration from the end point of Suhoe Gugok to the beginning point of Nosan Palkyung, reveal the pattern of space conflict and hegemony between Byeokgyes of Suip-ri and Nomun-ri. This is likely to be caused by the conflict between the historicity of the group that enjoyed Byeokgye prior to Hwaso's period and the strong territoriality of the space filled with the image of Hwaseo. Second, Byeokgye Gugok Vally was the secondary spatial system created by selecting the most scenic sites in Suip-ri while expanding the area of Nosan Palkyung. After establishment of Byeokgye Gugok Vally, the spatial identity of the entire Byeokgyecheon area was effectively established. This was a "Hwaseo-oriented" move, including the complete exclusion of the scenic sites from the pre-Hwaseo period such as Cheongseo Gujang and Suhoe Gugok's Letters Carved on the Rock. Consequently, the entire Byeokgyecheon area was reorganized into a cultural scenic site with Heoseo's influence. Third, Fifth, creations of Gugok(九曲) to determine the lineage of the Hwaseo School from Juja(朱子) to Yulgok(栗谷) to Uam(尤庵) to Hwaseo is likely to be an opportunity of birth and external motivation of the establishment of new Gugok Palkyung. In other words, Nosan Palkyung and Byeokgye Gugok Vally are likely to have been created as a reaction to the change of the center of the Hwaseo School to Okgyedong, and with strategic orientation based on the motivation and needs such as creation of the connecting space between Mui Gugok, Gosan Gugok, and Okgye Gugok, and the elevation of Hwaseo's status. Fourth, from the Hwaseo's Li-centric point of view, all revered sites in Beokwon(蘗園) that he managed existed as the spatial creative work to experience the existence of "li" through the objects in the landscape and the boundary of the spirit of emptiness of the aesthetic self. This clearly shows how Byeokgye Gugok Vally or Nosan Palkyung must be defined, and furthermore, appreciated and approached, prior to discussing it as the space associated with Hwaseo. Fifth, Nosan Palkyung was composed of cultural scenic landscapes of Gokjungkyung(曲中景) with eight scenic sites where Hwaseo gave his teachings and spend time around, in the Byeokgye of Nomun-ri area of Byeokgye Gugok Vally. The sceneries is, however, collected by depending on Hwaseo's Letters Carved on the Rock and poetry. Consequently, an inner exuberance of Nosan Palkyung is satisfied beside Byeokgye Gugok Vally, but its conceptual adequacy leaves room for questions.

The Effects of Diltiazem and Pentoxifylline on Apoptosis of Irradiated Rat Salivary Gland (흰쥐 침샘의 방사선조사시 Apoptosis에 대한 Diltiazem과 Pentoxifylline의 효과)

  • Yang, Kwang-Mo;Suh, Hyun-Suk
    • Radiation Oncology Journal
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    • v.16 no.4
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    • pp.367-375
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    • 1998
  • Purpose : Xerostomia is a complication met by almost all patients who have radiotherapy for cancers of head and neck. Many studies for prevention of xerostomia will be necessary. Radiation-induced acute response of salivary glands has been defined as interphase death or apoptosis. Increased intracellular calcium level have an important role in radiation-induced apoptosis. Calcium channel blocker may prevent radiation-induced apoptosis of salivary glands. This study was designed to evaluate the effectiveness of diltiazem known as calcium channel blocker and pentoxifylline with inhibition of inflammatory response on the apoptosis as an acute response of radiation in rat salivary glands. Materials and Methods : Sprague-Dawley rats with about body weight 200-250 g were divided into 5 study groups : control, radiation alone, diltiazem with radiation, pentoxifylline with radiation, and diltiazem and pentoxifylline with radiation. The diltiazen and pentoxifylline were injected intraperitoneally 20 mg/kg and 50 mg/kg, 30 and 20 mimute before irradiation. respectively. Irradiation was given with a 4 MV linear accelerator. The 1600 cGy of radiation was delivered in a single fraction through a single anterior portal encompassing the entire neck. After 24 h of irradiation, rats were sacrificed and parotid and submandibular glands were removed and stained with hematoxylin and eosin. The quantification of apoptosis was performed by microscopic examination of stained tissue sections at a magnification of 200X and the percentage of apoptotic cell was calculated. Results : On parotid glands, the percentage of apoptosis by radiation alone, diltiazem with radiation, pentoxifylline with radiation, and diltiazem and pentoxifylline with radiation were 1.72$\%$ (8.35/486), 0.64$\%$ (2.9/453), 0.23$\%$ (1.2/516), and 0.28$\%$ (1.1/399), respectively. The apoptosis was markedly reduced in the groups receiving drugs compared with groups receivinge, radiation alone (p<0.05). In serous cell of submandibular glands, the percentages of apoptosis of radiation alone, diltiazem with radiation, pentoxifylline with radiation, and diltiazem and pentoxifylline with radiation were 1.94$\%$ (l1/567), 0.34$\%$ (1.9/554), 0.28$\%$ (1.8/637), and 0.22$\%$ (1.3/601), respectively. In the mucus cell of submandibular glands, the percentages of apoptosis were 0.92$\%$ (5.1/552), 0.41$\%$ (2.5/612), 0.29$\%$ (1.3/455), and 0.18$\%$ (1.0/562), respectively. The apoptosis was markedly reduced in the serous glands (p<0.05), but there was no difference in development of apoptosis in each group of mucus gland. Conclusion : These results suggest that radiation-induced apoptosis of serous cells of salivary glands may be decreased by diltiazem and pentoxifylline administration.

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A study of the plan dosimetic evaluation on the rectal cancer treatment (직장암 치료 시 치료계획에 따른 선량평가 연구)

  • Jeong, Hyun Hak;An, Beom Seok;Kim, Dae Il;Lee, Yang Hoon;Lee, Je hee
    • The Journal of Korean Society for Radiation Therapy
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    • v.28 no.2
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    • pp.171-178
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    • 2016
  • Purpose : In order to minimize the dose of femoral head as an appropriate treatment plan for rectal cancer radiation therapy, we compare and evaluate the usefulness of 3-field 3D conformal radiation therapy(below 3fCRT), which is a universal treatment method, and 5-field 3D conformal radiation therapy(below 5fCRT), and Volumetric Modulated Arc Therapy (VMAT). Materials and Methods : The 10 cases of rectal cancer that treated with 21EX were enrolled. Those cases were planned by Eclipse(Ver. 10.0.42, Varian, USA), PRO3(Progressive Resolution Optimizer 10.0.28) and AAA(Anisotropic Analytic Algorithm Ver. 10.0.28). 3fCRT and 5fCRT plan has $0^{\circ}$, $270^{\circ}$, $90^{\circ}$ and $0^{\circ}$, $95^{\circ}$, $45^{\circ}$, $315^{\circ}$, $265^{\circ}$ gantry angle, respectively. VMAT plan parameters consisted of 15MV coplanar $360^{\circ}$ 1 arac. Treatment prescription was employed delivering 54Gy to recum in 30 fractions. To minimize the dose difference that shows up randomly on optimizing, VMAT plans were optimized and calculated twice, and normalized to the target V100%=95%. The indexes of evaluation are D of Both femoral head and aceta fossa, total MU, H.I.(Homogeneity index) and C.I.(Conformity index) of the PTV. All VMAT plans were verified by gamma test with portal dosimetry using EPID. Results : D of Rt. femoral head was 53.08 Gy, 50.27 Gy, and 30.92 Gy, respectively, in the order of 3fCRT, 5fCRT, and VMAT treatment plan. Likewise, Lt. Femoral head showed average 53.68 Gy, 51.01 Gy and 29.23 Gy in the same order. D of Rt. aceta fossa was 54.86 Gy, 52.40 Gy, 30.37 Gy, respectively, in the order of 3fCRT, 5fCRT, and VMAT treatment plan. Likewise, Lt. Femoral head showed average 53.68 Gy, 51.01 Gy and 29.23 Gy in the same order. The maximum dose of both femoral head and aceta fossa was higher in the order of 3fCRT, 5fCRT, and VMAT treatment plan. C.I. showed the lowest VMAT treatment plan with an average of 1.64, 1.48, and 0.99 in the order of 3fCRT, 5fCRT, and VMAT treatment plan. There was no significant difference on H.I. of the PTV among three plans. Total MU showed that the VMAT treatment plan used 124.4MU and 299MU more than the 3fCRT and 5fCRT treatment plan, respectively. IMRT verification gamma test results for the VMAT plan passed over 90.0% at 2mm/2%. Conclusion : In rectal cancer treatment, the VMAT plan was shown to be advantageous in most of the evaluation indexes compared to the 3D plan, and the dose of the femoral head was greatly reduced. However, because of practical limitations there may be a case where it is difficult to select a VMAT treatment plan. 5fCRT has the advantage of reducing the dose of the femoral head as compared to the existing 3fCRT, without regard to additional problems. Therefore, not only would it extend survival time but the quality of life in general, if hospitals improved radiation therapy efficiency by selecting the treatment plan in accordance with the hospital's situation.

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Consumer Responses to Retailer's Location-based Mobile Shopping Service : Focusing on PAD Emotional State Model and Information Relevance (유통업체의 위치기반 모바일 쇼핑서비스 제공에 대한 소비자 반응 : PAD 감정모델과 정보의 상황관련성을 중심으로)

  • Lee, Hyun-Hwa;Moon, Hee-Kang
    • Journal of Distribution Research
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    • v.17 no.2
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    • pp.63-92
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    • 2012
  • This study investigated consumer intention to use a location-based mobile shopping service (LBMSS) that integrates cognitive and affective responses. Information relevancy was integrated into pleasure-arousal-dominance (PAD) emotional state model in the present study as a conceptual framework. The results of an online survey of 335 mobile phone users in the U.S. indicated the positive effects of arousal and information relevancy on pleasure. In addition, there was a significant relationship between pleasure and intention to use a LBMSS. However, the relationship between dominance and pleasure was not statistically significant. The results of the present study provides insight to retailers and marketers as to what factors they need to consider to implement location-based mobile shopping services to improve their business performance. Extended Abstract : Location aware technology has expanded the marketer's reach by reducing space and time between a consumer's receipt of advertising and purchase, offering real-time information and coupons to consumers in purchasing situations (Dickenger and Kleijnen, 2008; Malhotra and Malhotra, 2009). LBMSS increases the relevancy of SMS marketing by linking advertisements to a user's location (Bamba and Barnes, 2007; Malhotra and Malhotra, 2009). This study investigated consumer intention to use a location-based mobile shopping service (LBMSS) that integrates cognitive and affective response. The purpose of the study was to examine the relationship among information relevancy and affective variables and their effects on intention to use LBMSS. Thus, information relevancy was integrated into pleasure-arousal-dominance (PAD) model and generated the following hypotheses. Hypothesis 1. There will be a positive influence of arousal concerning LBMSS on pleasure in regard to LBMSS. Hypothesis 2. There will be a positive influence of dominance in LBMSS on pleasure in regard to LBMSS. Hypothesis 3. There will be a positive influence of information relevancy on pleasure in regard to LBMSS. Hypothesis 4. There will be a positive influence of pleasure about LBMSS on intention to use LBMSS. E-mail invitations were sent out to a randomly selected sample of three thousand consumers who are older than 18 years old and mobile phone owners, acquired from an independent marketing research company. An online survey technique was employed utilizing Dillman's (2000) online survey method and follow-ups. A total of 335 valid responses were used for the data analysis in the present study. Before the respondents answer any of the questions, they were told to read a document describing LBMSS. The document included definitions and examples of LBMSS provided by various service providers. After that, they were exposed to a scenario describing the participant as taking a saturday shopping trip to a mall and then receiving a short message from the mall. The short message included new product information and coupons for same day use at participating stores. They then completed a questionnaire containing various questions. To assess arousal, dominance, and pleasure, we adapted and modified scales used in the previous studies in the context of location-based mobile shopping service, each of the five items from Mehrabian and Russell (1974). A total of 15 items were measured on a seven-point bipolar scale. To measure information relevancy, four items were borrowed from Mason et al. (1995). Intention to use LBMSS was captured using two items developed by Blackwell, and Miniard (1995) and one items developed by the authors. Data analyses were conducted using SPSS 19.0 and LISREL 8.72. A total of usable 335 data were obtained after deleting the incomplete responses, which results in a response rate of 11.20%. A little over half of the respondents were male (53.9%) and approximately 60% of respondents were married (57.4%). The mean age of the sample was 29.44 years with a range from 19 to 60 years. In terms of the ethnicity there were European Americans (54.5%), Hispanic American (5.3%), African-American (3.6%), and Asian American (2.9%), respectively. The respondents were highly educated; close to 62.5% of participants in the study reported holding a college degree or its equivalent and 14.5% of the participants had graduate degree. The sample represents all income categories: less than $24,999 (10.8%), $25,000-$49,999 (28.34%), $50,000-$74,999 (13.8%), and $75,000 or more (10.23%). The respondents of the study indicated that they were employed in many occupations. Responses came from all 42 states in the U.S. To identify the dimensions of research constructs, Exploratory Factor Analysis (EFA) using a varimax rotation was conducted. As indicated in table 1, these dimensions: arousal, dominance, relevancy, pleasure, and intention to use, suggested by the EFA, explained 82.29% of the total variance with factor loadings ranged from .74 to .89. As a next step, CFA was conducted to validate the dimensions that were identified from the exploratory factor analysis and to further refine the scale. Table 1 exhibits the results of measurement model analysis and revealed a chi-square of 202.13 with degree-of-freedom of 89 (p =.002), GFI of .93, AGFI = .89, CFI of .99, NFI of .98, which indicates of the evidence of a good model fit to the data (Bagozzi and Yi, 1998; Hair et al., 1998). As table 1 shows, reliability was estimated with Cronbach's alpha and composite reliability (CR) for all multi-item scales. All the values met evidence of satisfactory reliability in multi-item measure for alpha (>.91) and CR (>.80). In addition, we tested the convergent validity of the measure using average variance extracted (AVE) by following recommendations from Fornell and Larcker (1981). The AVE values for the model constructs ranged from .74 through .85, which are higher than the threshold suggested by Fornell and Larcker (1981). To examine discriminant validity of the measure, we again followed the recommendations from Fornell and Larcker (1981). The shared variances between constructs were smaller than the AVE of the research constructs and confirm discriminant validity of the measure. The causal model testing was conducted using LISREL 8.72 with a maximum-likelihood estimation method. Table 2 shows the results of the hypotheses testing. The results for the conceptual model revealed good overall fit for the proposed model. Chi-square was 342.00 (df = 92, p =.000), NFI was .97, NNFI was .97, GFI was .89, AGFI was .83, and RMSEA was .08. All paths in the proposed model received significant statistical support except H2. The paths from arousal to pleasure (H1: ${\ss}$=.70; t = 11.44), from information relevancy to intention to use (H3 ${\ss}$ =.12; t = 2.36), from information relevancy to pleasure (H4 ${\ss}$ =.15; t = 2.86), and pleasure to intention to use (H5: ${\ss}$=.54; t = 9.05) were significant. However, the path from dominance to pleasure was not supported. This study investigated consumer intention to use a location-based mobile shopping service (LBMSS) that integrates cognitive and affective responses. Information relevancy was integrated into pleasure-arousal-dominance (PAD) emotional state model as a conceptual framework. The results of the present study support previous studies indicating that emotional responses as well as cognitive responses have a strong impact on accepting new technology. The findings of this study suggest potential marketing strategies to mobile service developers and retailers who are considering the implementation of LBMSS. It would be rewarding to develop location-based mobile services that integrate information relevancy and which cause positive emotional responses.

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A Randomized, Double-Blind Study to Assess the Efficacy and Safety of Oral LB20304 (Gemifloxacin) at Doses of 160mg or 320mg (Equivalent to 200mg or 400mg of the Mesylate Salt) Once Daily for 7 Days for the Treatment of Acute Exacerbations of Chronic Bronchitis (AECB) in Korean Adult Population (한국인에서 만성기관지염의 급성악화를 치료하기 위한 LB20304(Gemifloxacin) 160mg 또는 320mg 1일 1회 7일간 투여의 유효성과 안전성에 대한 연구)

  • Kim, Young Whan;Shim, Young-Soo;Kim, Won Dong;Shim, Tae Sun;Kang, Hong Mo;Choi, ByoungWhui;Kim, Jae-Yeol;Kwon, O Jung;Kim, Hojoong;Kim, Ju Ock;Jung, Ki-Suck;Hyeon, In Gyou;Mo, Eun Kyung;Lee, Seung-Joon;Nam, Gui Hyun;Lee, Kye Young;Park, Jae Seuk
    • Tuberculosis and Respiratory Diseases
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    • v.55 no.1
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    • pp.69-87
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    • 2003
  • Background : LB20304(gemifloxacin) is a new fluoroquinolone antibacterial agent with excellent activity against both Gram-negative and Gram-positive organisms. In vitro studies using clinical isolates have shown gemifloxacin to be highly active against penicillin-resistant strains of S. pneumoniae and in contrast to other reference quinolones, gemifloxacin retained good activity against clinical isolates of S. pneumoniae that were resistant to other members of the quinolone class. Therefore, gemifloxacin is thought to be effective in treating acute bacterial exacerbation of chronic bronchitis(AECB). The objective of this study was to evaluate the efficacy and safety of oral gemifloxacin at doses of 160mg or 320mg once daily for 7 days for the treatment of AECB in Korean adult population. Methods : This was a randomized, multicenter, double-blind, parallel group Phase II study to assess the clinical and antibacterial efficacy and safety of oral gemifloxacin for the treatment of AECB. Treatment Group A (67 patients) took oral gemifloxacin 160mg once daily for seven days and treatment Group B (70 patients) took oral gemifloxacin 320mg once daily for seven days. Results : The demographic profiles of the two treatment groups were similar. The clinical response at follow-up was 84.2% in the gemifloxacin 160-mg group, and 88.7% in the gemifloxacin-320 mg group, showing no statistically significant difference between two treatment groups(p=0.49). The clinical response at the end of therapy was 96.5% in the 160-mg group, and 96.4% in the 320-mg group. The bacteriological response at the end of therapy and follow-up were 81.8% and 78.9%, respectively, in the 160-mg group, and 86.4% and 84.2%, respectively, in the 320-mg group, showing no statistically significant difference between two treatment groups(p=0.68 and 0.68, respectively). S. pneumoniae(12 isolates) and H. influenzae(10 isolates) were the most prevalent pathogens. The MICs were lower for gemifloxacin than other quinolones against these key pathogens, and for S. pneumoniae, the MICs for gemifloxacin were considerably lower(${\leq}0.03$ ug/mL) than those for other quinolones, beta-lactams and macrolides. In the period on-therapy plus 30 days post-therapy, a total of 18 patients(26.9%) in the gemifloxacin 160mg group and 22 patients(31.4%) in the 320mg group reported at least one adverse event(AE). The most frequently reported AE was abdominal pain(3/67 patients, 4.5%) in the gemifloxacin 160mg group and increased level of hepatic enzyme(5/70 patients, 7.1%) in the 320mg group. The overall AE profiles for the two treatment groups were similar. Two out of 67 patients(3.0%) in the gemifloxacin 160mg group and 1/70 patients(1.4%) in the 320mg group reported at least one serious AE, however, none of which was considered by the investigator to be of suspected or probable relationship to study medication. Conclusion : The results of this study showed that gemifloxacin at doses of 160mg or 320mg once daily for 7 days in the treatment of acute exacerbations of chronic bronchitis(AECB) in adult Koreans was a very effective and safe treatment both clinically and bacteriologically.