• Journal of Pharmaceutical Investigation
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• v.35 no.3
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• pp.179-185
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• 2005

Acebrophylline is a compound produced by salifying ambroxol with theophylline-7 -acetic acid. After acebrophylline administration, the salt splits into these two components which feature a peculiar pharmacokinetic behavior, an adequate ambroxol and a low theophylline-7-acetic acid serum levels. The purpose of the present study was to evaluate the bioequivalence of two acebrophylline capsules, Surfolase (Hyundai Pharm. lnd. Co., Ltd.) and Burophil (Kuhnil Pharm. Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of ambroxol from the two acebrophylline formulations in vitro was tested using KP VIII Apparatus II method with various dissolution media (pH 1.2, 4.0, 6.8 buffer solution and water). Twenty eight healthy male subjects, $23.25{\pm}1.43$ years in age and $64.82{\pm}6.77$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After two capsules containing 100 mg as acebrophylline were orally administered, blood was taken at predetermined time intervals and the concentrations of ambroxol in serum were determined using HPLC with electrochemical detector (ECD). The dissolution profiles of two formulations were similar at all dissolution media. In addition, 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 reference drug Surfolase, were -1.64, -3.33 and -0.92% 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 $(e.g., \;log\;0.93{\sim}log\;1.05\;and\;log\;0.88{\sim}log\;1.05$ for $AUC_t$, and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Burophil capsule was bioequivalent to Surfolase capsule.

• Journal of Pharmaceutical Investigation
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• v.36 no.3
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• pp.209-215
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• 2006

Zaltoprofen, (2-(10,11-dihydro-10-oxodibenzo[b,f]thiepin-2-yl)propionic acid) is an NSAID with powerful anti-inflammatory effects as well as an analgesic action on inflammatory pain. The purpose of the present study was to evaluate the bioequivalence of two zaltoprofen tablets, $Soleton^{\circledR}$ (CJ Corp.) and SCD Zaltoprofen (Samchundang Pharmaceutical Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of zaltoprofen from the two zatoprofen formulations in vitro was tested using KP Vlll Apparatus ll method with various dissolution media. Twenty six healthy male subjects, $23.2{\pm}2.26$ years in age and$64.7{\pm}8.08$ kg in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 80 mg as zaltoprofen was orally administered, blood samples were taken at predetermined time intervals and the concentrations of zaltoprofen in serum were determined using HPLC with UV detector. The dissolution profiles of two formulations were similar in all tested dissolution media. 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 reference drug, $Soleton^{\circledR}$ were 6.33, 5.91 and 17.7% for $AUC_t$, $C_{max}$ and untransformed $T_{max}$, 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 $1.01{\sim}1og\;1.11$ and log $0.928{\sim}1og\;1.18$ for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating SCD Zaltoprofen tablet was bioequivalent to $Soleton^{\circledR}$ tablet.

• Journal of Preventive Medicine and Public Health
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• v.23 no.1 s.29
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• pp.22-32
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• 1990

Associations between type A behavior Pattern (TABP) and parental social control were examined by a questionnaire survey in a sample of 803 undergraduates of the three universities in Daegu city in 1988. TABP was assessed by the Student Jenkins Activity Survey (SJAS, short form) and social control of parents by Bernstein and Brandis' Index of control and communication which were both dichotomized by median. The mean age of the sample was 20.7 (standard deviation, 2.2) and mean of total score of SJAS was 5.6 with its standard deviation and median, 2.7 and 5, respectively. In stratified analysis for TABP-social control association by the native place, sex and socioeconomic status (SES), males of rural origin with low SES showed odds ratio (OR), 2.49 but those with high SES 0.40. For females of rural origin, those with low SES showed OR, 1.02, whereas those with high SES did 0.35. For those who was of urban origin, males with low SES had OR 1.27, and those with high SES did 1.29. Females with high SES showed 0.85 and those with low SES 0.67. None of the TABP-social control associations among the strata showed confidence intervals not including unity. In multiple logistic regression by native place, for those with rural origin the only term showed a statistically significance was the social control-SES of parents interaction, OR 3.99 (95% confidence interval, $1.03{\sim}15.46$). For those of urban origin, none of the terms are statistically significant. These results suggest a social upward mobility by education of the rural disadvantaged group and a Confucian idea that regards academic achievement as one of social virtues, both of which may reflect the different sociocultural structures from the West.

• The Journal of Korean Society for Radiation Therapy
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• v.30 no.1_2
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• pp.73-81
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• 2018

Purpose : The aims of this study were to compare and assess the effectiveness of Volumetric Modulated Arc Therapy(VMAT) using jaw tracking(JT) and fixed jaw(FJ) in radiation therapy of multiple brain metastasis. Methode and material : Among the patients with Multiple Brain Metastasis treated with jaw tracking, 10 patients with more than 6 tumors and with the size of radiation field $14{\times}14cm^2$ or more were included. Each Treatment plans with jaw tracking(JT) and fixed jaw(FJ) was established with Eclipse (Ver. 13.6 Varian, USA). Gamma Index (3 mm, 3 % confidence interval - 95 %) and maximum dose difference were measured with an electronic portal imaging device(EPID). The $D_{max}$ and $D_{mean}$ of Organ At Risk(OAR) were assessed and compared, and the Conformity Index(CI) and Homogeneity Index(HI) were evaluated. Result : Evaluating jaw tracking(JT) and fixed jaw(FJ) outcomes, in all cases, Gamma Index met the permissible standard of 3 mm, 3 % confidence intervals of 95 %. The maximum dose difference value from the areas with leaf end transmission was measured at a maximum of 98.4 % and an average of 43.6 % in clockwise(CW), and 67.9 % and 41.0 % for each in Counter-Clockwise(CCW). With jaw tracking, the maximum value of $D_{max}$ for each normal organ in OAR decreased in 15.36 %~74.59 % with the average value decreasing in 2.84 %~39.80 %. The maximum value of $D_{mean}$ in OAR decreased in 27.90 %~65.23 %, with the average value decreasing in 7.70 %~41.71 %. No change has been found in Conformity Index and Homogeneity Index values. Conclusion : When Jaw tracking is used in treating patients with multiple brain metastasis with VMAT, the unnecessary exposure due to leakage and transmission of radiation in unspecified areas was reduced, without affecting the dose distribution of the planning target volume(PTV), and the availability of radiation therapy with lower doses in normal organs is expected.

• Korean Journal of Psychosomatic Medicine
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• v.26 no.2
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• pp.77-85
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• 2018

Objectives : This study aimed to investigate the level of distress using the distress thermometer (DT) and the factors associated with distress in postoperative breast cancer (BC) patients. Methods : DT and WHOQOL-BREF (World Health Organization Quality of Life Scale Abbreviated Version) along with sociodemographic variables were assessed in patients undergoing surgery for their first treatment of BC within one week postoperatively. The distress group consisted of participants with a DT score ${\geq}4$. The prevalence and associative factors of distress were examined by descriptive, univariable, and logistic regression analysis. Results : Three hundred seven women were recruited, and 264 subjects were finally analyzed. A total of 173 (65.5%) were classified into the distress group. The distress group showed significantly younger age (p=0.045), living without a spouse (p=0.032), and worse quality of life (QOL) as measured by overall QOL (p=0.009), general health (p=0.005), physical health domain (p<0.000), and psychological health domain (p=0.002). The logistic regression analysis showed that patients aged 40-49 years were more likely to experience distress than those aged ${\geq}60years$ (Odds ratios [OR]=2.992, 95% confidence interval [CI] 1.241-7.215). Moreover, the WHOQOL-BREF physical health domain was a predictive factor of distress (OR=0.777, 95% CI 0.692-0.873). Conclusions : A substantial proportion of patients are experiencing significant distress after BC surgery. It would be expected that distress management, especially in the middle-aged patients and in the domain of physical QOL (e.g., pain, insomnia, fatigue), from the early BC treatment stage might reduce chronic distress.

• Tuberculosis and Respiratory Diseases
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• v.44 no.1
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• pp.25-43
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• 1997

Introduction : The outcome and incidence of acute respiratory distress syndrome (ARDS) could be variable related to the varied definitions used for ARDS by researchers. The purpose of the national survey was to define the risk factors of ARDS and investigate the prognostic indicies related to mortality of ARDS in Korea according to the definition of ARDS determined by the American-European Concensus Conference on 1992 year. Methods : A Multicenter registry of 48 University or University-affliated hospital and 18 general hospital s equipped with more than 400 patient's beds conducted over 13 months of patients with acute respiratory distress syndrome using the same registry protocol. Results : 1. In the 12 months of the registry, 167 patients were enrolled at the 24 hospitals. 2. The mean age was 56.5 years (${\pm}17.2$ years) and there was a 1.9:1 ratio of males to females. 3. Sepsis was the most common risk factors (78.1%), followed by aspiration (16.6%), trauma (11.6%), and shock (8.5%). 4 The overall mortality rate was 71.9%. The mean duration was 11 days (${\pm}13.1$ days) from the diagnosis of ARDS to the death. Respiratory insufficiency appeared to be a major cause in 43.7% of the deaths followed by sepsis (36.1%), heart failure (7.6%) and hepatic failure (6.7%). 5. There were no significant differences in mortality based on sex or age. No significant difference in mortality in infectious versus noninfectious causes of ARDS was found. 6. There were significant differences in the pulse rate, platelet numbers, serum albumin and glucose levels, the amounts of 24 hour urine, arterial pH, $Pa0_2$, $PaCO_2$, $Sa0_2$, alveolar-arterial oxygen differences, $PaO_2/FIO_2$, and PEEP/$FI0_2$ between the survivors and the deaths on study days 1 through 6 of the first week after enrollment. 7. The survivors had significantly less organ failure and lower APACHE III scores at the time of diagnosis of ARDS (P<0.05). 8. The numbers of organ failure (odd ratio 1.95, 95% confidence intervals:1.05-3.61, P=0.03) and the score of APACHE III (odd ratio 1.59, 95% confidence interval:1.01-2.50, P=0.04) appeared to be independent risk factors of the mortality in the patients with ARDS. Conclusions : The mortality was 71.9% of total 167 patients in this investigation using the definition of American-European Consensus Conference on 1992 year, and the respiratory insufficiency was the leading cause of the death. In addition, the numbers of organ failure and the score of APACHE III at the time of diagnosis of ARDS appeared to be independent risk factors of the mortality in the patients with ARDS.

• Journal of Environmental Health Sciences
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• v.46 no.3
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• pp.285-296
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• 2020

Objective: The objective of this study was to describe the characteristics of exposure to humidifier disinfectants (HDs) and their association with the presence of a person who experienced the adverse health effects in general households in Korea. Methods: During the month of December 2016, a nationwide online survey was conducted on adults over 20 years of age who had experience of using HDs. It provided information on exposure characteristics and the experience of health effects. The final survey respondents consisted of 1,555 people who provided information on themselves and their household members during the use of HD. Exposure characteristics at the household level included average days of HD use per week, average hours of HD use per day, the duration within which one bottle of HD was emptied, average input frequency of HD, amount of HD (cc) per one time used, and active ingredients of HD products (PHMG, CMIT/MIT, PGH, or others). The risk of the presence of a person who experienced adverse health effects in the household was evaluated by estimating odds ratios (ORs) and 95% confidence intervals (CIs) adjusted for monthly income and region using a multiple logistic regression model. Subgroup analyses were conducted for households with a child (≤7 years) and households with a newborn infant during HD use. Results: The level of exposure to HD tended to be higher for households with a child or newborn infant for several variables including average days of HD use per week (P<0.0001) and average hours of HD use per day (P<0.0001). The proportion of households in which there was at least one person who experienced adverse health effects such as rhinitis, asthma, pneumonia, atopy/skin disease, etc. was 20.6% for all households, 25.3% for households with children, and 29.9% for households with newborn infants. The presence of a person who experienced adverse health effects in the household was significantly associated with average hours of HD use per day (P_trend<0.001), duration within which one bottle of HD was emptied (P_trend<0.001), average input frequency of HD (P_trend<0.001), amount of HD per one use (P_trend=0.01), and use of HDs containing PHMG (OR=2.23, 95% CI=1.45-3.43). Similar results were observed in subgroup analyses. Conclusion: Our results suggest that level of exposure to HD tended to be higher for households with a child or newborn infant and that exposure to HD is significantly associated with the presence of a person who experienced adverse health effects in the household.

• Pediatric Infection and Vaccine
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• v.23 no.2
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• pp.109-116
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• 2016

Purpose: Recent observational studies have found that vitamin D deficiency is associated with respiratory tract infections. However, randomized controlled trials (RCTs) regarding the efficacy of vitamin D in childhood respiratory tract infection (RTI) have yield inconsistent results. We performed a systematic review and meta-analysis to evaluate the association between vitamin D supplementation and the risk of RTI. Methods: A comprehensive search was conducted using MEDLINE, EMBASE, and the Cochrane Central Register of Controlled Trial. Randomized controlled trials of vitamin D supplementation for prevention of RTI in children were included for the analysis. Cochrane Collaboration's tool for assessing the risk of bias was used to assess the quality of the studies. Pooled risk ratios with 95% confidence intervals (CIs) were meta-analyzed using Review Manager 5.3. Results: A total of seven RCTs were included in the meta-analysis. According to a random-effects model, the risk ratio for vitamin D supplementation was 0.82 (95% CI: 0.69-0.98) and $I^2=62%$ for heterogeneity. On subgroup analysis, heterogeneity decreased in the subgroup with follow-up less than 1 year, participants ${\geq}5years$ of age, patients subgroup, and subgroup with dosing daily. Funnel plot showed that there might be publication bias in the field. Conclusions: The present meta-analysis supports a beneficial effect of vitamin D supplementation for the prevention of RTI in children. However, the result should be interpreted with caution due to limitations including a small number of available RCTs, heterogeneity among the studies, and potential publication bias.

• The Korean Journal of Nuclear Medicine Technology
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• v.13 no.3
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• pp.86-91
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• 2009

Purpose: The whole body scan in Nuclear Medicine is a widely accepted examination and procedure. Especially, it is mainly used in bone, I-131, MIBI, and HMPAO WBC scans. The diverse uses of the whole body scan range from the HMPAO WBC scan with a speed of 13cm/min, to a whole body bone scan using the Onco. Flash technique with a speed of 30cm/min. The accuracy of table movement has a strong correlation with the image quality, and inaccuracy of speed could negatively affect the image quality. The purpose of this study is to evaluate the accuracy of the table movement while considering the influence of the age of the equipment and the variability in the weight of the patients. Material and Methods: The study was conducted using two of Seoul Asan Medical Center's SIEMENS gamma cameras which are commonly used in our whole body study. The first one is the oldest gamma camera, an ECAM plus (installed in 2000), and the last is brand new one, a SYMBIA T2 (installed in 2008). Three trials were conducted with the tables moving at a different speed each time; 10, 15 and 30 cm/min. The tables' speeds were measured by checking how long it took for the table to move 10cm, and this was repeated every 10cm until the table reached 100 cm. With an average body weight of the patients of about 60~70 kg, the table speed was measured with weights of 0 kg, 66 kg and 110 kg placed on the table, then compared among conditions. Results: The coefficient of variance (CV) of the ECAM plus showed 1.23, 1.42, 2.02 respectively when the table movement speeds were set at 10, 15, and 30 centimeters per minute. Under the same conditions, the SYMBIA T2 showed 1.23, 1.83 and 2.28 respectively. As table movement speed more, the variance of CV as the speed increases. When the patient body weight was set to 0, 66 and 110kg, the CV values of both cameras showed 0.96, 1.45, 2.08 (0 Kg), 1.32, 1.72, 2.27 (66 Kg) and 1.37, 1.73, 2.14 (110 Kg). There was no significant difference (p>0.05) in 95 percent of confidence intervals and measured CV values were acceptable. However, the CV value of the SYMBIA T2 was relatively larger than the ECAM plus. Conclusion: The scan speed of the whole body scan is predetermined based on which examination is being performed. It is possible for the accuracy of the speed to be affected, such as the age of the equipment, the state of the bearings or the weight of a patient. These factors can have a negative impact on the diagnostic consistency and the image quality. Therefore, periodic quality control should be needed on the gamma cameras currently being used, focusing on the table movement speed in order to maintain accuracy and reproducibility.

• Journal of Preventive Medicine and Public Health
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• v.28 no.2 s.50
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• pp.462-472
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• 1995

This study examined the relation between anger-coping types and hypertension in employed men aged $40\sim60$ who consented to participate during the biannual physical checkup in the department of health management in 1988. The subjects analyzed were five hundred thirteen excluding those having hypertension history and/or current antihypertensive medications. Anger-coping types were constructed from the Harburg's model with two hypothetical anger-provoking situations involving wife and boss. Hypertensives were defined more than 140mmHg systolic blood pressure and/or 90mmHg diastolic blood pressure. Hypertensives were one hundred fifty two(29.6%) and those who suppressed their anger were 61.6% and 62.8% in wife and boss situations respectively. Items of anger, guilt, protest, and suppressed anger in wife situation showed odds ratios of 0.78-0.94 without statistical significance. But four items in boss situation showed odds ratios more than 1, especially anger-in types of anger item had 1.58 times the prevalence of hypertension of anger-out types(95% confidence intervals(CI) $1.06\sim2.35$) and subjects who indicated that suppressed their anger had 1.55 times the prevalence of hypertension of those who expressed their anger(95% CI $1.03\sim2.32$). For anger suppressed vs. expressed types of total suppressed anger index, prevalence of hypertension was 1.31 (95% CI $0.83\sim2.08$). After adjusting for age, body mass index, smoking and drinking, the odds ratios were slightly increased in both situations except guilt items compared with univariate analysis. These results suggest that the relation between Harburg's anger-coping model and hypertension is replicated partially in this subjects.