• Title/Summary/Keyword: Systemic analysis

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Bioequivalence Test of Gabapentin 400 mg Capsules (가바펜틴 400밀리그람 캡슐의 생물학적동등성시험)

  • Kim, Se-Mi;Kang, Hyun-Ah;Cho, Hea-Young;Shin, Sae-Byeok;Yoo, Hee-Doo;Yoon, Hwa;Lee, Yong-Bok
    • YAKHAK HOEJI
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    • v.52 no.3
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    • pp.195-200
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    • 2008
  • Gabapentin, [1-(aminomethyl) cyclohexaneacetic acid], a structural analog of $\gamma$-aminobutyric acid (GABA), is being developed for the treatment of epilepsy. Unlike GABA, gabapentin crosses the blood-brain barrier after systemic administration. Gabapentin is an effective antiepileptic drug in patients with partial and secondarily generalized seizures who are uncontrolled with use of existing anticonvulsant drug therapy. The purpose of the present study was to evaluate the bioequivalence of two gabapentin 400 mg capsules, $Neurontin^{(R)}$ capsule 400 mg (Pfizer Inc.) and Gabatin capsule 400 mg (Korean Drug Co. Ltd), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of gabapentin from the two gabapentin 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 six healthy male subjects, 23.58$\pm$1.50 years in age and 66.74$\pm$8.31 kg in body weight, were divided into two groups and a randomized 2$\times$2 cross-over study was employed. After one capsule containing 400 mg as gabapentin were orally administered, blood was taken at predetermined time intervals and the concentrations of gabapentin in serum were determined using HPLC with fluorescence detector. 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, $Neurontin^{(R)}$ capsule 400 mg, were 2.04, -3.68 and 16.79% 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 0.91$\sim$log 1.16 and log 0.87$\sim$log 1.11 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Gabatin capsule 400 mg was bioequivalent to $Neurontin^{(R)}$ capsule 400 mg.

Evaluation of Cyantraniliprole Residues Translocated by Lettuce, Spinach and Radish (상추, 시금치 및 알타리무에 의한 Cyantraniliprole의 흡수이행 잔류량 평가)

  • Yoon, Ji Hyun;Lee, Seung Won;Lim, Da Jung;Kim, Seon Wook;Kim, In Seon
    • Korean Journal of Environmental Agriculture
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    • v.40 no.4
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    • pp.335-344
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    • 2021
  • BACKGROUND: Cyantraniliprole is a systemic diamide insecticide that has been used to control lepidopteran pests in agriculture. Cyantraniliprole has become an issue due to its potentiality of unexpectable contamination in rotational crop cultivation. Thus, studies on the evaluation of cyantraniliprole translocated from soil into rotational crops are required. METHODS AND RESULTS: Cyantraniliprole was treated at a yearly maximum application level onto bare soil under greenhouse conditions in two geographically different regions. Lettuce was transplanted and spinach and radish were sown onto the soil 30 and 60 days-plant back intervals (PBIs) after cyantraniliprole treatment. The QuEChERS method was modified and coupled with LC/MS/MS analysis to determine the residues of cyantraniliprole in soil and plant samples. The methods for sample preparation and instrumental conditions were validated to meet the criteria of Codex guidelines and were successful to determine cyantraniliprole quantitatively and qualitatively in the samples. Cyantraniliprole residues in lettuce samples were 0.01 mg/kg for PBI 60 and 0.02 mg/kg for PBI 30, respectively. The residues in spinach samples were 0.01 mg/kg for PBI 60 and 0.01~0.02 mg/kg for PBI 30, respectively. Less than limit of the quantitation (LOQ) level (0.01 mg/kg) of cyantraniliprole was observed in radish samples. The residues in the plant samples were found as the levels less than maximum residue limit (MRL) for leafy and root vegetables. CONCLUSION(S): This study suggests PBI 30~60 days for rotational cultivation of lettuce, spinach and radish in greenhouse soil treated with cyantraniliprole at a yearly maximum application level.

Radiologic evaluation and survival rate of taper-straight designed implant with SLA surface: A 1-year follow-up retrospective study (SLA surface를 가진 taper straight designed implant의 방사선학적 평가와 생존율: 1년 추적 관찰을 통한 후향적 연구)

  • Kim, Jee Eun;Kim, Ye Seul;Kim, Ok-Su
    • The Journal of Korean Academy of Prosthodontics
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    • v.59 no.4
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    • pp.405-414
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    • 2021
  • Purpose. This study was conducted to evaluate clinical usefulness by evaluating the marginal bone resorption and survival rate of an implant with a taper straight type SLA surface domestically available on the market recently. Materials and methods. 40 implants satisfying the including criteria were observed for one year of 125 implants of 83 adult men and women who had KISPLANT® implanted from August 2016 to December 2019 at the Department of Periodontology, Chonnam National University Dental Hospital. The marginal bone level was measured on periapical radiographs taken initially and 1 year later and we analyzed implant survival and success rates. A t-test was used for the analysis of the association between the marginal bone resorption and the severity of periodontitis, supportive periodontal therapy, the inserted site, the cause of extraction, immediate placement, and systemic disease. Results. After 1 year of loading, the mesial bone resorption was 0.74 ± 1.07 mm, and the distal bone resorption was 0.53 ± 1.04 mm. The marginal bone resorption of 2 mm or more occurred at 3 implants out of 40 implants after 1 year, so the success rate of implant was 92.5% and survival rate was 100%. There was a significant difference in mesial marginal bone resorption according to the inserted site and no significant differences were found between marginal bone resorption and the other factors. Conclusion. As a result of marginal bone resorption, success rate, and survival rate in this study, we found little marginal bone resorption and high survival and success rate. It can be concluded that they represent excellent clinical results.

The effects of zoledronic acid on the progression of experimental periodontitis in rats: histological and microtomographic analyses

  • de Marcelos, Priscylla Goncalves Correia Leite;da Cruz Perez, Danyel Elias;Soares, Diego Moura;de Araujo, Samuel Silva;Evencio, Liriane Baratella;Pontual, Maria Luiza dos Anjos;Ramos-Perez, Flavia Maria de Moraes
    • Journal of Periodontal and Implant Science
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    • v.51 no.4
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    • pp.264-275
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    • 2021
  • Purpose: Periodontitis is considered a local risk factor for medication-related osteonecrosis of the jaws (MRONJ). However, little is known about the progression of periodontitis in the presence of zoledronic acid (ZOL). The aim of this study was to evaluate the effects of the systemic use of ZOL on the progression of experimental periodontitis (EP) in rats, as ZOL could modulate the progression of periodontitis and concomitantly cause MRONJ in individuals with periodontitis. Methods: Forty-eight male Wistar rats were randomly distributed in 6 groups (n=8 each). To induce EP, ligatures were placed around the right first mandibular molars. Three groups were treated with ZOL (0.15 mg/kg/week, intraperitoneal), and 3 with 0.9% saline solution (controls). In the ZOL/Lig30 and ZOL/Lig 15 groups, after 4 weeks of treatment with ZOL, EP was induced and euthanasia was performed after 30 and 15 days of EP induction, respectively. In both groups, the animals continued to receive ZOL after EP until the end of the experiment. In the Lig/ZOL group, EP was induced first, and 15 days later, ZOL was administered for 8 weeks, with euthanasia 1 week after the last dose. After euthanasia, the mandibles were evaluated using micro-computed microtomography (micro-CT) and histomorphometry. Bone loss was measured, and the presence of osteonecrosis was evaluated histologically. The data were evaluated using the Student t-test and the Mann-Whitney test, with a significance level of 5%. Results: In the Lig/ZOL group, micro-CT revealed less alveolar bone resorption in the distal root (P<0.01) than in the control group (Lig/Con). Histomorphometric analysis confirmed less alveolar bone resorption in the Lig/ZOL group (P=0.001). Histologically, osteonecrosis was more common in the ZOL groups. Conclusion: ZOL decreased alveolar bone resorption in rats with EP. However, it presented a higher risk for MRONJ.

A Change in the Diagnosis of a Korean Pediatric Outpatients following the COVID-19 Pandemic (코로나19 유행에 따른 한방소아청소년과 외래 환자의 진단명 변화)

  • Seo, Hae Sun;Park, So Hyun;Park, Sul Gi;Lee, Sun Haeng;Lee, Jin Yong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.4
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    • pp.16-33
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    • 2021
  • Objectives This study aims to provide directions for future Korean pediatric medicine treatment and researches by analyzing the characteristics of diseases of Korean pediatric outpatients before and after the COVID-19 epidemic. Methods We analyzed the medical records of 10,868 new patients aged 0-18 who visited the Korean pediatrics at Kyung Hee university hospital from January 1, 2019 to June 30, 2021. All patients were divided into 2 groups; patients who visited from January 1, 2019 to December 31, 2019, before the coronavirus epidemic, and patients who visited from January 1, 2020 to June 30, 2021, after the coronavirus epidemic. Within the two groups, the diagnosis distribution was performed for the entire population, by gender and by age group. Diagnoses were classified as allergy, growth, gastrointestinal, respiratory, general body supplementation, neuropsychiatric, skin, urogenital, musculoskeletal, and other systems. Results According to the comparative analysis results of before and after the COVID epidemic, there was a decreasing trend of diagnoses in relates to allergy, respiratory, urogenital, musculoskeletal system. On the other side, there was an increasing trend in gastrointestinal, general body supplementation, growth, neuropsychiatric, skin and other system. Changes in diagnosis based on gender and age group will be described below. Conclusions This study analyzed the characteristics of diseases of Korean pediatric outpatients before and after the COVID-19 epidemic, and suggested the direction of future Korean medicine treatment and researches for pediatrics. Also, this study aimed to propose proper treatments for children by showing the role of Korean pediatric medicine related to growth and development of children during the epidemic. However, this study has limitations such as failure to track the long-term impact of COVID-19. Thus, long term follow-up studies are needed to show the effect of COVID-19 on Korean pediatric medicine.

Salivary Flow According to Elderly's Whole Health and Oral Health Status: According to Application of Oral exercise and Salivary Gland Massage

  • Oh, Ji-Young;Noh, Eun-Mi;Park, Hye-Young;Lee, Min-Kyung;Kim, Hye-Jin
    • Biomedical Science Letters
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    • v.25 no.3
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    • pp.218-226
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    • 2019
  • In old age, measures to cope with the natural phenomenon of aging and various diseases of the elderly due to the deterioration of physical function are also a challenge for this society. While interest in systematic health is increasing, it is true that awareness and interest in oral-related diseases is relatively lacking. This study aims to present basic data necessary to improve the quality of life for senior citizens aged 65 or older by improving the oral dryness caused by systemic health. By research method, improve oral dryness caused by whole-body health with the elderly over 65 and promote their oral health, inducing the increase of the salivary flow rate through oral health care education, oral exercise, and salivary gland massage. First, on the DMSQ according to the general characteristics of the elderly, the recognition of the whole body and oral health status, independent sample t-test and One-way ANOVA were conducted. Second, on changes in the salivary flow rate and saliva pH according to the general characteristics of the elderly, recognition of oral and whole-body health status, and whole-body health, paired samples t-test was conducted. Studies have shown that salivary gland flow increased significantly after oral exercise and salivary gland massage, the salivary flow rate significantly increased. In all variables of the recognition of the oral health status, the salivary flow rate increased after oral exercise and salivary gland massage, and in the whole-body health, regardless of hypertension, diabetes, cardiovascular disorders, and osteoporosis, the salivary flow rate increased after oral exercise and salivary gland massage, and the salivary flow rate increased after oral exercise and salivary gland massage if the subjects responded that they did not have thyroid abnormality, anemia, abnormalities of breathing, hypotension, gastrointestinal disturbance, or kidney diseases. As a comprehensive analysis of this study, many felt oral dryness when they had a problem with the whole-body health, and many felt oral dryness when they had a problem with oral health cognition. After applying oral exercise and salivary gland massage as intervention methods in the oral health care for the elderly, the salivary flow rate significantly increased, and it is judged that the methods were very effective for controlling oral dryness. Furthermore, it is judged that the factors affecting oral health, whole-body health, and oral dryness would be identified, which would be helpful for the promotion of whole-body health and oral health. It is judged that continuous research would be needed so that measures for the application of the oral care program and system for the elderly would be prepared in the future.

Effect of Cognitive Behavioral Art Treatment Using Smart Devices on the Changes of an Emotionally Disturbed Child (스마트기기 활용 인지행동 미술치료가 정서불안 아동의 변화에 미치는 효과)

  • Park, Mija;Lim, Keol
    • Journal of Digital Convergence
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    • v.17 no.5
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    • pp.89-97
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    • 2019
  • The purpose of this study was to understand educational changes and effects of cognitive behavioral art therapy using the smart device. The participant of the study was a 4th grade of male elementary school student who had aggressiveness and impulsiveness with emotional instability. The study was conducted one to two times a week for six months with a total of 30 educational sessions. Among 80 minutes per session, 60 minutes of art therapy and 20 minutes of cognitive behavioral therapy were applied, and during the sessions, cognitive action art therapy (drawing and shaping activities), cognitive restructuring, behavioral modification, systemic dullness, social skills training, empathy and landscaping training were applied. For the numeral assessment, Traffic Anxiety Inventory for Children (TAIC), Beck Anxiety Inventory (BAI) and emotional instability measures were used. Research showed that cognitive behavioral art therapy using smart devices had the effect of positive emotional change in children with emotional anxiety, and based on this, future development directions including systematic instructional design, scientific analysis and feedback technologies were discussed.

Korean Guidelines for Diagnosis and Management of Interstitial Lung Diseases: Part 2. Idiopathic Pulmonary Fibrosis

  • Lee, Sang Hoon;Yeo, Yoomi;Kim, Tae-Hyung;Lee, Hong Lyeol;Lee, Jin Hwa;Park, Yong Bum;Park, Jong Sun;Kim, Yee Hyung;Song, Jin Woo;Jhun, Byung Woo;Kim, Hyun Jung;Park, Jinkyeong;Uh, Soo-Taek;Kim, Young Whan;Kim, Dong Soon;Park, Moo Suk;Korean Interstitial Lung Diseases Study Group
    • Tuberculosis and Respiratory Diseases
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    • v.82 no.2
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    • pp.102-117
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    • 2019
  • Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive fibrosing interstitial pneumonia, which presents with a progressive worsening dyspnea, and thus a poor outcome. The members of the Korean Academy of Tuberculosis and Respiratory Diseases as well as the participating members of the Korea Interstitial Lung Disease Study Group drafted this clinical practice guideline for IPF management. This guideline includes a wide range of topics, including the epidemiology, pathogenesis, risk factors, clinical features, diagnosis, treatment, prognosis, and acute exacerbation of IPF in Korea. Additionally, we suggested the PICO for the use of pirfenidone and nintendanib and for lung transplantation for the treatment of patients with IPF through a systemic literature review using experts' help in conducting a meta-analysis. We recommend this guideline to physicians, other health care professionals, and government personnel in Korea, to facilitate the treatment of patients with IPF.

The Determinants of Public Attitudes toward Welfare Spending in Korea: Focusing on Welfare Perceptions and the Quality of Government (복지태도의 결정요인 분석: 복지수준과 '정부의 질'에 대한 인식의 효과를 중심으로)

  • Lee, Jiho;Hwang, Ah Ran
    • 한국사회정책
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    • v.23 no.1
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    • pp.257-285
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    • 2016
  • The purpose of this paper is to examine the determinants of public attitudes toward welfare spending in relation with the perception of welfare level. Data from the national survey of 'the SSK Good Government Research Unit' are used to perform a logistic regression analysis of the association between welfare attitudes and government perceptions, political orientations, and socio-economic backgrounds. The most prominent finding is that the determinants of welfare attitudes differ markedly between the two different groups of welfare perception. The empirical results say that persons living in a corrupt government tend to prefer welfare spendings despite having low level of welfare, and persons living in a unjust government tend to prefer welfare expansion because welfare level must be low. Persons living in a government of great capacity tend to have positive attitudes to welfare spending despite having a high level of welfare, whereas persons living in a government of less capacity tend to have negative attitudes to welfare expansion because the level of welfare is too high beyond government capacity. This distinction between the two perceptions of welfare level provides a systemic understanding of public attitudes toward welfare spending.

Awareness and Use of Complementary and Alternative Medicine in Korean Lung Cancer Patients

  • Choi, Joon Young;Ji, Wonjun;Choi, Chang-Min;Chung, Chaeuk;Noh, Jae Myoung;Park, Cheol-Kyu;Oh, In-Jae;Yoon, Hong In;Kim, Hyeong Ryul;Kim, Ho Young;Yeo, Chang Dong;Jang, Seung Hun;Public Relation Committee of the Korean Association for Lung Cancer
    • Tuberculosis and Respiratory Diseases
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    • v.84 no.2
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    • pp.105-114
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    • 2021
  • Background: Complementary and alternative medicine (CAM) has been used frequently, and its use continues to increase in lung cancer patients, despite insufficient scientific of its efficacy. To investigate this situation, we analyzed the current awareness and use of CAM in Korean lung-cancer patients. Methods: This prospective survey-based study was performed at seven medical centers in South Korea between August and October 2019. The survey assessed general patient characteristics and the awareness and use of CAM. We analyzed differences in the clinical parameters of patients aware and not aware of CAM and of CAM non-users and users. Results: Of the 434 patients included in this study, 68.8% responded that they were aware of CAM and 30.9% said they had experienced it. In univariate analysis, the patients aware of CAM were younger with poor performance status, had advanced-stage lung cancer, received more systemic therapy, and received concurrent chemoradiation therapy (CCRT). By multiple logistic regression, younger age, poor performance status, advanced stage, and prior CCRT were identified as independent risk factors for CAM awareness. There were no significant differences in the general characteristics and cancer-associated clinical parameters of CAM non-users and users. Conclusion: Specific clinical parameters were associated with patients' awareness of CAM, although there were no significantly different characteristics between CAM users and non-users.