• Title/Summary/Keyword: Clinical guideline

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Bioequivalence Test of Rebamipide 100 mg Tablets (레바미피드 100 mg 정제의 새울학적동등성)

  • Kim, Se-Mi;Cho, Hea-Young;Kang, Hyun-Ah;Lee, Yong-Bok
    • Korean Journal of Clinical Pharmacy
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    • v.18 no.1
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    • pp.38-44
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    • 2008
  • Rebamipide, ($\pm$)-2-(4-chlorobenzoylamino)-3-[2(1H)-quinolinon-4-yl] propionic acid, is used for mucosal protection, healing of gastroduodenal ulcers, and treatment of gastritis. It works by enhancing mucosal defense, scavenging free radicals and temporarily activating genes encoding cyclooxygenase-2. The purpose of the present study was to evaluate the bioequivalence of two rebamipide tablets, $Mucosta^{(R)}$ (Korea Otsuca Pharmaceuticals Co., Ltd.) and Mustar (Korean Drug Co., Ltd.), according to the guidelines of the Korea Food and Drug Administration (KFDA). The release of rebamipide from the two rebamipide formulations in vitro was tested using KP VIII Apparatus II method with pH 6.8 dissolution medium. Twenty six healthy male subjects, $23.46{\pm}2.63$ years in age and $66.62{\pm}8.97\;kg$ in body weight, were divided into two groups and a randomized $2{\times}2$ cross-over study was employed. After a single tablet containing 100 mg as rebamipide was orally administered, blood samples were taken at predetermined time intervals and the concentrations of rebamipide in serum were determined using HPLC with fluorescence detector. The dissolution profiles of two formulations were similar in the tested dissolution medium. 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, $Mucosta^{(R)}$ were -5.08, 3.52 and -9.71 % for $AUC_t$, $C_{max}$ and $T_{max}$, respectively. There were no sequence effects between two formulations in these parameters. The 90% confidence intervals using logarithmically transformed data were within the acceptance range of log 0.8 to log 1.25 (e.g., log 0.84$\sim$log 1.07 and log 0.90$\sim$log 1.17 for $AUC_t$ and $C_{max}$, respectively). Thus, the criteria of the KFDA bioequivalence guideline were satisfied, indicating Mustar tablet was bioequivalent to $Mucosta^{(R)}$ tablet.

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Characteristics of Respiration and Phonation in Normal Health Elderly (정상 노년층의 호흡 및 발성 특성)

  • Woo, Mee-Ryung;Choi, Hong-Shik;Baek, Seung-Jae;Nam, Chung-Mo;Choi, Yae-Lin
    • Phonetics and Speech Sciences
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    • v.2 no.4
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    • pp.245-252
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    • 2010
  • Korea does not have a certain criteria on the respiratory ability and phonation of the normal aged, and also has no clear standard to examine the boundaries of geriatric diseases. This study analyzed the characteristics in respiration and phonation of the aged in normal healthy elderly from diverse angles with different variables. Thirty-three participants in total, seven males and eight females in the age group 55-64 participated in the study. Seven males and eleven females in the age group 65-74 were selected for the respiration and phonation experiments, and 10 different variables such as FVC, $FEV_1$, $FEV_1$/FVC, MPT, MFR, Psub, f0, jitter, shimmer and NHR were comparatively analyzed for each group of different age and gender. To see the difference in respiration and phonation by age and gender, the study conducted a two-way ANOVA. First, from the result of the analysis on respiratory ability, FVC of male appeared to be significantly greater than female. In both age groups of 55-64 and 65-74, male displayed greater FVC than female did. Second, as for $FEV_1$, $FEV_1$/FVC, the age group of 55-64 showed greater values than the values measured in the age group of 65-74. Third, MFR showed a significant difference by gender. In both age groups, male showed significantly higher MFR than female. Fourth, for different gender, a significant difference in MFR was observed. In both age groups of 55-64 and 65-74, male exhibited higher MFR than female. This study has a clinical implication in that it analyzed the criteria on respiration and phonation in normal healthy elderly according to gender and age. The normal aged showed a difference in their respiratory and phonatory functions by age and gender, it was closely related to the decline of pulmonary function due to the physical aging and the weak respiration coming from weakness of respiratory muscles. Also, the physical differences in height, weight, and the muscles in laryngeal and respiratory system between males and females had an influence on the performance. These results from this study might be a helpful guideline for the clinical criterion in the future.

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Evaluation of the Pharmacy Student Practice Programs in the Mono Community Pharmacy and Multiple Community Pharmacies (단일약국과 다약국 프로그램에서 수행한 지역약국 필수실무실습에 대한 평가)

  • Lee, Min Cheol;Cho, Min Hwi;Jung, Young Joon;Lee, Ji Young;Yoon, Hyonok
    • Korean Journal of Clinical Pharmacy
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    • v.24 no.4
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    • pp.296-303
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    • 2014
  • Background: The first pharmacy student practice undergoing 6 year pharmacy school curriculum have begun in the hospital pharmacy, community pharmacy, pharmaceutical company and administrative office since 2013. Although most of practice sites have prepared the program of pharmacy student practice education for several years under guideline of Korean Association of Pharmacy Education, generally community pharmacies which start the pharmacy student practice education have difficulty in performing the desirable student practice program due to absent experience for it. So we reported the comparison of student practice programs between mono pharmacy and multiple pharmacies conducted by Gyeongsang National University College of Pharmacy to provide the future design information of the ideal pharmacy student practice in community pharmacy. Method: Students who practiced both multiple (multi) and mono pharmacy (mono) programs for each 5 weeks were participated the survey to evaluate the student practice programs. Results: The results of the survey on the student practice program reported that students were much more satisfied with the multiple pharmacies program than mono pharmacy program in both practical contents ($4.12{\pm}0.72$ : $3.27{\pm}1.28$; multi : mono) and satisfaction ($4.54{\pm}0.54$ : $3.54{\pm}1.3$; multi : mono) and they all gave the highest points ($5.00{\pm}0.00$) to multiple pharmacies program for recommendation because the multiple pharmacies program was significantly helpful for their experience to plan the future career. Conclusion: Mono and multiple pharmacy practice programs would be a great helpful for student's future career. However, the disadvantages of each program should be amended gradually for the unified and specialized program to be established the ideal community pharmacy student practice in Korea. The results will be affected the pharmacy practice program for students in community pharmacy and the other colleges of pharmacy to design the ideal community pharmacy practice program.

Development of Guidelines for Setting Up Sensory Integration Rooms in Korea Using the Delphi Method (국내 감각통합치료실 구성을 위한 가이드라인 개발: 델파이 연구)

  • Lee, Chan-Hwa;Hwang, Sun-Mi;Park, Seo-Yul;Chae, Song-Eun;Kim, Jung-Ran
    • The Journal of Korean Academy of Sensory Integration
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    • v.18 no.2
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    • pp.1-14
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    • 2020
  • Objective : This study presents guidelines for setting up a sensory integration room by applying the Delphi method. Methods : The Delphi method was applied in a survey of 22 expert panels asked to review sensory integration therapy from May to June 2020 to collect expert opinions. The survey was conducted in two rounds. The first round involved the collection of opinions based on prior research that used a total of 40 assessment tools, 23 closed questions about treatment tools, and 10 questions about the physical environment. Based on the results of the first round, the second was conducted using a process of item deletion and modification. Results : A total of 59 items were selected in the first round of the survey. In the second the contents of these 59 items were analyzed: each item scored .42 or higher, so no items were deleted. The stability of the survey was also calculated and found to be less than 0.5, so no further testing was required. The average content feasibility ratio of the final Delphi survey was .92, stability .15, convergence .36, and consensus .80, showing high agreement. Conclusion : This study is expected to help institutions and clinical therapists who want to create a sensory integration therapy room in their facilities by examining the physical environment, treatment tools, and evaluation tools used in sensory integration therapy rooms and understanding the views on such environments obtained from the clinical site to sensory integration therapists.

Korean Medication Algorithm Project for Bipolar Disorder 2018 (KMAP-BP 2018): Fourth Revision

  • Woo, Young Sup;Bahk, Won-Myong;Lee, Jung Goo;Jeong, Jong-Hyun;Kim, Moon-Doo;Sohn, InKi;Shim, Se-Hoon;Jon, Duk-In;Seo, Jeong Seok;Min, Kyung Joon;Kim, Won;Song, Hoo-Rim;Yoon, Bo-Hyun
    • Clinical Psychopharmacology and Neuroscience
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    • v.16 no.4
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    • pp.434-448
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    • 2018
  • Objective: The Korean Medication Algorithm Project for Bipolar Disorder (KMAP-BP) was first published in 2002 through an expert consensus of opinion, and updated in 2006, 2010, and 2014. This study constitutes the fourth revision of the KMAP-BP. Methods: A 50-item questionnaire was used to obtain the consensus of experts regarding pharmacological treatment strategies for various phases of adult bipolar disorder and six items for pediatric bipolar disorder. The review committee included 84 Korean psychiatrists and 43 child and adolescent psychiatry experts. Results: The preferred first-step strategies for acute mania were the combination of a mood stabilizer (MS) and an atypical antipsychotic (AAP), MS monotherapy, and AAP monotherapy. A combination of a MS and an AAP, and AAP monotherapy were preferred for psychotic mania. The first-step strategies for mild to moderate bipolar depression were monotherapy with MS, AAP, or lamotrigine (LMT), and the combination of a MS and an AAP or LMT, or a combination of an AAP and LMT. The combination of two among a MS, AAP, and LMT were preferred for non-psychotic severe depression. A combination of a MS and an AAP or the combination of an AAP with an antidepressant or LMT were the first-line options for psychotic severe depression. Conclusion: The recommendations of the KMAP-BP 2018 have changed from the previous version by reflecting recent developments in pharmacotherapy for bipolar disorder. KMAP-BP 2018 provides clinicians with a wealth of information regarding appropriate strategies for treating patients with bipolar disorder.

Research Areas and Trends in Articles on Pediatric and Adolescent Tuberculosis in Korea (국내 소아청소년 결핵 관련 논문의 연구 영역과 동향)

  • Lim, Ho Yoon;Lee, Jung Hyun;Jung, Yu Jin;Oh, Chi Eun
    • Pediatric Infection and Vaccine
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    • v.26 no.2
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    • pp.89-98
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    • 2019
  • Purpose: Despite the decline in tuberculosis (TB) incidence and mortality rates in the Republic of Korea through a national TB control program, TB remains one of the most critical infectious diseases in Korean children. We investigated the trends and research areas of published articles on TB in Korean children and adolescents. Methods: In 6 Korean and overseas databases, we searched titles and abstracts including "tuberculo*" or "TB," "child*" or "adolescen*" or "neonat*" or "infant*" or "pediatric*," and "korea*." The publication type, publication year, research areas, journal title, and research subjects were analyzed. Results: Out of the 257 searched documents, 120 papers were included in the analysis. Of these, 82 were original articles (68.3%), 33 case reports (27.5%), 4 review articles (3.3%), and 1 guideline (0.8%). In the original articles, the most common subject of studies was the clinical characteristics of patients with TB (36.6%), followed by diagnostics (29.3%), contact investigations (9.8%), epidemiology (6.1%), treatment (4.9%), vaccine (3.6%), latent TB infection (3.6%), complications (3.6%), and surveys on perception of TB (2.4%). From 1962, 4 articles were published in the 1960s, 10 articles in the 1970s, 11 articles in the 1980s, 22 articles in the 1990s, 26 articles in the 2000s, and 47 articles since 2010. Conclusions: The amount of research on TB in Korean children has increased over the past 5 decades; however, it has mainly focused on the clinical characteristics and diagnostics. Research in different areas, such as treatment and vaccine, is needed in the future.

Korean Society of Heart Failure Guidelines for the Management of Heart Failure: Management of the Underlying Etiologies and Comorbidities of Heart Failure

  • Sang Min Park;Soo Youn Lee;Mi-Hyang Jung;Jong-Chan Youn;Darae Kim;Jae Yeong Cho;Dong-Hyuk Cho;Junho Hyun;Hyun-Jai Cho;Seong-Mi Park;Jin-Oh Choi;Wook-Jin Chung;Seok-Min Kang;Byung-Su Yoo;Committee of Clinical Practice Guidelines, Korean Society of Heart Failure
    • Korean Circulation Journal
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    • v.53 no.7
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    • pp.425-451
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    • 2023
  • Most patients with heart failure (HF) have multiple comorbidities, which impact their quality of life, aggravate HF, and increase mortality. Cardiovascular comorbidities include systemic and pulmonary hypertension, ischemic and valvular heart diseases, and atrial fibrillation. Non-cardiovascular comorbidities include diabetes mellitus (DM), chronic kidney and pulmonary diseases, iron deficiency and anemia, and sleep apnea. In patients with HF with hypertension and left ventricular hypertrophy, renin-angiotensin system inhibitors combined with calcium channel blockers and/or diuretics is an effective treatment regimen. Measurement of pulmonary vascular resistance via right heart catheterization is recommended for patients with HF considered suitable for implantation of mechanical circulatory support devices or as heart transplantation candidates. Coronary angiography remains the gold standard for the diagnosis and reperfusion in patients with HF and angina pectoris refractory to antianginal medications. In patients with HF and atrial fibrillation, longterm anticoagulants are recommended according to the CHA2DS2-VASc scores. Valvular heart diseases should be treated medically and/or surgically. In patients with HF and DM, metformin is relatively safer; thiazolidinediones cause fluid retention and should be avoided in patients with HF and dyspnea. In renal insufficiency, both volume status and cardiac performance are important for therapy guidance. In patients with HF and pulmonary disease, beta-blockers are underused, which may be related to increased mortality. In patients with HF and anemia, iron supplementation can help improve symptoms. In obstructive sleep apnea, continuous positive airway pressure therapy helps avoid severe nocturnal hypoxia. Appropriate management of comorbidities is important for improving clinical outcomes in patients with HF.

The Workflow for Computational Analysis of Single-cell RNA-sequencing Data (단일 세포 RNA 시퀀싱 데이터에 대한 컴퓨터 분석의 작업과정)

  • Sung-Hun WOO;Byung Chul JUNG
    • Korean Journal of Clinical Laboratory Science
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    • v.56 no.1
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    • pp.10-20
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    • 2024
  • RNA-sequencing (RNA-seq) is a technique used for providing global patterns of transcriptomes in samples. However, it can only provide the average gene expression across cells and does not address the heterogeneity within the samples. The advances in single-cell RNA sequencing (scRNA-seq) technology have revolutionized our understanding of heterogeneity and the dynamics of gene expression at the single-cell level. For example, scRNA-seq allows us to identify the cell types in complex tissues, which can provide information regarding the alteration of the cell population by perturbations, such as genetic modification. Since its initial introduction, scRNA-seq has rapidly become popular, leading to the development of a huge number of bioinformatic tools. However, the analysis of the big dataset generated from scRNA-seq requires a general understanding of the preprocessing of the dataset and a variety of analytical techniques. Here, we present an overview of the workflow involved in analyzing the scRNA-seq dataset. First, we describe the preprocessing of the dataset, including quality control, normalization, and dimensionality reduction. Then, we introduce the downstream analysis provided with the most commonly used computational packages. This review aims to provide a workflow guideline for new researchers interested in this field.

Evaluation of clinical status of fixed prosthesis (고정성 보철물의 임상적 상태에 대한 평가)

  • Yun, Mi-Jung;Jeon, Young-Chan;Jeong, Chang-Mo
    • The Journal of Korean Academy of Prosthodontics
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    • v.47 no.2
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    • pp.99-107
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    • 2009
  • Statement of problem: Restoring and replacing teeth with fixed prostheses commonly used in dental practice. Because of improper oral hygiene care and inaccurate laboratory procedure, complications of fixed prostheses were found in the mouth of patients. Although many efforts have been continually made to obtain the data of long term prognosis of fixed prostheses, it was difficult to do it. Purpose: The purpose of this study was to evaluate the clinical status of fixed prostheses. Material and methods: In order to assess the clinical status of fixed prostheses, a total of 161 individuals(aged 17-85, 99 women and 62 men with 1596 unit of fixed prostheses, and 1169 abutments) who first visited the Department of Prosthodontics, Pusan National University Hospital, between April to September, in 2007 were examined. Results and conclusion: The results of this study were as follows: 1. Length of service of fixed prostheses was $8.6{\pm}0.6$ years(mean), 10.0 years(median). 2. Location of fixed prostheses was found to have no statistically significant influence on longevity of fixed prostheses(P>.05). But, the success rate was high in posterior region and in mandible where the failure rate was high in combination(P<.05). 3. Longevity of fixed prostheses made of metal was longest(mean: $13.0{\pm}9.3$, median: 14.0), gold, precious ceramic, non-precious ceramic trailing behind(P<.05). 4. Number of units in fixed prostheses was found to have no statistically significant influence on longevity of fixed prostheses(P>.05). But, the success rate was high in Single-unit and the failure rate was high in over 3-unit(P<.05). 5. Condition of opposing dentition was found to have no statistically significant influence on longevity of fixed prostheses(P>.05). But, the success rate was high in natural dentition(P<.05). 6. Defective margin(28.2%), dental caries(23.0%), periodontal disease(19.3%), periapical disease(16.9%) were frequent complications. In 30.1% of the cases, abutment state after removing fixed prostheses was needed to be extracted.

Clinical Analysis of the Surgical Treatments for Large Primary Spontaneous Pneumothorax (외과적 치료를 시행한 대량 일차성 자연기흉의 임상분석)

  • Kim, Byung-Ho;Huh, Dong-Myung;Han, Won-Kyung
    • Journal of Chest Surgery
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    • v.42 no.3
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    • pp.344-349
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    • 2009
  • Background: The clinical history and physical findings of the patients with spontaneous pneumothorax depend largely on the extent of the collapse of the lung and the presence of pre-existing pulmonary disease. Large primary spontaneous pneumothorax is a possible serious condition and. so more active treatment will be necessary for these patients. The therapeutic guideline for large pneumothorax remains controversial. Therefore, by assessing the clinical results of surgical treatment for large primary pneumothorax, we aim to determine the indicators of treatment. Material and Method: Among 348 patients with primary spontaneous pneumothorax and who underwent surgical treatment from August 2004 through December 2007, 58 patients who responded to treatment for a large primary pneumothorax were included in the current study. We then retrospectively evaluated the operative findings and the surgical results. The patients with a pneumothorax of 80% or more, including those patients with tension pneumothorax, were considered to have a "large pneumothorax". Most of these patients Should be treated with a 12F chest tube. Thoracoscopic wedge resection was considered for treating recurrent pneumothorax, continuous air leakage, controlateral pneumothorax and first episode pneumothorax with visible blebs (> 1cm) seen on the computed tomography. Result: There were 50 men and 8 women with a mean age of 28.2 years (range: $14\sim54$ years). The mean length of hospitalization was 5.3 days (range: $2\sim10$ days). Nine patients underwent chest tube drainage only. Forty-nine patients underwent thoracoscopic wedge resection. The mean follow up time was 27.8 months (range: $10\sim58$ months). The actual site of air leakage could be located in 35 patients (71.4%) and this was correlated with pleural adhesion (p=0.005). The initial air leakage tended to be more correlated with intra-operative air leakage, although this was not statistically significant (p=0.066). The recurrence rate was 11.1 % for the patients with chest tube drainage and 2.0% for the patients with thoracoscopic wedge resection. Conclusion: Large primary pneumothorax requires an early diagnosis and early treatment. Thoracoscopic wedge resection may help to prevent recurrence of large primary pneumothorax.