• Title/Summary/Keyword: 무작위임상시험

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Administration of Yijung-tang, Pyeongwi-san, and Shihosogan-tang for Standardization of Korean Medicine Pattern Identification for Functional Dyspepsia: A Study Protocol of a Randomized, Assessor-blind, 3-Arm, Parallel, Open-label, Multicenter Clinical Trial (기능성 소화불량 한의 변증 표준화를 위한 이중탕, 평위산 및 시호소간탕 투여 : 무작위 배정, 평가자 눈가림, 3군 비교, 평행 설계, 공개, 다기관 임상시험 프로토콜)

  • Boram Lee;Min-Jin Cho;Young-Eun Choi;Ojin Kwon;Mi Young Lim;Seok-Jae Ko;So-yeon Kim;Yongjoo Kim;Donghyun Nam;Dong-Jun Choi;Jun-Hwan Lee;Jae-Woo Park;Hojun Kim
    • The Journal of Internal Korean Medicine
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    • v.43 no.6
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    • pp.1105-1121
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    • 2022
  • Objectives: The purpose of this study is to explore the effectiveness and safety of frequently used clinical herbal medicines (Yijung-tang [Lizhong-tang, LJT], Pyeongwi-san [Pingwei-san, PWS], and Shihosogan-tang [Chaihu Shugan-tang, SST]) in patients with functional dyspepsia (FD) when administered according to herbal medicine and Korean medicine pattern identification. The results of this study will be used to standardize the diagnostic instrument used in Korean medicine and to investigate biomarkers of Korean medicine pattern identification. Methods: This study will be a randomized, assessor-blind, 3-arm, parallel, open-label, multi-center clinical trial. A total of 300 FD participants will be recruited from 3 Korean medical hospitals and assigned to the LJT (n=100), PWS (n=100), and SST (n=100) groups according to FD pattern identification. The patients will take the medication for 8 weeks, 3 times a day, before or between meals. The primary outcome will be total dyspepsia symptom (TDS) and the secondary outcomes will be adequate relief (AR) for dyspepsia, overall treatment effect (OTE), visual analogue scale (VAS), functional dyspepsia-related quality of life (FD-QoL), gastrointestinal symptom score (GIS), and pattern identification questionnaires. For the exploratory outcomes, we will analyze blood and fecal metabolome profiles, microbiota from fecal and saliva samples, single nucleotide polymorphism (SNP), and results of Korean medicine diagnosis device measurements (heart rate variability, and tongue, pulse, and abdominal diagnosis). Conclusions: The results of this study will prove objectivity for Korean medicine pattern identifications, and the effectiveness and safety of herbal medicines for the population with FD.

A Multicenter, Randomized, Open, Comparative Study for the Efficacy and Safety of Oral Moxifloxacin 400 mg Once a Day and Clarithromycin 500 mg Twice Daily in Korean Patients with Acute Exacerbations of Chronic Bronchitis (한국인의 만성 기관지염의 급성 악화 환자를 대상으로 한 Moxifloxacin 400mg 1 일 1회 요법과 Clarithromycin 500mg 1일 2회 요법의 치료효과 및 안전성 비교)

  • Kim, Seung-Joon;Kim, Seok-Chan;Lee, Sook-Young;Yoon, Hyeong-Kyu;Kim, Tae-Yon;Kim, Young-Kyoon;Song, Jeong-Sup;Park, Sung-Hak;Kim, Ho-Joong;Chung, Man-Pyo;Suh, Gee-Young;Kwon, O-Jung;Lee, Shin -Hyung;Kang, Kyung-Ho;Lee, Eh-Hyung;Hwang, Sung-Chul;Han, Myung-Ho
    • Tuberculosis and Respiratory Diseases
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    • v.49 no.6
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    • pp.740-751
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    • 2000
  • Background : Moxifloxacin is a newly developed drug which is more potent and safe compared to previous fluoroquinolones. This drug effectively eradicates organisms such as beta-lactamase-producing or other resistant bacteria. Moxifloxacin is known to be effective in treating respiratory infections such as Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, Chlamydia pneumoniaeme, Legionella spp. and Mycoplasma pneumoniae. Methods : In a multicenter, randomized, open, comparative study, the efficacy and safety of oral moxifloxacin taken 400 mg once a day and clarithromycin taken 500 mg twice daily for 7 days were compared for the treatment of Korean patients with acute exacerbations of chronic bronchitis. Results : A total of 170 patients were enrolled, and they were divided into two groups: 87 in the moxifloxacin group and 83 in the clarithromycin group. Of those enrolled, 76 (35 for bacteriologic efficacy) in the moxifloxacin group and 77 (31 for bacteriologic efficacy) in the clarithromycin group were included in the efficacy analysis. All were included in the safety analysis. Clinical success was noted in 70 (92.1%) of 76 moxifloxacin-treated patients and 71 (92.2%) of 77 clarithromycin-treated patients. Bacteriologic success rate seemed to be higher in moxifloxacin group (73.5%) than in clarithromycin group (54.8%), but statistically insignificant (p=0.098). Drug susceptibility among organisms initially isolated was higher in moxifloxacin group on Streptococcus pneumoniae, Pseudomonas aeruginosa, Klebsiella pneumoniae (p<0.001). Adverse events were reported by 12.8% of 86 patients receiving moxifloxacin and 21.7% of 83 patients receiving clarithromycin. Headache (4.7% vs 4.8%, moxifloxacin group vs clarithromycin group, respectively) and indigestion (2.3% vs 6.0%, moxifloxacin group vs clarithromycin group, respectively) were the most frequent side effects in the two groups. Conclusion : This study demonstrated that for the treatment of acute exacerbations of chronic bronchitis a 7-day course of moxifloxacin 400 mg od was clinically equivalent and microbiologically superior to clarithromycin 500 mg bid.

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Effect of Probiotics on Risk Factors for Human Disease: A Review (인간 질병의 위험 요인에 대한 Probiotics의 효과: 총설)

  • Chon, Jung-Whan;Kim, Dong-Hyeon;Kim, Hyun-Sook;Kim, Hong-Seok;Hwang, Dae-Geun;Song, Kwang-Young;Yim, Jin-Hyuk;Choi, Dasom;Lim, Jong-Soo;Seo, Kun-Ho
    • Journal of Dairy Science and Biotechnology
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    • v.32 no.1
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    • pp.17-29
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    • 2014
  • GRAS probiotics can be used to modulate intestinal microbiota and to alleviate various gastrointestinal disorders. In several recent studies, researchers have explored the potential expansion and usability of probiotics to reduce the risk factors associated with diseases, including obesity, hypercholesterolemia, arterial hypertension, hyperhomocysteinemia, and oxidative stress. In this review, our aim was to clarify the mechanism underlying interactions between hosts (animal or human) and probiotics and the beneficial effects of probiotics on human health.

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Effect of Glucose Control, SDSCA and Quality of Life of D-chiro-inositol(DCI) in patients with type 2 diabetes: A Path Analysis (제2형 당뇨병 환자의 D-chiro-inositol의 혈당강하 효과와 당뇨 자가관리 및 삶의 질: 경로분석)

  • Kang, Young Mi;Kim, Hyun Jin;Lee, Tae-Yong;Ku, Bon-Jeong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.10
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    • pp.243-253
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    • 2018
  • This study aimed to investigate the effects of DCI on glucose control, quality of life(SF-36 Version 2.0, Korean) and SDSCA(Summary of Diabetes Self-Care Activities) in patients with type 2 diabetes mellitus. A randomized, double-blind, placebo-controlled study was performed on 46 patients with HbA1c 7.0% taking triple anti-diabetic drug regimen who visited the department of Endocrinology and Metabolism in Chungnam National University Hospital between March 2015 and May 2016. As a result, DCI treatment in the intervention group resulted in significantly reduced HbA1c levels $8.75{\pm}0.79%$(baseline), $8.36{\pm}1.03%$(after 12weeks), and $8.65{\pm}0.81%$(after 24weeks). However, patients in the control group did not show any significant change. Interestingly, both DCI treatment group and the control group significantly showed improvements in SDSCA. Participants in the intervention group showed a small yet significant improvement in their only fasting blood glucose test in SDSCA and revealed significant increase in the quantitative levels of quality of life, from $73.05{\pm}16.85$ to $82.74{\pm}10.68$. By using pathway analysis, improvement of SDSCA scores(${\beta}=-0.505$, t=-2.743) was the most influential factor to the fasting blood glucose. The quality of life of patients with type 2 diabetes mellitus was affected by changes of SDSCA scores(${\beta}=0.411$, t=2.024) and fasting c-peptide(${\beta}=-0.445$, t=-2.668) in DCI treatment group. In conclusion, treatment of DCI effectively improved glucose control in patients with type 2 DM(HbA1c level>7.0%) after 12 weeks of treatment, although it had no impact on glucose control after 24 weeks of treatment. Improved glucose control may encourage diabetic patients to conduct self-care activities and improve the quality of life. Based on the present study, we suggest that diabetes self-management, as well as consideration of comprehensive laboratory findings, may be important factor in regulating the quality of life in type 2 DM patients.

The Usefulness and Safety of Natural Stent in a Canine Model of Tracheal Stenosis (Nd-YAG laser를 이용한 기관협착 동물모델에서 Natural 스텐트의 안전성 및 유효성 -Dumon 스텐트와의 비교 실험-)

  • Kim, Ho-Joong;Koh, Won-Jung;Suh, Gee-Young;Chung, Man-Pyo;Kim, Jhin-Gook;Suh, Soo-Won;Kwon, O-Jung
    • Tuberculosis and Respiratory Diseases
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    • v.53 no.4
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    • pp.431-438
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    • 2002
  • Background : In order to investigate the usefulness and safety of Natural Stent, we performed this study in a canine model of tracheal stenosis induced using Nd-YAG laser. Materials and Methods : After tracheal stenosis was induced in 12 Mongrel dogs using Nd-YAG laser, either Dumon (n=6) or Natural (n=6) stent was inserted into the trachea. To assess the degree of stent migration and mucostasis, bronchoscopy was performed every week for 4 weeks, after which all stents were removed. One week after stent removal, tracheal stenosis was evaluated by bronchoscopy. Results : The degree of stent migration was not different between the dogs with Dumon stent ($3.0{\pm}0.8$) and those with Natural ($2.0{\pm}1.0$), nor was the degree of mucostasis, at Dumon ($1.7{\pm}0.5$) and Natural Stent ($1.5{\pm}0.6$), respectively. One week after stent removal, the degree of tracheal stenosis was not different between the Dumon ($1.5{\pm}0.5$) and the Natural group ($1.0{\pm}0.4$). In addition, there was no death and the degree of tracheal stenosis remained always within the safe limit (less than 2.0) in all animals. Conclusion : In a canine model of tracheal stenosis induced using Nd-YAG laser, the usefulness and safety of Natural Stent were similar to those of Dumon Stent. A clinical trial is necessary to document the usefulness and safety of Natural Stent in patients with tracheal stenosis.

The Prognostic Factors Affecting Survival in Muscle Invasive Bladder Cancer Treated with Radiotherapy (방사선치료를 받은 근 침윤성 방광암의 예후 인자)

  • Chung Woong-Ki;Oh Bong-Ryoul;Ahn Sung Ja;Nah Byung Sik;Kwon Dong-Deuk;Park Kwangsung;Ryu Soo-Bang;Park Yang-IL
    • Radiation Oncology Journal
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    • v.20 no.2
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    • pp.130-138
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    • 2002
  • Purpose : This study analyzed the prognostic factors affecting the survival rate and evaluated the role of radiation therapy in muscle-invading bladder cancer. Materials and Methods : Twenty eight patients with bladder cancer who completed planned definitive radiotherapy in the Departments of Therapeutic Radiology and Urology, Chonnam National University Hospital between Jan. 1986 to Dec. 1998 were retrospectively analyzed. The reviews were peformed based on the patients' medical records. There were 21 males and 7 females in this study. The median of age was 72 years old ranging from 49 to 84 years. All patients were confirmed as having transitional cell carcinoma with histological grade 1 in one patient, grade 2 in 15, grade 3 in 9, and uninformed in 3. Radiation therapy was peformed using a linear accelerator with 6 or 10 MV X-rays. Radiation was delivered daily with a 1.8 or 2.0 Gy fraction size by 4 ports (anterior-posterior, both lateral, alternatively) or 3 ports (Anterior and both lateral). The median radiation dose delivered to the isocenter of the target volume was 61.24 Gy ranging from 59 to 66.6 Gy. The survival rate was calculated by the Kaplan-Meier method. Multivariate analysis was peformed on the prognostic factors affecting the survival rate. Results : The survival rate was $76\%,\;46\%,\;33\%,\;33\%$ at 1, 2, 3, 5 years, respectively, with 19 months of median survival. The potential factors of age (less than 70 years vs above 70), sex, diabetes mellitus, hypertension, hydronephrosis, 1-stage (T3a vs T3b), TUR, chemotherapy, total duration of radiotherapy, radiation dose (less than 60 Gy vs above 60 Gy), and the treatment response were investigated with uniand multivariate analysis. Un univariate analysis, the T-stage (p=0.078) and radiation dose (p=0.051) were marginally significant, and the treatment response (p=0.011) was a statistically significant factor on the survival rate. Multivariate analysis showed there were no significant prognostic factors affecting the survival rate. Conclusion : The treatment response and radiation dose are suggested as th은 statistically significant factors affecting the survival rate of muscle invasive bladder cancer. A Further prospective randomized study is needed to confirm these prognostic factors.

A STUDY ON THE BONDING OF COMPOMER TO DECIDUOUS DENTIN (컴포머와 유치 상아질의 결합에 관한 연구)

  • Kim, Jee-Tae;Kim, Yong-Kee;Kim, Jong-Soo;Kwon, Soon-Won
    • Journal of the korean academy of Pediatric Dentistry
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    • v.29 no.4
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    • pp.509-518
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    • 2002
  • The purpose of this study was to evaluate the bonding of compomer to deciduous dentin which is known to have been developed to improve the weak properties of glass ionomer cement and composite resin. 120 sound primary molars were used for the shear bond strength test and another 24 for the scanning electron microscopic evaluation. Each material was ailed into polyethylene mold attached to exposed dentinal surface($3{\times}4mm$ in diameter) of sample blocks. Shearbond strength was measured using Universal testing machine and data were analyzed statistically with Oneway-ANOVA and Scheffe test. Scanning electron microscopic observation was performed in order to evaluate the pattern of distribution and penetration of resin tags and hybrid layer. Compomer groups(II-V) showed significantly higher bond strength values than glass ionomer group(I)(p<.05). Etching-compomer groups(III, V) showed the significantly higher bond strength than non-etching compomer groups(II, IV)(p<.05), but slightly lower values than composite resin group(VI) with no statistically significant difference(p>.05). No significantly different bond strength was found between compomer groups of different bonding system(p>.05). Scanning electron micrographs showed more irregular distribution of short and thin resin tags in non-etching compomer groups(II, IV) whereas the more regular and intimate distribution of long and thick tags in etching compomer groups(III, V) and composite resin group(VI). The evaluation of hybrid layer also showed more regular formation of thicker layer in etching compomer groups(III, V). Based on the results of present study, the use of compomer as an esthetic restorative material for primary molars might be justified.

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A Review of Statistical Methods in the Korean Journal of Orthodontics and the American Journal of Orthodontics and Dentofacial Orthopedics (대한치과교정학회지(KJO)와 미국교정학회지(AJODO)에서 사용된 통계기법의 비교분석 및 고찰(1999-2003))

  • Lim, Hoi-Jeong
    • The korean journal of orthodontics
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    • v.34 no.5 s.106
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    • pp.371-379
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    • 2004
  • The purpose of this study was to investigate the changes and types of statistical methods used in the Korean Journal of Orthodontics (KJO) and the American Journal of Orthodontics and Dentofacial Orthopedics (AJODO) from )999 to 2003. The frequency of use, transitions, assumption check of statistical methods and types of advanced statistical methods were examined from each journal. The study consisted of 247 articles published in the KJO and randomly chosen 50 articles per year which were original articles and used statistical methods T-test, analysis of variance(ANOVA), correlation analysis, nonparametric analysis. regression analysis chi-square test. factor analysis, were the order of statistical methods most frequently used in the KJO, while t-test. ANOVA, nonparametric analysis, correlation analysis, regression analysis, chi-square test. factor analysis. were the order of statistical methods used in the AJODO The changes of statistical methods observed in the KJO were not significant $(X^2=17.4\;p=0.5881)$ but the changes observed in the AJODO was seen to be significant $(x^2=42.4,\;p=0.0397)$ Some of the studies examined had overlooked the assumptions of the statistical methods employed. Data investigation such as outlier should be performed before analysis and alternative statistical approaches are applied for a small sample size. Types of advanced statistical methods were factor analysis and discriminant analysis in the KJO and Intention-To-Treat (ITT) analysis in clinical trials through multi-center, survival analysis and Generalized Estimating Equations (GEE) in the AJODO. Appropriate analysis approaches and interpretations should be applied for the correlated and repeated measurements of the orthodontic data set.

Meta-analysis of Intravitreal Injection of Anti-vascular Endothelial Growth Factors for Diabetic Macular Edema (당뇨황반부종에서 항혈관성장인자의 유효성과 안전성: 네트워크 메타분석)

  • Tchoe, Hajin;Shin, Sang Jin;Suh, Jae Kyung;Cho, Songhee;Yang, Jangmi;Kang, Min Joo;Jee, Donghyun
    • Journal of The Korean Ophthalmological Society
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    • v.60 no.2
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    • pp.144-151
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    • 2019
  • Purpose: Intravitreal aflibercept, ranibizumab, bevacizumab, and dexamethasone are the most widely used drugs in the treatment of diabetic macular edema (DME). The aim of this study was to compare the efficacy and safety of anti-vascular endothelial growth factors and dexamethasone for the treatment of DME. Methods: There were nine previous systematic reviews on this topic; we updated these high-quality reviews. Seven studies were added to two studies following a literature search. Efficacy outcomes were 1) average improvement in visual acuity, 2) proportion of patients who experienced an improvement in vision (an increase in best-corrected visual acuity (BCVA) of ${\geq}15$ in the Early Treatment Diabetic Retinopathy Study [ETDRS]), and 3) proportion of patients who experienced worsening vision (a decrease in BCVA of ${\geq}15$ in the ETDRS). Safety outcomes included systemic adverse events and ocular-related adverse events. Results: The mean difference in the BCVA for ranibizumab versus bevacizumab treatment was 0.16 (95% confidence interval [CI]: -0.02, 0.34), and that for ranibizumab versus aflibercept was -0.08 (95% CI: -0.26, 0.10). The mean difference in the change of BCVA for aflibercept versus ranibizumab was -0.20 (95% CI: -0.40, -0.01), and that for aflibercept versus bevacizumab was -0.34 (95% CI: -0.53, -0.14). Other efficacy outcomes showed similar trends, and there was no significant difference between treatments. There was also no significant difference in both systemic and ocular adverse events rates between the treatments. Conclusions: In DME patients, the efficacy of aflibercept was found to be higher with respect to BCVA changes compared with ranibizumab or bevacizumab. However, there were no significant difference in terms of visual acuity improvement or visual acuity of more than 15 letters, nor in terms of anti-vascular endothelial growth factors (as a safety outcome).

Association of coffee consumption with health-related quality of life and metabolic syndrome in Korean adults: based on 2013~ 2016 Korea National Health and Nutrition Examination Survey (한국 성인 남녀의 커피 섭취와 건강관련 삶의 질 및 대사증후군과의 관련성 : 2013 ~ 2016 국민건강영양조사 자료를 이용하여)

  • Kim, Hyesook;Kim, Yu Jin;Lim, Yeni;Kwon, Oran
    • Journal of Nutrition and Health
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    • v.51 no.6
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    • pp.538-555
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    • 2018
  • Purpose: This study examined the association of the type and frequency of coffee consumption with the health-related quality of life and metabolic bio-markers in adult men and women from the 2013 ~ 2016 Korea National Health and Nutrition Examination Survey (KNHANES). Methods: A total of 11,201 subjects (4,483 men and 6,718 women) were classified according to the type of coffee consumption (non-coffee, black coffee, 3-in-1 coffee) and type and frequency of coffee consumption (non-coffee, ${\leq}2$ times/day of black coffee, > 2 times/day of black coffee, ${\leq}2$ times/day of 3-in-1 coffee, > 2 times/day of 3-in-1 coffee) using food frequency questionnaires. Dietary nutrient intake data were assessed using food frequency questionnaires. The health-related quality of life was measured using the EuroQol-5 dimension (EQ-5D) and EQ-5D index score. Data on metabolic bio-markers were obtained from a health examination. Results: Among men and women, the proportion of subjects with an energy intake below the estimated energy requirement (EER) was lower among the 3-in-1 coffee consumption group, and the proportion of subjects with iron intakes below the estimated average requirements (EAR) was lower among the 3-in-1 coffee consumption group. Women (OR: 0.810, 95% CI: 0.657 ~ 0.998) with the ${\leq}2$ times/day of 3-in-1 coffee had a lower risk of impaired health-related quality of life (lowest 20% level in the EQ-5D score) compared to the non-coffee consumers after a multivariable adjustment. In both men and women, the type and frequency of coffee consumption was not associated with metabolic bio-markers risk after multivariable adjustment. Conclusion: These results suggest that 3-in-1 coffee consumption may be associated with a lower risk of impaired health-related quality of life and may not be associated with the metabolic bio-markers risk in adult men and women.