• Title/Summary/Keyword: double blind method

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Efficacy and safety of vitamin D3 B.O.N intramuscular injection in Korean adults with vitamin D deficiency

  • Choi, Han Seok;Chung, Yoon-Sok;Choi, Yong Jun;Seo, Da Hea;Lim, Sung-Kil
    • Osteoporosis and Sarcopenia
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    • v.2 no.4
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    • pp.228-237
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    • 2016
  • Objective: There has been no prospective study that examined intramuscular injection of high-dose vitamin D in Korean adults. The aim of this study was to assess the efficacy and safety of high-dose vitamin $D_3$ after intramuscular injection in Korean adults with vitamin D deficiency. Method: This study was a 24-week, prospective, multicenter, randomized, double-blind, placebo-controlled trial. A total of 84 subjects ${\geq}19$ and <65 years of age were randomly allocated to either the vitamin $D_3$ or placebo group in a 2:1 ratio. After randomization, a single injection of plain vitamin $D_3$ 200,000 IU or placebo was intramuscularly administered. If serum 25-hydroxyvitamin D (25[OH]D) concentrations were <30 ng/mLon week 12 or thereafter, a repeat injection was administered. Results: After a single intramuscular injection of vitamin $D_3$ to adults with vitamin D deficiency, the proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 12 weeks was 46.4% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). The proportion of subjects with serum 25(OH)D concentrations ${\geq}30ng/mL$ within 24 weeks was 73.2% in the vitamin $D_3$ group and 3.6% in the placebo group (p<0.0001). Mean change in serum 25(OH)D concentrations at weeks 12 and 24 after vitamin $D_3$ injection was $12.8{\pm}8.1$ and $21.5{\pm}8.1ng/mL$, respectively, in the vitamin $D_3$ group, with no significant changes in the placebo group. Serum parathyroid hormone concentrations showed a significant decrease in the vitamin $D_3$ group but no change in the placebo group. Conclusion: Intramuscular injection of vitamin $D_3$ 200,000 IU was superior to placebo in terms of its impact on serum 25(OH)D concentrations, and is considered to be safe and effective in Korean adults with vitamin D deficiency.

Development of a smart cane concept for guiding the visually impaired - focused on design thinking learning practices for students - (시각장애인을 위한 길 안내용 스마트 지팡이 콘셉트 개발)

  • Park, Hae Rim;Lee, Min Sun;Yang, Ho Jung
    • Journal of Service Research and Studies
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    • v.13 no.1
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    • pp.186-200
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    • 2023
  • This study aims to improve the usability of the white cane, which is walking equipment that most local visually impaired people use and carry when going out, and to contribute to the prevention of safety accidents and the walking rights of visually impaired people by providing improvement and resolution measures for the problems identified. Also, this study is a study on the visually impaired, primarily targeting the 1st to 2nd degree visually impaired people, who cannot go out on their own without walking equipment such as a white cane, corresponding to 20% among approximately 250,000 blind and low vision people in the Korean population. In the study process, the concept has been developed from the user's point of view in order that the white cane becomes a real help in the walking step of the visually impaired and the improvement of usability of the white cane, the main walking equipment for the visually impaired, are done by problem identification through the Double Diamond Model of Design Thinking (Empathize → Define → Ideate → Prototype → Test (verify)). As a result of the investigation in the process of Empathy, a total of five issues was synthesized, including an increase in the proportion of the visually impaired people, an insufficient workforce situation to help all the visually impaired, an improvement and advancement of assistive devices essential for the visually impaired, problems of damage, illegal occupation, demolition, maintenance about braille blocks, making braille block paradigms for the visually impaired and for everyone. In Ideate and Prototype steps, situations derived from brainstorming were grouped and the relationship were made through the KJ method, and specific situations and major causes were organized to establish the direction of the concept. The derived solutions and major functions are defined in four categories, and representative situations requiring solutions and major functions are organized into two user scenarios. Ideas were visualized by arranging the virtual Persona and Customer Journey Map according to the situation and producing a prototype through 3D modeling. Finally, in the evaluation, the final concept derived is a device such a smart cane for guidance for the visually impaired as ① a smart cane emphasizing portability + ② compatibility with other electronic devices + ③ a product with safety and convenience.

A Comparison of Tiotropium 18㎍, Once Daily and Ipratropium 40㎍, 4 Times Daily in a Double-Blind, Double-Dummy, Efficacy and Safety Study in Adults with Chronic Obstructive Pulmonary Disease (만성폐쇄성폐질환 환자에서 Tiotropium 1일 1회, 1회 18㎍ 요법과 Ipratropium 1일 4회, 1회 40㎍ 요법의 치료효과 및 안전성 비교)

  • Kim, Seung Joon;Kim, Myung Sook;Lee, Sang Haak;Kim, Young Kyoon;Moon, Hwa Sik;Park, Sung Hak;Lee, Sang Yeub;In, Kwang Ho;Lee, Chang Youl;Kim, Young Sam;Kim, Hyung Jung;Ahn, Chul Min;Kim, Sung Kyu;Kim, Kyung Rok;Cha, Seung Ick;Jung, Tae Hoon;Kim, Mi Ok;Park, Sung Soo;Choi, Cheon Woong;Yoo, Jee Hong;Kang, Hong Mo;Koh, Won Jung;Ham, Hyoung Suk;Kang, Eun Hae;Kwon, O Jung;Lee, Yang Deok;Lee, Heung Bum;Lee, Yong Chul;Rhee, Yang Keun;Shin, Won Hyuk;Kwon, Sung Yeon;Kim, Woo Jin;Yoo, Chul Gyu;Kim, Young Whan;Shim, Young Soo;Han, Sung Koo;Park, Hye Kyung;Kim, Yun Seong;Lee, Min Ki;Park, Soon Kew;Kim, Mi Hye;Lee, Won Yeon;Yong, Suk Joong;Shin, Kye Chul;Choi, Byoung Whui;Oh, Yeon Mok;Lim, Chae Man;Lee, Sang Do;Kim, Woo Sung;Kim, Dong Soon;Jung, Sung Soo;Kim, Ju Ock;Ko, Young Chun
    • Tuberculosis and Respiratory Diseases
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    • v.58 no.5
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    • pp.498-506
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    • 2005
  • Background : This study compared the bronchodilator efficacy and safety of tiotropium inhalation capsules ($18{\mu}g$ once daily) with a ipratropium metered dose inhaler (2 puffs of $20{\mu}g$ q.i.d.) in patients with chronic obstructive pulmonary disease (COPD). Method : After the initial screening assessment and a two-week run-in period, patients received either tiotropium $18{\mu}g$ once daily or ipratropium $40{\mu}g$ four times daily over a period of 4 weeks in a double blind, double dummy, parallel group study. The outcome measures were the lung function, the daily records of the peak expiratory flow rate (PEFR), the patients' questionnaire, and the use of concomitant salbutamol. The forced expiratory volume in one second ($FEV_1$) and the forced vital capacity (FVC) were measured 5 minutes before inhalation, and 0.5, 1, 2 and 3 hours after inhaling the study drug on days 0, 14 and 28. Result : In 16 centers, 134 patients with a mean (SD) age of 66 (7) years and a predicted $FEV_1$ of 42 (12)% were analyzed. The trough $FEV_1$ response was significantly higher in the tiotropium group than in the ipratropium group after a four-week treatment period. The weekly mean morning PEFR of the tiotropium group was consistently higher than that of the ipratropium group during the 4-week treatment period with differences ranging from 12.52 to 13.88 l/min, which were statistically significant. Tiotropium was well tolerated by the COPD patients during the 4-week treatment period and had a similar safety profile to ipratropium. Conclusion : This study shows that tiotropium administrated once daily has a superior bronchodilator effect with a similar safety profile in treating COPD patients compared with ipratropium, inhaled four times daily.

Reevaluation of Clinical Efficacy of Peripheral Vasodilator: Ethaverine HCl (말초혈관(襪梢血管) 확장제(擴張劑) Ethaverine HCl의 임상효과(臨床效果)의 재평가(再評價))

  • Kim, Yoon-Young;Cho, Young-W.
    • The Korean Journal of Pharmacology
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    • v.11 no.1 s.17
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    • pp.33-38
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    • 1975
  • The clinical efficacy of Ethaverine, a peripheral vasodilator, was studied according to a double-blind, non-cross over method in 29 diabetic patients with peripheral arterial diseases. The clinical improvement was assessed from the history of patients including the incidence and frequency of intermitten claudication. Ethaverine, after 4 weeks of therapy, was not effective in improving clinical symptoms compared to placebo. Ethaverine, however, was an efective vasodilator than placebo. The quality of vasodilation induced by Ethaverine, was similar to that of alcohol. A new clinical method of studying peripheral vasodilator was presented. The clinical symptoms of peripheral vascular arterial disease in the lower extrimities include reduced intensity of palpable pulses, coldness, and discoloration of the skin. Intermittent claudication may be present. Pathologic changes in vessel architecture precede the symptoms, and recognition of impending vascular insufficiency is a determining factor in selecting vasodilating therapy or surgical management. Also, post-operative patients who have chronic peripheral vascular arterial disease may be candidates for subsequent vasodilating therapy. Peripheral vasodilators, according to the series of reports, may be indicated in vasospastic peripheral vascular condition rather than an occlusive vascular disease and the vessel responds best when a relatively large vascular beds are involved rather than a small, capillary beds. Recently, the clinical efficacy of peripheral vasodilators have been challanged by many clinical investigators and clinicians. In this study, we have re-evaluated the efficacy of Ethaverine HCl as peripheral vasodilator in patients with vasospastic peripheral arterial disease. Ethaverine is claimed to be two to four times as potent a spasmolytic agent as papaverine in a variety of laboratory and clinical work.

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Is Premedication Necessary for Outpatient Fiberoptic Bronchoscopy (외래환자의 기관지내시경검사시 전처치의 필요성)

  • Won, Jun-Hee;Park, Jae-Yong;Cha, Seung-Ick;Kang, Tae-Kyong;Park, Ki-Su;Kim, Yeon-Jee;Kim, Chang-Ho;Jung, Tee-Hoon
    • Tuberculosis and Respiratory Diseases
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    • v.46 no.2
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    • pp.251-259
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    • 1999
  • Background: Even though the necessity for premedication has been questioned, some combinations of antisialogogues, sedatives and analgesics are usually employed by most bronchoscopists. The goal of this study was to determine whether fiberoptic bronchoscopy(FOB) could be performed safely and effectively without premedication while using a standardized topical anesthetic. Method: Eighty outpatients were randomized in a double-blind manner into group I(n=20) with 1 ml normal saline, group II(n=20) with 0.5mg of atropine, group III(n=20) with 0.5mg of atropine plus 5mg of midazolam, and group IV(n=20) with 0.5mg of atropine plus 50mg of meperidine, given intramuscularly 30 minutes before FOB as premedication Topical anesthetics administered were same in each group. Each patient was given 5ml(200mg) of 4% nebulized lidocaine and additional intratracheobronchial 2% lidocaine. Oxygen saturation, pulse rate and electrocardiogram were monitored and recorded before, during, just after and 2 minutes after FOB. Immediately after FOB, the bronchoscopists answered four questions such as ease of procedure, extent of coughing, extent of secretion, and overall impression. Before leaving bronchoscopy suite, patients completed similar questions on discomfort during procedure, and willingness to return for a repeat procedure. Results: Age, gender, baseline pulmonary function, dose of 2% lidocaine used for topical anesthesia, and duration of FOB were not significantly different. There was no statistical difference among group I to IV with regard to extent of coughing answered by bronchoscopist. But extent of secretion was significantly different between group I without atropine and group II-IV with atropine. And there was also significant difference in ease of procedure and overall impression among groups. There was no statistical difference in patient's willingness and level of discomfort among the groups. Thirteen patients(16%) showed hypoxemia(arterial oxygen saturation: <90%), and 3 patients(4%) showed significant tachyarrhythmia(heart rate: > l60/min), but the rate of complication was not statistically different among the groups. Conclusion: These results suggest that the value of premedication is questionable for outpatient FOB, although it may be necessary in excessively anxious patient.

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Changes of Sputum Matrix Metalloproteinases and Tissue Inhibitor of Matrix Metalloproteinase-1 by Antibiotic Treatment in Acute Exacerbation of Chronic Bronchitis (만성 기관지염의 급성 악화에서 항생제 투여에 의한 유도객담 내 Matrix metalloproteinase와 Tissue inhibitor of matrix metalloproteinase의 변화)

  • Yoon, Hyoung-Kyu;Ahn, Joong-Hyun;Kim, Chi-Hong;Kwon, Soon-Seog;Kim, Young-Kyoon;Kim, Kwan-Hyung;Moon, Hwa-Sik;Park, Sung-Hak;Song, Jeong-Sup
    • Tuberculosis and Respiratory Diseases
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    • v.53 no.4
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    • pp.420-430
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    • 2002
  • Background : Excessive extracellular matrix (ECM) deposition by airway inflammation is presumed to play an important role in the pathogenesis of worsening airflow obstruction (Ed- acceptable three-word noun) seen during acute exacerbations of chronic bronchitis. Although many proteases can cleave ECM molecules, matrix metalloproteinases (MMPs) and their inhibitors are likely to be the physiologically relevant mediators of ECM degradation. Objectives ; The purpose of this study was to demonstrate that antibiotic treatment can change airway MMPs and TIMP-1 concentrations/levels by controlling airway inflammation in acute exacerbation of chronic bronchitis. Methods : We studied 40 patients, all of whom had an acute exacerbation of chronic bronchitis. The patients were treated with two different antibiotics, moxifloxacin and clarithromycin, in a double-blind manner for 7 days. Sputum samples were induced and collected before and after antibiotic therapy. We measured the sputum concentration of MMP-1,-9, TIMP-1, IL-8 and secretory leukocyte proteinase inhibitor (SLPI) in sputum supernatants by ELISA method. Results : There was no difference after antibiotic treatment in the sputum concentrations of MMP-1,-9, TIMP-1, IL-8 and SLPI between the patients treated with moxifloxacin and those treated with clarithromycin. But the sputum concentrations of TIMP-1, and SLPI, and the TIMP-1/MMP-1 ratio were significantly reduced by the antibiotic therapy. There were significant positive correlations between sputum TIMP-1 levels and IL-8 levels (p<0.01, r=0.751), and between the sputum TIMP-1/MMP-1 ratio and IL-8 levels (p<0.01, r=0.752). The sputum SLPI levels were significantly elevated by antibiotic treatment and were negatively correlated with sputum TIMP-1 levels (p<0.01, r=-0.496) and TIMP-1/MMP-1 levels (p<0.01, r=-0.456). Conclusion : The study shows that the worsening of airway inflammation in acute exacerbation of chronic bronchitis is associated with an imbalance between the concentrations/levels of TIMP-1 and MMPs. Antibiotic treatment can prevent progression of airway narrowing in acute exacerbation of chronic bronchitis by modulation of the protease and anti-protease imbalance.

A Clinical Study about Effectiveness of Essential Oil-Containing Dental Paste in Controlling Oral Malodor (아로마 함유 치약이 구취에 미치는 영향에 관한 임상적 연구)

  • Jeon, Lee-Sun;Kang, Soo-Kyung;Chun, Yang-Hyun;Hong, Jung-Pyo
    • Journal of Oral Medicine and Pain
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    • v.30 no.2
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    • pp.141-148
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    • 2005
  • Since many reports for the influence of the essential oils on the oral microorganism were presented, it is important to use the essential oils in clinical field. At the present day which emphasized the quality of life, oral malodor is one of the serious problems, so we need to try to decrease of oral malodor. This study was designed to make on evidence of the effect of essential oils to oral malodor clinically and to develop on effective treatment for oral malodor by using the dental paste which contains essential oils. 40 dental students volunteered to participate in this study and double blind test was used. At the beginning, all subjects were measured their morning malodor prior to this experiment, at the 3cm posterior to their incisal edge of the oral cavity by Halimeter(Interscan Co. Chatsworth, CA). After that we divided the students in half into two groups A and B. We have supplied different tooth pastes, dental paste A and B, to two groups respectively. The dental paste B contained essential oils which are tea tree, lemon and peppermint. All students used different tooth pastes everyday for 3 weeks. And all students were measured their morning malodor every week with the same method by using Halimeter. This study was resulted that ; 1. The dental paste which contains essential oils has continuously decreased the morning malodor during the whole period of experiments. 2. The number of students with increase in their morning malodor was generally decreased in the group B who used the toothpaste which contains essential oils, compared with the group A who used the toothpaste which didn't contain essential oils on the 2nd and 3rd week of the experiment. 3. In the group B, the average data on increasing rate of morning malodor was less than in the group A. 4. In the 2nd and 3rd week of the experiment, the data on the rate of morning malodor of the group B was generally decreased continuously compared with the group A. These results have statistically significance under 95% confidence interval of the difference.(p$\leq$0.05) As the result, the toothpaste which was containing essential oils was effective in decreasing the morning malodor.