• Title/Summary/Keyword: 약물 안전성

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A Study on Pre-school Teachers' Perception of 7 Guidelines of Safety Education: Using IPA Methodology (유아교사가 인식하는 유치원 안전교육 표준안에 대한 연구 : IPA기법을 중심으로)

  • Kang, Min-Jung;Han, Sun-Ah
    • The Journal of the Korea Contents Association
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    • v.17 no.6
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    • pp.661-671
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    • 2017
  • The purpose of this study is to compare and analyze the difference between the importance perceived by pre-school teachers and their actual performance in regards to the 7 Guidelines of Safety Education set out by the Ministry of Education, and through the analysis, to identify the items that need priority support and those that need long-term improvement efforts for exemplary safety education for young children. For this, mean average and standard deviation were calculated and paired sample t-test conducted, and IPA(Importance-Performance Analysis) matrix method was performed to analyze the priority and long-term support items and improvement needs. The study results show differences in all areas and all items in the 7 Guidelines of Safety Education by the MoE in the pre-school teachers' perceived importance and actual performance. Areas and items that are identified to be in need of priority support for exemplary safety education in pre-schools; 2 items under 'Violence and Personal Safety' area and I item under 'Substance and Internet Addictions' area. Areas and items that are identified to be in need of long-term improvement efforts are; 6 items under 'First Aid and Emergency Treatment' area, 1 item under 'Violence and Personal Safety' area, 3 items under 'Workplace Safety Culture' area, 3 items under 'Substance and Internet Addictions' area and 1 item under 'Disaster and Safety' area.

A Study on the Optimal Safety Measurement Classification System by Correcting and Deriving Statistical Items for External Causes of Death (통계청 사망외인 통계항목군의 수정도출을 통한 최적의 안전측정 분류체계(안) 연구)

  • Park, Hyung-joo
    • The Journal of the Convergence on Culture Technology
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    • v.6 no.4
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    • pp.535-543
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    • 2020
  • The KSA caused an error in deriving the statistical measurement items due to the misconfiguration of the safety variables and sub-modules that constitute the safety statistics framework for external causes of death, and pathogenesis, without considering the academic classification system of the field and area of the disaster/accident. By naming it as a mechanism, it was analyzed that the result of poor statistical validity has arrived. Therefore, in this study, by changing the safety parameters according to the WHO safety definition and setting the sub-modules appropriately, the categories of falls, drowning accidents, and accidents exposed to inanimate mechanical forces are classified as accidents at industrial sites and work in daily life. As a result, by systematically re-establishing the complex group of statistical items of the NSO by deriving the field of disasters/accidents according to the nature of the source of external causes of death and setting the relevant domains academically, statistical validity gets better and It is anticipated to play an important role in determining the direction of safe investment.

A Double-blind, Randomized, Placebo-controlled Intervention Study of the Efficacy and Safety of 'Atomento solution & cream' in patients with Atopic Dermatitis (아토피 피부염 환자에 대한 위약 대조 시험법에 의한 'Atomento solution & cream'의 유효성 및 안전성을 평가하기 위한 단일기관, 무작위배정, 이중맹검, 위약대조, 비교 임상연구)

  • Hwang, Sun-Bok;Park, Sung-Min;Oh, Min-Jee;Kim, Hee-Taek
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.22 no.2
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    • pp.223-237
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    • 2009
  • 본 임상연구는 임상연구 모집 공고를 통하여 모집된 대상자 중 Atopic Dermatitis Research Group (2005) 한국인 아토피 피부염 진단기준에 따라 아토피 피부염으로 판정되고 현재 약물(한약, 양약)치료나 외용제 치료를 하고 있지 않은 만 5$\sim$50세의 아토피 피부염 환자를 대상으로 하였다. 피험자들을 이중맹검, 블록무작위배정하여 시험군과 대조군으로 나누어 6주간의 시험기간 동안 육안적 평가, 혈액학적 검사, 피부측정 장비를 통한 기기적 평가를 시험 전후에 실시하여, 시험군에 사용된 제품이 대조군 사용된 제품에 비하여 얼마나 효과적으로 아토피 피부염으로 손상된 피부 장벽을 회복하는지 관찰하였다. 본 임상시험을 통해 'Atomento solution & cream'이 손상된 피부장벽을 회복시키고 피부 보습력을 증가시켜 아토피 피부염에 효과적이었으며, 인체에 이상반응이나 부작용 없이 안전하게 사용될 수 있음을 확인하였다.

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Recent clinical trials with ultrasound induced blood-brain barrier opening (초음파 기반 혈뇌장벽 개방에 관한 최신 임상시험 연구 현황)

  • Park, Juyoung
    • The Journal of the Acoustical Society of Korea
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    • v.41 no.5
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    • pp.564-569
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    • 2022
  • Blood-Brain Barrier (BBB) is the brain protecting system blocking the inflow of harmful substances into brain parenchyma from brain blood vessel. However, the BBB has a negative effect on the treatment of various brain diseases such as Alzheimer's dementia or brain tumors because it also prevents drug delivery into brain parenchyma. To overcome this problem, a brain drug delivery technique using Focused Ultrasound (FUS) which allows BBB to be temporarily opened by inducing the acoustic cavitation effect of microbubbles has been developed. Thus far, various studies using the FUS technique has been conducted to improve drug delivery efficiency, and therefore, this paper discusses recently developed drug delivery technologies using the FUS-induced BBB opening.

An Open-label, Randomized, Comparative Assessment of the Efficacy and Safety between Tofisopam and Lorazepam in Anxiety Disorder (Tofisopam과 lorazepam의 항불안효과와 안전성에 대한 비교 연구)

  • Lee, Min Soo;Kim, Yong-Ku;Kwak, Dong-Il
    • Korean Journal of Biological Psychiatry
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    • v.4 no.2
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    • pp.265-271
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    • 1997
  • Objective : A 4-week, single-blind, parallel group study was conducted to evaluate the efficacy and safety of tofisopam and lorazepam in 32 outpatients with anxiety disorder. Methods : Patients were randomized to receive either tofisopam(N=17) or lorazepam(N=15). The starting dose of tofisopam was 50mg t.i.d. daily, which could be increased to a maximum of 100mg t.i.d. according to the patient's clinical response and side effect. The starting dose of lorazepam was 0.75mg b.i.d. daily, which could be increased to a maximum of 1.5mg b.i.d. depending on the patient's clinical response and side effect. Efficacy evaluations at baseline, week 1, 2, and 4 used the 14-item Hamilton Rating Scale for Anxiety(HAM-A) and Clinical Global Impression(CGI). Tolerability was assessed by response to a nonleading question concerning adverse events. Laboratory parameters including vital sign, EKG, hematological, and biochemical values were measured during trial. Results : No significant differences between HAM-A total scores, two HAM-A factors(psychic, somatic) and CGI severity scores were recorded at any point during tofisopam and lorazepam treatments. However, in each group there was a significant decrease in HAM-A total scores, two HAM-A factor s(psychic, somatic), CGI severity scores over time. The pecentages of patients with tofisopam who at least minimally improved increased from 64.7% at week 1 to 94.1% at week 4. The pecentages of patients with lorazepam who at least minimally improved increased from 40.0% at week 1 to 66.7% at week 4. The pecentages of patients with tofisopam who had not any adverse event increased from 58.8% at week 1 to 87.9% at week 4. The pecentages of patients with lorazepam who had not any adverse event were not changed from 46.7% at week 1 to 46.7% at week 4. Laboratory parameters including vital sign, EKG, hematological, and biochemical values showed no significant changes during the trial in both groups. Conclusion : These data suggest that tofisopam may be effective in reducing anxiety and is a anti-anxiety drug of identical potency with lorazepam. Tolerability of tofisopam was superior to lorazepam. These findings should be confirmed by using double-blind crossover study with a large member of patients.

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Characterization of Chitin and Chitosan as a Biomedical Polymer (생체의료용 재료로써 키틴·키토산의 특성)

  • Jang, Mi-Kyeong;Nah, Jae-Woon
    • Applied Chemistry for Engineering
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    • v.19 no.5
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    • pp.457-465
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    • 2008
  • Development of various medical systems was accomplished through the progress of biotechnological method for therapy of human diseases. Furthermore, drug delivery systems have been investigated to carry the bioactive materials such as drug or gene in the body effectively. The most important thing in this system is to develop biomedical polymers having biocompatibility, biodegradability, and non-toxicity. Chitosan, a natural polymer, has been importantly considered as biomedical materials due to its good biocompatibility and various bio-active characteristics. Since the property of chitosan is differently explained according to the crystalline structures of chitin, the study for structural analysis of chitin has to proceed to apply as a biomaterial. From this point of view, this article introduced the analysis of crystalline structural of chitin, general property of chitosan and potential characteristics of low molecular weight water-soluble chitosan (LMWSC) as a biomaterials. Furthermore, chemical modification of LMWSC using various functional groups was also performed to enhance its bioavailability and emphasize their potential as drug delivery carriers (DDS).

Precision and Safety Comparison for SM, CRM and ATD in Phase I Clinical Trials (제 1상 임상시험의 SM, CRM, ATD에서 결정된 MTD의 정확성과 안전성 비교)

  • Kim, Dong-Uk;Kil, Sun-Kyoung
    • Communications for Statistical Applications and Methods
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    • v.16 no.1
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    • pp.51-65
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    • 2009
  • The purpose of a phase I clinical trial is to determine the maximum tolerated dose(MTD) of a new drug. This paper investigates the performance of standard method, continual reassessment method and accelerated titration designs in phase I clinical trials. Especially we study the precision and safety at the MTD of these methods. We utilize hyperbolic tangent function and power function to define dose-toxicity model. For each method, expected toxicity rate at MTD is computed and compared with target toxicity probability. We also suggest some modifications of these methods and show some improvements in performance.

Therapeutic Effect of Amantadine in Traumatic Brain Injury Patients : Two Cases and Review (외상성 뇌손상 환자에서 Amantadine의 치료적 효과 : 2증례 및 고찰)

  • Jung, Han Yong;Lee, Soyoung Irene;Kim, Yang Rae
    • Korean Journal of Biological Psychiatry
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    • v.8 no.1
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    • pp.156-161
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    • 2001
  • We reported two cases of amantadine treatment in traumatic brain injury patients and reviewed the literature of amantadine treatment of those patients. Problems with short-term memory, attention, planning, problem solving, impulsivity, disinhibition, poor motivation, and other behavioral and cognitive deficit could occur following traumatic brain injury or other types of acquired brain injury. This report described results of amantadine using in two patients with this type of symptom profile. Patients received neuropsychiatric examination as well as BPRS and Barthel index. These patients were improved, respectively from 57 point to 82 point(case 1), from 85 to 94(case 2) in Barthel index, and from 66 point to 35 point(case 1), from 55 to 32 point(case 2) in BPRS. These two patients did not reveal any other adverse effect. The rationale for using amantadine were discussed.

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Comparison of polyethylene glycol 4000 and lactulose for treatment of chronic functional constipation in children (소아의 만성 기능성 변비 치료에 polyethylene clycol 4000과 락툴로스의 효과 비교)

  • Uhm, Ji Hyun
    • Clinical and Experimental Pediatrics
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    • v.50 no.8
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    • pp.752-756
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    • 2007
  • Purpose : The aim of this study was to compare 2 laxatives, namely, polyethylene glycol 4000 without electrolytes and lactulose, evaluating the efficacy and safety for the treatment of constipation in children. Methods : Fifty-six children with chronic functional constipation were randomly assigned to receive polyethylene glycol 4000 (24 patients) or lactulose (32 patients). Patients or their parents reported defecation frequency, stool consistency, abdominal pain, stool incontinence and side effects after 1, 3, 6 and 12 months of treatment. Percentage of recovered patients were compared with each group. Results : Defecation frequency, abdominal pain and stool incontinence were improved in each group. At 12 months of follow up, 60% of patients treated with polyethylene glycol and 57.7% of patients treated with lactulose were considered as recovered. Conclusion : In this study, both polyethylene glycol and lactulose were equally effective and safe in the long-term treatment of constipation in children. There were no significant differences in recovery rates between 2 groups.

A COMPARISON OF THE SEDATIVE EFFECT ON CHLORAL HYDRATE DOSAGE IN THE SEDATION OF THE PEDIATRIC DENTAL PATIENTS (소아환자 진정요법에서 chloral hydrate의 용량에 따른 진정효과에 관한 연구)

  • Rho, Seung-Chul;Kim, Young-Jae;Jang, Ki-Taeg;Hahn, Se-Hyun
    • Journal of the korean academy of Pediatric Dentistry
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    • v.32 no.3
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    • pp.517-524
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    • 2005
  • Despite the widespread use of chloral hydrate with hydroxyzine in the sedation of children, there is little agreement among pediatric dentists regarding its therapeutic dosage for the management of very uncooperative young children. Also, increasing concern has been raised with respect to its frequent failure to provide adequate levels of sedation when used according to the manufacturer's recommended dosage. Therefore, there has been many suggestions with respect to sedative effectiveness and safety of varying drug dosage, and some pediatric dental articles have advocated dosages exceeding manufacturer's recommendations. This study was performed to compare the effectiveness and safety in behavior management of the manufacturer's recommended dose of chloral hydrate(50mg/kg) with those of a higher dose(70mg/kg) used together with hydroxyzine(2mg/kg) and nitrous oxide(50%) when young children were sedated for dental treatment. The following results were obtained; 1. II group(70mg/kg) displayed higher mean score compared to I group(50mg/kg) with regard to the degree of sleep, crying, movement and overall behavior. The difference was statistically significant(p<0.05). 2. In comparison of success rates for sedation between the two groups, I group and II group showed 38.7% and 71.0% success rates respectively. An analysis of variance was statistically significant(p<0.05). 3. Comparing the occurrence rate hypoxia between the two groups, there were 22.6% and 19.4% occurrence of hypoxia in I group and II group. An analysis of variance was not statistically significant(p>0.05).

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