• Title/Summary/Keyword: efficacy and safety

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Efficacy and Safety of Herb Medication According to Cold-heat Tendency of Knee Osteoarthritis Patients (퇴행성 슬관절염 환자의 한열 성향에 따른 한약 제제의 유효성과 안전성 비교)

  • Song, Ji-Yeon;Kim, Min-Jung;Sung, Won-Seok;Kim, Pil-Kun;Goo, Bon-Hyuk;Kwak, Hyun-Young;Kim, Ji-Hye;Kim, Dong-Hyuk;Park, Yeon-Cheol;Seo, Byung-Kwan;Baek, Yong-Hyeon;Choi, Do-Young;Lee, Jae-Dong;Park, Dong-Suk
    • Journal of Acupuncture Research
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    • v.29 no.5
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    • pp.97-108
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    • 2012
  • Objectives : To demonstrate the importance of syndrome differentiation in clinical research of herb medication, through the comparative study on efficacy and safety of herb medication according to cold-heat tendency of OA knee patients. Methods : During December 2010 to July 2011, 138 knee OA patients were randomly assigned to WIN-34B 600mg(300mg, b.i.d.), 1,200mg(600mg, b.i.d.) and placebo b.i.d. for 8 weeks. Patient were re-classified into cold-heat tendency group according to cold-heat questionnaires. To investigate efficacy and safety, we assessed the 100mm pain VAS at baseline and 8 weeks later, and we monitored adverse event of patients during treatment period. Results : 1. Efficacy study : In WIN-34B 1,200mg group, VAS mean changes of heat tendency group showed slightly increase than those of cold tendency, but no significant difference within two groups. In heat tendency group, WIN-34B 1,200mg group showed a significant decrease of VAS compared to placebo group. but there were no significant difference in cold tendency group. 2. Safety study; In WIN-34B 600mg group, incidence of adverse events of cold tendency group was higher than those of heat tendency, but not in WIN-34B 1,200mg group. Conclusions : This study suggests that WIN-34B tend to have more efficacy in heat tendency-knee OA patients and WIN-34B is safe drug relatively, regardless of cold-heat tendency. In further clinical research on efficacy and safety of WIN-34B, stratification using syndrome differentiation is required.

Good Laboratory Practice Requirements in Oriental Pharmacy

  • Seo, Min-Jun;Lee, Jae-Jun;Park, Jin-Han
    • Journal of Evidence-Based Herbal Medicine
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    • v.1 no.1
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    • pp.29-34
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    • 2008
  • Good Laboratory Practice(GLP) is becoming more and more important in the research and development of Oriental Pharmacy(OP) and its globalization. If a OP product is to be registered as Over-the-Counter(OTC) drug and enter international markets, the safety and efficacy studies conducted according to GLP requirements is necessary. The article introduces the content of GLP requirements and the recent development of GLP. The safety and efficacy assessment for OP or herbal medicines under GLP are also covered. This paper also briefly describes the areas that should be covered by GLP regulation and the areas that do not need to follow GLP requirements.

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A Study on the Effects of Aviation Safety Perception among College Students Majoring in Aviation Service on Major Recognition, Major Commitment, and Employment Efficacy (항공서비스전공 대학생의 항공안전 인식이 전공인식, 전공몰입, 취업효능감에 미치는 영향에 관한 연구)

  • Ha Young Kim
    • Journal of the Korean Society for Aviation and Aeronautics
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    • v.31 no.3
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    • pp.119-132
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    • 2023
  • In recent years, the competition for employment among college students has become more intense. It is also the time when strong personal beliefs and will to develop careers are required for successful employment through stable major study. Therefore, in this study, we tried to find out the effect on major attitude and employment efficacy according to the level of aviation safety perception, which is an important issue in the aviation industry. For analysis, survey is conducted targeting college students majoring in aviation service who are enrolled in universities in the metropolitan area and Chungcheong area. To verify the hypotheses of the study, demographic characteristics are identified based on questionnaires, reliability and validity of measurement items are verified, and structural equation model analysis is performed to verify the hypotheses. The analysis results are as follows. First, it is found that safety knowledge and safety consciousness, which are sub-factors of aviation safety perception of college students majoring in aviation service, have a positive (+) effect on subject recognition, learning process recognition, and career recognition of major recognition. Second, subject recognition, learning process recognition, and career recognition, which are sub-factors of major recognition, are found to have a positive effect on major commitment. Third, it is found that major commitment have a positive (+) effect on employment efficacy. Based on the research results, practical support plans and strategies for effective major study and successful employment are presented.

Effects of Participation in Survival Swimming Education on Elementary School Students' Underwater Anxiety, Physical Self-efficacy and Water Safety Awareness (생존수영교육 참여가 초등학생의 수중불안, 신체적 자기효능감 및 수상안전 의식에 미치는 영향)

  • Bae, Jun-seok;Cho, Gun-Sang;Kwon, Yong-Chul
    • Journal of Digital Convergence
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    • v.19 no.3
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    • pp.415-423
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    • 2021
  • The purpose of this study was to report the changes in underwater anxiety, physical self-efficacy, and water safety consciousness in elementary school students through participation in survival swimming education, and the relationship between variables. For this purpose, 300 out of 312 elementary school students who participated in survival swimming education in Busan were used as valid samples. The collected data were analyzed through exploratory factor analysis, reliability analysis, correspondence sample t-test, and multiple regression analysis using the SPSS 25.0 statistical program, and the results are as follows. First, the underwater anxiety of elementary school students before and after participating in survival swimming education decreased, and the physical self-efficacy and water safety awareness increased. Second, underwater anxiety of elementary school students who participated in survival swimming education partially negatively affected physical self-efficacy and water safety consciousness, and physical self-efficacy partially positively affected water safety consciousness. Based on these results, the effectiveness of survival swimming education could be confirmed, and the direction of qualitative expansion of the program could be reconsidered.

Patient Safety Management Activities of Korean Nurses: A Meta-Analytic Path Analysis (국내 간호사의 환자안전관리활동에 대한 메타경로분석)

  • Jeong, Seohee;Jeong, Seok Hee
    • Journal of Korean Academy of Nursing
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    • v.52 no.4
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    • pp.363-377
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    • 2022
  • Purpose: This study aimed to test a hypothetical model of Korean nurses' patient safety management activities using meta-analytic path analysis. Methods: A systematic review, meta-analysis, and meta-analytic path analysis were conducted following the PRISMA and MOOSE guidelines. Seventy-four studies for the meta-analysis and 92 for the meta-analytic path analysis were included. The R software program (Version 3.6.3) was used for data analysis. Results: Four variables out of 49 relevant variables were selected in the meta-analysis. These four variables showed large effect sizes (ESr = .54) or median effect sizes (ESr = .33~.40) with the highest k (number of studies) in the individual, job, and organizational categories. The hypothetical model for the meta-analytic path analysis was established using these variables and patient safety management activities. Twelve hypothetical paths were set and tested. Finally, the perception of the importance of patient safety management and patient safety competency directly affected patient safety management activities. In addition, self-efficacy, the perception of the importance of patient safety management, patient safety competency, and patient safety culture, indirectly affected patient safety management activities. Conclusion: Self-efficacy, the perception of the importance of patient safety management, patient safety competency, and the organization's patient safety culture should be enhanced to improve nurses' patient safety management activities.

The Relationship analysis between Safety Consciousness, Self-Efficacy, and Life-Respect according to Participation in Survival Swimming Program of Elementary School Students for interdisciplinary convergence research (학제 간 융합연구를 위한 생존수영프로그램 참여 초등학생의 안전의식과 자아효능감 및 생명존중의 관계 분석)

  • Kang, Hyo-Min;Lee, Yong-Kuk
    • Journal of Digital Convergence
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    • v.17 no.6
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    • pp.401-408
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    • 2019
  • The purpose of this study was to identify the relationship analysis between safety consciousness, self-efficacy, and life-respect according to participation in survival swimming program of elementary school students for interdisciplinary convergence research. In order to achieve this purpose, 248 elementary school students were selected from registered in Kangwon-do area by the cluster sampling method. Frequency analysis, confirmatory factor analysis, reliability analysis, correlations analysis and structural equation model analysis were executed using SPSS Statistics 23.0 Version and AMOS 23. As the results, First, it was discovered that the Safety Consciousness had static influence to the Self-Efficacy. Second, it showed that the Safety Consciousness did not gave static influence to the Life-Respect. Finally, it showed that the Self-Efficacy had static influence to the Life-Respect. In conclusion, the safety consciousness of elementary school students participating in the survival swimming program influences self-efficacy. It also has a positive effect on respect for life through self-efficacy. Therefore, various approaches to survival swimming education program are needed from the perspective of interdisciplinary fusion research.

Development and effect of elementary school upper-grade safety health education program (초등학교 고학년 안전보건교육 프로그램 개발과 효과검증)

  • Jung, Hyun-Min;Lee, Hyo-Cheol
    • The Korean Journal of Emergency Medical Services
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    • v.17 no.3
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    • pp.149-168
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    • 2013
  • Purpose: The purpose of this study is to develop a safety health education program for the upper graders of elementary school children and to evaluate the program. Methods: The study was designed for learner centered safety education and heath education based on a theory of lifelong education. After a model development of the program was set up, five major units were selected after five stages of program planning, design, acting, evaluation and feedback: school safety, traffic safety, home safety, life safety, and first-aid. Twenty things were selected as what to teach, and a lesson plan of 12 sessions was mapped out by arranging what to teach. The subjects in this study were 114 elementary school students who were in five different sixth-grade classes. Each class received education for five days, in four sessions each, according to the program. Results: The learners showed improvement in safety consciousness, safety knowledge, self-efficacy and safety behavior after they received education according to the safety health education program, and they expressed a lot of satisfaction with the program. Conclusion: It is important to develop the lifelong education for safety health education for the elementary school children.

Factor Analysis on the Effect of Win-win Smart Factory Education on Job Satisfaction of Medium and Small-sized Enterprises (상생형 스마트팩토리 교육이 중소기업 직무만족에 미치는 요인분석)

  • Seo, Hongeil;Kim, Taesung
    • Journal of the Korea Safety Management & Science
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    • v.23 no.3
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    • pp.47-55
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    • 2021
  • Developed countries that have experienced decline in productivity due to the economic crisis in the past have come to recognize the smart factory as an important means to strengthen the competitiveness of the manufacturing industry due to the increase in labor costs, the avoidance of the manufacturing industry, and the resolution of the shortage of skilled manpower. The necessity of nurturing manpower for self-maintenance was felt through identifying factors for successful smart factory introduction by companies and providing smart factory education. Therefore, the effects of educational satisfaction and operational competency on self-efficacy as a parameter and self-efficacy as a parameter were analyzed using research models and hypotheses to determine whether there was an effect between job satisfaction as a dependent variable. As a result of the analysis, it was found that the mediating effect of self-efficacy and self-efficacy on job satisfaction was found to have significant effects on operational competency and self-efficacy as parameters, as well as educational satisfaction and operational competency. The implication of this study is that continuous education and innovation activities are important in order to increase the business performance of companies, and through this, the manufacturing competitiveness of SMEs can be improved.

Comparative Efficacy and Safety of Long-acting Injectable and Oral Second-generation Antipsychotics for the Treatment of Schizophrenia: A Systematic Review and Meta-analysis

  • Park, Seon-Cheol;Choi, Mi Young;Choi, Jina;Park, Eunjung;Tchoe, Ha Jin;Suh, Jae Kyung;Kim, Young Hoon;Won, Seung Hee;Chung, Young-Chul;Bae, Kyung-Yeol;Lee, Sang-Kyu;Park, Chan Mi;Lee, Seung-Hwan
    • Clinical Psychopharmacology and Neuroscience
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    • v.16 no.4
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    • pp.361-375
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    • 2018
  • We aimed to compare the efficacy and safety of long-acting injectable (LAI) and oral second-generation antipsychotics (SGAs) in treating schizophrenia by performing a systematic review and meta-analysis. MEDLINE, EMBASE, PsycINFO, CINAHL, and the Cochrane Library, as well as five Korean databases, were systemically searched to identify studies published from 2000 to 16 April 2015, which compared the efficacy and safety of LAI and oral SGAs. Using data from randomized controlled trials (RCTs), meta-analyses were conducted. In addition, the GRADE (the Grading of Recommendations, Assessment, Development and Evaluation) approach was applied to explicitly assess the quality of the evidence. A total of 30 studies including 17 RCTs and 13 observational studies were selected. The group treated with LAI SGAs was characterized by significantly lower relapse rates, longer times to relapse and fewer hospital days, but also by a higher occurrence of extrapyramidal syndrome and prolactin-related symptoms than that in the group treated with oral SGAs. Our findings demonstrate that there is moderate to high level of evidence suggesting that in the treatment of schizophrenia, LAI SGAs have higher efficacy and are associated with higher rates of extrapyramidal syndrome and prolactin-related symptoms. Additionally, the use of LAI SGAs should be combined with appropriate measures to reduce dopamine $D_2$ antagonism-related symptoms.

Comparison of Early Complications of Oral Anticoagulants after Totally Thoracoscopic Ablation: Warfarin versus Non-vitamin K Antagonist Oral Anticoagulants

  • MuHyung Heo;Dong Seop Jeong;Suryeun Chung;Kyoung Min Park;Seung Jung Park;Young Keun On
    • Journal of Chest Surgery
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    • v.56 no.2
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    • pp.90-98
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    • 2023
  • Background: Atrial fibrillation (AF) is the most common type of cardiac arrhythmia. Totally thoracoscopic ablation (TTA) is a surgical treatment showing a high success rate as a hybrid procedure with radiofrequency catheter ablation to control AF. This study compared the early complications of warfarin and non-vitamin K antagonist oral anticoagulants (NOACs) in patients who underwent TTA. Methods: This single-center retrospective cohort study enrolled patients who underwent planned TTA for AF from February 2012 to October 2020. All patients received postoperative anticoagulation, either with warfarin or a NOAC (apixaban, rivaroxaban, dabigatran, or edoxaban). Propensity score matching was performed for both groups. Early complications were assessed at 12 weeks after TTA and were divided into efficacy and safety outcomes. Both efficacy and safety outcomes were compared in the propensity score-matched groups. Results: Early complications involving efficacy outcomes, such as stroke and transient ischemic attack, were seen in 5 patients in the warfarin group and none in the NOAC group. Although the 2 groups differed in the incidence of efficacy outcomes, it was not statistically significant. In safety outcomes, 11 patients in the warfarin group and 24 patients in the NOAC group had complications, but likewise, the between-group difference was not statistically significant. Conclusion: Among patients who underwent TTA, those who received NOACs had a lower incidence of thromboembolic complications than those who received warfarin; however, both groups showed a similar bleeding complication rate. Using a NOAC after TTA does not reduce efficacy and safety when compared to warfarin.