• Korean Journal of Clinical Pharmacy
• /
• v.29 no.2
• /
• pp.71-78
• /
• 2019

Objective: This study aimed to provide efficacy and safety information on the use of erenumab for prevention of episodic and chronic migraines. Methods: The keywords "Erenumab and migraine" were used to search the PubMed database to then compile efficacy and safety data for erenumab. Data from relevant Phase 2 and Phase 3 clinical trials were analyzed, using RevMan for statistical analysis. Results: Three clinical trials (one Phase 2 and two Phase 3 studies) were retrieved. All three trials used the same primary endpoint (change from baseline in monthly migraine days (CBMD)) to evaluate efficacy and safety of erenumab use for prevention of episodic and chronic migraines. Subcutaneous doses of erenumab (70 or 140 mg) were administered monthly in each trial, for 3 months (Studies 2, and 3) or 6 months (Study 1). The mean differences in CBMD in the 70 mg and 140 mg erenumab arms were -1.36 and -1.98, respectively, compared to that in the placebo arm. Some adverse events, such as nasopharyngitis and upper respiratory tract infection, were reported, but no differences in safety between erenumab and placebo were found to be significant. Conclusions: Erenumab showed superior efficacy in prevention of migraines compared to placebo. However, additional information regarding the long-term safety of erenumab should be collected. Therefore, post-marketing surveillance for adverse events is needed.

• Translational and Clinical Pharmacology
• /
• v.26 no.3
• /
• pp.118-127
• /
• 2018

The safety and efficacy of fimasartan have been evaluated through post-marketing surveillance in real world clinical practice. The multi-center, prospective, open-label and non-interventional study. A total of 3,945 patients (3,729 patients for safety assessment and 3,473 patients for efficacy assessment) were screened in patients with essential hypertension in 89 study centers from 9 September 2010 through 8 September 2016. Among the total patients, 2,893 patients (77.6%) were administered fimasartan for 24 weeks or longer and were classified as 'patients with long-term follow-up', and the additional safety and efficacy analysis were performed. The improvement was defined as systolic blood pressure (SBP) controlled to ${\leq}140mmHg$ or decreased SBP differences ${\geq}20mmHg$ after treatment or diastolic blood pressure (DBP) controlled to ${\leq}90mmHg$ or decreased DBP differences ${\geq}10mmHg$ after treatment. Adverse drug reactions (ADRs) were reported in 3.8% patients; dizziness, and hypotension were the most frequently reported ADRs in total patients. The results of patients with long-term follow-up were comparable with total patients. The overall improvement rate in all efficacy assessment at the last visit was 87.1% (3,025/3,473 patients). The overall improvement rate of the patients with long-term follow-up was 88.9%. Fimasartan was well tolerated, with no new safety concerns identified and an effective treatment in the real world clinical practice for Korean patients with hypertension.

• Fire Science and Engineering
• /
• v.33 no.3
• /
• pp.143-153
• /
• 2019

The aim of this study was to reduce the number of negligent accidents by improving the fire safety consciousness of infant and child teachers working in a day care center. For this purpose, 242 early childhood teachers working in the national nursery school in Daejeon and Chungcheongnam-do were surveyed. For the survey, the questionnaire consisted of job satisfaction, teacher's efficacy, and fire safety consciousness. The survey data were analyzed using the SPSS 20.0 win program. The factor of job satisfaction and teacher's efficacy had a significant positive influence on the fire safety consciousness of the early childhood teachers (<.05). The teacher's efficacy was found to mediate the relationship between the job satisfaction and fire safety consciousness. In conclusion, this study suggests that teacher's fire safety consciousness is high when the teacher's job satisfaction and efficacy are high. This study is expected to contribute to basic research to increase the teachers' consciousness of fire safety.

• Korean Journal of Pharmacognosy
• /
• v.35 no.2 s.137
• /
• pp.122-127
• /
• 2004

This study was conducted to investigate the safety and efficacy of an oriental herbal composition, Kamihonghwatang(KH-19), for the reduction of the side effects of chemotherapeutic drug. KH-19 prevented the reduction of white blood cells including lymphocytes, monocytes and eosinophiles in C57BL/6 mice injected with fluorouracil, a commonly used anticancer drug. KH-19 also prevented the reduction of cell densities in bone marrow and spleen of fluorouracil-injected mice. To evaluate the safety of KH-19, single-dose toxicity test was conducted using SD rats. No dead animal was found and the minimum lethal dose of KH-19 was more than 5000 mg/kg.

• Journal of the Korea Safety Management & Science
• /
• v.18 no.3
• /
• pp.99-107
• /
• 2016

The purpose of this study includes: Firstly, to examine the effects of authentic leadership on leader trust, self efficacy, and creative behavior. Secondly, to examine the mediating effect of the leader trust, self efficacy on the relationship between authentic leadership and creative behavior. In order to verify the relationships and mediating effect, data were collected from convenient sample of 323 employees at small and medium enterprises in Busan, Ulsan, Gyeongju city to test theoretical model and its hypotheses. All data collected from the survey were analyzed using with SPSS 18.0 and AMOS 18.0. This study reports findings as followed: first, the relationship between the authentic leadership and the leader trust is positively related. Second, there was also a positive correlation between the authentic leadership and the self efficacy. Third, there was also a positive correlation between the authentic leadership and the creative behavior. Fourth, the relationship between the leader trust and the self efficacy is positively related. Fifth, there was also a positive correlation between the leader trust and the creative behavior. Sixth, there was also a positive correlation between the self efficacy and the creative behavior. Finally, the leader trust and self efficacy played as a partial mediator on the relationship between authentic leadership and creative behavior. Based on these findings, the limitations of the study and some directions for future studies were presented.

• Journal of Radiation Protection and Research
• /
• v.32 no.2
• /
• pp.89-96
• /
• 2007

Radiation safety managements in medical institutions are needed to protect certain radiation damages as a part of National Coalition. This study investigates the characteristics of self-efficacy that become the major factor on the knowledge, attitude, and behavior on the radiation safety management of radiation workers as an approach of educational aspects and analyzes the relationship between such factors to provide basic materials for improving the activity level of radiation safety managements. In order to implement the goal or this study, a survey was performed for 1,200 workers who were engaged in radiation treatments in medical centers, such as general hospital, university hospital, private hospital, and public health center for 42 days from July 23,2006. Then, the results of the analysis can be summarized as follows: 1. Average scores on knowledge, attitude, and behavior in the radiation safety management were presented as $75.76{\pm}11.20$, $90.55{\pm}8.59$, $80.58{\pm}11.70$, respectively. Also, the average score of self-efficacy was recorded as $73.55{\pm}9.82$. 2. Knowledge levels in the radiation safety management showed significant differences according to the sex, age, marriage, education, and experience. Also, males of married, older, highly educated, and largely experienced represented high knowledge levels. Attitude levels in the radiation safety management showed certain significant differences according to the type of medical centers in which private hospitals showed a relatively low level compared to that of high levels in university hospitals. Behavior levels in the radiation safety management also represented significant differences according to the age, marriage, education, experience, and types of medical centers. Factors in married, general hospital, older, highly educated, and largely experienced showed high behavior levels. In addition, the self-efficacy showed certain differences according to the marriage and types of medical centers. Factors in married and general hospital demonstrated high self-efficacy levels. 3. Relationship between knowledge, attitude, behavior, and self-efficacy on the radiation safety management showed statistical differences according to the relationship between the knowledge and the attitude, the knowledge and the behavior, the attitude and the behavior, the attitude and the self-efficacy, and the behavior and the self-efficacy. The relationship between the behavior and the self-efficacy was represented as r = 0.482, which was the strongest relationship in such factors. Also, the knowledge and self-efficacy didn't show certain relationships.

• Korean Journal of Biological Psychiatry
• /
• v.3 no.1
• /
• pp.102-108
• /
• 1996

This was an open trial to evaluate the efficacy and safety of moclobemide twice daily for treatment of Korean patients with major depressive disorder(DSM-III-R). The duration of the trial was 6 weeks with the initial dose of moclobemide being fixed lor the first two weeks at 300mg/day(150mg twice daily, each token after morning and evening meals). Thereafter, when necessary, the dose was allowed to increase to 600mg/day or decrease to 150mg/day according to the seventy of the depression and/or the tolerability of the drug. Hypnotics and/or sedatives from a benzodiazepine group could be concomitantly administered at usual dosage. Patients were assessed at baseline and at days 14, 28 and 42. Efficacy was primarily judged on the Hamilton Rating Scale for Depression(HAM-D) and Beck Depression Inventory(BDI). Patients had to score at least 17 respectively an both scales to enter the trial. Secondary efficacy parameters included Clinical Global Impression(CGI) for severity of illness and improvement. Safety and tolerability were judged on reported adverse events, vital signs and laboratory parameters. In addition, there was a series of questions and assessments for the psychiatrists and patients to complete at the end of the trial Twenty nine patients completing trial were included in the analysis of efficacy : of thirty one patients participating in the safety and tolerability analysis, those who withdraw voluntarily without particular reasons or violated the treatment schedule were not included. The efficacies as determined by HAM-D, BDI or CGI were found to be significant compared to baseline. The number of responders defined as patients with a total score of 10 or less or with a total score of 50% or less of the baseline score on HAM-D and BDI were 17(59%) and 18(62%) respectively. Regarding safety and tolerability, nine patients(29%) reported mild adverse events probably related to moclobemide : of these one patient dropped out because of poor tolerability : however, there were no appreciable changes in blood pressure, pulse rate, body weight or laboratory parameters for all patients over the trial period. Furthermore, the physicians' and patients' opinions at final evaluation showed that moclabemide has a good antidepressant effect as well as a favorable tolerability. In conclusion, a twice-daily dosage schedule with maclobemide is recommendable for the treatment of Korean patients with major depressive disorder since its efficacy and safety were demonstrated in this study.

• The Journal of Korean Medicine
• /
• v.38 no.3
• /
• pp.170-184
• /
• 2017

Objectives: The objective of this study was to summarize randomized clinical trials (RCTs) that have assessed efficacy and safety of mahuang and ephedrine on treatment of obesity and to propose better process of study. Methods: NLM Medline (pubmed), the Cochrane library, Scopus, Science Direct, RISS, KISS were systemically searched for clinical trials investigating the efficacy, safety of mahuang and ephedrine on treatment of obesity from 2000 to 2017. Results: 16 RCTs met all the inclusion criteria. In most reports, mahuang and ephedrine significantly reduced body weight, body fat mass. There were no serious adverse events associated with mahuang and ephedrine in all studies. Conclusions: In appropriate dose of mahuang and ephedrine for healthy adult was safe, and weight loss effect of mahuang and ephedrine was better than control group. Improved clinical practice guidelines should be developed for safe use of mahuang and ephedrine.

• Journal of the Korea Safety Management & Science
• /
• v.19 no.4
• /
• pp.241-251
• /
• 2017

The purpose of this study is to review the effects of organizational citizenship behavior on innovative behavior and intention to leave, and the moderating effects of self-efficacy in Korea Politechnics' teachers and professors. In order to verify and achieve the purposes mentioned above, questionnaire data were gathered and analysed from 206 employees of Korea Politechnics campus. Empirical survey's findings are as follows; First, altruism, conscientiousness, sportsmanship appeared to be positively related with innovative behavior. Second, courtesy, conscientiousness, sportsmanship appeared to be negatively related with intention to leave. Third, self-efficacy moderated negatively the relationship between altruism and intention to leave. Fourth, self-efficacy moderated negatively the relationship between sportsmanship and intention to leave.

• Journal of the Korea Safety Management & Science
• /
• v.17 no.1
• /
• pp.231-240
• /
• 2015

This paper reviewed the relationship between job burnout and service quality, and the moderating effect of self-efficacy. Based on the responses from 232 employees, the results of multiple regression analysis appeared as follow; 1) emotional exhaustion and depersonalization effected negatively on all service quality factors(empathy, reliability, responsiveness). 2) the reduced personal accomplishment effected negatively on two service quality factors(reliability, responsiveness). 3) self-efficacy effected positively on the relationship between emotional exhaustion and service quality. 4) self-efficacy effected positively on the relationship between he reduced personal accomplishment and service quality.