• 한국임상약학회지
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• 제28권3호
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• pp.230-237
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• 2018

Objective: To compare adverse event reporting patterns between ethical-the-counter and over-the-counter drugs from community pharmacies and outpatient settings. Methods: We conducted a descriptive study using the adverse event reporting database, wherein data were collected from the regional pharmacovigilance centers of the Korean Pharmaceutical Association between January 1, 2016 and December 31, 2016. The reported drugs were classified into either ethical-the-counter or over-the-counter drugs, and we compared the distribution of patient age and gender, frequent adverse events and medications, serious adverse events, and causality assessment results, where causality assessments were performed according to the World Health Organization-The Uppsala Monitoring Centre's system. Results: We included 17,570 reports (75,451 drug-adverse event pairs). Ethical-the-counter and over-the-counter drugs accounted for 81.4% and 18.6% of the total adverse event reports, respectively. The use of over-the-counter drugs was higher in females and patients aged <18 years, whereas the use of ethical-the-counter drugs was higher in those aged >65 years. Alimentary tract and metabolism drugs, and respiratory system drugs were the most frequent ethical-the-counter and over-the-counter drugs, respectively. From causality assessment results, "possible" (75.4%) was the most commonly assigned category for ethical-the-counter drugs, while "possible" (44.0%) and "unlikely" (47.7%) were the most common categories for over-the-counter drugs. The distribution of serious adverse events were similar for both ethical-the-counter and over-the-counter drugs. Conclusion: Differences were observed in age, gender, reported medications, and symptoms for both ethical-the-counter and over-the-counter drugs. Further pharmacovigilance activities considering the adverse event characteristics of over-the-counter drugs, which are comparable to ethical-the-counter drugs, should be performed.

• 대한한의학회지
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• 제41권1호
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• pp.21-44
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• 2020

Objectives: This study was aimed to develop a pharmacovigilance practice training course for future doctors of Korean medicine, the graduate students of a college of Korean medicine, and to verify the educational effect of the curriculum. Methods: Fifty-six students were given a training course designed as follows: 1) pre-class homework (basic theory self-study, online course, causality assessment, and adverse event reporting simulation); 2) in-class: homework submission and case discussion; 3) after-class: homework revision and resubmission. An online survey to assess the change of the level of basic knowledge and attitudes toward pharmacovigilance, the willingness to report adverse events, and self-efficacy for the causality assessment and adverse event reporting was conducted before and after education. Results: The survey participation rate was 96.5% in pre-education and 64.3% in the post-education survey. After education, knowledge level was improved (mean score from 4.3±2.11 to 6.7±1.96 points, modal value from 3 to 8 points) and positive changes were observed in almost all questions on attitudes. In the post-education survey, more students felt that they could do causality assessment (from 13% to 80.5%), could report adverse events to the agency in charge (from 7.4% to 96.2%), and expressed their strong willingness to report adverse events in the future (from 77.8% to 88.9%) than in the pre-education survey. Conclusions: More schools of Korean medicine need to adopt pharmacovigilance training courses in their curriculum to foster future doctors of Korean medicine with pharmacovigilance capabilities. Such efforts will be the basis for achieving an evidence-based, safe use of herbal medicine.

• 한국콘텐츠학회논문지
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• 제9권2호
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• pp.106-114
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• 2009

본 연구에서는 국내 약물부작용감시시스템 연구의 활성화 및 상용화를 목표로 약물부작용 시스템 사례를 분석하고 비즈니스인텔리전스(BI) 기술을 적용하여 약물부작용감시시스템의 기술구조를 제시한다. 최근에는 전자적과정(electronic review)과 수동적 리뷰과정(manual review process)을 병행하는 방법으로 약물부작용을 탐지하는 추세이며, 본 연구에서는 BI 기술중 ETL(Extract, Transform, Loading)을 적용하여 CDW(Clinical DataWarehouse)구축하였다. 부작용 판별 결과 처방의사 701명, 대상 환자는 남자 1,528명, 여자 1,531명으로 기간 내 환자는 총 3059명 이었으며 이중에서 약물부작용으로 의심되는 사례는 전체 318,222건 중에서 약 0.6%에 해당하는 2,085건으로 확인되었다. 이를 신호별로 분류하면 단순유형의 T.Bilirubin> 3mg/dL(부작용 유형-LabR0005)가 전체 2085건에서 548건으로 가장 높았다.

• 대한한의학회지
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• 제31권2호
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• pp.78-90
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• 2010

Objective: The aim of this study was to review case reports about adverse events of acupuncture or moxibustion treatments in Korea. Methods: Electronic literature searches were performed for adverse events of acupuncture or moxibustion treatments in Korea up to October 2009. Results: Sixteen case reports or case series were retrieved in total. Among them, 10 were reporting about acupuncture, 5 about pharmaco-acupuncture (3 bee venom acupuncture and 2 others), and 1 was reporting about moxibustion treatment. The incidence of adverse effects couldn't be proven due to the lack of prospective studies. Conclusion: Acupuncture treatment seems to be one of the safer forms of medical interventions, when performed by skilled Korean medical doctors. However, prospective studies are necessary to reach conclusions about safety. In addition, a system for collecting and managing adverse effects of Korean medical interventions as well as a reeducation system for clinicians is needed.

• Journal of Acupuncture Research
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• 제29권4호
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• pp.35-42
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• 2012

Objectives : This study was to observe clinical application of auto-microneedle therapy system (AMTS) in patients with peripheral facial paralysis. Methods : 27 peripheral facial paralysis patients were observed after taking AMTS at Facial Palsy Center, Kyung Hee University Oriental Medicine Hospital from March 1, 2011 to January 9, 2012. We assessed the symptoms of facial paralysis with Yanagihara unweighted grading system, Sunnybrook facial grading system(SBGS) and facial disability index(FDI), and observed adverse events and total safety of the treatment. Results : The scores of facial palsy scales increased after AMTS in Yanagihara grading system and Sunnybrook facial grading system. AMTS-related adverse events were mild pain(5.9%) and fatigue(3.5%), which needed no extra treatment. The total safety evaluation was between 'safe' and 'nearly safe' level. There were no other serious adverse events. In addition, patients were satisfied with subjective improvement including facial tingling and numbness. Conclusions : AMTS can be applied as an adjunctive treatment for patients with peripheral facial paralysis due to its safety and clinical usefulness. It is easier to stimulate wide skin area in a short time. Further clinical research is required to investigate the effectiveness of ATMS in a more rigorous RCTs.

• Asian Pacific Journal of Cancer Prevention
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• 제17권2호
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• pp.867-872
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• 2016

Background: Esophageal cancer is one of the most serious malignancies. Due to the aggressive nature of this cancer, the prognosis is poor. A network meta-analysis with simultaneous comparison of multiple treatments can help determine better treatment options that have higher effects on overall survival of patients with lower adverse events. The aim of this review is to simultaneously compare efficacy and adverse events of treatment interventions for esophageal cancer. Materials and Methods: In this review, only randomized control trials (RCT) will be considered for network meta-analysis. All international electronic databases including Medline, Web of Sciences, Scopus, Cochran's library, EMBASE and Cancerlit will be searched to find randomized control trials which compared two or more treatment interventions for esophageal cancer. A network plot will be drawn for visual representation of all available treatment interventions. Bayesian approach will be used to combine the direct and indirect evidence. Treatment effects (e.g. hazard ratio for time to event outcomes, risk ratio for binary outcomes, and rate ratio for count outcomes with 95% credible interval) will be reported. Moreover, cumulative probability of the treatment ranks will be reported using the surface under the cumulative ranking (SUCRA) graphs. Consistency assumption will be assessed by the loop-specific and design-by-treatment interaction approaches. Conclusions: The results of this study may be helpful for the patients, clinicians and health policy makers in selecting treatments that have the best effect on survival and lowest adverse events.

• 한방비만학회지
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• 제7권1호
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• pp.71-85
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• 2007

Objectives : This study was performed to identify the efficacy and safety of ephedra and green tea mesotherapy on localized fat. Methods : Twenty-five healthy $20{\sim}35$ year overweight women (body mass $index{\geq}23kg/m^2$) were recruited and randomly assigned to two groups : experimental(mahuang and green tea) group (n=13), placebo(Normal saline) group (n=12). Total 8 times of herbarl mesotherapy treatment were performed once per week, 4 times were performed on right thigh (1st period), after wash-out for 1 week, the other 4 times were performed on left thigh (2nd period) without any modification of diet or exercise. Body composition, thigh circumferences were measured at each period before and after the intervention. Subcutaneous fat was measured by CT scan at before and after the 1st period of intervention and free fatty acid(FFA) was measured immediately before 1st intervention, 1 hour later, 24 hours later, and 7 days later. Satisfaction score and adverse events were evaluated. Results : In the subcutaneous fat, there were no significances, but in the circumferences. Experimental group had significant change when compared with placebo group (p<0.05). In FFA, experimental group has significant elevation at after 1 hour (p<0.05) evaluation. There were no serious adverse events in both groups. Conclusions : Experimental group had some significant findings in circumference, FFA, and had no serious adverse events comparing with placebo group, and no serious adverse events have been reported in both group. Mesotherapy with herb have a possibility of treating localized fat

• 성인간호학회지
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• 제17권5호
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• pp.697-708
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• 2005

Purpose: This study was to develop, implement, and evaluate an e-learning education program for improving practical knowledge and preventing nursing errors and adverse events of nurses working in the operating room (OR). Method: The e-learning program was developed and evaluated according to the following processes: 1) preparation phase 2) implementation phase 3) evaluation phase. In evaluation phase, the effectiveness was analyzed based on the Kirkpatrick's model. Results: The e-learning program consisted of OR basic nursing skills and techniques and nursing activities' manual based on the categories of nursing errors: surgical operation preparation, nursing skills and techniques, environment management, patient safety and comfort, and patient monitoring. The program was provided through on-line, http://cafe.daum.net/pnuhorn, for 4 weeks. The mean score(percent) of participants' satisfaction was $21.24{\pm}1.71$(68.2%). Their total knowledge level was significantly improved(Z=-3.00, p=.003) and specifically in the category of environment management(Z=-3.77, p<.001) and patient monitoring(Z=-2.46, p=.014). The occurrence of nursing errors or adverse events was a little decreased, but not statistically significant(Z=-3.10, p=.756). Conclusion: E-learning for nurses is one way of effective and efficient teaching-learning strategies. For better e-learning, it is important to develop the vital content of the education and objective measures for detecting nursing errors and adverse events.

• Journal of the Korean Academy of Child and Adolescent Psychiatry
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• 제30권2호
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• pp.74-82
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• 2019

Objectives: The objective of this study was to investigate clinical and neuropsychological factors associated with treatment response and adverse events of atomoxetine in children with attention-deficit/hyperactivity disorder (ADHD) in Korea. Methods: Children with ADHD were recruited at the Department of Psychiatry of Asan Medical Center from April 2015 to April 2018. Diagnoses of ADHD and comorbid psychiatric disorders were confirmed with the Kiddie-Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version. The subjects were subsequently treated with atomoxetine for 12 weeks and illness severity was scored using the ADHD Rating Scale, Clinical Global Impression-Severity scale (CGI-S) and/or Improvement scale (CGI-I), at pre- and post-treatment. They also completed the Advanced Test of Attention (ATA), while their caregivers completed the Korean Personality Rating Scale for Children (KPRC) at pre- and post-treatment. Independent t-test, Fisher's exact test, ${\chi}^2$ test, mixed between-within analysis of variance and correlation analysis were used for statistical analysis. Results: Sixty-five children with ADHD (mean age: $7.9{\pm}1.4years$, 57 boys) were enrolled, of which, 33 (50.8%) were treatment responders. Scores on the social dysfunction subscale of the KPRC (p=0.021) and commission errors on the visual ATA (p=0.036) at baseline were higher in treatment non-responders than in responders; however, the statistical significances disappeared after adjusting for multiple comparisons. Mood changes were also observed in 13 subjects (20.0%), and three of them discontinued atomoxetine due to this. Additionally, atomoxetine-emergent mood change was observed more frequently in girls (p=0.006), while the intelligence quotient (p=0.040) was higher in those subjects with mood changes than in those without. Conclusion: The results of our study suggest that clinical and neuropsychological factors could be associated with treatment response or adverse events of atomoxetine in children with ADHD. Further long-term studies with larger samples are needed.

• Journal of Gastric Cancer
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• 제22권4호
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• pp.408-417
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• 2022

Purpose: Treatment options are limited after the failure of first-and second-line treatments in patients with HER2⁺ metastatic gastric cancer (mGC). The present study aimed to explore the efficacy, safety, and prognostic factors of apatinib efficacy as a third-line therapy for patients with human epithelial growth factor receptor 2-positive (HER2⁺) mGC. Materials and Methods: A total of 59 HER2⁺ mGC patients who received apatinib as third-line therapy were retrospectively enrolled in this two-center, single-arm, cohort study; the clinical response, survival data, and adverse events were retrieved. Results: The median progression-free survival (PFS) was 5.2 months (95% confidence interval [CI], 3.9-6.5), and the median overall survival (OS) was 8.2 months (95% CI, 6.6-9.8) Furthermore, forward stepwise multivariate Cox regression analysis showed that a higher Eastern Cooperative Oncology Group performance status score and multiple metastases were independently correlated with decreased PFS and OS (both P<0.05). The main adverse events were leukopenia (45.8%), hypertension (44.1%), thrombocytopenia (39.0%), hand-foot syndrome (37.3%), and elevated transaminase (33.9%). Grade 3 adverse events mainly included hypertension (5.1%) and neutropenia (5.1%); grade 4 adverse events did not occur. Conclusions: Apatinib is efficient and well tolerated in patients with HER2⁺ mGC as a third-line treatment, suggesting that it may be a candidate of choice for these patients.