• Journal of Acupuncture Research
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• v.39 no.1
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• pp.29-35
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• 2022

Background: Electronic moxibustion has the advantage of temperature control and maintenance, and overcomes the limitations of the existing moxibustion process without the use of the combustion process. However, as the application of electronic moxibustion in clinical practice has increased, safety issues are emerging. Methods: Clinical cases of electronic moxibustion treatment for knee osteoarthritis where burns occurred were collected. In addition, adverse events reported in clinical studies using electronic moxibustion for patients with knee osteoarthritis were collected from studies retrieved from Korean and international databases. Results: There were 3 cases of superficial 2^nd degree burns retrospectively collected through chart reviews. Among the selected 5 studies for literature review, 2 studies reported adverse events which were burns milder than those reported in these 3 cases in this retrospective case review. Conclusion: Since the risk of superficial 2^nd degree burn was discovered in the cases reviewed, further research on safe electronic moxibustion treatment is required without compromising the effectiveness of moxibustion.

• Korean Journal of Clinical Pharmacy
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• v.27 no.4
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• pp.221-227
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• 2017

Background: As personalized healthcare industry has attracted much attention, big data analysis of healthcare data is essential. Lots of healthcare data such as product labeling, biomedical literature and social media data are unstructured, extracting meaningful information from the unstructured text data are becoming important. In particular, text mining for adverse drug reactions (ADRs) reports is able to provide signal information to predict and detect adverse drug reactions. There has been no study on text analysis of expert opinion on Korea Adverse Event Reporting System (KAERS) databases in Korea. Methods: Expert opinion text of KAERS database provided by Korea Institute of Drug Safety & Risk Management (KIDS-KD) are analyzed. To understand the whole text, word frequency analysis are performed, and to look for important keywords from the text TF-IDF weight analysis are performed. Also, related keywords with the important keywords are presented by calculating correlation coefficient. Results: Among total 90,522 reports, 120 insulin ADR report and 858 tramadol ADR report were analyzed. The ADRs such as dizziness, headache, vomiting, dyspepsia, and shock were ranked in order in the insulin data, while the ADR symptoms such as vomiting, 어지러움, dizziness, dyspepsia and constipation were ranked in order in the tramadol data as the most frequently used keywords. Conclusion: Using text mining of the expert opinion in KIDS-KD, frequently mentioned ADRs and medications are easily recovered. Text mining in ADRs research is able to play an important role in detecting signal information and prediction of ADRs.

• Clinical and Experimental Pediatrics
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• v.62 no.7
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• pp.269-273
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• 2019

Purpose: There is limited data on the use of perampanel in children under 12 years of age. We evaluated the efficacy and tolerability of adjunctive perampanel treatment in children under 12 years of age with refractory epilepsy. Methods: This retrospective observational study was performed in Kyungpook National University Hospital from July 2016 to March 2018. A responder was defined as a patient with ${\geq}50%$ reduction in monthly seizure frequency compared with the baseline. Adverse events and discontinuation data were obtained to evaluate tolerability. Results: Twenty-two patients (8 males, 14 females) aged 3.1-11.4 years (mean, $8.0{\pm}2.5years$) were included in this study. After an average of 9.2 months (range, 0.5-19 months) of follow-up, 15 patients (68%) showed a reduction in seizure frequency, including 5 patients (23%) with seizure freedom. The age at epilepsy onset was significantly lower (P=0.048), and the duration of epilepsy was significantly longer (P=0.019) in responders than in nonresponders. Nine patients (41%) experienced adverse events, including somnolence (23%), respiratory depression (9%), violence (4.5%), and seizure aggravation (4.5%). The most serious adverse event was respiratory depression, which required mechanical ventilation in 2 patients (9%). Eight patients (36%) discontinued perampanel due to lack of efficacy or adverse events. Three out of 4 patients (75%) who discontinued perampanel due to adverse events had an underlying medical condition. Conclusion: Perampanel offers a treatment option for refractory epilepsy in children. Adjunctive treatment with perampanel requires special consideration in those with underlying medical conditions to prevent serious adverse events.

• The Korea Journal of Herbology
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• v.36 no.5
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• pp.69-79
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• 2021

Objectives : In clinical practice, there are many cases of co-administration of herbal medicine and synthetic drugs. This study tried to identify whether the combined administration of herbal medicine and synthetic drugs including amoxicillin increases Helcicobacter pylori eradication rate compared to the single administration of synthetic drugs or the combined administration of synthetic drugs and placebo herbal medicine through systematic review. Methods : Relevant randomized controlled trials were searched in PubMED database. The risk of biases was assessed through the Cochrane Risk of Bias criteria. Three reviewers were extracted the characteristics and outcomes of each study. Meta-analysis of eradication rate and adverse event was conducted. Results : Four RCTs were selected. In meta-analysis, the combination of herbal medicine and synthetic drugs showed eradication effect, but it was not statistically significant (Odds Ratio [OR] 0.46; 95% confidence interval [CI] 0.17 to 1.24; p=0.13; I²=56%) than administration of synthetic medicine alone. Combination of herbal medicine and synthetic medicine did not increased the incidence of adverse event(OR 1.07; 95% CI 0.72 to 1.59; p=0.68, I²=0%) compared to single administration of synthetic medicine. Conclusion : Although no significant difference was observed between the two groups in the eradication rate and the incidence rate of adverse events, it was difficult to draw a clear conclusion due to the heterogeneity between studies and the low quality of reporting. A number of studies that have overcome these limitations in the future will lead to definite conclusions.

• Korean Journal of Clinical Pharmacy
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• v.30 no.1
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• pp.19-30
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• 2020

Objective: To describe patterns of spontaneous reporting on adverse events following immunization (AEFIs) using the human papilloma virus (HPV) vaccine according to the Brighton Collaboration (BC) criteria. Methods: We used the Korea Adverse Event Reporting System (KAERS) database including vaccinations between 2008 and 2017. To apply BC criteria, we classified 58 BC AEFIs into World Health Organization Adverse Reaction Terminology (WHO-ART) codes. We applied MedDRA standard medical queries that were pre-defined as five BC AEFIs. Terminology mapping between MedDRA and WHO-ART terms was performed by three researchers. Descriptive statistics of individual case safety reports were analyzed according to BC applicability. Disproportionality analyses were performed on each BC AEFI and each preferred AEFI term according to the case-noncase approach; reporting odds ratio (ROR) and 95% confidence intervals (CI) were calculated. Results: Among the 30,266 reports of vaccinations between 2008 and 2017, 2,845 reports included the HPV vaccine. Of these reports, 1,511 (53.1%) included at least one BC AEFI. Reports from physicians or manufacturers included more BC AEFIs than from other reporters. Injection site reactions and fever were frequently reported in BC AEFIs; spontaneous abortion and ectopic pregnancy (ROR, 14.29 [95% CI, 4.30-47.49]) and vasculitic peripheral neuropathy (ROR, 8.57 [95% CI, 2.61-28.10]) showed the highest ROR. Among non-BC AEFIs, dizziness or myalgia were frequently reported; exposure during pregnancy (ROR, 23.95 [95% CI, 16.27-35.25]) and inappropriate schedule of administration (ROR, 22.89 [95% CI, 16.74-31.31]) showed the highest ROR. Conclusion: BC criteria would be applicable for labeled AEFIs, whereas analyzing non-BC AEFIs would be useful for detecting unlabeled AEFIs.

• Journal of Society of Preventive Korean Medicine
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• v.19 no.3
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• pp.91-102
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• 2015

Objective : The purpose of this study is to find out the possibility of application to herbal medicine's report form for adverse drug reaction (ADR) by reviewing and analyzing Asian countries's ADR report forms. Method : We investigated, compared, and analyzed ADR report forms (ADR-RF) of Asian countries's ADR institutions (ACAI), such as, Korea institute of drug safety & risk management and Dongguk university Ilsan oriental hospital (DUIOH) in Korea, national center for ADR monintoring (NCAM) in China, pharmaceuticals and medical devices agency (PMDA) in Japan, Ministry of Health and Welfare (MOHW) in Taiwan, and drug office, department of health, the government of the Hong Kong special administrative region (GHKSAR) in Hong Kong. Results : ADR-RF for ACAI included common contents, such as, patients information (name(initial), gender, age, weight), adverse event (AE)'s report information (Recognition and report for AE occurrence, first or follow up report, Severe AE), the detailed information of AE (the title of AE, onset & closing date of AE symptoms, the progress & results detailed test of AE), the information of AE's medicine (the types of medicine, product name, ingredient name, suspected or combination drug, single dose & frequency, dosage form, administration route, dealing for AE-suspected medicine), and AE reporter's information (reporter's information, institution's information). Taiwan had ADR-RF and the department exclusively for herbal medicine (HM), but others (except DUIOH) had not only no ADR report form but also contents for HM. Conclusion : ADR-RF for HM have to include the common contents of ACAI at least, as well as HM information related to ADR, such as the title, composition and types of HM, history related to HM's ADR, and the contents of drug-induced liver injury and so on. In addition, the main department of government for HM's ADR will be needed.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.29 no.2
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• pp.141-158
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• 2019

Objectives: An adverse outcome pathway is a biological pathway that disturbs homeostasis and causes toxicity. It is a conceptual framework for organizing existing biological knowledge and consists of the molecular initiating event, key event, and adverse output. The AOP concept provides intuitive risk identification that can be helpful in evaluating the carcinogenicity of chemicals and in the prevention of cancer through the assessment of chemical carcinogenicity predictions. Methods: We reviewed various papers and books related to the application of AOPs for the prevention of occupational cancer. We mainly used the internet to search for the necessary research data and information, such as via Google scholar(http://scholar.google.com), ScienceDirect(www.sciencedirect.com), Scopus(www.scopus. com), NDSL(http: //www.ndsl.kr/index.do) and PubMed(http://www.ncbi.nlm.nih.gov/pubmed). The key terms searched were "adverse outcome pathway," "toxicology," "risk assessment," "human exposure," "worker," "nanoparticle," "applications," and "occupational safety and health," among others. Results: Since it focused on the current state of AOP for the prediction of toxicity from chemical exposure at work and prospects for industrial health in the context of the AOP concept, respiratory and nanomaterial hazard assessments. AOP provides an intuitive understanding of the toxicity of chemicals as a conceptual means, and it works toward accurately predicting chemical toxicity. The AOP technique has emerged as a future-oriented alternative to the existing paradigm of chemical hazard and risk assessment. AOP can be applied to the assessment of chemical carcinogenicity along with efforts to understand the effects of chronic toxic chemicals in workplaces. Based on these predictive tools, it could be possible to bring about a breakthrough in the prevention of occupational and environmental cancer. Conclusions: The AOP tool has emerged as a future-oriented alternative to the existing paradigm of chemical hazard and risk assessment and has been widely used in the field of chemical risk assessment and the evaluation of carcinogenicity at work. It will be a useful tool for prediction, and it is possible that it can help bring about a breakthrough in the prevention of occupational and environmental cancer.

• The Journal of Internal Korean Medicine
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• v.42 no.4
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• pp.590-604
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• 2021

Objectives: The purpose of this study is to examine the safety of Korean medicine treatment in patients vaccinated with the AstraZeneca COVID-19 vaccine (ChAdOx1 nCoV-19/AZD1222). Methods: We investigated patients at Kyung Hee University Korean Medicine Hospital who were vaccinated with the AstraZeneca COVID-19 vaccine between June 1, 2021 and June 30, 2021. The safety of Korean medicine treatment was evaluated by examining adverse events that occurred within seven days of vaccination, including liver function and kidney function testing, assessment of the severity of adverse events, and examination of causality to vaccines and Korean medicine treatment. Results: Eleven patients vaccinated with the first dose of the AstraZeneca COVID-19 vaccine were included. A total of 19 adverse events were reported: 15 systemic adverse events, three local adverse events, and one alanine aminotransferase increase. The most commonly reported systemic adverse events were fatigue (4 cases, 36.4%), headache (4 cases, 36.4%), and myalgia (4 cases, 36.4%). All adverse events were rated below moderate (grade 2) in severity. Systemic and local adverse events were evaluated as definitely related to vaccination and unlikely to be related to Korean medicine treatment, while alanine aminotransferase increase was evaluated as unlikely to be related to either the vaccine or Korean medicine treatment. Aspartate transaminase, Blood urea nitrogen, and creatinine were measured within the reference range after vaccination. Conclusion: Our results suggest that the severity and frequency of adverse events in patients vaccinated with the AstraZeneca COVID-19 vaccine did not increase after Korean medicine treatment.

• Communications for Statistical Applications and Methods
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• v.26 no.2
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• pp.163-173
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• 2019

Simon's two-stage designs are frequently used in phase II single-arm trials for efficacy studies. A concern of safety studies is too many patients who experience an adverse event. We show that Simon's two-stage designs for efficacy studies can be similarly used to design a two-stage safety study by modifying some of the design parameters. Given the type I and II error rates and the proportion of adverse events experienced in the first stage cohort, we prescribe a procedure whether to terminate the trial or proceed with a stage 2 trial by recruiting additional patients. We study the relationship between a two-stage design with a safety endpoint and an efficacy endpoint as well as use simulation studies to ascertain their properties. We provide a real-life application and a free R package gen2stage to facilitate direct use of two-stage designs in a safety study.

• Journal of Yeungnam Medical Science
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• v.39 no.1
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• pp.62-66
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• 2022

Immune checkpoint inhibitor (ICI)-associated adrenal insufficiency is rare but may become a serious adverse event in patients treated with ICIs. The present case report documents two cases of adrenal insufficiency developed during chemotherapy plus tislelizumab (百泽安, Baize'an; BeiGene Ltd.) therapy in patients with advanced gastric cancer. Adrenal insufficiency developed after 6 and 13 cycles of treatment and was well controlled with hydrocortisone. The patients also developed hypothyroidism, which was managed with levothyroxine. Two patients showed a partial response, and one patient out of two achieved a near-complete response, sustaining over 11 months. Increased awareness of ICI-related adrenal insufficiency is crucial for early detection and prompt management of patients treated with ICIs.