• Clinical and Experimental Pediatrics
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• 제54권10호
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• pp.422-424
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• 2011

Acute disseminated encephalomyelitis (ADEM) is an inflammatory demyelinating disease of the central nervous system that typically follows an infection or vaccination and has a favorable long-term prognosis. We describe the first reported case of ADEM after vaccination against novel influenza A (H1N1). A previously healthy 34-month-old boy who developed ADEM presented with a seizure and left-sided weakness 5 days after vaccination against novel influenza A (H1N1). Cerebrospinal fluid examination revealed elevated cell counts. T2-weighted images and fluid-attenuated inversion recovery images revealed multiple patchy hyperintense lesions in the frontal and parietal subcortical white matter and the left thalamus. After the administration of intravenous corticosteroid, the patient's clinical symptoms improved and he recovered completely without neurologic sequelae.

• 한방재활의학과학회지
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• 제28권1호
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• pp.61-72
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• 2018

Objectives The authors propose a new checklist model adapted for safety miniscalpel acupuncture procedure of cervical and lumbar spine. Methods On the basis of available literature and expert opinion, a prototype checklist was developed. The checklist was adapted on the basis of observation of daily practice. Results The checklist has three parts: 1. prevention and management of healthcare associated infections, 2. verification list before and after miniscalpel acupuncture treatment, 3. adverse event monitoring after procedure. We presented a summary checklist based on the above contents. Conclusions We propose the first patient safety checklist for minicalpel acupuncture treatment of cervical and lumbar spine. The checklist will be complemented using further research methodologies.

• 한방재활의학과학회지
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• 제28권3호
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• pp.119-124
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• 2018

Three cases of simple exanthematous eruption were suspected during Sumsu (Bufonis Venenum) pharmacopuncture (SP) topical anesthesia for acupotomy. Patients had skin rash with pruritus on both ankle, posterior neck, and left shoulder after 11, 12, and 7 times of SP treatment, respectively. There were no cases of systemic manifestations or changes in vital signs. As a result of using the World Health Organization-Uppsala Monitoring Centre (WHO-UMC) causality assessment, all the cases were evaluated as 'unlikely'. However, the results of using the Korean algorithm for assessing the causality of drug adverse reactions version 2.0 were evaluated as 'possible'. This report is the first case report on adverse events suspected of occurring after SP treatment. Although the causal relationship between suspected intervention and the adverse event is not clear, there was a difficulty in completely excluding the possibility. Additional safety studies will be required to make SP more widely available.

• Journal of Acupuncture Research
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• 제39권1호
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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.

• 한국임상약학회지
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• 제27권4호
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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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• 제62권7호
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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.

• 대한본초학회지
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• 제36권5호
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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.

• Clinical Endoscopy
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• 제55권6호
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• pp.775-783
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• 2022

Background/Aims: Colorectal endoscopic submucosal dissection (ESD) is burdened by its associated high risk of adverse events and long procedure time. Recently, a waterjet-assisted knife was introduced to simplify and speed up the procedure. The aim of this study was to evaluate the efficacy and safety of waterjet-assisted ESD (WESD) compared to that of the conventional ESD (CESD) technique. Methods: The charts of 254 consecutive patients who underwent colorectal ESD between January 2014 and February 2021 for colorectal neoplasms were analyzed. The primary outcome was the en-bloc resection rate. Secondary outcomes were complete and curative resection rates, the need to switch to a hybrid ESD, procedure speed, the adverse event rates, and the recurrence rates. Results: Approximately 174 neoplasias were considered, of which, 123 were removed by WESD and 51 by CESD. The en-bloc resection rate was higher in the WESD group (94.3% vs. 84.3%). Complete resection rates and curative resection rates were similar. The need to switch to a hybrid ESD was greater during CESD (39.2% vs. 13.8%). Procedure speed and adverse event rates were similar. During follow-up, one recurrence occurred after a WESD. Conclusions: WESD allows a high rate of en-bloc resections and less frequently requires a rescue switch to the hybrid ESD compared to CESD.

• 한국임상약학회지
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• 제30권1호
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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.

• 대한예방한의학회지
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• 제19권3호
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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.