• 대한한방소아과학회지
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• 제28권3호
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• pp.1-16
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• 2014

Objectives The purpose of this study is to investigate the incidence and clinical features of adverse events associated with herbal medicine, and to analyze their causality and severity. Methods This study was carried out from 159 children and adolescents who took herbal medicine in the Department of Pediatrics, ${\bigcirc}{\bigcirc}$ Korean Medical Hospital from december, 2013 to april, 2014. The data was collected by survey in person or telephone. The World Health Organization (WHO)-Uppsala Monitoring Center (UMC) criteria was used to analyze causality for each adverse events. Results 1. 207 cases were surveyed from 159 children and adolescents who took one or more kinds of herbal medicine. 2. A total of 12 general adverse events (5.8%) were reported from the study. Among these adverse events, 8 cases (3.9%) were associated with herbal medicine. 3. Gastro-intestinal system disorders were most frequently reported (70%) as adverse events, which is followed by psychiatric disorders (15%), skin and appendages disorders (10%), urinary system disorders (5%). 4. The most common clinical symptom was abdominal pain (20%), followed by diarrhea (15%), loose stools (10%), vomiting (10%) and borborygmus (10%). 5. The severity of adverse drug reactions was mostly mild (87.5%), and moderate (12.5%). There was no severe case. Conclusions The adverse events from herbal medicine on children and adolescents were mostly minor, most of them could continue herbal medicines.

• Clinical and Experimental Pediatrics
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• 제63권5호
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• pp.184-188
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• 2020

Background: Many critically ill patients require transfer to a higher-level hospital for complex medical care. Despite the publication of the American Academy of Pediatrics guidelines for pediatric interhospital transportation services and the establishment of many pediatric transport programs, adverse events during pediatric transport still occur. Purpose: To determine the incidence of adverse events occurring during pediatric transport and explore their complications and risk factors. Methods: This prospective observational study explored the adverse events that occurred during the interhospital transport of all pediatric patients referred to the pediatric intensive care unit of Ramathibodi Hospital between March 2016 and June 2017. Results: There were 122 pediatric transports to the unit. Adverse events occurred in 25 cases (22%). Physiologic deterioration occurred in 15 patients (60%). Most issues (11 events) involved circulatory problems causing patient hypotension and poor tissue perfusion requiring fluid resuscitation or inotropic administration on arrival at the unit. Respiratory complications were the second most common cause (4 events). Equipment-related adverse events occurred in 5 patients (20%). The common causes were accidental extubation and endotracheal tube displacement. Five patients had both physiologic deterioration and equipment-related adverse events. Regarding transport personnel, the group without complications more often had a physician escort than the group with complications (92% vs. 76%; relative risk, 2.4; P=0.028). Conclusion: The incidence of adverse events occurring during the transport of critically ill pediatric patients was 22%. Most events involved physiological deterioration. Escort personnel maybe the key to preventing and appropriately monitoring complications occurring during transport.

• Pediatric Infection and Vaccine
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• 제16권1호
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• pp.54-60
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• 2009

목 적: 황열은 모기에 의해 전염되는 급성 바이러스 출혈열로 중부아프리카와 열대 남아메리카에서 주로 발생한다. 이 연구는 황열 백신을 접종한 소아 및 청소년 여행객에게 이상반응에 대한 임상적 고찰을 시행하여 백신의 안전성 및 이상반응에 대한 정보를 제공하고자 시행하였다. 방 법: 이 연구에서는 2007년 4월 1일-2008년 6월 30일까지 국립의료원 해외여행클리닉을 방문한 소아 및 청소년 125명을 대상으로 하였다. 황열백신 투여 이후 6회의 전화면담을 통해 백신투여와 이상반응과의 관련성에 대하여 평가하였다. 결 과: 황열백신을 투여한 11개월에서 19세 사이의 소아 및 청소년 125명 중 이상반응의 발생은 31명(24.8 %)이었다. 증상으로는 주사부위의 통증(8.8%)이 가장 많았고 뒤를 이어 부종(6.4%), 발적(5.6%), 발열(4.0%), 두통(4.0%)순서였다. 대부분의 이상반응은 백신 투여 후 7일 이내에 발생했으며 성별 및 연령과 이상반응간의 유의한 차이가 없었다. 증상을 호소한 모두 자연적으로 혹은 보존적인 치료에 증상이 호전되었다. 결 론: 이 연구에서 황열백신은 우리나라 소아나 청소년에게 심각한 이상반응 없이 널리 사용될 수 있음을 보여주었다. 그러나 심각한 부작용의 원인이나 위험요소에 대한 연구는 지속적으로 필요할 것이다.

• Korean Journal of Acupuncture
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• 제29권3호
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• pp.421-430
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• 2012

Objectives : We investigated the incidence rate and type of adverse events associated with RCTs(Randomized Controlled Trials) of acupuncture and moxibustion. Methods : This study included 949 patients who received acupuncture or moxibustion or usual care from 8 RCTs. We collected data including gender and age of patients, intervention, treatment frequency and type of adverse events in clinical trials from their case report forms. Results : Among the 949 patients, 83 patients(8.7%) suffered at least one adverse event throughout the clinical trials. Types of adverse event in acupuncture & moxibustion clinical trials are common cold, skin changes, pain, dizziness, bruise, gastrointestinal diseases, changes of blood chemistry, burn. Adverse events were significantly correlated to patients' age, intervention, body mass index and treatment group. Conclusions : A Guide-line for collecting and managing adverse events of acupuncture & moxibustion clinical trials are needed.

• Journal of Preventive Medicine and Public Health
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• 제47권5호
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• pp.273-280
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• 2014

Objectives: To evaluate the occurrence of patient adverse events in Korean hospitals as perceived by nurses and examine the correlation between patient adverse events with the nurse practice environment at nurse and hospital level. Methods: In total, 3096 nurses working in 60 general inpatient hospital units were included. A two-level logistic regression analysis was performed. Results: At the hospital level, patient adverse events included patient falls (60.5%), nosocomial infections (51.7%), pressure sores (42.6%) and medication errors (33.3%). Among the hospital-level explanatory variables associated with the nursing practice environment, 'physician-nurse relationship' correlated with medication errors while 'education for improving quality of care' affected patient falls. Conclusions: The doctor-nurse relationship and access to education that can improve the quality of care at the hospital level may help decrease the occurrence of patient adverse events.

• Journal of Acupuncture Research
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• 제28권4호
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• pp.65-76
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• 2011

Objectives : The aim of this study is to survey adverse events of acupuncture in the course of peripheral facial palsy treatments. Methods : The prospective observational study included patients hospitalized to receive acupuncture treatments for peripheral facial palsy. All patients were surveyed daily for adverse events associated with the acupuncture treatments applied the day before. Results : A total of 50 patients received $37.68{\pm}20.37$ acupuncture treatments in average. 36 patients reported experiencing at least one adverse event. Total 163 adverse events were reported. Common adverse events were bleeding(62), bruise(33), pain(30), tiredness(11), hematoma(7). The others were paresthesia(4), erythema(3), delay of removing needles(2), edema(2), aggravation of symptoms(2), declining of appetite(2), pruritus(1), drowsiness(1), anxiety(1), sweating(1), headache(1). Conclusions : Acupuncture has adverse events, like any therapeutic approaches. However, it is a relatively safe treatment. In future study, organized large scale prospective survey should be carried out to fully prove that acupuncture is safe.

• 한국임상약학회지
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• 제31권3호
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• pp.188-197
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• 2021

Objective: PD-1 inhibitors have demonstrated improved health outcomes in cancer patients. PD-1 inhibitors are well-tolerated and associated with immune-related adverse events. The objectives of this study are to analyze use patterns of PD-1 inhibitors in patients with cancer and to investigate the incidence of thyroid-related adverse reactions in patients treated with PD-1 inhibitors. Methods: The study included patients who had been administered PD-1 inhibitors (either nivolumab or pembrolizumab) at the Samsung Medical Center between October 1, 2016 and June 30, 2017. Data was collected from electronic medical records and tested using Mann-Whitney tests and Chi-Square tests for statistical significance. Associations between PD-1 inhibitors and incidence of adverse events were tested using Cox regression for age, gender, BMI, ECOG PS and medication. Results: Two hundred fifteen patients were identified as eligible for analyses. Thyroid-related adverse events occurred in 20% of patients (n=43). Thyroid function tests (TFTs) was performed in 109 patients (50.7%). Positive results of PD-L1 testing were found in 53.2% of the 94 patients who had the test. Approved doses of nivolumab (3 m/kg) and pembrolizumab (200 mg) were administered in 70.4% and 53% of patients, respectively. The analysis of risk factor of thyroid-related adverse reaction did not show statistically significant differences (Cox regression). Conclusion: Thyroid-related adverse events are common in patients treated with PD-1 inhibitors and hypothyroidism is the most frequent adverse reaction. Routine TFTs monitoring is strongly recommended to evaluate thyroid function in real-world clinical practice.

• 한국임상약학회지
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• 제21권2호
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• pp.100-105
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• 2011

The perception of the 20 adverse events of targeted therapy for metastatic renal cell carcinoma was compared among medical professionals. Thirty-seven oncologists, 167 nurses and 79 pharmacists participated in the survey, and the response rate was 61.9%, 98.2%, 84.9%, respectively. Results showed that the most serious adverse event was GI perforation (8.83 points, 10 being the most serious), whereas the least serious was anemia (5.32 points). There were significant differences among oncologists, nurses and pharmacists especially for the moderately-serious adverse event such as wound-healing complication and lymphopenia. Adverse Events Composite Score (AECS) for each targeted therapy was calculated by multiplying adverse event incidence rate and seriousness score. Sunitinib had the highest score at 6.86 point and bevacizumab had the lowest at 2.1. Among professional groups oncologists showed the lowest AECS, whereas nurses had the highest. The gap on the perception of the adverse events among medical professionals needs to be reduced to get better outcomes of medical therapies for cancer patients.

• Journal of Acupuncture Research
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• 제28권1호
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• pp.45-63
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• 2011

Objectives : The aim of this study is to review papers on adverse events in the course of Oriental Medical treatments in the JKAMS and the JCTKAM. Methods : We searched papers up to December 2010 in the JKAMS and The JCTKAM. Electronic and manual literature searches were performed. Results : 92 papers were retrived in total. Out of these, 62 reported the occurrence of adverse events whereas 30 reported none. Adverse events in treatments were generally transient and mild. However, this result had limitations due to the insufficient number of papers reporting adverse events and the inconsistency in the methodology according to each paper. Conclusions : Reports on adverse events are necessary in clinical research. In future research, organized case reports and systemic reviews should be carried out. Furthermore, prospective studies should be done as well.

• 대한한방내과학회지
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• 제42권4호
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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.