• Clinical and Experimental Pediatrics
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• v.63 no.5
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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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• v.16 no.1
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• pp.54-60
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• 2009

Purpose : Yellow fever, a mosquito-borne viral hemorrhagic fever, is one of the most lethal diseases. Recently there have been an increasing number of Korean children who have travelled to yellow fever endemic zones and were administered yellow fever vaccine (YFV). Therefore, we carried out this study to provide child travelers with safety information of YFV. Methods : This study was conducted at the International Clinic of National Medical Center in Seoul between April 2007 and June 2008 for the evaluation of adverse events of YFV. One hundred twenty-five children received YFV (17-DD) and were prospectively monitored for adverse events through telephone interviews on day 3, 6, 9, 16, 23 and 30 after vaccination. Results : Adverse events were observed in 31 (24.8%) of 125 child travelers who received the YFV. The mean age was 12.5${\pm}$5.0 years. Sixty-six of the child travelers (52.8%) were males. The common adverse events were pain in 11 (8.8%), swelling in 8 (6.4%) and redness in 7 children (5.6%) at the injection site. The systemic adverse events included mild fever in 5 (4.0%), headache in 5 (4.0%), cough in 4 (3.2%), abdominal pain in 3 (2.4%), and vomiting in 2 children (1.6%). Most of the adverse events were detected within 7 days of administration and there were no differences in adverse events by gender or age. All travelers who had complained of symptoms improved spontaneously or following symptomatic treatment. Conclusion : This study showed that YFV is well-tolerated and there were no reports of severe adverse events. Studies are ongoing to clarify the cause and risk factors for rare adverse events.

• Korean Journal of Acupuncture
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• v.29 no.3
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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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• v.47 no.5
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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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• v.28 no.4
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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.

• Korean Journal of Clinical Pharmacy
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• v.31 no.3
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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.

• Korean Journal of Clinical Pharmacy
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• v.21 no.2
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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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• v.28 no.1
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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.

• 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.

• Pediatric Gastroenterology, Hepatology & Nutrition
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• v.16 no.3
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• pp.171-177
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• 2013

Purpose: This study was aimed to evaluate the frequency and course of adverse events associated with azathioprine treatment in Korean pediatric patients with inflammatory bowel disease. Methods: Total of 174 pediatric patients (age range, 1 to 19 years) with inflammatory bowel disease who received azathioprine in order to maintain remission at Samsung Medical Center (Seoul, Korea) from January 2002 through December 2012 were included in this study. Medical records of these subjects were retrospectively reviewed regarding the development of adverse events associated with azathioprine treatment. Results: Ninety-eight patients (56.3%) of 174 patients experienced 136 episodes of adverse events, requiring dose reduction in 31 patients (17.8%), and discontinuation in 18 patients (10.3%). The mean dose of azathioprine that had been initially administered was $1.32{\pm}0.42$ mg/kg/day. Among the adverse reactions, bone marrow suppression developed in 47 patients (27.0%), requiring dose reduction in 22 patients (12.6%) and discontinuation in 8 patients (4.6%). Other adverse events that occurred were gastrointestinal disturbance (15.5%), hair loss (12.1%), pancreatitis (7.5%), arthralgia (6.9%), hepatotoxicity (2.9%), skin rash/allergic reactions (2.9%), headache/dizziness (2.3%), sepsis (0.6%), and oral mucositis (0.6%). Conclusion: Bone marrow suppression, especially leukopenia was most commonly associated with azathioprine treatment in Korean pediatric inflammatory bowel disease patients. Close observation for possible adverse events is required in this population with inflammatory bowel diseases who are under treatment with azathioprine.