• Neonatal Medicine
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• v.18 no.2
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• pp.345-352
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• 2011

Purpose: Nursing quality influences patient' outcomes in the neonatal intensive care unit (NICU). We compared differences in adverse events (AEs) by differences in the level of nursing experience at the NICU, developed guidelines to prevent AE, and then investigated the change in AE. Methods: AEs related to nursing were investigated from January 1, 2009 to December 31 2009 at the NICU of the newly established A hospital and B hospital that has been operating for 14 years. We also assessed the level of nursing experience. Guidelines to prevent nursing-related AEs were prepared at A hospital, and the change in the incidence of AE was investigated after 1 year. Results: Twenty nurses (80%) had <2 years experience at A hospital, whereas 13 nurses (65%) had 2 years or longer but less than 4 years experience at B hospital (P<0.001). The number of incidences of AE that occurred in 2009 in A hospital was higher (46) than that at B hospital (10). Intravenous (IV) injection-related incidents had the highest share in both hospitals: 24 incidents (52.2%) at hospital A and eight incidents (80%) at hospital B. After the guidelines were instituted in 2009, the number of nursing AEs decreased to 17, of which the number of IV incidents was the highest (6, 35%), athough its share decreased. Conclusion: Supervision and prevention guidelines should be in place to reduce nursing AEs, which would improve the quality of NICU service.

• The Journal of Pediatrics of Korean Medicine
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• v.35 no.1
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• pp.104-121
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• 2021

Objectives The purpose of this study is to evaluate the efficacy and safety of herbal medication for the treatment of functional abdominal pain in children by analyzing randomized controlled trials conducted in China. Methods Literatures from China National Knowledge Infrastructure published up to 23 November, 2020 were searched. Then they were collected and analyzed by their publication year, demographic information, treatment methods used, duration of illnesses, duration of treatments, follow-up periods, outcome measurement and adverse events. Results A total of 27 studies were selected for the analysis. In all studies, the total efficacy of the herbal medicine treatment group was reported to be higher than that of the control group. The most frequently used medical herb was Root of Glycyrrhiza uralensis Fischer (甘草). The most frequently used classes of herbal medications are Qi regulating medicine (理氣藥), Qi tonics (補氣藥), Aromatic wet medicine (芳香化濕藥), and Digestant (消食藥). The adverse events rate for the herbal medicine treatment group were significantly lower than those in the Western medicine treatment group. Conclusions This study showed that herbal medicine treatment can be effective and safe option for treating pediatric functional abdominal pain. However, additional well-designed clinical studies are needed to solidify the findings.

• Korean Journal of Clinical Pharmacy
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• v.23 no.3
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• pp.223-231
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• 2013

Objective: This study aimed to identify the status and risk factors of rituximab infusion-related adverse events (ADE) in rituximab-na$\ddot{i}$ve patients with cancer diseases. Method: A retrospective analysis using electronic medical records review was conducted. Inclusions were patients with a diagnosis of cancer disease with the initiation of rituximab-included treatment who were na$\ddot{i}$ve to rituximab during January 2011 to March 2013 at National Cancer Center (NCC) in Korea. Result: Total 110 patients, 582 cases of rituximab administrations, were reported in the study. About 57.2% of patients were 51-70 years old and evenly distributed between two genders and 72.7% were BMI less than $25kg/m^2$. All of study patients were diagnosed with non-Hodgkin lymphoma. Fifty patients (45.4%) and 54 cases (9.3%) were experienced rituximab infusion-related AEs even with conservative administration protocol at NCC. The most frequently occurring AEs were shivering followed by rash and itching. In single variant analysis, we found that the early stage of NHL, low exposure to rituximab administrations, high white blood cell counts, high lymphocyte counts, high absolute neutrophil count and low lactate dehydrogenase were associated with infusion-related AEs (p<0.05). The early stage of disease, high lymphocyte counts, low exposure to rituximab administrations were also related significantly with AEs in multiple variants analysis (p<0.05). Conclusion: Rituximab infusion-related AEs for patients who were na$\ddot{i}$ve to rituximab were still a concern with conservative administration protocol. The adverse drug reactions were significantly associated with early stage of NHL, higher lymphocyte counts and low exposure to rituximab administrations. The factors need to be considered with close monitoring to prevent rituximab infusion-related AE.

• Korean Journal of Clinical Pharmacy
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• v.31 no.3
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• pp.237-246
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• 2021

Background: Pembrolizumab, an anti-cancer drug, is known to increase the activity of the immune system, leading to side effects called immune-related adverse events (irAE), including type 1 diabetes. This study analyzed the correlation between blood glucose level and pembrolizumab administration and investigated the covariates that affect those changes in cancer treatment. Methods: The information of 133 adult cancer patients was obtained from the electronic medical record (EMR) to identify the changes in random blood glucose (RBG) levels during the pembrolizumab treatment. Subjects were classified into subgroups according to their baseline RBG level, history of diabetes, and the use of steroids, and linear regression analysis was conducted. In addition, a secondary analysis was performed within the group of subjects having a strong correlation to glycemic change, which was based on the Pearson correlation coefficient being less than -0.7 or greater than +0.7. Univariate and multivariate logistic regressions were conducted to identify the risk factors to glycemic increase. Results: The RBG level tended to descend without significant differences in total patients during the administration period of pembrolizumab. Despite the insignificance, the logistic regression analysis presents that the odds ratios of baseline RBG less than 130 mg/dL, prophylactic steroid use, and higher dose of pembrolizumab per cycle (mg/kg/cycle) were greater than 1. Conclusions: Prophylactic administration of steroids and a higher dose of pembrolizumab per cycle may increase the blood glucose level as irAE in cancer patients with a strong tendency to glycemic change.

• The Journal of Korean Medicine
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• v.36 no.1
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• pp.33-44
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• 2015

Objectives: The aim of this study was to understand the characteristics of herbal-drug-associated adverse events (AEs) reported in the internet newspaper articles and to take a countermeasure against the safety issue of herbal drugs. Methods: We searched the internet newspaper articles published from 2010 to 2014 in the 3 major portal sites in Korea, NAVER, DAUM, and GOOGLE. Search terms were the Korean words equivalent of 'herbal drug' and 'side effects'. Informations on the type and characteristics of suspected herbal drugs, AEs, and the patient records were extracted from the articles reporting the herbal-drug-associated AE occurred in Korea. Results: From 8,806 articles, a total of 36 AEs were found. The most frequently reported age group was 20s, and women outnumbered men. Obesity was the most common cause of administration. Doctors of Korean medicine clinic were the most commonly referred prescribers and purchasing route (11 cases). The most frequently mentioned medicinal herb was Ephedra sinica (7 cases) and the most commonly reported AEs were abdominal pain (8 cases), dizziness (6 cases), diarrhea (5 cases), and vomiting (5 cases) were followed in order. Ten cases were judged as serious AEs, and the others were not. Conclusions: Current customers demand health care providers to offer them sufficient information on the safety of herbal drugs. To satisfy their requirements, physicians of Korean medicine should be able to explain, predict, prepare, recognize, and deal with the herbal-drug-associated AEs. We propose an establishment of pharmacovigilance system for herbal medicine, in which doctors of Korean medicine are participated as important personnel, to collect and analyze the related AEs and offer credible information on the safety of herbal drug.

• Infection and chemotherapy
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• v.50 no.4
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• pp.301-310
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• 2018

Backgroud: Influenza vaccination is recommended for adults aged ${\geq}65$ years as they are at high risk of significant morbidity and mortality. This open-label, multicenter, post-marketing surveillance study assessed the safety of the MF59-adjuvanted trivalent inactivated subunit influenza vaccine, which is marketed as $FLUAD^{(R)}$ and $VANTAFLU^{(R)}$, in South Korean subjects aged ${\geq}65$ years. Materials and Methods: Solicited local and systemic adverse events (AEs) were collected from day 1 to 4 of the study. All unsolicited AEs and serious AEs (SAEs) were recorded from day 1 until study termination (day 29). Results: Of the 770 subjects enrolled ($FLUAD^{(R)}$, n = 389; $VANTAFLU^{(R)}$, n = 381), 39% overall experienced any solicited AE. Local AEs were reported by 33% of subjects overall; with the most common events being injection-site pain (30%) and tenderness (27%). Systemic AEs were reported by 19% of subjects overall with the most common events being myalgia (11%) and fatigue (8%). Conclusion: These results show that the MF59-adjuvanted influenza vaccine known as $FLUAD^{(R)}$ or $VANTAFLU^{(R)}$ had acceptable safety profiles in older adults (aged ${\geq}65$ years) in South Korea.

• Journal of Food Hygiene and Safety
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• v.26 no.4
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• pp.302-307
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• 2011

One of the most important objectives of post-marketing monitoring of dietary supplements is the early detection of unknown and unexpected adverse events (AEs). Several causality algorithms, such as the Naranjo scale, the RUCAM scale, and the M & V scale are available for the estimation of the likelihood of causation between a product and an AE. Based on the existing algorithms, the Korea Food & Drug Administration has developed a new algorithm tool to reflect the characteristics of dietary supplements in the causality analysis. However, additional work will be required to confirm if the newly developed algorithm tool has reasonable sensitivity and not to generate an unacceptable number of false positives signals.

• The Journal of Korean Medicine
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• v.43 no.1
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• pp.87-98
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• 2022

Objectives: The purpose of this study was to investigate the effect of weight loss in Korean Medicine (KM) obesity treatment combined with self-monitoring and to identify the relevant factors which are related to successful weight loss. In addition to this, adverse events reported by the patients were analyzed to assess the safety of KM treatments for obesity Methods: This was a retrospective observational study that analyzed the medical records of the patients that participated in the 10-week of KM treatment. All patients took herbal medicine for weight loss and were instructed to reduce calorie intake and adhere to self-monitoring. Clinical data including body weight were collected for evaluating the effect of the treatments. Behavior factors affecting weight loss were collected. The correlation between each factor and weight loss was analyzed. Adverse events (AEs) were collected at each time to evaluate the safety of the intervention. Results: One hundred eighteen patients' records were included in this study. The average weight loss was 7.64kg(74.59kg to 66.95kg). 94.9% of patients lost 5% or more of their initial weight. The degree of weight loss was identified to be related to self-assessment of diet control and self-assessment of appetite control. The average self-weighing frequency significantly increased(2.45 times/week before treatment and 4.70 times/weeks during treatment). Constipation, insomnia, and dizziness were found to be the most frequent AEs, and except for one case, most AEs were mild cases. Conclusion: From this study, we found that KM obesity treatment combined with self-monitoring showed significant weight loss without serious AE.

• Journal of Acupuncture Research
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• v.39 no.1
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• pp.10-16
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• 2022

This study aimed to analyze the status of adverse events (AEs) in the treatment of musculoskeletal conditions/diseases using thread embedding acupuncture (TEA). Five electronic databases were searched to retrieve data on clinical studies published in the last 5 years (2016 to 2021). Of the 151 studies retrieved, 22 studies analyzed AEs and were selected for this review. There were no AEs reported in 6 studies (27.3%); of the remaining 16 studies, 4 studies (18.2%) reported AEs that were not related to TEA. The most common AEs reported in the Chinese studies were redness of skin with/without swelling and tingling sensation, and in the Korean studies they were stiffness, a foreign body sensation, and bruising. The percentage of patients with AE experience was 5.1% in the Chinese studies and 19.9% in the Korean studies. The discrepancies between the findings in the Chinese and Korean studies may be attribute to differences in the diameter of needles, thread materials, TEA treatment procedure, and evaluation methods for AEs. Most of the reported AEs were of a mild status and did not last for a long time. However, further research on the clinical course after TEA treatment is needed.

• The Journal of the Korea Contents Association
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• v.15 no.1
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• pp.357-365
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• 2015

Folk medicine is traditionally passed down to cure disease, and adverse events (AEs) of folk medicine are any unfavorable and unintended discomforts temporally associated with the use of folk medicine. The aim of this study was to analyze AEs types and risks of folk medicine through the internet news articles. Included in this analysis are all articles on the topic of folk medicine and AE reported in the top 3 online news websites (NAVER, DAUM and NATE) determined by InternetTrend$^{TM}$(www.internettrend.co.kr). It was searched in the last five years (between 1 January 2009 and 28 February 2014). In total, 18 AEs articles of 973 news articles met our inclusion criteria. A total of 27 people were experienced AEs associated with use of folk medicine. Age was from 4 months to 76 years old, and it was occurred in both men and women. Folk medicine that caused AEs in twice or more was therapy that patient taking the dictamnus or aconitum of toxic herbal medicines, vinegar therapy of external use to topical skin, and cupping or bee sting therapy by practitioners. Death as a kind of serious AEs was 11 people, and 10 people were died after treatment by unqualified practitioner. Folk medicine that is popular and widely used in Korea is actively interacted with information on the internet, so it apt to misuse and abuse without guidance of health professionals. Aspects of health care system, we point out that the need for government and medical society establish not only correct health information plan and promotion of risk but also system as reporting and monitoring of AEs by folk medicine.