• Neonatal Medicine
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• 제18권2호
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• pp.345-352
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• 2011

목적: 신생아중환자실은 간호 요구도가 높은 곳으로 간호 수준이 환자 결과에 영향을 미치는 것으로 알려져 있다. 저자들은 신생아중환자실에서 간호 숙련성의 차이에 따른 위해 사건의 차이를 비교하고 간호 위해 사건에 대한 예방 지침 마련 후 위해 사건의 변화를 알고자 하였다. 방법: 새로 설립된 A병원과 14 년간 운영되어 온 B병원의 신생아중환자실을 대상으로 2009년 1월 1일부터 2009년 12월 31일 까지 1년간의 간호 위해 사건과 당시 근무한 간호 인력의 경력을 조사하였다. 그리고 A병원에서 간호 위해 사건 예방을 위한 지침을 마련한 후 1년 뒤의 사고 변화를 조사하였다. 결과: A병원의 간호 인력은 2년 이내 경력자가 20명(80%)인 반면 B병원의 간호 인력은 2년 이상 4년 미만의 경력자가 13명(65%)으로 많아 간호 숙련성에 있어 유의한 차이가 있었다(P<0.001). 2009년도에 확인된 간호 위해 사건은 A병원에서 46건, B병원에서 10건으로 전체적으로 A병원에서 많이 발생했고 두 병원에서 정맥주사 관련 사고가 각각 24건(52.2%), 8건(80%)으로 가장 많은 비율을 차지했다. 위해 사건 예방을 위한 간호 지침 마련 후 2010년도에 확인된 간호 위해 사건은 17건으로 총 발생빈도가 감소하였으며 정맥 주사 관련 사고가 6건(35%)으로 가장 많았으나 비율이 감소하였음을 확인하였다. 결론: 간호 숙련성이 높을수록 위해 사건의 빈도가 적었고 위해 사건을 예방하기 위한 지침 마련 후 사고 빈도가 감소함을 확인하였다. 예방 가능한 간호 위해 사건의 빈도를 줄이기 위하여 자체적인 감시와 예방 지침의 강구가 필요하며 이는 중환자실 서비스의 질을 높이는 방법이 될 것이다.

• 대한한방소아과학회지
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• 제35권1호
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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.

• 한국임상약학회지
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• 제23권3호
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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.

• 한국임상약학회지
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• 제31권3호
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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.

• 대한한의학회지
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• 제36권1호
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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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• 제50권4호
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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.

• 한국식품위생안전성학회지
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• 제26권4호
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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.

• 대한한의학회지
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• 제43권1호
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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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• 제39권1호
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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.

• 한국콘텐츠학회논문지
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• 제15권1호
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• pp.357-365
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• 2015

민간요법 유해사례란 예로부터 민간에 전해 내려오는 질병 치료법인 민간요법 사용 중에 발생되는 바람직하지 않거나 의도되지 않은 모든 불편감이다. 본 연구는 인터넷 뉴스기사를 통해 민간요법 유해사례의 형태와 위험성을 분석하고자 하였다. 인터넷트렌드(www.internettrend.co.kr)의 웹사이트 분석평가에 의한 점유율 상위 3개 포털 사이트인 네이버(NAVER), 다음(DAUM), 네이트(NATE)를 검색 대상으로 선정하여 최근 5년간(2009년 1월 1일부터 2014년 2월 28일까지) 민간요법 유해사례의 신문기사를 검색하였다. 총 973건의 신문기사가 검색되었고 18건이 포함기준에 만족되었다. 유해사례를 경험한 사람은 총 27명으로 연령은 4개월부터 76세까지이고, 남녀 모두에게 발생하였다. 2회 이상 반복적인 유해사례를 일으킨 민간요법으로는 독성 약재인 봉삼 또는 초오를 재료로 사용하여 복용한 요법, 피부에 외용하는 식초요법, 시술자에 의한 벌침 또는 부항요법이었다. 중대한 유해사례로서 사망이 11명이 있었으며 자신이 직접 복용한 1명을 제외하고는 모두 의료인이 아닌 무자격자의 시술에 의한 사망이었다. 국내에서 대중적인 민간요법은 인터넷 상에서 정보가 활발히 상호 교류되며 전문 의료인의 지도 없이 오, 남용되고 있는 것이 현실이다. 국민의 보건의료측면에서 국가나 의료계가 민간요법 유해사례에 대한 위험성 홍보 및 올바른 건강정보 제공 계획을 세우고 나아가 유해사례를 보고 및 감시하는 체계도 확립해야 할 필요성이 있음을 지적하는 바이다.