• 한국약용작물학회:학술대회논문집
• /
• 한국약용작물학회 2006년도 Proceedings of The Convention of The Korean Society of Applied Pharmacology
• /
• pp.43-48
• /
• 2006

• 대한방사선기술학회지:방사선기술과학
• /
• 제30권4호
• /
• pp.305-311
• /
• 2007

조영제는 영상검사를 위해 유용한 의약품이며 점차 그 사용량이 늘어나고 있지만, 불가항력적인 부작용이 발생한다. 부작용에 대비해서 작성하게 되는 조영제 사용 동의서는 의료기관에게는 유리하고 피검자에는 불리한 내용이 담겨져 있어, 동의서에 부작용이 발생할 수 있다는 것에 동의하였다고 하여 그에 대한 손해배상책임까지 면제된다고 볼 수는 없다. 또한 조영제를 사용하는 검사 시 검사자와 조영제제조자는 선량한 관리자의 주의의무, 예견의무, 결과회피의무를 다하여야 하며, 의무를 소홀히 하게 되면 민사상의 책임이 있다. 조영제는 생산, 제조, 유통과정에 결함이 생길 수 있기 때문에 조영제제조자는 의약품 결함으로 인해 손해가 발생된다면 제조물책임을 지게 된다. 결함은 제조물의 제조 설계 또는 표시 상의 결함이나 기타 통상적으로 기대할 수 있는 안전성이 결여되어 있는 것으로 정의하고 있다. 제조물책임이란 제조물의 결함으로 말미암아 그 제조물의 이용자 또는 제 3자가 생명 신체 또는 재산상 손해를 입었을 때 그 제조물의 제조자나 판매자에게 그 결함제조물로 인하여 입은 손해를 배상하도록 책임을 묻는 것을 말한다. 조영제 사용의 증가 추세에 따른 부작용 발생빈도가 높아질 개연성과 함께 피검자들의 건강권에 대한 권리 의식이 점차 강조되고 있는 현실을 감안한다면 이제는 그에 대한 법적 책임이 정리되어야 하고, 조영제제조자는 조영제 사고에 대비하여 자구적인 대처방안을 수립하거나, 조영제 제조단체 공동으로 제조물책임보험을 들도록 하는 방안이 마련되어야 할 것이다. 의료기관과 조영제 회사 간의 거래 계약 체결 시 조영제 부작용에 대한 내용을 포함함으로써 의료기관이나 검사 당사자의 조영제 부작용 법적 책임을 경감할 수 있을 것이다.

• 한국임상약학회지
• /
• 제23권3호
• /
• pp.223-231
• /
• 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
• /
• 제21권4호
• /
• pp.353-363
• /
• 2011

The World Health Organization (WHO) declared the outbreak of H1N1 pandemic in 2009. South Korea also had outbreaks of H1N1 virus and used oseltamivir in large volume with increased reports of adverse drug reaction(ADR). The present study was aimed to investigate the ADR frequency, the factors related to ADR, and characteristics of oseltamivir's ADR. Participants for the study were patients randomly drawn from those who were prescribed oseltamivir for treatment from CHA Bundang Medical Center during October 1 and October 30. The information examined as factors related to ADR were collected by a subsequent cross-sectional telephone survey. The factors are the following; a) age; b) gender; c) patient medical history; d) diagnosis of H1N1 virus; e) adherence; f) whether taking other medication with oseltamivir or not; and g) the number of combined medications. We also asked ADR after taking oseltamivir. Total subjects were 86 patients. The average age is $22.6{\pm}18.48$ years old. The gender was 45.3% women and 54.7% men. Half (50%) of all respondents showed one or more ADR, 67.4% were positively diagnosed for H1N1 virus, and 54.7% were completed the full course of oseltamivir (i.e. twice daily x 5days). The most frequently reported ADR symptoms were: dizziness (15.1%), nausea (11.6%), lethargy (10.4%), diarrhea (10.4%), abdominal pain (8.1%), headache and vomiting (6.9%). ADR classifications by categories are gastro intestinal (44.2%), neuropsychiatric events (22.1%), systemic symptom (20.9%), skin events (5.8%), eye events (4.7%), and other cases (2.3%). The onset of ADR 'after taking 1~3 doses' was 69.7%. No increase in neuropsychiatric events was detected in children and adolescents. No factors examined for the study do have significant influence on the presence of ADR. This study showed that ADR of oseltamivir have occurred in half of the patients. The use of oseltamivir is essential for treatment and prophylaxis of influenza A(H1N1). But mass treatment should be properly monitored for ADR.

• 동의생리병리학회지
• /
• 제35권6호
• /
• pp.219-227
• /
• 2021

The purpose of this study is to analyze the side effects (ADR) of Traditional Chinese Medicine (TCM) injections by age, injection type, symptoms, and causes, and to find preventive solutions for ADR. For the ADR of TCM injection data collected during the search period from January 1, 2010 to December 31, 2020, the correlation between each section was analyzed by subdividing it into age, injection type, symptoms and causes. CNKI, PubMed, and EMBASE were used to collect the clinical data. 'Chinese herbal injection', 'Traditional Chinese Medicine injection', 'Chinese herbal injection side effect', 'Chinese herbal injection adverse drug reaction' were used for the keyword from the database. All data were collected mainly for TCM injection and the causes of ADR due to TCM injection. However, data not related to the relevant study or TCM injection were excluded from this study. Among a total of 941 studies collected during the search period from January 1, 2010 to December 31, 2020, a total of 10 studies were selected for final analysis. In 1462 clinical data sets, ADR by gender was higher in males than females. By age, 41 to 60 years were the most common. The incidence of ADR by injection type was highest in the blood regulating injection type. Data analysis showed Xueshuantong injection had the highest ADR. Among the symptoms of ADR, skin diseases were the most common. The most common cause of ADR was the unreasonable use of drugs. In China, for ADR management, the use of TCM injections is recommended according to the basic principles for the clinical use of TCM injections established by the Chinese government. In this study, we analyzed the current status and causes of ADR in TCM injections, and found a preventive solution. It is expected that it can be used as basic data to increase the usability of pharmacopuncture and herbal medicines in Korea in the future.

• 한방재활의학과학회지
• /
• 제30권4호
• /
• pp.133-142
• /
• 2020

Objectives Studies on Chinese herbal injections are increasing. But, its safety are still not well reported. We have reviewed the literature related to the safety of Chinese herbal injection, especially those related to anaphylaxis. Methods The PubMed database was used to select the literatures related to anaphylaxis in China and to study the quality control and safety of Chinese herbal injection. Results Chinese herbal injection is a major traditional medical treatment in China, but it is the cause of adverse drug reactions including anaphylaxis. In order to solve this problem, various proposals have been made to identify the pharmacological and chemical causes of major side effects and to use them safely clinically. In addition, various researches have been conducted from preclinical to postmarketing surveillance to secure the safety of Chinese herbal injection. Based on this, it was found that various efforts are needed to secure the safety of bee sting needles. Conclusion In order to secure the safety of chinese herbal injections, it is necessary to identify the main mechanism of action and the pharmacological components contributing to it, and to develop a standardized formulation based on this. In addition, institutional pharmacovigilance is required.

• 한국정보처리학회:학술대회논문집
• /
• 한국정보처리학회 2022년도 춘계학술발표대회
• /
• pp.549-552
• /
• 2022

최근 소셜미디어 리뷰 데이터를 활용한 약물 이상 반응 탐지 연구가 활발히 진행되고 있지만, 약물을 복용하기 전 증상과 약물 이상 반응을 구분하지 못한다는 한계가 있다. 본 논문에서는 약물 이상 반응 탐지에서 약물 복용 전의 증상을 구분할 수 있는 Filtering Clinical BERT(FC-BERT) 모델을 제안하였다. FC-BERT 는 약물 복용 전 증상과 다른 약물에 대한 부작용 표현을 제거하기 위해 약물명이 나오기 전 모든 문장을 제거하는 필터링과 약물-부작용 쌍을 추출하는 모델을 사용했다. 성능 평가 실험을 위해 문장에 대한 ADE(Adverse Drug Event) 여부가 들어있는 ADE Corpus V2 데이터를 활용하였고 SPARK NLP 라이브러리에서 제공하는 ADE Pipeline 모델과 비교하여 성능 평가를 실시하였다. 실험 결과 필터링을 활용한 FC-BERT 모델이 기존 모델보다 정확도, 평균 정밀도, 평균 재현율, 평균 F1-score 가 모두 높은 결과를 보여주었다. 본 논문에서 제시한 모델은 기존 연구의 한계점을 보완하여 보다 정확한 약물 부작용 시그널을 탐지하는데 기여할 수 있을 것이다.

• 대한한방소아과학회지
• /
• 제37권1호
• /
• pp.45-57
• /
• 2023

Objectives This study aimed to provide a basis for the research on the trend and safety of Korean herbal medicines among children and adolescents. Methods Patients aged <19 years who received outpatient treatment at the Korean pediatrics department of Kyung Hee University Hospital from January 1, 2017 to October 31, 2022 were included. The current state of annual visits and herbal medicine prescriptions was analyzed. A retrospective chart review was conducted by examining the medical records of subjects who received herbal medicines, including deer antler. Adverse drug reactions in patients who received herbal medicine were also investigated. Results A total of 57,457 people visited the Korean pediatrics department, and 51,768 people (90.1%) were prescribed herbal medicine. Among these, 21,826 patients (42.2%) were prescribed with deer antler. A total of 117 adverse drug reactions were reported among the patients who received herbal medicines. Conclusions This study aimed to determine the trends and safety of herbal medicine treatment, particularly deer antlers, in children and adolescents. Well-designed, long-term, multi-institutional follow-up studies are required to expand the field of Korean pediatrics.

• Genomics & Informatics
• /
• 제17권2호
• /
• pp.15.1-15.7
• /
• 2019

Automatically detecting mentions of pharmaceutical drugs and chemical substances is key for the subsequent extraction of relations of chemicals with other biomedical entities such as genes, proteins, diseases, adverse reactions or symptoms. The identification of drug mentions is also a prior step for complex event types such as drug dosage recognition, duration of medical treatments or drug repurposing. Formally, this task is known as named entity recognition (NER), meaning automatically identifying mentions of predefined entities of interest in running text. In the domain of medical texts, for chemical entity recognition (CER), techniques based on hand-crafted rules and graph-based models can provide adequate performance. In the recent years, the field of natural language processing has mainly pivoted to deep learning and state-of-the-art results for most tasks involving natural language are usually obtained with artificial neural networks. Competitive resources for drug name recognition in English medical texts are already available and heavily used, while for other languages such as Spanish these tools, although clearly needed were missing. In this work, we adapt an existing neural NER system, NeuroNER, to the particular domain of Spanish clinical case texts, and extend the neural network to be able to take into account additional features apart from the plain text. NeuroNER can be considered a competitive baseline system for Spanish drug and CER promoted by the Spanish national plan for the advancement of language technologies (Plan TL).

• Asian Pacific Journal of Cancer Prevention
• /
• 제15권17호
• /
• pp.7195-7200
• /
• 2014

Background: The aim of this study was to evaluate how CYP2C19 affects icotinib and metabolite' exposure, and to determine whether the exposure and EGFR genotype influences survival time, tumor metastasis and adverse drug reactions. Materials and Methods: 274 NSCLC patients who accepted 125mg icotinib/t.i.d. were chosen from a phase III study. Blood samples were obtained in $672^{nd}$ ($4^{th}$ week) and $1,680^{th}$ hours ($10^{th}$ week), and plasma was used to quantify the concentration of icotinib and blood cells were sampled to check the genotypes. Clinical data were also collected at the same time, including EGFR genotypes. Plasma concentrations were assessed by HPLC-MS/MS and genotype by sequencing. All data were analyzed through SPSS 17.0 and SAS 9.2. Results: CYP 2C19 genotypes affected bio-transformation from icotinib to M24 and M26, especially in poor-metabolisers. Higher icotinib concentrations (>1000 ng/mL) not only increased patient PFS and OS but also reduced tumor metastasis. Patients with mutant EGFR experienced a higher median PFS and OS (234 and 627 days), especially those with the 19del genotype demonstrating higher PR ratio. Patients who suffered grade II skin toxicity had a higher icotinib exposure than those with grade I skin toxicity or no adverse effects. Liver toxic reactions might occur in patients with greater M20 and M23 plasma concentrations. Conclusions: CYP2C19 polymorphisms significantly affect icotinib, M24 and M26 exposure. Patients with mutant EGFR genotype and higher icotinib concentration might have increased PFS and OS and lower tumor metastasis. Liver ADR events and serious skin effects might be respectively induced by greater M20, M23 and icotinib concentrations.