• 제목/요약/키워드: Drug safety assessment

검색결과 245건 처리시간 0.034초

Changes in the Expression of Ras-family Genes in Rats Exposed to Formaldehyde by Inhalation

  • Li, Guang-Yong;Lee, Hye-Young;Choi, You-Jin;Lee, Mi-Ock;Shin, Ho-Sang;Kim, Hyeon-Young;Lee, Sung-Bae;Lee, Byung-Hoon
    • Toxicological Research
    • /
    • 제24권3호
    • /
    • pp.201-206
    • /
    • 2008
  • Exposure to formaldehyde(FA) is closely associated with adverse health effects such as irritation, inflammation, and squamous cell carcinomas of the nasal cavities. Owing to its rapid metabolism and elimination, exposure to FA does not always result in an increased concentration in blood or urine of animals and humans. Therefore, the development of biomarkers for FA exposure is necessary for risk assessment. In the present study, the effects of FA were investigated on the expression of genes involved in the MAPK pathway in vitro and results confirmed in rats exposed to FA by inhalation. Treatment of Hs 680.Tr human tracheal epithelial cells with FA induced gene expression for PDGFA, TNFSF11, SHC1, and HRAS. HRAS expression was also increased in tracheas of rats exposed to FA. In addition, FA exposure induced the expression of RASSF4, a member of the Rasassociation domain family of Ras effectors, in rat tracheas. In conclusion, data showed FA-inducible expression of genes involved in the MAPK pathway occurred and increased expression of HRAS and RASSF4 was noted in rat tracheas subchronically exposed to FA by inhalation. These genes may serve as molecular targets of FA toxicity facilitating the understanding of the toxic mechanism.

Sodium Picosulphate with Magnesium Citrate versus Polyethylene Glycol for Bowel Preparation in Children: A Systematic Review

  • Dziechciarz, Piotr;Ruszczynski, Marek;Horvath, Andrea
    • Pediatric Gastroenterology, Hepatology & Nutrition
    • /
    • 제25권3호
    • /
    • pp.228-239
    • /
    • 2022
  • Purpose: To compare the effectiveness, tolerability, acceptability, and safety of sodium picosulphate with magnesium citrate (PS/Mg) and polyethylene glycol (PEG) in children (≤18 years) preparing for colonoscopy. Methods: Three electronic databases (MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials) were searched till July 2020. Only randomized controlled trials (RCTs) were included. At least two authors independently selected studies and performed risk of bias assessment and data extraction. Results: Four RCTs (n=390), with overall good quality were included. A meta-analysis of two trials (n=224) found no statistically significant difference between the groups with respect to the proportion of patients who had excellent and good scores (≥6 points) according to the Boston Bowel Preparation Scale (relative risk: 0.99; 95% confidence interval [CI]: 0.90 to 1.08). Excellent and good scores were observed in both groups in approximately 90% of children. A meta-analysis of two other trials (n=150) showed no significant difference between the groups with respect to the mean total score for the Ottawa Bowel Preparation Scale (mean difference: 0.20; 95% CI: -0.74 to 1.14). Both regimens provided a comparable safety profile; however, PS/Mg was significantly superior to high volume PEG in terms of tolerability (abdominal pain, nausea, vomiting, bloating/flatulence/fullness) and acceptability (ease of formulation consumption, taste acceptance, need for nasogastric tube, compliance with full dose). Conclusion: PS/Mg provides a quality and safety profile similar to PEG for bowel cleansing; however, it has better acceptance and tolerance in children preparing for colonoscopy.

인체 바이오모니터링 지식 모델링 및 데이터베이스 구축 (Knowledge Modeling and Database Construction for Human Biomonitoring Data)

  • 이장우;양세희;이헌주
    • 한국식품위생안전성학회지
    • /
    • 제35권6호
    • /
    • pp.607-617
    • /
    • 2020
  • 인체 바이오모니터링(Human biomonitoring, HBM) 데이터는 뇨와 혈액 등 생체지표으로부터 환경유해물질의 측정을 통해 획득되며, 다양한 노출원과 경로로부터 노출되는 유해물질의 인체노출수준 및 건강영향과의 상관성을 파악하기 위해 매우 중요하다. 국내의 경우 식품의약품안전처를 비롯한 국가기관의 다양한 HBM 프로그램을 통하여 HBM 데이터가 생산되고 있다. 그러나, 목적, 시기, 연구자 및 측정 장비의 차이에 의하여 서로 다른 형식에 따라 생산되다 보니, 데이터의 호환성의 문제로 인하여 특정 HBM 데이터를 신속하게 조회해야 하거나 인구집단별 시간적 추이분석 내지는 다른 국가의 자료와 비교에 난점을 가지고 있다. 따라서, 본 연구에서는 HBM 데이터를 체계적으로 데이터베이스(Database, DB)화하고 활용성을 증진하게 시킬 목적으로 지식 모델링을 실시하였다. 지식 모델링은 HBM 데이터의 생산되는 변수들을 그룹화하고 관계를 분석하여 2차원 구조의 개체 및 집합론에 기초한 방법론인 관계형 데이터 모델링 기법을 활용하여 실시하였다. 지식모델은 조사대상자를 인구집단으로 중심으로 설문자료, 측정자료, 노출 평가자료 개체로 구성하고 그 안에 속성들을 정의하고, 개체간에 관계를 설정하는 방식으로 구성하였다. 또한, 도출된 지식 모델을 기반으로 식품의약품안전처에서 2006년-2018년까지 수행한 HBM의 원시데이터를 수집, 정제 및 정규화하여 통합 DB를 구축하였다. 이와 같이 통합된 HBM-DB는 개별 자료원 내지는 특정 자료원들을 선택하여 기간별 농도 수준에 대한 통계분석은 물론, 다양한 검색조건을 통하여 데이터 추출을 할 수 있는 구조로 구축하였다. 본 HBM-DB는 관계형 DB모델로 구축되어 지속적인 대용량 DB 축적이나 HBM 데이터 해석을 위한 도구로써 효율적으로 수행할 수 있을 것으로 생각된다.

곡류 및 그 가공품 중 아플라톡신과 데옥시니발레놀의 안전성 평가 (The Safety Assessment of Aflatoxins and Deoxynivalenol in Cereals and Their Products)

  • 김영수;김영숙;김명길;이성봉;이주예;오상헌;정유정;서미영;성진희;이완;이정복;윤미혜
    • 한국식품위생안전성학회지
    • /
    • 제28권2호
    • /
    • pp.158-167
    • /
    • 2013
  • This study was carried out to assess the safety of cereals and their products (20 species, 205 samples) distributed in Gyeonggi province by analyzing contamination levels such as exposure frequency of Aflatoxins and Deoxynivalenol (DON). Aflatoxins were detected in 16 (8%) samples in total with a range of 0.01~27.88 ${\mu}g/kg$, including 3 of 9 bake flour (33%), 2 of 6 dried corn (33%), 3 of 12 frying flour (25%) and 2 of 11 sorghum (18%). DON was found in 56 (27%) samples including 11 of 13 adlay (85%), 6 of 8 wheat (75%), 6 of 10 processed corn for popcorn (60%), 6 of 11 sorghum (55%) and 7 of 16 barley (44%) with a range of 2.2~754.4 ${\mu}g/kg$. In particular, both Aflatoxins and DON were detected in 8 samples (2 millet, 2 wheat, 1 sorghum, 1 adlay, 1 dried corn, 1 bake flour) simultaneously. As a result of this study, we found that an adult is exposed to Aflatoxins of $0.80({\times})10^{-3}{\mu}g/kg$ b.w./day and DON of 0.18 ${\mu}g/kg$ b.w./day. The quantity of exposure to DON amounted to 18.5 percentage level compared with PMTDI 1 ${\mu}g/kg$ b.w./day suggested on JECFA, therefore we can assess that the possibility of health risks by intake cereals distributed in Gyeonggi province is low. However the concentration of Aflatoxins in one dried corn was 27.88 ${\mu}g/kg$ which was over the maximum residue limits (MRL) suggested on internal and external level, the monitoring about mycotoxin should be conducted on continuously.

노인 운전자의 운전 위험성 자각 특성 분석 (Analyzing Driving Risk Self-Perception Characteristics of Elderly Drivers)

  • 최성열
    • 융합정보논문지
    • /
    • 제10권7호
    • /
    • pp.223-231
    • /
    • 2020
  • 노인 운전자는 기능저하로 인해 사고 위험성이 증가하지만 스스로 변화를 점검하는 자가-조절 능력 또한 발달한다. 이에 실제 노인 운전자가 운전 능력과 위험성 변화에 대응하는 특성에 대한 정보는 노인의 운전 능력 평가 현장과 연구에 의미있는 근거를 제공할 수 있다. 따라서 본 연구의 목적은 한국 노인 운전자의 운전 위험성 자각 특성을 운전 중 행동과 운전관련 기능변화의 측면에서 분석하여 노인 운전자 평가를 위한 기초 자료를 제공하는 것이다. 지역사회에 거주하는 노인 운전자 500명을 대상으로 자가-보고식 평가를 실시하고 노인 운전자의 운전 위험성 자각 징후를 분석하였다. 그 결과 다수의 노인 운전자가 시각 및 청각이 저하되거나 운전 여건 변화에 적응하는데 어려움을 느낄 때 운전 위험성을 자각하는 특성이 있음을 확인하였다. 반면, 약물 복용이나 간질, 발작, 의식손실 등 의학적 건강 상태 변화에는 둔감하게 반응하는 특성이 확인되었다. 본 연구 결과가 고령화가 가속화되는 한국의 노인 운전자 안전 관리에 기여할 수 있기를 기대한다.

피나물 중 boscalid 및 pyraclostrobin의 토양 처리시 잔류특성 및 안전성 평가 (Residue Characteristics and Risk Assessment of Pesticides (Boscalid and Pyraclostrobin) in Hylomecon vernalis)

  • 유지우;송민호;김진찬;이광헌;고락도;금영수;이지호
    • 한국환경농학회지
    • /
    • 제41권2호
    • /
    • pp.95-100
    • /
    • 2022
  • BACKGROUND: This study was aimed to determine characteristics of residues of the soil-treated boscalid and pyraclostrobin within Hylomecon vernalis and to evaluate the risks from intake of the residual pesticides in the crop. METHODS AND RESULTS: The pesticides were treated to soils at two different concentrations, and the plant samples were collected 57 days after seeding. The samples were extracted using the QuEChERS extraction kit (MgSO4 4 g, NaCl 1 g). The quantitative methods for boscalid and pyraclostrobin were validated using linearity, recovery, and CV (coefficient of variation). Risk assessment of the pesticides was performed using Korea national nutrition statistics 2019. CONCLUSION(S): The residual levels of boscalid were 0.02-0.05 mg/kg (for the treatment at 6 Kg/10a) and 0.05-0.08 mg/kg (for the treatment at 12 Kg/10a), respectively. The residual concentrations of pyraclostrobin were below the LOQ. The amounts of pesticides were less than Maximum Residue Limits specified by the Korean Ministry of Food and Drug Safety. The maximum hazard indices of boscalid in chwinamul and amaranth for consumers were 0.0075% and 0.1525%, respectively, and it indicates that the risk of the pesticides from the crop is considered to be low.

Public Health Risks: Chemical and Antibiotic Residues - Review -

  • Lee, M.H.;Lee, H.J.;Ryu, P.D.
    • Asian-Australasian Journal of Animal Sciences
    • /
    • 제14권3호
    • /
    • pp.402-413
    • /
    • 2001
  • Food safety is a term broadly applied to food quality that may adversely affect human health. These include zoonotic diseases and acute and chronic effects of ingesting natural and human-made xenobiotics. There are two major areas of concern over the presence of residues of antibiotics in animal-derived foodstuffs with regard to human health. The first is allergic reactions. Some antibiotics, such as penicillins can evoke allergic reactions even though small amounts of them are ingested or exposed by parenteral routes. The second is development of antibiotic resistance in gut bacteria of human. Recently multi-resistant pneumococcal, glycopeptide-resistant enterococci and gram negative bacteria with extended-spectrum $\beta$-lactamases have spread all over the world, and are now a serious therapeutic problem in human. Although it is evident that drugs are required in the efficient production of meat, milk and eggs, their indiscriminate use should never be substituted for hygienic management of farm. Drug should be used only when they are required. In addition to veterinary drugs, environmental contaminants that were contaminated in feed, water and air can make residues in animal products. Mycotoxins, heavy metals, pesticides, herbicides and other chemicals derived from industries can be harmful both to animal and human health. Most of organic contaminants, such as dioxin, PCBs and DDT, and metals are persistent in environment and biological organisms and can be accumulated in fat and hard tissues. Some of them are suspected to have endocrine disrupting, carcinogenic, teratogenic, immunodepressive and nervous effects. The governmental agencies concerned make efforts to prevent residue problems; approval of drugs including withdrawal times of each preparation of drugs, establishment of tolerances, guidelines regarding drug use and sanitation enforcement of livestock products. National residue program is conducted to audit the status of the chemical residues in foods. Recently HACCP has been introduced to promote food safety from farm to table by reducing hazardous biological, chemical and physical factors. Animal Production Food Safety Program, Quality Assurance Programs, Food Animal Residue Avoidance Databank are para- or non-governmental activities ensuring food safety. This topic will cover classification and usage or sources of chemical residues, their adverse effects, and chemical residue status of some countries. Issues are expanded to residue detection methodologies, toxicological and pharmacokinetic backgrounds of MRL and withdrawal time establishments, and the importance of non-governmental activities with regard to reducing chemical residues in food.

악성 고형암의 항암제 동반진단 기술에서 분자진단기술의 적용 (Application of Molecular Diagnostics Technology in the Development of a Companion Diagnostics for Malignant Solid Tumors)

  • 김진희
    • 한국콘텐츠학회논문지
    • /
    • 제19권3호
    • /
    • pp.365-374
    • /
    • 2019
  • 악성종양은 양성종양과 달리 전이가 가능하고 재발이 쉬울 뿐 아니라 생존율 및 삶의 질이 떨어지는 질환이다. 국내의 경우 악성종양 치료 시 건강보험심사평가원이 제시한 항암화학요법 일반원칙에 따라 일괄적으로 치료하는 경향이 있다. 하지만 근래에는 일방적인 약물치료보다는 동반진단제를 사용을 권고하는데 이는 바이오마커를 이용한 분자진단기법으로 동반진단하여 치료 전에 환자의 약물 반응을 예측할 수 있기 때문이며, 국내외 식품의약품안전처에서는 의약품의 반응성 및 안전성을 확보하기 위하여 신약개발단계에서 동반진단제를 함께 개발하기를 권고한다. 본 종설에서는 악성 고형암을 중심으로 동반진단제의 개발방향 및 개발현황을 문헌고찰을 통해 분석하였고, 동반진단제로 사용되는 다양한 분자진단기법, 예컨대 면역조직화학염색법, 중합효소연쇄반응법, 제자리부합법, 차세대염기서열분석법 등에 따른 동반진단제 개발현황 및 미국 식품의약품안전청의 승인사례를 조사하여 최신 동반진단 개발동향을 함께 살폈다. 그리고 동반진단제 개발과정에서 기술적 사항으로 허가시점에 맞춘 분자진단기술을 선택과 진단제에 대한 명확한 기전이해와 더불어 치료와 동반진단제의 융합을 제언하였고, 사회적으로 동반진단제에 대한 공공보험의 급여책정이 필요함을 제언하였다.

홈베이킹 조리기구에서 용출되는 유해금속 실태조사 (Monitoring of Hazardous Metals Migrated from Home-Cooking Utensils)

  • 박성희;김명길;손미희;서미영;장미경;구은정;채선영;박용배
    • 한국식품위생안전성학회지
    • /
    • 제36권3호
    • /
    • pp.264-270
    • /
    • 2021
  • 2020년 경기도내 대형매장과 베이킹 전문매장 등에서 유통 중인 홈베이킹 조리기구 69건(폴리에틸렌테레프탈레이트(PET)제, 불소수지(FR)제, 가공셀룰로스제, 고무제, 종이제, 금속제, 유리제)을 대상으로 유해금속 9종(납, 카드뮴, 비소, 아연, 니켈, 안티몬, 게르마늄, 6가크롬, 알루미늄)의 용출량 및 알루미늄의 식품으로의 이행량을 조사하여 홈베이킹 조리기구의 안전관리를 위한 기초자료로 활용하고자 하였다. 홈베이킹에서 사용되는 69건의 조리기구는 식품용 기구 및 용기·포장 공전의 용출규격 기준에 모두 적합하였다. 금속제의 니켈이 최대 0.009 mg/L 검출되었으나 기준에 적합하였고 이외 유해금속은 불검출이었다. 규격 기준 이외의 금속에서 주로 용출된 유해금속은 알루미늄으로 7개의 재질에서 모두 용출되었으며, 4% 초산으로 용출된 종이제(1.417 mg/L)와 가공셀룰로스제(5.069 mg/L)에서 높은 용출량을 보였다. 홈베이킹에서 주로 사용되는 조리조건인 180℃, 30분 용출실험 결과, 식품용 기구 및 용기·포장 공전에 따른 용출실험 대비, 종이제의 알루미늄의 용출량이 7.2배 유의하게 증가하였다(P<0.05). 이외 납 등 다른 유해금속이 추가로 검출되었다. 180℃, 30분으로 용출온도가 증가하여도 식품용 기구 및 용기·포장 공전의 용출규격 기준에는 모두 적합하였다. 알루미늄의 위해도 평가결과, 종이제 > 금속제 > FR제 > 고무제 및 유리제 > PET제 및 가공셀룰로스제 순으로 나타났으며, 전체 위해도는 0.000-0.045% 수준으로 국민생활건강에 위해를 끼치지 않는 안전한 수준으로 확인되었다. 홈베이킹 조리기구의 용출량 조사결과, 유해금속은 안전하게 관리되고 있는 것을 확인하였고, 본 연구의 결과는 향후 식품용 기구 및 용기·포장의 안전관리를 위한 과학적인 근거자료로 활용될 수 있을 것으로 사료된다.

전국 권역별, 연령별 여자 성인과 노인의 짠맛 미각판정치, 식태도 및 식행동 비교 (A Comparison of Salty Taste Assessment, Dietary Attitude and Dietary Behavior among Adult and Senior Women by Region and by Age in Korea)

  • 지앙린;정윤영;김형숙;남기선;윤진숙;김종욱;이연경
    • 대한지역사회영양학회지
    • /
    • 제20권2호
    • /
    • pp.109-119
    • /
    • 2015
  • Objectives: The purpose of this study was to compare and analyze the results of salty taste assessment, dietary attitudes, and dietary behaviors among adult and senior women by region and by age. The results generated from this was expected to provide fundamental data for implementing a nationwide salt reduction education program. Methods: The salty taste assessment tool was applied to 4,064 subjects from 15 areas in Korea. Also, a survey of dietary attitude and dietary behavior related to salt intake was conducted for all subjects participated in this study. Results: The salty taste assessment scores by region and by age were the lowest in capital (p < 0.01) and was highest among the 70+ year age group (p < 0.01). The dietary attitude scores and dietary behavior scores showed that Gyeongsang was the highest (p < 0.001) and the capital was the lowest. The dietary attitude scores were highest at 20&30's followed by 40's and 70's group (p < 0.001). Dietary behavior scores showed that 20's~30's and 40's groups were higher than the other age groups (p < 0.001). The score of 'I like kimchi' was $3.46{\pm}0.88$, which was the highest among 10 dietary behavior questions. The score of 'I eat a lot of kimchi' was $3.30{\pm}0.90$, which was the highest among 10 dietary behavior questions related to salt intake. The scores of salty taste assessment had significant positive correlations between the scores of dietary attitude (p < 0.001), dietary behavior (p < 0.001) and self-awareness (p < 0.001). Conclusions: Based on the results of salty taste assessment, we observed a tendency that older people and regions except the capital had higher preference for salty taste. Our results suggested the necessity for a nationwide salty reduction education program tailored for regions and for different age groups.