• 환경생물
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• 제39권1호
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• pp.88-99
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• 2021

본 연구에서는 해양생태계 위해성 평가 시 생물학적, 비생물학적 요인에 대한 인공생태계 실험의 초기 안정성을 객관적으로 평가하기 위해 육상 기반 해양 폐쇄형 메조코즘(LMCM) 실험을 수행하였다. 변동계수(CV)의 진폭 변화는 실험의 안정성 분석 자료로 사용하였다. 본 연구에서 LMCM 그룹(200, 400, 600, 1,000 L) 내 비생물학적 실험변수에 대한 CV 값은 20~30% 범위로 유지되었다. 그러나 엽록소-a, 식물플랑크톤 및 동물플랑크톤과 같은 생물학적 요인의 CV 진폭 파이는 600L와 1,000L LMCM 그룹에서 높게 분석되었다. 이와 같은 결과는 실험 초기에 생물학적 변수에 대한 제어가 부족하여 발생한 것으로 해석된다. 또한 ANOVA 분석에 따르면, LMCM 그룹 간 CV 값은 생물학적 요인과 연관된 실험변수들에서 유의한 차이를 보였다(p<0.05). 본 연구에서 생물학적 변수의 안정화는 LMCM 그룹의 크기와 그룹 내 생물의 생태-생리학적 활동의 복잡성을 감안할 때 수질 및 영양염 성분을 제외하면 실험 초기 생물학적 변수의 변동성을 제어하고 유지할 필요가 있으나 현실적으로 어려운 부분이 많았다. 결론적으로 해양에서 과학적 도구로써 인공생태계 실험은 생물학적, 비생물학적 요인을 구분하여 명확한 측정요소(endpoint)를 비교 분석할 수 있는 연구목적 수립, 실험조건의 안정성 유지 및 실험결과를 객관적으로 해석할 수 있는 표준화된 분석 기법의 도입이 필요한 것으로 판단된다.

• The Korean journal of internal medicine
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• 제39권3호
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• pp.501-512
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• 2024

Background/Aims: Optimal risk stratification based on simplified geriatric assessment to predict treatment-related toxicity and survival needs to be clarified in older patients with diffuse large B-cell lymphoma (DLBCL). Methods: This multicenter prospective cohort study enrolled newly diagnosed patients with DLBCL (≥ 65 yr) between September 2015 and April 2018. A simplified geriatric assessment was performed at baseline using Activities of Daily Living (ADL), Instrumental ADL (IADL), and Charlson's Comorbidity Index (CCI). The primary endpoint was event-free survival (EFS). Results: The study included 249 patients, the median age was 74 years (range, 65-88), and 125 (50.2%) were female. In multivariable Cox analysis, ADL, IADL, CCI, and age were independent factors for EFS; an integrated geriatric score was derived and the patients stratified into three geriatric categories: fit (n = 162, 65.1%), intermediate-fit (n = 25, 10.0%), and frail (n = 62, 24.9%). The established geriatric model was significantly associated with EFS (fit vs. intermediate-fit, HR 2.61, p < 0.001; fit vs. frail, HR 4.61, p < 0.001) and outperformed each covariate alone or in combination. In 87 intermediate-fit or frail patients, the relative doxorubicin dose intensity (RDDI) ≥ 62.4% was significantly associated with worse EFS (HR, 2.15, 95% CI 1.30-3.53, p = 0.002). It was related with a higher incidence of grade ≥ 3 symptomatic non-hematologic toxicities (63.2% vs. 27.8%, p < 0.001) and earlier treatment discontinuation (34.5% vs. 8.0%, p < 0.001) in patients with RDDI ≥ 62.4% than in those with RDDI < 62.4%. Conclusions: This model integrating simplified geriatric assessment can risk-stratify older patients with DLBCL and identify those who are highly vulnerable to standard dose-intensity chemoimmunotherapy.

• 농약과학회지
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• 제14권2호
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• pp.104-109
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• 2010

우리나라에서 재배된 과채류 8작물 중 neonicotinoid계 농약 5종(acetamiprid, clothianidin, imidacloprid, thiacloprid, thamethoxam)의 잔류량을 모니터링 한 후 잔류량과 식품섭취량을 근거로 해서 확정론적 접근방법을 이용하여 노출평가를 실시하였다. 과채류 8종의 시료 240점에 대해 모니터링을 실시한 결과, acetamiprid가 가장 높은 빈도로 검출되었으며, 고추에서 가장 높은 잔류량을 나타냈다. 과채류 중 검출된 농약 모두 MRL을 초과하지는 않았다. 확정론적 접근을 통한 만성 및 급성 노출평가를 실시한 결과, 해당 독성 기준치에 50배 이하로 나타나 안전한 수준으로 평가되었다. 본 연구의 노출결과는 확정론적 접근법을 이용한 결과이므로, 향후 확률적 접근법을 이용하여 노출평가를 실시하여 과채류에 함유된 neonicotionid계 농약의 위해관리를 위한 의사결정 과정에서 주요하게 고려해야 할 부분을 평가하여야 할 것이다.

• 한국환경보건학회지
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• 제45권2호
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• pp.192-202
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• 2019

Objectives: According to the central limit theorem, the samples in population might be considered to follow normal distribution if a large number of samples are available. Once we assume that toxicity dataset follow normal distribution, we can treat and process data statistically to calculate genus or species mean value with standard deviation. However, little is known and only limited studies are conducted to investigate whether toxicity dataset follows normal distribution or not. Therefore, the purpose of study is to evaluate the generally accepted normality hypothesis of aquatic toxicity dataset Methods: We selected the 8 chemicals, which consist of 4 organic and 4 inorganic chemical compounds considering data availability for the development of species sensitivity distribution. Toxicity data were collected at the US EPA ECOTOX Knowledgebase by simple search with target chemicals. Toxicity data were re-arranged to a proper format based on the endpoint and test duration, where we conducted normality test according to the Shapiro-Wilk test. Also we investigated the degree of normality by simple log transformation of toxicity data Results: Despite of the central limit theorem, only one large dataset (n>25) follow normal distribution out of 25 large dataset. By log transforming, more 7 large dataset show normality. As a result of normality test on small dataset (n<25), log transformation of toxicity value generally increases normality. Both organic and inorganic chemicals show normality growth for 26 species and 30 species, respectively. Those 56 species shows normality growth by log transformation in the taxonomic groups such as amphibian (1), crustacean (21), fish (22), insect (5), rotifer (2), and worm (5). In contrast, mollusca shows normality decrease at 1 species out of 23 that originally show normality. Conclusions: The normality of large toxicity dataset was not always satisfactory to the central limit theorem. Normality of those data could be improved through log transformation. Therefore, care should be taken when using toxicity data to induce, for example, mean value for risk assessment.

• 한국식품위생안전성학회지
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• 제16권1호
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• pp.21-26
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• 2001

유기인계 농약은 주로 수확률을 증가시킬 목적으로 과일, 채소, 곡류를 포함한 농산물에 사용하는 살충제로, 최근의 위해성평가기술은 독성기전이 동일한 물직들에 대해서 기준이 되는 물질의 특성을 1로하여 상대독성계수를 고려하므로 동시노출평가(cumulative risk assessment)를 수행하고 있다. 본 연구에서는 식품섭취를 통한 유기인계 농약의 동시다중노출에 기인된 위해정도를 판단하기 위하여 유기인계 농약과 다소비노출가능식품 등을 대상으로 cumulative risk assessment 를 실시코자 하였다. 펑가에 고려된 농약은 우리나라에서 사용빈도가 높은 농약(Acephate, Azinphos-methyl, Chlorpyrifos, Diazinon, Dimethoate, Ethion, Malathion, Methamidophos, Methidathion, Parathion-methyl, Phosmet, Pirimiphos-methyl) 12종이었고, 평가대상식품은 국내에서 유통되는 다소비식품을 위주로 곡류 4종(쌀, 보리, 밀, 옥수수), 과일류 5종(사과, 감, 밀감, 바나나, 배), 및 채소류 13종(배추, 양배추, 상추, 시금치, 오이, 토마토, 호박, 양파, 고추, 마늘, 무, 파, 당근)을 포함하여 총 22종의 식품을 대상으로 하였으며, 시료의 대표성을 부여하기 위하여 샘플링은 전국 4개 대도시(서울, 부산, 광주, 대전)를 대상으로 총2회 실시하였다. 12종의 유기인계 농약의 동시다중 노출에 대한 위해성평가를 위하여 노출평가시 TEF(독성등가치, Toxic Equivalency Factor) 방법을 적용하였고, FAO/WHO 의 만성인체노출평가방법을 기초로 우리나라 일반 성인을 대상으로 다수의 식품섭취를 통한 다수의 농약에 대한, 동시인체노출평가를 실시하였다. 노출의 안전수준을 결정하기 위해 필요한 독성값은 chlorpyrifos를 기준으로 하여 U.S.EPA 에서 제시한 AChE저해작용을 endpoint로 하는 RfD 값을 활용하였으며, 다수의 유기인계 농약으로부터 동시노출 되었을 때 나타날 수 있는 비발암독성에 대한 위해도를 결정하기 위하여 위험지수(Hazard Index, HI) 방법을 사용하였다.

• 동의생리병리학회지
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• 제32권4호
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• pp.291-297
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• 2018

The purpose of pilot clinical trial is to evaluate the efiicacy and safety of Needle-Embedding acupuncture therapy on TEWL(Transepidermal Water Loss) and Skin hydration. A total of 24 human who visited Dongshin Oriental Medical Center from December 1st, 2016 to July 31st, 2017 were included in the pilot clinical trial. Needle-Embedding acupuncture therapy performed at Gokji(LI11). We observed change of TEWL(Transepidermal Water Loss), Skin hydration before and after Needle-Embedding acupuncture therapy. In the primary endpoint, index of TEWL showed a statistically insignificant decline ($8.5{\pm}2.12{\rightarrow}7.8{\pm}1.53g/h/m^2$). Index of skin hydration showed a statistically significant result ($38.2{\pm}6.77{\rightarrow}36.8{\pm}6.64$). To evaluate the safety, Adverse events and Vital sign check were conducted and there were no problem. And when the physical response, self-awareness, skin system, musculoskeletal pain, and other abnormal responses were assessed 60 minutes and 24 hours and 7 days after Needle-Embedding acupuncture therapy at Gokji(LI11) for stability assessment, Adverse events disappeared during a pilot clinical trial. According to the above pilot clinical trial, it is suggested Needle-Embedding acupuncture therapy were effective for Skin moisturizing and safe.

• 대한치과교정학회지
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• 제50권6호
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• pp.373-382
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• 2020

Objective: To compare computer-aided design and computer-aided manufacturing (CAD/CAM) customized nitinol retainers with standard stainless-steel fixed retainers over a 12-month study period. Methods: This randomized controlled trial (RCT) was conducted on 62 patients randomly allocated to a control group that received stainless-steel retainers or a test group that received customized CAD/CAM nickel-titanium retainers. Four time points were defined: retainer placement (T0) and 1-month (T1), 6-month (T2), and 12-month (T3) follow-up appointments. At each time point, Little's irregularity index (LII) (primary endpoint) and dental stability measurements such as intercanine width were recorded in addition to assessment of periodontal parameters. Radiological measurements such as the incisor mandibular plane angle (IMPA) were recorded at T0 and T3. Failure events (wire integrity or debonding) were assessed at each time point. Results: From T0 to T3, LII and other dental measurements showed no significant differences between the two groups. The data for periodontal parameters remained stable over the study period, except for the gingival index, which was slightly, but significantly, higher in the test group at T3 (p = 0.039). The IMPA angle showed no intergroup difference. The two groups showed no significant difference in debonding events. Conclusions: This RCT conducted over a 12-month period demonstrated no significant difference between customized CAD/CAM nickel-titanium lingual retainers and standard stainless-steel lingual retainers in terms of dental anterior stability and retainer survival. Both retainers eventually appeared to be equally effective in maintaining periodontal health.

• Asian Pacific Journal of Cancer Prevention
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• 제15권8호
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• pp.3533-3536
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• 2014

Background: Breast cancer is one of the most common cancers in women in the world. Health-related quality of life (HRQL) at treatment endpoint in cancer clinical trials is widely considered to be increasingly important. The aim of this review was to provide a literature-based assessment of the validity, reliability and responsiveness of breast cancer-specific HRQL instruments in women breast cancer patients. Materials and Methods: The databases consulted were Medline, PubMed, and Embase. The inclusion criteria required studies to: (1) involve use of HRQL measures; (2) cover women with breast cancer under standard treatment (surgery, radiation therapy, chemotherapy, hormone therapy, and targeted therapy); (3) involve the validity, reliability, or responsiveness of HRQL; (4) deal with validation of breast cancer-specific HRQL instruments. Results: A total of 16 studies were identified through the literature search that met the 4 inclusion criteria. Some seven instruments were assessed among these 16 studies: EORTC QLQ-BR23, FACT-B, FACT-ES, HFRDIS, LSQ-32, QLICP-BR, and SLDS-BC. EORTC QLQ-BR23, FACT-B, LSQ-32, QLICP-BR, and SLDS-BC are more general breast cancer-specific HRQL instruments. FACT-EB is the endocrine subscale combined with FACT-B in order to measure the side effects and putative benefits of hormonal treatment administered in breast cancer patients. HFRDIS is the HRQL measure focusing on hot flash concerns. Conclusions: This paper provides an overall understanding on the currently available breast cancer-specific HRQL instruments in women breast cancer patients.

• 한국물환경학회지
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• 제23권1호
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• pp.144-154
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• 2007

The acute and chronic toxicity of ambient and effluent water discharged to Lake Shihwa were investigated by using Vibrio fischeri, Daphnia magna and Oryzias latipes. Physicochemical characteristics including biochemical oxygen demand (BOD) and nine heavy metals in a total of 15 water samples were evaluated and were satisfied with relevant Korean Water Quality Standards (KWQS) except for Hg in one sample. Acute toxicity was observed in five samples collected from three sampling locations. When impacts on reproduction and growth after chronic exposure were evaluated with D. magna, all the samples showed significant chronic effects. Reproduction appeared relatively more sensitive endpoint. In 21 days chronic tests on O. latipes, survival, mean egg number per female per day, hatching success rate and time to hatch were affected by increasing sample concentration. The organ-level changes such as gonadosomatic index (GSI), and hepatosomatic index (HSI), and molecular biomarker of vitellogenin (Vtg) induction that evaluated with O. latipes increased as exposure concentrations increased. It is noteworthy that the samples that did not exceed the KWQS resulted in acute and chronic toxicities. The results suggested that numeric criteria based on physicochemical parameters may not be protective of aquatic ecosystem. Acute and chronic toxicity tests with organisms representing different trophic groups should be supplemented in order to provide adequate level of environmental protection.

• 대한화장품학회지
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• 제29권2호
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• pp.79-104
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• 2003

Introducing to the market place, safe and effective product is an important responsibility of clinical investigators as well as regulatory agencies in all developed countries. Products claiming to improve skin wrinkles are no exceptions. To date, Renova(R) (all-trans retinoic acid), Avage(R) (tazarotene), and Botox(R) (botulinum toxin) are the only agents FDA approved to ameliorate wrinkles associated with photoaged skin in the USA. For all three, clinical evaluation of wrinkle severity was the primary endpoint required for the approval process. No sophisticated instrument measurements of wrinkles were required, nor used in the pivotal studies. The Division of Dermatologic & Dental Products of the US FDA (Director, Jonathan Wilkin, MD) is not against the use of mechanical instruments in assessing wrinkle severity. Its position on this issue however, remains that any such device must be grounded in patients' or product users' perspective, which means that the evaluation instrument must be clinically relevant and clinically perceptible. Sophisticated devices that can detect minimal improvement, but imperceptible to the users are considered useless in the eyes of the US FDA. Two instruments that have been tried in some antiwrinkle studies in the USA are silicone replicas and Primos. Despite their sophistications, they have clear limitations; thus have never replaced clinical evaluations in these studies. At most, they have served as secondary measures to provide corroborative data on the clinical efficacy of antiwrinkle products. For the foreseeable future, at least in the USA, careful clinical assessment of wrinkles will continue to serve as the critical benchmark to determine whether an antiwrinkle product has enough efficacy to benefit its users. We must not lose sight of the fact that sophisticated devices are only to serve in generating supportive evidence, and not the primary evidence, in any clinical studies.