• Toxicological Research
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• 제34권2호
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• pp.111-125
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• 2018

Solvents can be used in the manufacture of medicinal products provided their residual levels in the final product comply with the acceptable limits based on safety data. At worldwide level, these limits are set by the "Guideline Q3C (R6) on impurities: guideline for residual solvents" issued by the ICH. Diisopropyl ether (DIPE) is a widely used solvent but the possibility of using it in the pharmaceutical manufacture is uncertain because the ICH Q3C guideline includes it in the group of solvents for which "no adequate toxicological data on which to base a Permitted Daily Exposure (PDE) was found". We performed a risk assessment of DIPE based on available toxicological data, after carefully assessing their reliability using the Klimisch score approach. We found sufficiently reliable studies investigating subchronic, developmental, neurological toxicity and carcinogenicity in rats and genotoxicity in vitro. Recent studies also investigated a wide array of toxic effects of gasoline/DIPE mixtures as compared to gasoline alone, thus allowing identifying the effects of DIPE itself. These data allowed a comprehensive toxicological evaluation of DIPE. The main target organs of DIPE toxicity were liver and kidney. DIPE was not teratogen and had no genotoxic effects, either in vitro or in vivo. However, it appeared to increase the number of malignant tumors in rats. Therefore, DIPE could be considered as a non-genotoxic animal carcinogen and a PDE of 0.98 mg/day was calculated based on the lowest No Observed Effect Level (NOEL) value of $356mg/m^3$ (corresponding to 49 mg/kg/day) for maternal toxicity in developmental rat toxicity study. In a worst-case scenario, using an exceedingly high daily dose of 10 g/day, allowed DIPE concentration in pharmaceutical substances would be 98 ppm, which is in the range of concentration limits for ICH Q3C guideline class 2 solvents. This result might be considered for regulatory decisions.

• Journal of Korean Neurosurgical Society
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• 제64권3호
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• pp.427-436
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• 2021

Objective : The fate of partially thrombosed intracranial aneurysms (PTIAs) is not well known after endovascular treatment. The authors aimed to analyze the treatment outcomes of PTIAs. Methods : We retrospectively reviewed the medical records of 27 PTIAs treated with endovascular intervention between January 1999 and March 2018. Twenty-one aneurysms were treated with intraluminal embolization (ILE), and six were treated with parent artery occlusion (PAO) with or without bypass surgery. Radiological results, clinical outcomes and risk factors for major recurrence were assessed. Results : The initial clinical status was similar in both groups; however, the last status was better in the ILE group than in the PAO group (p=0.049). Neurological deterioration resulted from mass effect in one case and rupture in one after ILE, and mass effect in two and perforator infarction in one after PAO. Twenty cases (94.2%) in the ILE group initially achieved complete occlusion or residual neck status. However, 13 cases (61.9%) showed major recurrence, the major causes of which included coil migration or compaction. Seven cases (33.3%) ultimately achieved residual sac status after repeat treatment. In the PAO group, all initially showed complete occlusion or a residual neck, and just one case ultimately had a residual sac. Two cases showed major recurrence, the cause of which was incomplete PAO. Aneurysm wall calcification was the only significantly protective factor against major recurrence (odds ratio, 36.12; 95% confidence interval, 1.85 to 705.18; p=0.018). Conclusion : Complete PAO of PTIAs is the best option if treatment-related complications can be minimized. Simple fluoroscopy is a useful imaging modality because of the recurrence pattern.

• 한국해양학회지:바다
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• 제19권2호
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• pp.155-163
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• 2014

마산만 표층퇴적물에서 미량금속의 오염도 및 잠재적 생태계 위해도를 평가하기 위하여 미량금속(Cu, Pb, Zn, Cd, Ni)의 총 농도 및 화학적 존재형태를 분석하였다. 미량금속의 농도는 Ni을 제외한 모든 금속이 만의 내측에 위치한 마산항 주변에서 높게 나타났다. 미량금속의 화학적 존재형태 중 Cd과 Pb은 비잔류 부분이 각각 92%, 88%로 인위적 기원에 의해서 주로 공급되는 것으로 나타난 반면, Ni은 잔류 부분이 70%로 주로 자연적 기원에 의해서 공급된 것으로 나타났다. 미량금속의 오염도 및 생태계 위해도를 다양한 지수로 평가한 결과, pollution load index (PLI)는 만의 바깥쪽 정점을 제외한 모든 정점에서 1을 초과하여 인위적 오염 상태를 보였다. Ecological risk index (ERI)는 만의 내측에서 considerable 또는 moderate risk 수준이었으며, 만의 바깥쪽에서는 low risk 수준이었다. Cd의 ecological index (Ei) 값은 대부분의 정점에서 높게 나타났으며, Cd이 산가용성 부분에서 가장 높은 농도를 보여 Cd이 마산만에서 저서생물에게 잠재적으로 높은 위해도를 미칠 것으로 판단된다.

• 한국방사성폐기물학회:학술대회논문집
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• 한국방사성폐기물학회 2004년도 학술논문집
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• pp.24-31
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• 2004

원자력발전소를 안전하게 해체하기 위해서는, 해체부지 개방기준의 준수여부를 확인하기 위해 수행되는 환경이나 설비의 방사선학적 조사의 계획, 실시 그리고 평가에 대한 상세 지침을 제공하는 절차가 필요하다. 본 연구에서는 해외 원전 해체 사례와 MARSSIM을 근간으로 부지운영이력평가, 오염범위조사, 오염현황 상세 조사, 제염복구 지원조사, 최종부지조사의 순으로 해체 부지내 잔류방사능을 조사하는 절차를 제시하였다.

• The Journal of Asian Finance, Economics and Business
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• 제7권3호
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• pp.137-148
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• 2020

The purpose of this study is to investigate factors influencing risk assessment of material misstatement in Vietnamese enterprises listed on stock market. Expert interview method was conducted to discover the scales for three variables including information system, trademark, and risk assessment of material misstatement. Survey method was used to examine the impacts of eight factors on risk assessment of material misstatement. Data is collected from 317 auditors who have excellent experience in auditing financial statements of companies listed on stock market. Then, data is processed by descriptive statistics, reliability analysis, factor extracted analysis, correlative regression analysis, and analysis variance of residual change. The research findings showed that business characteristic, stakeholder pressure, and economic environment have positive relationships with risk assessment of material misstatement. Three variables including operation control and monitor, control environment, and information system negatively affect to risk assessment. Specially, business characteristic and information system, which are elements in internal control, have strongest impact on risk assessment. One the other hand, assessment of internal control plays an important role not only in the audit plan stage but also throughout the stages of the audit implementation and ending. Therefore, appropriate solutions are proposed to carry out all audit stages.

• 한국건축시공학회:학술대회논문집
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• 한국건축시공학회 2012년도 춘계 학술논문 발표대회
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• pp.95-97
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• 2012

Recycled aggregate (RA) produced from demolished concrete waste can bring about several problems on concrete performance, when it is used as aggregate for new concrete. Because RA generally has lower quality than natural aggregate due to the residual cement paste attached on RA and various impurities. It is also very difficult to ensure that the quality of RA remains consistent, because generally RA is produced variously. Thus, in concrete recycling, it is extremely important to estimate the risk of the impurities which could affect performances of recycled aggregate concrete (RAC) focusing on the material flow of concrete waste and its recycling. This study suggests an evaluation result to expect the possibility of impurity mixing in RA production procedure. and suggests a risk evaluation model to expect the changes of RAC performances based on conventional data in Japan.

• 대한환경공학회지
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• 제33권6호
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• pp.453-479
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• 2011

오늘날 전세계적으로 수환경에서의 잔류 의약물질들의 오염에 대한 연구결과들이 많이 보고되고 있다. 이들 잔류 의약물질들은 다양한 종류와 그들이 가지는 물리 화학적인 특성들로 인해 수환경에서의 거동, 오염현황, 영향 및 독성 등도 매우 다양하여 수환경 및 수처리 공정에서의 거동을 예측 평가하기가 어렵다. 선진 외국의 경우 환경 중에서의 오염 현황 및 사용량을 정량화하기 위한 조사를 이미 시작하였고, 잔류 의약물질들의 인체에 대한 잠재적 위험성뿐만 아니라 상수나 하수처리 공정에서의 제거기술에 관한 다양한 연구도 활발히 진행하고 있다. 그러나 국내의 경우 잔류 의약물질들에 대해 전국 주요하천과 상수원에 대한 모니터링 결과도 매우 부족한 실정이다. 우선 국내의 경우는 상수원으로 이용되는 전국 주요 하천과 호소에 대해 주기적이고 체계적인 오염현황 평가가 선행되어야 하며, 잔류 의약물질들이 비교적 고농도로 검출되는 상수원에 대해서는 주오염원에 대한 조사도 병행되어야 한다. 또한, 의약물질 사용량은 지속적으로 증가할 것으로 전망되기 때문에 하수처리 시설에 대한 부하도 지속적으로 증가할 것이다. 따라서 수환경에서의 유해도를 저감시키기 위해 효과적인 하수처리 공법의 도입이 절실하며, 상수에 대한 안전성 확보를 위해서도 잔류 의약물질들의 수환경중에서의 물리 화학적 거동에 대한 면밀한 연구가 요구된다.

• Journal of Korean Neurosurgical Society
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• 제48권4호
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• pp.330-334
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• 2010

Objective : Residual aneurysm from incomplete clipping or slowly recurrent aneurysm is associated with high risk of subarachnoid hemorrhage. We describe complete treatment of the lesions by surgical clipping or endovascular treatment. Methods : We analyzed 11 patients of residual or recurrent aneurysms who had undergone surgical clipping from 1998 to 2009. Among them, 5 cases were initially clipped at our hospital. The others were referred from other hospitals after clipping. The radiologic and medical records were retrospectively analyzed. Results : All patients presented with subarachnoid hemorrhage at first time, and the most frequent location of the ruptured residual or recurrent aneurysm was in the anterior communicating artery to posterior-superior direction. Distal anterior cerebral artery, posterior communicating artery, and middle cerebral artery was followed. Repositioning of clipping in eleven cases, and one endovascular treatment were performed. No residual aneurysm was found in postoperative angiography, and no complication was noted in related to the operations. Conclusion : These results indicate the importance of postoperative or follow up angiography and that reoperation of residual or slowly recurrent aneurysm should be tried if such lesions being found. Precise evaluation and appropriate planning including endovascular treatment should be performed for complete obliteration of the residual or recurrent aneurysm.

• Journal of Gastric Cancer
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• 제10권4호
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• pp.182-187
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• 2010

Purpose: Additional surgery is commonly recommended in gastric cancer patients who have a high risk of lymph node metastasis or a positive resection margin after endoscopic resection. We conducted this study to determine factors related to residual cancer and to determine the appropriate treatment strategy. Materials and Methods: A total of 28 patients who underwent curative gastrectomy due to non-curative endoscopic resection for early gastric cancer between January 2006 and June 2009 were enrolled in this study. Their clinicopathological findings were reviewed retrospectively and analyzed for residual cancer. Results: Of the 28 patients, surgical specimens showed residual cancers in eight cases (28.6%) and lymph node metastasis in one case (3.8%). Based on results of the endoscopic resection method, the rate of residual cancer was significantly different between the en-bloc resection group (17.4%) and the piecemeal resection group (80.0%). The rate of residual cancer was significantly different between the diffuse type group (100%) and the intestinal type group (20%). The rate of residual cancer in the positive lateral margin group (25.0%) was significantly lower than that in the positive vertical margin group (33.3%) or in the positive lateral and vertical margin group (66.7%). Conclusions: We recommended that patients who were lateral and vertical margin positive, had a diffuse type, or underwent piecemeal endoscopic resection, should be treated by surgery. Minimal invasive procedures can be considered for patients who were lateral margin positive and intestinal type through histopathological examination after en-bloc endoscopic resection.

• Journal of Chest Surgery
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• 제28권3호
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• pp.237-246
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• 1995

Between March 1989 and December 1994, one-stage repair was performed for correction of the intracardiac malformations associated with aortic coarctation in 34 patients or interrupted aortic arch in 8 patients via median sternotomy. There were 26 male and 16 female patients, and their body weight ranged from 1.8 to 8 kg [mean weight, 4.0 1.4 kg . The age at the operation ranged from 7 days to 18 months [mean age, 3.1 $\pm$ 3.8 months . The repair of aortic coarctation or interrupted aortic arch was performed using extended end-to-end anastomosis in most of the patients [86%, 36/42 , and six patients underwent ductal tissue excision and patch aortoplasty. Intracardiac defects were corrected concomitantly through the right atrium unless the anatomy dictated otherwise. Obstructive outlet septum was resected whenever necessary. There were seven early deaths [16.8 % , and three late deaths with a mean follow-up period of 25 months [range from 1 to 65 months . Three patients were reoperated upon residual subaortic stenosis, stenosis at the RPA origin, and subacute bacterial endocarditis respectively. None showed any significant residual or anastomotic stenosis postoperatively. One stage repair of the aortic coarctation and interrupted aortic arch associated with intracardiac defect leaves no native coarctation shelf tissue or residual hypoplasia in the repaired segment, has low incidence of recurrent or residual stenosis, minimizes reoperation and incisions, and manages arch hypoplasia easily. We concluded that surgical results of one-stage repair for the intracardiac malformation associated with aortic coarctation or interrupted aortic arch are reasonable.