• Title/Summary/Keyword: Safety Assessment

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Optimal Duration of Dual Antiplatelet Therapy after Stent-Assisted Coil Embolization of Unruptured Intracranial Aneurysms : A Prospective Randomized Multicenter Trial

  • Ban, Seung Pil;Kwon, O-Ki;Kim, Young Deok;Kim, Bum-Tae;Oh, Jae Sang;Kim, Kang Min;Kim, Chang Hyeun;Kim, Chang-Hyun;Choi, Jai Ho;Kim, Young Woo;Lim, Yong Cheol;Byoun, Hyoung Soo;Park, Sukh Que;Chung, Joonho;Park, Keun Young;Park, Jung Cheol;Kwon, Hyon-Jo;Korean NeuroEndovascular Society,
    • Journal of Korean Neurosurgical Society
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    • v.65 no.6
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    • pp.765-771
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    • 2022
  • Objective : Stent-assisted coil embolization (SAC) has been increasingly used to treat various types of intracranial aneurysms. Delayed thromboembolic complications are major concerns regarding this procedure, so dual antiplatelet therapy with aspirin and clopidogrel is needed. However, clinicians vary the duration of dual antiplatelet therapy after SAC, and no randomized study has been performed. This study aims to compare the safety and efficacy of long-term (12 months) dual antiplatelet therapy and short-term dual antiplatelet therapy (6 months) after SAC for patients with unruptured intracranial aneurysms (UIAs). Methods : This is a prospective, randomized and multicenter trial to investigate the optimal duration of dual antiplatelet therapy after SAC in patients with UIAs. Subjects will receive dual antiplatelet therapy for 6 months (short-term group) or 12 months (long-term group) after SAC. The primary endpoint is the assessment of thromboembolic complications between 1 and 18 months after SAC. We will enroll 528 subjects (264 subjects in each group) and perform 1 : 1 randomization. This study will involve 14 top-performing, high-volume Korean institutions specializing in coil embolization. Results : The trial will begin enrollment in 2022, and clinical data will be available after enrollment and follow-up. Conclusion : This article describes that the aim of this prospective randomized multicenter trial is to compare the effect of short-term (6 months) and long-term (12 months) dual antiplatelet therapy on UIAs in patients undergoing SAC, and to find the optimal duration.

Analysis of the Disposal Rate of Fresh Frozen Femoral Head in the Bone Bank of a Single Hospital (단일 병원 인체조직은행에서 채취한 신선 동결 대퇴골두의 폐기율 분석)

  • Lee, Jaeyoung;Lee, Donghun;Jeon, Jinhwa;Lee, Kee Haeng
    • Journal of the Korean Orthopaedic Association
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    • v.56 no.4
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    • pp.305-309
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    • 2021
  • Purpose: This study analyzed the increase in disposal rate of femoral heads in the bone bank of a single hospital from medical disease and drug history, as assessed by the Korean health insurance review and assessment service. Materials and Methods: The disposal rate and cause of 340 femoral heads were analyzed according to the regulations of the bone bank based on the standard model of the Ministry of food and drug safety. Results: One hundred and seven (33%) of 323 femoral heads collected from 2009 to 2018, and 65 (46%) of 142 femoral heads collected from 2015 to 2018 were discarded. The most common causes were related to the history of dementia and the administration of radioisotope for nuclear medicine. Conclusion: The current methods and screening tools can lead to errors in disposing of the available tissues in a bone bank. Thus, improved standards and screening methods are needed.

A Study on the Exposure Factors Used in the Assessment of Inhalation Exposure to Household Chemicals (생활화학제품의 흡입노출평가에 사용되는 노출계수에 대한 고찰)

  • Yoon, Chungsik;Kwon, Taehong;Oh, Gitaek;Kim, Minjung;Kim, Boowook;Shin, CheolWoong;Lee, Kiyoung;Zoh, Kyungduk
    • Journal of Environmental Health Sciences
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    • v.48 no.4
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    • pp.195-205
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    • 2022
  • Background: The biggest concern when using household chemical products is the health risk from inhalation exposure. Objectives: The purpose of this paper was to provide information necessary for estimating inhalation exposure factors in several countries/organizations and to present some examples. Methods: We attempted to use PRISMA-ScR for a systematic review, but no major reports were found. We used the Google search function instead to find 'exposure factor handbook'. As for the results, inhalation exposure factors from South Korea, the United States, Canada, the EU, Australia, Japan, and China were compared. Results: The basic concept and origin of exposure factors was the US Environmental Protection Agency's Exposure Factor Handbook. Its latest version is 2011, but several chapters have been updated in 2017, 2018, and 2019. South Korea's Exposure Factor Handbook was updated in 2019, more recently than those of other countries, and was systematically investigated. In South Korea, the average daily respiratory rate is 14.62 m3/day for adults and 12.73 m3/day for children. It is difficult to compare breathing rate by country because each country divides age groups differently and uses different methods to estimate it. Information on household chemical products, space used, and ventilation rate are in the exposure factor handbook in some countries and not in others. It is not in the handbook in South Korea, but in the notice from the NIER (National Institute of Environmental Research), a sub-regulation of the Chemical Product Safety Act. Conclusions: The exposure factors registered in South Korea's exposure factor handbook have been systematically studied and reflect the most recent data. When using data not in the relevant handbook, data from other countries might be applied, but it should be determined whether the nature and quality of the original data have been managed.

Analytical methods to manage potential impurities in drug substances (의약품 중 잠재적 불순물 관리를 위한 분석법 연구 동향)

  • Park, Kyung Min;Kim, Won Mi;Ahn, Su Hyun;Lee, Ha Lim;Hwang, Su Hyeon;Lee, Wonwoong;Hong, Jongki
    • Analytical Science and Technology
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    • v.35 no.3
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    • pp.93-115
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    • 2022
  • Potential impurities in pharmaceuticals could be produced during manufacture, distribution, and storage and affect quality and safety of pharmaceuticals. In particular, highly reactive impurities could result in carcinogenic (mutagenic) effects on human body. International Conference on Harmonisation (ICH) has provided M7(R1) guideline for "Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk" and recommended an adoption of this guideline to the authorities. ICH M7(R1) guideline provides classification, accepted intakes, and controls of potential impurities in pharmaceuticals. However, since appropriate and unified analytical methods for impurities in pharmaceuticals have not been provided in this guideline, most potential impurities in pharmaceuticals are still difficult to manage and supervise by pharmaceutical companies and regulatory authorities, respectively. In this review, we briefly described definition of unintended mutagenic impurities, basic information in ICH M7(R1) guideline, and analytical methods to determine potential impurities. This review would be helpful to manage and supervise potential impurities in pharmaceuticals by pharmaceutical companies and regulatory authorities.

Performance of Feature-based Stitching Algorithms for Multiple Images Captured by Tunnel Scanning System (터널 스캐닝 다중 촬영 영상의 특징점 기반 접합 알고리즘 성능평가)

  • Lee, Tae-Hee;Park, Jin-Tae;Lee, Seung-Hun;Park, Sin-Zeon
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.26 no.5
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    • pp.30-42
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    • 2022
  • Due to the increase in construction of tunnels, the burdens of maintenance works for tunnel structures have been increasing in Korea. In addition, the increase of traffic volume and aging of materials also threatens the safety of tunnel facilities, therefore, maintenance costs are expected to increase significantly in the future. Accordingly, automated condition assessment technologies like image-based tunnel scanning system for inspection and diagnosis of tunnel facilities have been proposed. For image-based tunnel scanning system, it is key to create a planar image through stitching of multiple images captured by tunnel scanning system. In this study, performance of feature-based stitching algorithms suitable for stitching tunnel scanning images was evaluated. In order to find a suitable algorithm SIFT, ORB, and BRISK are compared. The performance of the proposed algorithm was determined by the number of feature extraction, calculation speed, accuracy of feature matching, and image stitching result. As for stitching performance, SIFT algorithm was the best in all parts of tunnel image. ORB and BRISK also showed satisfactory performance and short calculation time. SIFT can be used to generate precise planar images. ORB and BRISK also showed satisfactory stitching results, confirming the possibility of being used when real-time stitching is required.

A Review of the Stroke Stage and Outcome Measures in Stroke Motor Sequelae Clinical Studies in Korea (뇌졸중으로 인한 운동 관련 후유증의 한의 치료 연구에서 뇌졸중 시기 및 평가 척도에 대한 국내 문헌 고찰)

  • Lee, Ji-eun;Chun, Se-eun;Jeon, Min-gyeol;Shin, Yong-jeen;Leem, Jung-tae;Shin, Sun-ho
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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    • pp.656-679
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    • 2022
  • Objectives: The aims of this study were to evaluate the fidelity of stroke stage reporting, the timeliness of the outcome measures, and the use of the core outcome set. Methods: We searched the literature using 6 domestic databases. We selected studies that used Korean medicine interventions and targeted stroke patients with motor sequelae. We examined whether the included studies reported the stroke stage and whether they used the outcome measures in the appropriate period based on the recommendations of the "Stroke Evidence Database to Guide Effectiveness". We also confirmed the use of the essential assessment tools suggested by the core outcome set. Results: Overall, 77 studies were finally selected, with 16 (21%), 55 (71%), and 6 (8%) published on the acute, subacute, and chronic phases, respectively. Only 11 of the studies directly mentioned the stroke stage. The most commonly used assessments were the National Institutes of Health Stroke Scale, Modified Barthel Index, and Manual Muscle Testing. Only 5 studies failed to apply the stage-related outcome measures at the recommended period. The outcome variables used inadequately were the National Institutes of Health Stroke Scale, Functional Ambulation Categories, 36-Item Short Form Health Survey, and Mini-Mental State Examination. Among the core outcome set items, some studies used liver and renal function tests, but no herbal medicine safety reporting was conducted. Conclusions: In future studies, we propose to ensure accurate reporting of the stroke stage with reliable outcome measures to deliver better clinical and research outcomes. Furthermore, in future clinical studies on stroke, a standard protocol that reflects the core outcome set should be developed.

Efficacy and Safety of a Biodegradable Hyaluronic Acid Microneedle Patch for Dry Skin in Atopic Dermatitis : A Single-blinded, Split-body, Randomized Controlled Trial (아토피피부염 피부건조 증상 개선에 대한 용해성 마이크로니들 패치의 유효성 및 안전성 평가 임상연구)

  • Ji-Hoon Song;Gi-Hyun Lee;Min-Yeong Jung;Jung-Hwa Choi;Soo-Yeon Park
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.1
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    • pp.78-95
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    • 2023
  • 목적 : 마이크로니들 패치는 피부장벽의 주요 구성성분인 각질층을 관통할 수 있어 일반적인 경피를 통한 약물 전달 수단보다 더 효율적으로 약물을 전달할 수 있다는 장점이 있어 다양한 분야에서 응용되고 있다. 본 임상연구는 아토피피부염 환자의 피부 건조 증상에 대하여 용해성 히알루론산 마이크로니들 패치와 외용제를 병행하여 용해성 마이크로니들 패치의 유효성과 안전성을 평가하였다. 방법 : 본 연구는 단일 기관, 연구자 주도, 평가자 눈가림, 인체 분할 연구로 설계된 무작위 배정 임상시험으로, 피부건조 증상이 있는 아토피피부염 환자 20명을 대상으로 임상연구를 수행하였다. 한 명의 피험자에서 2곳의 시험 병변을 선택한 후, 무작위 배정으로 각각 시험 병변과 대조 병변을 결정하여 2주 동안 매일 양측 병변에 모두 아로마 크림을 도포한 다음, 시험 병변에만 용해성 히알루론산 마이크로니들 패치를 추가로 부착하였다. 결과 : 1차 유효성 평가지표인 local scoring atopic dermatitis(L-SCORAD) index는 치료 후에 시험 병변이 대조 병변보다 유의성 있게 호전되었다. 2차 유효성 평가지표 중 피부 건조감 VAS와 피부 수분 함유량도 시험 병변이 대조 병변보다 유의성 있는 개선을 보였다. Investigator's Global Assessment scale, 소양감 VAS, 경피수분손실량에 있어서는 시험 병변과 대조 병변 모두 치료 후에 유의성 있게 호전되었으나, 두 병변 간의 차이에는 유의성이 없었다. 이상 반응은 나타나지 않았으므로 안전성도 확인되었다. 결론 : 용해성 히알루론산 마이크로니들 패치와 외용제 병행치료는 외용제만 사용하였을 때보다 L-SCORAD index 및 피부 건조감 VAS, 피부 수분 함유량에 있어서 아토피피부염의 증상을 유의성 있게 개선시켰다.

Groundwater control measures for deep urban tunnels (도심지 대심도 터널의 지하수 변동 영향 제어 방안)

  • Jeong, Jae-Ho;Kim, Kang-Hyun;Song, Myung-Kyu;Shin, Jong-Ho
    • Journal of Korean Tunnelling and Underground Space Association
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    • v.23 no.6
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    • pp.403-421
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    • 2021
  • Most of the urban tunnels in Korea, which are represented by the 1st to 3rd subways, use the drainage tunnel by NATM. Recently, when a construction project that actively utilizes large-scale urban space is promoted, negative effects that do not conform to the existing empirical rules of urban tunnels may occur. In particular, there is a high possibility that groundwater fluctuations and hydrodynamic behavior will occur owing to the practice of tunnel technology in Korea, which has mainly applied the drainage tunnel. In order to solve the problem of the drainage tunnel, attempts are being made to control groundwater fluctuations. For this, the establishment of tunnel groundwater management standard concept and the analysis of the tunnel hydraulic behavior were performed. To prevent the problem of groundwater fluctuations caused by the construction of large-scale tunnels in urban areas, it was suggested that the conceptual transformation of the empirical technical practice, which is applied only in the underground safety impact assessment stage, to the direction of controlling the inflow in the tunnel, is required. And the relationship between the groundwater level and the inflow of the tunnel required for setting the allowable inflow when planning the tunnel was derived. The introduction of a tunnel groundwater management concept is expected to help solve problems such as groundwater fluctuations, ground settlement, depletion of groundwater resources, and decline of maintenance performance in various urban deep tunnel construction projects to be promoted in the future.

A Review of the Deterioration and Damage of the Top Flange of the Highway PSC Box Girder Bridge based on the Condition Assessment Results (상태평가 결과 기반 고속도로 PSC Box 거더교 상부플랜지 열화·손상 실태 고찰)

  • Ku, Young-Ho;Han, Sang-Mook
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.26 no.6
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    • pp.23-32
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    • 2022
  • Although PSCB girder bridges account for 4% of the bridges in use on highways, they do not account for much, but 98% of PSCB girder bridges are 1st type and 2nd type of bridge. Also, the total length of the PSCB girder bridge is 16% (192km) of the total length of the highway bridge. Thus, the PSCB girder bridge can be one of the bridge types where maintenance is important. In order to analyze the damage types of PSCB girder bridges, a detailed analysis was conducted by selecting 62 places (477 spans) precision safety diagnosis reports considering ratio of the construction method and snow removal environment exposure class. Analysis of report and a field investigation was conducted, and as a result, most of the causes of deterioration damage were caused by rainwater (salt water) flowing into the bridge pavement soaking in between the top flange and the interface. After concrete slab deteriorate occurred then bridge pavement cracking and breaking increased and exfoliation of concrete occurred by corrosion and expansion of the reinforcing bars occurred. In addition, the cause of cracks in the longitudinal direction on the bottom of the top flange is considered to be cracks caused by restrained drying shrinkage. In conclusion, for reasonable maintenance considering the characteristics of PSCB girder bridges, it should be suggested in the design aspect that restrained drying shrinkage crack on top flange. Also, it is believed that differentiated maintenance method should be proposed according to snow removal environment exposure class.

Risk Assessment of Smoke Generated During Combustion for Some Wood (일부 목재의 연소 시 발생되는 연기의 위험성 평가)

  • Chung, Yeong-Jin;Jin, Eui
    • Applied Chemistry for Engineering
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    • v.33 no.4
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    • pp.373-380
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    • 2022
  • In this study, Chung's equations 1, 2, and 3 were extended to standardize smoke safety rating evaluation in case of fire, and Chung's equations-V, smoke performance index-V, and smoke growth index-V were calculated. Five types of wood were selected and their smoke indices were measured using the cone calorimeter method according to ISO 5660-1. The smoke risk was graded by the smoke risk index-VI according to Chung's equation-VI. Smoke risk index-VI increased in the order of PMMA (1) ≈ maple (1.01) < ash (1.57) < needle fir (4.98) < paulownia (46.15) < western red cedar (106.26). It was predicted that maple and ash had the lowest smoke risk, and paulownia and western red cedar had the highest. The five samples' CO mean production rate (COPmean) was 0.0009~0.0024 g/s, indicating that these woods were incompletely burned than the polymethyl methacrylate (PMMA) reference material. Regarding the smoke properties of the chosen woods, the smoke performance index-V (SPI-V) increased as the bulk density increased, and the smoke risk index-VI (SRI-VI) decreased.