• Title/Summary/Keyword: Risk assessment.

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Hepatic and Renal Safety of Concurrent Use of Conventional and Herbal Medications for Musculoskeletal Disorders: A Retrospective Observational Study (근골격계 질환에 대한 양약 및 한약 병용의 간과 신장에 대한 안전성: 후향적 관찰 연구)

  • Kim, Se-Yoon;Kim, Hyungsuk;Kang, Doyoung;Ko, Junhyuk;Kim, Jongyeon;Kim, Koh-Woon;Kim, Bo-Hyung;Cho, Jae-Heung;Song, Mi-Yeon;Chung, Won-Seok
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.3
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    • pp.131-140
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    • 2022
  • Objectives This study aimed to investigate whether the concurrent use of conventional and herbal medications affects liver and kidney function, by examining blood test data. Methods We retrospectively reviewed the electronic medical records of 590 inpatients with musculoskeletal diseases between 2013 and 2017. We investigated cases of drug-induced liver injury (DILI) according to the Roussel Uclaf Causality Assessment Method criteria and cases of drug-induced kidney injury (DIKI) based on the Kidney Disease Improving Global Outcomes definition. Results One case (0.17%) of DILI and one case (0.17%) of DIKI were identified. Significant improvements in serum laboratory data were observed after the concurrent use of both types of medications (p<0.05). The kappa coefficients ranged from 0.26 to 0.72, indicating that the values after the concurrent use of conventional and herbal medications showed a fair similarity to the baseline values of the patients. The linear regression test showed that female sex and high body mass index (BMI) were risk factors for an increase in the serum blood levels of liver function parameters. Conclusions The concurrent use of conventional and herbal medications for musculoskeletal disorders is relatively safe; however, clinicians should exercise caution when prescribing these medications to female patients and patients with a high BMI because of their potential effect on hepatic function.

[Republished study] Assessing Nutritional Status in Outpatients after Gastric Cancer Surgery: A Comparative Study of Five Nutritional Screening Tools ([재출판] 위암 수술 후 외래환자의 영양상태 평가: 5가지 영양검색도구의 비교연구)

  • Cho, Jae Won;Youn, Jiyoung;Choi, Min-Gew;Rha, Mi Young;Lee, Jung Eun
    • Korean Journal of Community Nutrition
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    • v.27 no.3
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    • pp.205-222
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    • 2022
  • Objectives: This study examined the characteristics of patients according to nutritional status assessed by five nutritional screening tools: Patient-Generated Subjective Global Assessment (PG-SGA), NUTRISCORE, Nutritional Risk Index (NRI), Prognostic Nutritional Index (PNI), and Controlling Nutritional Status (CONUT) and to compare the agreement, sensitivity, and specificity of these tools. Methods: A total of 952 gastric cancer patients who underwent gastrectomy and chemotherapy from January 2009 to December 2012 were included. The patients were categorized into malnutrition and normal status according to five nutritional screening tools one month after surgery. The Spearman partial correlation, Cohen's Kappa coefficient, the area under the curve (AUC), sensitivity, and specificity of each two screening tools were calculated. Results: Malnutrition was observed in 86.24% of patients based on the PG-SGA and 85.82% based on the NUTRISCORE. When NRI or CONUT were applied, the proportions of malnutrition were < 30%. Patients with malnutrition had lower intakes of energy and protein than normal patients when assessed using the PG-SGA, NUTRISCORE, or NRI. Lower levels of albumin, hemoglobin, total lymphocyte count, and total cholesterol and longer postoperative hospital stays were observed among patients with malnutrition compared to normal patients when NRI, PNI, or CONUT were applied. Relatively high agreement for NUTRISCORE relative to PG-SGA was found; the sensitivity was 90.86%, and the AUC was 0.78. When NRI, PNI, and CONUT were compared, the sensitivities were 23.72% for PNI relative to NRI, 44.53% for CONUT relative to NRI, and 90.91% for CONUT relative to PNI. The AUCs were 0.95 for NRI relative to PNI and 0.91 for CONUT relative to PNI. Conclusions: NUTRISCORE had a high sensitivity compared to PG-SGA, and CONUT had a high sensitivity compared to PNI. NRI had a high specificity compared to PNI. This relatively high sensitivity and specificity resulted in 77.00% agreement between PNI and CONUT and 77.94% agreement between NRI and PNI. Further cohort studies will be needed to determine if the nutritional status assessed by PG-SGA, NUTRISCORE, NRI, PNI, and CONUT predicts the gastric cancer prognosis.

Invasive Brain Stimulation and Legal Regulation: with a special focus on Deep Brain Stimulation (침습적 뇌자극기술과 법적 규제 - 뇌심부자극술(Deep Brain Stimulation)을 중심으로 -)

  • Choi, Min-Young
    • The Korean Society of Law and Medicine
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    • v.23 no.2
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    • pp.119-139
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    • 2022
  • Brain stimulation technology that administers electrical and magnetic stimulation to a brain has shown a significant level of possibility for treating a wide range of various neurological and psychiatric disorders. Depending on its nature, the technology is defined either as invasive or non-invasive, and deep brain stimulation (DBS) is one of the most well-known invasive brain stimulation technologies. Currently categorized as grade 4 medical device in accordance with Guideline On Medical Devices And Their Grades, a Notification of Ministry of Food and Drug Safety (MFDS), the DBS has been used as a stable treatment for several diseases. At the same time, the DBS technology has recently achieved substantial advancement, encouraging active discussions for its use from various perspectives. On the contrary, debates over legal regulation related to the use of DBS has relatively been smaller in numbers. In this context, this article aims to 1) introduce the DBS technology and its safety in setting out the tone; 2) touch upon major legal issues that would potentially rise from its use for four different purposes of treatment, clinical study, areas of non-standard treatment where no other methods are available, and enhancement; and finally 3) highlight disputes concerning common emerging issues observed in the aforementioned four purposes from the viewpoint of legal responsibility and liability of using the DBS, which are benefit-risk assessment, physicians' duty of information, patients' capacity to consent, control for device, and insurance coverage.

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.

Decision Making of Seismic Performance Management for the Aged Road Facilities Based on Road-Network and Fragility Curve (취약도곡선을 이용한 도로망기반 노후도로시설물 내진성능관리 의사결정)

  • Kim, Dong-Joo;Choi, Ji-Hae
    • Journal of the Korea institute for structural maintenance and inspection
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    • v.25 no.5
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    • pp.94-101
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    • 2021
  • According to the Facility Management System (FMS) operated by the Korea Authority of Land & Infrastructure Safety, it is expected that the number of aging facilities that have been in use for more than 30 years will increase rapidly to 13.9% in 2019 and 34.5% in 2929, and end up with a social problem. In addition, with the revision of "Common Application of Seismic Design Criteria" by the Ministry of Public Administration and Security in 2017, it is mandatory to re-evaluate all existing road facilities and if necessary seismic reinforcement should be done to minimize the magnitude of earthquake damage and perform normal road functions. The seismic performance management-decision support technology currently used in seismic performance management practice in Korea only determines the earthquake-resistance reinforcement priority based on the qualitative index value for the seismic performance of individual facilities. However with this practice, normal traffic functions cannot be guaranteed. A new seismic performance management decision support technology that can provide various judgment data required for decision making is needed to overcome these shortcomings and better perform seismic performance management from a road network perspective.

A Study on Process Safety System Analysis for Application Process Safety Performance Indicators (공정안전성과지표 적용을 위한 공정안전시스템 분석방안 연구)

  • Ko, Byung Seok;Lim, Dong-Hui;Kim, Min-Seop;Seol, Ji Woo;Yoo, Byung Tae;Ko, Jae-Wook
    • Journal of the Korean Institute of Gas
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    • v.26 no.2
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    • pp.27-38
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    • 2022
  • In developed countries, the number of accidents has significantly decreased with the introduction of the process safety management system, but it has a regulatory nature and it is difficult to show the actual situation of workplace safety management. Many organizations recommend the use of process safety performance indicators to comprehensively monitor process safety status. In this study, for the application of process safety performance indicators, the related guidelines were compared and analyzed, and the method of using the process safety system of the workplace as an indicator was reviewed. In literature indicators, compliance with procedures is mainly checked, whereas in system-based indicators, procedures or inspections for a specific purpose of the safety system can be clearly identified, and the operation status can be measured and monitored. It can be seen that this characteristic is more advantageous in terms of the clarity of the supplements derived in operating safety management activities. Using this, it is possible to effectively show the level of safety management in the workplace.

A Research on the Residual Pesticide Content of Dried Agricultural Products from Ulsan (울산지역 건조농산물 가공품의 잔류농약 분석)

  • Kim, Dae-Kyo;Kim, Seon-Hwa;Kim, Su-Hui;Choi, Jae-Seon;Kim, Hui-jeong;Kim, Young-Min
    • Journal of Food Hygiene and Safety
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    • v.37 no.4
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    • pp.238-248
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    • 2022
  • This study was conducted to evaluate the safety of 208 types of residue pesticides on 150 dried agricultural products in Ulsan. The pesticide residues were detected using GC-MS/MS, LC-MS/MS, GC/ECD, GC/NPD, and LC/PDA. The detection rate was 19.3% (29 of 150 samples), and 28 types of pesticides were detected. Two of the 29 pesticide residues exceeded the maximum residue limit (MRL). Difenoconazole was detected in Ulleungdo aster, and chlorothalonil and chlorpyrifos were detected in chili pepper leaves. In the vegetable group, the frequency of pesticide residues was found to be the highest in dried leafy vegetables, followed by dried fruiting vegetables other than cucurbit vegetables, and then dried stalk and stem vegetables. The pesticide types detected in the commercial dried agricultural products were fungicide (60%), insecticide (23.8%), and acaricide (16.3%). In the validation study, the values of limit of detection (LOD), limit of quantitation (LOQ), coefficient of determination (R2), and recovery rate were in the range of 0.0001-0.0409 mg/kg, 0.0003-0.1241 mg/kg, 0.994-0.999, and 81.58-116.79%, respectively. The ratio of estimated daily intake (EDI)/acceptable daily intake (ADI) was 0.00002-0.31395%.

Establishment of Complex Disaster Scenario on the Utility Tunnel Study for Digital Twin System Application (디지털트윈 시스템 적용을 위한 공동구 복합재난 시나리오 구축)

  • Yon Ha Chung; So Dam Kim;Hyun Jeong Seo;Hojun Lee;Tae Jung Song
    • Journal of the Society of Disaster Information
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    • v.18 no.4
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    • pp.861-872
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    • 2022
  • The purpose of this study was to establish a complex disaster scenario that can comprehensively consider various disaster situations that may occur in the utility tunnel. Method: In order to comprehensively consider the correlation between disasters, a composite disaster scenario was derived from a combination of damage factors, respectively. A risk assessment was performed in order to derive the priorities of the scenarios. And based on the results, the priorities of complex disaster scenarios were set. Result: Based on the disaster cases in the utility tunnel, a plan was prepared for complex disaster scenarios centered on damage. A complex disaster scenario was specified using a semi-quantitative evaluation method for single and multiple disaster factors such as fire, flooding, and earthquake. Conclusion: The composite disaster scenario derived from this study can be used for the prevention and preparation of damage when the precursor symptoms of a disaster are detected. In addition, the results of this study are expected to be used as basic data for preparing strategic plans and preparing complex disaster response technologies to induce rapid response and recovery in case of emergency disasters.

Landscape Engineers' Perceptions of the Safety Climate and Safety Behavior in Landscape Construction - Focused on Landscape Constructors and Designers - (조경공사에서 안전분위기와 안전행동에 대한 조경기술자들의 인식 - 조경시공자와 조경설계자를 대상으로 -)

  • Oh, Chang-Song;Sim, Jisoo
    • Journal of the Korean Institute of Landscape Architecture
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    • v.51 no.4
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    • pp.90-100
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    • 2023
  • The construction safety policy of Korea requires safety reviews at design stages, which affect the perceptions and attitudes of the workers toward safety. Despite this heightened social interest in safety, there is no related research in the field of landscape architecture. This study entails a review of the status of landscape construction accidents in Korea and an assessment of landscape engineers' perception of construction safety climate and safety behaviors. A survey of landscape constructors and designers was performed, and the obtained data were statistically analyzed. The results indicate the following: (1) More than half of the accidents which are registered in CSI occurred in apartment houses ordered by the private sector in the type of facility and planting works in the landscaping process; (2) Landscape designers were better aware of safety than landscape constructors. Among them, safety attitude, work risk, work participation, and work pressure were statistically significant; Apart from the statistical significance, landscape designers recognized the importance of safety highly but they tended to have a relatively low perception of specific safety behaviors. (3) Lastly, landscape constructors attributed less importance to safety review during the design stage compared to other items.

Factors affecting Non-suicidal self-injury: Ecological Momentary Assessment using a Daily Diary Method study (일상생활에서의 비자살적 자해에 영향을 미치는 요인: 생태순간평가 일기법 연구)

  • Hoin Kwon ;Sunjin Kim
    • Korean Journal of Culture and Social Issue
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    • v.29 no.3
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    • pp.321-340
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    • 2023
  • This study was conducted to understand the emotional and situational context where non-suicidal self-injury occurs in everyday life. Sixty adults(age 19-35) completed daily surveys assessing positive and negative emotions, stressful events, self-injury thoughts, and behaviors for two weeks. Using a total of 663 collected entries, we analyzed specific personal emotions and stressful events related to non-suicidal self-injurious thoughts and behaviors. As a result, high negative emotions, low positive emotions, and total stress event scores were significantly related to self-injury thoughts and behaviors. In the model in which both emotion and stress were inserted as predictors, the low level of positive emotion showed a significant related to non-suicidal self-injurious behavior. These results suggest that negative emotion management and overall positive emotion reinforcement are important in emotion regulation intervention for non-suicidal self-injurious patients. The meaning of this study is that it searched for risk factors of non-suicidal injury in everyday life using a short-term longitudinal method.