• 한국임상약학회지
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• 제32권3호
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• pp.226-237
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• 2022

Background: Monoclonal antibodies for the treatment of patients with different types of cancer, such as cetuximab, have been widely used for the past 10 years in oncology. Although drug information package insert contains some representative adverse events which were observed in the clinical trials for drug approval, the overall adverse event patterns on the real-world cetuximab use were less investigated. Also, there have been no published papers that deal with the full spectrums of adverse drug events of cetuximab using national-wide drug safety surveillance systems. Methods: In this study, we detected new adverse event signals of cetuximab in the Korea Adverse Event Reporting System (KAERS) by utilizing proportional reporting ratios, reporting odds ratios, and information components indices. Results: The KAERS database included 869,819 spontaneous adverse event reports, among which 2,116 reports contained cetuximab. We compared the labels of cetuximab among the United States, European Union, Australia, Japan, and Korea to compare the current labeling information and newly detected signals of our study. Some of the signals including hyperkeratosis, tenesmus, folliculitis, esophagitis, neuralgia, disseminated intravascular coagulopathy, and skin/throat tightness were not labeled in the five countries. Conclusion: We identified new signals that were not known at the time of market approval.

• 한국환경보건학회지
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• 제35권6호
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• pp.468-477
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• 2009

To evaluate the current indoor air quality condition of private academic facilities in Korea and investigate its association with subjective symptoms of student residing at the same academic facilities, air quality monitoring was carried out in total of 20 academic facilities located in Seoul, Daejon and Chungnam from the beginning of January to the end of April, 2009. To assess the air quality condition of academic facilities, 6 air pollutants with temperature and humidity were measured simultaneously inside and outside of academic facilities. The rate of exceeding the Indoor Air Quality (IAQ) guideline concentrations in 6 air pollutants were 5%, 85%, 15%, 5%, 10% and 30% for CO, $CO_2$, PM10, HCHO, TVOCs and TBC, respectively. A questionnaire on 16 subjective symptoms related to indoor air quality was given to 342 students who studied at the 20 academic facilities. The most frequent symptom of students was 'I feel easily tired or sleepy', and this was followed by 'I feel muscular pain or stiffness on shoulder, back and neck'. The association of net difference (subjective symptoms at the academic facility - subjective symptoms of the usual situation) with air pollutants was analyzed using spearman rank correlation. In logistic analysis using proportional odds method, the students whose indoor air concentration of HCHO was ${\geq}60{\mu}g/m^3$ hadsignificant odds of having more subjective symptoms of 'My eyes are dry or feel irritated or itching' (OR=5.026: CI=1.587-15.911), 'I feel easily tired or sleepy' (OR=2.956: CI=1.072-8.152), 'I lose my concentration and I feel my memory is falling' (OR=7.745: CI=1.938-30.955) and 'I feel dizzy' (OR=4.424: CI=1.292-15.149) than those of <$60{\mu}g/m^3$.

• Journal of Chest Surgery
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• 제55권6호
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• pp.435-441
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• 2022

Background: This study aimed to evaluate the impact of the treatment modality on post-procedural acute kidney injury (AKI) and other clinical outcomes in patients with advanced chronic kidney disease who underwent surgical or transcatheter aortic valve replacement (AVR). Methods: A total of 147 patients with advanced chronic kidney disease (stage 3 to 5) who underwent isolated surgical AVR (SAVR group; n=70) or transcatheter AVR (TAVR group; n=77) were retrospectively studied. Postprocedural AKI was defined according to the RIFLE definition (an acronym corresponding to the risk of renal dysfunction, injury to the kidney, failure of kidney function, loss of kidney function, and end-stage kidney disease). Factors associated with postoperative complications and mortality were analyzed using multivariable logistic regression models and Cox proportional hazard models. Results: Postprocedural AKI occurred in 17 (24.3%) and 6 (7.8%) patients in the SAVR and TAVR groups, respectively (p=0.006). Multivariable analyses demonstrated that the SAVR group had higher risks of AKI (odds ratio [OR], 5.63; 95% confidence interval [CI], 1.85-17.73; p=0.002) and atrial fibrillation (OR, 16.65; 95% CI, 4.44-62.50; p<0.001), whereas the TAVR group had a higher risk of permanent pacemaker insertion (OR, 5.67; 95% CI, 1.21-26.55; p=0.028). The Cox proportional hazard models showed that the occurrence of AKI, contrary to the treatment modality, was associated with overall survival. Conclusion: In patients with chronic kidney disease, the risk of postprocedural AKI might be higher after SAVR than after TAVR.

• Safety and Health at Work
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• 제11권3호
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• pp.347-352
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• 2020

Background: Low self-esteem can be an issue among health-care workers due to the hierarchical medical system. Health-care workers are also in a high pressure environment that can lead to stress and burnout. This study was conducted to estimate the proportion of health-care workers with low self-esteem, high stress, and burnout and the factors associated with these in a private hospital in Bangalore city. Methods: This cross-sectional study included a random sample of health-care workers of various cadres - doctors, nurses, nursing aides, technicians, and workers in ancillary departments such as laundry, dietary, central sterile supply department, and pharmacy, with probability proportional to size. Rosenberg Scale for Self-esteem, Cohen's Perceived Stress Scale, and Shirom-Melamed Burnout Measure were used as study tools. Results: Among the 306 health-care workers, there were high levels of low self-esteem (48.4%), stress (38.6%), and burnout (48.7%), with the lowest levels being among doctors. Those aged younger than 30 years had significantly lower self-esteem and greater stress. Conclusions: Health-care workers with low self-esteem were nearly thrice more likely to suffer high stress, Odds Ratio (OR) = 2.84 (1.36-5.92), and those who were stressed had more than three times higher chance of experiencing burnout, OR = 3.6 (2.02-6.55). Path analysis showed that low self-esteem among health-care workers had a direct effect on burnout, as well as an indirect effect through stress (mediator variable). This study indicates the need for screening and counseling for low self-esteem, stress, and burnout as part of a periodic medical examination of all cadres of health workers.

• Journal of Chest Surgery
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• 제53권1호
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• pp.1-7
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• 2020

Background: The aim of this study was to evaluate the short-term and long-term results of surgical treatment for native valve endocarditis (NVE) and to investigate the risk factors associated with mortality. Methods: Data including patients' characteristics, operative findings, postoperative results, and survival indices were retrospectively obtained from Hallym University Sacred Heart Hospital. Results: A total of 29 patients underwent surgery for NVE (affecting the mitral valve in 20 patients and the aortic valve in 9) between 2003 and 2017. During the follow-up period (median, 46.9 months; interquartile range, 19.1-107.0 months), the 5-year survival rate was 77.2%. In logistic regression analysis, body mass index (p=0.031; odds ratio [OR], 0.574; 95% confidence interval [CI], 0.346-0.951), end-stage renal disease (ESRD) (p=0.026; OR, 24.0; 95% CI, 1.459-394.8), and urgent surgery (p=0.010; OR, 34.5; 95% CI, 2.353-505.7) were significantly associated with in-hospital mortality. Based on Cox proportional hazard regression analysis, the statistically significant predictors of long-term outcomes were hypertension, ESRD, and urgent surgery. Conclusion: Surgical treatment for NVE is associated with considerable mortality. The in-hospital mortality and 5-year survival rates of this study were 13.8% and 77.2%, respectively. Underlying conditions, including hypertension and ESRD, and urgent surgery were independent risk factors for unfavorable outcomes.

• Safety and Health at Work
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• 제3권2호
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• pp.92-100
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• 2012

Objectives: The French National Occupational Diseases Surveillance and Prevention Network (RNV3P) is a French network of occupational disease specialists, which collects, in standardised coded reports, all cases where a physician of any specialty, referred a patient to a university occupational disease centre, to establish the relation between the disease observed and occupational exposures, independently of statutory considerations related to compensation. The objective is to compare the relevance of disproportionality measures, widely used in pharmacovigilance, for the detection of potentially new disease ${\times}$ exposure associations in RNV3P database (by analogy with the detection of potentially new health event ${\times}$ drug associations in the spontaneous reporting databases from pharmacovigilance). Methods: 2001-2009 data from RNV3P are used (81,132 observations leading to 11,627 disease ${\times}$ exposure associations). The structure of RNV3P database is compared with the ones of pharmacovigilance databases. Seven disproportionality metrics are tested and their results, notably in terms of ranking the disease ${\times}$ exposure associations, are compared. Results: RNV3P and pharmacovigilance databases showed similar structure. Frequentist methods (proportional reporting ratio [PRR], reporting odds ratio [ROR]) and a Bayesian one (known as BCPNN for "Bayesian Confidence Propagation Neural Network") show a rather similar behaviour on our data, conversely to other methods (as Poisson). Finally the PRR method was chosen, because more complex methods did not show a greater value with the RNV3P data. Accordingly, a procedure for detecting signals with PRR method, automatic triage for exclusion of associations already known, and then investigating these signals is suggested. Conclusion: This procedure may be seen as a first step of hypothesis generation before launching epidemiological and/or experimental studies.

• Radiation Oncology Journal
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• 제36권4호
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• pp.325-331
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• 2018

Purpose: Soft tissue sarcoma (STS) is a rare and heterogeneous cancer with over 50 known subtypes. It is difficult to understand the role of adjuvant treatment in STS. We aimed to determine the benefits of adjuvant treatment for a rare STS subset: non-extremity STS with moderate chemosensitivity. Materials and Methods: We reviewed medical records from Pusan National University Hospital and Kosin University Gospel Hospital, which had detailed pathological reports on patients diagnosed between 2006 and 2016. The most important inclusion criterion was resection with curative intent. We grouped STS by chemosensitivity based on reported data and analyzed non-extremity STS with moderate chemosensitivity. Results: We investigated 142 patients with 20 pathological subtypes of STS. Eighty-six patients had extremity STS and 56 had non-extremity STS. Thirty-eight of 56 patients were categorized as having moderate chemosensitivity. Seventeen of 38 patients (44.7%) received adjuvant radiotherapy and 14 (36.8%) received adjuvant chemotherapy. A log-rank test showed longer disease-free survival (DFS) in the adjuvant radiotherapy group than in the group treated without adjuvant radiotherapy (not reached vs. 1.468 years, p = 0.037). Multivariate Cox proportional hazard analysis, with covariates including age, stage, resection margin, adjuvant chemotherapy, and adjuvant radiotherapy, revealed that adjuvant radiotherapy was associated with longer DFS (odds ratio = 0.369, p = 0.045). Overall survival was not correlated with adjuvant radiotherapy. Conclusion: Adjuvant radiotherapy may be associated with longer DFS in patients with non-extremity STS with moderate chemosensitivity.

• Gut and Liver
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• 제12권6호
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• pp.633-640
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• 2018

Background/Aims: Obesity is a risk factor for gastroesophageal reflux disease (GERD), with several studies demonstrating positive associations between body mass index (BMI) and GERD symptoms. However, little is known about the effect of BMI changes on erosive esophagitis (EE). In this study, we investigated whether BMI reduction could resolve EE. Methods: A retrospective cohort study was performed to assess the natural course of EE according to changes in BMI. Participants undergoing health check-ups from 2006 to 2012 were enrolled, and 1,126 subjects with EE were included. The degree of esophagitis was measured by upper endoscopy and serially checked over a 5-year follow-up. Logistic regression and Cox proportional hazards models were used to investigate the association between BMI reduction and EE resolution. Results: Substantial weight loss is associated with EE resolution. The adjusted odds ratio for EE resolution was 1.44 (95% confidence interval [CI], 1.09 to 1.92) among participants with a decrease in BMI compared to those with no decrease in BMI. The EE resolution rate was related to the degree of BMI reduction. The effect of weight loss on EE resolution was higher among subjects who lost more weight. Compared with subjects with no decrease in BMI, the hazard ratios for EE resolution were 1.09 (95% CI, 0.89 to 1.35), 1.31 (95% CI, 1.01 to 1.72) and 2.12 (95% CI, 1.44 to 3.12) in subjects with BMI reductions of ${\leq}1$, 1-2, and >$2kg/m^2$, respectively. Conclusions: EE resolution is associated with a decrease in BMI, and weight loss is potentially an effective GERD treatment.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• 제45권1호
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• pp.9-14
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• 2019

Objectives: This study aimed to evaluate the effect of clinical factors on the outcome of arthrocentesis in the treatment of temporomandibular joint (TMJ) internal derangement. Materials and Methods: Fifty patients with TMJ internal derangement underwent arthrocentesis using ringer's lactate. The present study evaluated the contribution of the clinical variables of age, time since onset, visual analogue scale (VAS) pain level, and range of motion (ROM) on the outcomes of TMJ arthrocentesis: age (${\leq}25\;years$, >25 and ${\leq}40\;years$, >40 and ${\leq}60\;years$), VAS pain level (${\leq}5$, >5 and ${\leq}7$, >7 and ${\leq}10$), and ROM (<25 and ${\geq}25mm$). Odds ratios (ORs) were used to describe the proportional benefit of each variable the on successful outcome of arthrocentesis. For the OR to be clinically relevant or even clinically noticeable, we assumed that the OR would need to be larger than 2. Results: Mean preoperative pain score was $6.49{\pm}1.560$ and at 6 months postoperative was $0.46{\pm}1.147$ with an average decrease of pain score 6 (P<0.001). The mean preoperactive maximum mouth opening was $26.14{\pm}4.969mm$ and mean maximum mouth opening at 6-month inerval was $38.92{\pm}3.392mm$. The mean increase in the mouth opening was a mean difference of 12.78 mm (P<0.001). Logistic regression showed that the maximum benefit occurred in patients aged <25 years (OR, 12.01; P=0.012), a VAS pain level of >7 (OR, 11.25; P=0.039), and a maximum vertical opening of <25 mm (OR, 7.70; P=0.038). Conclusion: Lavage of the superior joint space with ringer's lactate resulted in significant reduction in pain and improvement in mouth opening. Patients with a greater inflammatory component and younger patients benefitted more from arthrocentesis. Evaluation of these clinical variables helped in predictive modelling, which may provide clinicians with the opportunity to identify "at-benefit" patients early and initiate specific treatment.

• 한국융합학회논문지
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• 제13권4호
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• pp.79-88
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• 2022

본 연구의 목적은 한국에서 COVID-19 유행 기간 동안 건강 행동 변화와 우울한 기분의 연관성을 평가하는 것이다. 한국 성인의 비례표본을 이용하여 인터넷 기반 단면 설문조사를 실시하였고, 로지스틱 회귀모형을 이용하여 연관성을 평가하였다. 그 결과, COVID-19 유행 기간 동안 앉거나 눕는 시간, 걷는 시간, 흡연 및 음주의 부정적인 변화는 우울한 기분으로의 변화와 관련이 있었다 [교차비(OR): 2.23(95% CI=1.77-2.81), 2.04(95% CI=1.63-2.56), 2.84(95% CI=1.51-5.36) 및 1.82(95% CI=1.26-2.63)]. COVID-19 유행기간 동안 긍정적인 건강 변화(활동 증가, 흡연 및 알코올 감소)를 증진시키기 위한 전략은 정신적 스트레스 경감에 도움이 될 수 있다.