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Lipomas are one of the most common mesenchymal tumors in the human body, exhibiting a heightened prevalence between the ages of 40 and 60 years. However, primary intraoral lipomas are rare. Myxoid lipoma, which is characterized by abundant mucoid components, is a particularly rare histological subtype of lipoma. This study presents two cases of myxoid lipoma that occurred outside the common age range for occurrence, one in the right submandibular area of a 67-year-old male and the other in the lower lip of a 3-year-old child. Through these case reports, the aim was to introduce myxoid lipoma, a rare subtype affecting facial areas, and provide a brief review to assist in the differential diagnosis, emphasizing the importance of pathological assessment. Even in age groups and anatomical locations not typically associated with lipomas, it is crucial to emphasize the necessity of careful evaluation.
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BACKGROUND: Lymph node (LN) metastasis is an established prognostic factor for patients with surgically resected ampulla of Vater (AoV) cancer. The standard procedure for radical resection, including removal of regional LNs, is pancreaticoduodenectomy (PD); however, local excision has been considered as an alternative option for patients in the early stage cancer with significant comorbidities. In the present study, we elucidated the preoperative factors associated with LN metastasis to determine the appropriate surgical extent for T1 AoV cancer. METHODS: We included patients who underwent surgery for T1 AoV cancer at Samsung Medical Center and Severance Hospital between 2000 and 2019. Risk factors were analyzed to identify the preoperative parameters associated with LN metastasis or regional LN recurrence during follow-up. Finally, using the identified risk factors, a prediction model was constructed. RESULTS: Among 342 patients, 311 patients underwent PD, whereas 31 patients underwent transduodenal ampullectomy. Fourty-eight patients had LN metastasis according to pathology report, and two patients presented with regional LN recurrence. Age, carbohydrate antigen 19 - 9 (CA 19 - 9), and tumor differentiation were identified as factors associated with the increased risk of LN metastasis or regional LN recurrence. The area under the curve of the prediction model with these three factors was 0.728. CONCLUSION: Our newly developed prediction model using age, CA 19 - 9, and tumor differentiation can help select patients who require PD over local excision. Nevertheless, additional in-depth analysis is warranted to select appropriate surgical extent for patients with presumed T1 AoV cancer.
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Ampola Hepatopancreática , Neoplasias do Ducto Colédoco , Metástase Linfática , Pancreaticoduodenectomia , Humanos , Ampola Hepatopancreática/patologia , Ampola Hepatopancreática/cirurgia , Masculino , Feminino , Metástase Linfática/patologia , Pessoa de Meia-Idade , Neoplasias do Ducto Colédoco/cirurgia , Neoplasias do Ducto Colédoco/patologia , Idoso , Estudos Retrospectivos , Fatores de Risco , Prognóstico , Estadiamento de Neoplasias , Recidiva Local de Neoplasia/patologia , Linfonodos/patologia , Linfonodos/cirurgia , Adulto , Antígeno CA-19-9/sangue , Período Pré-Operatório , Excisão de Linfonodo , Idoso de 80 Anos ou maisRESUMO
BACKGROUND: There is a lack of robust evidence on the efficacy of laparoscopic pancreatoduodenectomy compared to open surgery. This study was aimed to compare time to functional recovery (FR) between laparoscopic and open pancreatoduodenectomy. MATERIALS AND METHODS: This pragmatic, multicenter, randomized controlled phase 3 trial was conducted in seven tertiary centers. Patients with periampullary tumors were randomized using a block design in a 1:1 ratio and stratified by pancreatic fistula risk. Participants were randomized to undergo open or laparoscopic pancreatoduodenectomy by expert pancreatic surgeons. The primary outcome was the time to FR, defined as the number of days until FR was achieved in all five domains. The secondary endpoints included perioperative and short-term oncological outcomes. RESULTS: Between March 2019 and June 2022, 252 patients were randomly assigned to the laparoscopic (n=125) or open groups (n=127). Primary outcomes were reported in 235 patients. The mean time to FR was shorter in laparoscopic group compared to the open group (7.7 d vs. 9.0 d, P=0.03). Laparoscopic group exhibited a higher cumulative rate of FR compared to the open group (Hazard ratio,1.34; 95% confidence interval, 1.03-1.74; P=0.02). Severe complications, R0 resection, the number of retrieved lymph nodes and short-term survival rates were comparable between the two groups. CONCLUSION: Laparoscopic pancreatoduodenectomy demonstrated modest advantages in FR time over open surgery for selected patients with experienced surgeons.
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PURPOSE: To explore the predictive potential of serial computed tomography (CT) radiology reports for pancreatic cancer survival using natural language processing (NLP). METHODS: Deep-transfer-learning-based NLP models were retrospectively trained and tested with serial, free-text CT reports, and survival information of consecutive patients diagnosed with pancreatic cancer in a Korean tertiary hospital was extracted. Randomly selected patients with pancreatic cancer and their serial CT reports from an independent tertiary hospital in the United States were included in the external testing data set. The concordance index (c-index) of predicted survival and actual survival, and area under the receiver operating characteristic curve (AUROC) for predicting 1-year survival were calculated. RESULTS: Between January 2004 and June 2021, 2,677 patients with 12,255 CT reports and 670 patients with 3,058 CT reports were allocated to training and internal testing data sets, respectively. ClinicalBERT (Bidirectional Encoder Representations from Transformers) model trained on the single, first CT reports showed a c-index of 0.653 and AUROC of 0.722 in predicting the overall survival of patients with pancreatic cancer. ClinicalBERT trained on up to 15 consecutive reports from the initial report showed an improved c-index of 0.811 and AUROC of 0.911. On the external testing set with 273 patients with 1,947 CT reports, the AUROC was 0.888, indicating the generalizability of our model. Further analyses showed our model's contextual interpretation beyond specific phrases. CONCLUSION: Deep-transfer-learning-based NLP model of serial CT reports can predict the survival of patients with pancreatic cancer. Clinical decisions can be supported by the developed model, with survival information extracted solely from serial radiology reports.
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Aprendizado Profundo , Processamento de Linguagem Natural , Neoplasias Pancreáticas , Tomografia Computadorizada por Raios X , Humanos , Neoplasias Pancreáticas/mortalidade , Neoplasias Pancreáticas/diagnóstico por imagem , Tomografia Computadorizada por Raios X/métodos , Masculino , Feminino , Pessoa de Meia-Idade , Idoso , Estudos Retrospectivos , Prognóstico , Curva ROCRESUMO
The digital transformation of healthcare in South Korea, accelerated by COVID-19, has led to increased focus on critically ill patients in large hospitals. To address this, a monitoring system was developed to ensure safe inpatient treatment and improve staff efficiency. This aligns with the Medical Data-Centric Hospitals initiative, which leverages data for healthcare innovation. The case study highlights the implementation of a ward critical care monitoring system, which has improved patient safety, work efficiency, and expanded patient monitoring scope. Key lessons include the importance of addressing technical and user challenges, aligning innovations with national policies, and the potential of data-driven solutions to tackle healthcare challenges.
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COVID-19 , República da Coreia , Humanos , Monitorização Fisiológica , Cuidados Críticos/organização & administração , SARS-CoV-2 , Segurança do Paciente , Registros Eletrônicos de SaúdeRESUMO
BACKGROUND/PURPOSE: The eighth edition of the AJCC staging system introduced a shift in the staging of distal bile duct cancer (DBC), emphasizing the depth of invasion over adjacent organ invasion. This study aimed to evaluate the clinical impact of pancreatic invasion in pT1-stage DBC and identify prognostic factors for long-term survival. METHODS: This multicenter retrospective analysis encompassed DBC patients who underwent pancreaticoduodenectomy between 2009 and 2019 in six Korean tertiary centers, specifically those with final pathology confirming AJCC eighth edition T1 stage and intrapancreatic bile duct tumor origin. Primary endpoints were five-year recurrence-free survival (RFS) and overall survival (OS). Secondary objectives included the identification of prognostic determinants. RESULTS: This study involved 287 patients, comprising 190 without and 97 with pancreatic invasion. Pancreatic invasion did not significantly influence five-year OS and RFS rates (OS: without pancreatic invasion 69.9% vs. with pancreatic invasion 54.1%, p = .25; RFS: 56.3% vs. 55.4%, p = .97). Multivariate analysis highlighted male gender, age, lymphovascular invasion, and N stage as significant OS determinants. Notably, male gender, ampulla of Vater invasion, lymphovascular invasion, and N1 stage were also associated with RFS. CONCLUSIONS: In pT1 DBC, pancreatic invasion demonstrates no substantial impact on long-term prognosis, in accordance with the depth-based paradigm of the eighth edition AJCC staging system. The prognostic factors influencing OS were identified as male gender, age, lymphovascular invasion, and nodal metastasis.
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We have examined whether the copper reduction slag (CRS) generated after recovering valuable metals from copper slag (CS) by reduction process can be used as supplementary cementitious materials (SCMs). According to the test results, the Cu secondary slag with low Fe, Cu, and heavy metal contents had a suitable oxide composition for using as a SCM. CRS showed better grinding efficiency than that of ground blast furnace slag (GGBS). Ground CRS contributed to the formation of tobermorite under autoclaved curing conditions. The compressive strength of CRS mortar replacing 50 % of OPC generated 93 % of that of the OPC mortar. Based on the results of this study, we found that the CRS has highly appropriate engineering characteristics for using as SCMs for concrete. In addition, it is judged that the method of using secondary slag as a material for precast concrete produced under hydrothermal conditions can greatly contribute to the construction process of buildings by securing mechanical performance.
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Warts caused by the human papillomavirus (HPV) are generally treated with cryotherapy, CO2 laser ablation, interferon injections, and bleomycin injections. However, it is sometimes difficult to treat children because the treatment can be painful. In addition, recurrence may occur after treatment. In this study, warts completely disappeared following the administration of herbal medicine in two children, with warts in multiple parts of the hands and around the nails. Two pediatric patients visited the hospital for treatment of warts around their fingers and nails. Both patients received Taeeumjowi-tang (TJT) as a decoction for 60 days. TJT was performed twice per day for the 11-year-old patient and once per day for the 7-year-old patient. Patient progress was observed monthly, and the visual condition of the warts was photographed during the visits. After approximately two months of treatment, the warts disappeared from the fingers and nails of both patients. This case study suggests that the oral administration of TJT may be effective for pediatric patients with warts. Further studies are required to determine the efficacy and safety of these therapies.
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OBJECTIVE: Driving under the influence (DUI) of alcohol is a major risk factor for fatal road traffic injuries (RTIs) worldwide. This study aimed to investigate the relationship between the implementation of new acts on DUI of alcohol and the clinical outcomes of patients with severe RTIs in Korea. METHODS: This is a community-based cross-sectional study using a nationwide severe trauma registry in Korea. In 2018, 2 acts with the Yoon Chang-Ho Act (Yoon's Act) were passed to strengthen the punishment for drunk driving fatal RTIs (first Yoon's act) and lower the blood alcohol concentration limit to restrict driver's licenses (second Yoon's act). The first Yoon's act was implemented on December 18, 2018, and the second Yoon's act was implemented on June 25, 2019. The study periods were categorized as pre-Act-1, pre-Act-2, Act-1, and Act-2 according to the application of Yoon's Act, and the study outcome was in-hospital mortality. Multivariable logistic regression analysis was conducted to estimate the relationship of the new acts and in-hospital mortality. RESULTS: Among a total of 20,376 patients with severe RTIs and 7,928 patients (drivers) with RTIs (hereafter drivers), the in-hospital mortality rates were 20.8% and 17.0%, and alcohol-related RTIs accounted for 9.7% and 8.1%, respectively. Severe RTIs tended to increase with each period (25.5 cases/day, 24.5 cases/day, 26.8 cases/day, and 30.4 cases/day, P for trend <.01). In-hospital mortality significantly decreased during the Act-2 period compared to the pre-Act-2 period for all patients with severe RTIs (adjusted odds ratio = 0.54, 95% confidence interval 0.43-0.67) and drivers with RTIs (adjusted odds ratio = 0.50, 95% confidence interval 0.34-0.73). CONCLUSIONS: Implementation of the new acts on DUI of alcohol was associated with lower odds for in-hospital mortality for patients with severe RTIs. Further studies are needed to evaluate the long-term impact of the new acts on reducing alcohol-related RTIs.
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This study aimed to assess the predictive ability of the shock index (SI) and the shock index, pediatric age-adjusted (SIPA) for mortality among pediatric patients with trauma (aged ≤ 18 years). A systematic search used PubMed, Embase, and Cochrane Library databases to identify pertinent articles published from their inception to 13 February 2023. For each SI and SIPA, the pooled sensitivity, specificity, diagnostic odds ratio (DOR), and area under the summary receiver operating characteristic curve (AUC) with the corresponding 95% confidence intervals were calculated. We planned a priori meta-regression analyses to explore heterogeneity using the following covariates: country, clinical setting, type of center, data source, and cutoff value. Twelve studies were included based on the inclusion criteria. Among them, nine studies with 195,469 patients were included for the SIPA at the hospital, four studies with 4,970 patients were included for the pre-hospital SIPA, and seven studies with 606,445 patients were included to assess the ability of the SI in predicting mortality. The pooled sensitivity and specificity with 95% confidence interval for predicting mortality were as follows: 0.58 (0.44-0.70) and 0.72 (0.60-0.82), respectively, for the SIPA at the hospital; 0.61 (0.47-0.74) and 0.67 (0.61-0.73), respectively, for the pre-hospital SIPA; and 0.71 (0.59-0.81) and 0.45 (0.31-0.59), respectively for the SI. The DOR were 3.80, 3.28, and 2.06 for the SIPA at the hospital, pre-hospital SIPA, and SI, respectively. The AUC were 0.693, 0.689, and 0.618 for the SIPA at the hospital, pre-hospital SIPA, and SI, respectively. The SI and SIPA are simple predictive tools with sufficient accuracy that can be readily applied to pediatric patients with trauma, but SIPA and SI should be utilized cautiously due to their limited sensitivity and specificity, respectively.
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Choque , Ferimentos e Lesões , Humanos , Criança , Choque/mortalidade , Choque/diagnóstico , Ferimentos e Lesões/mortalidade , Adolescente , Curva ROC , Pré-Escolar , PrognósticoRESUMO
PURPOSE: This study aimed to assess metabolic changes to monitor the progression from normal liver to hepatitis B virus (HBV)-related hepatitis and liver fibrosis using hyperpolarized 13C magnetic resonance imaging (MRI). PROCEDURES: Hepatitis was induced in mice (n = 16) via hydrodynamic injection of HBV 1.2 plasmid (25 µg). Among them, liver fibrosis was induced in the mice (n = 8) through weight-adapted administration of thioacetamide with ethanol. Normal control mice (n = 8) were injected with a phosphate buffer solution. Subsequently, a hyperpolarized 13C MRI was performed on the mouse liver in vivo. The level of hepatitis B surface antigen (HBsAg) in blood serum was measured. Statistical analysis involved comparing the differential metabolite ratios, blood biochemistry values, and body weight among the three groups using the Kruskal-Wallis one-way analysis of variance. RESULTS: HBsAg was absent in the normal and fibrosis groups, while it was detected in the hepatitis group. The ratios of [1-13C] lactate/pyruvate, [1-13C] alanine/pyruvate, [1-13C] lactate/total carbon, and [1-13C] alanine/total carbon were significantly lower in the normal control group than in the hepatitis and fibrosis groups (p < 0.05). Moreover, these ratios were significantly higher in the fibrosis group than in the hepatitis group (p < 0.05). However, no significant differences were observed in either [1-13C] pyruvate-hydrate/pyruvate or [1-13C] pyruvate-hydrate/total carbon among the three groups. CONCLUSIONS: The levels of [1-13C] lactate and [1-13C] alanine in vivo may serve as valuable indicators for differentiating between HBV-related hepatitis, liver fibrosis, and normal liver.
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Progressão da Doença , Vírus da Hepatite B , Cirrose Hepática , Imageamento por Ressonância Magnética , Animais , Cirrose Hepática/diagnóstico por imagem , Cirrose Hepática/virologia , Cirrose Hepática/patologia , Cirrose Hepática/metabolismo , Imageamento por Ressonância Magnética/métodos , Hepatite B/complicações , Hepatite B/diagnóstico por imagem , Masculino , Camundongos , Fígado/metabolismo , Fígado/diagnóstico por imagem , Fígado/patologia , Antígenos de Superfície da Hepatite B/sangue , Antígenos de Superfície da Hepatite B/metabolismo , Isótopos de CarbonoRESUMO
OBJECTIVES: Road traffic injuries (RTIs) pose a significant public health burden, and more than half of these fatalities are attributed to vulnerable road users (VRUs). This study aimed to evaluate the epidemiology and outcomes of severe RTIs in Korea by focusing on different types of road users. METHODS: This is nationwide retrospective observational study. Using data from the Korean Nationwide Severe Trauma Registry, this study analyzed severe RTI cases from 2016 to 2020. The study included EMS-treated severe trauma patients, defining severe RTI as cases with an injury severity score (ISS) ≥16 or out-of-hospital cardiac arrest (OHCA). The main variable of interest was the road user type, classified as motor vehicle occupants (MVOs), pedestrians, motorcyclists, and bicyclists. Trends and injury characteristics by road user type were analyzed, and multivariate logistic regression was conducted to calculate the adjusted odds ratios (AORs) and 95 % confidence intervals (CIs) of road user type for in-hospital mortality. RESULTS: Of the 143,021 EMS-treated severe trauma cases, 24,464 were included in this study. Pedestrians represented the largest group (n = 8,782; 35.9 %). More than half of the patients died (n = 12,620, 51.6 %), and a high proportion of patients had OHCA (n = 10,048, 41.1 %). There was no significant change in the overall severe RTI numbers from 2016 to 2020, but a decrease in pedestrian cases and an increase in motorcyclist cases were noted (both p for trend<0.05). Low usage of safety devices was observed (28.2 % of motor vehicle occupants used seat belts, 35.9 % of motorcyclists used helmets, and 9.6 % of bicyclists used helmets). Head injuries were most common, particularly among bicyclists (77.0 %) and motorcyclists (69.8 %). Compared to motor vehicle occupants, pedestrians (AOR [95 % CI] 1.12 [1.04-1.20]) and others (AOR [95 % CI] 1.30 [1.02-1.65]) had higher odds of mortality, while motorcyclists (AOR [95 % CI] 0.64 [0.59-0.69]) and bicyclists (AOR [95 % CI] 0.68 [0.60-0.76]) had lower odds of mortality. CONCLUSION: We found varying trends and injury characteristics in severe RTIs according to road user type. Adapting prevention strategies for evolving road user patterns, with particular attention to increasing safety device usage and addressing the high mortality associated with severe RTIs are warranted.
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Rituximab is a monoclonal antibody that targets CD20 antigen in B cells. For pemphigus, rituximab has been highly effective in steroid-sparing therapy for moderate to severe cases. Originator rituximab has demonstrated favorable treatment effects in patients with pemphigus, but its high cost remains a challenge. Biosimilar rituximab is expected to offer a potential solution. However, it is required for the comparative study of efficacy and safety between biosimilar and originator because all biosimilars may not be identical to the originator. In this study, we compared the treatment effects and safety of biosimilar (Truxima) and originator (MabThera) rituximab in patients with pemphigus. A final cohort of 52 patients in the MabThera group and 72 patients in the Truxima group was enrolled. Except for the intravenous immunoglobulin administration rate, there were no differences in baseline characteristics between the two groups, and for the purpose of comparing efficacy, investigations into time to complete remission, total steroid intake to complete remission, and total steroid intake for 6 months following rituximab treatment revealed no significant differences between the two groups. Truxima can be considered a relatively affordable alternative treatment option for pemphigus, offering cost-effectiveness to patients who are indicated for the treatment with MabThera.
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Medicamentos Biossimilares , Pênfigo , Rituximab , Humanos , Rituximab/efeitos adversos , Rituximab/uso terapêutico , Rituximab/administração & dosagem , Pênfigo/tratamento farmacológico , Pênfigo/imunologia , Medicamentos Biossimilares/efeitos adversos , Medicamentos Biossimilares/uso terapêutico , Medicamentos Biossimilares/administração & dosagem , Medicamentos Biossimilares/economia , Masculino , Feminino , Pessoa de Meia-Idade , Adulto , Resultado do Tratamento , Idoso , Fatores Imunológicos/uso terapêutico , Fatores Imunológicos/efeitos adversos , Fatores Imunológicos/administração & dosagem , Indução de Remissão/métodos , Estudos RetrospectivosRESUMO
PURPOSE: As people living with cancer increase in the aging society, cancer-related emergency department (ED) visits are also increasing. This study aimed to investigate the epidemiologic characteristics of non-emergent cancer-related ED visits using a nationwide ED database. MATERIALS AND METHODS: A cross-sectional study was conducted using the National Emergency Department Information System (NEDIS) database. All cancer-related ED visits between 2016 and 2020 were included. The study outcome was non-emergent ED visits, defined as patients triaged into non-emergent condition at both the time of arrival at ED and discharge from ED and were discharged without hospitalization. RESULTS: Among 1185871 cancer-related ED visits over 5 years, 19.0% (n=225491) were classified as non-emergent visits. While abdominal pain and fever are the top chief complaints in both emergent and non-emergent visits, non-emergent visits had high proportions of abdomen distension (4.8%), ascite (2.4%), and pain in lower limb (2.0%) compared with emergent visits. The cancer types with a high proportion of non-emergent visits were thyroid (32.4%) and prostate cancer (30.4%). Adults compared with children or older adults, female, medical aid insurance, urban/rural ED, direct-in compared with transfer-in, and weekend visit were associated with high odds for non-emergent visits. CONCLUSION: Approximately 20% of cancer-related ED visits may be potentially non-emergent. A significant number of non-emergent patients visited the ED due to cancer-related symptoms. To improve the quality of care for people living with cancer, the expansion of supportive care resources besides of ED, including active symptom control, is necessary.
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Serviço Hospitalar de Emergência , Neoplasias , Humanos , Serviço Hospitalar de Emergência/estatística & dados numéricos , Masculino , Feminino , Neoplasias/epidemiologia , Neoplasias/terapia , Estudos Transversais , Pessoa de Meia-Idade , República da Coreia/epidemiologia , Adulto , Idoso , Adolescente , Adulto Jovem , Criança , Pré-Escolar , Bases de Dados Factuais , Idoso de 80 Anos ou mais , Visitas ao Pronto SocorroRESUMO
BACKGROUND AND AIMS: Vitamin D is known to influence the risk of cardiovascular disease, which is a recognized risk factor for sudden cardiac arrest (SCA). However, the relationship between vitamin D and SCA is not well understood. Therefore, this study aims to investigate the association between vitamin D and SCA in out-of-hospital cardiac arrest (OHCA) patients compared to healthy controls. METHODS AND RESULTS: Using the Phase II Cardiac Arrest Pursuit Trial with Unique Registration and Epidemiologic Surveillance (CAPTURES II) registry, a 1:1 propensity score-matched case-control study was conducted between 2017 and 2020. Serum 25-hydroxyvitamin D (vitamin D) levels in patients with OHCA (454 cases) and healthy controls (454 cases) were compared after matching for age, sex, cardiovascular risk factors, and lifestyle behaviors. The mean vitamin D levels were 14.5 ± 7.6 and 21.3 ± 8.3 ng/mL among SCA cases and controls, respectively. Logistic regression analysis was used adjusting for cardiovascular risk factors, lifestyle behaviors, corrected serum calcium levels, and estimated glomerular filtration rate (eGRF). The adjusted odds ratio (aOR) for vitamin D was 0.89 (95% confidence interval [CI] 0.87-0.91). The dose-response relationship demonstrated that vitamin D deficiency was associated with SCA incidence (severe deficiency, aOR 10.87, 95% CI 4.82-24.54; moderate deficiency, aOR 2.24, 95% CI 1.20-4.20). CONCLUSION: Vitamin D deficiency was independently and strongly associated with an increased risk of SCA, irrespective of cardiovascular and lifestyle factors, corrected calcium levels, and eGFR.
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Biomarcadores , Morte Súbita Cardíaca , Parada Cardíaca Extra-Hospitalar , Sistema de Registros , Deficiência de Vitamina D , Vitamina D , Humanos , Deficiência de Vitamina D/sangue , Deficiência de Vitamina D/epidemiologia , Deficiência de Vitamina D/complicações , Deficiência de Vitamina D/diagnóstico , Masculino , Feminino , Vitamina D/sangue , Vitamina D/análogos & derivados , Pessoa de Meia-Idade , Estudos de Casos e Controles , Medição de Risco , Idoso , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/etiologia , Morte Súbita Cardíaca/prevenção & controle , Parada Cardíaca Extra-Hospitalar/sangue , Parada Cardíaca Extra-Hospitalar/diagnóstico , Parada Cardíaca Extra-Hospitalar/epidemiologia , Parada Cardíaca Extra-Hospitalar/fisiopatologia , Fatores de Risco , Biomarcadores/sangueRESUMO
Background: The JAVELIN Bladder 100 phase 3 trial demonstrated the efficacy and safety of avelumab administered as first-line (1L) maintenance treatment in patients with advanced urothelial carcinoma (UC) without disease progression after 1L platinum-based chemotherapy. This study provides the first real-world data from Korea regarding avelumab 1L maintenance treatment, comprising data obtained from a nationwide expanded access program (EAP). Methods: This open-label EAP was conducted at five centers from September 2021 until June 2023. Eligible patients had unresectable locally advanced or metastatic UC and were progression free after 1L platinum-based chemotherapy. Patients received avelumab 10 mg/kg intravenously every 2 weeks per local prescribing information. Safety and effectiveness were assessed by treating physicians according to routine practice. Results: Overall, 30 patients were enrolled. At initial UC diagnosis, 20 patients (66.7%) had stage 4 disease and 12 (40.0%) had visceral metastases. The most common 1L chemotherapy regimen was gemcitabine + cisplatin (21 patients; 70.0%). All but one patient (96.7%) had received 4-6 cycles of 1L chemotherapy. The median interval from end of 1L chemotherapy to start of avelumab was 4.4 weeks. Median duration of avelumab treatment was 6.2 months (range, 0.9-20.7); nine patients (30.0%) received >12 months of treatment. Adverse events related to avelumab occurred in 21 patients (70.0%) and were grade ≥3 or classified as serious in three patients (10.0%). Median progression-free survival was 7.9 months (95% CI, 4.3-13.1). Overall survival was not analyzed because only one patient died. Conclusion: Results from this EAP demonstrated the clinical activity and acceptable safety of avelumab 1L maintenance treatment in Korean patients with advanced UC, consistent with previous studies.
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OBJECTIVES: The effect of the case volume of emergency medical services (EMS) on the clinical outcomes of trauma is uncertain. The purpose of this study was to evaluate the association between the case volume of an ambulance station and clinical outcomes in moderate to severe trauma patients. METHODS: Adult trauma patients with injury severity scores greater than 8 who were transported by the EMS between 2018 and 2019 were analyzed. The main exposure was the annual case volume of moderate to severe trauma at the ambulance station where the patient-transporting ambulance was based: low-volume (less than 60 cases), intermediate-volume (between 60 and 89 cases), and high-volume (equal or greater than 90 cases). The primary outcome was in-hospital mortality. Multilevel multivariable logistic regression analysis was conducted to calculate adjusted odds ratios (AORs) and 95% confidence intervals (CIs), with the high-volume group used as the reference. RESULTS: In total, 21,498 trauma patients were analyzed. The high-volume group exhibited lower in-hospital mortality, 447 (9.0%), compared to 867 (14.1%) in the intermediate-volume group and 1,458 (14.1%) in the low-volume group. There were a significantly higher odds of in-hospital mortality: the low-volume group (AOR 95% CI: 1.20 (0.95-1.51)) and intermediate-volume group (AOR 95% CI: 1.29 (1.02-1.64)) when compared to the high-volume group. CONCLUSIONS: The case volume at an ambulance station is associated with in-hospital mortality in patients with moderate to severe trauma. These results should be considered when constructing an EMS system and education program for prehospital trauma care.
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Immune-related adverse events (irAEs) caused by immune checkpoint inhibitors (ICIs) are rare but fatal, requiring systemic steroid use. Therefore, to examine the outcomes, incidence, timing, and risk factors of ICI-associated steroid-requiring severe irAEs, we conducted a nationwide, retrospective, cohort study utilizing the Korean Health Insurance and Review Assessment database. We identified 357,010 patients with lung cancer, bladder cancer, or skin melanoma, eligible for ICI reimbursement in Korea between January 2012 to June 2020. Steroid-requiring severe irAEs following ICI treatment or treatment-emergent AEs following cytotoxic chemotherapy were defined as moderate- or high-dose steroid administration for over 2 consecutive days, along with corresponding ICD-10 codes indicating affected organ systems. The ICI-exposed group (N = 10,118) was compared to a matched cohort of 55,436 ICI-unexposed patients treated with cytotoxic chemotherapy. Incidences of acute severe irAEs requiring moderate- and high-dose steroids were higher in the ICI-exposed group (1.95% and 6.42%, respectively). The ICI-exposed group also had a higher risk of developing delayed severe irAEs requiring moderate- and high-dose steroid use (3.89% and 7.39%). Male sex, high comorbidity index, or previously diagnosed autoimmune diseases were associated with an increased risk of severe irAEs. Notably, 27.4-38.8% of the patients experienced recurrent severe irAEs after re-challenge with ICIs following moderate- or high-dose steroid use, with the severity matching the initial episode. Steroid-requiring severe irAEs were significantly more prevalent among patients exposed to ICIs than among those treated with chemotherapy in acute and delayed periods.
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Inibidores de Checkpoint Imunológico , Humanos , Inibidores de Checkpoint Imunológico/efeitos adversos , Estudos Retrospectivos , Masculino , Feminino , Fatores de Risco , Incidência , Pessoa de Meia-Idade , Idoso , República da Coreia/epidemiologia , Melanoma/tratamento farmacológico , Melanoma/imunologia , Neoplasias Pulmonares/tratamento farmacológico , Neoplasias Pulmonares/imunologia , Adulto , Neoplasias da Bexiga Urinária/tratamento farmacológico , Neoplasias da Bexiga Urinária/imunologia , Neoplasias Cutâneas/tratamento farmacológico , Neoplasias Cutâneas/imunologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Esteroides/uso terapêutico , Esteroides/administração & dosagemRESUMO
The beach chair position (BCP) is widely used in shoulder surgery; however, it frequently leads to hypotension. Hypotension in BCP is prevalent among older patients who are at risk of secondary complications such as ischemic injuries. Therefore, this prospective study aimed to investigate the association and predictive value of frailty, as assessed by ultrasound-measured quadriceps depth and questionnaire, in patients aged ≥65 years undergoing elective shoulder surgery under general anesthesia. A multivariable logistic regression analysis was performed to identify independent risk factors for hypotension in BCP under general anesthesia. Receiver operating characteristic curves were constructed to assess the predictive values of various parameters. The results indicated that a quadriceps depth < 2.3 cm and BCP for an extended period significantly increased the risk of hypotension. The combined consideration of quadriceps depth < 2.3 cm and frailty demonstrated markedly superior predictive power compared with each factor individually. In conclusion, the study findings facilitate the screening and identification of risk factors for older patients undergoing surgery in BCP, thereby enhancing perioperative management.