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Background: This phase Ib study was performed to determine the safety of combination capecitabine with alpleisib (phosphatidylinositol 3-kinase catalytic subunit p110α blockade) and determine the maximal tolerated dose (MTD) and recommended phase ll dose (RP2D) of this combination regimen in patients with advanced solid tumors refractory to standard therapy. The synergistic anti-tumor activity and pharmacokinetics (PK) were investigated. Methods: Dose escalation phases were conducted in patients with advanced solid cancers who were refractory to standard therapy regardless of PIK3CA mutation. Patients were administered orally once daily alpelisib (200mg and 300mg) and twice daily capecitabine (850mg, 1000mg, 1250mg orally, days 1-14) every 3 weeks. Standard "3 + 3" dose escalation was used to define the MTD. The effect of alpelisib on the PK of capecitabine was assessed. Results: Patients with 6 colorectal cancer (three PIK3CA mutation) and 6 breast cancer (all PIK3CA mutation) were enrolled. The first three patients in dose level 0 (alpelisib 200mg daily, capecitabine 1,000 mg/m2 twice daily) had no dose-limiting toxicities (DLTs). In dose level 1 (alpelisib increased to 300 mg daily, capecitabine 1,000mg twice daily), one of six patients had DLT (grade (Gr) 3 hyperglycemia). When dose level 2 (alpelisib 300mg daily, capecitabine 1,250 mg/m2 twice daily) was expanded to 3 patients, no patients had DLTs. The combination of alpelisib 300mg daily and capecitabine 1,250 mg/m2 twice daily was declared as the MTD/RP2D in patients with advanced solid tumors. The most common AEs were Gr 1-3 hyperglycemia (75.0%). Frequent all-grade, treatment-related AEs included Gr 2-3 nausea (75.0%), Gr 1-2 diarrhea (50.0%), Gr 1-2 hand-foot syndrome (41.7%), Gr 1-2 anorexia (41.7%), Gr 2 mucositis (33.3%). Antitumor activity was observed in patients with PIK3CA mutant breast cancer (3 partial response and 3 stable disease of total 6 patients). Alpelisib exposure (Cmax and AUC0-12) was unaffected by concomitant capecitabine. There were no clinically relevant drug-drug interactions observed between alpelisib and capecitabine. Conclusions: The combination of alpelisib and capecitabine is generally tolerated, without pharmacokinetic interactions, and shows antitumor activity in patients with PIK3CA mutant advanced cancers.
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Obesity is a major cause of metabolic dysfunction-associated steatohepatitis (MASH) and is characterized by inflammation and insulin resistance. Interferon-γ (IFNγ) is a pro-inflammatory cytokine elevated in obesity and modulating macrophage functions. Here, we show that male mice with loss of IFNγ signaling in myeloid cells (Lyz-IFNγR2-/-) are protected from diet-induced insulin resistance despite fatty liver. Obesity-mediated liver inflammation is also attenuated with reduced interleukin (IL)-12, a cytokine primarily released by macrophages, and IL-12 treatment in vivo causes insulin resistance by impairing hepatic insulin signaling. Following MASH diets, Lyz-IFNγR2-/- mice are rescued from developing liver fibrosis, which is associated with reduced fibroblast growth factor (FGF) 21 levels. These results indicate critical roles for IFNγ signaling in macrophages and their release of IL-12 in modulating obesity-mediated insulin resistance and fatty liver progression to MASH. In this work, we identify the IFNγ-IL12 axis in regulating intercellular crosstalk in the liver and as potential therapeutic targets to treat MASH.
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Fígado Gorduroso , Resistência à Insulina , Interferon gama , Interleucina-12 , Fígado , Macrófagos , Camundongos Knockout , Obesidade , Transdução de Sinais , Animais , Interferon gama/metabolismo , Interleucina-12/metabolismo , Masculino , Obesidade/metabolismo , Camundongos , Fígado Gorduroso/metabolismo , Fígado Gorduroso/patologia , Macrófagos/metabolismo , Fígado/metabolismo , Fígado/patologia , Camundongos Endogâmicos C57BL , Dieta Hiperlipídica/efeitos adversos , Receptores de Interferon/metabolismo , Receptores de Interferon/genética , Receptor de Interferon gama , Cirrose Hepática/metabolismo , Cirrose Hepática/patologia , Cirrose Hepática/genéticaRESUMO
Purpose: The objective of this study was to assess postoperative direct medical expenses and medical utilization of elderly patients who underwent either hemiarthroplasty (HA) or internal fixation (IF) for treatment of a femoral intertrochanteric fracture and to analyze differences according to surgical methods and age groups. Materials and Methods: Data from the 2011 to 2018 Korean National Health Insurance Review & Assessment Service database were used. Risk-set matching was performed for selection of controls representing patients with the same sex, age, and year of surgery. A comparative interrupted time series analysis was performed for evaluation of differences in medical expenses and utilization between the two groups. Results: A total of 10,405 patients who underwent IF surgery and 10,405 control patients who underwent HA surgery were included. Medical expenses were 18% lower in the IF group compared to the HA group during the first year after the fracture (difference-in-difference [DID] estimate ratio 0.82, 95% confidence interval [CI] 0.77-0.87, P<0.001), and 9% lower in the second year (DID estimate ratio 0.91, 95% CI 0.85-0.99, P=0.018). Length of hospital stay was significantly shorter in the IF group compared to the HA group during the first two years after time zero in the age ≥80 group. Conclusion: A noticeable increase in medical expenses was observed for patients who underwent HA for treatment of intertrochanteric fractures compared to those who underwent IF over a two-year period after surgery. Therefore, consideration of such findings is critical when designing healthcare policy support for management of intertrochanteric fractures.
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AIMS/HYPOTHESIS: The aim of this study was to compare the effectiveness of stand-alone intermittently scanned continuous glucose monitoring (isCGM) with or without a structured education programme and blood glucose monitoring (BGM) in adults with type 2 diabetes on multiple daily insulin injections (MDI). METHODS: In this 24 week randomised open-label multicentre trial, adults with type 2 diabetes on intensive insulin therapy with HbA1c levels of 58-108 mmol/mol (7.5-12.0%) were randomly assigned in a 1:1:1 ratio to isCGM with a structured education programme on adjusting insulin dose and timing according to graphical patterns in CGM (intervention group), isCGM with conventional education (control group 1) or BGM with conventional education (control group 2). Block randomisation was conducted by an independent statistician. Due to the nature of the intervention, blinding of participants and investigators was not possible. The primary outcome was change in HbA1c from baseline at 24 weeks, assessed using ANCOVA with the baseline value as a covariate. RESULTS: A total of 159 individuals were randomised (n=53 for each group); 148 were included in the full analysis set, with 52 in the intervention group, 49 in control group 1 and 47 in control group 2. The mean (± SD) HbA1c level at baseline was 68.19±10.94 mmol/mol (8.39±1.00%). The least squares mean change (± SEM) from baseline HbA1c at 24 weeks was -10.96±1.35 mmol/mol (-1.00±0.12%) in the intervention group, -6.87±1.39 mmol/mol (-0.63±0.13%) in control group 1 (p=0.0367 vs intervention group) and -6.32±1.42 mmol/mol (-0.58±0.13%) in control group 2 (p=0.0193 vs intervention group). Adverse events occurred in 28.85% (15/52) of individuals in the intervention group, 26.42% (14/53) in control group 1 and 48.08% (25/52) in control group 2. CONCLUSIONS/INTERPRETATION: Stand-alone isCGM offers a greater reduction in HbA1c in adults with type 2 diabetes on MDI when education on the interpretation of graphical patterns in CGM is provided. TRIAL REGISTRATION: ClinicalTrials.gov NCT04926623. FUNDING: This study was supported by Daewoong Pharmaceutical Co., Ltd.
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Automonitorização da Glicemia , Glicemia , Diabetes Mellitus Tipo 2 , Hemoglobinas Glicadas , Hipoglicemiantes , Insulina , Educação de Pacientes como Assunto , Humanos , Diabetes Mellitus Tipo 2/tratamento farmacológico , Diabetes Mellitus Tipo 2/sangue , Masculino , Feminino , Pessoa de Meia-Idade , Automonitorização da Glicemia/métodos , Insulina/administração & dosagem , Insulina/uso terapêutico , Glicemia/metabolismo , Glicemia/efeitos dos fármacos , Hemoglobinas Glicadas/metabolismo , Hemoglobinas Glicadas/análise , Educação de Pacientes como Assunto/métodos , Hipoglicemiantes/administração & dosagem , Hipoglicemiantes/uso terapêutico , Idoso , Adulto , Monitoramento Contínuo da GlicoseRESUMO
Background: The objective of our study was to analyze the postoperative direct medical expenses and hospital lengths of stay (LOS) of elderly patients who had undergone either hemiarthroplasty (HA) or total hip arthroplasty (THA) for femoral neck fractures and to determine the indication of THA by comparing those variables between the 2 groups by time. Methods: In this comparative large-sample cohort study, we analyzed data from the 2011 to 2018 Korean National Health Insurance Review and Assessment Service database. The included patients were defined as elderly individuals aged 60 years or older who underwent HA or THA for a femoral neck fracture. A 1:1 risk-set matching was performed on the propensity score, using a nearest-neighbor matching algorithm with a maximum caliper of 0.01 of the hazard components. In comparative interrupted time series analysis, time series were constructed using the time unit of one-quarter before and after 3 years from time zero. For the segmented regression analysis, we utilized a generalized linear model with a gamma distribution and logarithmic link function. Results: A total of 4,246 patients who received THA were matched and included with 4,246 control patients who underwent HA. Although there was no statistically significant difference in direct medical expense and hospital LOS for the first 6 months after surgery, direct medical expenses and hospital LOS in THA were relatively reduced compared to the HA up to 24 months after surgery (p < 0.05). In the subgroup analysis, the THA group's hospital LOS decreased significantly compared to that of the HA group during the 7 to 36 months postoperative period in the 65 ≤ age < 80 age group (p < 0.05). Direct medical expenses of the THA group significantly decreased compared to those of the HA group during the period from 7 to 24 months after surgery in the men group (p < 0.05). Conclusions: When performing THA in elderly patients with femoral neck fractures, the possibility of survival for at least 2 years should be considered from the perspective of medical expense and medical utilization. Additionally, in healthy and active male femoral neck fracture patients under the age of 80 years, THA may be more recommended than HA.
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Artroplastia de Quadril , Fraturas do Colo Femoral , Hemiartroplastia , Idoso , Humanos , Masculino , Tempo de Internação , Estudos de Coortes , Análise de Séries Temporais Interrompida , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/cirurgia , Fraturas do Colo Femoral/cirurgiaRESUMO
Bee venom contains several bioactive components, including enzymatic and non-enzymatic proteins. There is increasing interest in the bioactive components of bee venom since they have exhibited various pharmacological effects. Recently, Apis mellifera waprin (Amwaprin) was identified as a novel protein in Apis mellifera (honeybee) venom and characterized as an antimicrobial agent. Herein, the novel biological function of Amwaprin as an antioxidant is described. In addition, the antioxidant effects of Amwaprin in mammalian cells were investigated. Amwaprin inhibited the growth of, oxidative stress-induced cytotoxicity, and inflammatory response in mammalian NIH-3T3 cells. Amwaprin decreased caspase-3 activity during oxidative stress and exhibited protective activity against oxidative stress-induced cell apoptosis in NIH-3T3 and insect Sf9 cells. The mechanism underlying the cell protective effect of Amwaprin against oxidative stress is due to its direct binding to the cell membrane. Furthermore, Amwaprin demonstrated radical-scavenging activity and protected against oxidative DNA damage. These results suggest that the antioxidant capacity of Amwaprin is attributed to the synergistic effects of its radical-scavenging action and cell shielding, indicating its novel role as an antioxidant agent.
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A high-fiber diet is widely recognized for its positive effects on the gut microbiome. However, the specific impact of a high-fiber diet on the gut microbiome and bowel habits of patients with colon cancer remains poorly understood. In this study, we aimed to assess the effects of a modified microbiota-accessible carbohydrate (mMAC) diet on gut microbiota composition and clinical symptoms in colon cancer patients who underwent surgical resection. To achieve this, we enrolled 40 patients in two groups: those who received adjuvant chemotherapy and those who did not. Fecal samples were collected before and after dietary interventions for microbial and metabolite analyses. Each group was randomized in a 1: 1 ratio to follow either a 3-week conventional diet followed by a 3-week mMAC diet, or the reverse sequence. Although there were no significant differences in the microbial diversity data before and after the mMAC diet in both the non-chemotherapy and chemotherapy groups, distinct differences in gut microbial composition were revealed after the mMAC diet. Specifically, the abundance of Prevotella, which is associated with high-fiber diets, was further elevated with increased concentrations of acetate and propionate after the mMAC diet. Additionally, patients who experienced improved diarrhea and constipation after the mMAC diet exhibited an enrichment of beneficial bacteria and notable changes in metabolites. In conclusion, this study provides valuable insights into the potential benefits of the mMAC diet, specifically its impact on the gut microbiome and clinical symptoms in postoperative colorectal cancer (CRC) patients. These findings emphasize the potential role of a high-fiber diet in influencing the gut microbiome, and the clinical symptoms warrant further investigation.
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BACKGROUND: Reverse transcription-quantitative PCR (RT-qPCR) is commonly used to diagnose SARS-CoV-2, but it has limited sensitivity in detecting the virus in asymptomatic close contacts and convalescent patients. In this study, we propose the use of reverse transcription-digital droplet PCR (RT-ddPCR) to detect SARS-CoV-2 in clinical samples. METHODS: The clinical performance of RT-ddPCR targeting of ORF1ab and N genes was evaluated in parallel with RT-qPCR using 200 respiratory samples collected from close contacts and patients at different phases of infection. RESULTS: The limits of detection (LODs) for RT-ddPCR assays were determined using six dilutions of ACCUPLEX SARS-Cov-2 reference material. The LODs of ORF1ab and N genes were 3.7 copies/reaction and 2.2 copies/reaction, respectively. Compared to RT-qPCR, RT-ddPCR increased the positive rate by 12.0% in 142 samples from SARS-CoV-2-infected patients. Additionally, RT-ddPCR detected SARS-CoV-2 in three of 26 specimens from close contacts that tested negative by RT-qPCR, and infection was confirmed using follow-up samples. Finally, RT-ddPCR improved the equivocal results from RT-qPCR in 56.3% (9/16) of convalescent patient samples. CONCLUSIONS: Detecting SARS-CoV-2 in samples with low viral loads using RT-qPCR can be challenging. However, our study suggests that RT-ddPCR, with its higher sensitivity and accuracy, is better suited for detecting low viral copies in samples, particularly those from close contacts and convalescent patients.
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COVID-19 , Humanos , COVID-19/diagnóstico , SARS-CoV-2/genética , Reação em Cadeia da Polimerase em Tempo Real/métodos , Limite de Detecção , Carga Viral/métodos , RNA Viral/genética , Sensibilidade e Especificidade , Teste para COVID-19RESUMO
Background: Marfan syndrome (MFS) is caused by fibrillin-1 gene (FBN1) variants. Mutational hotspots and/or well-established critical functional domains of FBN1 include cysteine residues, calcium-binding consensus sequences, and amino acids related to interdomain packaging. Previous guidelines for variant interpretation do not reflect the features of genes or related diseases. Using the Clinical Genome Resource (ClinGen) FBN1 variant curation expert panel (VCEP), we re-evaluated FBN1 germline variants reported as variants of uncertain significance (VUSs). Methods: We re-evaluated 26 VUSs in FBN1 reported in 161 patients with MFS. We checked the variants in the Human Genome Mutation Database, ClinVar, and VarSome databases and assessed their allele frequencies using the gnomAD database. Patients' clinical information was reviewed. Results: Four missense variants affecting cysteines (c.460T>C, c.1006T>C, c.5330G>C, and c.8020T>C) were reclassified as likely pathogenic and were assigned PM1_strong or PM1. Two intronic variants were reclassified as benign by granting BA1 (stand-alone). Four missense variants were reclassified as likely benign. BP5 criteria were applied in cases with an alternate molecular basis for disease, one of which (c.7231G>A) was discovered alongside a pathogenic de novo COL3A1 variant (c.1988G>T, p.Gly633Val). Conclusions: Considering the high penetrance of FBN1 variants and clinical variability of MFS, the detection of pathogenic variants is important. The ClinGen FBN1 VCEP encompasses mutational hotspots and/or well-established critical functional domains and adjusts the criteria specifically for MFS; therefore, it is beneficial not only for identifying pathogenic FBN1 variants but also for distinguishing these variants from those that cause other connective tissue disorders with overlapping clinical features.
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Síndrome de Marfan , Humanos , Fibrilina-1/genética , Mutação , Síndrome de Marfan/diagnóstico , Síndrome de Marfan/genética , Síndrome de Marfan/patologia , Mutação de Sentido Incorreto , Frequência do Gene , Cisteína/genéticaRESUMO
CONTEXT: The decision on diagnostic lobectomy for follicular neoplasms (FN) is challenging. OBJECTIVE: This meta-analysis investigates whether an appropriate size cutoff exists for recommending surgery for thyroid nodules diagnosed as FN by fine needle aspiration. METHODS: The Ovid-Medline, EMBASE, Cochrane, and KoreaMed databases were searched for studies reporting the malignancy rate of FN/suspicious for FN (FN/SFN) according to tumor size, using search terms "fine needle aspiration," "follicular neoplasm," "lobectomy," "surgery," and "thyroidectomy." RESULTS: Fourteen observational studies comprising 2016 FN/SFN nodules with postsurgical pathologic reports were included, and 2 studies included malignancy rates with various tumor sizes. The pooled malignancy risk of FN/SFN nodules according to size was: odds ratio (OR) 2.29 (95% CI, 1.68-3.11) with cutoff of 4 cm (9 studies), OR 2.39 (95% CI, 1.45-3.95) with cutoff of 3 cm (3 studies), and OR 1.81 (95% CI, 0.94-3.50) with cutoff of 2 cm (5 studies). However, tumors ≥2 cm also showed a higher risk (OR 2.43; 95% CI, 1.54-3.82) based on the leave-one-out meta-analysis after removal of 1 influence study. When each cutoff size was evaluated by summary receiver operating characteristic (sROC) curves, the cutoff of 4 cm showed the highest summary area under the curve (sAUC, 0.645) compared to other cutoffs (sAUC, 0.58 with 2 cm, and 0.62 with 3 cm), although there was no significant difference. CONCLUSION: Although the risk of malignancy increases with increasing tumor size, the risk remains significant at all tumor sizes and no cutoff limit can be recommended as a decision-making parameter for diagnostic surgery in Bethesda IV thyroid nodules.
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Adenocarcinoma Folicular , Neoplasias da Glândula Tireoide , Nódulo da Glândula Tireoide , Tireoidectomia , Humanos , Adenocarcinoma Folicular/patologia , Adenocarcinoma Folicular/cirurgia , Adenocarcinoma Folicular/diagnóstico , Neoplasias da Glândula Tireoide/patologia , Neoplasias da Glândula Tireoide/cirurgia , Neoplasias da Glândula Tireoide/diagnóstico , Neoplasias da Glândula Tireoide/epidemiologia , Nódulo da Glândula Tireoide/patologia , Nódulo da Glândula Tireoide/cirurgia , Nódulo da Glândula Tireoide/diagnóstico , Biópsia por Agulha Fina , Carga Tumoral , Medição de Risco/métodosRESUMO
Previous results regarding the association between types of ß-blockers and outcomes in patients on hemodialysis (HD) were inconsistent. Our study aimed to evaluate patient survival according to the type of ß-blockers administered using a large sample of patients with maintenance HD. Our study included patients on maintenance HD patients from a national HD quality assessment program (n = 54,132). We divided included patients into four groups based on their use and type; Group 1 included patients without a prescription of ß-blockers, Group 2 included patients with a prescription of dialyzable and cardioselective ß-blockers, Group 3 included patients with a prescription of non-dialyzable and non-cardioselective ß-blockers, and Group 4 included patients with prescription of non-dialyzable and cardioselective ß-blockers. The number of patients in Groups 1, 2, 3, and 4 were 34,514, 2789, 15,808, and 1021, respectively. The 5-year survival rates in Groups 1, 2, 3, and 4 were 69.3%, 66.0%, 68.8%, and 69.2%, respectively. Univariate Cox regression analyses showed the hazard ratios to be 1.10 (95% CI, 1.04-1.17) in Group 2 and 1.05 (95% CI, 1.02-1.09) in Group 3 compared to Group 1. However, multivariate Cox regression analyses did not show statistical significance among the four groups. Our study showed that there was no significant difference in patient survival based on the use or types of ß-blockers.
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This study aimed to evaluate the effect of statin solubility on the survival of patients undergoing hemodialysis (HD). This retrospective study used laboratory and clinical data from a national HD quality assessment program and claims data (n = 53,345). The use of statins was defined as prescription ≥30 days during 6 months of each HD quality assessment period. We divided the patients into three groups based on the use and solubility of statins: No group, patients without a prescription of statins (n = 37,944); Hydro group, patients with a prescription of hydrophilic statins (n = 2823); and Lipo group, patients with a prescription of lipophilic statins (n = 12,578). The 5-year survival rates in the No, Hydro, and Lipo groups were 69.6%, 67.9%, and 67.9%, respectively (p < 0.001 for the trend). Multivariable Cox regression analyses showed that the Lipo group had better patient survival than the No group. However, multivariable analyses did not show statistical significance between the Hydro and No or Lipo groups. In all subgroups based on sex, age, presence of diabetes mellitus, and heart disease, the Lipo group had better patient survival than the No group. We identified no significant association between hydrophilic and lipophilic statins and patient survival. However, patients taking lipophilic statins had a modest survival benefit compared with those who did not receive statins.
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Gout is the most common form of arthritis, with the prevalence increasing worldwide. The present treatment guidelines provide recommendations for the appropriate treatment of acute gout, management during the inter-critical period, and prevention of chronic complications. The guidelines were developed based on evidence-based medicine and draft recommendations finalized after expert consensus. These guidelines are designed to provide clinicians with clinical evidence to enable efficient treatment of gout.
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Artrite Gotosa , Gota , Humanos , Gota/diagnóstico , Gota/tratamento farmacológico , Povo Asiático , Consenso , República da CoreiaRESUMO
CONTEXT: The relationship of blood pressure (BP) with cardio-renal events and all-cause mortality in type 2 diabetes mellitus (T2DM) is still controversial. OBJECTIVE: To investigate the optimal BP target in Korean individuals with T2DM. METHODS: Using the Korean National Health Insurance System database, data of individuals with T2DM who underwent regular health checks from January 1, 2007, to December 31, 2007, were extracted (N = 1 800 073). Among them, a total of 326 593 individuals were included in the final study. The study population was divided into 7 groups according to their observed systolic blood pressure (SBP) (<110, 110-119, 120-129, 130-139, 140-149, 150-159, 160-169, and ≥170 mmHg) and diastolic blood pressure (DBP) (<65, 65-69, 70-74, 75-79, 80-84, 85-89, and ≥90 mmHg). Hazard ratios (HRs) of cardio-renal events and all-cause mortality according to BP categories were analyzed. RESULTS: Compared with SBP of 120-129 mmHg and DBP of 75-79 mmHg, SBP of ≥130 mmHg and DBP of ≥ 80 mmHg were associated with an increase in HR of major cardiovascular adverse events (MACEs). SBP of 120-129 mmHg and DBP 75-79 mmHg were associated with the lowest HR of all-cause mortality. Both lower BP (SBP/DBP <120/70 mm) and higher BP (SBP/DBP ≥130/80 mmHg) were associated with an increased HR of all-cause mortality. Contrary to MACE, the lower the SBP, the lower the HR of renal events. CONCLUSION: In patients with T2DM, the optimal cutoff value of BP associated with a lower incidence of MACE and mortality may be 120-129 mmHg for SBP and 75-79 mmHg for DBP. However, lower SBP may be helpful for T2DM patients with a high risk of renal disease.
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Diabetes Mellitus Tipo 2 , Hipertensão , Nefropatias , Humanos , Pressão Sanguínea/fisiologia , Diabetes Mellitus Tipo 2/complicações , Diabetes Mellitus Tipo 2/epidemiologia , Hipertensão/complicações , Hipertensão/epidemiologia , Programas Nacionais de SaúdeRESUMO
Gout is the most common form of arthritis, with the prevalence increasing worldwide. The present treatment guidelines provide recommendations for the appropriate treatment of acute gout, management during the inter-critical period, and prevention of chronic complications. The guidelines were developed based on evidence-based medicine and draft recommendations finalized after expert consensus. These guidelines are designed to provide clinicians with clinical evidence to enable efficient treatment of gout.
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INTRODUCTION: The aim of our study is to analyze the association of usage and type of warming device with the risk of surgical site infection (SSI) in patients who underwent hip arthroplasty, and to analyze the factors that increase the risk of SSI if the warming device is not used. MATERIALS AND METHODS: This retrospective cross-sectional study identified subjects from data of "Evaluation of the Appropriate Use of Prophylactic Antibiotics". Included patients were defined as those who underwent elective unilateral hip hemiarthroplasty or total hip arthroplasty (THA). Patients were classified into no intraoperative warming device, forced air warming devices, and devices using conduction. Multiple logistic regression analysis was conducted to estimate adjusted odds ratios (aORs) and 95% confidence intervals (CIs) to assess the association between warming devices and SSI. RESULTS: A total of 3945 patients met the inclusion criteria. Compared to those who received an intraoperative warming device, the odds of developing SSI were 1.9 times higher in those who did not receive intraoperative warming devices (aOR 1.9; 95% CI 1.1-3.6). The risk of SSI was 2.2 times higher with forced air warming devices compared to devices using conduction but this difference was not statistically significant (aOR 2.2; 95% CI 0.7-6.8). The risk of SSI increased in males (aOR 2.8; 95% CI 1.1-7.2), in patients under 70 years of age (aOR 4.4; 95% CI 1.6-10.4), in patients with a Charlson`s comorbidity index of 2 or higher (aOR 3.3; 95% CI 1.3-8.7), and in patients who underwent THA (aOR 3.8; 95% CI 1.7-8.3) when intraoperative warming devices were not used. CONCLUSIONS: The use of intraoperative active warming devices is highly recommended to prevent SSI during elective hip arthroplasty. In particular, male patients younger than 70 years, those with a high CCI, and those undergoing THA are at significantly increased risk of SSI if intraoperative active warming devices are not used. Intraoperative warming device using conduction is likely superior to forced air warming device, but further studies are needed to confirm this.
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Artroplastia de Quadril , Artroplastia do Joelho , Humanos , Masculino , Estudos Retrospectivos , Artroplastia de Quadril/efeitos adversos , Infecção da Ferida Cirúrgica/epidemiologia , Infecção da Ferida Cirúrgica/etiologia , Infecção da Ferida Cirúrgica/prevenção & controle , Estudos Transversais , Artroplastia do Joelho/efeitos adversos , Fatores de RiscoRESUMO
The aim of this study was to evaluate survival rates according to iron status in patients undergoing maintenance hemodialysis (HD). Thus, the National HD Quality Assessment Program dataset and claims data were used for analysis (n = 42,390). The patients were divided into four groups according to their transferrin saturation rate and serum ferritin levels: Group 1 (n = 34,539, normal iron status); Group 2 (n = 4476, absolute iron deficiency); Group 3 (n = 1719, functional iron deficiency); Group 4 (n = 1656, high iron status). Using univariate and multivariable analyses, Group 1 outperformed the three other groups in terms of patient survival. Using univariate analysis, although Group 2 showed a favorable trend in patient survival rates compared with Groups 3 and 4, the statistical significance was weak. Group 3 exhibited similar patient survival rates to Group 4. Using multivariable Cox regression analysis, Group 2 had similar patient survival rates to Group 3. Subgroup analyses according to sex, diabetic status, hemoglobin level ≥ 10 g/dL, and serum albumin levels ≥ 3.5 g/dL indicated similar trends to those of the total cohort. However, subgroup analysis based on patients with a hemoglobin level < 10 g/dL or serum albumin levels < 3.5 g/dL showed a weak statistical significant difference compared with those with hemoglobin level ≥ 10 g/dL, or serum albumin levels ≥ 3.5 g/dL. In addition, the survival difference between Group 4 and other groups was greater in old patients than in young ones. Patients with a normal iron status had the highest survival rates. Patient survival rates were similar or differed only modestly among the groups with abnormal iron status. In addition, most subgroup analyses revealed similar trends to those according to the total cohort. However, subgroup analyses based on age, hemoglobin, or serum albumin levels showed different trends.
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Anemia Ferropriva , Eritropoetina , Deficiências de Ferro , Humanos , Ferro , Transferrina/análise , Diálise Renal/efeitos adversos , Hemoglobinas/metabolismo , Albumina Sérica , Anemia Ferropriva/epidemiologiaRESUMO
Pregnant women are vulnerable to developing influenza complications. Influenza vaccination during pregnancy is crucial to avoid infection. The COVID-19 pandemic might exacerbate fear and anxiety in pregnant women. The purpose of this study was to evaluate the effect of the COVID-19 pandemic on influenza vaccination and determine the factors associated with influenza vaccine acceptance among pregnant women in Korea. We conducted a cross-sectional study using an online survey in Korea. A survey questionnaire was distributed among pregnant or postpartum women within 1 year after delivery. Multivariate logistic regression analysis was performed to identify the factors associated with influenza vaccination among pregnant women. A total of 351 women were included in this study. Of them, 51.0% and 20.2% were vaccinated against influenza and COVID-19 during pregnancy, respectively. The majority of participants who had a history of influenza vaccination reported that the COVID-19 pandemic did not affect (52.3%, n = 171) or increased the importance (38.5%, n = 126) of their acceptance of the influenza vaccine. Factors associated with influenza vaccine acceptance were knowledge of influenza vaccine (OR 1.21; 95% CI 1.09, 1.35), trust in healthcare providers (OR 2.57; 95% CI 1.43, 4.65), and COVID-19 vaccination during pregnancy (OR 6.11, 95% CI 2.86, 13.01). Participants were more likely to accept the influenza vaccine when they received a COVID-19 vaccine during pregnancy, but the rate of influenza vaccination was not affected by the COVID-19 pandemic. This study showed that the COVID-19 pandemic did not influence influenza vaccine uptake in the majority of pregnant women in Korea. The results emphasize the necessity of appropriate education for pregnant women to enhance awareness of vaccination.
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Cardiovascular disease (CVD) is one of the most common comorbidities in breast cancer survivors. Recently, the target population and treatment period for aromatase inhibitor (AI) treatment in breast cancer patients has been expanding. However, information on adverse CVD events from the long-term use of AI is still lacking. The aim of this study was to investigate the CVD side effects of AI treatment and to evaluate the changes in lipid profile during AI treatment. A systematic search of PubMed (Medline), EMBASE, and Cochrane Library databases reporting on cardiovascular outcomes or lipid profiles change in adult female breast cancer patients (>19 years old) with AI was performed. The pooled analysis of 25 studies showed that the prevalence rate of any type of cardiovascular disease was 6.08 per 100 persons (95% CI 2.91-10.31). Angina was the most common type of heart-related cardiovascular event accounting for 3.85 per 100 persons, followed by any type of stroke (3.34) and venous thromboembolism (2.95). Ischemic stroke (OR 1.39, 95% CI 1.07-1.81) and myocardial infarction (OR 1.30, 95% CI 0.88-1.93) were more common in AI compared with tamoxifen, whereas the prevalence of venous thromboembolism (OR 0.61, 95% CI 0.37-1) was significantly lower in the AI group. In addition, treatment with AI for 6-12 months showed a decrease in HDL-cholesterol and an increase in LDL-cholesterol and total cholesterol. Various CVDs can occur when using AI, and in particular, the risk of MI and ischemic stroke increases in comparison with the adverse effect of tamoxifen. The occurrence of CVD might be related to the deterioration of the lipid profile after AI treatment. Therefore, a customized individualization strategy considering each patient's CV risk factors is needed during AI treatment.