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BACKGROUND AND PURPOSE: Intracranial aneurysm treatment using flow-diverters and flow-disruptors requires a higher level of expertise when compared to more traditional methods. Our hypothesis was that the procedural success and the rate of complications are dependent on the annual case load of a center. MATERIALS AND METHODS: Conducting a retrospective analysis on the Database of the German Society for Interventional Radiology for the years 2020 to 2021, we examined flow-diverter and flow-disruptor procedures. We categorized centers into four groups according to their annual case load and proceeded to analyze success rates, complication rates, and fluoroscopy times across these centers. RESULTS: No statistically significant differences were observed among the groups in both flow-diverter and flow-disruptor cases concerning fluoroscopy time and the incidence of technical complications. However, within the subgroup of flow-disruptor cases, centers with lower case load exhibited significantly higher rates of hemorrhagic and clinically relevant complications. Additionally, it was noted that the rate of therapeutic success in the flow-diverter group significantly increased in centers with higher case volumes. CONCLUSION: Our findings support the intention towards centralization of medical care especially for complex neuroendovascular procedures. Furthermore, our findings are an argument to further develop a standardized educational and procedural algorithm based on defined case numbers and training modules for complex neurovascular procedures as already implemented by the Database of the German Society for Interventional Radiology.
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BACKGROUND: There is still great need to develop new strategies to improve the efficacy of allergen immunotherapies with optimal safety standards for patients. A new promising approach is to couple allergoids to mannan. The objective of this phase IIa/IIb study was to identify the optimal dose of mannan-conjugated birch pollen allergoids for the short-course treatment of birch pollen-induced allergic rhinoconjunctivitis. METHODS: For this prospective, randomized, double-blind, placebo-controlled, dose-finding study, 246 birch pollen-allergic adults received 0.5 mL placebo or 1000, 3000 or 10,000 mTU/mL of mannan-conjugated birch pollen allergoids at five pre-seasonal visits. Efficacy was assessed by comparing allergic rhinoconjunctivitis symptoms and use of anti-allergic medication during the peak of the birch pollen season 2020. Immunologic, tolerability and safety effects were also analysed. RESULTS: The highest dose of mannan-conjugated birch pollen allergoids reduced the combined symptom and medication score during the peak birch pollen season by a median of 24.7% compared to placebo. The production of Bet v 1 specific IgG4 significantly increased in a dose-dependent manner (3.6- and 4.5-fold) in the 3000 and 10,000 mTU/mL groups. The Bet v 1 specific IgE/IgG4 ratio was also strongly reduced (up to -70%). No fatalities nor serious adverse events were reported, and no adrenaline was used. In total, four systemic reactions occurred (two grade I and two grade II). CONCLUSION: All doses of mannan-conjugated birch pollen allergoids can be considered as safe. Since the application of 10,000 mTU/mL resulted in the highest efficacy, this dose qualifies for further investigation.
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Conjuntivitis Alérgica , Conjuntivitis , Rinitis Alérgica Estacional , Adulto , Humanos , Alergoides , Rinitis Alérgica Estacional/diagnóstico , Rinitis Alérgica Estacional/terapia , Alérgenos , Polen , Betula , Mananos , Estudios Prospectivos , Desensibilización Inmunológica/métodos , Conjuntivitis/etiología , Resultado del Tratamiento , Método Doble Ciego , Inmunoglobulina GRESUMEN
Acute pharyngitis can cause sore throat. This multicentre, active-controlled, randomised, open-label, and parallel-group study, conducted according to the German Medical Devices Act, compared the effectiveness and tolerability of ERS09 mouth and throat spray with a well-established device for the treatment of sore throat caused by acute pharyngitis and dry cough. Patients were randomised 1:1 into ERS09/comparator groups (EMSER® Sore Throat Spray) for 7 ± 2 days. Patients and investigators reported effectiveness (change in total symptom score [TSS]) and safety endpoints (incidence of adverse events [AEs]; adverse device effects [ADEs]). A total of 186 patients were included (ERS09: n = 92; comparator: n = 94). The baseline-adjusted mean TSS over 7 days was -90.14 and -74.91 in the ERS09 and comparator groups, respectively (p < 0.05). The majority of patients reached a 50% reduction in symptoms by day 6 (ERS09 = 78.85; comparator = 75.8%). Most patients reported a soothing effect within five minutes (ERS09 = 82%; comparator = 71%). Improvements in individual symptoms were similar with no significant differences between groups; more patients in the ERS09 group reported an improvement in pharyngeal redness/swelling. Three AEs unrelated to medication, one ADE following ERS09, and no serious AE/ADE were reported. ERS09 was as well tolerated and effective as the established device, showing greater improvement in the management of some symptoms and greater patient preference.
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With the changing epidemiology of COVID-19 and its impact on our daily lives, there is still an unmet need of COVID-19 therapies treating early infections to prevent progression. The current study was a randomized, parallel, double-blind, placebo-controlled trial. Ninety SARS-CoV-2 positive patients were randomized into 3 groups receiving placebo, 0.02% or 0.1% azelastine nasal spray for 11 days, during which viral loads were assessed by quantitative PCR. Investigators assessed patients' status throughout the trial including safety follow-ups (days 16 and 60). Symptoms were documented in patient diaries. Initial viral loads were log10 6.85 ± 1.31 (mean ± SD) copies/mL (ORF 1a/b gene). After treatment, virus load was reduced in all groups (p < 0.0001) but was greater in the 0.1% group compared to placebo (p = 0.007). In a subset of patients (initial Ct < 25) viral load was strongly reduced on day 4 in the 0.1% group compared to placebo (p = 0.005). Negative PCR results appeared earlier and more frequently in the azelastine treated groups: being 18.52% and 21.43% in the 0.1% and 0.02% groups, respectively, compared to 0% for placebo on day 8. Comparable numbers of adverse events occurred in all treatment groups with no safety concerns. The shown effects of azelastine nasal spray may thus be suggestive of azelastine's potential as an antiviral treatment.Trial registration: The study was registered in the German Clinical Trial Register (DRKS-ID: DRKS00024520; Date of Registration in DRKS: 12/02/2021). EudraCT number: 2020-005544-34.
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COVID-19 , SARS-CoV-2 , Humanos , Rociadores Nasales , Carga Viral , Método Doble Ciego , Resultado del TratamientoRESUMEN
Ivy leaves extracts have been used successfully to treat acute cough, and data from well-controlled trials is accumulating. We present a meta-analysis of two double-blind, randomized, placebo-controlled trials. Patients with acute respiratory tract infection (ARTI) received ivy leaves dry extract EA 575 (n = 228) or placebo (n = 162) for 7 days, followed by a 7-day period without treatment. The main efficacy outcome was the Bronchitis Severity Score (BSS). Individual patient data meta-analyses were performed using mixed models for repeated measures, analysis of covariance and logistic ordinal regression. Significant BSS differences between EA 575 and placebo occurred already after 2 days and increased until treatment end, with BSS reductions of 8.6 ± 0.2 and 6.2 ± 0.2 (marginal means ± SEM; p < 0.001). The score reduction for placebo after 7 days was comparable to that for EA 575 after 4 days. In the EA 575 group, the proportion of cough-free patients was 18.1% at treatment end and 56.2% at end of follow-up, compared to 9.3% and 25.6% for placebo, respectively. Adverse event rates for EA 575 and placebo were comparable. EA 575 reduces effectively the intensity of acute cough associated with ARTIs and leads to a significant acceleration of recovery. No safety signals were observed.
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Bronquitis , Infecciones del Sistema Respiratorio , Humanos , Tos/tratamiento farmacológico , Tos/inducido químicamente , Bronquitis/tratamiento farmacológico , Bronquitis/inducido químicamente , Infecciones del Sistema Respiratorio/tratamiento farmacológico , Método Doble Ciego , Extractos Vegetales/uso terapéutico , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Background: The European Academy of Allergy and Clinical Immunology recommended the Combined Symptom and Medication Score (CSMS) as primary endpoint in clinical trials on allergen-specific immunotherapy (AIT) in allergic rhinoconjunctivitis. Here, the correlation between the CSMS and the validated standardised Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ(S)), Rhinitis Control Assessment Test (RCAT) and Visual Analogue Scale (VAS) was analysed. Methods: Two prospective, multicentre, non-interventional studies on tree pollen, grass pollen and house dust mite allergic patients were performed. The first study comprised 167 patients receiving AIT (AIT population), and the second included 56 patients treated with symptomatic medication only (control population). For up to two seasons (pollen)/exposure periods (house dust mites), participants documented their symptoms and medication intake in a CSMS diary, including VAS. In addition, the standardised RQLQ(S) and the RCAT were completed during study visits. Results: Comparison between CSMS and RQLQ(S) revealed a positive correlation in the AIT population (r = 0.426) and in the control population (r = 0.569). For CSMS and RCAT, a negative correlation with r = -0.409 (AIT) and r = -0.547 (control) was shown. Positive correlation between CSMS and VAS was also demonstrated with r = 0.585 (AIT) and r = 0.563 (control). Conclusion: These results support the assumption that the CSMS correlates with quality of life, symptom severity and symptom control on the one hand, while the moderate strength of correlations on the other hand mirrors distinctions of the CSMS compared to the assessments used here.
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BACKGROUND: The World Allergy Organization and the European Academy of Allergy and Clinical Immunology recommend to perform product-specific meta-analyses for allergen-specific immunotherapies because of the high degree of heterogeneity between individual products. This meta-analysis evaluates the efficacy and safety of Glutaraldehyde-modified and MCT® (MicroCrystalline Tyrosine)-adsorbed allergoids (MATA). METHODS: The databases MEDLINE, LILACS, embase, LIVIVO, Web of Science and Google (Scholar) were searched for publications on MATA up to June 2019. Primary endpoint was the combined symptom and medication score (CSMS). Secondary endpoints were single scores, immunogenicity and improvement of allergic condition. Secondary safety endpoints were the occurrence of side effects. A random effects model was applied with (standardized) mean differences ([S]MDs) including confidence intervals (CI). Heterogeneity was analyzed using the I2 index and publication bias using Egger's test and Funnel plots. Subgroups were analyzed regarding age and asthma status. RESULTS: Eight randomized double-blind placebo-controlled trials were selected for efficacy and 43 publications for safety analysis. In total, 4531 patients were included in this analysis including eight studies containing data on children and adolescents. AIT with MATA significantly reduced allergic symptoms and medication use with a SMD for CSMS of -0.8 (CI: -1.24, -0.36) in comparison to placebo. Heterogeneity was moderate between the studies. The total symptom score (-1.2 [CI: -2.11, -0.29]) and the total medication score (-2.2 [CI: -3.65, -0.74]) were also significantly reduced after MATA treatment. Patient's condition improved significantly after treatment with MATA, with an odds ratio of 3.05 (CI: 1.90, 4.90) when compared to placebo. The proportion of patients, who developed side effects was 38% (CI: 19%, 57%). No serious side effects occurred. Safety in the subgroups of asthmatic patients, children and adolescents did not differ from the overall patient population. CONCLUSIONS: This meta-analysis reveals a large body of evidence from publications investigating MATA. MATA significantly improved allergic symptoms and reduced the use of anti-allergic medication in comparison to placebo, with an excellent safety profile. Especially for children and asthmatic patients, the use of MATAs can be considered as safe, because the safety profiles in these groups did not differ from the total patient population.
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Chronic inflammation and proteinuria is a risk factor for cardiovascular disease (CVD) in patients with chronic kidney diseases and rheumatologic disorders. Our aim was to investigate the CVD events (CVDEs) and survival between the patients with FMF-related AA amyloidosis and glomerulonephropathies (GN) to define possible predictors for CVDEs. A prospective follow-up study with FMF-amyloidosis and glomerulonephropathy (GN) was performed and patients were followed for CVDEs. Flow-mediated dilatation (FMD), FGF-23, serum lipid, hsCRP levels, BMI and HOMA were assessed. A Cox regression analysis was performed to evaluate the risk factors for CVDEs. There were 107 patients in the FMF-amyloidosis group and 126 patients with GN group. Forty-seven CVDEs were observed during the 4.2-years follow up; all 28 patients in the FMF-amyloidosis group and 14/19 patients with GN developed CVDEs before the age of 40 (p = 0.002). CVD mortality was 2.8 times higher (95% CI 1.02-7.76) in patients with FMF-amyloidosis. Across both groups, FMD and FGF23 (p < 0.001) levels were independently associated with the risk of CVDEs. Patients with FMF-amyloidosis are at increased risk of early CVDEs with premature mortality age. FGF 23, FMD and hsCRP can stratify the risk of early CVD in patients with FMF-related AA amyloidosis.
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Amiloidosis/complicaciones , Enfermedades Cardiovasculares/complicaciones , Fiebre Mediterránea Familiar/complicaciones , Enfermedades Renales/complicaciones , Adulto , Femenino , Factor-23 de Crecimiento de Fibroblastos , Humanos , Masculino , Persona de Mediana Edad , Medición de Riesgo , Adulto JovenRESUMEN
BACKGROUND: Smoking, alcohol use, performing regular physical exercise, dietary habits, and anxiety level may cause platelet activation. We aimed to evaluate the anxiety levels, smoking status, alcohol intake, and sportive habits of donors, and determine their impact on the quality of apheresis-platelets. METHODS: State and Transient Anxiety Inventory (STAI) was used to determine the level of donors' anxiety. STAI has two subscales: S-anxiety scale (STAI-I) and T-anxiety scale (STAI-II), each comprising 20 questions rated on a 4-point Likert scale. Data on smoking, alcohol consumption, and performing regular physical exercise were obtained from a questionnaire filled out before donation. Flow cytometric analysis was used to quantify activated platelets. RESULTS: The STAI-I level of 86 participants was normal, while that of 12 was higher. No significant difference was found in the active platelet absolute count [1.8×1011 (2.7) and 1.4×1011 (1.3), respectively; P=0.665] between donors with normal STAI-I levels and those with higher STAI-I levels. Of 98 donors, 42 had normal STAI-II levels, while 56 had higher STAI-II levels. No significant difference was found in the active platelet absolute count [2.3×1011 (3.1) and 1.5×1011 (2.3), respectively; P=0.224] between donors with normal STAI-II levels and those with higher STAI-II levels. Platelet counts of individuals who perform regular physical exercise were significantly higher than those of individuals who did not perform regular physical exercise (6.3±1.4×1011 vs. 5.5±1.4×1011). CONCLUSION: The quality of apheresis platelets is not affected by anxiety levels and lifestyle characteristics of blood donors. There is no need to organize apheresis blood donor pool considering with these subjects.
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INTRODUCTION: The aim of this study was to investigate the validity and reliability of the Turkish version of the Questionnaire for the Assessment of DYsphagia in MUltiple Sclerosis (DYMUS) that has been developed for evaluating dysphagia in patients with multiple sclerosis. METHODS: This methodological study was conducted in the neurology clinic and outpatient department of a training hospital between March 15 and September 15, 2015. The study included 117 patients aged 18 years and over who had a definite diagnosis of multiple sclerosis, could communicate in Turkish, and volunteered to be included. Data were collected using a descriptive information form, the DYMUS, and the Eating Assessment Tool (EAT-10). The scale was translated and back translated to determine the language validity, and a specialist was consulted to make sure the content was valid. We used the EAT-10 and Kurtzke's Expanded Disability Status Scale (EDSS) concurrently to test the criterion-related validity. The test-retest procedure was used at 1-week intervals for 37 patients in this study. Descriptive statistics, factor analysis, Kappa analysis, reliability analysis, and correlation analysis were used to analyze the data. RESULTS: Factor analysis revealed that the scale was bifactorial, and this was consistent with its original form. There were positive and statistically significant relationships between the DYMUS and EAT-10 (r=0.90, p<0.001) and the mean EDSS scores (r=0.49, p<0.001). The internal consistency of the total scale was high (Cronbach's alpha coefficient= 0.91). The Cronbach's alpha coefficients pertaining to dysphagia for solids and liquids were determined to be 0.88 and 0.83, respectively. The total scale and subscales demonstrated a high test-retest reliability (r=0.79-0.95, p<0.001). CONCLUSION: In this study, the Turkish version of the DYMUS was found to be a valid and reliable tool for evaluating dysphagia in patients with multiple sclerosis.
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AIM: To evaluate the effectiveness and the use of Glasgow Coma Score (GCS) and Full Outline of Unresponsiveness (FOUR) score by nurses in the follow-up and evaluation of patients admitted to the neurosurgical intensive care unit for cranial surgery or head trauma. MATERIAL and METHODS: The study was performed at a neurosurgical intensive care unit. Sample size was determined as 47 patients (a= 0.05, power= 0.95). The correlation coefficient less than 0.5 was accepted as weak. In the first 24 hours, Karnofsky Performance Scale was applied and the Acute Physiology and Chronic Health Evaluation II (APACHE II) Score calculated for patients who were admitted to the intensive care unit for cranial surgery or head trauma. Also FOUR and GCS were applied by two different nurses twice a day. Intraclass Correlation Coefficient, Pearson Correlation and Cronbach?s Alpha Security Index analyses were used to evaluate the data. RESULTS: Concordance was above 0.810 and correlation was above 0.837 between GCS and FOUR score evaluation results of nurses. Correlation of two different evaluation at every shift for GCS was 0.887, and for FOUR was 0.827 and above. Karnofsky Performance Scale correlation with FOUR and GCS scores of patients at admission and discharge from the intensive care unit was 0.709 and above. The correlation between APACHE II and FOUR was 0.851; between APACHE II and GCS 0.853. There was no difference between the evaluations of two scores and two nurses statistically. CONCLUSION: Concordance between nurses was found high both for GCS and FOUR. The FOUR score is as effective as GCS on the follow-up of patients who are managed in the neurosurgical intensive care units.
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Coma/clasificación , Escala de Coma de Glasgow , Índices de Gravedad del Trauma , Adulto , Anciano , Neoplasias Encefálicas/clasificación , Neoplasias Encefálicas/complicaciones , Coma/enfermería , Traumatismos Craneocerebrales/clasificación , Traumatismos Craneocerebrales/complicaciones , Estudios Transversales , Femenino , Humanos , Unidades de Cuidados Intensivos , Masculino , Persona de Mediana Edad , Reproducibilidad de los ResultadosRESUMEN
Juvenile spondyloarthropathies (JSpA) are a group of rheumatologic diseases with a disease onset before 16; characterized with enthesitis, lower extremity oligoarthritis, involvement of the axial skeleton and HLA B27 positivity. The diversity of classification criteria along with the phenotype heterogeneity makes the classification of JSpA challenging. The aim of our study was to evaluate the performance of the pre-determined and recently proposed classification criteria for JSpA. The study group consisted of 113 patients with JSpA and 150 patients with juvenile idiopathic arthritis (JIA). Eligible criteria for JSpA were applied to all of the enrolled patients. The analysis of sensitivity, specificity and the kappa index were used to verify the performance of the JSpA criteria. The Amor criteria showed the highest sensitivity (98.2%) while the ASAS criteria for the axial SpA had highest specificity (100%). The sensitivity and specificity of the remaining criteria were: 93.8 and 63.8% for ESSG, 95.6 and 62.7% for Garmisch-Partenkirchen, 91.2 and 75.3% for ASAS criteria for peripheral SpA, respectively. Criteria proposed by our group showed the high sensitivity, specificity and kappa value: 90.3, 90.7, 0.843%, respectively. We suggest that criteria proposed by us could be used in the classification of JSpA. However, neither the pre-determined nor the new criteria are totally adequate and efficacious for the classification and diagnosis of this disease. The evaluation of the validity and reliability of proposed criteria in multicentric studies are mandatory, to increase its utility in routine clinical practice.
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Reumatología/normas , Índice de Severidad de la Enfermedad , Espondiloartropatías/clasificación , Espondiloartropatías/diagnóstico , Adolescente , Edad de Inicio , Artritis Juvenil/diagnóstico , Biomarcadores/sangre , Estudios de Casos y Controles , Niño , Diagnóstico Diferencial , Humanos , Reproducibilidad de los Resultados , Sensibilidad y Especificidad , Método Simple Ciego , Espondiloartropatías/sangre , Espondiloartropatías/fisiopatologíaRESUMEN
PURPOSE: The present prospective, randomised, placebo-controlled, clinical trial was designed to evaluate the clinical effects of a commercially available dentifrice containing fluoride, xylitol or xylitol-probiotic on the decrease of plaque and gingival inflammation in children between 13 and 15 years of age. MATERIALS AND METHODS: Forty-eight adolescents were randomly grouped into three groups of n = 16 each: study group A received xylitol (Xyliwhite) toothpaste; study group B received xylitol-probiotic (Periobiotic) toothpaste; and the control group C received fluoride (Colgate Max Fresh) toothpaste. The subjects were instructed to use the dentifrice determined and a modified Bass brushing technique twice a day for two minutes over a 6-week perioed. Clinical evaluation was performed using a gingival index and a plaque index at baseline and at the end of the 6-week period. RESULTS: From day 0 to 42, reductions in the plaque index were statistically significant in all groups, Colgate Max Fresh, PerioBiotic and Xyliwhite (p-values 0.001, 0.001 and 0.035, respectively), but reductions in the gingival index were statistically significant only in the Colgate Max Fresh and PerioBiotic groups (both with p = 0.001), not in the Xyliwhite group (p = 0.116). PerioBiotic toothpaste was found to be better than Xyliwhite and Colgate Max Fresh toothpastes at reducing plaque and gingival scores. However, statistically significant differences with PerioBiotic and Colgate Max Fresh toothpaste were not observed. CONCLUSION: It was concluded that PerioBiotic was an all-round dentifrice that produced a significant reduction in both gingivitis and plaque.
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Cariostáticos/uso terapéutico , Placa Dental/prevención & control , Dentífricos/uso terapéutico , Fluoruros/uso terapéutico , Gingivitis/prevención & control , Probióticos/uso terapéutico , Edulcorantes/uso terapéutico , Xilitol/uso terapéutico , Adolescente , Niño , Método Doble Ciego , Femenino , Humanos , Masculino , Estudios ProspectivosRESUMEN
BACKGROUND: The aim of this study was to determine the impacts of different administration modes on sensitivity and specificity of Edinburgh Claudication Questionnaire (ECQ) in estimation of Ankle Brachial Index (ABI) detecting lower extremity arterial disease (LEAD). METHODS: Eligible respondents aged fifty years or older underwent first a self-administered (SA-) ECQ, and then an interviewer-administered (IA-) ECQ. Interviewing included additional guidance on symptoms relevant to claudication. ABI was measured by hand-held Doppler. RESULTS: A total of 177 respondents (age: 64.67±9.19, male/female: 80/97) were enrolled. Questions 1, 2, 3, and 5 (collectively defines claudication) were responded significantly different on SA-ECQ and IA-ECQ modes. Markings of pain on the figure of ECQ also changed significantly when the procedure was guided. Of the respondents, none on SA-ECQ and 13.6% on IA-ECQ with positive claudication had a low ABI. Subjects with higher formal education level did similar to the whole group in both modes. Sensitivity and specificity of IA-ECQ was calculated as 25% and 88.5%, respectively, for ABI detected LEAD. CONCLUSIONS: Respondents' perceptions of pain, discomfort, exertion or body regions described on ECQ may subject to errors without guidance. ECQ seems reliable in evaluating claudication only when specifically interviewed by an observer.
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Claudicación Intermitente/diagnóstico , Extremidad Inferior/fisiopatología , Enfermedad Arterial Periférica/diagnóstico , Encuestas y Cuestionarios , Anciano , Anciano de 80 o más Años , Índice Tobillo Braquial , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Factores de Riesgo , Autoinforme , TurquíaRESUMEN
Fundamento: Até o momento, diversos escores de risco baseados em pacientes foram estabelecidos para a predição de mortalidade em pacientes com infarto do miocárdio com supradesnivelamento do segmento ST (IAMCSST). O escore de Gensini foi originalmente desenvolvido para quantificar a gravidade de doença arterial coronariana (DAC). Objetivos: Avaliar a associação entre a gravidade de DAC avaliada pelo escore de Gensini e mortalidade intra-hospitalar em pacientes com IAMCSST submetidos à intervenção coronária percutânea primária (ICP-P). Métodos: Foram incluídos 539 pacientes com IAMCSST, submetidos à ICP-P dentro das primeiras 12 horas do início dos sintomas. A gravidade da DAC foi expressa como a soma do escore de Gensini para cada lesão. Variáveis demográficas, anamnese e características clínicas dos pacientes, bem como eventos hospitalares significativos, foram obtidos de relatórios médicos. Resultados: Dos 539 pacientes, 416 (77,2%) eram do sexo masculino, e a idade média era 59,14 ± 12,68 anos. A taxa de mortalidade intra-hospitalar foi de 5,4% (29 pacientes, 16 homens). A taxa de mortalidade foi de 10,5% em pacientes do sexo feminino e 3,8% em pacientes do sexo masculino (P=0,004). Os escores de Gensini médios mostraram-se significativamente diferentes na comparação entre pacientes que sobreviveram (54,54 ± 26,34) e aqueles que foram a óbito (80,17 ± 26,51) (P = 0,001). O modelo de análise multivariada de regressão de Cox de risco proporcional revelou que o escore de Gensini (P = 0,037), o sexo feminino (P = 0,039), níveis séricos de ureia (P = 0,041), níveis de ácido úrico (P = 0,008) e FEVE (P = 0,001) estavam independentemente associados à mortalidade intra-hospitalar em pacientes com IAMCSST submetidos à ICP-P. Conclusões: O escore de Gensini está independentemente associado à mortalidade intra-hospitalar em pacientes com IAMCSST tratados com ICP-P. Portanto, o escore pode ter um papel importante na estratificação de risco de pacientes com IAMCSST
Background: To date, several validated patient-based risk scores have been established to predict mortality and morbidity in patients presenting with ST-segment elevation myocardial infarction (STEMI). The Gensini score was originally developed to quantify the severity of coronary artery disease (CAD). Objectives: We intend to assess the association between severity of CAD assessed by Gensini score and in-hospital mortality in patients with STEMI undergoing primary percutaneous coronary intervention (P-PCI). Methods: A total of 539 patients presenting with acute STEMI, who underwent P-PCI within the first 12 hours from the onset of symptoms, were included. The severity of CAD was expressed as the sum of the Gensini scores for each lesion. Patients' demographic variables, medical histories and clinical features, as well as in hospital major adverse events were obtained from the medical reports. Results: Of these 539 patients, 416 (77.2%) were male and mean age was 59.14 ± 12.68 years. In-hospital mortality rate was 5.4% (29 patients; 16 men). Mortality rate was 10.5% in female patients and 3.8% in males (P = 0.004). Mean Gensini scores were significantly different in the comparison between patients who survived (54.54 ± 26.34) and those who died (80.17 ± 26.51) (P = 0.001). The multivariable Cox proportional hazards regression analysis model revealed that the Gensini score (P = 0.037), female gender (P = 0.039), serum urea levels (P = 0.041), uric acid levels (P = 0.008) and LVEF (P = 0.001) were independently associated with in-hospital mortality in patients with STEMI undergoing P-PCI. Conclusion: The Gensini score is independently associated with in-hospital mortality in STEMI patients treated with P-PCI. Therefore, it might play an important role in risk stratification of STEMI patients
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Humanos , Masculino , Femenino , Persona de Mediana Edad , Interpretación Estadística de Datos , Mortalidad Hospitalaria , Infarto del Miocardio , Intervención Coronaria Percutánea/métodos , Angiografía Coronaria/métodos , Enfermedad de la Arteria Coronaria/complicaciones , Enfermedad de la Arteria Coronaria/diagnóstico , Análisis Multivariante , Estudios Retrospectivos , Factores de RiesgoRESUMEN
OBJECTIVE: In the last decade, substantial evidence has accumulated about the use of cryopreserved platelet concentrates, especially in trauma. However, little reference has been made in these studies to the morphological and functional changes of platelets. Recently platelets have been shown to be activated by cryopreservation processes and to undergo procoagulant membrane changes resulting in the generation of platelet-derived microparticles (PMPs), platelet degranulation, and release of platelet-derived growth factors (PDGFs). We assessed the viabilities and the PMP and PDGF levels of cryopreserved platelets, and their relation with thrombin generation. MATERIALS AND METHODS: Apheresis platelet concentrates (APCs) from 20 donors were stored for 1 day and cryopreserved with 6% dimethyl sulfoxide. Cryopreserved APCs were kept at -80 °C for 1 day. Thawed APCs (100 mL) were diluted with 20 mL of autologous plasma and specimens were analyzed for viabilities and PMPs by flow cytometry, for thrombin generation by calibrated automated thrombogram, and for PDGFs by enzyme-linked immunosorbent assay testing. RESULTS: The mean PMP and PDGF levels in freeze-thawed APCs were significantly higher (2763±399.4/µL vs. 319.9±80.5/µL, p<0.001 and 550.9±73.6 pg/mL vs. 96.5±49 pg/mL, p<0.001, respectively), but the viability rates were significantly lower (68.2±13.7% vs. 94±7.5%, p<.001) than those of fresh APCs. The mean endogenous thrombin potential (ETP) of freeze-thawed APCs was significantly higher than that of the fresh APCs (3406.1±430.4 nM.min vs. 2757.6±485.7 nM.min, p<0.001). Moreover, there was a significant positive poor correlation between ETP levels and PMP levels (r=0.192, p=0.014). CONCLUSION: Our results showed that, after cryopreservation, while levels of PMPs were increasing, significantly higher and earlier thrombin formation was occurring in the samples analyzed despite the significant decrease in viability. Considering the damage caused by the freezing process and the scarcity of evidence for their in vivo superiority, frozen platelets should be considered for use in austere environments, reserving fresh platelets for prophylactic use in blood banks.
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Plaquetas/citología , Micropartículas Derivadas de Células/metabolismo , Criopreservación , Eliminación de Componentes Sanguíneos , Donantes de Sangre , Plaquetas/metabolismo , Supervivencia Celular , Dimetilsulfóxido/química , Ensayo de Inmunoadsorción Enzimática , Citometría de Flujo , Congelación , Humanos , Factor de Crecimiento Derivado de Plaquetas/análisis , Tiempo de TrombinaRESUMEN
AIM: The aim of this study is to analyze possible autonomic nerve system alterations and assess the efficacy of heart rate variability (HRV) analysis in anticipation of cardiovascular risks in pediatric patients with familial Mediterranean fever (FMF). METHOD: In this study, cardiac autonomic functions were investigated in children with FMF by analyzing HRV and its other probable cardiac effects by echocardiography. We studied 70 pediatric patients with FMF and 50 healthy controls. RESULTS: The time-domain parameters of HRV were compared between the FMF and control groups. SDNN (standard deviation of all NN intervals) was significantly decreased in patients with FMF as compared to control subjects. The other time-domain parameters of HRV and the frequency-domain parameters of HRV were similar in both groups. Frequency-dependent HRV parameters were similar in both groups, as were conventional echocardiographic parameters. CONCLUSION: HRV is a convenient and reliable technique for evaluation of autonomic functions. There are only a few studies on the assessment of autonomic functions by means of HRV in adult FMF patients but not in pediatric patients. Further studies are required to assess whether there is autonomic dysfunction in children with FMF.
Asunto(s)
Sistema Nervioso Autónomo/fisiopatología , Fiebre Mediterránea Familiar/fisiopatología , Frecuencia Cardíaca , Corazón/inervación , Adolescente , Enfermedades Cardiovasculares/etiología , Enfermedades Cardiovasculares/fisiopatología , Estudios de Casos y Controles , Niño , Ecocardiografía , Electrocardiografía Ambulatoria , Fiebre Mediterránea Familiar/complicaciones , Fiebre Mediterránea Familiar/diagnóstico , Femenino , Humanos , Masculino , Valor Predictivo de las Pruebas , Factores de Riesgo , Factores de TiempoRESUMEN
Violence in the workplace is an increasing occupational health concern worldwide. Health care workers are at high risk of assault. To develop, monitor, and manage prevention policies, baseline data should be available. This cross-sectional study was designed to determine the current extent of workplace violence nationwide in Turkey. The study population of 12.944 health care workers was a stratified sample of all health care workers (612,639) in the country. A probabilistic sampling was made on the basis of the "multistage stratified random cluster sampling method." This study was conducted by a structured questionnaire in a face-to-face interview. The questionnaire items were adapted and translated into Turkish based on questionnaires of International Labor Organization, International Council of Nurses, World Health Organization, and Public Services International. The percentage of health care workers who experienced workplace violence in Turkey in the previous 12 months was 44.7%. The types of violence included physical 6.8%, verbal 43.2%, mobbing (bullying) 2.4%, and sexual harassment 1%. Multivariate analysis showed that level of health care system, type of institution, gender, occupation, age, working hours, and shift work were independent risk factors for experiencing workplace violence ( p < .05). Our study indicates that the workplace violence among health care workers is a significant problem. The results of the study can serve as the basis for future analytical studies and for development of appropriate prevention efforts.