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BACKGROUND AND OBJECTIVES: The efficacy and safety of video-assisted thoracoscopic surgery (VATS) versus open thoracotomy in the treatment of non-small cell lung cancer (NSCLC) were evaluated with a focus on mediastinal lymph node dissection, postoperative recovery, and longterm outcomes including survival rates and disease-free intervals. Materials and Methods: This retrospective study analyzed data from 228 NSCLC patients treated at the Institute of Oncology Bucharest from 2016 to 2022. Both VATS and open surgical approaches were compared, with variables including demographic data, comorbidities, surgical outcomes, and postoperative complications meticulously recorded. Statistical significance was assessed using chi-square and independent samples t-tests. Results: Among the findings, VATS demonstrated significantly better two-year progression-free survival rates for patients in early stages (Stages 1-3) of NSCLC compared to open surgery, with p-values 0.01 and 0.001, respectively. In contrast, no significant difference was observed in Stage 4. Furthermore, VATS resulted in shorter operative times (mean 299 vs. 347 minutes, p 0.001), less estimated blood loss (98.68 mL vs. 160.88 mL, p 0.001), reduced chest tube duration (5.78 days vs. 12.17 days, p 0.001), and decreased hospital stays (12.0 days vs. 27.7 days, p 0.001). Conclusions: VATS is associated with improved long-term disease-free survival for early-stage NSCLC and more favorable short-term surgical outcomes, highlighting its advantages over open thoracotomy. Despite its benefits, VATS did not significantly reduce postoperative complications compared to open surgery.
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Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Escisión del Ganglio Linfático , Estadificación de Neoplasias , Tempo Operativo , Neumonectomía , Cirugía Torácica Asistida por Video , Toracotomía , Humanos , Carcinoma de Pulmón de Células no Pequeñas/cirugía , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Carcinoma de Pulmón de Células no Pequeñas/patología , Cirugía Torácica Asistida por Video/métodos , Estudios Retrospectivos , Masculino , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Femenino , Persona de Mediana Edad , Toracotomía/métodos , Anciano , Resultado del Tratamiento , Neumonectomía/métodos , Neumonectomía/mortalidad , Escisión del Ganglio Linfático/métodos , Tasa de Supervivencia , Adulto , Rumanía/epidemiología , Supervivencia sin Enfermedad , Tiempo de Internación/estadística & datos numéricosRESUMEN
BACKGROUND AND OBJECTIVES: The efficacy and safety of video-assisted thoracoscopic surgery (VATS) versus open thoracotomy in the treatment of non-small cell lung cancer (NSCLC) were evaluated with a focus on mediastinal lymph node dissection, postoperative recovery, and longterm outcomes including survival rates and disease-free intervals. Materials and Methods: This retrospective study analyzed data from 228 NSCLC patients treated at the Institute of Oncology Bucharest from 2016 to 2022. Both VATS and open surgical approaches were compared, with variables including demographic data, comorbidities, surgical outcomes, and postoperative complications meticulously recorded. Statistical significance was assessed using chi-square and independent samples t-tests. Results: Among the findings, VATS demonstrated significantly better two-year progression-free survival rates for patients in early stages (Stages 1-3) of NSCLC compared to open surgery, with p-values 0.01 and 0.001, respectively. In contrast, no significant difference was observed in Stage 4. Furthermore, VATS resulted in shorter operative times (mean 299 vs. 347 minutes, p 0.001), less estimated blood loss (98.68 mL vs. 160.88 mL, p 0.001), reduced chest tube duration (5.78 days vs. 12.17 days, p 0.001), and decreased hospital stays (12.0 days vs. 27.7 days, p 0.001). Conclusions: VATS is associated with improved long-term disease-free survival for early-stage NSCLC and more favorable short-term surgical outcomes, highlighting its advantages over open thoracotomy. Despite its benefits, VATS did not significantly reduce postoperative complications compared to open surgery.
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Carcinoma de Pulmón de Células no Pequeñas , Neoplasias Pulmonares , Escisión del Ganglio Linfático , Estadificación de Neoplasias , Tempo Operativo , Neumonectomía , Cirugía Torácica Asistida por Video , Toracotomía , Humanos , Carcinoma de Pulmón de Células no Pequeñas/cirugía , Carcinoma de Pulmón de Células no Pequeñas/mortalidad , Carcinoma de Pulmón de Células no Pequeñas/patología , Cirugía Torácica Asistida por Video/métodos , Estudios Retrospectivos , Masculino , Neoplasias Pulmonares/cirugía , Neoplasias Pulmonares/mortalidad , Neoplasias Pulmonares/patología , Femenino , Persona de Mediana Edad , Toracotomía/métodos , Anciano , Resultado del Tratamiento , Neumonectomía/métodos , Neumonectomía/mortalidad , Escisión del Ganglio Linfático/métodos , Tasa de Supervivencia , Adulto , Rumanía/epidemiología , Supervivencia sin Enfermedad , Tiempo de Internación/estadística & datos numéricosRESUMEN
The anatomical variations in the lower limb veins play a critical role in venous reflux surgeries. This study presents an analysis of the great saphenous vein (GSV) proximal part's anatomical peculiarities, with 257 patients included, who were operated for venous reflux. This study highlighted a progressive increase in the GSV diameter in conjunction with the complexity of the anatomical variations, ranging from no tributaries to more than five tributaries, an anterior accessory GSV, or venous aneurysms. Statistical analysis evidenced this expansion to be significantly correlated with the variations. Additionally, the progression of the chronic venous disease (CVD) stages was notably more prevalent in the complex anatomical variations, suggesting a nuanced interplay between the GSV anatomy and CVD severity. Conclusively, our research articulates the paramount importance of recognizing GSV anatomical variations in optimizing surgical outcomes for CVD patients. These insights not only pave the way for enhanced diagnostic accuracy but also support the strategic framework within which surgical and interventional treatments are devised, advocating for personalized approaches to venous reflux surgery.
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Background: This study evaluates the predictive value of preoperative inflammatory markers (NLR, PLR, APRI, SII) and liver function tests in determining the risk of fistula development postcolorectal cancer surgery. The objective was to determine the association between elevated marker levels and fistula risk and establish thresholds for preoperative risk stratification. Methods: A retrospective cohort study was conducted at the "Pius Brinzeu" Clinical Emergency Hospital from 2018 to 2023, analyzing data from 219 patients undergoing colorectal cancer surgery. Results: Among the markers studied, the Systemic Inflammation Index (SII) with a cutoff 460.5 showed the highest sensitivity (75.6%) and specificity (71.3%), resulting in an AUC of 0.774 (p=0.001). Albumin levels 2.9 g/dL also significantly predicted fistula occurrence with 77.3% sensitivity and 73.8% specificity (AUC 0.788, p 0.001). Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR) presented cutoffs of 3.95 and 191.6 respectively, demonstrating substantial predictive value with AUCs of 0.732 and 0.746 (p 0.001 and p=0.001, respectively). Conclusions: Elevated levels of specific preoperative inflammatory markers and liver function tests are significantly associated with the risk of developing fistulas in patients undergoing colorectal cancer surgery. These findings support the integration of these biomarkers into preoperative evaluations to enhance patient risk stratification and optimize surgical outcomes, providing a valuable tool for clinical decision-making in colorectal surgery settings.
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Neoplasias Colorrectales , Pruebas de Función Hepática , Neutrófilos , Valor Predictivo de las Pruebas , Humanos , Neoplasias Colorrectales/cirugía , Neoplasias Colorrectales/sangre , Masculino , Estudios Retrospectivos , Femenino , Persona de Mediana Edad , Pronóstico , Anciano , Recuento de Linfocitos , Recuento de Plaquetas , Medición de Riesgo/métodos , Factores de Riesgo , Biomarcadores/sangre , Sensibilidad y Especificidad , LinfocitosRESUMEN
BACKGROUND: Premature newborns are at a significant risk for Systemic Inflammatory Response Syndrome SIRS, a condition associated with high morbidity and mortality. This study aimed to evaluate the predictive and diagnostic capability of laboratory markers like Neutrophil to Lymphocyte Ratio (NLR), derived Neutrophil to Lymphocyte Ratio (dNLR), Platelet-to-Lymphocyte Ratio (PLR), and Neutrophil-to-Lymphocyte-to-Platelet Ratio (NLPR) in diagnosing SIRS in premature newborns. METHODS: Premature newborns with and without SIRS were evaluated in a prospective design during a one-year period. Among 136 newborns, early and 72 h post-birth analyses were performed. RESULTS: At 24 h, NLR's cutoff value was 8.69, yielding sensitivity and specificity rates of 52.77% and 83.47% (p = 0.0429), respectively. The dNLR showed a cutoff of 5.61, with corresponding rates of 63.27% and 84.15% (p = 0.0011), PLR had a cutoff of 408.75, with rates of 51.89% and 80.22% (p = 0.1026), and NLPR displayed a cutoff of 0.24, with rates of 75.85% and 86.70% (p = 0.0002). At 72 h, notable sensitivity and specificity improvements were observed, particularly with NLPR having a cutoff of 0.17, showing sensitivity of 77.74% and specificity of 95.18% (p < 0.0001). NLR above the cutoff indicated a 33% increase in SIRS risk, with a hazard ratio (HR)of 1.33. The dNLR was associated with a twofold increase in risk (HR 2.04). NLPR demonstrated a significant, over threefold increase in SIRS risk (HR 3.56), underscoring its strong predictive and diagnostic value for SIRS development. CONCLUSION: Integrating these findings into clinical practice could enhance neonatal care by facilitating the early identification and management of SIRS, potentially improving outcomes for this vulnerable population.
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The aim of this study is to investigate the impact of the COVID-19 pandemic on the surgical treatment of lung cancer patients. Data from patients who underwent surgery during the pandemic were analyzed and compared to pre-pandemic and post-pandemic periods. Multiple parameters were examined, and their changes yielded significant results compared to other periods of the study. The statistical analysis revealed a significant decrease in the number of surgical interventions during the pandemic (p < 0.001), followed by a significant rebound thereafter. During this period, there was a significant increase in the T stage of cancer compared to both pre-pandemic and post-pandemic periods (p = 0.027). Additionally, the mean Charlson comorbidity index score was significantly higher during the pandemic compared to the pre-pandemic period (p = 0.042). In this crisis period, a significant decrease was recorded in both the total hospitalization duration (p = 0.015) and the pre-operative hospitalization duration (p = 0.006). These findings provide evidence of significant changes in clinical and therapeutic strategies applied to lung cancer surgery patients during the study period. The pandemic has had a substantial and complex impact, the full extent of which remains to be fully understood.
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COVID-19 , Neoplasias Pulmonares , Pandemias , Humanos , COVID-19/epidemiología , COVID-19/prevención & control , Neoplasias Pulmonares/cirugía , Masculino , Femenino , Persona de Mediana Edad , Anciano , SARS-CoV-2 , Tiempo de Internación/estadística & datos numéricos , Estudios Retrospectivos , Comorbilidad , Hospitalización/estadística & datos numéricosRESUMEN
Inflammation-related parameters serve as pivotal indicators in the prognosis and management of lung cancer. This retrospective investigation aimed to explore the relationship between inflammatory markers and diverse clinical variables in non-small-cell lung cancer patients. A cohort of 187 individuals undergoing elective lobectomy for lung cancer was retrospectively analyzed, spanning an 11-year data collection period. Six inflammation ratios derived from complete peripheral blood counts were assessed. Significantly elevated levels of neutrophil-to-lymphocyte ratio (NLR) (p = 0.005), platelet-to-lymphocyte ratio (PLR) (p = 0.001), Aggregate Index of Systemic Inflammation (AISI) (p = 0.015), Systemic Inflammation Response Index (SIRI) (p = 0.004), and Systemic Immune Inflammation Index (SII) (p = 0.004) were observed in patients with advanced T stages. Significantly, elevated values (p < 0.05) of these parameters were observed in the study's smoker patients compared to non-smokers. A statistically significant correlation was identified between the NLR parameter and tumor size (p = 0.07, r = 0.204), alongside a significant elevation in SIRI (p = 0.041) among patients experiencing postoperative complications. Inflammatory biomarkers emerge as invaluable prognostic indicators for patients with non-small-cell lung cancer, offering potential utility in forecasting their prognosis.
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BACKGROUND AND OBJECTIVES: To minimize stroke-related deaths and maximize the likelihood of cerebral reperfusion, medical professionals developed the "code stroke" emergency protocol, which allows for the prompt evaluation of patients with acute ischemic stroke symptoms in pre-hospital care and the emergency department (ED). This research will outline our experience in implementing the stroke code protocol for acute ischemic stroke patients and its impact on door-to-needle time (DTN) in the ED. METHODS: Our study included patients with a "code stroke alert" upon arrival at the emergency department. The final sample of this study consisted of 258 patients eligible for intravenous (IV) thrombolysis with an onset-to-door time < 4.5 h. ED admissions were categorized into two distinct groups: "day shift" (from 8 a.m. to 8 p.m.) (n = 178) and "night shift" (from 8 p.m. to 8 a.m.) (n = 80) groups. RESULTS: An analysis of ED time targets showed an increased median during the day shift for onset-to-ED door time of 310 min (IQR, 190-340 min), for door-to-physician (emergency medicine doctor) time of 5 min (IQR, 3-9 min), for door-to-physician (emergency medicine doctor) time of 5 min (IQR, 3-9 min), and for door-to-physician (neurologist) time of 7 min (IQR, 5-10 min), also during the day shift. During the night shift, an increased median was found for door-to-CT time of 21 min (IQR, 16.75-23 min), for door-to-CT results of 40 min (IQR, 38-43 min), and for door-to-needle time of 57.5 min (IQR, 46.25-60 min). Astonishingly, only 17.83% (n = 46) of these patients received intravenous thrombolysis, and the proportion of patients with thrombolysis was significantly higher during the night shift (p = 0.044). A logistic regression analysis considering the door-to-needle time (minutes) as the dependent variable demonstrated that onset-to-ED time (p < 0.001) and door-to-physician (emergency medicine physicians) time (p = 0.021) are predictors for performing thrombolysis in our study. CONCLUSIONS: This study identified higher door-to-CT and door-to-emergency medicine physician times associated with an increased DTN, highlighting further opportunities to improve acute stroke care in the emergency department. Further, door-to-CT and door-to-CT results showed statistically significant increases during the night shift.
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This study investigates the differential expression of miRNA gene subtypes in tumoral versus benign nevi in individuals with melanoma, aiming to identify clinically significant correlations that could serve as reliable markers for assessing tumor stage and progression. Conducted between 2019 and 2022, this descriptive, quantitative observational research analyzed 90 formalin-fixed paraffin-embedded (FFPE) samples from the Pius Brinzeu County Emergency Clinical Hospital, Timisoara, including 45 samples of advanced-stage melanoma and 45 samples of pigmented nevi. miRNA purification and analysis were performed using the miRNeasy Kit and the Human Cancer PathwayFinder miScript miRNA PCR Array, with statistical analysis (including logistic regression) to determine associations with cancer staging, such as high Breslow index risk, number of mitoses, and vascular invasion. After the analysis and comparison of 180 miRNA gene subtypes, we selected 10 of the most upregulated and 10 most downregulated genes. The results revealed that hsa-miR-133b, hsa-miR-335-5p, hsa-miR-200a-3p, and hsa-miR-885-5p were significantly upregulated in melanoma samples, with fold changes ranging from 1.09 to 1.12. Conversely, hsa-miR-451a and hsa-miR-29b-3p showed notable downregulation in melanoma, with fold changes of 0.90 and 0.92, respectively. Additionally, logistic regression analysis identified hsa-miR-29b-3p (OR = 2.51) and hsa-miR-200a-3p (OR = 2.10) as significantly associated with an increased risk of a high Breslow index, while hsa-miR-127-3p and hsa-miR-451a were associated with a reduced risk. Conclusively, this study underscores the significant alterations in miRNA expression in melanoma compared to benign nevi and highlights the potential of specific miRNAs as biomarkers for melanoma progression. The identification of miRNAs with significant associations to melanoma characteristics suggests their utility in developing non-invasive, cost-effective diagnostic tools and in guiding therapeutic decisions, potentially improving patient outcomes in melanoma management.
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Biomarcadores de Tumor , Progresión de la Enfermedad , Melanoma , MicroARNs , Humanos , Melanoma/genética , Melanoma/patología , MicroARNs/genética , Masculino , Femenino , Persona de Mediana Edad , Biomarcadores de Tumor/genética , Neoplasias Cutáneas/genética , Neoplasias Cutáneas/patología , Anciano , Adulto , Regulación Neoplásica de la Expresión Génica , Nevo Pigmentado/genética , Nevo Pigmentado/patologíaRESUMEN
This systematic review investigates the intersection of early-onset colorectal cancer (EOCRC), sexual functioning, and associated quality of life (QoL), aiming to understand the comprehensive impact of EOCRC on these critical dimensions. Through an extensive search across PubMed, Scopus, and Embase up until November 2023, this study synthesized evidence from the literature while adhering to PRISMA guidelines. The studies included EOCRC patients under 50 years, which examined sexual functioning and QoL using validated instruments, and were published in English. After a rigorous screening process, five relevant studies were identified from an initial pool of 2184 articles. This review includes data from five studies involving 2031 EOCRC patients. The key findings revealed a high prevalence of sexual dysfunction, with up to 50% of men experiencing impotence and 58% reporting sexual dysfunction, alongside 36% of women in some studies. Pain was described by 12% to 31% of patients. Anxiety and depression were notably prevalent, affecting up to 69% of participants. EOCRC profoundly impacts sexual functioning and QoL, with a significant prevalence of sexual dysfunction and psychological distress among affected individuals. These findings suggest the need for oncological management strategies that include not only medical treatment but also psychological support and sexual health interventions. This systematic review emphasizes the importance of holistic patient care approaches, advocating for further research and clinical attention to address the complex needs of younger EOCRC patients.
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This systematic review critically evaluates the impact of systemic treatments on outcomes and quality of life (QoL) in patients with RAS-positive stage IV colorectal cancer, with studies published up to December 2023 across PubMed, Scopus, and Web of Science. From an initial pool of 1345 articles, 11 relevant studies were selected for inclusion, encompassing a diverse range of systemic treatments, including panitumumab combined with FOLFOX4 and FOLFIRI, irinotecan paired with panitumumab, regorafenib followed by cetuximab ± irinotecan and vice versa, and panitumumab as a maintenance therapy post-induction. Patient demographics predominantly included middle-aged to elderly individuals, with a slight male predominance. Racial composition, where reported, showed a majority of Caucasian participants, highlighting the need for broader demographic inclusivity in future research. Key findings revealed that the addition of panitumumab to chemotherapy (FOLFOX4 or FOLFIRI) did not significantly compromise QoL while notably improving disease-free survival, with baseline EQ-5D HSI mean scores ranging from 0.76 to 0.78 and VAS mean scores from 70.1 to 74.1. Improvements in FACT-C scores and EQ-5D Index scores particularly favored panitumumab plus best supportive care in KRAS wild-type mCRC, with early dropout rates of 38-42% for panitumumab + BSC. Notably, cetuximab + FOLFIRI was associated with a median survival of 25.7 months versus 16.4 months for FOLFIRI alone, emphasizing the potential benefits of integrating targeted therapies with chemotherapy. In conclusion, the review underscores the significant impact of systemic treatments, particularly targeted therapies and their combinations with chemotherapy, on survival outcomes and QoL in patients with RAS-positive stage IV colorectal cancer, and the need for personalized treatment.
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Cystic echinococcosis (CE) is a neglected parasitic disease caused by the tapeworm Echinococcus granulosus. The aim of this study was to assess the epidemiological features of human cystic echinococcosis in patients from Western Romania. We retrospectively investigated the medical records of patients hospitalized with CE between 1 January 2007 and 1 September 2022. A total of 366 patients (range 18-90 years) were recorded. The number of hospitalized individuals was higher in patients aged 50-59 years (83/366, 22.7%), in females (194/366, 53%), and in residents of rural areas (225/366, 61.5%). The liver was the most common localization of the cysts (302/366, 82.5%). Ninety-eight patients (26.8%) presented complications, including biliary fistula, allergies, and infection of the cyst. Patients with complications had a longer mean hospital stay (15.7 ± 8.3 days) compared to patients without complications (11.5 ± 7.3 days) (p < 0.001). The results of this study revealed that patients diagnosed with CE required hospitalization and extended medical care, indicating that this zoonotic disease remains a significant public health problem in Western Romania. Public health authorities should enhance CE surveillance by implementing control programs and mandatory notification of new cases.
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Background and Objectives: Metformin is currently the leading drug of choice for treating type 2 diabetes mellitus, being one of the most widely used drugs worldwide. The beneficial effects of Metformin, however, extend far beyond the reduction of blood glucose. Therefore, this study aimed to evaluate Metformin's effects both in vitro and in ovo. Materials and Methods: Metformin has been tested in five different concentrations in human hepatocytes -HepaRG, in terms of cell viability, morphology, structure and number of nuclei and mitochondria, as well as the effect on cell migration. Through the application of HET-CAM, the biocompatibility and potential anti-irritant, as well as protective effects on the vascular plexus were also assessed. Results: According to the results obtained, Metformin increases cell viability without causing morphological changes to cells, mitochondria, or nuclei. Metformin displayed an anti-irritant activity rather than causing irritation at the level of the vascular plexus. Conclusions: In conclusion, Metformin enhances cell viability and proliferation and, has a protective effect on the vascular plexus. Nonetheless, more studies are required to clarify the mechanism of hepatoprotective effect of metformin.
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Diabetes Mellitus Tipo 2 , Metformina , Glucemia/metabolismo , Diabetes Mellitus Tipo 2/tratamiento farmacológico , Hepatocitos/metabolismo , Humanos , Hipoglucemiantes/farmacología , Hipoglucemiantes/uso terapéutico , Metformina/metabolismo , Metformina/farmacología , Metformina/uso terapéutico , MitocondriasRESUMEN
Chondrosarcoma (CHS) is a malignant tumor of soft tissue with cartilaginous differentiation that represent one tenth of all malignant proliferations developed from bone tissues. Even if CHS represents the third malignancy with bone localization, after myeloma and osteosarcoma, it is far less diagnosed in the head and neck region. The current paper presented two cases of conventional CHSs, which were diagnosed in Department of Thoracic Surgery and Department of Otorhinolaryngology of Emergency City Hospital, Timisoara, Romania, between February and June 2021. The malignant cases were of peripheral CHSs, one of scapula, and the other one had an extremely rare tracheal location with microscopic features of conventional low-grade tumors (grade 1). In all cases, conservative surgical curative treatment was performed, with a favorable postoperative evolution.
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Neoplasias Óseas , Condrosarcoma , Osteosarcoma , Condrosarcoma/diagnóstico por imagen , Condrosarcoma/cirugía , Humanos , RumaníaRESUMEN
OBJECTIVE: The purpose of this study was to determine whether or not patients with pectus excavatum (PE) exhibit costal cartilage overgrowth compared to normal subjects. MATERIALS AND METHODS: The computed tomography acquisitions of 32 patients with PE and 35 normal controls were analyzed. On axial images the length of the 4th-7th costal cartilages was measured to calculate the Haller index. The ratio between the length of the cartilages and the median of the transverse and longitudinal thorax diameters were recorded to account for anatomical variability. The length of the cartilages was compared between the PE and control subjects using the independent-samples t test. For patients with asymmetric PE the length of the 4th-7th costal cartilages was compared between the rotated and nonrotated sides. RESULTS: The mean transverse and coronal thorax diameters were 233.29 ± 24.47 and 231.69 ± 22.47 mm for PE patients and 252.67 ± 37.25 and 238.64 ± 27.40 mm for controls, respectively, with no significant differences between the two groups (p = 0.816 and 0.145). The mean sagittal diameter (59.30 ± 14.21 mm) and Haller index (4.02 ± 1.34) in the PE group were significantly different from the controls (107.34 ± 19.59 and 2.2 ± 0.54 mm, respectively; p = 0.00). Actual and relative lengths of costal cartilages were similar in both PE subjects and controls for all 4 costal cartilages measured. In subjects with asymmetric PE, both relative and absolute costal cartilage lengths were similar on the rotated and nonrotated side. CONCLUSIONS: The length of the 4th, 5th, 6th and 7th costal cartilages was similar in PE patients and the control subjects. These was also similar between the rotated and nonrotated sides of the sternum in patients with asymmetric PE.
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Cartílago Costal/fisiología , Tórax en Embudo/fisiopatología , Adolescente , Adulto , Estudios de Casos y Controles , Niño , Femenino , Tórax en Embudo/diagnóstico por imagen , Humanos , Masculino , Tomógrafos Computarizados por Rayos X , Adulto JovenRESUMEN
Objetivo: Investigar el efecto preventivo a largo plazo del inmunoterápico OM-89 en comparación con placebo en la infección del tracto urinario (ITU) recurrente en una gran cohorte de mujeres. Métodos: Fueron seleccionadas en este estudio doble ciego multicéntrico, mujeres adultas 3 con cuadro clínico de ITU aguda y análisis de orina (mayo que 10 bacterias/mL). Las pacientes recibieron el inmunoterápico OM-89 ó 1 cápsula al día durante 90 días, 3 meses sin tratamiento, luego los primeros 10 días de los meses 7, 8 y 9, realizándose seguimiento durante 12 meses. Los criterios de eficacia primarios fueron los índices de ITU durante los 12 meses, la distribución de las ITU y la proporción de pacientes con ITU. Resultados: Se trató a un total de 453 pacientes, 231 en el grupo activo y 222 en el grupo placebo. La tasa promedio de ITU luego del inicio del tratamiento fue significativamente menor en el grupo activo que en el grupo placebo (0,84 versus 1,28; p menor que 0,003), correspondiente a una reducción de 34 por ciento en las ITU en las pacientes tratadas con OM-89. En el grupo activo, 93 pacientes (40,3 por ciento) tuvieron 185 ITU luego del inicio del estudio, en comparación con 276 ITU en 122 pacientes (55,0 por ciento) en el grupo placebo (p = 0,001). El perfil de seguridad de OM-89 fue bueno. Conclusiones: OM-89 redujo significativamente la incidencia de ITU durante los 12 meses del periodo del estudio incluyendo 3 meses de tratamiento y tres cursos de refuerzo de 10 días. Estos resultados confirman que OM-89 es un componente valioso en el tratamiento de la ITU recurrente.
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Humanos , Femenino , Escherichia coli , Estudios Multicéntricos como Asunto , Infecciones Urinarias , Inmunoterapia , Método Doble CiegoRESUMEN
Pleuropulmonary tuberculosis (TB) is a relatively frequent condition (the incidence of (TB) was 176/100,000 in our county in 2004) and some of these patients with TB are undergoing surgical interventions. The authors share their experience in surgical treatment of pleuropulmonary tuberculosis, based on minimal invasive techniques such as VATS and filling the residual cavities with muscle or skin-muscle grafts. The authors are retrospectively revising 144 patients between 1 January 2001 and 31 December 2007 who underwent surgical treatment for tuberculosis in this period. Two hundred and thirteen surgical procedures were performed for pleuropulmonary tuberculosis, representing 4% of all the procedures done in the department. For most of the patients the etiological diagnosis was not established until the operations, all the patients were sputum-negative. The diagnoses at the admittance were: pulmonary nodules or tumors (42 patients), pleural collections (46), pleural thickening and post-tuberculosis syndromes (46), fibrocavitary tuberculosis (6), and tuberculous pericarditis (4). Of all the procedures applied, 14 were pulmonary resections, 50 atypical (wedge) resections, 70 video-assisted thoracic surgery (VATS) procedures, and nine patients needed muscle or skin-musle flap for residual pleural cavities. Eleven patients (7.6%) had to undergo secondary surgery due to complications. No in-hospital mortality was registered. The mean hospitalisation period was 10.1+/-4.2 (S.D.) days.
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Procedimientos Quirúrgicos Pulmonares , Tuberculosis Pleural/cirugía , Tuberculosis Pulmonar/cirugía , Adolescente , Adulto , Anciano , Femenino , Humanos , Tiempo de Internación , Masculino , Persona de Mediana Edad , Músculos/trasplante , Procedimientos Quirúrgicos Pulmonares/efectos adversos , Procedimientos Quirúrgicos Pulmonares/métodos , Reoperación , Estudios Retrospectivos , Trasplante de Piel , Colgajos Quirúrgicos , Cirugía Torácica Asistida por Video , Toracotomía , Factores de Tiempo , Resultado del Tratamiento , Tuberculosis Pleural/patología , Tuberculosis Pulmonar/patología , Adulto JovenRESUMEN
The Escherichia Coli bacterial extract (OM-89) is used in the treatment of rheumatoid arthritis (RA). We evaluated the immunological changes induced by oral administration of OM-89 in 12 RA patients (polyclonal T cell reactivity to PHA, T cell precursor frequencies specific for OM-89 and Tetanus toxoid (TT), a control antigen and the release of Th1 (IFN-gamma, TNF-alpha), Th2 (IL-4) and T regulatory 1 cell (Tr1) (IL-10) cytokines in the supernatants of PBMC cultures. Stimulation index in response to PHA decreased at month 3 as well as T cell precursor frequencies specific for TT with similar trends for OM-89-specific T cell precursor frequencies. OM-89 induced a strong production of IL-10, a significant decrease in IL-4 production while TNF-alpha and IFN-gamma production tended to decrease during the study. Our results suggest that OM-89 has immunomodulatory properties by inducing changes in PBMC cytokines release suggestive of an induced Tr1 response to OM-89.
Asunto(s)
Antígenos Bacterianos/uso terapéutico , Artritis Reumatoide/tratamiento farmacológico , Artritis Reumatoide/inmunología , Factores Inmunológicos/uso terapéutico , Linfocitos T/inmunología , Anciano , Artritis Reumatoide/patología , Ensayo de Inmunoadsorción Enzimática , Femenino , Humanos , Interferón gamma/sangre , Interleucina-10/sangre , Interleucina-4/sangre , Activación de Linfocitos/efectos de los fármacos , Masculino , Persona de Mediana Edad , Fitohemaglutininas/inmunología , Linfocitos T/citología , Factor de Necrosis Tumoral alfa/análisisRESUMEN
OBJECTIVE: To investigate the long-term preventive effect of the immunotherapeutic OM-89 versus placebo in uncomplicated recurrent UTI in a large cohort of female patients only. METHODS: Adult female patients could enroll in this multicenter, double-blind study if they had acute UTI at the enrollment visit and positive results of urinalysis (> or =10(3)bacteria/ml). Patients received the immunotherapeutic OM-89 or a matching placebo; 1 capsule per day for 90 days, 3 months without treatment, then the first 10 days in Months 7, 8 and 9 and were followed up during 12 months. Primary efficacy criteria were UTI rates over 12 months, distribution of UTIs and proportion of patients with UTI. RESULTS: A total of 453 patients were treated, 231 in the active group and 222 in the placebo group. Mean rate of post-baseline UTIs was significantly lower in the active group than in the placebo group (0.84 vs. 1.28; p<0.003), corresponding to a 34% reduction of UTIs in patients treated with OM-89. In the active group, 93 patients (40.3%) had 185 post-baseline UTIs, compared to 276 UTIs in 122 patients (55.0%) in the placebo group (p=0.001). The safety profile of OM-89 was good and consistent with that reported in previous studies. CONCLUSIONS: OM-89 significantly reduced the incidence of UTI during the 12 months of the study including 3 months of treatment and three 10-day booster courses. These results confirm that OM-89 is a valuable component of the management of recurrent UTI.