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1.
Eur Rev Med Pharmacol Sci ; 27(21): 10690-10696, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37975394

RESUMO

OBJECTIVE: In clinical practice, identifying abscesses in tonsillar infections is crucial for early therapeutic management. Diagnosis of a peritonsillar abscess is usually based on clinical symptoms. Complementary examination procedures, such as laboratory parameters and imaging, are available for confirmation. PATIENTS AND METHODS: A retrospective analysis was carried out of data for 752 patients who presented with acute tonsillar infection and were hospitalized between January 2012 and February 2021. The data analyses involved evaluating the patient's clinical symptoms, inflammatory parameters, and previous medical history in relation to the predictive power of these factors for the presence of an abscess. RESULTS: Predictor analysis for the presence of an abscess showed significant values for trismus (OR 2.392; 95% CI, 1.305 to 4.383; p=0.005) and palatal arch protrusion (OR 29.679; 95% CI, 17.460 to 50.447; p=0.000). The inflammatory parameter C-reactive protein and the leukocyte count were not statistically significant as predictors. CONCLUSIONS: The presence of a tonsillar abscess can be diagnosed from the clinical presentation alone if the findings are clear. Further diagnostic procedures are indicated in case of inconclusive findings, and ultrasound should be the primary noninvasive method. Computed tomography is only required in selected cases. Inflammatory parameters can be assessed in order to monitor therapy, but do not predict the presence of an abscess. However, if defined action sequences are being considered, tonsillar abscesses can be differentiated at an early point.


Assuntos
Abscesso Peritonsilar , Tonsilite , Humanos , Estudos Retrospectivos , Tonsilite/diagnóstico , Tonsilite/terapia , Abscesso Peritonsilar/diagnóstico , Abscesso Peritonsilar/terapia , Contagem de Leucócitos , Proteína C-Reativa
2.
Eur Arch Otorhinolaryngol ; 280(11): 4827-4834, 2023 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-37219684

RESUMO

PURPOSE: The European and Japanese system for cholesteatoma classification proposed an anatomical differentiation in five sites. In stage I disease, one site would be affected and in stage II, two to five. We tested the significance of this differentiation by analyzing the influence of the number of affected sites on residual disease, hearing ability and surgical complexity. METHODS: Cases of acquired cholesteatoma treated at a single tertiary referral center between 2010-01-01 and 2019-07-31 were retrospectively analyzed. Residual disease was determined according to the system. The air-bone gap mean of 0.5, 1, 2, 3 kHz (ABG) and its change with surgery served as hearing outcome. The surgical complexity was estimated regarding the Wullstein's tympanoplasty classification and the procedure approach (transcanal, canal up/down). RESULTS: 513 ears (431 patients) were followed-up during 21.6 ± 21.5 months. 107 (20.9%) ears had one site affected, 130 (25.3%) two, 157 (30.6%) three, 72 (14.0%) four and 47 (9.2%) five. An increasing number of affected sites resulted in higher residual rates (9.4-21.3%, p = 0.008) and surgical complexity, as well poorer ABG (preoperative 14.1 to 25.3 dB, postoperative 11.3-16.8 dB, p < 0.001). These differences existed between the means of cases of stage I and II, but also when only considering ears with stage II classification. CONCLUSION: The data showed statistically significant differences when comparing the averages of ears with two to five affected sites, questioning the pertinence of the differentiation between stages I and II.


Assuntos
Colesteatoma da Orelha Média , Humanos , Colesteatoma da Orelha Média/cirurgia , Estudos Retrospectivos , Resultado do Tratamento , Nigéria , Timpanoplastia/métodos
3.
Eur Rev Med Pharmacol Sci ; 27(8): 3622-3630, 2023 04.
Artigo em Inglês | MEDLINE | ID: mdl-37140313

RESUMO

OBJECTIVE: Confocal laser endomicroscopy (CLE) allows the visualization of epithelium in a thousand-fold magnification. This study analyzes the architectural differences at the cellular level of the mucosa and squamous cell carcinoma (SCC). PATIENTS AND METHODS: A total of 60 CLE sequences recorded in 5 patients with SCC undergoing laryngectomy between October 2020 and February 2021 were analyzed. The corresponding histologic sample derived from H&E staining was assigned to each sequence, capturing CLE images of the tumor and healthy mucosa. In addition, the cellular structure analysis was performed to diagnose SCC by measuring the total number of cells and cell size in 60 sequences in a fixed field of view (FOV) with 240 µm in diameter (45,239 µm2). RESULTS: Out of 3,600 images, 1,620 (45%) showed benign mucosa and 1,980 (55%) SCC. The automated analysis yielded a difference in cell size, with healthy epithelial cells being 171.9±82.0 µm2 smaller than SCC cells, which were 246.3±171.9 µm2 and showed greater variability in size (p=0.037). In addition, due to the probe's fixed FOV, there was a difference in cell count with a total of 188.7±38.3 and 124.8±38.6 cells in images of normal epithelium and SCC (p<0.001), respectively. Regarding cell density as a criterion for the differentiation of benign/malign, using a cut-off value of 145.5 cells/FOV, we obtained sensitivity and specificity of 88.0% and 71.9%, respectively. CONCLUSIONS: SCC reveals marked differences at a cellular level compared to the healthy epithelium. Our results further support the importance of this feature for identifying SCC during CLE imaging.


Assuntos
Carcinoma de Células Escamosas , Neoplasias de Cabeça e Pescoço , Humanos , Microscopia Confocal/métodos , Carcinoma de Células Escamosas de Cabeça e Pescoço , Carcinoma de Células Escamosas/patologia , Contagem de Células , Lasers
4.
Eur Rev Med Pharmacol Sci ; 27(6): 2605-2618, 2023 03.
Artigo em Inglês | MEDLINE | ID: mdl-37013778

RESUMO

OBJECTIVE: The aim of this study was to investigate the influence of obstructive sleep apnea and continuous positive airway pressure on the nasal microbiome. PATIENTS AND METHODS: Endonasal swabs from the olfactory groove of 22 patients with moderate and severe obstructive sleep apnea (OSA) and a control group of 17 healthy controls were obtained at the Department of Otorhinolaryngology of the Friedrich-Alexander-Universität Erlangen-Nürnberg. 16S rRNA gene sequencing was performed to further evaluate the endonasal microbiome. In a second step, the longitudinal influence of continuous positive airway pressure (CPAP) therapy on the nasal microbiome was investigated (3-6 and 6-9 months). RESULTS: Analysis of the bacterial load and ß-diversity showed no significant differences between the groups, although patients with severe OSA showed increased α-diversity compared to the control group, while those with moderate OSA showed decreased α-diversity. The evaluation of longitudinal changes in the nasal microbiota during CPAP treatment showed no significant difference in α- or ß-diversity. However, the number of bacteria for which a significant difference between moderate and severe OSA was found in the linear discriminant analysis decreased during CPAP treatment. CONCLUSIONS: Long-term CPAP treatment showed an alignment of the composition of the nasal microbiome in patients with moderate and severe OSA as well as an alignment of biodiversity with that of the healthy control group. This change in the composition of the microbiome could be both part of the therapeutic effect in CPAP therapy and a promoting factor of the adverse side effects of the therapy. Further studies are needed to investigate whether the endonasal microbiome is related to CPAP compliance and whether CPAP compliance can be positively influenced in the future by therapeutic modification of the microbiome.


Assuntos
Microbiota , Apneia Obstrutiva do Sono , Humanos , Pressão Positiva Contínua nas Vias Aéreas/efeitos adversos , RNA Ribossômico 16S/genética , Apneia Obstrutiva do Sono/terapia , Nariz , Cooperação do Paciente
5.
Eur Rev Med Pharmacol Sci ; 26(5): 1674-1682, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35302216

RESUMO

OBJECTIVE: This prospective study compared the accuracy of two different company-specific registration methods (Fiagon GmbH, Hennigsdorf, Germany) in the electromagnetic navigation of the frontal skull base. A newly developed photo registration technology (Fiagon tracey©) promises an increase in accuracy and user-friendliness, but there is no phantom-based prospective study comparing the new method with the classic approach of tactile surface registration. MATERIALS AND METHODS: A phantom skull was prepared with 27 markers in the sagittal, axial and coronary planes, and their reference coordinates were determined using a navigational CT (low dose, slice 0.6 mm). Subsequently, 20 runs of automatic photo registration and tactile surface registration were carried out, and the resulting marker coordinates were compared with the reference coordinates. The target registration error (TRE) of the 27 markers was assessed and compared between the two methods using a 2-factor ANOVA with repeated measures. RESULTS: The mean TRE using surface registration was 1.97 mm ± 0.57, while the mean TRE of the automatic photo registration was 1.54 mm ± 0.24 (p < 0.001). In a subgroup analysis limited to markers in anatomical regions of clinical relevance in terms of paranasal sinus surgery, the mean TRE for the photo registration procedure can even be reduced to 1.29 mm (± 0.43) compared to tactile registration (1.80 mm; ±0.50; p=0.01). CONCLUSIONS: Photo registration is a promising new technology in the field of electromagnetic navigation in paranasal sinus surgery. This prospective phantom-based study showed that the photo registration method achieves a significantly lower target registration error (1.29 mm) compared to the surface-based tactile registration procedure (1.80 mm).


Assuntos
Marcadores Fiduciais , Cirurgia Assistida por Computador , Estudos Prospectivos , Base do Crânio/diagnóstico por imagem , Base do Crânio/cirurgia , Cirurgia Assistida por Computador/métodos , Tecnologia
6.
Eur Rev Med Pharmacol Sci ; 26(1): 257-269, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-35049003

RESUMO

OBJECTIVE: Surgical closure of persistent tracheoesophageal fistulas (TEFs) is complex. Most patients present with multiple risk factors, which may negatively impact the outcome and influence the treatment strategies. PATIENTS AND METHODS: This retrospective study included 22 patients presenting with persistent TEFs. Preoperative RT, comorbidities, tissue conditions of the TEFs and neck skin, and surgical techniques were evaluated regarding a possible impact on success rates and outcome. RESULTS: 21 patients were operated, 95.45% with final success. However, in 52.39% repeated surgery was needed. Final closure of TEFs was achieved in 91.47% only after more invasive surgery was performed. The surgical technique applied had the most significant impact on success rates and outcome compared to all other risk factors analyzed. Our own data and that of the literature point out that the surgical strategy should be adapted to the patients' individual risk factors. CONCLUSIONS: According to the literature, surgical closure of persistent TEFss is demanding. Our data suggest that, considering that the majority of patients with persistent TEFs exhibit multiple risk factors, early performance of more invasive surgery seems associated with a better outcome.


Assuntos
Fístula Traqueoesofágica , Humanos , Reoperação/efeitos adversos , Estudos Retrospectivos , Fístula Traqueoesofágica/complicações , Fístula Traqueoesofágica/cirurgia , Resultado do Tratamento
7.
Br J Oral Maxillofac Surg ; 59(10): 1204-1208, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34274171

RESUMO

The aim of this study was to compare several surgical modalities with respect to the incidence of positive margins and focal capsular exposure of pleomorphic adenoma of the parotid gland. The clinical records and histopathological findings of all patients who underwent parotidectomy for pleomorphic adenoma between 2006 and 2020 were retrospectively evaluated (n = 845). The lesion was removed by extracapsular dissection in 577 cases (68%) and facial nerve dissection in 268 (32%). Our analysis did not reveal a statistically significant difference between the examined modalities regarding positive margins (p=0.648) or capsular exposure (p=0.112). Recurrences were detected in 7/845 cases (0.82%) with a mean (range) follow-up time of 82.3 (6-183) months. The choice of surgical method does not seem to have a significant effect on the incidence of positive margins, or on the capsular exposure of a pleomorphic adenoma.


Assuntos
Adenoma Pleomorfo , Neoplasias Parotídeas , Humanos , Margens de Excisão , Recidiva Local de Neoplasia , Glândula Parótida , Complicações Pós-Operatórias , Estudos Retrospectivos
8.
Eur Rev Med Pharmacol Sci ; 24(22): 11620-11627, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33275229

RESUMO

OBJECTIVE: Near-Infrared (NIR) fluorescence imaging is a novel technique for intraoperative sentinel lymph node (SLN) identification. It has demonstrated promising results in several surgical specialties. The study aims to evaluate the feasibility of identifying the SLN by indocyanine green (ICG) enhanced NIR endoscopy in squamous cell carcinoma of the oral cavity (OCSCC). PATIENTS AND METHODS: Seven patients with (cT1-3 N0) OCSCC were included. We injected 1-1.25 ml of ICG (5 mg/ml) at four to five points around the primary. After the elevation of a platysma flap and posterior retraction of the sternocleidomastoid muscle, fluorescence images were taken via IMAGE1 STM NIR/ICG system to define the SLN(s). We sampled fluorescence marked SLN(s) stratified to lymph node levels, followed by level-specified elective neck dissection. RESULTS: The detection of at least one unilateral or bilateral SLN (range 1-5) was possible in every case. The fluorescence signal occurred, on average, 5.0 ± 2.2 minutes after injection. A total of 22 SLN could be identified. Among 331 histologically examined lymph nodes we could detect one micrometastasis, which was correctly defined as SLN (1/22). There were no false-negative findings. No adverse reactions to ICG occurred. CONCLUSIONS: Our first results are indicating the concept of SLN concerning OCSCC after the application of real-time NIR fluorescence endoscopy. However, this has to be verified by more extended studies.


Assuntos
Carcinoma de Células Escamosas/diagnóstico por imagem , Boca/diagnóstico por imagem , Linfonodo Sentinela/diagnóstico por imagem , Idoso de 80 Anos ou mais , Carcinoma de Células Escamosas/cirurgia , Estudos de Viabilidade , Humanos , Pessoa de Meia-Idade , Boca/cirurgia , Projetos Piloto , Estudos Prospectivos , Linfonodo Sentinela/cirurgia , Espectroscopia de Luz Próxima ao Infravermelho
9.
Eur Rev Med Pharmacol Sci ; 24(3): 1211-1218, 2020 02.
Artigo em Inglês | MEDLINE | ID: mdl-32096150

RESUMO

OBJECTIVE: This study aimed to clarify the impact of delayed adjuvant therapy on the outcome of HPV associated oropharyngeal squamous cell carcinoma (HPV-OPSCC). PATIENTS AND METHODS: A total of 157 patients with HPV-OPSCC treated by surgery and adjuvant radiotherapy or chemoradiation therapy were analyzed retrospectively. We divided participants into two groups implementing adjuvant therapy within or after 50 days. Primary endpoints were the rates of locoregional recurrence and distant metastases, overall survival, and disease-specific survival. RESULTS: Adjuvant treatment began within 50 days (average: 38.8 days) in 79 cases compared to 78 cases after 50 days (average: 71.5 days). Five-year overall survival was 85.7% and 87.4% (p=0.588), the rates of local and regional recurrence were 3.8% and 6.4% (p=0.455) and of distant metastases 5.1% and 9% (p=0.369) implementing adjuvant treatment within or later than 50 days, respectively. CONCLUSIONS: These results suggest that adjuvant therapy initiated later than seven weeks after primary ablative surgery may still be effective HPV-OPSCC.


Assuntos
Quimiorradioterapia/métodos , Genes p16 , Neoplasias Orofaríngeas/cirurgia , Infecções por Papillomavirus/cirurgia , Tempo para o Tratamento/tendências , Idoso , Estudos de Coortes , Terapia Combinada , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Neoplasias Orofaríngeas/mortalidade , Neoplasias Orofaríngeas/terapia , Infecções por Papillomavirus/mortalidade , Infecções por Papillomavirus/terapia , Estudos Retrospectivos , Taxa de Sobrevida/tendências
11.
Appl Clin Inform ; 5(1): 92-117, 2014.
Artigo em Inglês | MEDLINE | ID: mdl-24734127

RESUMO

UNLABELLED: The US government allocated $30 billion to implement electronic health records (EHRs) in hospitals and provider practices through policy addressing Meaningful Use (MU). Most small, rural hospitals, particularly those designated as Critical Access Hospitals (CAHs), comprising nearly a quarter of US hospitals, had not implemented EHRs before. Little is known about implementation in this setting. Socio-technical factors differ between larger hospitals and CAHs, which continue to lag behind other hospitals in EHR adoption. OBJECTIVE: The main objective is to provide EHR implementation advice for CAHs from a spectrum of experts with an emphasis on recommendations from their peers at CAHs that have undertaken the process. The secondary objective is to begin to identify implementation process differences at CAHs v. larger hospitals. METHODS: We interviewed 41 experts, including 16 CAH staff members from EHR teams at 10 CAHs that recently implemented EHRs. We qualitatively analyzed the interviews to ascertain themes and implementation recommendations. RESULTS: Nineteen themes emerged. Under each theme, comments by experts provide in-depth advice on all implementation stages including ongoing optimization and use. We present comments for three top themes as ranked by number of CAH peer experts commenting - EHR System Selection, EHR Team, and Preparatory Work - and for two others, Outside Partners/Resources and Clinical Decision Support (CDS)/Knowledge Management (KM). Comments for remaining themes are included in tables. DISCUSSION: CAH experts rank the themes differently from all experts, a likely indication of the differences between hospitals. Comments for each theme indicate the specific difficulties CAHs encountered. CAH staffs have little or no EHR experience before implementation. A factor across themes is insufficient system and process knowledge, compounded by compressed implementation schedules. Increased, proactive self-education, via available outside partners and information resources, will mitigate difficulties and aid CAHs in meeting increased CDS requirements in MU Stages 2 and 3.


Assuntos
Registros Eletrônicos de Saúde , Prova Pericial , Implementação de Plano de Saúde , Acessibilidade aos Serviços de Saúde , Hospitais Rurais , Grupo Associado , Sistemas de Apoio a Decisões Clínicas , Humanos
12.
Ann Oncol ; 20(11): 1829-35, 2009 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-19605509

RESUMO

Expression of the Bcl-2 protein confers resistance to chemotherapy-mediated apoptotic signals in patients with breast cancer. We investigated effects of Bcl-2 down-regulation by the Bcl-2 antisense oligodeoxynucleotide oblimersen in breast tumor biopsies. Oblimersen targets Bcl-2 messenger RNA (mRNA), down-regulates Bcl-2 protein translation and enhances antitumor effects of subtherapeutic chemotherapy doses. Within a phase I trial, we administered escalating doses of oblimersen (3, 5 or 7 mg/kg/day) as continuous infusion on days 1-7 in combination with standard-dose docetaxel (Taxotere), Adriamycin and cyclophosphamide (TAC) on day 5 as preoperative chemotherapy in 28 patients with T2-4 tumors. Effects of oblimersen were evaluated in tumor biopsies and peripheral blood mononuclear cells (PBMCs) 4 days after start of oblimersen and before TAC treatment by quantitative microfluidic real-time PCR. Read-outs consisted in measurement of Bcl-2 mRNA modulations and of 18 putative predictive markers. Two of 13 patients showed a diminution of Bcl-2 transcripts after 4 days of treatment with oblimersen 5 mg/kg/day. PBMCs could not be evaluated as a surrogate tissue because no qualified RNA could be isolated. Nevertheless, we demonstrated feasibility to process clinical samples and to obtain good quality RNA from tumor biopsies and indicated the potential of oblimersen to lower Bcl-2 mRNA in breast cancer.


Assuntos
Antineoplásicos/administração & dosagem , Apoptose/efeitos dos fármacos , Neoplasias da Mama/tratamento farmacológico , Expressão Gênica/efeitos dos fármacos , Genes bcl-2/efeitos dos fármacos , Tionucleotídeos/administração & dosagem , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Apoptose/genética , Ciclofosfamida/uso terapêutico , Docetaxel , Regulação para Baixo , Doxorrubicina/uso terapêutico , Feminino , Humanos , Pessoa de Meia-Idade , Terapia Neoadjuvante , Período Pré-Operatório , RNA Mensageiro/análise , Reação em Cadeia da Polimerase Via Transcriptase Reversa , Taxoides/uso terapêutico
13.
Ann Oncol ; 19(11): 1882-7, 2008 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-18669868

RESUMO

BACKGROUND: The combination of docetaxel (Taxotere), cisplatin, and fluorouracil improved efficacy in gastric cancer, but was associated with substantial toxicity. This study was designed to incorporate docetaxel into a tolerable biweekly (once every 2 weeks) oxaliplatin-based chemotherapy regimen. PATIENTS AND METHODS: Patients with measurable, metastatic adenocarcinoma of the stomach or esophagogastric junction and no prior chemotherapy received oxaliplatin 85 mg/m(2), leucovorin 200 mg/m(2), and fluorouracil 2600 mg/m(2) as a 24-h infusion in combination with docetaxel 50 mg/m(2) (FLOT) on day 1 every 2 weeks. Prophylactic growth factors were not administered. RESULTS: Fifty-nine patients were enrolled; 54 received treatment. Patients had a median age of 60 years (range 29-76) and most (93%) of them had metastatic disease. Objective responses were observed in 57.7% of patients with a median time to treatment response of 1.54 months. Median progression-free survival (PFS) and overall survival were 5.2 and 11.1 months, respectively. Twenty-five percent of patients experienced prolonged (>12 months) PFS. Frequent (>10%) grade 3 or 4 toxic effects included neutropenia in 26 (48.1%), leukopenia in 15 (27.8%), diarrhea in 8 (14.8%), and fatigue in 6 (11.1%) patients. Complicated neutropenia was observed in two (3.8%) patients, only. CONCLUSIONS: Biweekly FLOT is active and has a favorable safety profile.


Assuntos
Adenocarcinoma/tratamento farmacológico , Protocolos de Quimioterapia Combinada Antineoplásica/administração & dosagem , Neoplasias Esofágicas/tratamento farmacológico , Junção Esofagogástrica/patologia , Neoplasias Gástricas/tratamento farmacológico , Adenocarcinoma/patologia , Adulto , Idoso , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Intervalo Livre de Doença , Docetaxel , Esquema de Medicação , Feminino , Fluoruracila/administração & dosagem , Fluoruracila/efeitos adversos , Humanos , Leucovorina/administração & dosagem , Leucovorina/efeitos adversos , Masculino , Pessoa de Meia-Idade , Metástase Neoplásica , Compostos Organoplatínicos/administração & dosagem , Compostos Organoplatínicos/efeitos adversos , Oxaliplatina , Neoplasias Gástricas/patologia , Taxoides/administração & dosagem , Taxoides/efeitos adversos
14.
Ann Oncol ; 19(10): 1698-705, 2008 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-18477581

RESUMO

BACKGROUND: Combining the Bcl-2 down-regulator oblimersen with cytotoxic treatment leads to synergistic antitumor effects in preclinical trials. This multicentric phase I study was carried out to evaluate maximum tolerated dose (MTD), safety and preliminary efficacy of oblimersen in combination with docetaxel, adriamycin and cyclophosphamide as neo-adjuvant systemic treatment (NST) in primary breast cancer (PBC). METHODS: Previously untreated patients with PBC T2-4a-c N0-3 M0 received one cycle of docetaxel 75 mg/m(2), adriamycin 50 mg/m(2) and cyclophosphamide 500 mg/m(2) administered on day 5 combined with escalating doses of oblimersen as a 24-h continuous infusion on days 1-7 followed by five cycles of combination of docetaxel, adriamycin and cyclophosphamide (TAC) without oblimersen every 3 weeks. Prophylactic antibiotic therapy and granulocyte colony-stimulating factor administration were used in all six cycles. Blood serum samples were taken throughout the treatment period for pharmacokinetic analysis. RESULTS: Twenty-eight patients were enrolled (median age, 50 years; ductal-invasive histology, 68%; tumorsize 2-5 cm, 61%; grade 3, 43%; hormone receptor negative, 36%; Her2 positive 18%) and received oblimersen in a dose of 3 mg/kg/day (cohort I, nine patients), 5 mg/kg/day (cohort II, nine patients) and 7 mg/kg/day (cohort III, 10 patients) respectively. No dose-limiting toxicity occurred. Following oblimersen combined with TAC, the most severe toxicity was neutropenia [National Cancer Institute-Common Toxicity Criteria (NCI-CTC) grades 1-2/3/4] which developed in 0/0/56% of patients (cohort I), 11/0/56% of patients (cohort II) and 20/20/50% of patients (cohort III). No febrile neutropenia occurred. Most common adverse events (all NCI-CTC grade < or = 2) were fatigue, nausea, alopecia, headache and flue-like symptoms observed in 78% (cohort I), 89% (cohort II) and 90% (cohort III) of patients. With increasing dose of oblimersen, a higher incidence of grade IV leukopenia and neutropenia was noted. At the MTD of 7 mg/kg/day of oblimersen, serious adverse events occurred in 40% of the patients. CONCLUSION: Oblimersen up to a dose of 7 mg/kg/day administered as a 24-h infusion on days 1-7 can be safely administered in combination with standard TAC on day 5 as NST in patients with PBC. The safety and preliminary efficacy warrants further evaluation of oblimersen in combination with every cycle of the TAC regimen in a randomized trial.


Assuntos
Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Carcinoma Ductal de Mama/tratamento farmacológico , Adulto , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapêutico , Neoplasias da Mama/sangue , Carcinoma Ductal de Mama/sangue , Ciclofosfamida/administração & dosagem , Ciclofosfamida/efeitos adversos , Docetaxel , Relação Dose-Resposta a Droga , Doxorrubicina/administração & dosagem , Doxorrubicina/efeitos adversos , Feminino , Humanos , Pessoa de Meia-Idade , Terapia Neoadjuvante , Taxoides/administração & dosagem , Taxoides/efeitos adversos , Tionucleotídeos/administração & dosagem , Tionucleotídeos/efeitos adversos , Tionucleotídeos/farmacocinética
15.
Z Kardiol ; 94(7): 474-8, 2005 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15997350

RESUMO

Cerebral ischaemia caused by thromboembolism is a possible complication of diagnostic and interventional cardiac catheterization. In this case report we describe the diagnostic steps and successful treatment strategy in the management of a patient who suffered from cerebral ischaemia during cardiac catheterization. Initial CT scanning to exclude cerebral haemorrhage was followed by angiography through the cardiac catheterization sheath in the right femoral artery. Occlusion just before the intracranial bifurcation of the right internal carotid artery was found and local thrombolysis given with a reduced dose of 34 mg rt-PA. The subsequent angiogram showed restored perfusion in the affected vessel after completion of thrombolytic therapy and resolution of neurological symptoms.


Assuntos
Isquemia Encefálica/tratamento farmacológico , Isquemia Encefálica/etiologia , Cateterismo Cardíaco/efeitos adversos , Tromboembolia/tratamento farmacológico , Tromboembolia/etiologia , Terapia Trombolítica/métodos , Ativador de Plasminogênio Tecidual/administração & dosagem , Relação Dose-Resposta a Droga , Feminino , Fibrinolíticos/administração & dosagem , Humanos , Pessoa de Meia-Idade , Resultado do Tratamento
16.
J Neural Transm (Vienna) ; 112(5): 649-60, 2005 May.
Artigo em Inglês | MEDLINE | ID: mdl-15517433

RESUMO

UNLABELLED: Increasing evidence has suggested that oxidative stress may be involved in the pathogenesis of amyotrophic lateral sclerosis (ALS). The antioxidant vitamin E (alpha-tocopherol) has been shown to slow down the onset and progression of the paralysis in transgenic mice expressing a mutation in the superoxide dismutase gene found in certain forms of familial ALS. The current study, a double blind, placebo-controlled, randomised, stratified, parallel-group clinical trial, was designed to determine whether vitamin E (5000 mg per day) may be efficacious in slowing down disease progression when added to riluzole. METHODS: 160 patients in 6 German centres with either probable or definite ALS (according to the El Escorial Criteria) and a disease duration of less than 5 years, treated with riluzole, were included in this study and were randomly assigned to receive either alpha-tocopherol (5000 mg per day) or placebo for 18 months. The Primary outcome measure was survival, calculating time to death, tracheostomy or permanent assisted ventilation, according to the WFN-Criteria of clinical trials. Secondary outcome measures were the rate of deterioration of function assessed by the modified Norris limb and bulbar scales, manual muscle testing (BMRC), spasticity scale, ventilatory function and the Sickness Impact Profile (SIP ALS/19). Patients were assessed at entry and every 4 months thereafter during the study period until month 16 and at a final visit at month 18. Vitamin E samples were taken for compliance check and Quality Control of the trial. For Safety, a physical examination was performed at baseline and then every visit until the treatment discontinuation at month 18. Height and weight were recorded at baseline and weight alone at the follow-up visits. A neurological examination as well as vital signs (heart rate and blood pressure), an ECG and VEP's were recorded at each visit. Furthermore, spontaneously reported adverse experiences and serious adverse events were documented and standard laboratory tests including liver function tests performed. For Statistical Analysis, the population to be considered for the primary outcome measure was an "intent-to-treat" (ITT) population which included all randomised patients who had received at least one treatment dose (n = 160 patients). For the secondary outcome measures, a two way analysis of variance was performed on a patient population that included all randomised patients who had at least one assessment after inclusion. RESULTS: Concerning the primary endpoint, no significant difference between placebo and treatment group could be detected either with the stratified Logrank or the Wilcoxon test. The functional assessments showed a marginal trend in favour of vitamin E, without reaching significance. CONCLUSION: Neither the primary nor the secondary outcome measures could determine whether a megadose of vitamin E is efficacious in slowing disease progression in ALS as an add-on therapy to riluzol. Larger or longer studies might be needed. However, administration of this megadose does not seem to have any significant side effects in this patient population.


Assuntos
Esclerose Lateral Amiotrófica/tratamento farmacológico , Fármacos Neuroprotetores/uso terapêutico , Riluzol/uso terapêutico , Vitamina E/administração & dosagem , Vitaminas/administração & dosagem , Esclerose Lateral Amiotrófica/mortalidade , Relação Dose-Resposta a Droga , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Vitamina E/efeitos adversos , Vitamina E/sangue , Vitaminas/efeitos adversos , Vitaminas/sangue
17.
Neuromuscul Disord ; 14(7): 438-41, 2004 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-15210167

RESUMO

External ocular muscle palsies in patients with ophthalmic zoster are traditionally interpreted as diseases of III, IV or VI cranial nerves. Orbital myositis associated with zoster ophthalmicus has been diagnosed only rarely. We describe a patient with ophthalmic zoster and external ophthalmoplegia due to ocular myositis demonstrated by MR imaging. Treatment with acyclovir and cortisone resulted in a rapid improvement of the ophthalmoplegia. In ophthalmic herpes zoster associated with external ocular muscle palsies, ocular myositis is an important differential diagnosis to inflammatory involvement of the cranial nerves III, IV, and VI.


Assuntos
Herpes Zoster Oftálmico/complicações , Miosite/complicações , Oftalmoplegia/etiologia , Aciclovir/uso terapêutico , Idoso , Antivirais/uso terapêutico , Tronco Encefálico/efeitos dos fármacos , Tronco Encefálico/patologia , Cortisona/uso terapêutico , Feminino , Gadolínio , Herpes Zoster Oftálmico/diagnóstico , Herpes Zoster Oftálmico/tratamento farmacológico , Humanos , Imageamento por Ressonância Magnética/métodos , Miosite/diagnóstico , Miosite/tratamento farmacológico , Oftalmoplegia/diagnóstico , Oftalmoplegia/tratamento farmacológico
18.
J Neural Transm (Vienna) ; 109(10): 1229-40, 2002 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-12373557

RESUMO

Meta-hydroxyephedrine (HED) comprises four stereoisomers consisting of two enantiomeric pairs related to ephedrine and pseudoephedrine. HED is transported into adrenergic neurons and radiolabeled HED has been employed in positron emission tomography (PET) to image adrenergic neurons in vivo. To extend structure-activity analyses of binding sites within monoamine transporters and to determine which stereoisomer displayed the best selectivity for PET imaging applications, we tested the HED compounds for their abilities to inhibit [(3)H]neurotransmitter uptake into platelets, transfected cells, and chromaffin vesicles. We hypothesized that the HED compounds would be most potent at the norepinephrine transporter (NET) compared to the serotonin or dopamine transporters and that the 1R diastereomers would be more effective than 1S diastereomers. Supporting the hypotheses, all stereoisomers were most potent at the NET and the 1R,2S stereoisomer was the most potent inhibitor overall. However, the 1S,2R isomer may be preferred for PET applications because of better selectivity among the transporters and reduced neuronal recycling.


Assuntos
Monoaminas Biogênicas/metabolismo , Proteínas de Transporte/antagonistas & inibidores , Efedrina/análogos & derivados , Efedrina/farmacologia , Proteínas de Membrana Transportadoras , Neuropeptídeos , Animais , Plaquetas/efeitos dos fármacos , Plaquetas/metabolismo , Proteínas de Transporte/química , Bovinos , Membrana Celular/metabolismo , Células Cultivadas , Grânulos Cromafim/efeitos dos fármacos , Grânulos Cromafim/metabolismo , Dopamina/metabolismo , Glicoproteínas de Membrana/metabolismo , Norepinefrina/metabolismo , Serotonina/metabolismo , Estereoisomerismo , Transfecção , Proteínas Vesiculares de Transporte de Aminas Biogênicas
19.
J Med Internet Res ; 3(3): E24, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11720966

RESUMO

BACKGROUND: Digital information technology can facilitate informed decision making by individuals regarding their personal health care. The digital divide separates those who do and those who do not have access to or otherwise make use of digital information. To close the digital divide, health care communications research must address a fundamental issue, the consumer vocabulary problem: consumers of health care, at least those who are laypersons, are not always familiar with the professional vocabulary and concepts used by providers of health care and by providers of health care information, and, conversely, health care and health care information providers are not always familiar with the vocabulary and concepts used by consumers. One way to address this problem is to develop a consumer entry vocabulary for health care communications. OBJECTIVES: To evaluate the potential of controlled vocabulary resources for supporting the development of consumer entry vocabulary for diabetes. METHODS: We used folk medical terms from the Dictionary of American Regional English project to create extended versions of 3 controlled vocabulary resources: the Unified Medical Language System Metathesaurus, the Eurodicautom of the European Commission's Translation Service, and the European Commission Glossary of popular and technical medical terms. We extracted consumer terms from consumer-authored materials, and physician terms from physician-authored materials. We used our extended versions of the vocabulary resources to link diabetes-related terms used by health care consumers to synonymous, nearly-synonymous, or closely-related terms used by family physicians. We also examined whether retrieval of diabetes-related World Wide Web information sites maintained by nonprofit health care professional organizations, academic organizations, or governmental organizations can be improved by substituting a physician term for its related consumer term in the query. RESULTS: The Dictionary of American Regional English extension of the Metathesaurus provided coverage, either direct or indirect, of approximately 23% of the natural language consumer-term-physician-term pairs. The Dictionary of American Regional English extension of the Eurodicautom provided coverage for 16% of the term pairs. Both the Metathesaurus and the Eurodicautom indirectly related more terms than they directly related. A high percentage of covered term pairs, with more indirectly covered pairs than directly covered pairs, might be one way to make the most out of expensive controlled vocabulary resources. We compared retrieval of diabetes-related Web information sites using the physician terms to retrieval using related consumer terms We based the comparison on retrieval of sites maintained by non-profit healthcare professional organizations, academic organizations, or governmental organizations. The number of such sites in the first 20 Results from a search was increased by substituting a physician term for its related consumer term in the query. This suggests that the Dictionary of American Regional English extensions of the Metathesaurus and Eurodicautom may be used to provide useful links from natural language consumer terms to natural language physician terms. CONCLUSIONS: The Dictionary of American Regional English extensions of the Metathesaurus and Eurodicautom should be investigated further for support of consumer entry vocabulary for diabetes.


Assuntos
Participação da Comunidade , Bases de Dados Factuais/normas , Vocabulário Controlado , Humanos , Serviços de Informação/normas , Serviços de Informação/provisão & distribuição
20.
Stud Health Technol Inform ; 84(Pt 1): 381-4, 2001.
Artigo em Inglês | MEDLINE | ID: mdl-11604768

RESUMO

BACKGROUND: Retrieval tests have assumed that the abstract is a true surrogate of the entire text. However, the frequency of terms in abstracts has never been compared to that of the articles they represent. Even though many sources are now available in full-text, many still rely on the abstract for retrieval. METHODS: 1,138 articles with their abstracts were downloaded from Journal of the American Medical Association, New England Journal of Medicine, Lancet, and the British Medical Journal. Words were extracted from the articles and their abstracts and the frequency of each word was counted in both sources. Each article and its abstract were tested using a chi-squared test to determine if the words in the abstract occurred as frequently as would be expected. RESULTS: 96% of the abstracts tested as samples of the article they represented. CONCLUSION: In these four journals, the abstracts are lexical, as well as intellectual, surrogates for the documents they represent.


Assuntos
Indexação e Redação de Resumos , Bibliometria , Vocabulário , Distribuição de Qui-Quadrado , Armazenamento e Recuperação da Informação , Publicações Periódicas como Assunto
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