RESUMO
OBJECTIVE: To assess the efficacy and side effects of methotrexate and leflunomide in patients with rheumatoid arthritis (RA) as the first disease-modifying antirheumatic drug (DMARD). METHODS: We performed a systematic review and meta-analysis of clinical studies that included patients who took methotrexate, leflunomide, placebo or another DMARD for RA treatment. A systematic review yielded 1971 articles from databases; once completely reviewed, 73 trials that completed inclusion criteria were selected. In structured workshops for discussion and assessment of each article, 6 could be meta-analyzed for the primary and secondary outcomes: achievement of American College of Rheumatology (ACR) 20 and its core set components; and change of serum C-reactive protein (CRP) levels, Health Assessment Questionnaire Disability Index (HAQ-Di), liver enzyme aspartate transaminase/alanine transaminase ratio, new gastrointestinal (GI) side effects and infections. RESULTS: A total of 1984 patients were included: 986 took leflunomide and 998 methotrexate. The probability of achieving ACR 20 had an odds ratio (OR) of 0.88 (95% confidence interval [CI] 0.74, 1.06) with a trend toward favoring methotrexate; reduction of the swollen joint count was greater for methotrexate: mean difference=0.82 (95%CI 0.24, 1.39); tender joint count, physician global assessment, HAQ-Di, and serum CRP levels revealed no significant difference between groups. Increased liver enzymes were more frequent in the leflunomide group, OR=0.38 (95%CI 0.27, 0.53), and new GI complaints were more common with methotrexate (OR=1.44; 95%CI 1.17, 1.79). There was no difference in the incidence of non-severe infections. CONCLUSION: Leflunomide used as the first DMARD in RA seemed to be as efficacious as methotrexate; only the reduction of swollen joint count was more marked for methotrexate. Leflunomide was linked to a greater increase in liver enzymes, but there were fewer GI complaints.
Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Imunossupressores/uso terapêutico , Leflunomida/uso terapêutico , Metotrexato/uso terapêutico , Alanina Transaminase/sangue , Anti-Inflamatórios não Esteroides/efeitos adversos , Antirreumáticos/efeitos adversos , Aspartato Aminotransferases/sangue , Proteína C-Reativa/análise , Doença Hepática Induzida por Substâncias e Drogas/etiologia , Ensaios Clínicos como Assunto , Avaliação da Deficiência , Quimioterapia Combinada , Gastroenteropatias/induzido quimicamente , Humanos , Imunossupressores/efeitos adversos , Leflunomida/efeitos adversos , Metotrexato/efeitos adversos , Resultado do Tratamento , gama-Glutamiltransferase/análiseRESUMO
UNLABELLED: INTRODUCTION AND AIM. There is scarce information about primary prophylaxis in cirrhotic patients. The aim was to assess the efficacy of ciprofloxacin for primary prophylaxis for bacterial infections in patients with cirrhosis of the liver and ascites. MATERIAL AND METHODS. A randomized, double-blind placebo-controlled clinical trial was conducted. Patients were randomized to receive oral ciprofloxacin 500 mg/day or placebo for one month. A basal evaluation and repeated assessments at 4, 6, 12, 18, and 24 weeks afterwards, or whenever a primary endpoint occurred were done. STATISTICAL ANALYSIS: probability curves were constructed with the Kaplan-Meier method and compared by the log-rank test. RESULTS. 95 patients were randomized to ciprofloxacin group (n = 49; 51.6%) and placebo group (n = 46; 48.4%). Six-teen (32.6%) patients in the ciprofloxacin group developed bacterial infections and thirteen (28.2%) patients developed bacterial infections in the placebo group (p = NS). The probability to remain free of bacterial infections did not reach statistical significance (p = 0.38). Probability of survival at 24 weeks was 91% in placebo group and 98% in the ciprofloxacin group (p = 0.28). The absolute risk reduction was 5%, the relative risk reduction was 6% and the NNT was 20 patients. CONCLUSION. Primary prophylaxis with ciprofloxacin for one month in cirrhotic patients with ascites who do not have a currently accepted indication, did not show a preventive effect on the development of bacterial infections at one month follow-up. Moreover in women could increases the odds for UTI. The administration of ciprofloxacin seemed to decrease the risk of mortality.
Assuntos
Antibacterianos/uso terapêutico , Ascite/complicações , Infecções Bacterianas/prevenção & controle , Ciprofloxacina/uso terapêutico , Cirrose Hepática/complicações , Peritonite/prevenção & controle , Adulto , Idoso , Infecções Bacterianas/complicações , Método Duplo-Cego , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Peritonite/complicações , Resultado do TratamentoRESUMO
OBJECTIVES: To evaluate the accuracy of endoscopic ultrasound (EUS) to determine vascular invasion in patients with pancreatic cancer. METHODS: Data were obtained prospectively from patients with a pancreatic lesion who underwent EUS, computed tomographic (CT) imaging, and surgery from March 2005 to March 2010. RESULTS: Fifty patients were included with a mean ± SD age 61 ± 11.5 years; 27 (54%) were women. The sensitivity, specificity, positive predictive value, and negative predictive value for EUS were the following: 61.1 (95% CI, 38.6-79.7), 90.3 (95% CI, 75.1-96.7), 78.6 (95% CI, 52.4-92.4), and 80 (95% CI, 64.1-90), respectively. The area under the curve for EUS and that for CT were 0.80 (95% CI, 0.68-0.92) and 0.74 (95% CI, 0.61-0.86), respectively. The positive predictive value for arterial invasion was 100% (95% CI, 61-100) for EUS and 60% (95% CI, 31.3-83.2) for CT. There were no complications associated with the EUS or the CT. CONCLUSION: Endoscopic US is a very good option to detect vascular invasion in patients with pancreatic cancer and is especially sensitive for arterial invasion. When it is available, we recommend that it be performed in addition to CT staging.
Assuntos
Adenocarcinoma/patologia , Endossonografia , Tomografia Computadorizada Multidetectores , Neoplasias Pancreáticas/patologia , Neoplasias Vasculares/secundário , Adenocarcinoma/diagnóstico por imagem , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Invasividade Neoplásica , Neoplasias Pancreáticas/diagnóstico por imagem , Estudos Retrospectivos , Sensibilidade e Especificidade , Neoplasias Vasculares/diagnóstico por imagemRESUMO
BACKGROUND AND AIM: Intraoperative blood loss is a frequent complication of hepatic resection and orthotopic liver transplantation. Recombinant activated coagulation factor VII (rFVIIa) is a coagulation protein that induces hemostasis by directly activating factor X. There is no clear information about the prophylactic value of rFVIIa in hepatobiliary surgery, specifically in liver resection and orthotopic liver transplantation. The aim of this study was to assess the effect of rFVIIa prophylaxis to prevent mortality and bleeding resulting from hepatobiliary surgery. METHODS: Relevant randomized trials were identified by searching The Cochrane Central Register of Controlled Trials in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index. Randomized clinical trials comparing different rFVIIa prophylactic schemas against placebo or no intervention to prevent bleeding in hepatobiliary surgery were included. Adults undergoing liver resection, partial hepatectomy, or orthotopic liver transplantation were included. Dichotomous data were analyzed calculating odds ratios (ORs) and 95% confidence intervals (CIs). Continuous data were analyzed calculating mean differences (MD) and 95% CIs. RESULTS: Four randomized controlled trials were included. There were no significant differences between rFVIIa and placebo for mortality (OR 0.96; 95% CI 0.35-2.62), red blood cell units (MD 0.32; 95% CI -0.08-0.72) or adverse events (OR 1.55; 95% CI 0.97-2.49). CONCLUSIONS: The available information is limited, precluding the ability to draw conclusions regarding bleeding prophylaxis in hepatobiliary surgery using rFVIIa. Although an apparent lack of effect was observed in all outcomes studied, further research is needed.