Infliximabe no tratamento inicial da retocolite ulcerativa moderada e grave. Terapia top down: Relato preliminar

The first option for the treatment of UC is both: salicylates or corticoids. Recently, in late November of 2006, the Brazilian Ministry of Health has approved infliximab (Remicade c, Mantecorp, Brazil) to treat ulcerative colitis. We report the use of infliximab as a first option for the treatment of two patients with severe ulcerative colitis. Case report: Patient 1: AZF, 52 years-old, female, was first diagnosed with UC after history and clinical examination; colonoscopy showed pancolitis with positive biopsy (crypt microabscess). Her Mayo score was 10 (range: 0 to 12/asymptomatic to severe colitis). She received intra venous infusion of infliximab at a dose of 5mg/Kg of body weigh at week 0, 2, 6 and 14. Then, patient was given mesalazine 4.5 g/day for maintenance therapy. Clinical response was defined as a decreased from baseline in the total Mayo score of at least 3 points. At present, patient is asymptomatic with Mayo score of 3 one moth after the last dose of infliximab. Patient 2: MLA, 45 years-old, female was first diagnosed with bloody diarrhea; colonoscopy showed left colitis and the biopsy was positive for ulcerative colitis. Her Mayo score was 9. She was offered and accepted the step down treatment. She was given infliximab 5mg/Kg of body weight at week 0, 2, 6 and 14. After initial treatment with infliximab, she received mesalazine 4.2 g/day. At present, she is asymptomatic with Mayo score of 2 eighteen days after the last dose of infliximab. At our knowledge, this is the first Brazilian report of the use of infliximab as fist-line therapy in ulcerative colitis. Few days after the begging of the infusion, an impressive clinical and colonoscopy improvement was seen in these two patients. Recently, it has been reported the use of infliximab as first-line therapy in pediatric Crohn disease. Infliximab could be a good option in cases of moderate and severe UC to avoid the side effects of the use of high doses of corticoids in patients with moderate and severe UC. However, the question if step-down therapy in ulcerative colitis is better then conventional therapy with salicylates and corticoids needs to be answered by randomized trials.

A systematic review of anti-inflammatories for mild to moderate carpal tunnel syndrome

The purpose of this study was to evaluate anti-inflammatory drugs in the medium- and long-term management of mild to moderate carpal tunnel syndrome (CTS). The authors conducted a systematic review of the literature on the effectiveness of steroidal and nonsteroidal anti-inflammatory drugs for mild and moderate cases of CTS. There were included only randomized, double-blind clinical trials. Six publications referring to five trials were included in the review. No study on nonsteroidal anti-inflammatory drugs met our inclusion criteria. Although neurophysiological studies have not shown great differences resulting from the application of corticosteroids, the symptomatic benefit provided by such drugs is clear. In the short term, local infiltration provides better results than systemic administration of corticosteroids. Over a 1-year period, however, this difference does not persist. Further double-blind randomized trials evaluating therapeutic efficacy for a longer follow-up period are required to provide stronger evidence for both steroidal and nonsteroidal anti-inflammatories. © 2009 by Lippincott Williams & Wilkins.

Recuperação acelerada após reparo cirúrgico aberto eletivo do aneurisma da aorta abdominal: revisão sistemática da literatura

Pós-graduação em Anestesiologia - FMB

Placement of dental implants in the maxillary tuberosity: a systematic review

The aim of this systematic review was to identify clinical studies on implants placed in the tuberosity region to determine the survival rate of these implants when compared to implants placed in other regions of the maxilla. A search for data published up until March 2014 was undertaken using the PubMed, Cochrane Library, Embase, and ScienceDirect databases. Eligible studies were selected according to inclusion and exclusion criteria. The first database search revealed 310 titles. After inclusion and exclusion criteria were applied, five studies remained for the detailed analysis. A total of 113 patients were followed for a period of 6-144 months; 289 implants were placed in the patients evaluated. There were eight failures/losses of dental implants in the tuberosity region; the overall survival rate was 94.63% for these implants. In controlled studies, the cumulative survival rates for implants placed in the maxillary tuberosity and other maxillary regions were 96.1% and 95%, respectively. In conclusion, implants placed into the maxillary tuberosity are a predictable alternative for the treatment of patients with insufficient bone volume in the maxillary region. However, randomized trials are needed to assess the effectiveness of this treatment.

Selección del tratamiento farmacológico en el estado de mal epiléptico en niños

The status epilepticus (SE) is characterized by a series of crises which occur without recovery of consciousness or a single seizure lasting more than 30 minutes and can damage the central nervous system and systemic. The duration and frequency of attacks are directly related to patient prognosis. Whether seizures occur often and are longer, increase the risk of neurological and systemic complications. Child population has a higher frequency of seizures and it is associated with a lower threshold of immature brain to trigger these episodes. Aim: To determine the safest drugs prescribed for children in SE, their doses and schedules. A bibliographic survey was performed in electronic databases. Methods: The scientific health descriptors used for search was: “status epilecticus” and “anticonvulsivants” and “child”. Results: This strategy identified 396 manuscripts, of whom four were considered eligible for the study, after the assessment by floating reading and criteria. Of these, two were randomized trials and two descriptive. The studies address the use of oral midazolam, rectal diazepam and intravenous lorazepam. Conclusions: All investigated drugs were effective in treat in status epilepticus. Lorazepam is highlight, since it has fewer secondary effects and, as an alternative to the intravenous, oral midazolam. However, there is a need for further studies to demonstrate the efficacy and safety in the use of drugs in children.

Maintaining Tissue Perfusion in High-Risk Surgical Patients: A Systematic Review of Randomized Clinical Trials

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES)

Ximelagatran versus warfarin for prophylaxis of venous thromboembolism in major orthopedic surgery: systematic review of randomized controlled trials

INTRODUÇÃO: O ximelagatrano foi recentemente estudada para profilaxia do tromboembolismo venoso (TEV). OBJETIVO: Avaliar se o ximelagatrano comparado com a varfarina melhora a profilaxia do TEV em pacientes submetidos à cirurgia ortopédica do joelho. FONTE DE DADOS: Estudos randomizados identificados por pesquisa eletrônica na literatura médica, até 2006, cujos dados foram compilados no programa Review Manager, versão 4.2.5. RESULTADOS: Foram incluídos três estudos randomizados bem conduzidos envolvendo 4.914 participantes. Foram definidos dois sub-grupos com dosagens diferentes de ximelagatrano (24 mg and 36 mg, duas vezes ao dia). O tratamento com ximelagatrano mostrou freqüência significantemente menor de TEV que o tratamento com varfarina, mas somente na dosagem de 36-mg [risco relativo, RR 0.72 ([intervalo de confiança, IC, 95% 0.64, 0.81), p < 0.00001]. A freqüência de TEV no sub-grupo de 24-mg foi similar a da varfarina [RR 0.86 (IC 95% 0.73, 1.01), p = 0.06]. Para TEV maior, embolia pulmonar, sangramento e sangramento maior não houve diferença entre varfarina e a ximelagatrano. Ao final do tratamento, a elevação da alanino-aminotransferase (ALT) foi menos freqüente no sub-grupo de 24 mg de ximelagatrano que no grupo da varfarina [RR 0.33 (IC 95% 0.12, 0.91) p = 0.03], mas no período de acompanhamento essa elevação foi maior com 36 mg de ximelagatrano [RR 6.97 (IC 95% 1.26, 38.50) p = 0.03]. CONCLUSÃO: O ximelagatrano foi mais efetivo que a varfarina quando usado em dosagens maiores (36 mg, 2 vezes ao dia), mas às expensas de aumento de enzimas hepáticas no período de acompanhamento.

Cabergoline versus bromocriptine in the treatment of hyperprolactinemia: a systematic review of randomized controlled trials and meta-analysis

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Effects of motor intervention in elderly patients with dementia: An analysis of randomized controlled trials

The objective of this study was to analyze randomized controlled trials published in the last decades involving motor intervention as a treatment for dementia, based on Physiotherapy Evidence Database (PEDro) criteria. A database search was performed using the following keywords: randomized controlled trial, dementia, physiotherapy, physical therapy, occupational therapy, physical education, motor approach, exercise, and physical activity. Ten trials were found: 4 related to physiotherapy, 3 to occupational therapy, 1 to physical education, and 2 to interdisciplinary motor intervention. The efficacy of motor intervention was confirmed in the following variables: psychosocial function, physical health and function, affective status, and caregiver's distress (P < .05). Results related to mobility were not significant (P > .05). Behavior, cognitive performance, activities of daily living, and risk of falls were not similar among the articles. From a total score of 10 points, with excellence characterized as the highest punctuation, the articles were classified between 3 and 7 by PEDro. Motor intervention was shown to be an alternative for minimizing physical and mental decline. PEDro has been confirmed as a very reliable tool to analyze studies and as an evaluation criteria, both qualitative and quantitative, allowing the establishment of motor intervention strategies for the treatment of patients with dementia. © 2007 Lippincott Williams & Wilkins, Inc.

Systematic review of randomized controlled trials of new anticoagulants for venous thromboembolism prophylaxis in major orthopedic surgeries, compared with enoxaparin

Background: In the past 10 years, new anticoagulants (NACs) have been studied for venous thromboembolism (VTE) prophylaxis. Objective: To evaluate the risk/benefit profile of NACs versus enoxaparin for VTE prophylaxis in major orthopedic surgery. Methods: A systematic review of double-blind randomized phase III studies was performed. The search strategy was run from 2000 to 2011 in the main medical electronic databases in any language. Independent extraction of articles was performed by 2 authors using predefined data fields, including study quality indicators. Results: Fifteen published clinical trials evaluating fondaparinux, rivaroxaban, dabigatran, and apixaban were included. Primary efficacy (any deep vein thrombosis [DVT], nonfatal pulmonary embolism, or all-cause mortality) favored fondaparinux (relative risk [RR] 0.50; 95% CI, 0.39, 0.63) and rivaroxaban (RR, 0.50; 95% CI, 0.34, 0.73) over enoxaparin, although significant heterogeneity was observed in both series. The primary efficacy of dabigatran at 220 mg, apixaban, and bemiparin were similar, with RRs of 1.02 (95% CI, 0.86, 1.20), 0.63 (95% CI, 0.39, 1.01), and 0.87 (95% CI, 0.65, 1.17), respectively. The primary efficacy of dabigatran at 150 mg (RR, 1.20; 95% CI, 1.03, 1.41), was inferior to enoxaparin. The incidence of proximal DVT favored apixaban (RR, 0.45; 95% CI, 0.27, 0.75) only. Rivaroxaban (RR, 0.45; 95% CI, 0.27, 0,77) and apixaban (RR, 0.38; 95% CI, 0.16, 0.90) produced significantly lower frequencies of symptomatic DVT. The incidence of major VTE favored rivaroxaban (RR, 0.44; 95% CI, 0.25, 0.81), only. Bleeding risk was similar for all NACs, except fondaparinux (RR, 1.27; 95% CI, 1.04, 1.55), which exhibited a significantly higher any-bleeding risk compared with enoxaparin, and apixaban (RR, 0.88; 95% CI, 0.79, 0.99), which was associated with a reduced risk of any bleeding. Alanine amino transferase was significantly lower with 220 mg of dabigatran, (RR, 0.67; 95% CI, 0.79, 0.99) than with enoxaparin. Conclusions: NACs can be considered alternatives to conventional thromboprophylaxis regimens in patients undergoing elective major orthopedic surgery, depending on clinical characteristics and cost-effectiveness. The knowledge of some differences concerning efficacy or safety profile, pointed out in this systematic review, along with the respective limitations, may be useful in clinical practice. © 2013 Elsevier Inc. All rights reserved.

A quantitative and qualitative evaluation of reports of clinical trials published in six Brazilian dental journals indexed in the Scientific Electronic Library Online (SciELO)

Introduction: Open access publishing is becoming increasingly popular within the biomedical sciences. SciELO, the Scientific Electronic Library Online, is a digital library covering a selected collection of Brazilian scientific journals many of which provide open access to full-text articles. This library includes a number of dental journals some of which may include reports of clinical trials in English, Portuguese and/or Spanish. Thus, SciELO could play an important role as a source of evidence for dental healthcare interventions especially if it yields a sizeable number of high quality reports. Objective: The aim of this study was to identify reports of clinical trials by handsearching of dental journals that are accessible through SciELO, and to assess the overall quality of these reports. Material and methods: Electronic versions of six Brazilian dental Journals indexed in SciELO were handsearched at www.scielo.br in September 2008. Reports of clinical trials were identified and classified as controlled clinical trials (CCTs - prospective, experimental studies comparing 2 or more healthcare interventions in human beings) or randomized controlled trials (RCTs - a random allocation method is clearly reported), according to Cochrane eligibility criteria. Criteria to assess methodological quality included: method of randomization, concealment of treatment allocation, blinded outcome assessment, handling of withdrawals and losses and whether an intention-to-treat analysis had been carried out. Results: The search retrieved 33 CCTs and 43 RCTs. A majority of the reports provided no description of either the method of randomization (75.3%) or concealment of the allocation sequence (84.2%). Participants and outcome assessors were reported as blinded in only 31.2% of the reports. Withdrawals and losses were only clearly described in 6.5% of the reports and none mentioned an intention-to-treat analysis or any similar procedure. Conclusions: The results of this study indicate that a substantial number of reports of trials and systematic reviews are available in the dental journals listed in SciELO, and that these could provide valuable evidence for clinical decision making. However, it is clear that the quality of a number of these reports is of some concern and that improvement in the conduct and reporting of these trials could be achieved if authors adhered to internationally accepted guidelines, e. g. the CONSORT statement.

A comparison between diuretics and angiotensin-receptor blocker agents in patients with stage I hypertension (PREVER-treatment trial): Study protocol for a randomized double-blind controlled trial

Background: Cardiovascular disease is the leading cause of death in Brazil, and hypertension is its major risk factor. The benefit of its drug treatment to prevent major cardiovascular events was consistently demonstrated. Angiotensin-receptor blockers (ARB) have been the preferential drugs in the management of hypertension worldwide, despite the absence of any consistent evidence of advantage over older agents, and the concern that they may be associated with lower renal protection and risk for cancer. Diuretics are as efficacious as other agents, are well tolerated, have longer duration of action and low cost, but have been scarcely compared with ARBs. A study comparing diuretic and ARB is therefore warranted.Methods/design: This is a randomized, double-blind, clinical trial, comparing the association of chlorthalidone and amiloride with losartan as first drug option in patients aged 30 to 70 years, with stage I hypertension. The primary outcomes will be variation of blood pressure by time, adverse events and development or worsening of microalbuminuria and of left ventricular hypertrophy in the EKG. The secondary outcomes will be fatal or non-fatal cardiovascular events: myocardial infarction, stroke, heart failure, evidence of new subclinical atherosclerosis and sudden death. The study will last 18 months. The sample size will be of 1200 participants for group in order to confer enough power to test for all primary outcomes. The project was approved by the Ethics committee of each participating institution.Discussion: The putative pleiotropic effects of ARB agents, particularly renal protection, have been disputed, and they have been scarcely compared with diuretics in large clinical trials, despite that they have been at least as efficacious as newer agents in managing hypertension. Even if the null hypothesis is not rejected, the information will be useful for health care policy to treat hypertension in Brazil. Clinical trials registration number: ClinicalTrials.gov: NCT00971165. © 2011 Fuchs et al; licensee BioMed Central Ltd.

An alternative approach to deal with the absence of clinical trials: a proportional meta-analysis of case series studies

PURPOSE: Systematic reviews are criticized for frequently offering inconsistent evidences and absence of straightforward recommendations. Their value seems to be depreciated when the conclusions are uncertain. To describe an alternative approach of evaluating case series studies in health care when there is absence of clinical trials. METHODS: We provide illustrations from recent experiences. Proportional meta-analysis was performed on surgical outcomes: (a) case series studies, (b) use of cryoablation or radiofrequency ablation, and (c) patients with small renal cell carcinoma. The statistically significant difference between both interventions studied was defined if their combined 95% confidential interval (CI) did not overlap. RESULTS: As demonstrated by the example, this analysis is an alternative approach to provide some evidence of the intervention´s effects under evaluation and plotting all available case series in the absence of clinical trials for the health field. CONCLUSIONS: Although we are leading to a low level of evidence to determine efficacy, effectiveness and safety of interventions this alternative approach can help surgeons, physicians and health professionals for a provisionally decision in health care along with their clinical expertise and the patient´s wishes and circumstances in the absence of high-quality primary studies. It´s not a replacement for the gold standard randomized clinical trial, but an alternative analysis for clinical research.

Polidocanol versus hypertonic glucose for sclerotherapy treatment of reticular veins of the lower limbs: study protocol for a randomized controlled trial

Fundação de Amparo à Pesquisa do Estado de São Paulo (FAPESP)