The reasons of the nursing staff to notify adverse events

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

Overall-Mouth Disinfection by Photodynamic Therapy Using Curcumin

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

Cirurgia a laser e anestesia

JUSTIFICATIVA E OBJETIVOS: As cirurgias com a utilização do laser apresentam riscos para o paciente e para a equipe médica. O objetivo deste artigo é apresentar noções básicas sobre o laser e regras para aumentar a segurança dos procedimentos com sua utilização. CONTEÚDO: O presente artigo contém noções de física aplicadas ao laser, regras de segurança e a conduta em caso de ocorrência de eventos adversos com a utilização do laser. CONCLUSÕES: Concluímos que, quando manipulado por profissionais treinados, e respeitadas as normas de segurança, o laser é útil e seguro, tanto para o paciente quanto para a equipe médica.

Caracterização das quedas de pacientes segundo notificação em boletins de eventos adversos

Este estudo foi desenvolvido com o objetivo de caracterizar as quedas de pacientes internados ocorridas em hospital terciário. Foram analisados 826 Boletins de Notificação de Eventos Adversos, de um período de 30 meses, que registraram 0,30 quedas por 1000 pacientes/dia. Quedas do leito foram mais frequentes (55%), com maior prevalência na enfermaria de neurologia. Maior frequência de quedas foi verificada no período noturno (63,7%), nos primeiros cinco dias da admissão (61,7%), nos pacientes de sexo masculino (57,5%) e na faixa etária maior de 60 anos (50%). Nos casos de quedas do leito, os diagnósticos relacionaram-se a doenças infecciosas e parasitárias (18,2%), doenças do sistema nervoso (18,2%) e doenças do aparelho circulatório (13,7%). Nas quedas da própria altura, os diagnósticos relacionaram-se a neoplasias (19,4%) e doenças do aparelho geniturinário (16,1%). A caracterização desses eventos adversos auxilia no reconhecimento dos grupos de maior risco e na elaboração de propostas preventivas.

Eventos adversos: análise de um instrumento de notificação utilizado no gerenciamento de enfermagem

A direção de enfermagem de um hospital universitário terciário da região Centro-Sul do Estado de São Paulo, visando a segurança do paciente e o estabelecimento de meio de comunicação entre equipe e direção, implementou em janeiro de 2004 o Boletim de Notificação de Eventos Adversos. O objetivo deste estudo foi analisar a utilização deste instrumento de comunicação e identificar: frequência, tipo, natureza e período dos incidentes/eventos adversos. Realizou-se análise descritiva dos dados de 826 boletins elaborados no período de janeiro/2004 a junho/2006. Verificou-se adesão à utilização do instrumento. Predominaram notificações de ocorrências assistenciais, embora notificações administrativas tenham apresentado número crescente de registros. Eventos adversos mais frequentes relacionaram-se à medicação, quedas, cateteres, sondas/drenos e integridade da pele. A praticidade do instrumento viabilizou sua utilização também por auxiliares e técnicos de enfermagem. A análise sistematizada e acompanhamento dos eventos adversos associados aos recursos de comunicação mostraram-se fundamentais para a segurança do paciente.

Fluvoxamina no transtorno depressivo maior: um estudo multicêntrico aberto

OBJETIVO: Este trabalho estudou a eficácia e a tolerabilidade da fluvoxamina no tratamento, de forma aberta, sem comparação com placebo ou outros agentes, por 6 semanas, de pacientes com o diagnóstico de transtorno depressivo maior (TDM). Constitui-se em objetivo secundário do estudo avaliar os efeitos da fluvoxamina sobre o sono dos pacientes. MÉTODOS: Foram incluídos 104 pacientes, maiores de 18 anos, com o diagnóstico de TDM, de acordo com os critérios do Manual Diagnóstico e Estatístico de Transtornos Mentais, 4ª edição (DSM-IV), e com escores, na Escala de Hamilton para Depressão, versão de 17 itens (HAM-D 17), de 17 pontos ou mais. Avaliou-se a eficácia da fluvoxamina por meio das Escalas HAM-D 17 e da CGI (Impressão Clínica Global). A análise dos itens 4, 5 e 6 da HAM-D 17 foi utilizada para a avaliação do sono dos pacientes. Avaliaram-se a segurança e a tolerabilidade da fluvoxamina ao longo das 6 semanas, registrando-se quaisquer eventos adversos. A fluvoxamina foi inicialmente ministrada em doses de 50 ou 100 mg/dia, podendo haver aumentos progressivos até 300 mg/dia. RESULTADOS: Dos 104 pacientes incluídos, 81 (78%) concluíram o estudo. Obtiveram resposta favorável (diminuição de 50% ou mais na HAM-D 17) 69% dos pacientes, e a taxa de remissão (HAM-D 17 < 7) foi de 52%. A análise da CGI indicou ter havido melhora significante (p < 0,001) em relação aos escores de base. A análise específica dos itens relativos ao sono, na HAM-D 17, revelou melhora significativa já na segunda visita, mantendo-se ao longo das 6 semanas. Os eventos adversos foram os esperados para inibidores seletivos de recaptação da serotonina, predominando as queixas gastrointestinais, em sua maioria transitórias e de pequena intensidade. CONCLUSÃO: O estudo vem confirmar a eficácia e a tolerabilidade da fluvoxamina no tratamento do transtorno depressivo maior, assim como sua eficácia no tratamento das alterações do sono encontradas nos pacientes deprimidos. O perfil de eventos adversos foi o esperado para os ISRS, ressaltando-se o fato de que poucos pacientes relataram disfunção sexual (2,5% dos pacientes).

Coronariografia via transradial: curva de aprendizagem, avaliada por estudo multicêntrico

INTRODUÇÃO: A via de acesso femoral tem sido a preferida para os procedimentos diagnósticos e terapêuticos coronarianos, mas apresenta limitações, principalmente relacionadas a complicações vasculares e hemorrágicas. O aces-so transradial é uma técnica mais recentemente empregada com o objetivo principal de diminuir essas complicações, além de produzir maior conforto e redução dos custos de hospitalização, embora com maior curva de aprendizagem. O objetivo deste estudo foi avaliar a realização de coronariografia transradial, executada por operadores sem experiência na técnica, e comparar com a abordagem clássica (Sones e femoral) em termos de sucesso do procedimento e complicações, analisando a influência da curva de aprendizagem. MÉTODO: Estudo multicêntrico realizado em 14 hospitais do interior de São Paulo, no período de um ano. Foram randomizados mil pacientes de maneira equivalente para as técnicas transradial ou clássica. RESULTADOS: A taxa de sucesso em ambos os grupos foi similar (97,8% vs. 98,5%; P = 0,47). No grupo clássico, 95,2% dos procedimentos foram realizados pela técnica de Sones. O número de cateteres utilizados, a duração do procedimento e o tempo de exposição aos raios X foram maiores no grupo transradial (P < 0,001). Não houve diferença quanto às complicações maiores (morte, infarto e acidente vascular cerebral) e quanto às complicações vasculares e hemorrágicas. Os grupos que realizaram mais de 100 procedimentos pela artéria radial (3 centros/5 operadores) obtiveram menor taxa de insucesso (1,6% vs. 3,6%; P = 0,04). CONCLUSÃO: Um período de aprendizagem para a realização de procedimentos pela via transradial mostra-se necessário, porém não se acompanha de menor índice de sucesso, nem tampouco de maior taxa de complicações para os pacientes.

CHARACTERISTICS OF ARTERIAL-HYPERTENSION IN RESPONSE TO BOLUS INJECTION OF PHENYLEPHRINE IN ATROPINIZED PATIENTS

The changes of arterial pressure promoted by bolus injection of 50 mg phenylephrine (PHE) were studied in 20 atropinized patients (5 normal subjects, 13 patients with mitral valve disease, 1 patient with essential arterial hypertension and 1 patient with hypertrophic cardiomyopathy) submitted to routine catheterism. Patients with aortic valve disease, left ventricular outflow tract obstruction and intracardiac shunt were excluded from the study. All patients were in sinus rhythm, without heart failure. Arterial pressure started to increase at 14.8 +/- 5.4 s (range, 5.6 to 27 s; mean +/- SD) after PHE. There was an increase of 37.8 +/- 16.7 mmHg (range, 12.5 to 70 mmHg) in systolic pressure and of 26.6 +/- 11.1 mmHg (range, 7.5 to 42.5 mmHg) in diastolic pressure. Peak hypertension was attained at 36.6 +/- 16.4 s (range, 10.8 to 64.9 s) and hypertension continued for 176 +/- 92 s (range, 11 to 365 s). Heart rate was 114 +/- 21 bpm before PHE and 111 +/- 21 bpm (P<0.05) after PHE. There were no adverse events associated with intravenous PHE injection in any patient, in accordance with the general view that bolus injection of PHE is a safe and practical maneuver to promote arterial hypertension.

Effectiveness and safety of a new vaginal misoprostol product specifically labeled for cervical ripening and labor induction

Objective. The purpose of this study was to evaluate the effectiveness and safety of misoprostol in two different formulations: vaginal tablets of 25 mu g and one-eighth of a 200-mu g oral tablet, also administered intravaginally, for cervical ripening and labor induction of term pregnancies with an indication for that. Methods. A single-blind, randomized, controlled clinical trial was carried out in 120 pregnant women who randomly received one of the two formulations. The main dependent variables were mode of delivery, need for additional oxytocin, time between beginning of induction and delivery, perinatal results, complications, and maternal side effects. Student's t, Mann-Whitney, chi(2), Fisher's Exact, Wilcoxon and Kolmogorov-Smirnoff tests, as well as survival analysis, were used in the data analysis. Results. There were no significant differences between the groups in terms of general characteristics, uterine contractility, and fetal well-being during labor, cesarean section rates, perinatal outcomes, or maternal adverse events. The mean time between the beginning of cervical ripening and delivery was 31.3 h in the vaginal tablet group and 30.1 h in the oral tablet group, a difference that was not statistically significant. Conclusion. The results showed that the 25-mu g vaginal tablets of misoprostol were as effective and safe for cervical ripening and labor induction as the dose-equivalent fraction of 200-mu g oral tablets.

The results of a randomized trial looking at 24 weeks vs 48 weeks of treatment with peginterferon alpha-2a (40 kDa) and ribavirin combination therapy in patients with chronic hepatitis C genotype 1

Peginterferon-alpha plus ribavirin is the most effective therapy for chronic hepatitis C. This study was designed to evaluate the effect of peginterferon alpha-2a (40 kDa) plus ribavirin on sustained virological response (SVR) when administered for 24 vs 48 weeks in genotype 1 naive patients. One hundred and seventeen patients were enrolled in this controlled trial. Genotype 1 patients were randomized to 24 weeks treatment vs 48 weeks treatment. Genotype non-1 patients received 24 weeks treatment as an observational group. Outcomes were SVR (defined by hepatitis C virus-RNA-negative at week 24 of follow-up) and tolerability across the study period. The end-of-treatment response was 59% for genotype 1 (24 weeks treatment), 80% for genotype 1 (48 weeks treatment) and 92% for genotype non-1 (24 weeks treatment). The end-of-follow-up response was 19% (95% confidence interval (CI): 7.2-36.4) (genotype 1, 24 weeks) and 48% (95% CI: 30.2-66.9; P = 0.0175) (genotype 1, 48 weeks). Among genotype non-1, SVR was 76% (95% CI: 62.3-86.5). There were no unexpected adverse events.Almost half of the genotype 1 patients achieved an SVR after 48 weeks treatment with peginterferon alpha-2a (40 kDa) and low-dose ribavirin and confirmed that they should be treated for 48 weeks. Safety profile was acceptable.

A phase III randomized double-blind placebo-controlled clinical trial to determine the efficacy of low level laser therapy for the prevention of oral mucositis in patients undergoing hematopoietic cell transplantation

Introduction Oral mucositis (OM) is a significant early complication of hematopoietic cell transplantation (HCT). This phase III randomized double-blind placebo-controlled study was designed to compare the ability of 2 different low level GaAlAs diode lasers (650 nm and 780 nm) to prevent oral mucositis in HCT patients conditioned with chemotherapy or chemoradiotherapy.Materials and methods Seventy patients were enrolled and randomized into 1 of 3 treatment groups: 650 nm laser, 780 nm laser or placebo. All active laser treatment patients received daily direct laser treatment to the lower labial mucosa, right and left buccal mucosa, lateral and ventral surfaces of the tongue, and floor of mouth with energy densities of 2 J/cm(2). Study treatment began on the first day of conditioning and continued through day +2 post HCT. Mucositis and oral pain was measured on days 0, 4, 7, 11, 14, 18, and 21 post HCT.Results the 650 nm wavelength reduced the severity of oral mucositis and pain scores. Low level laser therapy was well-tolerated and no adverse events were noted.Discussion While these results are encouraging, further study is needed to truly establish the efficacy of this mucositis prevention strategy. Future research needs to determine the effects of modification of laser parameters (e.g., wavelength, fluence, repetition rate of energy delivery, etc.) on the effectiveness of LLE laser to prevent OM.

An open-label, comparative study of the efficacy and safety of once-daily dose of enoxaparin versus unfractionated heparin in the treatment of proximal lower limb deep-vein thrombosis

Background: Treatment of deep-vein thrombosis (DVT) with a once-daily regimen of enoxaparin, rather than a continuous infusion of unfractionated heparin (UFH) is more convenient and allows for home care in some patients. This study was designed to compare the efficacy and safety of these two regimens for the treatment of patients with proximal lower limb DVT. Methods: 201 patients with proximal lower limb DVT from 13 centers in Brazil were randomized in an open manner to receive either enoxaparin [1.5 mg/kg subcutaneous (s.c.) OD] or intravenous (i.v.) UFH (adjusted to aPTT 1.5-2.5 times control) for 5-10 days. All patients also received warfarin (INR 2-3) for at least 3 months. The primary efficacy endpoint Was recurrent DVT (confirmed by venography or ultrasonography), and safety endpoints included bleeding and serious adverse events. The rate of pulmonary embolism (PE) was also collected. Hospitalization was at the physician's discretion. Results: Baseline patient characteristics were comparable between groups. The duration of hospital stay was significantly shorter with enoxaparin than with UFH (3 versus 7 days). In addition, 36% of patients receiving enoxaparin did not need to be hospitalized, whereas all of the patients receiving UFH were! hospitalized. The treatment duration was slightly longer with enoxaparin (8 versus 7 days). There was a nonsignificant trend toward a reduction in the rate of recurrent DVT with enoxaparin versus UFH, and similar safety. Conclusions: A once-daily regimen of enoxaparin 1.5 mg/kg subcutaneous is at least as effective and safe as conventional treatment with a continuous intravenous infusion of UFH. However, the once daily enoxaparin regimen is easier to administer (subcutaneous versus intravenous), does not require aPTT monitoring, and leads to both a reduced number of hospital admissions and an average 4-day-shorter hospital stay. (C) 2004 Elsevier Ltd. All rights reserved.

Intraoperative bleeding during vitrectomy for diabetic tractional retinal detachment with versus without preoperative intravitreal bevacizumab (IBeTra study)

Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq)

Panretinal photocoagulation versus PRP plus intravitreal bevacizumab for high-risk proliferative diabetic retinopathy (IBeHi study)

Purpose: To evaluate the effects of panretinal photocoagulation (PRP) compared with PRP plus intravitreal bevacizumab on best corrected visual acuity (BCVA) and total area of fluorescein leakage from active new vessels (NVs) in patients with high-risk proliferative diabetic retinopathy (PDR).Methods: We carried out a prospective study of patients with high-risk PDR and no prior laser treatment who were randomly assigned to receive PRP (PRP group) or PRP plus intravitreal injection of 1.5 mg of bevacizumab (PRP-plus group). In all patients, the PRP was administered at two time-points (weeks 1 and 3), with the intravitreal bevacizumab delivered at the end of the second laser episode in the PRP-plus group. Standardized ophthalmic evaluation including Early Treatment Diabetic Retinopathy Study BCVA as well as stereoscopic fundus photography and fluorescein angiography were performed at baseline and at weeks 4, 9 (+/- 1) and 16 (+/- 2). Main outcome measures included changes in BCVA and in total area of fluorescein leakage from active NVs.Results: Twenty-two (n = 30 eyes) consecutive patients completed the 16-week follow-up. There was no significant difference between the PRP and PRP-plus groups with respect to age, gender, type or duration of diabetes, area of fluorescein leakage from active NVs or BCVA. No significant difference in BCVA was observed between the groups throughout the study period. However, the total area of actively leaking NVs was significantly reduced in the PRP-plus group compared with the PRP group at weeks 4, 9 and 16 (p < 0.001). No major adverse events were identified.Conclusions: In the short-term, the adjunctive use of intravitreal bevacizumab with PRP was associated with a greater reduction in the area of active leaking NVs than PRP alone in patients with high-risk PDR.

Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial

Background Some children with juvenile idiopathic arthritis either do not respond, or are intolerant to, treatment with disease-modifying antirheumatic drugs, including anti-tumour necrosis factor (TNF) drugs. We aimed to assess the safety and efficacy of abatacept, a selective T-cell costimulation modulator, in children with juvenile idiopathic arthritis who had failed previous treatments.Methods We did a double-blind, randomised controlled withdrawal trial between February, 2004, and June, 2006. We enrolled 190 patients aged 6-17 years, from 45 centres, who had a history of active juvenile idiopathic arthritis; at least five active joints; and an inadequate response to, or intolerance to, at least one disease-modifying antirheumatic drug. All 190 patients were given 10 mg/kg of abatacept intravenously in the open-label period of 4 months. of the 170 patients who completed this lead-in course, 47 did not respond to the treatment according to predefined American College of Rheumatology (ACR) paediatric criteria and were excluded. of the patients who did respond to abatacept, arthritis, and 62 were randomly assigned to receive placebo at the same dose and timing. The primary endpoint was time to flare of arthritis. Flare was defined as worsening of 30% or more in at least three of six core variables, with at least 30% improvement in no more than one variable. We analysed all patients who were treated as per protocol. This trial is registered, number NCT00095173.Findings Flares of arthritis occurred in 33 of 62 (53%) patients who were given placebo and 12 of 60 (20%) abatacept patients during the double-blind treatment (p=0.0003). Median time to flare of arthritis was 6 months for patients given placebo (insufficient events to calculate IQR); insufficient events had occurred in the abatacept group for median time to flare to be assessed (p=0.0002). The risk of flare in patients who contined abatacept was less than a third of that for controls during that double-blind period (hazard ratio 0.31, 95% CI 0.16-0.95). During the double-blind period, the frequency of adverse events did not differ in the two treatment groups, Adverse events were recorded in 37 abatacept recipients (62%) and 34 (55%) placebo recipients (p=0.47); only two serious adverse events were reported, bouth in controls (p=0.50).Interpretation Selective modulation of T-cell costimulation with abatacept is a rational alternative treatment for children with juvenile idiopathic arthritis.Funding Bristol-Myers Squibb.