Current practices in the use of sildenafil for pulmonary arterial hypertension in Brazilian hospitals

<p>Abstract</p> <p>Background</p> <p>Sildenafil is a cyclic guanosine monophosphate-specific phosphodiesterase-5 inhibitor used for treating pulmonary hypertension. Although the use of sildenafil in patients under 18 years old is off-label, this inhibitor has been widely prescribed for children treatment at hospitals in Brazil. In this work we evaluated the current practices in using sildenafil in the three main reference hospitals of Rio de Janeiro to design a clinical trial. Then we analyzed the content of sildenafil in powder paper preparations used in these institutions.</p> <p>Methods and Results</p> <p>We assessed the data about the use of sildenafil in three reference hospitals including Instituto Nacional de Cardiologia – INC, Instituto Estadual de Cardiologia Aloysio de Castro – IECAC and Hospital Pro-Cardíaco – HPC. The pharmacy records were analyzed from April 1st, 2008 to April 30th, 2008 and interviews with the pharmacists were also performed. Our results showed that INC used the greatest amount of sildenafil in: treatment of pulmonary arterial hypertension (PAH), management of transient PAH during surgery, preparation for cardiac transplantation and haemodynamic studies during cardiac catheterization. Meanwhile IECAC and HPC used sildenafil only for treating PAH in few patients during the period evaluated. In INC and IECAC, sildenafil was available in tablets, and powder papers prepared by two private pharmacies and one public hospital pharmacy. In contrast all patients of HPC received sildenafil in tablets with no external manipulation. Our quantification analysis results using reverse-phase high performance liquid chromatography method showed that powder papers prepared by the private pharmacies from the sildenafil tablets presented only 58.5 to 89.3% of the declared concentration in contrast to samples from the public hospital pharmacy (104.4 to 105.3%).</p> <p>Conclusion</p> <p>Few patients received the prescribed sildenafil dose at the reference hospitals evaluated in Rio de Janeiro, which may importantly compromise this inhibitor effect in the current treatment. This study reinforced the need of checking the practices of preparing and administering sildenafil continually.</p

TREC-Rio trial: a randomised controlled trial for rapid tranquillisation for agitated patients in emergency psychiatric rooms [ISRCTN44153243]

Agitated or violent patients constitute 10% of all emergency psychiatric treatment. Management guidelines, the preferred treatment of clinicians and clinical practice all differ. Systematic reviews show that all relevant studies are small and none are likely to have adequate power to show true differences between treatments. Worldwide, current treatment is not based on evidence from randomised trials. In Brazil, the combination haloperidol-promethazine is frequently used, but no studies involving this mix exist. TREC-Rio (Tranquilização Rápida-Ensaio Clínico [Translation: Rapid Tranquillisation-Clinical Trial]) will compare midazolam with haloperidol-promethazine mix for treatment of agitated patients in emergency psychiatric rooms of Rio de Janeiro, Brazil. TREC-Rio is a randomised, controlled, pragmatic and open study. Primary measure of outcome is tranquillisation at 20 minutes but effects on other measures of morbidity will also be assessed. TREC-Rio will involve the collaboration of as many health care professionals based in four psychiatric emergency rooms of Rio as possible. Because the design of this trial does not substantially complicate clinical management, and in several aspects simplifies it, the study can be large, and treatments used in everyday practice can be evaluated

Liquid vs Solid Culture Medium to Evaluate Proportion and Time to Change in Management of Suspects of Tuberculosis-A Pragmatic Randomized Trial in Secondary and Tertiary Health Care Units in Brazil.

BACKGROUND: The use of liquid medium (MGIT960) for tuberculosis (TB) diagnosis was recommended by WHO in 2007. However, there has been no evaluation of its effectiveness on clinically important outcomes. METHODS AND FINDINGS: A pragmatic trial was carried out in a tertiary hospital and a secondary health care unit in Rio de Janeiro City, Brazil. Participants were 16 years or older, suspected of having TB. They were excluded if only cerebral spinal fluid or blood specimens were available for analysis. MGIT960 technique was compared with the Lowenstein-Jensen (LJ) method for laboratory diagnosis of active TB. Primary outcome was the proportion of patients who had their initial medical management changed within 2 months after randomisation. Secondary outcomes were: mean time for changing the procedure, patient satisfaction with the overall treatment and adverse events. Data were analysed by intention-to-treat. Between April 2008 and September 2011, 693 patients were enrolled (348 to MGIT, 345 to LJ). Smear and culture results were positive for 10% and 15.7% of participants, respectively. Patients in the MGIT arm had their initial medical management changed more frequently than those in the LJ group (10.1% MGIT vs 3.8% LJ, RR 2.67 95% CI 1.44-.96, p = 0.002, NNT 16, 95% CI 10-39). Mean time for changing the initial procedure was greater in LJ group at both sites: 20.0 and 29.6 days in MGIT group and 52.2 and 64.3 in LJ group (MD 33.5, 95% CI 30.6-36.4, p = 0.0001). No other important differences were observed. CONCLUSIONS: This study suggests that opting for the MGIT960 system for TB diagnosis provides a promising case management model for improving the quality of care and control of TB. TRIAL REGISTRATION: Controlled-Trials.com ISRCTN79888843

Current practices in managing acutely disturbed patients at three hospitals in Rio de Janeiro-Brazil: a prevalence study

BACKGROUND: The medical management of aggressive and violent behaviour is a critical situation for which there is little evidence. In order to prepare for a randomised trial, due to start in the psychiatric emergency rooms of Rio de Janeiro in 2001, a survey of current practice was necessary. METHODS: A seven day survey of pharmacological management of aggressive people with psychosis in the emergency rooms of all four public psychiatric hospitals in Rio de Janeiro, Brazil. RESULTS: In one hospital data were not available. Of the 764 people with psychosis attending these ERs, 74 were given IM medication for rapid tranquillisation (9.7%, 2.1/week/100,000). A haloperidol-promethazine mix (with or without other drugs) was used for the majority of patients (83%). CONCLUSION: The haloperidol-promethazine mix, given intramuscularly for rapid tranquilization, is prevalent in Rio, where it is considered both safe and efficient. However, scientific evaluation of all pharmacological approaches to rapid tranquilization of psychotic people is inadequate or incomplete and a randomized trial of IM haloperidol-promethazine is overdue

Effectiveness of pharmacological treatments for severe agitation in real-world emergency settings: protocol of individual-participant-data network meta-analysis.

BACKGROUND Severe psychomotor agitation and aggression often require immediate pharmacological intervention, but clear evidence-based recommendations for choosing among the multiple options are lacking. To address this gap, we plan a systematic review and individual-participant-data network meta-analysis to investigate their comparative effectiveness in real-world emergency settings with increased precision. METHODS We will include randomized controlled trials investigating intramuscular or intravenous pharmacological interventions, as monotherapy or in combination, in adults with severe psychomotor agitation irrespective of the underlying diagnosis and requiring rapid tranquilization in general or psychiatric emergency settings. We will exclude studies before 2002, those focusing on specific reasons for agitation and placebo-controlled trials to avoid concerns related to the transitivity assumption and potential selection biases. We will search for eligible studies in BIOSIS, CENTRAL, CINAHL Plus, Embase, LILACS, MEDLINE via Ovid, PubMed, ProQuest, PsycINFO, ClinicalTrials.gov, and WHO-ICTRP. Individual-participant data will be requested from the study authors and harmonized into a uniform format, and aggregated data will also be extracted from the studies. At least two independent reviewers will conduct the study selection, data extraction, risk-of-bias assessment using RoB 2, and applicability evaluation using the RITES tool. The primary outcome will be the number of patients achieving adequate sedation within 30 min after treatment, with secondary outcomes including the need for additional interventions and adverse events, using odds ratios as the effect size. If enough individual-participant data will be collected, we will synthesize them in a network meta-regression model within a Bayesian framework, incorporating study- and participant-level characteristics to explore potential sources of heterogeneity. In cases where individual-participant data are unavailable, potential data availability bias will be explored, and models allowing for the inclusion of studies reporting only aggregated data will be considered. We will assess the confidence in the evidence using the Confidence in Network Meta-Analysis (CINeMA) approach. DISCUSSION This individual-participant-data network meta-analysis aims to provide a fine-tuned synthesis of the evidence on the comparative effectiveness of pharmacological interventions for severe psychomotor agitation in real-world emergency settings. The findings from this study can greatly be provided clearer evidence-based guidance on the most effective treatments. SYSTEMATIC REVIEW REGISTRATION PROSPERO CRD42023402365

The study of vancomycin use and its adverse reactions associated to patients of a brazilian university hospital

<p>Abstract</p> <p>Background</p> <p>Vancomycin is an antibiotic of growing importance in the treatment of hospital infections, with particular emphasis on its value in the fight against methicillin-resistant <it>Staphylococcus aureus</it>. However its usage profile must be evaluated to assure maximum benefit and minimum risk.</p> <p>Findings</p> <p>A cross-sectional retrospective study was carried out among inpatients that received vancomycin in a Brazilian quaternary hospital. The occurrence of adverse reactions reported was evaluated in medical records relating to patients taking vancomycin during a one year period. Males comprised 52% (95% CI: 41.7-60.2%) of the sample population, with a mean age of 50.6 (95% CI: 47.2-54.0) years and mean treatment period of 9.7 (95% CI: 8.0-11.5) Days. It was verified that nephrotoxicity occurred in 18.4% (95% CI: 11.3-27.5) of patients, Red man syndrome occurred in 2% (95% CI 0.2-7.2), while the occurrence of thrombocytopenia was 7.1% (95% CI: 2.9-14.2).</p> <p>Conclusions</p> <p>It may be noted that even after 50 years of use, adverse reactions associated with vancomycin continue with high frequency, presenting a public health problem, especially considering its current use in cases of multidrug resistant infections. In this context, we emphasize the importance of intensive pharmacovigilance in hospital as a surveillance tool after drug approval by the sanitary authority.</p

O uso prolongado de benzodiazepínicos em mulheres de um centro de convivência para idosos

Apesar das recomendações contra o uso prolongado de benzodiazepínicos em idosos, as pesquisas indicam que o uso desses medicamentos aumenta com a idade. O padrão de uso de benzodiazepínicos e os fatores associados ao uso prolongado destes foram examinados com base em um questionário padronizado, aplicado a 634 mulheres com mais de sessenta anos, participantes de um centro de convivência para idosos no Rio de Janeiro, entre maio de 1992 e dezembro de 1995. A prevalência de uso de benzodiazepínicos na última quinzena foi estimada em 21,3% (IC 95% 18,1-24,5), e a prevalência de uso diário por 12 meses ou mais em 7,4% (IC 95% 5,4-9,4). Em uma análise multivariada, o número de medicamentos consumidos mostrou uma associação importante e progressiva com o uso prolongado de benzodiazepínicos, com OR = 2,77 (IC 95% 1,17-6,57) para aquelas que consomem entre quatro a seis medicamentos e OR = 7,62 (IC 95% 3,18-18,26) para aquelas que consomem mais de sete medicamentos. Queixas de insônia (OR = 8,87 IC 95% 2,53-31,06) e cefaléia (OR = 3,53 IC 95% 1,82-6,89) também estiveram fortemente associadas a este padrão de uso

Haloperidol plus promethazine for agitated patients: a systematic review

Submitted by Alexandre Sousa ([email protected]) on 2015-12-01T12:36:28Z No. of bitstreams: 1 Rev_Bras_Psiq_31_265-270.pdf: 352715 bytes, checksum: 61c3ac77165f1c3a9ebeb1756727a6a6 (MD5)Approved for entry into archive by Alexandre Sousa ([email protected]) on 2015-12-01T12:51:35Z (GMT) No. of bitstreams: 1 Rev_Bras_Psiq_31_265-270.pdf: 352715 bytes, checksum: 61c3ac77165f1c3a9ebeb1756727a6a6 (MD5)Made available in DSpace on 2015-12-01T12:51:35Z (GMT). No. of bitstreams: 1 Rev_Bras_Psiq_31_265-270.pdf: 352715 bytes, checksum: 61c3ac77165f1c3a9ebeb1756727a6a6 (MD5) Previous issue date: 2009Fundação Oswaldo Cruz. Instituto Nacional de Controle de Qualidade em Saúde. Rio de Janeiro, RJ, Brasil.Fundação Oswaldo Cruz. Escola Nacional de Saúde Pública Sérgio Arouca. Rio de Janeiro, RJ, Brasil.University of Nottingham. Cochrane Schizophrenia Group. Nottingham, United KingdomOBJETIVO: A tranquilização farmacológica rápida e segura de episódios de agitação/agressividade é muitas vezes inevitável. Esta revisão investiga a efetividade da combinação haloperidol e prometazina intramuscular, muito utilizada no Brasil. MÉTODO: Através de busca nos registros do Cochrane Schizophrenia Group, foram incluídos todos os ensaios clínicos nos quais a combinação haloperidol e prometazina foi avaliada em pacientes agressivos com psicose. Todos os estudos relevantes foram avaliados quanto à qualidade e tiveram seus dados extraídos de forma confiável. RESULTADOS: Foram identificados quatro estudos relevantes de alta qualidade. A combinação haloperidol e prometazina foi comparada com midazolam, lorazepam, haloperidol isolado e olanzapina, todos administrados por via intramuscular. No Brasil, a combinação foi efetiva, com mais de 2/3 dos pacientes tranquilos em 30 minutos, mas midazolam foi mais rápido. Na Índia, comparado a lorazepam, a combinação haloperidol e prometazina foi mais efetiva. Após as primeiras horas, as diferenças foram negligenciáveis. O uso de haloperidol isolado acarretou maior incidência de efeitos adversos. Olanzapina promove tranquilização tão rapidamente quanto a combinação, mas não tem efeito tão duradouro e mais pessoas necessitaram medicação adicional nas quatro horas subseqüentes. CONCLUSÃO: Todos os medicamentos avaliados são eficazes, mas esta revisão demonstra vantagens no uso da combinação haloperidol e prometazina.OBJECTIVE: Rapid and safe tranquillisation is sometimes unavoidable. We conducted this systematic review to determine the value of the combination haloperidol plus promethazine, frequently used in Brazil. METHOD: We searched the Cochrane Schizophrenia Group’s Register and included all randomised clinical trials involving aggressive people with psychosis for which haloperidol plus promethazine was being used. We reliably selected, quality assessed and extracted data from all relevant studies. RESULTS: We identified four relevant high quality studies. The combination haloperidol plus promethazine mix was compared with midazolam, lorazepam, haloperidol alone and olanzapine Intramuscular. In Brazil, haloperidol plus promethazine was effective with over 2/3 of people being tranquil by 30 minutes, but midazolam was more swift and in India, compared with lorazepam, the combination was more effective. Over the next few hoursreported differences are negligible. Haloperidol given without promethazine in this situation causes frequent serious adverse effects. Olanzapine is as rapidly tranquillising as haloperidol plus promethazine, but did not have an enduring effect and more people needed additional drugs within 4 hours. CONCLUSION: All treatments evaluated are effective, but this review provides compelling evidence as to clear advantages of the haloperidol plus promethazine combination