Safety of zidovudine dose reduction in treatment-naïve HIV infected patients. A randomized controlled study (MiniZID).

BACKGROUND: Since September 2014, zidovudine (ZDV)-based therapy for HIV has been the preferred second-line WHO regimen in Cameroon, but its use is limited by the risk of anaemia at standard dosage. We assessed the safety of a reduced vs. standard dose of ZDV to decrease the risk of anaemia in treatment-naïve, HIV-infected individuals. METHODS: In a prospective, randomized, open-label trial in an HIV clinic in Cameroon, 142 eligible adults (CD4 count < 350 cells/µL) were randomized to receive 24 weeks of a regimen comprising lamivudine plus nevirapine with either a reduced (400 mg) or standard dose (600 mg) of ZDV. The primary endpoint was the proportion of participants with new/worsening anaemia. RESULTS: Median age was 35 years; 58.5% were women; median body mass index was 23.2 kg/m(2) . At baseline, median haemoglobin was 11.6 g/dL, median CD4 cell count was 163 cells/µL, and median plasma HIV-1 RNA load was 5.4 log10 copies/mL. The proportion of participants with new/worsening anaemia was 37.5% (400 mg ZDV) and 32.9% (600 mg ZDV) (P = 0.563). Ten patients with severe anaemia required a switch from ZDV to tenofovir (11.4% in standard-dose arm vs. 2.8% in low-dose arm; P = 0.054). At 24 weeks, there was no significant difference between treatment groups, including median CD4 T-cell count increases. CONCLUSIONS: No significant difference was observed in the overall rate of anaemia between HIV-infected individuals starting a ZDV-based treatment according to a standard- or reduced-dose regimen. Severe anaemia and treatment switches related to study drug, however, were more frequent with 600 mg than 400 mg ZDV.

Neumonía intrahospitalaria: guía clínica aplicable a Latinoamérica preparada en común por diferentes especialistas / Clinical guidelines for the treatment of nosocomial pneumonia in Latin America an interdisciplinary consensus document

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Consenso argentino de ventilación no invasiva / Argentine consensus of non-invasive ventilation

Non-invasive ventilation (NIV) is nowadays increasingly used. The significant decrease in tracheal intubation related complications makes it particularly attractive in patients with moderately acute respiratory failure (ARF) who still have some degree of respiratory autonomy. It has also been used to support patients with chronic respiratory failure. However, final outcomes are variable according to the conditions which determined its application. This Consensus was performed in order to review the evidence supporting the use of positive pressure NIV. The patho-physiological background of NIV and the equipment required technology are described. Available evidence clearly suggests benefits of NIV in acute exacerbation of chronic obstructive pulmonary disease (COPD) and in cardiogenic pulmonary edema (Recommendation A). When considering ARF in the setting of acute respiratory distress syndrome results are uncertain, unless dealing with immunosupressed patients (Recommendation B). Positive results are also shown in weaning of mechanical ventilation (MV), particularly regarding acute exacerbation of COPD patients (Recommendation A). An improved quality of life in chronic respiratory failure and a longer survival in restrictive disorders has also been shown (Recommendation B) while its benefit in stable COPD patients is still controversial (Recommendation C). NIV should be performed according to pre-established standards. A revision of NIV related complications is performed and the cost-benefit comparison with invasive MV is also considered.(AU)

La ventilación no invasiva (VNI) ha alcanzado notable difusión en los últimos años. El ahorro delas complicaciones causadas por la intubación traqueal la hace especialmente atractiva en pacientesque presentan insuficiencia respiratoria aguda (IRA) no muy grave y que conservan cierta autonomía respiratoria.También se han descripto efectos terapéuticos en pacientes con insuficiencia respiratoria crónica de etiologías diversas. No obstante, los resultados obtenidos son variables según las circunstancias que motivan su aplicación. A fin de revisar la evidencia a favor de su uso se elaboró este Consenso referido particularmente a la VNI a presión positiva. Se describen su fundamento fisiopatológico, esencial para su correcta aplicación, y elequipamiento necesario para implementarla. La evidencia existente en la literatura establece definida utilidad de la VNI en la exacerbación de la EPOC y en el edema agudo de pulmón cardiogénico (Recomendación A).Su beneficio es aún incierto en pacientes con IRA secundaria a síndrome de dificultad respiratoria aguda, salvoen el subgrupo de pacientes inmunosuprimidos (Recomendación B). Los resultados son también favorablesen la desvinculación de la asistencia respiratoria mecánica (ARM), especialmente en pacientes ventilados por exacerbación de EPOC (Recomendación A). En la insuficiencia respiratoria crónica se ha hallado mejoría en la calidad de vida y mayor sobrevida en pacientes con enfermedades restrictivas (Recomendación B), mientrasque existe aún controversia sobre su utilidad en pacientes con EPOC estable (Recomendación C). La VNI debeser aplicada con estándares de cuidados que son establecidos. Se revisan las eventuales complicaciones derivadasde su uso y el beneficio costo-efectividad ahorrando recursos de mayor complejidad y disminuyendolos riesgos que implica la ARM invasiva.(AU)

Consenso argentino de ventilación no invasiva / Argentine consensus of non-invasive ventilation

Non-invasive ventilation (NIV) is nowadays increasingly used. The significant decrease in tracheal intubation related complications makes it particularly attractive in patients with moderately acute respiratory failure (ARF) who still have some degree of respiratory autonomy. It has also been used to support patients with chronic respiratory failure. However, final outcomes are variable according to the conditions which determined its application. This Consensus was performed in order to review the evidence supporting the use of positive pressure NIV. The patho-physiological background of NIV and the equipment required technology are described. Available evidence clearly suggests benefits of NIV in acute exacerbation of chronic obstructive pulmonary disease (COPD) and in cardiogenic pulmonary edema (Recommendation A). When considering ARF in the setting of acute respiratory distress syndrome results are uncertain, unless dealing with immunosupressed patients (Recommendation B). Positive results are also shown in weaning of mechanical ventilation (MV), particularly regarding acute exacerbation of COPD patients (Recommendation A). An improved quality of life in chronic respiratory failure and a longer survival in restrictive disorders has also been shown (Recommendation B) while its benefit in stable COPD patients is still controversial (Recommendation C). NIV should be performed according to pre-established standards. A revision of NIV related complications is performed and the cost-benefit comparison with invasive MV is also considered.

La ventilación no invasiva (VNI) ha alcanzado notable difusión en los últimos años. El ahorro delas complicaciones causadas por la intubación traqueal la hace especialmente atractiva en pacientesque presentan insuficiencia respiratoria aguda (IRA) no muy grave y que conservan cierta autonomía respiratoria.También se han descripto efectos terapéuticos en pacientes con insuficiencia respiratoria crónica de etiologías diversas. No obstante, los resultados obtenidos son variables según las circunstancias que motivan su aplicación. A fin de revisar la evidencia a favor de su uso se elaboró este Consenso referido particularmente a la VNI a presión positiva. Se describen su fundamento fisiopatológico, esencial para su correcta aplicación, y elequipamiento necesario para implementarla. La evidencia existente en la literatura establece definida utilidad de la VNI en la exacerbación de la EPOC y en el edema agudo de pulmón cardiogénico (Recomendación A).Su beneficio es aún incierto en pacientes con IRA secundaria a síndrome de dificultad respiratoria aguda, salvoen el subgrupo de pacientes inmunosuprimidos (Recomendación B). Los resultados son también favorablesen la desvinculación de la asistencia respiratoria mecánica (ARM), especialmente en pacientes ventilados por exacerbación de EPOC (Recomendación A). En la insuficiencia respiratoria crónica se ha hallado mejoría en la calidad de vida y mayor sobrevida en pacientes con enfermedades restrictivas (Recomendación B), mientrasque existe aún controversia sobre su utilidad en pacientes con EPOC estable (Recomendación C). La VNI debeser aplicada con estándares de cuidados que son establecidos. Se revisan las eventuales complicaciones derivadasde su uso y el beneficio costo-efectividad ahorrando recursos de mayor complejidad y disminuyendolos riesgos que implica la ARM invasiva.

Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease.

The efficacy and safety of budesonide/formoterol in a single inhaler compared with placebo, budesonide and formoterol were evaluated in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD). In a 12-month, randomised, double-blind, placebo-controlled, parallel-group study in 812 adults (mean age 64 yrs, mean forced expiratory volume in one second (FEV1) 36% predicted normal), patients received two inhalations twice daily of either budesonide/formoterol (Symbicort) 160/4.5 microg (delivered dose), budesonide 200 microg (metered dose), formoterol 4.5 microg or placebo. Severe exacerbations and FEV1 (primary variables), peak expiratory flow (PEF), COPD symptoms, health-related quality of life (HRQL), mild exacerbations, use of reliever beta2-agonist and safety variables were recorded. Budesonide/formoterol reduced the mean number of severe exacerbations per patient per year by 24% versus placebo and 23% versus formoterol. FEV1 increased by 15% versus placebo and 9% versus budesonide. Morning PEF improved significantly on day 1 versus placebo and budesonide; after 1 week, morning PEF was improved versus placebo, budesonide and formoterol. Improvements in morning and evening PEF versus comparators were maintained over 12 months. Budesonide/formoterol decreased all symptom scores and use of reliever beta2-agonists significantly versus placebo and budesonide, and improved HRQL versus placebo. All treatments were well tolerated. These results suggest a role for budesonide/formoterol in the long-term management of moderate-to-severe chronic obstructive pulmonary disease.

[Respiratory failure in the Guillain Barré syndrome]. / Compromiso respiratorio en el síndrome de Guillain Barré.

Severe involvement of the respiratory muscles is seen in 25% of patients with a diagnosis of Guillain Barré syndrome. In order to evaluate the clinical characteristics and evolution of this disorder we reviewed the clinical records of patients admitted with this diagnosis to our Hospital between January 1987 and December 1996. We identified 44 patients with respiratory failure. The age was 34.0 +/- 14.1 years, 31 patients were male and 13 female; 70.5% required mechanical ventilation (MV). The time elapsed between the beginning of symptoms and MV was 9.4 +/- 8.0 days. Total duration of MV was 1,224 +/- 1,208 hours. Patients who required ventilatory support during the first 48 hours of evolution had a significantly longer duration of MV compared to the rest of the group (2,100 +/- 2,076 vs 934 +/- 735 hours, p < 0.05). Two of the survivors needed ventilatory support for more than 6 months. All patients showed quadriparesia, 55% had cranial nerve involvement and 43% had autonomic dysregulation. Twenty-four percent had a positive serologic titer for cytomegalovirus infection. The vital capacity measured before the beginning of MV was 1,050 +/- 378 ml and at discharge 2,837 +/- 1,080 ml. Mortality was 18%, with a higher mean age among those who died (44.9 +/- 17.5 years vs 31.9 +/- 12.5, p < 0.02). Mortality was also related to sepsis, barotrauma and severe autonomic dysfunction. In our group, we identified male preponderance, a high percentage of MV with an extended duration, and a longer MV time in the group of patients with a faster evolution.

Compromiso respiratorio en el síndrome de Guillain Barré. / [Respiratory failure in the Guillain Barré syndrome]

Severe involvement of the respiratory muscles is seen in 25

of patients with a diagnosis of Guillain Barré syndrome. In order to evaluate the clinical characteristics and evolution of this disorder we reviewed the clinical records of patients admitted with this diagnosis to our Hospital between January 1987 and December 1996. We identified 44 patients with respiratory failure. The age was 34.0 +/- 14.1 years, 31 patients were male and 13 female; 70.5

required mechanical ventilation (MV). The time elapsed between the beginning of symptoms and MV was 9.4 +/- 8.0 days. Total duration of MV was 1,224 +/- 1,208 hours. Patients who required ventilatory support during the first 48 hours of evolution had a significantly longer duration of MV compared to the rest of the group (2,100 +/- 2,076 vs 934 +/- 735 hours, p < 0.05). Two of the survivors needed ventilatory support for more than 6 months. All patients showed quadriparesia, 55

had cranial nerve involvement and 43

had autonomic dysregulation. Twenty-four percent had a positive serologic titer for cytomegalovirus infection. The vital capacity measured before the beginning of MV was 1,050 +/- 378 ml and at discharge 2,837 +/- 1,080 ml. Mortality was 18

, with a higher mean age among those who died (44.9 +/- 17.5 years vs 31.9 +/- 12.5, p < 0.02). Mortality was also related to sepsis, barotrauma and severe autonomic dysfunction. In our group, we identified male preponderance, a high percentage of MV with an extended duration, and a longer MV time in the group of patients with a faster evolution.