Comparison of the efficacy and safety of ciclesonide 160 μg once daily vs. budesonide 400 μg once daily in children with asthma

Ciclesonide is an onsite-activated inhaled corticosteroid (ICS) for the treatment of asthma. This study compared the efficacy, safety and effect on quality of life (QOL) of ciclesonide 160 microg (ex-actuator; nominal dose 200 microg) vs. budesonide 400 microg (nominal dose) in children with asthma. Six hundred and twenty-one children (aged 6-11 yr) with asthma were randomized to receive ciclesonide 160 microg (ex-actuator) once daily (via hydrofluoroalkane metered-dose inhaler and AeroChamber Plus spacer) or budesonide 400 microg once daily (via Turbohaler) both given in the evening for 12 wk. The primary efficacy end-point was change in forced expiratory volume in 1 s (FEV1). Additional measurements included change in daily peak expiratory flow (PEF), change in asthma symptom score sum, change in use of rescue medication, paediatric and caregiver asthma QOL questionnaire [PAQLQ(S) and PACQLQ, respectively] scores, change in body height assessed by stadiometry, change in 24-h urinary cortisol adjusted for creatinine and adverse events. Both ciclesonide and budesonide increased FEV1, morning PEF and PAQLQ(S) and PACQLQ scores, and improved asthma symptom score sums and the need for rescue medication after 12 wk vs. baseline. The non-inferiority of ciclesonide vs. budesonide was demonstrated for the change in FEV1 (95% confidence interval: -75, 10 ml, p = 0.0009, one-sided non-inferiority, per-protocol). In addition, ciclesonide and budesonide showed similar efficacy in improving asthma symptoms, morning PEF, use of rescue medication and QOL. Ciclesonide was superior to budesonide with regard to increases in body height (p = 0.003, two-sided). The effect on the hypothalamic-pituitary-adrenal axis was significantly different in favor of ciclesonide treatment (p < 0.001, one-sided). Both ciclesonide and budesonide were well tolerated. Ciclesonide 160 microg once daily and budesonide 400 microg once daily were effective in children with asthma. In addition, in children treated with ciclesonide there was significantly less reduction in body height and suppression of 24-h urinary cortisol excretion compared with children treated with budesonide after 12 wk.     

Nephrology and renal replacement therapy in Romania--transition still continues (Cinderella story revisited).

INTRODUCTION. This report describes the current status of nephrology and renal replacement therapy (RRT) in Romania, a country with previously limited facilities, highlighting national changes in the European context. METHODS: Trends in RRT development were analysed in 2003, on a national basis, using the same questionnaires as in previous surveys (1991, 1995). Survival data and prognostic risk factors were calculated retrospectively from a large representative sample of 2284 patients starting RRT between January 1, 1995 and December 31, 2001 (44% of the total RRT population investigated). RESULTS: In 2003, RRT incidence [128 per million population (p.m.p.)] and prevalence (250 p.m.p.) were six and five times higher, respectively, than in 1995. The annual rate of increase in the stock of RRT patients (11%) was supported mainly by an exponential development of the continuous ambulatory peritoneal dialysis (CAPD) population (+600%), while the haemodialysis (HD) growth rate was stable (+33%) and renal transplantation made a marginal contribution. Renal care infrastructure followed the same trend: nephrology departments (+100%) and nephrologists (+205%). The characteristics of RRT incident patients changed accordingly to current European epidemiology (increasing age and prevalence of diabetes and nephroangiosclerosis). The estimated overall survival of RRT patients in Romania was 90.6% at 1 year [confidence interval (CI) 89.4-91.8] and 62.2% at 5 years (CI 59.4-65.0). Patients' survival was negatively influenced (Cox regression analysis) by age >65 years (P < 0.001), lack of pre-dialysis monitoring by a nephrologist [P = 0.01, hazards ratio (HR) = 0.8], severe anaemia, lack of erythropoetin treatment (P < 0.001, HR = 0.6), and co-morbidity, e.g. cardiovascular diseases (P < 0.001, HR = 1.8) and diabetes mellitus (P < 0.001, HR = 2.2). CONCLUSIONS: Although the rate of increase in RRT patient stock in 1996-2003 in Romania was the highest in Europe, the prevalence remained below the European mean. As CAPD had the greatest expansion, followed by HD, an effective transplantation programme must be set up to overcome the imbalance. The quality of RRT appears to be good and survival was similar to that in other registries. Further evolution implies strategies of prevention, based on national surveys, supported by the Romanian Renal Registry.     

Combined evaluation of first pass radionuclide angiography and equilibrium radionuclide ventriculography in the diagnosis of coronary artery disease

Results of 203 patients who underwent first pass radionuclide angiography (FP) and quantitative equilibrium radionuclide ventriculography (qERNV) were stored in a data base system and evaluated statistically. Eighty eight of these patients also underwent exercise equilibrium radionuclide ventriculography (E-qERNV). In patients with coronary artery disease (CAD) without previous myocardial infarction (MI), evaluation of global and regional ejection fraction (gEF, rEF) at rest revealed a poor sensitivity of 64%, the specificity was about 71% (qERNV). FP at rest revealed similar values of sensitivity (69%) and specificity (83%). Additional assessment of stress induced changes of gEF, significantly (P<0.05) improved sensitivity of qERNV in CAD patients without a history of previous MI to 84% (specificity 86%). In patients with one previous MI, however, similar values of sensitivity were found (RFP: 87%, R-qERNV: 84%, E-qERNV: 93%). In patients with several MI's, sensitivity was above 90% at rest and during exercise (R-FP: 96%, R-qERNV: 93%, E-qERNV: 100%).     

Intravitreal bevacizumab in aggressive posterior retinopathy of prematurity.

The anatomic response to intravitreal bevacizumab injection in three patients with aggressive, posterior retinopathy of prematurity is described. In all cases, the worse eye was treated with a single intravitreal injection of 0.75 mg of bevacizumab as monotherapy or complementary to laser therapy. In 24 hours, all injected eyes showed regression of the tunica vasculosa lentis and iris vessel engorgement and disappearance of iris rigidity. In addition, plus disease and retinal proliferation began to regress. None of the eyes required additional treatment. Follow-up of up to 10 months     

Use of the ATP bioassay to assess toxic effects in marsh treatment systems

A firefly luciferase bioluminescent assay of bacterial adenosine triphosphate (ATP) was used to measure the toxic effects of metal ions on six bacterial genera isolated from two geographically different marsh treatment systems. The toxicity of eleven different metals, as well as metal mixtures, was monitored using the agar plate test and the resazurin reduction test in addition to measurement of intracellular ATP. All the organisms surveyed tended to be sensitive to much lower concentrations of metals when the metals were present in mixtures. Isolates from a marsh system constructed on normal soil exhibited lower metal resistance patterns than organisms isolated from a marsh built on mine tailings. The intracellular ATP assay appeared to be the most sensitive method of determining the viability of bacterial cells following metal treatment.     

Working With Human Research Protections

PURPOSE: To provide a primer for novice nurse scientists about the increasingly regulated human research environment. ORGANIZING CONSTRUCTS: Federal regulations and international guidelines about protection of human research participants are discussed, with particular attention to institutional review boards for human research. CONCLUSION: Understanding the processes used by institutional review boards to foster ethical human research promotes collaborative interactions and supports compliant research work.