Clinical equivalence of salmeterol/fluticasone propionate in combination (50/100 microg twice daily) when administered via a chlorofluorocarbon-free metered dose inhaler or dry powder inhaler to patients with mild-to-moderate asthma.

This multi-centre, randomized, double-blind, double-dummy, parallel-group study was designed to investigate the hypothesis of equivalent efficacy and comparable safety of two inhaled presentations of salmeterol/fluticasone propionate combination product (SALM/FP) 50/100 microg administered twice daily to patients with mild-to-moderate asthma for 12 weeks. The delivery systems were a 25/50 microg strength hydrofluoroalkane (HFA) metered-dose inhaler (MDI) and a Diskus inhaler (50/100 microg strength). A third group received FP 100 microg twice daily via a chlorofluorocarbon MDI (50 microg strength). A total of 497 patients aged 11-79 years with reversible airways obstruction who were symptomatic on inhaled corticosteroid (ICS) therapy and had room for improvement in lung function were randomized to treatment in a double-blind, parallel-group design (SALM/FP MDI: n=165; SALM/FP Diskus: n=167; FP MDI: n=165) for 12 weeks. A total of 383 patients completed the study according to the protocol. According to the primary efficacy variable, increase in mean morning PEF over weeks 1-12, the two inhaled presentations of SALM/FP were clinically equivalent (adjusted mean increases 43 and 46 l min(-1); treatment difference 3 l min(-1); 95% confidence interval: -6 to 11 l min(-1)). Equivalence was also demonstrated by all secondary efficacy measures. The SALM/FP MDI was significantly superior to the FP MDI for increase in mean morning PEF (treatment difference 19 l min(-1); P<0.001) and for all secondary measures except FEV1 and symptom-free nights. There was no significant difference between the groups with respect to adverse events and serum cortisol levels. These results demonstrate that the SALM/FP 25/50 microg HFA MDI (two inhalations twice daily) is clinically equivalent to the SALM/FP 50/100 microg Diskus (one inhalation twice daily). Patients switching to SALM/FP from other MDI-based asthma treatments may now do so without a change of delivery device.

An individual scoring system for the prediction of postpartum anaemia.

BACKGROUND: Postpartum anaemia (PPA) is a common postpartum complication. The goal of this study was to prospectively construct a predictive score for individual risk of PPA. PATIENTS ET METHOD: We prospectively analyzed factors associated with PPA (<10gdL(-1) at 48hours postpartum). Parameters analyzed were demographic data, pregnancy characteristics, delivery and postpartum characteristics. Univariate analysis was performed using Anova or X(2); the Cox model was used for multivariate analysis. The scoring system was validated using ROC curve. RESULTS: Analysis was performed in 475 patients and validation was carried using an additional 95 patients. Multivariate analysis found four factors independently associated with PPA: anaemia during the third trimester of the pregnancy, Southeast Asian ethnic origin, episiotomy and severe postpartum haemorrhage (PPH) identified by the use of sulprostone. According to the score derived from the Cox model, patients were classified as low (22%, score=0), medium (55%, score=2 or 3) and high (86%, score>3) probability of PPA. Using the AUC of the ROC curve for both the first and the validation cohorts (performed on 95 further patients), we recorded AUCs of 72% and 70% respectively. CONCLUSIONS: This study allowed the derivation and validation of a predictive score of PPA. This score might be useful in targeting prophylactic strategies for PPA. Such strategies could include a more active treatment of iron deficiency (increasing oral iron treatment observance or intravenous iron therapy) especially in exposed population, improvement in the prevention and treatment of postpartum haemorrhage and decreasing the use of episiotomy. Future studies must focus on the external validation and generalisation of this scoring system.

[Opioid-sparing effect of ketamine during tonsillectomy in children]. / Effet d'épargne morphinique de la kétamine au cours de l'amygdalectomie chez l'enfant.

INTRODUCTION: In the adult population, Ketamine is currently used as an antihyperalgesic and opioid-sparing agent during the perioperative period. However, for doses of ketamine up to 0.5mg/kg, these effects have not been found in pediatric population. The aim of the present study was to evaluate the efficacy of a preoperative bolus of 1mg/kg of ketamine on postoperative pain intensity and morphine consumption in children undergoing tonsillectomy. METHODS: We have undertaken a retrospective comparison of 60 consecutive children operated for tonsillectomy in our institution before (first 30 patients) and after (last 30 patients) the introduction of a preoperative bolus of 1mg/kg of ketamine. Data collected were: age, ASA score, dose of intraoperative sufentanil, OPS score during PACU stay and the first postoperative day, morphine consumption during PACU stay and the first postoperative day, psychodysleptic manifestations, pain at first solid oral intake and postoperative respiratory complications or haemorrhage. RESULTS: No difference was found between the two groups in terms of demographic characteristics. Perioperative doses of sufentanil, postoperative opioid consumption or pain score in PACU or during 24hours were similar between the two groups. The two groups did not differ in terms of pain at first oral intake, or other adverse effects. CONCLUSION: These results suggest that 1mg/kg of ketamine administered right after anaesthesia induction in children undergoing tonsillectomy did not result in an opioid sparing effect.