Stiripentol, a new antiepileptic drug inhibiting cytochrome P450-enzymes, suggested some efficacy when combined with carbamazepine in an open trial in refractory partial epilepsy of childhood. Our objective was to test these results in a placebo-controlled trial. To limit the number of patients included, we used an enrichment and withdrawal design. Among the 67 children entered in a 4-month open add-on stiripentol study following a 1-month single-blind placebo baseline, the 32 responders were randomized for 2 months either to continue stiripentol (n = 17) or to withdraw to placebo (n = 15). If seizures increased by at least 50% after randomization compared with baseline, the patients dropped out (primary end point): there were six patients on stiripentol and eight patients on placebo (not significant). However, a decrease in seizure frequency compared with baseline (secondary end point) was greater on stiripentol (-75%) than on placebo (-22%) (P < .025). Twelve patients experienced at least one adverse event on stiripentol (71%) compared with four patients on placebo (27%); none were reported as severe. The combination of stiripentol and carbamazepine proved to reduce seizure frequency in children with refractory partial epilepsy, although it failed to show a significant impact according to the escape criteria selected as the primary end point in the present study, for ethical reasons.
Considerable effort should be made to optimise parenteral nutrition of preterm infants in order to limit the development of postnatal growth restriction. A monocentric before-and-after study design was used to determine the effects of computerising parenteral nutrition ordering on the composition of parenteral nutrition (PN) solutions and early clinical outcomes of preterm infants born < or =28 weeks of gestation. Parenteral protein intake during the first week of life and parenteral lipid, glucose and energy intakes during the first and second week of life were significantly higher in infants assessed after the introduction of computerised parenteral nutrition ordering. This led to a significant reduction in the cumulative energy deficit over the first 28 days of life and to an improvement in both early growth and pulmonary outcome. Computerising the PN ordering process improves the nutrient content of the PN solutions and early postnatal outcome.
The purpose of this prospective randomized trial was to compare the efficacy of propranolol and amiodarone in suppressing ventricular arrhythmias during the first 6 months following myocardial infarction (MI). 97 patients were treated with either amiodarone (n = 48) or propranolol (n = 49) starting on the 9th day following MI. Holter monitoring was carried out on four occasions: on D7, D21, D90 and D180. There was no statistical difference in the incidence of 'major' arrhythmias (an average of at least 10 ventricular premature complexes (VPCs) h-1, multiform or paired VPCs or runs) between the two groups on D7. A significant difference in favour of amiodarone became apparent at D180 (P = 0.04). Patients were also classified according to whether treatment failed or was successful. 'Success' was recorded when arrhythmias remained minor or became minor (less than 10 uniform VPCs h-1) and 'failure' when arrhythmias remained major or became major, or when patients were withdrawn because of side-effects, or lost to follow-up. The difference remained in favour of amiodarone (P = 0.03 at D21; P = 0.05 at D90; P = 0.06 at D180). Evaluation of the percentage reduction in the number of VPCs at D21, D90 or D180 compared with D7 showed superiority of amiodarone at D90 (P less than 0.01) and D180 (P less than 0.04). In this study, the overall effect of amiodarone on ventricular arrhythmias following MI was shown to be superior to that of propranolol.
BackgroundThree vitamin and lipid mixtures are produced by the parenteral nutrition unit. Besides the checks performed on these preparations, a membrane filtration sterility test (STERITEST) is carried out as required by the European Pharmacopoeia (EP). Due to constraints associated with these tests (duration, visual interpretation) alternative methods are available such as those for septicaemia diagnosis: Bact/ALERT 3D. It consists of directly inoculating a culture medium followed by automated microbial detection. This method doesn’t meet all the criteria required by the EP, but seems acceptable if validated.PurposeTo compare the two methods and to assess their respective efficiency.Material and methodsGrowth promotion tests of aerobic, anaerobic micro-organisms (MO) and fungi were performed with 5 colony-forming units (CFUs) of S. aureus, B. subtilis, C. sporogenes, A. brasiliensis, C. albicans, and P. aeruginosa seeded in two different media. Afterwards the three kinds of mixture were produced in a microbiological safety cabinet. Both methods were tested at the same time on three samples of each MO and mixture (54 pairs of samples). Daily readings and identifications of MO were then performed in collaboration with the bacteriology department. The averages of the growth period of each method were compared using a t-test.Results100% of MO seeded on the 54 pairs of Bact/ALERT were detected versus 91% on STERITEST. The t-test showed a significant difference between the two methods: the average growth period with STERITEST (5.8 days) was longer than that with Bact/ALERT (2.5 days) (p = 1.27 E-18).ConclusionBact/ALERT is more efficient than STERITEST for the detection of MO: increased sensitivity and reproducibility, faster detection and identification of MO, less bias of reading. All these reasons drove us to choose the new BacT/ALERT sterility test instead of STERITEST.ReferenceEuropean Pharmacopoeia 7.7 sterility 2.6.1No conflict of interest.
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