Administration of hepatitis A vaccine at 6 and 12 months of age concomitantly with hexavalent (DTaP-IPV-PRP approximately T-HBs) combination vaccine.

BACKGROUND: Administration of two doses of hepatitis A (HA) vaccine to children > or = 2 years of age has been shown to be protective. The present study assessed whether HA vaccine can be administered as early as 6 months of age and whether it can be administered concomitantly with a hexavalent (HV) vaccine at this age. METHODS: In an open label, randomized, parallel group study, the liquid HV vaccine (HEXAVAC) (diphtheria, tetanus, 2-component acellular pertussis, inactivated poliomyelitis vaccine, Haemophilus influenzae type b conjugated to tetanus protein and hepatitis B) was administered at 2, 4, 6, and 12 months of age to all children. HA vaccine (VAQTA) was given at 7 and 13 months in the separate administration group (Group 1) and at 6 and 12 months in the concomitant administration group (Group 2). Serum samples were obtained at 2, 7, 12, and 14 months in Group 1 and at 2, 7, 12, and 13 months in Group 2. The primary immunogenicity outcomes were the seroconversion rates for HA 1 month after the second dose of HA vaccine in initially seronegative subjects, and the seroconversion rates for each HV antigen 1 month after the third dose of the HV vaccine (both at 7 months of age). RESULTS: HA seropositivity rates 1 month after the second dose were 100% in both groups, regardless of initial serostatus. The responses to each HV antigen 1 month after the third dose were similar in both groups. The vaccines were generally well tolerated in both groups regardless of vaccine(s) administered. CONCLUSIONS: A schedule of two doses of HA vaccine, 6 months apart beginning at 6 months of age is highly immunogenic and well tolerated when administered alone or concomitantly with HV vaccine at 6 and 12 months of age.

[Effects of rilmenidine (hyperium) on lipid balance in hyperlipidemic hypertensive patients. Randomized, controlled, double-blind 8-week study vs. captopril in parallel groups]. / Effets de la rilmenidine (hyperium) sur l'équilibre lipidique des patients hypertendus hyperlipidémiques. Etude randomisée à double insu et en groupes parallèles, contrôlée contre captopril, pendant 8 semaines.

Rilmenidine (dose of 1 mg once or twice a day) is the first oxazoline compound with antihypertensive properties. Its effects on lipid parameters [total cholesterol, HDL and LDL fractions, triglycerides, apolipoprotein A1 and B, lipoprotein (a)] were compared under double-blind conditions and in parallel groups to those of captopril (50 to 100 mg per day, in 2 divided doses) over a period of 8 weeks, in 51 hyperlipidaemic hypertensive patients [age: 56.3 +/- 1.5 years, systolic and diastolic blood pressure (SBP/DBP): 165.1 +/- 2.0/99.1 +/- 0.6 mmHg, LDL cholesterol: 5.38 +/- 0.16 mmol/L]. No significant difference was demonstrated between the groups on inclusion for any of the clinical parameters (SBP, DBP, heart rate (HR)) and laboratory parameters, apart from apolipoprotein A1, for which the mean value was higher in the rilmenidine group than in the captopril group (p < 0.05). No difference between the groups was demonstrated during the 8 weeks of treatment for the course of blood pressure: SBP and DBP decreased by 20.5 and 13.9 mmHg, respectively, in the rilmenidine group and by 21.3 and 13.1 mmHg in the captopril group (no significant difference: NS). HR decreased by 0.3 beats per minute (bpm) in the rilmenidine group and by 4.1 bpm in the captopril group (NS). No statistically significant difference in lipid parameters was observed between the two groups. No clinically significant variation in any of the lipid parameters was observed after 8 weeks of treatment with rilmenidine or captopril. These results confirm the antihypertensive efficacy and neutrality of rilmenidine on lipid metabolism over a period of 8 weeks. Rilmenidine therefore represents a useful alternative in the first-line treatment of hypertension in hyperlipidaemic hypertensive patients.

The effects of rilmenidine and atenolol on mental stress, dynamic exercise and autonomic function in mild to moderate hypertension.

1. The effects of 4 week treatment with rilmenidine or atenolol on tests of mental stress, dynamic exercise, autonomic function and psychometric tests were evaluated in a randomized, double-blind, placebo-controlled, cross-over study. 2. After a 4 week placebo run-in, 12 patients with essential hypertension (blood pressure [BP] 160/95 +/- 15/7 mmHg) received rilmenidine 1-2 mg day-1, and atenolol 50-100 mg day-1, each for 4 weeks, with a 4 week placebo wash-out between drug treatments. 3. Both agents produced a comparable reduction in supine and erect BP. During the mental arithmetic test, BP and heart rate (HR) responses were similar for rilmenidine and atenolol. 4. During bicycle exercise, the increase in HR was significantly greater after rilmenidine (+50 vs 41 beats min-1, P = 0.04). During recovery, the areas under the curve for diastolic BP (46,450 vs 51,400 mmHg s, P = 0.02) and HR (49,445 vs 63,597 beats min-1 s, P = 0.001) were significantly less with atenolol than rilmenidine. 5. Neither rilmenidine nor atenolol affected mental performance as judged by arithmetic and psychomotor tests. Physiological responses to autonomic function tests (deep breathing, facial immersion, isometric handgrip and cold pressor) were preserved with both drugs. The standing to lying ratio was higher on atenolol (P = 0.01) and Valsalva ratio was higher on rilmenidine (P = 0.03). 6. In conclusion, rilmenidine and atenolol exerted comparable antihypertensive effects both at rest and during mental and dynamic stress. Atenolol attenuated HR responses to dynamic exercise and the Valsalva manoeuvre; rilmenidine did not interfere with the physiological responses of BP and HR during autonomic function tests.

Lipid profile and antihypertensive efficacy in hyperlipidemic hypertensive patients: comparison of rilmenidine and captopril.

In hypertensive patients with lipid abnormalities, an ideal antihypertensive agent would control blood pressure without interfering with lipid metabolism. The aim of the present study was to assess whether in addition to angiotensin-converting enzyme inhibitors, calcium antagonists, and alpha 1-antagonists, rilmenidine (RIL), the first antihypertensive drug that is selective to imidazoline receptors, fulfills these requirements. To assess the effects of RIL (daily doses of 1 mg o.d. or b.i.d.) in comparison to captopril (CAP) (doses of 25 or 50 mg b.i.d.), an 8-week, double-blind, randomized, parallel-group study was carried out. Fifty-one patients (mean age: 56.3 +/- 1.5 years) with mild-to-moderate hypertension (supine systolic/diastolic blood pressure, 165.1 +/- 2.0/99.1 +/- 0.6 mm Hg) and type 2a or 2b hyperlipidemia (low-density lipoprotein (LDL) cholesterol: 5.38 +/- 0.16 mmol/L) were included in the study, and they were followed by their general practitioner at 4-week intervals. Twenty-six patients received RIL, and 25 received CAP. The permanence of hypercholesterolemia was checked twice before inclusion into the study, at 3-week intervals, for patients who had already been on a hypocholesterolemic diet for 6 weeks. Plasma lipid evaluation included total, LDL and high-density lipoprotein (HDL) cholesterol, triglycerides, apolipoproteins A1 and B, lipoprotein (a), and, last, a uric acid assay. Assays were centralized at the Lipid Laboratory, CHU Pitié-Salpétrière, Paris. In each group, 1 patient withdrew from the study for personal reasons, and four patients required a dose adjustment (double dose) at the week 4 visit. After 8 weeks of therapy, systolic blood pressure decreased significantly in both groups, with no statistically significant difference between groups (RIL, 20.5 mm Hg; CAP, 21.3 mm Hg; NS). Diastolic blood pressure also decreased (RIL, 13.9 mm Hg; CAP, 15.1 mm Hg; NS). No difference between groups was observed on the changes of lipid parameters between week 0 and week 8 visits. No severe adverse event occurred other than an asymptomatic atrial fibrillation in a CAP group patient at week 8. This study provides evidence that over a follow-up period of 8 weeks, both RIL and CAP are efficient and well-tolerated drugs in the first-line treatment of hypertensive patients with lipid abnormalities.

Dose-effect relationship of rilmenidine after chronic administration.

The antihypertensive efficacy and acceptability of 3 doses of rilmenidine (0.5, 1 and 2 mg, once daily) and a placebo over a 4 week period have been compared in a randomised, double-blind, parallel-group trial in 60 mild to moderate hypertensive patients. Six patients dropped out: 4 in the 2 mg-group and one in the 1 mg-group because of adverse events, and one in the placebo group for personal reason. The blood pressure was significantly decreased after the 1 and 2 mg doses with the maximum antihypertensive effect already being obtained after 1 mg. A significant dose-effect relationship was shown for supine systolic blood pressure (P = 0.05) but not for the supine diastolic blood pressure. The most beneficial efficacy/acceptability ratio was achieved at the dose of 1 mg once daily, which demonstrated the maximum antihypertensive effect associated with a low incidence of adverse events.

[Treatment of severe hyaline membrane disease with a single-dose of natural exogenous surfactant of porcine origin. A randomized trial: immediate effects and outcome at 28 days of life]. / Traitement de formes sévères de la maladie des membranes hyalines par une dose unique d'un surfactant exogène naturel d'origine porcine. Un essai randomisé: effets immédiats et devenir à 28 jours de vie.

The results obtained with porcine surfactant (Curosurf) administration for the treatment of hyaline membrane disease (HMD) are reported. Thirty premature infants weighing 700 to 2,000 g with severe HMD (mechanical ventilation and oxygen requirement (FiO2) greater than 60% were randomly allocated at 2 to 15 hours postnatal age. Eight of the 30 patients included in this group participated in a multicenter european trial. The fifteen infants with mean gestational age (GA) of 29.5 weeks included in the treatment group (T), were treated at 8.6 hours of life with a single dose of 200 mg/kg Curosurf given intratracheally while 15 infants of mean GA 30 weeks formed the control group (C). Infants in the T group showed an immediate, dramatic and sustained improvement of oxygenation as reflected by increased PaO2/FiO2 and arterial to alveolar PO2 ratios within 1 hour. This significant improvement in favor of T group (p less than 0.005) persisted for 2 days when control infants began to recover. This improvement in oxygenation allowed a significant decrease of FiO2 (p less than 0.005) and mean airway pressure (p less than 0.01) in the T group within 1 hour and up till the second day. Despite this early improvement obtained with Curosurf the survival rate at 28 days of life and the incidence of associated HMD complications were not significantly modified. However the tendency was towards decreased respiratory morbidity. The discussion will consider the value of multiple doses.

[Prophylactic antibiotic therapy using oxacillin (Bristopen) in pediatric orthopedic surgery]. / Antibiothérapie prophylactique par oxacilline (Bristopen) en chirurgie orthopédique infantile.

The aim of this study was to evaluate the efficiency of oxacillin in the prophylaxis of bone infections in orthopaedic surgery in children. Staphylococcus is the usual pathogen in orthopaedics. This is the reason of our choice: oxacillin. 420 patients are included: 195 control patients did not receive any prophylactic antibiotherapy; 225 patients received oxacillin. The oxacillin treatment started at anaesthetic induction and was carried on for 72 hours. In the control group, 7 superficial and 4 deep infections were observed, while a single superficial infection was noted in the oxacillin-treated group. This easy and inexpensive prophylactic treatment gave excellent results. We think that it should be systematically administered in orthopedic surgery to ensure as little complication as possible to the child.

[Radiculomyeloencephalitis caused by Angiostrongylus cantonensis in children]. / Radiculomyéloencéphalite à Angiostrongylus cantonensis chez l'enfant.

A case of radiculoencephalomyelitis caused by central nervous system involvement by Angiostrongylus cantonensis is reported in a 14 month-old girl. Evolution was spontaneously favourable, which is not usual in severe types. Lesions concerned the nevraxe and especially the spinal cord and are due to the migration of the larvae, creating eosinophilic inflammatory reactions.

[Significance of hemodilution and deferred autotransfusions in spinal surgery in the child and the adolescent]. / Intérêt de l'hémodilution et des autotransfusions différées dans la chirurgie du rachis de l'enfant et de l'adolescent.

Homologous blood transfusions may involve immunological risks, as much as the risk of transmitting viral bacterial or parasitic illnesses. 140 children and adolescents having been operated for scoliosis were evaluated in order to compare hemodilution plus deferred auto-transfusion against standard transfusion techniques. By combining hemodilution and deferred autotransfusion, pre and post-surgery transfusions drop from 2725 to 370 ml of homologous blood, on the average. The combined use of these two techniques thus reduces the need for new homologous blood most significantly.

[Value of deliberate normovolemic hemodilution associated with a capillary vasoconstrictor, ornipressin, in surgery of the spine]. / Intérêt de l'hémodilution normovolémique intentionnelle associée à un vaso-constricteur capillaire, l'ornipressine, dans la chirurgie du rachis.

This study of sixty-seven children divided in two groups compared the blood loss and the amount of blood transfused during and after the operation. The operations were carried out without haemodilution nor the local injection of vasoconstrictor (twenty-four patients) and following haemodilution and the local injection of vasoconstrictor (forty-three patients). The blood loss during operation was 344 +/- 455 ml per vertebra in the first group, and 151 +/- 54 ml in the second. The blood loss in the post operative period did not seem to be modified by haemodilution, as the level of hemoglobulin was virtually the same in the two groups eleven days after the operation. A mean of seven units of blood were transfused to the first group, whilst only three in the second group. In the post-operative period, both groups received a mean of one unit each. Associating haemodilution and a vasoconstrictor, ornipressin, reduced very significantly the need for homologous blood.