Efficacy and safety of desloratadine/pseudoephedrine combination vs its components in seasonal allergic rhinitis.

BACKGROUND: Antihistamines are first-line therapy for the treatment of seasonal allergic rhinitis (AR); however, an oral decongestant is often added to improve control of nasal congestion. OBJECTIVE: To examine whether a tablet combining the nonsedating antihistamine desloratadine and the decongestant pseudoephedrine was more effective than either drug administered alone in reducing the symptoms of seasonal AR, including nasal congestion. PATIENTS AND METHODS: In this multicenter, double-blind study, participants (N = 598) with symptomatic seasonal AR were administered either a combination tablet of desloratadine 2.5 mg/pseudoephedrine 120 mg (DL/PSE) bid, a desloratadine 5.0 mg qd and a placebo tablet, or pseudoephedrine 120 mg bid. Participants assessed their symptom severity twice daily over the 2-week treatment period. RESULTS: The primary variable to assess the effects of the antihistamine component--mean change from baseline in average AM/PM reflective total symptom score (TSS), excluding nasal congestion--was significantly greater (-6.54) for DL/PSE than for desloratadine (-5.09) or pseudoephedrine (-5.07) monotherapy (P < .001 for both). The primary variable to assess the effects of the decongestant component--mean change from baseline in average AM/PM reflective nasal congestion score--was also significantly greater (-0.93) for DL/PSE than for desloratadine (-0.66) or pseudoephedrine (-0.75) (P < .001 vs desloratadine; P = .006 vs pseudoephedrine). CONCLUSION: This study demonstrated that DL/PSE therapy was more effective in reducing symptoms of seasonal AR, including nasal congestion, than the individual components when administered alone, thus supporting use of this combination in participants with symptomatic seasonal AR and prominent nasal congestion.

A dose-ranging study of mometasone furoate aqueous nasal spray in children with seasonal allergic rhinitis.

BACKGROUND: The efficacy and safety of mometasone furoate aqueous nasal spray (MFNS; Nasonex) 200 microg once daily for the treatment and prophylaxis of seasonal allergic rhinitis (SAR) and treatment of perennial rhinitis have been demonstrated in adults. However, the dose response of MFNS in pediatric patients has not yet been characterized. OBJECTIVE: This study was conducted to determine the dose-response relationship of 3 different doses of MFNS in a pediatric population. METHODS: This was a multicenter, double-blind, active- and placebo-controlled study of 679 children 6 to 11 years of age with histories of SAR and documented positive skin test responses. Patients were randomized to one of the following treatment groups for 4 weeks: MFNS 25 microgram once daily, MFNS 100 microgram once daily, MFNS 200 microgram once daily, beclomethasone dipropionate 84 microgram twice daily (168 microgram/day), or placebo. Physician evaluations were performed at days 4, 8, 15, and 29, and patient evaluations were analyzed for days 1 to 15 and 16 to 29. RESULTS: The mean reduction from baseline in physician-evaluated total nasal symptom scores at day 8 (the primary efficacy variable) was significantly greater in the MFNS and beclomethasone dipropionate groups than in the placebo group (P

The use of theophylline clearance in pediatric status asthmaticus. I. Interpatient and intrapatient theophylline clearance variability.

A group of 167 pediatric asthmatics were followed up over four years, and their theophylline clearance values were recorded when they were admitted for status asthmaticus. A slow and gradual decrease of the clearance value was noted in all age groups. The clearance did not change significantly between the ages of 2 and 9 years. Longitudinal intrapatient clearance changes achieved statistical significance after the age of 9 years. When the patient groups were studied according to their initial clearance values, it became evident that only the patients with clearance values of 80 mL/kg/h showed significant changes of this value. In our patient group, obesity did not play a significant role in effecting a change in theophylline clearance.

Response of preterm infants to diphtheria-tetanus-pertussis immunizations.

To establish guidelines for the routine use of diphtheria, tetanus, and pertussis (DTP) vaccine in preterm infants, we quantitated antibody responses of preterm infants to DTP and determined the nature and extent of side effects. Twenty-five preterm infants were immunized with 0.5 ml DTP vaccine at routine intervals. Term infants served as controls. Immediately before each immunization and 2 months after the third, DTP-specific antibodies were quantitated. Clinical side effects were determined by parental report. After the second immunization, 100% of preterm infants had evidence of specific antibody production against diphtheria, tetanus, and pertussis. The incidence of side effects was low, but irritability was significantly more common in preterm infants after the second immunization. These observations suggest that the initiation of primary immunization with DTP in preterm infants need not be delayed beyond 2 months of age.

Absorption of oral aminoglycosides following bone marrow transplantation.

Four patients with severe gastrointestinal reactions receiving oral "nonabsorbable" antibiotics for gut sterilization following bone marrow transplantation absorbed clinically significant amounts of aminoglycoside (gentamicin and/or tobramycin). Serum concentrations of 2.2, 2.6, 5.8, and 12.0 micrograms/ml were measured. Two of these patients had acute graft versus host reactions and two had severe mucositis following cytoreduction with intensive chemotherapy and irradiation. Nephrotoxicity occurred in the latter patients. One patient was studied in detail. Her hospital course and investigative results are presented. Four additional patients with mild gastrointestinal reactions following cytoreduction did not absorb gentamicin when their toxicity was maximal. Serum aminoglycoside determinations are necessary in patients receiving oral aminoglycosides for gut sterilization following bone marrow transplantation if moderate to severe gastrointestinal reactions occur.

Transient alteration of theophylline half-life: possible association with Herpes simplex infection.

Transient alteration of theophylline half-life resulting in theophylline neurotoxicity is reported in a nine-year-old child. The alteration in theophylline elimination half-life was associated with Herpes simplex gingivostomatitis. This association has not previously been demonstrated. The report is contrasted with a study of theophylline clearance variability in children.

Hypoelectrolytemia as a presentation and complication of cystic fibrosis.

We describe three patients with cystic fibrosis (CF) with four episodes of hypoelectrolytemia, two of which were associated with documented metabolic alkalosis. CF should be included in the differential diagnosis of infants and children presenting with hypoelectrolytemia and metabolic alkalosis. Patients with CF are at risk of developing severe hypochloremia in hot weather and during intercurrent illness. An abrupt diminution of oral intake is an important suggestive sign, alerting the physician to look for the development of hypoelectrolytemia.

Actinobacillus endocarditis associated with periodontal disease.

Actinobacillus actinomycetemcomitans, an organism associated with rapidly destructive periodontal disease (periodontitis), is a rare cause of endocarditis in children. This report presents a case of A. actinomycetemcomitans endocarditis in a 6-year-old child with rapidly destructive periodontal disease. A leukotoxic antigen was documented in the strain of A. actinomycetemcomitans isolated from the patient's blood.