Background-We studied serum follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), triiodothyronine (T3), free T3 (FT3), cortisol and growth hormone (GH) concentrations in a population of pediatric patients. The reference intervals were determined separately for females and males stratified by age groups to assess age-and sex-related differences. Our objective was to obtain reference intervals for the 7 serum analytes for our pediatric population using the IMMULITE 1000 system. Methods-Serum samples of 800 in-and out-patients, newborn to 19 years old were analyzed using the DPC IMMULITE 1000 chemiluminescent immunoassay system.Results and conclusions-We report pediatric reference intervals for FSH, LH, E2, T3, FT3, cortisol, and GH. These reference intervals provide the basis for clinical interpretation of laboratory results using the IMMULITE 1000 system and the assessment of child development.
Introduction: Analyses examine the response rate at endpoint, as well as time course of response, in patients receiving duloxetine for management of diabetic peripheral neuropathic pain (DPNP).Methods: Data were pooled from 3 double-blind, randomized, placebo-controlled 12-week trials in patients with DPNP Ն 6 months duration, and without depression. Study 1 (N ϭ 457) compared duloxetine 20 mg once daily (QD), 60 mg QD, 60 mg twice daily (BID), and placebo; Studies 2 (N ϭ 334) and 3 (N ϭ 348) compared duloxetine 60 mg QD and 60 mg BID with placebo. Ethics committees approved the study protocol in accordance with Declaration of Helsinki principles. Patients provided written informed consent prior to study participation. Treatment response was defined a priori as 30% reduction in the primary efficacy measure, 24-hour average pain severity. Analysis was replicated using alternative criteria (50% reduction or 2-point reduction).Results: Endpoint response rates were significantly higher among patients receiving duloxetine (60 mg QD or 60 mg BID) than those receiving placebo, regardless of chosen response criterion. The proportion of patients responding (30% reduction in 24-hour average pain severity) to duloxetine was statistically greater than to placebo Week 1 and all subsequent visits. Similar results were obtained for the visitwise sustained response rate. Within the group with a sustained response at Week 12, the proportion of patients first exhibiting a response at Weeks 1 or 2 was higher in the duloxetine groups (60 mg QD, 65.0%; 60 mg BID, 62.0%) when compared with the placebo group (40.2%).Conclusion: Patients with DPNP receiving duloxetine 60 mg QD or 60 mg BID had significantly higher treatment response rates compared with patients receiving placebo, regardless of response criterion. Response to duloxetine treatment tended to occur early, with approximately 30% of patients responding at Week 1. Among duloxetine-treated patients with a sustained treatment response at Week 12, over 60% had maintained responder status for 10 to 11 weeks. Objective: To examine impact of age, gender, origin, duration of diabetic neuropathy, type of diabetes, and pain severity on treatment outcome of duloxetine (DLX) in the management of diabetic peripheral neuropathic pain (DPNP).Methods: Data from 3 12-week, multicenter, double-blind, placebo-controlled studies (1-3) were pooled. In Study 1, 457 patients with DPNP were randomly assigned to DLX 20 mg QD, 60 mg QD, 60 mg BID, or placebo. In Studies 2 and 3, 334 and 348 patients, respectively, were randomly assigned to DLX 60 mg QD, 60 mg BID, or placebo. DLX 20 mg QD was not included in the analyses due to its ineffectiveness found in Study 1. Primary efficacy measure was the weekly mean score of 24-Hour Average Pain Severity collected by patient's diary on 11-point Likert scale. Subgroup impact was evaluated for combined DLX doses with references to placebo group.Results: DLX 60 mg QD and 60 mg BID significantly improved weekly mean scores of 24-Hour Average Pain Severity in eac...
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