Ibuprofen, acetaminophen, and placebo treatment of febrile children.

A double-blind, parallel-group, triple-dummy-designed, single-oral-dose study compared the efficacy, tolerability, safety, and dose-response of 5 mg/kg (n = 32) and 10 mg/kg (n = 28) ibuprofen suspension, 10 mg/kg acetaminophen elixir (n = 33), and placebo liquids (n = 34) in 127 children (2 to 11 years of age) with fever (101 degrees to 104 degrees F). Blood samples, oral temperatures, pulse, blood pressure, and respiration were obtained before and 1/2, 1, 2, 3, 4, 5, 6, and 8 hours after the dose was administered. The study was terminated early if oral temperature was greater than 104 degrees F or if it increased 1 degree F above baseline. All agents were well tolerated and more effective than placebo (p less than 0.05) for fever control. Ibuprofen, 10 mg/kg, was favored over 10 mg/kg acetaminophen (p less than 0.05). For temperatures greater than 102.5 degrees F, a dose-response relationship for 5 and 10 mg/kg ibuprofen was demonstrated in terms of percentage of fever reduction and in terms of the initial 2-hour rate of decrease in temperature. Antipyretic efficacy for temperatures greater than 102.5 degrees F was 10 mg/kg ibuprofen greater than 5 mg/kg greater than 10 mg/kg acetaminophen greater than placebo. All treatments were well tolerated. No significant clinical or laboratory abnormalities were noted. Ibuprofen suspension may be a safe and effective antipyretic in children.

Is routine histological evaluation an accurate test for Helicobacter pylori infection?

AIM: To compare the diagnostic accuracy of routine histology for Helicobacter pylori infection, with histology by an expert pathologist, and to compare histology with the rapid urease test (RUT), 13C-urea breath test, IgG serology and culture of antrum and corpus specimens, in a consecutive series of untreated patients presenting for upper oesophago-gastro-duodenoscopy. MATERIALS AND METHODS: One-hundred and fifteen consecutive patients underwent multiple tests for H. pylori infection: rapid urease test, 13C-urea breath test, IgG serology and histology and culture on antrum and corpus biopsy specimens. Histology was first evaluated by the pathologists in a routine examination, and then blindly reviewed by an expert pathologist with a special interest in gastrointestinal pathology. The patients were considered to be H. pylori-positive if two or more tests were positive. RESULTS: Eighty-one patients (70.4%) were found to be H. pylori positive. 13C-urea breath test and IgG serology showed the best sensitivity and specificity (100%). Both the antral and body cultures, and the rapid urease test had the highest specificity (100%). Histological diagnosis after re-evaluation by an expert pathologist showed a high sensitivity (98. 8%) and specificity (100%), and was better than routine histology (sensitivity 92.6%; specificity 90.3%). The accuracy of the rapid urease test was greater than that of routine histology, and the combination of these two tests improved the sensitivity of H. pylori detection to up to 100%. CONCLUSION: All diagnostic tests usually utilised in clinical practice have a sensitivity higher than 90%. In patients who were not pre-treated with antisecretory agents or antibiotics, the sensitivity of histological diagnosis, however, seems to be influenced by the accuracy of the histological examination. The sensitivity of routine histology, but not of revised histological diagnosis, is improved by an additional rapid urease test.

Importance of using soluble derivatives in assessing bilirubin interference: the example of gamma-glutamyltransferase.

In assessing possible in vitro interference from bilirubin on analytical methods, different results are to be expected from using either unconjugated (uB) or conjugated (cB) bilirubin as test materials, because of their different solubilities. In vitro interference of a synthetic soluble bilirubin derivative (ditauro-bilirubin, dtB) on gamma-glutamyltransferase activity measurement has been studied, in comparison with uB. In three out of five analytical methods/systems for the measurement of the enzyme activity, significantly higher (negative) interference was observed in the presence of the soluble derivative. Whichever the mechanism for the observed effect, the opportuneness of using soluble derivatives in order to assess bilirubin interference is pointed out: pathological serum specimens, submitted for laboratory investigations, are indeed frequently loaded with soluble bilirubin conjugates.

S.A.M., the Italian Martian simulation chamber.

The Martian Environment Simulator (SAM "Simulatore di Ambiente Marziano") is a interdisciplinary project of Astrobiology done at University of Padua. The research is aimed to the study of the survival of the microorganisms exposed to the "extreme" planetary environment. The facility has been designed in order to simulate Mars' environmental conditions in terms of atmospheric pressure, temperature cycles and UV radiation dose. The bacterial cells, contained into dedicated capsules, will be exposed to thermal cycles simulating diurnal and seasonal Martian cycles. The metabolism of the different biological samples will be analysed at different phases of the experiment, to study their survival and eventual activity of protein synthesis (mortality, mutations and capability of DNA repairing). We describe the experimental facility and provide the perspectives of the biological experiments we will perform in order to provide hints on the possibility of life on Mars either autochthonous or imported from Earth.

Inter-method differences in the measurement of some specific plasma proteins: commutability of control materials.

We compared the inter-method differences shown by control materials and by patients' sera for the measurement of some plasma proteins in the same pair of analytical systems. Sets of 100 to 110 samples of patients' sera and of 18-19 control materials, including the recently available CRM 470, were assayed with up to five automatic analytical systems, in two different experiments. About 5500 values were produced and assessed statistically. Materials (either patients' sera or control materials) were considered non-commutable (i.e. exhibiting significantly different inter-method behaviour) when their distance from the regression line in a stated pair of methods exceeded 3 standard deviations. According to this criterion, less than 1.5% of the patients' sera, and an even lower proportion of control materials were non-commutable. However, the inter-method behaviour of control materials was usually slightly different from that of patients' sera. Some systematic inter-method difference in the measurements on patients' sera may therefore exist, even though inter-method equivalence has been demonstrated with control materials.

Comparison of multidose ibuprofen and acetaminophen therapy in febrile children.

OBJECTIVE: To determine whether febrile children receiving 2.5-, 5-, or 10-mg/kg ibuprofen therapy via a liquid or 15-mg/kg acetaminophen therapy via an elixir every 6 hours for 24 to 48 hours show equivalent fever reduction or suffer adverse effects of the drug administered. DESIGN: Randomized, double-blind, multidose, parallel-group, variable-duration (24 to 48 hours) clinical trial. SETTING: The academically affiliated Children's Hospital in Columbus, Ohio. PARTICIPANTS: 64 febrile (defined as oral or rectal temperature of 39 degrees C to 40.5 degrees C) but otherwise healthy children aged 6 months to 11 years 7 months randomly assigned to one of the four drug regimens. INTERVENTIONS: Treatment with either ibuprofen or acetaminophen as described above. Administration of antibiotics or intravenous fluids was allowed only after at least 24 hours of treatment with the assigned drug. MEASUREMENTS/MAIN RESULTS: In 61 of the 64 evaluable patients, treatments were effective and well tolerated during the entire study. While the rates of temperature reduction and maximal reduction of fever after administration of the initial dose were equal for patients receiving 10-mg/kg ibuprofen therapy and 15-mg/kg acetaminophen therapy, and both regimens were more effective than smaller doses of ibuprofen in reducing fever, after the second dose (and continuing to the end of the study) there were no statistically significant differences in temperature response among the treatment groups. Six children were withdrawn from the study, two because of dosing errors, three because of hypothermia (temperature of less than 35.6 degrees C; all three patients were in the acetaminophen group), and one because of gastrointestinal distress (this child was in the group receiving 2.5-mg/kg ibuprofen therapy). No other significant symptoms or adverse laboratory or physical findings were noted. While further confirmatory studies are needed, ibuprofen liquid (10 mg/kg) and acetaminophen elixir (15 mg/kg) administered every 6 hours for 24 to 48 hours appeared to be most effective in reducing fever. These two regimens were equally effective and equally tolerated in febrile children. Lower ibuprofen doses (2.5 and 5 mg/kg) were less effective than acetaminophen and 10-mg/kg ibuprofen therapy after the initial dose but were at least equally effective as these two higher-dose regimens thereafter.