[Prevention of COPD exacerbations: conducting a clinical trial evaluating the benefits of inhaled steroids].
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Adrenal Cortex Hormones↗
Biomedical subjects
J M Grouin
Publications and source records attributed to J M Grouin.
Efficacy of fusafungine in acute rhinopharyngitis: a pooled analysis.
Upper respiratory tract infections are generally mild but they are associated with an enormous loss in productivity. Treatment consists of reduction of local symptoms e.g. local inflammation and prevention of potential superinfections. Besides its bacteriostatic activity against most micro-organisms involved in respiratory tract infections fusafungine displays original anti-inflammatory properties. To optimise nasal and throat deposition, a new fusafungine oro-nasal spray using HFA 134a was developed and its efficacy was evaluated in patients with acute rhinopharyngitis based on improvement of significant nasal symptoms. Three randomised double-blind placebo-controlled parallel-group studies with identical objectives design and dosage were performed and results were pooled for a better evaluation of treatment effect (532 patients). The percentage of responders (patients with nasal symptom score improvement from Day 0 to Day 4) was 61.5 +/- 2.9% with fusafungine vs 46.8 +/- 3.1% with placebo (p=0.009) with an odds ratio of 1.8 (p=0.01) in favour of fusafungine. The nasal symptom score distribution at Day 4 showed an odds ratio of 1.56 (p=0.011) also in favour of fusafungine. For patients treated early (onset of symptoms 1 pounds day) the percentage of responders was 65.9 +/- 4.1% with fusafungine vs 38.3 +/- 4.0% with placebo (p=0.022) with an odds ratio of 3.08 (p=0.033) in favour of fusafungine. Therefore fusafungine through its dual bacteriostatic and original anti-inflammatory properties is an effective treatment of acute rhinopharyngitis especially when administered early.
Acute Disease↗
IgG subclass distribution in serum and various mucosal fluids of HIV type 1-infected subjects.
We measured total IgG1, IgG2, IgG3, and IgG4 concentrations by ELISA in serum (S), total saliva (TS), cervicovaginal secretions (CVS), seminal secretions (SPE), and rectal secretions (RS) from either CDC II/III HIV-1-infected subjects or healthy volunteers. Human serum albumin was measured in parallel to calculate the relative coefficient of excretion (RCE). Levels of IgG1 and IgG3 directed against gp120 MN also were measured by ELISA in all samples, and the specific activity (SA) calculated. HIV-1-specific IgG2 and IgG4 were not compared, as total IgG2 and total IgG4 levels in HIV-1-infected subjects were found to be lower than in the healthy controls. Despite substantial interindividual variability, total IgG1 and IgG3 concentrations in all fluids were greater in the HIV-1-infected subjects than in the healthy controls. Calculations of RCE indicated predominantly a transudative origin for IgG subclasses in the different mucosal fluids, except for CVS, in which IgG1, IgG2, and IgG4 was produced locally. The transduction behavior of IgG3 in secretions appears to be different from that of other IgG subclasses. HIV-1-infected subjects were considered positive for IgG1 and IgG3 antibodies against gp120 MN if their antibody levels exceeded the maximum titer measured in the control group. Positive levels of anti-gp120 MN IgG1 were detected for 100% of HIV-1-infected individuals in S, CVS, and SPE, 97% in TS, and 75% in RS. Fewer subjects had positive levels of IgG3 to gp120 MN in their secretions (maximum 67% in CVS). Despite the low concentrations of total IgG3, mean SA values for IgG3 to gp120 MN were greater in secretions than in serum. No significant difference in the SA values for IgG1 to gp120 MN was observed between the different fluids. Only CVS had a local production of HIV-specific IgG1 Our results highlight the importance of an HIV-specific IgG1 and IgG3 immune response in mucosal fluids from HIV-1-infected subjects.
Adult↗
Comparison of the distribution of IgG and IgA antibodies in serum and various mucosal fluids of HIV type 1-infected subjects.
We compared IgG and IgA distribution in serum, three different salivary samples, two different rectal secretion samples, cervicovaginal secretions, and seminal secretions from asymptomatic CDC stage II/III HIV-1-infected subjects (n = 44) and from HIV-1-seronegative volunteers (n = 52). In-house ELISAs were used to measure total IgG and total IgA levels, as well as HIV-specific anti-gp120 MN and anti-p24 LAI IgG and IgA. Human serum albumin was titrated in parallel to calculate the relative coefficient of excretion (RCE). In spite of substantial interindividual variability, total IgG concentrations in all fluids were found to be significantly greater in the HIV-1-infected group than in the seronegative subjects. Calculation of RCE values revealed three different types of mucosal secretion: secretions with no local Ig production, such as sperm; secretions with local production of IgA and transudative origin of IgG, such as salivary and rectal samples; and secretions with local production of both IgG and IgA, such as in cervicovaginal secretions. For all mucosal specimens from HIV-1-infected subjects, the response to HIV-1 was predominantly IgG, with highest titers observed in cervicovaginal secretions (although these were lower than serum levels). In contrast, the specific IgA response appeared weaker in the mucosa than in serum.
Adult↗
Development and standardization of methods to evaluate the antibody response to an HIV-1 candidate vaccine in secretions and sera of seronegative vaccine recipients.
Enzyme-linked immunosorbent assays (ELISA) were developed to test, in serum and mucosal samples, total IgG, total IgA, serum albumin, and anti-gp120 MN and anti-p24 LAI IgG and IgA levels. These ELISAs were optimized according to reagents and experimental conditions. Inter- and intra-assay coefficients of variation ranged from 3.3% to 18.6%. The ELISA results were linear and precise, and for anti-HIV-1 IgG and IgA, the analytical recovery was close to 100%. For IgG and IgA titration against gp120 MN and p24 LAI, standards were made using pooled sera or gammaglobulins with assigned titres in ELISA units per ml (EU/ml). These standards were used to obtain a linear regression curve that could then be used to obtain the titres of experimental samples. The cut-offs for positivity were determined for sera and mucosal fluid using healthy controls. Validation conditions were defined for ELISAs, and samples that did not satisfy these conditions were retested. Measurement of total IgG and IgA allowed normalization and comparison of the results of specific immunoglobulin levels between different samples. Serum albumin was tested as a marker of transudation from serum to mucosal fluid, allowing calculation of the relative coefficient of excretion, which is one element required to determine the origin of the immunoglobulin detected in mucosal samples. These ELISAs were developed with samples from HIV-1-infected and healthy subjects. We now have the tools to study and understand mucosal immunity in seronegative subjects vaccinated with an HIV-1 candidate vaccine.
AIDS Vaccines↗
Symptomatic efficacy of avocado/soybean unsaponifiables in the treatment of osteoarthritis of the knee and hip: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial with a six-month treatment period and a two-month followup demonstrating a persistent effect.
OBJECTIVE: To assess the efficacy and safety of avocado/soybean unsaponifiables (ASU) in the treatment of patients with symptomatic osteoarthritis (OA) of the knee or hip, as well as the potential residual effects of ASU after stopping treatment, to determine whether ASU might be a symptomatic slow-acting drug for the treatment of OA. METHODS: One hundred sixty-four patients with regular, painful, primary OA of the knee (n = 114) or hip (n = 50) entered a prospective, randomized, double-blind, placebo-controlled, parallel-group, multicenter trial with a 6-month treatment period and a 2-month posttreatment followup. A 15-day washout period for nonsteroidal antiinflammatory drugs (NSAIDs) preceded the study. Efficacy was judged according to 1) Lequesne's functional index (LFI) and 2) pain on Huskisson's visual analog scale (VAS; 100-mm scale), intake of NSAIDs/analgesics, and overall disability score (by 100-mm VAS). RESULTS: Eighty-five patients received ASU; 79 received placebo. One hundred forty-four patients were evaluable at month 6 (75 taking ASU; 69 taking placebo). The mean +/- SEM LFI score decreased from 9.7 +/- 0.3 to 6.8 +/- 0.4 in the ASU group and from 9.4 +/- 0.3 to 8.9 +/- 0.4 in the placebo group (P < 0.001 for intergroup difference at month 6). Pain decreased from 56.1 +/- 1.6 mm to 35.3 +/- 2.3 in the ASU group and from 56.1 +/- 1.8 mm to 45.7 +/- 2.6 in the placebo group (P = 0.003 at month 6). NSAID consumption was slightly lower in the ASU group. Fewer patients in the ASU group required NSAIDs (48%, versus 63% in the placebo group; P = 0.054). The success rate was 39% in the ASU group and 18% in the placebo group. Overall functional disability was significantly reduced in the ASU group. Improvement appeared more marked in patients with hip OA. A residual effect was observed at month 8. Tolerance was good to excellent for most patients. CONCLUSION: ASU treatment showed significant symptomatic efficacy over placebo in the treatment of OA, acting from month 2 and showing a persistent effect after the end of treatment.
Aged↗
Validation of an algofunctional index for osteoarthritis of the hand.
Although hand osteoarthritis is common, it has been the focus of few therapeutic trials. In addition to the problems raised by clinical trials in osteoarthritis in general and to the difficulties due to the unforeseeable course of osteoarthritis of the trapezometacarpal and finger joints, the lack of a clinical tool for assessing pain and function over time is an additional obstacle. We propose an algofunctional index designed for evaluation and symptomatic follow-up of patients with digital osteoarthritis. The index is based on a physician-administered questionnaire on 10 daily activities involving the hands. The patient is asked to answer each item using a 4-point verbal scale, from "possible without difficulty" (0) to "impossible" (3 points); thus, total scores range from 0 to 30. This index has been used in a few clinical placebo-controlled trials and was found sensitive to change. The aim of this study was to assess the metrological qualities of this index, including consistency (internal and external), sensitivity and specificity (by scoring the index in different groups of subjects), intra-observer reproducibility, and ease of use. Three hundred patients were recruited by 25 rheumatologists: 100 had a painful attack of digital and/or trapezometacarpal osteoarthritis (mean age: 64.9 years) with a score of more than 40 mm on a visual analog scale for overall pain severity (mean: 57.3 +/- 14 mm), 100 had "inactive" hand osteoarthritis (mean age 67.0 years), and 100 had no diseases of the upper limbs. Specificity/sensitivity: the mean index score was 12.41 +/- 5.41 in patients with painful OA, 4.28 +/- 3.87 in "inactive" cases, and 0.59 +/- 1.23 in controls. External consistency: the overall mean score was well correlated with pain severity: r = 0.49 (p < 0.001). Internal consistency: principal component analysis identified a primary axis responsible for 44.2% of the variance and two secondary axes each responsible for slightly more than 9% of the variance. None of the questions seemed redundant. Intra-observer reproducibility: two evaluations done one hour apart in symptomatic patients yielded the following scores: 12.32 +/- 5.41 and 12.5 +/- 5.51 (correlation: 0.95; mean difference: 0.17 +/- 1.64; coefficient of variation: 9.32%). Kappa values for both measurements of each item ranged from 0.68 to 0.87. Ease of use: mean time needed to determine the score 2.5 +/- 2 min. The scoring process was considered simple by 100% of investigators and easy/very easy by 98% of patients.(ABSTRACT TRUNCATED AT 400 WORDS)
Adult↗
Bayesian predictive approach for inference about proportions.
This paper investigates the Bayesian procedures for comparing proportions. These procedures are especially suitable for accepting (or rejecting) the equivalence of two population proportions. Furthermore the Bayesian predictive probabilities provide a natural and flexible tool in monitoring trials, especially for choosing a sample size and for conducting interim analyses. These methods are illustrated with two examples where antithrombotic treatments are administrated to prevent further occurrences of thromboses.
Bayes Theorem↗