[Profile and management of patients consulting for a non severe exacerbation of chronic obstructive pulmonary disease (Pragma survey)]. / Profil et prise en charge de patients venant consulter pour une exacerbation de bronchopneumopathie chronique obstructive non sévère (enquête Pragma) Etude observationnelle sur 4763 patients.

OBJECTIVES: To evaluate, in patients with chronic obstructive pulmonary disease (COPD), stage 0 or 1, the percentage of patients who had spirometry, and to study their sociodemographic, clinical and epidemiological characteristics. PATIENTS AND METHODS: An epidemiological survey was conducted with 2389 general practitioners concerning 4769 patients with early COPD, consulting for the first time for exacerbation of COPD, presumed to be bacterial. RESULTS: Spirometry under stable conditions was performed in only 30% of patients. When the physician does not have access to this examination to guide antibiotic prescription for an exacerbation presumed to be bacterial, recent guidelines have established a correlation between dyspnoea and the degree of severity of COPD (GOLD classification). This correlation was not confirmed by the present study: 34% of patients with stage 0 or 1 COPD complained of dyspnoea and 52% of patients with stage 2 or 3 COPD did not complain of dyspnoea. The main criterion in favour of a bacterial cause of exacerbation, frank purulent sputum, observed in one out of three patients, did not influence the decision to prescribe antibiotics, given to 98% of patients. Therapy used bronchodilators (73%), even in patients with no signs of obstruction, and inhaled steroids (72%), although, according to guidelines, they are only indicated in the most serious forms (stage 3). This survey illustrates the effort needed to ensure better concordance between guidelines and practice, by taking into account the difficulties encountered by practitioners.

[Routine use of extended-release clarithromycin tablets for short-course treatment of acute exacerbations of non-severe COPD]. / Utilisation de la clarithromycine à libération modifiée en traitement court des exacerbations aiguës d'une BPCO peu grave en pratique médicale courante.

OBJECTIVE: This study was designed to confirm, in routine clinical practice conditions, the success rates and safety of extended-release clarithromycin tablets in patients with acute exacerbation of chronic obstructive pulmonary disease (COPD), according to the usual empirical criteria in routine clinical practice. PATIENTS AND METHODS: An open-label, pharmacoepidemiological, clinical study in community practice was performed with 180 practitioners. The bacterial origin was suspected when sputum was obviously purulent. RESULTS: Seven hundred and nineteen adult patients with acute exacerbation of mild or moderately severe COPD were included. A favorable clinical course of the exacerbation was observed in 92.5% of cases, with resolution of frankly purulent sputum in 99% of cases, associated with good tolerance. CONCLUSION: These results confirm the value of extended-release clarithromycin tablets as first-line treatment for presumed bacterial exacerbation of mild or moderately severe, stable COPD according to the Société de pathologie infectieuse de langue française consensus.

[Efficacy and safety of telithromycin in the treatment of acute exacerbation of chronic obstructive pulmonary disease]. / Efficacité et tolérance de la télithromycine dans le traitement de l'exacerbation aiguë de bronchite chronique obstructive.

UNLABELLED: The aim of this study was to evaluate the clinical efficacy of telithromycin administered for 5 days at a dosage of 800 mg/day, in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) presenting with at least 2 of Anthonisen's criteria including the increase of purulence. METHODOLOGY: During this multicenter (211 private lung specialists), prospective, non-comparative, open-labeled French study, 365 patients were included between April 2002 and March 2003. Clinical efficacy was assessed on D12-D19 by the rate of clinical success as defined by recovery or clinical improvement (main endpoint) according to the number of exacerbation episodes during the previous year. RESULTS: On D12-D19 clinical success rate in the per protocol global population was 88.0% and respectively 87.9% in patients with or=4 episodes in the previous year. These success rates were similar to those in the intent-to-treat population. Safety, assessed on 359 patients, was satisfactory, with mainly digestive disorders related to the treatment in 3.9% of the patients. No treatment-related serious adverse events were observed. CONCLUSION: This study, conducted among private practitioners in France according to COPD classification as defined by official recommendations, validates the results obtained in previous studies. Our results confirm the place attributed to telithromycin in the treatment of patients presenting with AECOPD without chronic respiratory failure, according to ongoing official recommendations.

[Efficacy and safety of extended-release clarithromycin (5-day short-course) vs telithromycin, in acute bacterial exacerbation of chronic bronchitis]. / Efficacité et tolérance de la clarithromycine, forme à libération modifiée en traitement court de cinq jours dans les exacerbations aiguës de bronchite chronique, comparativement à la télithromycine.

BACKGROUND: The extended-release formulation of clarithromycin (CLA-ER) allows using this macrolide as a single daily dose. The purpose of this study was to evaluate the efficacy and safety of the CLA-ER formulation (500 mgx2) vs telithromycin (TELI) (400 mgx2) as a short course 5-day treatment, once a day, in patients with AECB. METHOD: This randomized double-blind study was conducted in patients with AECB without severe airflow limitation (FEV1>35%), with sputum purulence (mandatory criterion), and with either increased sputum volume or increased dyspnea, or both (Anthonisen criteria I or II). RESULTS: Three hundred sixty-two patients were assessed (62.6 years of age+/-12.9, men: 58.8%) positive culture on inclusion for 53.8%, with Haemophilus influenzae (N=57), Moraxella catarrhalis (N=42), and Streptococcus pneumoniae (N=41). In the per protocol population, the clinical success rate at day 8 was 97% (161/166) vs 97% (146/151), 97.5% CI=[-4.12 -4.71], the clinical cure rate at day 30 was 78% (129/166) versus 77% (116/151), P=0.85, and mean time without recurrence was 62 days versus 61 days (P=0.51), in CLA-ER and TELI groups, respectively. Fourteen patients in the CLA-ER group (8.2%) and 20 patients in the TELI group (12.4%) experienced at least one treatment-related adverse event (P=0.21), upon which gastrointestinal events were the most commonly reported treatment-related ones. CONCLUSION: CLA-ER (1000 mg once a day) for 5 days is at least as effective as telithromycin in the treatment of AECB without severe airflow limitation and is well tolerated.

[Hemothorax in a 78-year-old woman]. / Hémothorax d'origine iatrogène chez une femme de 78 ans.

We report an atypical presentation of hemothorax. Tamponade and subacute dyspnea occurred secondary to a wound of the right atrium caused by a pacemaker electrode in 78-year-old woman on oral anticoagulants for complete arrhythmia due to atrial fibrillation. This case illustrate an unusual pathophysiological mechanism of hemothorax.

Equally efficacious asthma management with budesonide 800 micrograms administered by Turbuhaler or with beclomethasone dipropionate > or = 1500 micrograms given through a pressurized metered-dose inhaler with spacer. The French Budesonide Trial Group.

To avoid the side effects associated with long-term administration of high doses of inhaled glucocorticosteroids, they should be used at the lowest effective dose. This study compared the clinical efficacy of budesonide given via a dry-powder, inspiratory flow-driven device (Turbuhaler), at a daily dose of 800 micrograms, with beclomethasone dipropionate (BDP) 1500 to 2000 micrograms given via pressurized metered-dose inhaler (pMDI) with spacer to adults requiring the latter dose of BDP to control their asthma. The study was performed as a 2-week run-in, 8-week open, randomized, multicenter, parallel-group design. Adult asthmatics with a forced expiratory volume in 1 second 55% or more of predicted normal and receiving BDP 1500 to 2000 micrograms daily entered the study. After a 2-week run-in, one group continued with BDP and the other was switched to budesonide through the Turbuhaler. After 8 weeks, morning peak expiratory flow (PEF) had increased by 5.9 L/min from a mean of 390 L/min in the budesonide group and by 1.9 L/min from a mean of 402 L/min in the BDP group. No clinically or statistically significant differences between groups were evident with regard to the change in this primary variable. Similarly, only small changes in evening PEF and secondary variables of lung function were seen, with no statistically significant difference between groups. The authors concluded that both treatments were equivalent in managing asthma in adult patients with stable asthma.

[Treatment of community-acquired pneumonia with levofloxacin: 500 mg once a day or 500 mg twice a day?]. / Traitement des pneumonies communautaires par lévofloxacine: 500 mg 1 fois par jour ou 500 mg 2 fois par jour?

LEVOFLOXACIN: A new anti-pneumococcal fluoroquinolone, levofloxacin, has received approval in France for the treatment of community-acquired pneumonia at the dose of 500 mg once or twice a day, depending on the severity of the disease, the germ susceptibility and the patient's weight. Levofloxacin has a powerful and rapid bactericidal activity, particularly against pneumococci, whatever the level of penicillin resistance. The pharmacokinetic properties of the compound allow once daily dosage. Pharmacodynamically, it has been clinically demonstrated that the most predictive parameter of efficacy is the Cmax/MIC ratio. PNEUMOCOCCAL PNEUMONIA: Because of the potential gravity of pneumococcal pneumonia, it might be preferrable to use levofloxacin at the dose of 500 mg twice daily. The efficacy of the two levofloxacin doses for the treatment of pneumococcal pneumonia was thus analyzed. Five clinical studies including 4 comparative trials, enrolling nearly 2,000 patients with community-acquired pneumonia were reported in the international approval document. Among these patients, 310 had documented pneumococcal pneumonia including 31% with bacteriemia. TASK FORCE REPORT: On the basis of available data, the level of proof is sufficient to prescribe levofloxacin at the dose of 500 mg once daily for the treatment of mild to moderately severe community-acquired pneumonia in ambulatory patients, including those with suspected pneumococcal pneumonia, with or without bacteriemia. It would be reasonable to propose the 500 mg twice daily dosage for severe community-acquired pneumonia warranting intensive care hospitalization in accordance with the criteria of the ERS Task Force Report. The well-founded rationale of this therapeutic strategy should be validated by the results of ongoing studies and by following the evolution of germ susceptibility to these new compounds.

[Efficacy of levofloxacin in the treatment of acute exacerbation of chronic bronchitis in patients with risk factors]. / Efficacité de la lévofloxacine dans le traitement des exacerbations aiguës de bronchite chronique chez les patients avec facteurs de risque.

Studies of acute exacerbations of chronic bronchitis (EXCB) included in the approval documents of levofloxacin (LVF) were reviewed in light of the good conditions of use defined by the French marketing approval and the AFSSAPS recommendations. The approval documents included two American studies comparing LVF 500 mg/d for 5-7 days with cefaclor 750 mg/d for 7-10 days or cefuroxime axetil (CXM) 500 mg/d for 7-10 days. A new descriptive analysis of efficacy was performed on a population meeting the recommendation criteria for antibiotic treatment in patients with clinical signs of obstruction. This analysis was stratified by number of risk factors (RF) for the following aggravating conditions: age above 65 years, diabetes or corticosteroid therapy. In the American studies, clinical efficacy, measured by rate of success in the total population, in the EXCB population requiring antibiotic therapy with or without risk factors, and in the EXCB population with at least one and at least two of the above-cited risk factors was 93.4% (351/376), 93.0% (268/288), 90.4% (122/135) and 94.4% (34/36) respectively with LVF and 92.2% (354/384), 92.5% (273/295), 87.7% (128/146) and 79.3% (23/29) respectively with the compared drugs. In the European study, the clinical efficacy in the total population, in the EXCB population requiring antibiotic therapy with or without risk factors, and in the EXCB population with at least one and at least two of the above-cited risk factors was 81.9% (195/238), 82.4% (182/221), 78.9% (112/142) and 75.0% (27/36) respectively with LVF and 72.5% (166/229), 74.0% (154/208), 73.1% (95/130) and 58.3% (21/36) respectively with the compared drugs. The efficacy of levofloxacin is thus confirmed for EXCB with signs of obstruction. When stratifying for RF, the efficacy of LVG persists with increasing numbers of RF, a result not observed with the compared drugs.

[Monotherapy using amoxicillin/clavulanic acid as treatment of first choice in community-acquired lung abscess. Apropos of 57 cases]. / Monothérapie par amoxicilline/acide clavulanique (AM-AC) en traitement de première intention dans les abcès pulmonaires communautaires. A propos de 57 cas.

In a multicentre open prospective trial the effectiveness of AM-CA as first-line treatment of community-acquired lung abscess was evaluated in immunocompetent adult patients. AM-CA was administered intravenously in doses of 4 g/day for at least 7 days, then orally in doses of 2 g/day for at least 14 days. Radio-clinical and laboratory evaluations were made during treatment, and 30 and 60 days after it was discontinued. The results of this trial concerned 57 patients (48 men, 9 women; mean age 52 years). The facilitating factors were those usually found in lung abscess. Twenty-seven patients had previously received an antibiotic treatment which had failed. The clinical picture, built up gradually in 42/37 patients, consisted of infectious syndrome (52 cases), altered general condition (39 cases), purulent expectoration (47 cases), sometimes foetid (10 cases), and thoracic clinical abnormalities (57 cases. X-ray films of the chest showed round abscess images (44 cases) or looked like necrotizing pneumonia (13 cases) with pleural reaction (8 cases). Protecting bacteriological sampling by BFW brushing and transtracheal or transparietal sample collecting was performed in 41 of the 57 patients. The pathogens, isolated in 31 cases, were: S. pneumoniae 5; Streptococcus spp. 12; Staph. aureus 4; H. influenzae 7; Enterobacteriaceae 6; anaerobes 7. These organisms were associated in 8 cases. With the exception of Enterobacter cloacae, all were sensitive to AM-CA in-vitro. The outcome was satisfactory in 52 patients.

[Acute dry coughs have underestimated impacts on patients' everyday lives]. / Les toux sèches aiguës ont des conséquences sous-estimées sur la vie quotidienne des patients.

OBJECTIVE: To describe the clinical features of dry cough, its socio-professional consequences and impact on patients' quality of life. METHOD: Cross-sectional observational study conducted in daily practice of general practice. RESULTS: One thousand and six hundred and five patients aged 43 years, 52.2% of whom were men, were included in the study. Pharyngeal irritation was present in 95.4% of the patients, asthenia in 90.2%, headache in 78.3%, muscle pain in 75.8%, dysphonia in 42.3%, a change in general condition in 23.1%, dysphagia in 19.8%, and dyspnoea in 17.4%. An infectious syndrome was the likely origin of the cough in 48.3% of the patients. The cough affected family life for 92.7% of them, professional life for 81.7%, and social life for 90.8%. The average CQLQ quality of life score was 56, reflecting a marked alteration in their quality of life. We noted that 47.3% of the patients were exhausted, 38.8% experienced nausea and 15.8% vomiting. Among the patients, 14.0% of the patients experienced release of urine, and in women this rate reached 28.0% of them; 76.7% of patients had trouble sleeping due to their cough and 24.4% had an Epworth score above 18, indicating a severe risk of drowsiness during the day. CONCLUSION: An effective treatment for coughing therefore appears to be an absolute necessity, since this goes far beyond simple coughing discomfort itself.

[Relevance of fluoroquinolone use in Lorraine: results of the first survey]. / Revue de pertinence des fluoroquinolones en Lorraine: résultats de la première évaluation.

OBJECTIVES: The Antibiolor network assessed the good use of fluoroquinolones (FQ) in the French Lorraine region by a relevance review. METHODS: At the beginning of 2008, the experts in voluntary hospitals filled out a standard card mentioning the indication, FQ name, route, and duration according to prescriptions in the last 3 months. Two experts checked the relevance of prescriptions according to the local Antibioguide, and determined a score of therapeutic adequacy index for each card. Each establishment was given its results. Corrective measures were adopted at a meeting of the regional antibiotics commission in January 2009. RESULTS: One hundred and twenty-four units (61 medical, 33 surgical, 17 ICU, 2 ER, 11 long-stay hospital) in 28 hospitals filled 1538 cards. The most frequent indications were: pulmonary (632), urinary (445), digestive (130). The FQ indication was non-conform for 36% of the cards (n=554). When the FQ indication was justified (984 cards), the chosen molecule was non-conform in 222 cases (23%), dose in 115 cases (12%), duration in 250 cases (25%), and route of administration in 83 cases (8%). The prescriptions were entirely conform for 425 cards (28%). CONCLUSION: The Lorraine hospitals massively took part in this study. The second survey will use the same methodology. The objective will be to reduce the number of unjustified FQ prescriptions and to increase the number of conform cards.

Moxifloxacin monotherapy compared to amoxicillin-clavulanate plus roxithromycin for nonsevere community-acquired pneumonia in adults with risk factors.

The objective of this study was to assess the efficacy and safety of moxifloxacin versus amoxicillin-clavulanate plus roxithromycin (comparator) in adult community-acquired pneumonia (CAP) patients with risk factors. In this comparative, randomized, multicenter, open-label study, patients hospitalized for CAP received a 10-day oral treatment with either moxifloxacin (400 mg o.d.) or amoxicillin-clavulanate (1,000/125 mg t.i.d.) plus roxithromycin (150 mg b.i.d.). Clinical and bacteriological outcomes were assessed during test of cure and follow-up visits (5-7 days and 21-28 days after the end of treatment, respectively). Of 349 randomized patients, 346 were included in the intent-to-treat analysis and 289 in the per-protocol analysis. Their baseline characteristics were comparable. The most frequent risk factors for mortality were age >65 years (50.0%), alcoholism (23.1%), and comorbidities (50.6%); chronic obstructive pulmonary disease (COPD) (25.4%) and diabetes mellitus (13.6%) were the most common associated comorbidities. A causative pathogen was documented in 66 of 346 (19.1%) of the patients (including 21 with positive blood cultures). Respective per-protocol clinical success rates at test-of-cure (primary efficacy endpoint) for moxifloxacin and comparator were 131 of 151 (86.8%) and 120 of 138 (87.0%), with a 95% confidence interval (CI) of -8.0-7.6 for the difference. Bacteriological success rates (eradication) were 23 of 30 (76.7%) and 23 of 31 (74.2%); rates for patients with positive blood cultures were 10 of 14 and 4 of 6. Persistent clinical success rates at follow-up were 118 of 120 (98.3%) and 102 of 106 (96.2%), with a 95%CI of -2.2-6.4 for the difference. The intent-to-treat analysis confirmed these results. Adverse events associated with moxifloxacin and the comparator drug were reported for 42 of 171 (24.6%) and 50 of 175 (28.6%) of the patients, respectively, and comprised predominantly digestive disorders, which occurred in 9.4% and 21.1%. On the basis of these results, once-daily oral moxifloxacin alone is as effective as amoxicillin-clavulanate plus roxithromycin for the treatment of CAP in patients with risk factors.

Efficacy and tolerance of cefpodoxime proxetil compared with ceftriaxone in vulnerable patients with bronchopneumonia.

This multicentre, randomized study compared the efficacy and tolerance of cefpodoxime proxetil and ceftriaxone in vulnerable patients with bronchopneumonia. Patients received cefpodoxime proxetil 200 mg bd orally or ceftriaxone 1 g daily im for a ten-day period. They were evaluated at days 10 and 30. Ninety-six patients were evaluated for tolerance, 85 for clinical efficacy and 65 for bacteriological efficacy. At entry all patients had radiographic evidence of pneumonia and 74% of bacteriological samples were positive. The percentage of overall success (cured or improved) was 97.7% (43/44) in the cefpodoxime proxetil group and 95.1% (39/41) in the ceftriaxone group. The bacteriological efficacy was 94.3% in the cefpodoxime proxetil group and 97.4% in the ceftriaxone group. Clinical tolerance was satisfactory in both groups. In this study, the clinical and bacteriological results obtained with cefpodoxime proxetil were comparable with those obtained with ceftriaxone in the treatment of community-acquired bronchopneumonia in patients with additional risk factors.

A double-blind randomized trial comparing the efficacy and safety of a 5-day course of cefotiam hexetil with that of a 10-day course of penicillin V in adult patients with pharyngitis caused by group A beta-haemolytic streptococci.

A 10-day course of penicillin is the antibiotic regimen currently recommended by the American Heart Association (AHA) as treatment for patients with tonsillitis caused by group A beta-haemolytic streptococci (GABHS), with the aim of preventing both the suppurative and non-suppurative complications of this infection. This prospective, multicentre, randomized, double-blind, double-dummy clinical trial was undertaken in order to compare the efficacy of, tolerability of and compliance with a 5-day course of cefotiam hexetil (CTM) 200 mg bd with that of a 10-day course of penicillin V (PEV) 1 megaunit (600 mg) tds, to investigate the significance of recovering GABHS during or after treatment and to evaluate the potential economic advantages of short-term regimens. Two hundred and fifty ambulatory adult patients with a presumptive diagnosis (based on a positive rapid antigen detection test) of GABHS tonsillitis were recruited in 60 centres; the diagnosis was subsequently confirmed by a positive culture of a throat swab. At the time of entry into the trial there was no statistically significant difference between the groups in terms of clinical symptoms. In an intention-to-treat analysis, both the clinical and bacteriological response rates at days 10 and 30 were comparable for each group i.e. 106 of 119 (89.1%) patients and 90 of 109 (82.6%) patients respectively in the CTM group and 103 of 117 (88.0%) patients and 92 of 107 (86.0%) patients respectively in the PEV group. The times until defervescence and resolution of symptoms were also similar. Of the 115 patients in each group who were assessed at day 90, there were three clinical relapses in the CTM group and seven in the PEV group. No non-suppurative complications of GABHS infection were detected. Tolerance was significantly better in the CTM group than in the PEV group, 14 of 119 (11.8%) patients and 26 of 117 (22.2%) patients in the former and latter groups respectively reporting adverse events. In three cases in each group treatment was discontinued prematurely because of adverse events; none of these in the CTM group was serious but one patient in the PEV group experienced a severe allergic reaction. Compliance in both groups was good during the first 5 days of therapy but, by the end of each course, 93.6% of patients in the CTM group had completed treatment, compared with 73.0% in the PEV group.(ABSTRACT TRUNCATED AT 400 WORDS)

["Plastic lung". Broncho-pulmonary pathology related to plastics (author's transl)]. / "Le poumon plastique". Pathologie broncho-pulmonaire liée aux matières plastiques.

Plastics can induce three main groups of respiratory accidents.--Acute and subacute intoxications related to the inhalation of volatil substances from decomposing plastics (mostly during burning and pyrolysis) or on the contrary during synthesis. They are accidental chemical broncho-pneumopathies (acute tracheo-bronchitis and pulmonary edema).--Chronic broncho-pneumopathies following repeated inhalation of dusts or suspension of plastics: pneumoconioses and thesaurismoses leading to pulmonary fibrosis.--Broncho-pneumopathies related to the irritant and sensitizing action of some components of plastics: professional asthma and sensitization pneumopathies. Diagnosis of such diseases therefore imposes a careful study of working conditions. Proof rests on two arguments:--curing by risk eviction;--analysis of the products in order to reveal their toxicity.