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Objective: To compare oral anticoagulant treatment (fluindione) started on either the 1st or the 10th day of a low-molecular-weight heparin (enoxaparin) treatment for deep vein thrombosis confirmed by venography. Design: An open, multicenter, randomized study in two parallel treatment groups. Interventions: All patients received enoxaparin, 1 mg/kg s.c. twice daily, and oral fluindione, 20 mg once daily, either beginning on day 1 or on day 10 of the enoxaparin treatment. Enoxaparin was discontinued once the international normalized ratio under fluindione was stable between 2.0 and 3.0 over 2 days. Fluindione treatment was maintained during a 3-month follow-up period. Outcome Measurements: Specific examinations (venography and/or V/Q lung scanning and/or angiography) were performed only in the event of a clinically suspected recurrence of venous thromboembolism during the 3-month follow-up period. All cases were blindly assessed by an independent Reading Committee. Results: A clinically suspected venous thromboembolism was confirmed by objective tests in 1 of 223 patients (group of delayed introduction of fluindione; n = 111). Equivalence was demonstrated between the two treatment schedules (p < 0.0001) for a maximal difference of 10% (90% confidence interval: –2.42 to 0.58). The mean duration of hospitalization was significantly reduced (p = 0.0001) in the group with early introduction of fluindione. The incidence of hemorrhage was comparable between the two treatment groups. Conclusion: Early and delayed introduction of oral anticoagulant treatment in association with subcutaneous enoxaparin in patients with deep vein thrombosis was shown to be equivalent in preventing the recurrence of venous thromboembolism. In patients with early introduction of oral anticoagulant, hospitalization was significantly reduced.

A Phase I trial of carboplatin therapy was performed on patients with locally advanced non-small cell lung cancer who had been previously treated with cisplatin, mitomycin and a vinca alkaloid. This was administered as a daily bolus infusion or as a continuous infusion for 6 weeks with concurrent daily thoracic radiation. All patients had to be objective responders or to show no change after chemotherapy. The carboplatin was started at 10 mg/m 2 per day, and increased to 15 mg/m 2 per day and 20 mg/m 2 per day, if treatment was feasible in successive cohorts of at least six patients. The radiation therapy consisted of 62–66 Gray on the tumor and the ipsilateral mediastinal nodes, 50 Gray on the mediastinum and 40–45 Gray on the supraclavicular lymph nodes. Twenty-nine patients took part in this study. Thrombocytopenia was the principal dose-limiting toxicity, with 15 mg/m 2 per day of bolus or continuous infusion. Other toxicities included a fall in haemoglobin level, a fall in white-blood cell count, nausea and vomiting. The median survival time is 12 months, but the response rate cannot be determined among patients selected on the basis of response to chemotherapy. The recommended Phase II dose for patients previously treated with cisplatin containing chemotherapy, is 10 mg/m 2 per day of either a bolus or continuous infusion.

Resume Une etude multicentrique, ouverte, randomisee, comparative a ete conduite en medecine de ville (67 medecins generalistes et pneumologues) sur deux groupes paralleles de patients atteints d'une exacerbation aigue presumee d'origine infectieuse bacterienne de bronchopneumopathie chronique obstructive (BPCO), afin de comparer l'efficacite clinique et la tolerance du cefadroxil et de l'association amoxicilline-acide clavulanique. Deux cent quarante quatre patients, d'âge moyen 62 ans, ont ete inclus, 126 dans le groupe cefadroxil et 118 dans le groupe amoxicilline-acide clavulanique. Apres verification des criteres d'eligibilite, consentement ecrit et randomisation, ils recevaient pendant 10 jours : soit cefadroxil a la dose de 2 g/j, soil l'association amoxicilline-acide clavulanique a la dose de 1,5 g/j. Les deux populations etaient comparables a l'inclusion a l'exception des deux criteres suivants : le sexe (p = 0,05) et le traitement adjuvant par kinesitherapie (p = 0,049). Une analyse complementaire a permis d'exclure tout effet de ces deux facteurs sur les resultats d'efficacite. La bronchite chronique etait l'etiologie principale de la BPCO pour 70,1 % des patients. Le stade 1 d'Anthonisen representait 63,5 % des patients et le stade 2, 34 % des patients. En ce qui concerne le critere principal (succes ou echec de l'antibiotique selon l'evolution des signes cliniques presents a J1), aucune difference significative n'a ete retrouvee entre les deux groupes de traitement avec respectivement 94,4 % de succes pour cefadroxil et 95,8 % pour l'association amoxicilline-acide clavulanique (analyse en intention de traiter). Aucune difference significative n'a ete observee entre les deux groupes de traitement pour le delai de regression des signes cliniques (delai moyen : 4,5 jours). La tolerance clinique globale a ete jugee bonne et comparable dans les deux groupes etudies. Cependant le nombre rapporte de diarrhees etait significativement plus important dans le groupe amoxicilline-acide clavulanique (p = 0,001). L'efficacite et la tolerance clinique du cefadroxil, observees au cours de cette etude, demontrent qu'il est un antibiotique de choix pour le traitement de premiere intention des surinfections de BPCO rencontrees en pratique liberale et qu'il s'inscrit parfaitement dans le cadre des References Medicales Opposables.

Resume Le cefaclor et l'association amoxicilline-acide clavulanique (AAC) sont utilises depuis de nombreuses annees au cours des surinfections de bronchite chronique. Le but de cette etude etait de reevaluer ces deux molecules au cours d'un essai clinique comparatif dans cette indication. Il s'agissait d'une etude clinique prospective, multicentrique (7 centres), ouverte et randomisee. Quatre-vingt-neuf patients ont ete inclus, 48 avec cefaclor (250 mg, 3 prises par jour, 10 a 15 jours) et 41 avec amoxicilline-acide clavulanique (500 mg trois prises par jour, 10 a 15 jours). Les 2 groupes etaient comparables selon l'âge, le sexe ratio, le debit de pointe moyen, les traitements associes et la duree moyenne de traitement. Pour mieux definir la comparabilite des 2 groupes au moment de l'inclusion une classification originale en 3 stades a ete proposee en fonction du croisement de criteres infectiologiques de gravite (niveau de purulence et volume de l'expectoration) et de criteres pneumologiques (niveau de dyspnee). Il n'y avait pas de difference entre les 2 groupes therapeutiques. Il n'y avait pas de difference significative entre les deux antibiotiques, a la fin du traitement 28 guerisons ou ameliorations marquees sur 35 pour AAC et 31 sur 43 pour Cefaclor, a la visite de controle (J30–40) la guerison etait confirmee 19 fois sur 27 patients pour AAC et 27 sur 31 pour cefaclor. Les auteurs concluent d'une part a une efficacite comparable des deux regimes therapeutiques en argumentant sur le taux d'echec plus eleve que ceux decrits dans la litterature et d'autre part sur la bonne tolerance du cefaclor.

Summary Purpose The purpose of the study was to assess the possible benefit of the combination vinorelbine (NVB)-cisplatin (DDP) in comparison with NVB alone in advanced non- small cell lung cancer (NSCLC), not treated previously. It also involved confirmation of the efficacy of vinorelbine as monotherapy. Patients and methods In this phase 111 trial, 231 eligible patients were stratified by centre and randomized to receive either NVB alone, 30 mg/m2/week or the combination of NVB 30 mg/m2/week and DDP 80 mg/m2/3 weeks. Patients were to be treated for a minimum of 6 weeks, with the first response assessment performed 9 weeks after the beginning of treatment. Results The two groups differed in terms of objective response rates (16% and 43%, respectively, p = 0.0001) and median time to progression (10 weeks and 20 weeks, p = 0.0001). However, the difference was not significant for median survival time (32 weeks, 33 weeks, p = 0.48). The addition of DDP resulted in an increase in toxicity, in particular renal, hematologic, neurologic and emetic. This toxicity led to treatment discontinuation in 8% and 21% of patients, respectively. Respectively 3% and 13% of patients stopped treatment early during objective response (toxicity or refusal). Conclusions The NVB-DDP combination increased objective response rates and time to progression in comparison with NVB alone, but did not influence the survival of patients. The activity of NVB in the treatment of advanced NSCLC was confirmed.

Since a high tissue penetration of dirithromycin (D) has been assessed in early studies, the aims of this study were to determine D concentrations in bronchial mucosa and secretions in patients suffering from an acute exacerbation of chronic bronchitis (AECB), to compare intra-individual bronchial mucosa and secretion concentrations and to relate bronchial concentrations of D and clinical efficacy. The main inclusion criteria were comprised of (1) AECB, defined by the presence of an increase in dyspnea, sputum production and change in sputum purulence, and (2) clinical indication of fiberoptic bronchoscopy allowing performance of bronchial biopsies. All patients were treated with a 500-mg once-daily D dose for 5 days. Patients were randomly divided into three groups, according to sampling times (24, 48 and 72 h after the last dose). Tissue concentration analyses were performed by one blinded microbiologist (microbiological agar diffusion assay). The results showed: (1) 37 out of the 46 patients (80.4%) had a favorable response to treatment at the time of fiberoptic bronchoscopy (14 cured, 23 improved); (2) bronchial mucosa concentrations were high in all groups, and (3) mean values at 24, 48 and 72 h after the last dose were respectively 6.51 ± 1.44, 6.61 ± 2.7, 5.67 ± 1.02 mg·kg–1; no statistical difference was observed between the groups. In bronchial secretions collected simultaneously, concentrations were lower, i.e. 1.26 ± 0.3, 0.61 ± 0.12, 0.84 ± 0.12. Significant associations were observed between bronchial mucosa and secretion concentrations (r = 0.71, p = 0.0001), and between clinical response and bronchial concentrations (p = 0.03, Kruskall-Wallis test). In conclusion, these results may confirm the clinical significance of tissue concentrations measured in bronchial tissues of patients with AECB.

We describe a 28-year-old subject employed as a roofer in a construction company since the age of 19, who developed work-related symptoms of a cough, shortness of breath, wheezing, rhinitis and headaches. A description of a usual day at work suggested that the symptoms worsened while he was sawing corrugated fiber cement. Baseline spirometry was normal, and there was a mild bronchial hyperresponsiveness to carbachol. A skin patch test to chromium was negative. A specific inhalation challenge showed a boderline fall in forced expiratory volume in 1 s (FEV1) after exposure to fiber cement dust. Exposure to nebulization of potassium dichromate (K2Cr2O7), at 0.1 mg·ml–1 for 30 min, was followed by an immediate fall by 20% FEV1. Simultaneously, a significant increase in bronchial hyperresponsiveness was demonstrated.

International audience; Previous studies have suggested the utility of D-Dimer ELISA assays in eliminating a diagnosis of pulmonary embolism (PE). Our objectives were to evaluate the performance of a new, rapid, quantitative, and automated Liatest D-Dimer Assay in patients with suspected PE. Three hundred eighty-six consecutive patients referred to our institution between March 1992 and December 1996 for clinically suspected PE, with recent clinical signs not exceeding 1 wk, were included in this study. Diagnosis of PE was based on clinical evaluation, radionuclide lung imaging, lower limb examination, and, when required, pulmonary angiography. D-Dimer performances, for both Liatest D-Dimer and standard D-Dimer ELISA (Asserachrom DDi), assays, were assessed at the end of the study. Among the 386 patients tested, 146 (37.8%) were classified as PE-positive. Liatest D-Dimer assay had a 100% sensitivity (95% confidence interval, 97 to 100%) and a negative predictive value of 100% (95% confidence interval, 94 to 100%). A normal result, below the cutoff of 500 ng/ml, occurred in 83 of the 386 (21%) patients. There was a strong agreement between Liatest D-Dimer and Asserachrom DDi analyses. These findings suggest that this rapid, quantitative, and automated D-Dimer assay provides a useful diagnostic tool for the clinician with regard to exclusion of PE.

International audience; In previous studies, enzyme-linked immunosorbent assays (ELISA) for plasma D-dimer analysis have demonstrated high sensitivity, suggesting their potential usefulness in excluding deep venous thrombosis (DVT). We evaluated the usefulness of a new D-dimer test (Liatest D-dimer) for suspected DVT in a prospective study of patients admitted to the hospital because of recent (not exceeding 1 week before admission) clinical signs. Contrast venography or compression ultrasonography or both were performed within 24 hours of admission. A new quantitative determination of D-dimer concentration using a suspension of microlatex particles coated with specific antibodies was tested. A standard plasma D-dimer ELISA measurement was also performed. Of 464 patients, 276 had a proven DVT (distal, 74; proximal, 202). For a cutoff level of 400 ng/mL, sensitivity of the Liatest method in the diagnosis of overall DVT was 94.6% (95% confidence interval, 92.0%-97.0%), and the specificity was 35% (95% confidence interval, 28%-42%). The sensitivity and negative predictive value were 98.5% and 95.6%, respectively, in the diagnosis of proximal DVT, but only 83.8% and 84.6%, respectively, in the diagnosis of distal DVT. This new rapid Liatest D-dimer assay seems to be highly sensitive and could replace the ELISA method in excluding patients with proximal DVT. Both methods provide lower sensitivity for distal DVT.

International audience; BACKGROUND: The value of a risk factor analysis in the presence of a clinically suspected deep venous thrombosis (DVT) has been assessed mainly in inpatient populations. The aim of this prospective study was to evaluate the potential association between DVT and acquired circumstances suspected as risk factors, in a cohort of outpatients with a clinically suspected DVT. METHODS: Consecutive outpatients referred for a clinically suspected DVT, with recent clinical signs, not exceeding 1 week, were included. Before venography, all patients were interviewed by a trained physician to detect the presence of risk factors. RESULTS: From March 1992 to February 1994, 277 patients were included; venography was positive in 162 (58.4%). Five independent variables were significantly associated with the occurrence of DVT; in a multivariate analysis, 64.7% of patients were correctly classified; odds ratios for having DVT in the presence of these underlying conditions were respectively: 1.75 for age over 65 years, 1.68 for prior history of venous thromboembolism, 1.69 for high risk circumstances (any type of surgery or leg trauma within the past 3 months), 5.59 for malignancy, and 2.56 for varicose veins. CONCLUSIONS: In outpatients referred for a clinically suspected DVT, recognition of associated conditions might increase the certainty of the diagnosis.

Adjuvant treatments of non-small cell lung cancer (radiotherapy and chemotherapy) before or after surgery, have been tested in numerous trials, more particularly as regards postoperative chemotherapy. For a long time the results were disappointing, and in randomized studies none of the therapeutic regimens prescribed could improve the patient’s survival. New hopes of advances in this matter were raised by Goldie and Coldman [1] whose mathematical concept recommended a systemic treatment applied as early as possible in cases with localized tumour. The advent of Platinum [2], the results obtained in metastatic tumours by some associations with Platinum and those obtained in localized tumours by chemotherapy-radiotherapy [3] have been promising. Many phase II studies have shown that surgery was feasible after 2 or 3 cycles of chemotherapy [4, 8] even thought 1 of them [9] had observed a high rate of progression after chemotherapy which prevented surgery.

We report the case of an asymptomatic 51-year-old man, presenting with chest X-ray abnormalities consisting in multiple pulmonary nodules; the diagnosis of mesenchymal cystic hamartoma of the lung was made by an open lung biopsy, revealing both nodules of mesenchymal cells and cysts with a lining of normal or metaplastic epithelium. Clinical and pathological characteristics of this rare entity are reviewed.

A Phase I trial of carboplatin therapy was performed on patients with locally advanced non-small cell lung cancer who had been previously treated with cisplatin, mitomycin and a vinca alkaloid. This was administered as a daily bolus infusion or as a continuous infusion for 6 weeks with concurrent daily thoracic radiation. All patients had to be objective responders or to show no change after chemotherapy. The carboplatin was started at 10 mg/m 2 per day, and increased to 15 mg/m 2 per day and 20 mg/m 2 per day, if treatment was feasible in successive cohorts of at least six patients. The radiation therapy consisted of 62–66 Gray on the tumor and the ipsilateral mediastinal nodes, 50 Gray on the mediastinum and 40–45 Gray on the supraclavicular lymph nodes. Twenty-nine patients took part in this study. Thrombocytopenia was the principal dose-limiting toxicity, with 15 mg/m 2 per day of bolus or continuous infusion. Other toxicities included a fall in haemoglobin level, a fall in white-blood cell count, nausea and vomiting. The median survival time is 12 months, but the response rate cannot be determined among patients selected on the basis of response to chemotherapy. The recommended Phase II dose for patients previously treated with cisplatin containing chemotherapy, is 10 mg/m 2 per day of either a bolus or continuous infusion.

Between April, 1981, and December, 1982, 32 patients with squamous cell bronchial carcinoma were treated with a chemotherapy regimen followed by operation. The preoperative chemotherapeutic agents used were cisplatin, bleomycin, and mitomycin C. A thoracotomy was performed 3 to 4 weeks after the last day of the last treatment. Of the 29 undergoing resection, three (10.3%) had no tumor cells in the resected specimen and four (12.5 %) had only a few neoplastic microcenters in tissue necrosis or fibrosis. We suggest that the use of this new chemotherapy combination with surgical resection provides excellent palliation, increases resectability, and has a potential for increasing the cure rate in squamous cell carcinoma of the lung.

Summary Eleven patients with bronchial epidermoid carcinoma and undergoing treatment with cis -D.D.P. (II) were kept under electrophysiological and clinical surveillance. No other neurotoxic medication was added. The total dose of cis -D.D.P. was 300 mg/m 2 over a period of three months: namely, three courses of 100 mg/m 2 distributed over 5 days. Following the pre-treatment check-up, the patients were divided into two groups: those without any electrophysiological abnormality (group A), and those without clinical abnormality but with a delayed latency H of the Hoffmann Reflex (group B). Patients in group A showed a slowing down of the motor nerve conduction velocity of the Median and Peroneal Nerves after a course of 100 mg, without accompanying worsening of the conduction velocity after 300 mg/m 2 , and prolongation of the distal latence of the sensory Median Nerve after 300 mg/m 2 , in group B, no significant change of electrophysiological clinical features were noted. In the two groups a non-significant reduction in amplitude of evoked responses were noted. These findings are more consistent with an axonal injury than with functional myelin injury. The authors review the existing literature and discuss the physiopathologic mechanisms of cis -D.D.P. peripheral neuropathies.

Resume Sur 147 dossiers de malades atteints d'allergies respiratoires, les auteurs ont entrepris une etude comparative des trois criteres diagnostiques suivants : tests cutanes, mesure des IgE specifiques par le RAST, evocation possible de l'allergene par un interrogatoire minutieux. Cette etude a permis de relever les concordances suivantes : -- entre RAST et tests cutanes : 97,7 p. cent pour les pollens, 88,2 p. cent pour les epithelia, 78,2 p. cent pour la poussiere ; -- entre tests, RAST et clinique : 68,8 p. cent pour la poussiere. Dans un deuxieme temps, l'etude de 50 dossiers de ceux des malades precedents qui avaient ete desensibilises a la poussiere a ete reprise, a la recherche d'une notion de la preeminence du RAST sur les deux autres criteres, dans la prevision d'un bon resultat therapeutique. Mais les effectifs ont ete trop faibles pour autoriser une conclusion significative. Les auteurs pensent cependant que le dosage des IgE par le RAST se revele comme une technique de choix dans le diagnostic in vitro des allergies respiratoires.

The visual evoked potentials (VEPs), somatosensory evoked potentials (SEPs) and the electroencephalogram (EEG) have been studied in 16 subjects presenting chronic respiratory insufficiency (CRI) with normal consciousness. The SEPs latencies were increased but the VEPs latencies were not. The EEG was little disturbed and did not seem to provide useful information in CRI without encephalopathy.

Age and circumstances of menopause (natural or artificial) are detailed in 104 cases of recent myocardial infarction (MI). The results of this study with statistical analysis show no correlation between the age at menopause and the age at onset of MI; so, for this study, an early menopause, cannot be considered, whatever circumstances, as a risk factor for coronary heart disease.

Antiperinuclear factor (APF) might be a specific serum rheumatoid factor directed towards keratohyaline granules. It was found to be present in 40 of 79 (50.6%) patients with primary and in 21 of 36 (58.3%) patients with metastatic lung cancer, compared with 12 of 95 (12.6%) sex- and age-matched normal controls. Additionally, APF frequency and titer correlated well with tumor dissemination, even though no relationship could be shown with histopathological type.

The results obtained with local treatments for inoperable squamous carcinomas of the lung (surgery with or without radiotherapy) depend solely on the stage of the tumor at the time of the operation and have been the same for several decades. We decided to conduct a preliminary, nonrandomized trial of preoperative chemotherapy in these cases because of: (1) the stable and reproducible nature of the postoperative survival curves which enable us to evaluate, if not measure, any possible therapeutic benefit, (2) the effectiveness of 5-day cycles of the combination of platinum-bleomycin in the histological group of squamous carcinomas (Israel et al. 1981a, 1981b; Elson et al. 1982), (3) the possible importance of the DNA repair process in the clinical resistance of these cancers and the role of the above combination in the inhibition of these processes (Okuyama and Mishina 1980; Israel et al. 1985).