Management of parotid gland surgery in a university teaching hospital.

The aim of our study was the evaluation of two controversial procedures used in surgical management of parotid tumours in a university teaching hospital: fine needle aspiration cytology (FNAC) and continuous operative facial monitoring with nerve integrity monitor (NIM). We present a retrospective study of 96 consecutive cases of parotid gland surgical procedures, performed in our department of ENT Surgery (Bichat University Hospital) during a 2-year period. After the exclusion of nine patients (4 recurrent tumours, 3 insufficient data and 2 obviously malignant tumours with preoperative facial paralysis and necessary peroperative facial nerve sacrifice), the final group included 40 men and 47 women (mean age 46 years). FNAC, final histological diagnosis, NIM use, postoperative facial disorders and operative time were analysed. Other variables included age, sex, type of surgery and other postoperative complications. FNAC: 78 patients underwent FNAC. Positive predictive value for malignancy was 100%; negative predictive value 94.4%; sensitivity 63.6%; specificity 100%. NIM: surgery was performed without NIM for 41 patients, with for 46 patients. There was no significant difference in occurrence of facial disorders between the two groups. Operative time was significantly lower in group operated with NIM for extracapsular dissection, superficial parotidectomy and total parotidectomy. Because continuous efforts of modern health systems to improve operating room schedules may threaten resident surgeons training, using NIM and performing preoperative FNAC may help operative planning and improve medical education in a teaching hospital.

Randomized clinical trial of post-operative radiotherapy versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement.

BACKGROUND AND PURPOSE: Post-operative radiotherapy is indicated for the treatment of head and neck cancers. In vitro, chemotherapy potentiates the cytotoxic effects of radiation. We report the results of a randomized trial testing post-operative radiotherapy alone versus concomitant carboplatin and radiotherapy for head and neck cancers with lymph node involvement. MATERIALS AND METHODS: The study involved patients undergoing curative-intent surgery for head and neck cancers with histological evidence of lymph node involvement. Patients were randomly assigned to receive radiotherapy alone (54-72Gy, 30-40 fractions, 6-8 weeks) or identical treatment plus concomitant Carboplatin (50mg/m(2) administered by IV infusion twice weekly). RESULTS: Between February 1994 and June 2002, 144 patients were included. With a median follow-up of 106 months (95% confidence interval (CI) [92-119]), the 2-year rate of loco-regional control was 73% (95% CI: 0.61-0.84) in the combined treatment group and 68% (95% CI: 0.57-0.80) in the radiotherapy group (p=0.26). Overall survival did not differ significantly between groups (hazard ratio for death, 1.05; 95% CI: 0.69-1.60; p=0.81). CONCLUSIONS: Twice-weekly administration of carboplatin concomitant to post-operative radiotherapy did not improve local control or overall survival rates in this population of patients with node-positive head and neck cancers.

Yearly incidence of rhinitis, nasal bleeding, and other nasal symptoms in mature women.

OBJECTIVES/HYPOTHESIS: To evaluate, by a prospective questionnaire study, the incidence of spontaneous nasal pathology in mature women over a 12-month period, in particular nasal bleeding and the relationships of these symptoms with various factors. METHODS: Participants were drawn from a sample of 12,735 adult French volunteers participating in a study of antioxidant nutrients ("SU.VI.MAX"); 3500 women aged 50-64 years were randomly selected from good responders in the SU.Vl.MAX population. The responses of 2197 women were analysed. RESULTS: Nearly 70% of subjects reported at least one episode of rhinitis, with a mean (SD) of 1.88 (2.17) episodes per subject. Rhinitis was related to passive exposure to tobacco smoke (adjusted odds ratio [OR] 1.31, 95% CI 1.05-1.63), menopause (OR 1.47, 95% CI 1.16-1.88), and occupational exposure to vapours or dusts (OR 1.55, 95% CI 1.01-2.37). Nasal bleeding was reported as traces of blood by 16.5% of subjects, and as epistaxis (significant nasal bleeding) by 7.6%. Both symptoms were related to passive exposure to tobacco smoke (OR 1.63, 95% CI 1.22-2.19; OR 1.56, 95% CI 1.05-2.32, respectively) but not to use of systemic or topical medication. CONCLUSION: A substantial number of mature women experience nasal symptoms during the course of a year. Rhinitis and nasal bleeding were correlated with passive exposure to tobacco smoke.

Epidemiologic study of conjunctivitis-otitis syndrome.

We conducted a prospective cross-sectional epidemiologic study of conjunctivitis-otitis syndrome during two 3-week periods of consecutive winters. A representative sample of 184 pediatricians and ear, nose and throat specialists in the Paris area recruited 2901 children from 6 to 36 months of age presenting with acute otitis media, of whom 465 (16%) also had purulent conjunctivitis. In sampled children, the culture of the conjunctival exudate yielded bacterial pathogens in 419 patients: Haemophilus influenzae, 371 (89%); Streptococcus pneumoniae, 72 (17%); and Branhamella catarrhalis, 23 (5%). Pulsed field gel electrophoresis analysis of paired H. influenzae isolates from the conjunctival exudate and middle ear fluid of 21 patients showed identical strains in each patient.

Molecular detection of Cellulosimicrobium cellulans as the etiological agent of a chronic tongue ulcer in a human immunodeficiency virus-positive patient.

Ulcerations appeared on the tongue of a 48-year-old human immunodeficiency virus-positive man. Histological findings of the biopsy specimen and the fact that the patient had resided in Louisiana led us to suspect "American histoplasmosis". A new ulcer appeared while the patient was being treated with itraconazole, and the gene for 16S rRNA of Cellulosimicrobium cellulans was amplified. The lesions healed during treatment with oral penicillin and azithromycin.

Hyperbaric oxygen therapy for radionecrosis of the jaw: a randomized, placebo-controlled, double-blind trial from the ORN96 study group.

PURPOSE: To determine the efficacy and safety of hyperbaric oxygen therapy (HBO) for overt mandibular osteoradionecrosis. PATIENTS AND METHODS: This prospective, multicenter, randomized, double-blind, placebo-controlled trial was conducted at 12 university hospitals. Ambulatory adults with overt osteoradionecrosis of the mandible were assigned to receive 30 HBO exposures preoperatively at 2.4 absolute atmosphere for 90 minutes or a placebo, and 10 additional HBO dives postoperatively or a placebo. The main outcome measure was 1-year recovery rate from osteoradionecrosis. Secondary end points included time to treatment failure, time to pain relief, 1-year mortality rate, and treatment safety. RESULTS: At the time of the second interim analysis, based on the triangular test, the study was stopped for potentially worse outcomes in the HBO arm. A total of 68 patients were enrolled and analyzed. At 1 year, six (19%) of 31 patients had recovered in the HBO arm and 12 (32%) of 37 in the placebo arm (relative risk = 0.60; 95% CI, 0.25 to 1.41; P = .23). Time to treatment failure (hazard ratio = 1.33; 95% CI, 0.68 to 2.60; P = .41) and time to pain relief (hazard ratio = 1.00; 95% CI, 0.52 to 1.89; P = .99) were similar between the two treatment arms. CONCLUSION: Patients with overt mandibular osteoradionecrosis did not benefit from hyperbaric oxygenation.

Air pollution, passive smoking, and respiratory symptoms in adults.

We studied the independent role of air pollution and passive smoking on respiratory symptoms and group of symptoms by following 46 adult nonsmokers for 14 wk. Outcomes included the incidence of 15 symptoms. After adjustment for passive smoking, clear rhinorrhea and cough were positively related to nitrogen dioxide (NO2), particles (PM10), and black smoke (BS); whereas headache was positively related to BS. Sneezing, sore throat, and cough were independently positively related to passive smoking. After adjustment for passive smoking, the occurrence of groups of symptoms and of the "sore throat group" were related to three pollutants. The occurrence of the "possible infection group" was positively related to BS. The occurrence of every group of symptoms was independently related to passive smoking. In conclusion, the prevailing levels of air pollution and passive smoking had independent effects on symptoms and groups of symptoms.

Immunohistochemical localization of plakophilins (PKP1, PKP2, PKP3, and p0071) in primary oropharyngeal tumors: correlation with clinical parameters.

Plakophilins (PKPs) are members of the armadillo multigene family. Armadillo-related proteins function in both cell adhesion and signal transduction, and also play a central role in tumorigenesis. Here we report the immunohistochemical localization of PKPs in 37 cases of human primary squamous cell carcinoma of the oropharynx lacking overt distant metastases that were followed clinically for 3 years. Immunoreactivity for the PKPs PKP1, PKP2, PKP3, and p0071 (also known as PKP4) was assessed on frozen unfixed sections using a semiquantitative scoring system. Results were correlated with tumor grade, clinicopathologic parameters, and patient survival. Only p0071 was associated with tumor growth, demonstrating an inverse correlation with tumor size. PKP1 and PKP3 immunoreactivity was inversely correlated with tumor histological grade and was observed only in tumors that did not metastasize. In contrast, strong PKP2 immunoreactivity was observed in 85.7% of metastatic tumors. Interestingly, patients with tumors in which PKP1 and PKP3 immunoreactivity was reduced or absent exhibited local recurrences or metastases, or both, as well as poor survival. Correlation of the subcellular localization of PKPs with routine histological and clinical parameters suggests that these proteins may serve as useful markers for predicting the clinical outcome of the disease. Although the 4 PKPs displayed different levels and patterns of subcellular distribution in tumors, there was a positive correlation between immunoreactivity for PKP2 and PKP3, as well as for PKP2 and p0071, suggesting possible functional similarities associated with differentiation, tumor growth, and disease prognosis. Nevertheless, the mechanisms involved in altering the subcellular localization in tumors compared with normal epithelium are unknown, and further investigation is needed to determine whether PKPs are causative factors for oral carcinogenesis or are merely characteristic of the phenotype.

Comparison of the efficacy and safety of faropenem daloxate and cefuroxime axetil for the treatment of acute bacterial maxillary sinusitis in adults.

In this multicentre, multinational, comparative, double-blind clinical trial, outpatients with both clinical signs and symptoms and radiographic evidence of acute sinusitis were randomly assigned to receive for 7 days either a twice-daily oral regimen of faropenem daloxate (300 mg) or a twice daily oral regimen of cefuroxime axetil (250 mg). Among 452 patients considered valid for clinical efficacy, faropenem daloxate treatment was found to be statistically equivalent to cefuroxime axetil (89.0% vs. 88.4%-95% CI=-5.2%; +6.4%) at the 7-16 days post-therapy assessment. At 28-35 days post-therapy, the continued clinical cure rate in the faropenem daloxate group was 92.6% and that for the cefuroxime axetil group was 94.9% (95% CI: -6.8%; +1.2%). A total of 148 organisms was obtained in 136 microbiologically valid patients (30.1%). The predominant causative organisms were Streptococcus pneumoniae (47.1%), Haemophilus influenzae (30.1%), Staphylococcus aureus (14.7%) and Moraxella catarrhalis (8.8%). The bacteriological success rate at the 7-16 days post-therapy evaluation was similar in both treatment groups: 91.5% and 90.8% in the faropenem daloxate and cefuroxime axetil groups, respectively (95% CI=-9.2%; +9.5%). Eradication or presumed eradication was detected for 97.3% and 96.3% of S. pneumoniae, 85.0% and 90.5% of H. influenzae, 88.9% and 90.9% of S. aureus and 100.0% and 83.3% of M. catarrhalis in faropenem daloxate and cefuroxime axetil recipients, respectively. At least one drug-related event was reported by 9.5% of the faropenem daloxate-treated patients and by 10.3% of those who received cefuroxime axetil. The most frequently reported drug-related events were diarrhoea (2.2% versus 2.9%), nausea/vomiting (1.5% vs. 0.7%), abdominal pain (0.7% vs 1.5%) and skin reactions (1.5% vs. 1.1%). Overall, faropenem daloxate was at least as effective clinically and bacteriologically as cefuroxime axetil and was well tolerated.

Total glossectomy without laryngectomy as first-line or salvage therapy.

OBJECTIVES/HYPOTHESIS: Advanced carcinoma of the tongue can require total glossectomy. Although radiation therapy is of limited efficacy in T3 and T4 tumors involving the base of the tongue, many surgeons are reluctant to suggest highly mutilating surgery. STUDY DESIGN: Retrospective cohort study. METHODS: We compared early postoperative complications, hospital stay duration, function, and oncological outcomes in patients who underwent total glossectomy without laryngectomy as first-line or salvage therapy. RESULTS: Postoperative course and functional outcomes were similar in the two groups. Overall survival was 32% at 3 years and 21% at 5 years. The risk factors for shorter survival were positive margins of resection (P =.002) and tumor spread into the mandible (P =.04). Salvage surgery was not associated with significantly lower survival (P =.09 [NS]). CONCLUSIONS: Postoperative morbidity and functional outcomes are similar after first-line and salvage total glossectomy without laryngectomy. Local tumor control is the main factor influencing survival.

Efficacy of 5-day cefpodoxime proxetil for recurrent pharyngitis in adults. A comparative study with 10-day penicillin V or amoxycillin---clavulanate.

OBJECTIVE: To compare the clinical and bacteriologic efficacy of a 5-day course of cefpodoxime proxetil (CPD) with that of a 10-day course of penicillin V (PNV) or amoxycillin---clavulanate (AMC) in recurrent pharyngitis in adults. A cost-effectiveness study (reported elsewhere) was carried out at the same time. METHODS: This multicenter, randomized, open label trial involved 580 adult patients consulting general practitioners for clinical recurrent pharyngitis (greater-than-or-equal3 episodes within the last 12 months) regardless of the bacterial etiology. Patients were treated for 5 days with CPD, 100 mg twice daily, or for 10 days with PNV, 1x106 IU three times a day, or for 10 days with AMC, 500 mg (amoxycillin) three times a day. Clinical and bacteriologic outcomes were noted at the end of treatment, and cases of clinical recurrence were recorded during a 6-month follow-up period. RESULTS: At the end of treatment, clinical response was satisfactory in 157 of 170 (92.3%) patients on CPD, 147 of 166 (88.5%) patients on PNV, and 168 of 177 (94.9%) patients on AMC. Group A beta-hemolytic streptococci (GABHS) were eradicated in 22 of 23 (95.65%) patients on CPD, 16 of 16 (100%) patients on PNV, and 19 of 20 (95%) patients on AMC. The rates of clinical success and GABHS eradication were not significantly different between the groups. Compliance (p<0.001) and tolerance (p<0.001) were significantly better in the CPD group than in the other two groups. Among the 389 patients evaluable 6 months after the end of treatment, the recurrence rate of acute pharyngitis (due to any bacterium) was significantly lower in the CPD group (p=0.01 versus PNV; p<0.01 versus AMC). A Kaplan---Meier analysis (469 patients over 6 months) of the rate of non-recurrence, with comparison by the log-rank test, also showed a significant difference in favor of CPD. CONCLUSIONS: A 5-day treatment of recurrent pharyngitis with CPD was as effective and better tolerated than a 10-day treatment with PNV or AMC. The risk of recurrence was lower with CPD.

Acute childhood otitis media: the diagnostic value of bacterial samples from the nasopharynx.

OBJECTIVE: To compare bacteriologic results in acute otitis media (AOM) from middle ear otorrhea and rhinopharyngeal samples. METHODS: Three hundred and fifty-four children suffering from AOM were included. Two samples were obtained for each patient, one in the middle ear fluid, and another in the rhinopharynx. RESULTS: The rhinopharyngeal sample shows a poor predictive value for the pathogen responsible for the AOM (only 30%). But antibiotic sensitivity from each bacteriologic sample (otorrhea and rhinopharynx) for the whole population showed a very good correlation. CONCLUSIONS: The collection of nasopharyngeal cultures should therefore be promoted for their collective epidemiologic value, especially with reference to the monitoring of pneumococcal susceptibility in children.

Pharmacokinetics of antibiotics in the middle ear.

The middle ear mucosa is described as a non-specialized site where drug substances diffuse passively. However, precise pharmacokinetic studies on antibiotic penetration into middle ear effusion (MEE) are difficult to conduct in humans because of ethical and methodological problems: (1) studies must involve the population in which acute otitis media (AOM) is most frequent (i.e. in children from 3 months to 3 years of age); (2) studies are commonly performed during surgery for chronic otitis media with effusion, whereas drug penetration into MEE is higher during AOM; (3) kinetics are deduced from data per individual obtained in groups with marked interindividual variations. Furthermore, the results of different studies are difficult to compare because of differences in protocols, antibiotic assay methods and interpretation. Clinical studies have nonetheless shown the poorly predictive nature of serum concentrations, given the large differences in drug delivery to the MEE among antibiotic classes, among members of the same class, and among individuals receiving a given antibiotic. Experimental studies can help to narrow the gap between in vitro and clinical data, as the more precise pharmacokinetic data they yield can throw light on the link between drug/host/pathogen factors and bacteriologic efficacy.