Day-case otological surgery

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Publication date: Available online 27 December 2016
Source:European Annals of Otorhinolaryngology, Head and Neck Diseases
Author(s): A. Uziel
The author reviews day-case otological surgery, which has become increasingly popular in France and all over the world over recent years. Ear surgery is particularly suitable for short-stay admission because of the rapidity of these procedures and possibilities of pain control. This article discusses the advantages of this mode of management (for the patient, the surgeon and the healthcare institution), organizational and safety constraints, and ineligibility criteria. Day-case otological surgery should now become the rule rather than an opportunity.

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Vagal and recurrent laryngeal nerves neuromonitoring during thyroidectomy and parathyroidectomy: A prospective study

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Publication date: Available online 27 December 2016
Source:European Annals of Otorhinolaryngology, Head and Neck Diseases
Author(s): N. Julien, E. Ferrary, A. Sokoloff, G. Lamas, O. Sterkers, D. Bernadeschi
ObjectivesThe aim of the study was to stimulate the vagal and the recurrent laryngeal nerves during and after thyroidectomy or parathyroidectomy, to record muscle responses, interpret the electrophysiological modifications and identify prognostic factors for postoperative vocal fold mobility.Patients and methodsA prospective study monitored 151 vagal nerves and 144 recurrent laryngeal nerves in 114 patients. Seven patients (14 vagal nerves) underwent continuous monitoring via an automatic periodic stimulation (APS®) electrode. In 15 patients (21 vagal nerves), the stimulation threshold was studied. Muscle response was recorded on direct vagal and/or recurrent laryngeal nerve stimulation by a monopolar electrode or direct repeated stimulation via an electrode on the vagal nerve. In case of signal attenuation on the first operated side, surgery was not extended to the contralateral side.ResultsThe vagal nerve stimulation checked inferior laryngeal nerve integrity and recurrent status, without risk of false negatives. The vagal nerve stimulation threshold, before and after dissection, that induced a muscle response of at least 100μV ranged from 0.1 to 0.8mA. Similarity between pre- and post-dissection responses to supramaximal stimulation, defined as 1mA, on the one hand, and between post-dissection vagal and laryngeal recurrent nerve responses on the other correlated with normal postoperative vocal cord mobility. Conversely, muscle response attenuation below 100μV and increased latency indicated a risk of vocal fold palsy.ConclusionVagal nerve stimulation allows suspicion or elimination of lesions on the inferior laryngeal nerve upstream of the stimulation point and detection of non-recurrent inferior laryngeal nerve. Intermittent monitoring assesses nerve function at the moment of stimulation, while continuous monitoring detects the first signs of nerve injury liable to induce postoperative recurrent nerve palsy. When total thyroidectomy is indicated, signal attenuation on the first operated side casts doubt on continuing surgery to the contralateral side in the same step.

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Real-life efficacy of volumetric modulated arc therapy in head and neck squamous cell carcinoma

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Publication date: Available online 27 December 2016
Source:European Annals of Otorhinolaryngology, Head and Neck Diseases
Author(s): C. Moncharmont, A. Vallard, J.-B. Guy, J.-M. Prades, C. Rancoule, N. Magné
ObjectivesThere is paucity of data on the efficacy of volumetric modulated arc therapy (VMAT) in head and neck squamous cell carcinoma (HNSCC). The objective of the present study was to investigate outcomes and patterns of recurrence in locally advanced HNSCC treated by VMAT.MethodsA retrospective study included all patients with stage III or IV HNSCC undergoing curative VMAT.ResultsFrom 2010 to 2013, 130 patients were treated for locally advanced oropharynx (n=55; 42%), hypopharynx (n=38; 29%), larynx (n=22; 17%) or oral cavity (n=15; 12%) SCC. Median age was 60 years (range, 39–85). Median follow-up was 18.1 months (range, 0–43.7). By end of follow-up, 60 patients (46%) had died. Two-year progression-free and overall survival were respectively 63.6% and 77.3% for laryngeal tumors, 60% and 60% for oral cavity tumors, 52.6% and 57.6% for oropharyngeal tumors, and 38.8% and 54.7% for hypopharyngeal tumors. Most recurrences were located within or marginal to radiation therapy fields.ConclusionThis retrospective analysis is, to our knowledge, the largest study of the efficacy of VMAT in HNSCC. Recurrence patterns and outcomes were consistent with those previously reported for intensity-modulated radiotherapy.

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Small RNAs regulate the biocontrol property of fluorescent Pseudomonas strain Psd

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Publication date: Available online 26 December 2016
Source:Microbiological Research
Author(s): Anamika Upadhyay, Mandira Kochar, Ashutosh Upadhyay, Soumya Tripathy, Manchikatla Venkat Rajam, Sheela Srivastava
The production of biocontrol factors by Pseudomonads is reported to be controlled at the post-transcriptional level by the GacS/GacA signal transduction pathway. This involves RNA-binding translational repressor proteins, RsmA and RsmE, and the small regulatory RNAs (sRNAs) RsmX, RsmY and RsmZ. While the former represses genes involved in secondary metabolite production, the latter relieves this repression at the end of exponential growth. We have studied the fluorescent Pseudomonas strain Psd, possessing good biocontrol potential, and confirmed the presence of rsmY and rsmZ by PCR amplification. Gene constructs for all the three small RNAs (RsmX, RsmY and RsmZ) carried on broad host-range plasmid, pME6032 were mobilized into strain Psd. Expression analysis of gacA in the recombinant strains over-expressing rsmX (Psd-pME7320), rsmY (Psd-pME6359) and rsmZ (Psd-pME6918) revealed a significant upregulation of the response regulator. Besides, a remarkable down-regulation of rsmA was also reported in all the strains. The variant strains were found to produce comparatively higher levels of phenazines. Indole acetic acid levels were higher to some extent, and strain Psd-pME6918 also showed elevated production of HCN. The tomato seedlings infected with Fusarium oxysporum and Verticillium dahliae in the presence of culture filtrate of the recombinant strains showed better plant protection response in comparison to wild-type strain Psd. These results suggested that small regulatory RNAs are important determinants in regulation of the biocontrol property of strain Psd.

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Treatment Outcomes in Infections Caused by “SPICE” (Serratia, Pseudomonas, Indole-positi ve Proteus, Citrobacter, and Enterobacter) Organisms: Carbapenem versus Noncarbapenem Regimens

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Publication date: Available online 26 December 2016
Source:Clinical Therapeutics
Author(s): Stanley Moy, Roopali Sharma
PurposeTechniques used to identify AmpC β-lactamases in SPICE (Serratia, Pseudomonas, indole-positive Proteus, Citrobacter, and Enterobacter) organisms are not yet optimized for the clinical laboratory and are not routinely used. Clinicians are often left with an uncertainty on the choice of antibiotic when a SPICE organism is isolated. The purpose of this study was to evaluate the outcomes of carbapenem versus noncarbapenem regimens in treating bacteremia or urinary tract infection from a SPICE organism in clinical practice.MethodsThis single-center, retrospective, cohort study analyzed data from adult patients who had clinical infection with a SPICE organism isolated from blood or urine cultures. Patients were assigned to a carbapenem- or noncarbapenem-treated group. The primary end point was clinical response, defined as a resolution of signs and symptoms of infection at the end of therapy.FindingsA total of 332 patients were assessed, and 145 patients met the inclusion criteria for the study. There were 20 patients who received a carbapenem, while 125 received a noncarbapenem regimen. The percentage of patients who were bacteremic was 46.2%. Clinical response overall was achieved in 80% of patients on a carbapenem versus 90.3% of patients on a noncarbapenem regimen (P = 0.24). The rate of microbiologic cure was 90% in patients on a carbapenem versus 91.2% in patients on a noncarbapenem regimen (P = 1).ImplicationsIn this study in patients treated for infection with a SPICE organism in clinical practice, the rates of clinical response did not differ significantly between the carbapenem and noncarbapenem groups. Current CLSI breakpoints set for SPICE organisms may still be reliable and may not require additional testing for AmpC β-lactamases.

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Sex Effect on Average Bioequivalence

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Publication date: Available online 26 December 2016
Source:Clinical Therapeutics
Author(s): Manuel Ibarra, Marta Vázquez, Pietro Fagiolino
PurposeGeneric formulations are by far the most prescribed drugs. This scenario is highly beneficial for society because medication expenses are significantly reduced after expiration of the exclusivity period conceded to the branded name drug. Correspondingly, these formulations must be adequately evaluated to avoid drug inefficacy and toxicity in the overall patient population. Bioequivalence studies are the only in vivo evaluation that a generic drug must overcome to reach the market. These clinical trials have not been exempt from underrepresentation of female subjects and a lack of sex-based analysis. Frequently, conclusions obtained in men are extrapolated to women. Furthermore, the obtained results are not analyzed to determine sex differences. The aim of this study was to discuss the effect that male and female differences in gastrointestinal physiology can have on bioequivalence conclusions and to show why a sex-based analysis must be conducted in these studies to improve the evaluation of generic drugs.MethodsThis discussion was based on observed sex differences in product bioavailability discrimination (sex-by-formulation interaction) and on residual variability through an analysis of average bioequivalence data previously reported by other researchers and data collected by our center. Bioequivalence studies of oral formulations, with a 2-period, 2-sequence, 2-treatment random crossover design performed in healthy subjects with at least 6 subjects of each sex, were included. In addition, the bioequivalence conclusion that would have been reached in each study if performed with only 1 sex was estimated.FindingsThe data reveal that differences in both product bioavailability discrimination and residual variability occur with a significant incidence in bioequivalence studies. In either Cmax or AUC, a significant sex-by-formulation interaction was present in 1 of 3 reviewed studies, whereas differences in residual variability between sexes were significant for >50% of studies. Moreover, the performed estimations suggest that the reported bioequivalence conclusions were not verified in at least 1 sex for 1 of 3 studies and were not verified in men and in women for 1 of 6 studies.ImplicationsThis research shows that extrapolation of bioequivalence results from the male population to the female population is not always valid. Bioequivalence studies must therefore be performed with both male and female subjects in similar proportions. Sex-based analysis in bioequivalence can improve study design, enhance the representativeness of conclusions, and provide important information regarding formulation performance, thereby promoting the efficacy and safety of generic drugs.

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