Efficacy of a Low-Dose Diosmin Therapy on Improving Symptoms and Quality of Life in Patients with Chronic Venous Disease: Randomized, Double-Blind, Placebo-Controlled Trial.

Chronic Venous Disease (CVD) is a common medical condition affecting up to 80% of the general population. Clinical manifestations can range from mild to more severe signs and symptoms that contribute to the impairment of the quality of life (QoL) of affected patients. Among treatment options, venoactive drugs such as diosmin are widely used in the symptomatic treatment in all clinical stages. The aim of this study is to determine the effectiveness of a new formulated diosmin in relieving symptoms and improving QoL in patients suffering from CVD. In this randomized, double-blind, placebo-controlled, multicenter clinical study, CVD patients with a Clinical-Etiology-Anatomy-Pathophysiology (CEAP) classification system between C2 and C4 were randomized to receive a bioavailable diosmin (as µsmin® Plus) 450 mg tablet once daily or a placebo for 8 weeks. Clinical symptoms and QoL were monitored using the measurement of leg circumference, visual analogue scale (VAS) for pain, Global Index Score (GIS) and Venous Clinical Severity Score (VCSS). A total of 72 subjects completed the study. From week 4, leg edema was significantly decreased in the active group (p < 0.001). An improvement in the VAS score was observed in the active group compared to placebo at the end of treatment (p < 0.05). GIS and VCSS scores were significantly improved in the active group at week 8 (p < 0.001). No treatment related-side effects were recorded. The results of this study showed that the administration of low-dose µsmin® Plus was safe and effective in relieving symptoms and improving QoL in subjects with CVD.

Macrophages expressing TREM-1 are involved in the progression of HPV16-related oropharyngeal squamous cell carcinoma.

INTRODUCTION: Many types of research have been performed to improve the diagnosis, therapy, and prognosis of oropharyngeal carcinomas (OP-SCCs). Since they arise in lymphoid-rich areas and intense lymphocytic infiltration has been related to a better prognosis, a TREM-1 putative function in tumour progression and survival has been hypothesized. MATERIALS AND METHODS: Twenty-seven human papillomavirus (HPV) 16+ OP-SCC specimens have been analyzed to relate TREM-1 expression with histiocytic and lymphocytic markers, HPV presence and patients' outcome. RESULTS: No differences have been shown between intratumoral and stromal CD4+ cells, while intratumoral CD8+ lymphocytes are higher with respect to the tumour stroma (p = .0005). CD68+ cells are more than CD35+ and TREM-1+; their presence is related to CD35± and TREM-1± histiocytes (p = .005 and .026, respectively). Intratumoral CD4+ lymphocytes are higher in p16+ cases (11/27) than in p16- (p = .042); moreover, p16 positivity correlates to a better survival (p = .034). CD4+, CD8+ and CD35+ cells have no impact on survival, while CD68 expression heavily influences progression and bad outcome (p = .037). TREM-1 positivity also leads to worst overall survival (p = .001): peritumoral expression and death-cause relationship are always significant, particularly when the cause is OP-SCC (p = .000). CONCLUSION: While p16 shows to better stratify HPV16+ patients' outcome, TREM-1+ macrophages suggest their key importance in HPV-related OP-SCCs progression.KEY MESSAGESTREM-1 positivity correlates to the worst overall survival of HPV16-positive OPSCCs-affected patients.p16-positive HPV16 related OPSCCs patients have a better prognosis with respect to p16-negative ones.

Endoscopic versus conventional septoplasty: objective/subjective data on 276 patients.

PURPOSE: Endoscopic approach represents a valid alternative to conventional septoplasty. The aim of this study is to analyze the objective and subjective data on 276 patients, who underwent traditional (147) or endoscopic (129) septoplasty. METHODS: This is a prospective observational study on 276 consecutive patients affected by deviated nasal septum (DNS), who underwent isolated septoplasty between 2011 and 2018. 147 of them were treated using an "open" approach, while 129 were treated with an endoscopic approach. The two groups were compared 3 months after surgery: the objective results (complications such as bleeding, hematoma, pain, synechiae, septal tears and incomplete correction), objective (rhinomanometric data) and subjective measurements (NOSE questionnaires). RESULTS: Both techniques are effective in decreasing nasal obstruction and discharge. Complications such as pain, synechiae, early postoperative bleeding, septal tears and incomplete correction are less frequent in the endoscopic group (p < 0.05). The rhinomanometric analysis reveal improvement in both groups without statistical differences. Subjective questionnaires show a good symptoms relief with an improved quality of life in all 276 patients without statistical difference between the two gropus. CONCLUSIONS: Both techniques are effective in reducing nasal obstruction and related symptoms with fewer overall complications in the endoscopic approach. The endoscope provides improved field of view, less mucosal damages and a more anatomic dissection. Finally, such approach can be a valuable teaching tool for assistants, residents and students.

Nasal Functions in Three-Dimensional Endoscopic Skull Base Surgery.

OBJECTIVES: Endoscopic transnasal transsphenoidal surgery has become the standard procedure for the majority of skull base diseases, including sellar, parasellar, and clival pathologies. The aim of this study was the objective evaluation of nasal airflow resistances and olfactory function in 3-dimensional (3D) endoscopic transnasal transsphenoidal surgery. METHODS: One hundred patients who underwent 3D transnasal endoscopic surgery for sellar, parasellar, and clival diseases were enrolled. Active anterior rhinomanometry and Sniffin' Sticks tests were performed before endoscopic surgery and at 3 and 6 months postoperatively. RESULTS: No significant difference about nasal airflow resistance and olfactory function was observed between preoperative and postoperative subjective and objective scores. In the group of patients with sellar and parasellar diseases, a worst nasal respiratory function was seen when crusting was present, and a worst olfactory function was observed in patients with synechiae. Nasal functions returned to previous levels when crusting or synechiae solved. No statistically significant correlation was observed between the evaluated nasal functions and the reconstruction with flaps. CONCLUSIONS: The 3D endoscopic transnasal transsphenoidal surgery represents a more and more important tool in skull base surgery. It does not determine nasal respiratory and olfactory alterations after the treatment, without an increase in nasal complaints that could worsen quality of life.

Cisplatin+Vinorelbine Treatment of Recurrent or Metastatic Salivary Gland Malignancies (RMSGM): A Final Report on 60 Cases.

OBJECTIVES: Recurrent or metastatic salivary gland malignancies (RMSGM) are not suitable for conventional treatment. We report the clinical outcomes of 60 patients affected by RMSGM who were treated with DDP+VNB as a first-line or second-line scheme. MATERIALS AND METHODS: Sixty patients between 2001 and 2008, affected by RMSGM were enrolled in this cohort prospective study; they received the following first-line or second-line chemotherapy (CT), for a maximum of 6 cycles: DDP at 80 mg/m on day 1+VNB at 25 mg/m on day 1 and 8, at 3-week intervals. RESULTS: Seventy percent of the patients received DDP+VNB as the first-line CT and 30% of them received it as the second-line CT. After 5 cycles (median) of first-line DDP+VNB, 7% of the patients achieved a complete response, 24% achieved a partial response, 33% achieved an no change, and 36% achieved a PD. After 4 cycles (median) of second-line CT, 0 patients achieved a CR, 5% achieved a PR, 33% achieved an NC, and 62% achieved a PD. The median overall survival period was 10 months for those who received the first-line CT and 4 months for those who received the second-line CT. The best ORR (54%) and median survival were observed, during first-line treatment, in adenocarcinomas, whereas undifferentiated tumours were unresponsive with a poor median survival (4.6 mo). CONCLUSIONS: Adenocarcinomas show the best response and prognosis with DDP+VNB scheme that seems to be an effective and well-tolerated first-line CT for RMSGM, whereas it has only low palliative activity as a second-line CT.

Use of the sternocleidomastoid flap in association with a dermal regeneration template and a skin graft in the temporal region reconstruction.

Since its first description in 1908, the sternocleidomastoid flap (SCM) has gained popularity in head-and-neck reconstruction as a regional flap. We reported a 69-year-old Caucasian male who was evaluated in our clinic for a large, bloody, esophitic, and ulcerated lesion of the right temporoparotideal region associated with several actinic keratoses of the head skin. After resection of the tumor, taking into consideration the patient's comorbidities and surgical defect characteristics, we decided to use the SCM flap for the reconstruction. The SCM flap was harvested as a muscular flap to avoid as possible skin paddle necrosis due to the poor conditions of the patient's vessels. Moreover, considering the surgical site depth and to prevent a postsurgical excessive scar retraction, the muscle was covered with Integra® Dermal Regeneration Template single layer and a skin graft was harvested from the left thigh. The follow-up at 1 year confirmed that both oncological and reconstructive goals were successfully achieved. In our experience, the SCM flap in association with a dermal regeneration template and a skin graft can be considered as a reliable and possible option in temporal region reconstruction when local or systemic conditions of the patient do not permit other reconstructive options.

Nasal and Tracheal Microbial Colonization in Laryngectomized Patients.

OBJECTIVE: Complete separation of upper and lower respiratory tract after total laryngectomy results in loss of physiological nasal functions and presence of "unconditioned" inspired air in lower airways. Aim of this study is evaluating the presence of a microbial colonization of nasal cavities and trachea in laryngectomized long-term survivors. METHODS: Twenty-five laryngectomized patients underwent symptoms' anamnestic evaluation, endoscopic fiber optic nasal and tracheal examination, specimen collection for microbiological exam, and culture. Enrolled patients had at least a 2-year follow-up period in order to evaluate long-term microflora. RESULTS: Gram positive polimicrobic flora represented the main finding in nasal cavities and trachea (92% and 48% of patients, respectively). Other bacteria were non-fermenters Gram negative bacteria, Enterobacteriaceae and Staphylococcus aureus. The same microflora was demonstrated in nasal cavity and trachea in 5 patients (20%), while sterile nasal cavity and trachea were seen in 3 (12%) and 4 (16%) cases, respectively. No fungi were observed in nasal cavity and trachea. CONCLUSION: Nasal cavities and trachea of laryngectomized patients are colonized by nonpathogenic and/or potentially pathogenic bacteria, in absence of signs and symptoms of infection. Colonizer microflora should be kept in mind when a culture from nasal or tracheal swabs is needed in daily practice.

Three-dimensional endoscopy in transnasal transsphenoidal approach to clival chordomas.

BACKGROUND: The purpose of this prospective, observational study was to evaluate the management of skull base chordomas surgically resected via a 3D-endoscopic transnasal approach. METHODS: Thirteen consecutive patients were observed and only 9 were surgically treated using a 3D-endoscopic transnasal approach assisted by a novel 3D visualization system. RESULTS: Nine consecutive male patients (mean age, 57.4 years) underwent exclusive 3D-endoscopic transnasal transsphenoidal resection of clival chordomas; gross total resection was achieved in 66.6% of cases (6 of 9 patients), near-total resection in 11.2% (1 of 9 patients), and partial resection in 22.2% (2 of 9 patients). The complications observed were 2 cases of postoperative cerebrospinal fluid (CSF) leaks and 1 case of temporary VI cranial nerve palsy. CONCLUSION: No discomfort was recorded; when a dura opening was required, 3D vision allowed an accurate intradural sharp dissection and a precise repair of the skull base. © 2015 Wiley Periodicals, Inc. Head Neck 38: E1814-E1819, 2016.

A study of neck and shoulder morbidity following neck dissection: The benefits of cervical plexus preservation.

We conducted a study to evaluate the hypothesis that the preservation of cervical root branches of the cervical plexus is associated with greater shoulder mobility, less loss of face and neck sensation, and better quality of life (QoL) following functional neck dissection in which the spinal accessory nerve is spared. We also investigated the impact of postoperative physiotherapy on these three outcomes. Our study population was made up of 54 patients-47 men and 7 women, aged 34 to 78 years (mean: 53.4)-who had undergone functional neck dissection as a treatment for head and neck cancer over a 3-year period at our institution. Patients were divided into two groups: 23 patients whose cervical root branches were preserved during surgery (preservation group) and 31 whose branches were removed (removal group). Shoulder mobility was measured by the Arm Abduction Test (AAT), face and neck sensation was assessed by fingertip touch in eight areas of the head and neck, and QoL was determined by the University of Washington-Quality of Life questionnaire (UW-QoL4). The AAT revealed that the preservation group had significantly better shoulder mobility. The fingertip touch evaluation revealed significantly less loss of sensation in Saffold regions A and D. Analysis of the UW-QoL4 results revealed that the preservation group experienced significantly less pain, significantly fewer shoulder complaints, and significantly fewer limitations on activities and recreation, as well as significantly better health-related and overall QoL. The preservation group also had a significantly better composite score, global score, social function score, and mood and anxiety score on the UW-QoL4 assessment. Finally, we found that physiotherapy improved both QoL and shoulder mobility, although these improvements were not statistically significant. We conclude that preservation of the cervical root branches significantly improves outcomes in patients who undergo functional neck dissection.

Late sensorial alterations in different radiotherapy techniques for nasopharyngeal cancer.

Intensity-modulated radiation therapy (IMRT) for nasopharyngeal cancer (NPC) allowed a better distribution of the dose to the tumor volume, sparing surrounding structures. Aim of the study is the objective evaluation of olfactory and gustatory impairments in patients who underwent chemo-radiotherapy for NPC. Correlation between smell and taste alterations, xerostomy, and radiation technique was investigated. Thirty healthy subjects and 30 patients treated with chemo-radiation therapy for NPC, with at least a 2-years follow-up period, were evaluated. All subjects underwent symptoms evaluation, endoscopic fiber optic nasal examination, taste strips, Sniffin' sticks tests, Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer late radiation morbidity scoring system. Patients were divided in 2 groups: 2-dimensional radiotherapy/conformal 3-dimensional radiotherapy and IMRT. A higher percentage of rhinorrhea, nasal obstruction, xerostomy, hyposmia, hypogeusia, mucosal hyperemia, and presence of nasopharyngeal secretions was found in irradiated subjects (P < 0.05). Concerning olfactory and gustatory scores, we demonstrated a statistically significant difference between healthy subjects and irradiated patients (P < 0.05), with lower gustatory total score in IMRT group (P < 0.01). In conclusion, chemo-radiotherapy for NPC induces long-term smell and taste impairments, which can compromise quality of life. Although based on small samples, it is also important to consider that IMRT can induce higher taste dysfunction compared with traditional techniques.

Plexiform schwannoma of the posterior pharyngeal wall in a patient with neurofibromatosis 2.

We report a case of plexiform schwannoma of the posterior pharyngeal wall that occurred in a 37-year-old man who had been previously diagnosed with neurofibromatosis type 2 (NF2). Plexiform schwannoma has been rarely reported in association with NF2. Moreover, as far as we know, only 6 cases of posterior pharyngeal wall schwannoma have been previously reported in the literature, none of which was associated with NF2 and none of which was histopathologically differentiated in schwannoma or plexiform schwannoma. The patient was treated with laser excision of the tumor via a transoral route, and at 6 and 12 months of follow-up, he exhibited no signs of recurrence. To the best of our knowledge, our patient represents the first reported case of a posterior pharyngeal wall schwannoma that occurred in association with NF2 and the first case in which the schwannoma was removed via transoral laser excision. This case illustrates that plexiform schwannoma is a possible finding in NF2 and that transoral laser excision is a safe surgical procedure in such a case.

Eosinophilic inflammation of chronic rhinosinusitis with nasal polyps is related to OX40 ligand expression.

The aims of this study were to investigate OX40 ligand expression in sinus tissue from patients with nasal polyposis compared with patients with chronic rhinosinusitis without nasal polyps (NPs), and to determine if OX40 ligand expression is related to eosinophilic sinus infiltration. Twenty patients with chronic rhinosinusitis (11 with and nine without NPs) and seven controls were enrolled in the study. The mRNA expression of OX40 ligand and thymic stromal lymphopoietin and its receptor were analyzed. The immunoreactivity score for OX40 ligand and the eosinophil count were obtained. The mRNA expression and immunoreactivity score of OX40 ligand were higher in patients with nasal polyposis than in patients without NPs, as well as healthy controls. The mRNA expression of thymic stromal lymphopoietin and its receptor was significantly higher in nasal polyposis than in the control, but not significantly higher than in chronic rhinosinusitis without NPs. A correlation between the number of OX40 ligand-positive cells and the number of eosinophils in sinus biopsies was found only in patients with nasal polyposis. In conclusion, the thymic stromal lymphopoietin/OX40 ligand axis is up-regulated in nasal polyposis and is related to the intensity of eosinophilic inflammation.

Ear, nose and throat foreign bodies: the experience of the Pediatric Hospital of Turin.

AIM: Ear, nose and throat (ENT) foreign body (FB) injuries represent an emerging problem in the paediatric population because of their human and social costs. The aim of the study is the site-specific evaluation of FB injuries in the paediatric population referred to the emergency department of the Pediatric Hospital of Turin. METHODS: This retrospective analysis was carried out sifting medical reports between 2002 and 2011. We collected information about 338 patients' FB characteristics, complications and hospitalisation. RESULTS: The mean age was 4.2 ± 2.9 years. Nose and ear are the most involved anatomical sites, followed by pharynx, oesophagus and trachea-bronchi. The most common FBs are balls, beads and toys parts (29.6%), followed by fishbones (13.6%). A lower mean age is observed in tracheo-bronchial and oesophageal FBs. The 9.2% of cases reported complications. CONCLUSIONS: A quick and proper diagnosis followed by an effective treatment of FB injuries and their complication is mandatory. Surveillance registries have a key role in prevention and management of FB injuries; useful information can be obtained also for nurse and ENT specialist training in order to create professionals ready to recognise and manage FB injuries in the most effective way.

A technical note about flap fixation technique to prevent salivary fistulas in reconstructive oral cavity surgery.

Salivary fistulas are frequent complications in oral oncological reconstructive surgery by means of pedicled or free flaps. The most common risk factors are malnutrition, advanced disease, and healing alterations due to radiation therapy or infections. However, they can be observed also in healthy patients where the flap suture breakdown is the only cause. During the reconstructive phase, flaps are anchored to the remnant tongue, hyoid bone, and residual gingival mucosa; the last structure often does not offer suitable margins for a strong suture. The aim of this study was to propose a transmandibular fixation of the flap that allows, in a safe, efficient, and unexpensive way, the creation of a saliva-proof neofloor of the mouth, independently from the quality and thickness of residual gingival mucosa.

Iatrogenic rhinopharyngeal isolated argyria induced by silver-containing nasal drug.

Localized nasal argyria has been reported in 3 published articles as secondary to occupational exposure and involving the anterior part of the nose. No previous cases of such pathology involving the rhinopharynx were described. Here we report the first case of localized argyria of the roof and of the posterior wall of the rhinopharynx secondary to prolonged use of nasal drops containing colloidal silver protein. The recognition of such pathology can be useful to increase the number of conditions that must be considered in the differential diagnosis of rhinopharyngeal mucosa alterations.

Detection of herpesviruses 1-6 and community-acquired respiratory viruses in patients with chronic rhinosinusitis with nasal polyposis.

OBJECTIVE: To evaluate the prevalence of human herpesviruses (HHV) 1-6 and community-acquired respiratory viruses (CARVs) in specimens from patients with nasal polyposis undergoing functional endoscopic sinus surgery (FESS) and investigate the potential clinical role. METHODS: Viral occurrence was evaluated by molecular methods in polyp, turbinate mucosa, and pre- and postoperative scraping specimens from 35 consecutive patients at different time points in relation to FESS. RESULTS: Overall, 21 patients (60%) were positive to at least one virus in at least one specimen; in particular, 12.1% of all specimens for HHV-6 (3/35 polyps, 11/31 turbinates, 1 presurgical scraping) and 10.5% for Epstein-Barr virus (EBV) (8/35 polyps, 3/31 turbinates, 1/29 pre- and 1/29 postsurgical scraping), followed by CMV and HSV-1 (both 1.6%; 1/35 polyps, 1/29 postsurgical scraping and 2/35 polyps, respectively). EBV positivity tended to be higher in polyps, as well as HHV-6 in adjacent healthy turbinate mucosa, although no significant association was found. Only one preoperative cytological specimen was positive to parainfluenza virus-1. CONCLUSION: No association between the development of nasal polyps, herpesviruses and CARVs seems to exist. However, the higher EBV frequency in polyps could suggest a causative role or persistence in the inflammatory lymphoid tissue.

[The prevention of noise inducted hearing loss: the new challenge of active electronic hearing protection]. / La prevenzione individuale del trauma acustico cronico: la nuova frontiera degli otoprotettori attivi.

Based on today's common hearing aid design and technology, the team of researchers successfully designed a DPI which allows the worker to be "protected" against loudness and in the same time guarantee a good level of communication and perception of the surrounding environment. The design of this new device is very much similar to a standard BTE hearing aid which allows the use of an active DPI very comfortable, robust and easy to use. The research using the prototypes was divided into 3 phases: Phase 1: 24 volunteers coming from non-industry companies did undergo a specific trial protocol. Phase 2: 6 workers coming from a mining company did undergo the same protocol used in Phase 1. Phase 3: The Acoustics Laboratory from the "Energetica" Department of the Polytechnic of Turin (University/Institute) took objective measures for the DPI attenuation figures used in phase 1 and 2.

[Socio-presbyacusis: definition and prevention]. / La sociopresbiacusia: cos'è e come si previene.

Socio-presbyacusis is a hot topic with an increasing incidence and high social costs. The main etiological factors are: genetics, smoking and drinking habits, diet, metabolic syndrome, chronic otitis and noise exposure (professional, environmental and recreative). Despite its multifactorial origin, the pathogenetic mechanism of cochlear damage is based on the increased production of Reactive Oxygen Species (ROS). The clinical characteristic feature of socio-presbyacusis is represented by slow cochlear degeneration causing a reduction of central hearing inputs. The result is a gradual social isolation of the deaf patient with a worsening of his Quality of Life. The main target of the management of socio-presbyacusis is the early diagnosis and prosthetic remediation in order to avoid patient's isolation. New preventive and remediative strategies are represented by antioxidant drugs.

The expression of TSLP receptor in chronic rhinosinusitis with and without nasal polyps.

Chronic Rhinosinusitis with or without Nasal Polyps (CRSwNP and CRSsNP) may be characterized by different cytokine profiles. Generally, Th2 cytokines and eosinophilic infiltration have been reported to be more specific of CRSwNP compared to CRSsNP, where neutrophils seem to play a major role. The epithelial cell-derived thymic stromal lymphopoietin (TSLP) has been recently identified as a key factor in Th2-inflammatory response. The aim of this study is to investigate the expression of TSLP Receptor (TSLP R) in surgical specimens obtained from patients affected by CRSwNP (n=10) and CRSsNP (n=5) by immunohistochemical techniques (immunostaining score, IS). TSLP R expression was significantly higher in the inflammatory infiltrate and in the epithelial cells of CRSwNP, CRSsNP patients compared to the control group (IS 4.5±0.68, 4.4±1.44 and 0.43±0.3 respectively, p=0.0024 for inflammatory infiltrate and IS 5.8±0.92, 7.8±2.06 and 0.86±0.55 respectively, p=0.0018 for epithelial cells). No significant difference was observed in IS of inflammatory infiltrate and epithelial cells in CRSwNP compared to CRSsNP. Very low IS for TSLP R was found in connective tissue of all the samples, with no difference among the groups. TSLP receptor is highly expressed in CRS compared to controls and independently from the polyps suggesting an early common inflammatory pathway in the two CRS phenotypes.

Induction chemotherapy with carboplatin and taxol followed by radiotherapy and concurrent weekly carboplatin + taxol in locally advanced nasopharyngeal carcinoma.

PURPOSE: Aim of this study was the clinical evaluation of carboplatin-taxol combination in a neoadjuvant and concomitant setting with conventional radiotherapy in loco-regionally advanced nasopharyngeal carcinoma (A-NPC). METHODS: Thirty patients were treated with three cycles of carboplatin (AUC6) plus taxol (175 mg/m(2)) on day 1 every 3 weeks, followed by weekly carboplatin (AUC1) plus Taxol (60 mg/m2) and concomitant radiotherapy (70 Gy). RESULTS: We observed the objective complete response rates of 33% (after chemotherapy) and 87% (after chemo-radiotherapy). Treatment tolerability and toxicity were controllable. Three- and five-year progression-free survival were 80 and 75%, respectively, and 3- and 5-year overall survival were 85 and 80% (follow-up 49.5 months). Five-year loco-regional control was 90.3%, and five-year distant metastases-free survival was 85%. CONCLUSIONS: Neoadjuvant chemotherapy with such protocol represents a feasible, efficient treatment for patients with A-NPC, ensuring excellent loco-regional disease control and overall survival with low incidence of distant metastases.