Efficacy of a Novel Intranasal Formulation of Azelastine Hydrochloride and Fluticasone Propionate, Delivered in a Single Spray, for the Treatment of Seasonal Allergic Rhinitis: Results from Russia.

BACKGROUND: The novel intranasal formulation of azelastine hydrochloride (AZE) and fluticasone propionate (FP) in a single spray (MP-AzeFlu) was compared with a first-line intranasal antihistamine spray (AZE) in Russian seasonal allergic rhinitis (SAR) patients. METHODS: Moderate-to-severe SAR/rhinoconjunctivitis patients (n = 149; aged 18-65 years) were randomized to receive MP-AzeFlu (137/50 µg AZE/FP per spray) or AZE (137 µg/spray), both as 1 spray/nostril twice daily, in a multicenter, open-label, 14-day, parallel-group trial. The primary outcome was change from baseline in morning and evening reflective total nasal symptom score (rTNSS). Secondary end points included: change from baseline in reflective total ocular symptom score (rTOSS), reflective total of 7 symptom scores (rT7SS), 28-item Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) overall score, and EuroQol-5D (EQ-5D) questionnaire score. RESULTS: When compared with AZE-treated patients, those treated with MP-AzeFlu experienced significantly greater reductions in rTNSS (difference: -2.47; 95% confidence interval [CI] -3.65 to -1.30; p < 0.001), rTOSS (difference: -1.62; 95% CI -2.32 to -0.92; p < 0.001), and rT7SS (difference: -4.34; 95% CI -5.98 to -2.70; p < 0.001). Superior relief observed on day 2 with MP-AzeFlu versus AZE was sustained throughout the study. MP-AzeFlu-treated patients experienced a greater improvement in QoL than AZE-treated patients as measured by overall RQLQ score (mean ± SD 2.91 ± 1.08 vs. 2.05 ± 1.15) and EQ-5D score (mean ± SD 87.4 ± 10.3 vs. 83.0 ± 12.8). MP-AzeFlu was well tolerated. CONCLUSIONS: MP-AzeFlu was superior to AZE in reducing moderate-to-severe SAR symptoms, providing earlier and more complete symptom relief.

Craniosynostosis of the Sphenofrontal Suture: Definition of the Main Signs of Craniofacial Deformity.

AIMS: The aim of this study is to compare clinical features of sphenofrontal craniosynostosis (SFC) and unilateral coronary craniosynostosis. SETTINGS AND DESIGN: This was a retrospective study with two groups of patients with sphenofrontal and coronary craniosynostosis. MATERIALS AND METHODS: This was a retrospective study of the 1999-2016 archive data in Russian Children's Clinical Hospital. Ninety-five patients were diagnosed with frontal plagiocephaly. Eighty-three had deformations of unilateral craniosynostosis of coronary suture, 12 had premature closures of sphenofrontal suture. The age at the time of diagnosis varied from 5 months to 2, 5 years. RESULTS: SFC is featured by ipsilateral flattening of forehead and supraorbital margin, and ipsilateral dystopia of supraorbital margin downward. X-ray signs are the closure of sphenofrontal suture on the lesion side with open and symmetrically located remaining skull sutures and contralateral deviation of the midline of the ethmoid. CONCLUSIONS: SFC distinguishes from other plagiocephalias by following signs: supraorbital margin on the affected side is shifted downward; tip of the nose is displaced toward the affected side, root of the nose toward the healthy side. These signs facilitate correct diagnosis and treatment tactics.

Mechanism of action of allergen immunotherapy.

BACKGROUND: Allergen immunotherapy (AIT) leads to the production of antiallergen immunoglobulin (IgG) or "blocking antibody" in the serum and an increase in antiallergen IgG and IgA in nasal secretions. There is also a decrease in the usual rise in antiallergen IgE that occurs after the pollen season. METHODS: In this paper, mechanisms of action of allergen immunotherapy is reviewed. RESULTS: Regulatory T (Treg) cells and their cytokines, primarily interleukin (IL) 10 and transforming growth factor beta, suppress T-helper type 2 immune responses and control allergic diseases in many ways. AIT induces a shift in the proportion of IL-4-secreting T-helper type 2 cells in favor of IL-10-secreting inducible Treg cells specific for the same allergenic epitope that increases in number and function. Different types of inducible Treg control several facets of allergic inflammation. There are two main types of immunotherapy: subcutaneous immunotherapy and sublingual immunotherapy. Subcutaneous immunotherapy is efficacious and is indicated for the reduction of seasonal symptoms. Sublingual immunotherapy involves the regular self-administration and retention of allergen extract under the tongue for 1-2 minutes before the extract is swallowed. The allergens cross the mucosa in 15-30 minutes and are then captured by tolerogenic dendritic cells and processed as small peptides. Next, via the lymphatic system, a systemic immune response is created to produce an early decrease in mast cell and basophil degranulation. CONCLUSION: AIT is indicated for the treatment of moderate-to-severe intermittent or persistent symptoms of allergic rhinitis. AIT can be administered to those >5 years of age and has been shown to be safe in children as young as 3 years of age. In this article, AIT and other types of immunotherapies were discussed as well as the indications for immunotherapy.

Septoplasty in children.

OBJECTIVES: Physicians have long had concerns about the potential harmful effects of pediatric septoplasties on the nasoseptal growth process because septal cartilage is important for the growth and development of the face. METHODS: In this review article, pediatric septoplasty and its indications are discussed, together with a literature survey. In addition, overviews of development of the nasal skeleton from neonate to adult, nasal growth, and cartilaginous septum are presented. Important issues and comments on pediatric septoplasties are provided. RESULTS: During septoplasty procedures, elevation of the mucoperichondrium unilaterally or bilaterally does not negatively affect growth of the face. Stabilization of the septum may be easier when mucosal elevation is performed unilaterally. The nasal floor mucosa should not be elevated so to avoid damage to the incisive nerves. Corrections and limited excisions may be done from the cartilaginous septum. Separation of the septal cartilage from the perpendicular plate, especially at the dorsal part, should not be performed because this area is important for the length and height of the nasal septum and nasal dorsum. Incisions or excisions should not be performed through the growing and supporting zones, especially at the sphenoethmoid dorsal zone. CONCLUSION: If there are severe breathing problems related to the septal deviation, septoplasty should be performed. In the majority of cases, septal surgery may be conducted in 6-year-old children. However, if necessary, septal surgery may be performed in younger children and even at birth.

A Russian adaptation of the tinnitus handicap inventory.

OBJECTIVE: To establish a Russian version of the English THI. DESIGN: The English THI (THI-E) was translated into Russian by two bilingual investigators, independently. The final Russian THI version (THI-R) was constructed by a third investigator, from the two translations. This version was administered to fifty consecutive patients at a tinnitus clinic. Participants also assessed the loudness of their tinnitus, and completed the Russian versions of the Beck's depression inventory and the state anxiety Inventory. STUDY SAMPLE: The participants were fifty consecutive patients (older than 18 years of age with a tinnitus lasting over three months) who were treated at a tinnitus clinic. RESULTS: A very good internal consistency was found (α = 0.94), with significant correlation between the THI-R score and the Beck depression inventory score. Factor analysis confirmed a uni-dimensional structure of the inventory. CONCLUSIONS: A valid and reliable THI-R questionnaire was constructed.

International study of the incidence of particular types of septal deformities in chronic rhinosinusitis patients: the outcomes from five countries.

BACKGROUND: Chronic rhinosinusitis (CRS) may be more frequent in patients with particular types of septal deformities. The aim of this article was to investigate the incidence of particular types of septal deformities in adult CRS patients and healthy volunteers in various countries to determine whether some of them are more frequent in those groups. METHODS: This international multicentric study involved 505 subjects from five countries: Croatia, Romania, Italy, Russia, and Turkey. The types of septal deformities were observed and grouped according to the Mladina classification. Subjects were examined by means of native anterior rhinoscopy, anterior rhinoscopy after decongestion, and fiber endoscopy with topical anesthesia. CRS patients have been diagnostically proved by computed tomography scanning of the paranasal sinuses. RESULTS: Considering the CRS patients, the prevalence of so-called vertical deformities (types 2, 3, and 4) was seen. Among them, type 3 deformity was found most frequently in Turkey, Croatia, Italy, and Romania. CONCLUSION: Type 3 deformity has been found frequently in CRS patients in all five of the countries. Russian subjects exhibited a high frequency of type 4 deformity. Because this type consists of types 2 and 3, the later, again, has been proven to be prevalent in CRS patients also in this group of patients.

Efficacy of long-term low-dose macrolide therapy in preventing early recurrence of nasal polyps after endoscopic sinus surgery.

BACKGROUND: This study assessed efficacy of clarithromycin "long-term" macrolide therapy as an adjunct to maintenance therapy with nasal corticosteroids to prevent recurrence of nasal polyps (NP) after functional endoscopic sinus surgery (FESS). METHODS: A total of 66 patients with chronic rhinosinusitis and bilateral NP were randomized into 3 study arms, 22 patients in each arm. After FESS, patients in the first and second groups were treated with clarithromycin 250 mg/day for 12 and 24 weeks, respectively, whereas patients in the third group did not receive any clarithromycin. Patients in all 3 groups received maintenance therapy with mometasone furoate 400 µg/day. Patient assessment was conducted before the surgery and 6, 12, and 24 weeks after surgery, using a visual analogue scale (VAS), 20-item SinoNasal Outcome Test (SNOT-20), acoustic rhinometry, rhinomanometry, saccharin transit time, nasal endoscopy, computed tomography (CT) of paranasal sinuses, and measurement of the level of eosinophil cationic protein (ECP) in their nasal secretions. RESULTS: The study confirmed efficacy of "long-term" macrolide therapy, resulting in significant improvement of all parameters except acoustic rhinometry and VAS in both clarithromycin groups as compared to the control. Concentration of ECP in the nasal secretions increased dramatically after surgery, then returned to baseline levels after 12 and 24 weeks of treatment with clarithromycin. In the control group, ECP level continued to increase and was significantly higher at the endpoint. Both groups with clarithromycin showed significantly better endoscopic and CT scores than the control group at the end point. CONCLUSION: "Long-term" low-dose clarithromycin 250 mg/day is able to control eosinophilic inflammation and prevent early relapse of NP after FESS.

Endonasal removal of a large ethmoidal cementoblastoma.

Cementoblastoma is a benign tumour, which pertains to the family of fibro osseous lesions of the jaws. A small number of clinical reports of cementum containing tumours locating in the paranasal sinuses have been published during the last three decades. Ethmoidal cementomas often attain a large size; they can destroy surrounding bone, invade the orbit and the skull base and usually require radical surgery for complete excision. We present a new case of a large cementoblastoma located in the left posterior ethmoid in the close vicinity of the optic nerve canal. In the 40-year old woman, endoscopic endonasal computer-assisted surgery allowed for complete tumour removal. No intraoperative damage to the orbit and the optic nerve occurred. No residual tumour was found at the follow-up visit three years after the surgery.

Endonasal endoscopic repair of spontaneous cerebrospinal fluid leaks.

OBJECTIVE: To analyze possible etiological factors of spontaneous cerebrospinal fluid (CSF) rhinorrhea and to assess the outcomes of endonasal endoscopic repair. DESIGN: Retrospective study. SETTING: Academic neurosurgical hospital. Patients Twenty-one consecutive patients who presented with spontaneous CSF leak and underwent endonasal endoscopic surgery from January 1999 through December 2001. INTERVENTION: Preoperative examination included computed tomographic scans; nasal endoscopy; measurement of glucose concentration in the nasal discharge; and, in some cases, cisternographic evaluations via computed tomography and/or magnetic resonance imaging. Telescopes, conventional endoscopic sinus surgery instruments, and a microdebrider were used for all patients who underwent endonasal surgery. A combination of plastic materials, ie, abdominal fat, fascia lata, rotated middle turbinate flaps, and fibrin glue, were used for fistula repair. RESULTS: At the time of surgery, CSF fistulas were found in the cribriform plate (6 patients), in the fovea ethmoidalis (6 patients), and in the sphenoid sinus (9 patients). In 5 of the 6 patients who had an extremely pneumatized sphenoid sinus, the source of the leak was located in the lateral extension of the sinus. A meningocele protruding through the bone defect was the source of the leak in 10 patients. Postoperative follow-up lasted from 9 to 42 months, and 20 patients were considered cured. There was only 1 recurrence, in a patient whose CSF rhinorrhea originated in the deep lateral recess of an overpneumatized sphenoid sinus. Thus, the overall success rate was 95.2%. There were no postoperative complications. CONCLUSIONS: Possible etiological factors of this disease include obesity, congenital malformations of the skull base, an overpneumatized sphenoid sinus (particularly in its lateral extensions), and the empty sella syndrome. Endoscopic endonasal repair of spontaneous CSF rhinorrhea appears to be a safe and successful procedure. However, techniques for endoscopic closure of CSF fistulas in the lateral part of the sphenoid sinus need further perfecting.

Chronic maxillary sinusitis of dental origin: is external surgical approach mandatory?

OBJECTIVE: The study evaluated a minimally invasive endoscopic shaver-assisted technique for treatment of chronic maxillary sinusitis of dental origin. STUDY DESIGN: A retrospective multicenter chart review was performed at two clinics of all patients who had a diagnosis of chronic maxillary sinusitis of dental origin and were treated using the technique. METHODS: The patients were divided into two main groups: patients with and without chronic oral antral fistula. Data from the patients were collected and analyzed. RESULTS: Seventy patients aged 16 to 62 years had surgery using the endoscopic technique. Thirty-nine patients presented with oral antral fistula of different locations, the most common being third molar fistula (26 cases). Foreign bodies were found in 21 sinuses, among them teeth roots (in 11), dental fillings (in 7), and packs (in 3). Fungal ball was found in six sinuses. The surgical technique included retrograde resection of the uncinate process, enlargement of the natural maxillary ostium posteriorly, and removal of the polyps and foreign bodies from the sinus through the middle meatal antrostomy window. Approach through the oral antral fistula facilitated additional access to the alveolar recess. Removal of polyps from the alveolar recess was performed using the microdebrider, which was introduced through the fistula under endoscopic control through the nasoantral window. The fistula was closed in two layers. Good results were obtained in all but four patients in terms up to 3 years. No complications occurred. Overall recovery rate after primary surgery was 94.7%. CONCLUSION: Endoscopic approach to chronic maxillary sinusitis of dental origin is a new, reliable method associated with less morbidity and lower incidence of complications.