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.

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.

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.