Dose-response relationship of a new Timothy grass pollen allergoid in comparison with a 6-grass pollen allergoid.

BACKGROUND: Subcutaneous allergen immunotherapy with grass pollen allergoids has been proven to be effective and safe in the treatment of patients with allergic rhinoconjunctivitis. Based on the extensive cross-reactivity among Pooideae species, it has been suggested that grass pollen extracts could be prepared from a single species, rather than from a multiple species mixture. OBJECTIVE: To find the optimal dose of a Phleum pratense (P. pratense) allergoid preparation and compare its efficacy and safety to a 6-grass pollen allergoid preparation. METHODS: In this double-blind, placebo-controlled study (EudraCT: 2011-000674-58), three doses of P. pratense allergoid (1800 therapeutic units (TU), standard-dose 6000 TU and 18 000 TU) were compared with placebo and the marketed 6-grass pollen allergoid (6000 TU). In a pre-seasonal dosing regimen, 102 patients were randomized to five treatment groups and received nine subcutaneous injections. The primary efficacy endpoint was the change in weal size (late-phase reaction [LPR]) in response to the intracutaneous testing (ICT) before and after treatment, comparing the active allergoids to placebo. Secondary outcomes were the change in Total Nasal Symptom Score (TNSS) assessed in the allergen exposure chamber (AEC), the changes in P. pratense-serum-specific IgG4 and the incidence of adverse events (AEs). RESULTS: All three doses of the P. pratense and the 6-grass pollen allergoid preparations were significantly superior to placebo for the primary outcome, whereas there were no significant differences in the change in TNSS. Compared to the standard-dose, the high-dose of P. pratense did not produce any additional significant benefit, but showed a slight increase in AEs. Yet this increase in AEs was lower than for the 6-grass pollen preparation. CONCLUSIONS & CLINICAL RELEVANCE: The standard-dose of the new P. pratense allergoid was comparable to the marketed 6-grass pollen preparation at equal dose for the parameters measured.

High probability of comorbidities in bronchial asthma in Germany.

Clinical experience has shown that allergic and non-allergic respiratory, metabolic, mental, and cardiovascular disorders sometimes coexist with bronchial asthma. However, no study has been carried out that calculates the chance of manifestation of these disorders with bronchial asthma in Saarland and Rhineland-Palatinate, Germany. Using ICD10 diagnoses from health care institutions, the present study systematically analyzed the co-prevalence and odds ratios of comorbidities in the asthma population in Germany. The odds ratios were adjusted for age and sex for all comorbidities for patients with asthma vs. without asthma. Bronchial asthma was strongly associated with allergic and with a lesser extent to non-allergic comorbidities: OR 7.02 (95%CI:6.83-7.22) for allergic rhinitis; OR 4.98 (95%CI:4.67-5.32) allergic conjunctivitis; OR 2.41 (95%CI:2.33-2.52) atopic dermatitis; OR 2.47 (95%CI:2.16-2.82) food allergy, and OR 1.69 (95%CI:1.61-1.78) drug allergy. Interestingly, increased ORs were found for respiratory diseases: 2.06 (95%CI:1.64-2.58) vocal dysfunction; 1.83 (95%CI:1.74-1.92) pneumonia; 1.78 (95%CI:1.73-1.84) sinusitis; 1.71 (95%CI:1.65-1.78) rhinopharyngitis; 2.55 (95%CI:2.03-3.19) obstructive sleep apnea; 1.42 (95%CI:1.25-1.61) pulmonary embolism, and 3.75 (95%CI:1.64-8.53) bronchopulmonary aspergillosis. Asthmatics also suffer from psychiatric, metabolic, cardiac or other comorbidities. Myocardial infarction (OR 0.86, 95%CI:0.79-0.94) did not coexist with asthma. Based on the calculated chances of manifestation for these comorbidities, especially allergic and respiratory, to a lesser extent also metabolic, cardiovascular, and mental disorders should be taken into consideration in the diagnostic and treatment strategy of bronchial asthma. BRONCHIAL ASTHMA: PREVALENCE OF CO-EXISTING DISEASES IN GERMANY: Patients in Germany with bronchial asthma are highly likely to suffer from co-existing diseases and their treatments should reflect this. Quoc Thai Dinh at Saarland University Hospital in Homburg, Germany, and co-workers conducted a large-scale study of patients presenting with bronchial asthma in the Saarland region between 2009 and 2012. Patients with asthma made up 5.4% of the region's total population, with a higher prevalence occurring in females. They found that bronchial asthma was strongly associated with allergic comorbidities such as rhinitis. Indeed, asthmatic patients had a seven times higher chance to suffer from allergic rhinitis than the rest of the population, and were at higher risk of respiratory diseases like pneumonia and obstructive sleep apnea syndrome. Further associations included cardiovascular, metabolic and mental disorders. Dinh's team call for asthma treatments to take such comorbidities into account.

[Epithetic replacement in otorhinolaryngology]. / Epithetische Versorgung in der HNO-Heilkunde.

The past century saw rapid development of craniofacial prostheses. Particularly the challenging issue of surgical fixation was the subject of intensive research and development. During the past three decades, the principle of osseointegration has proven to provide a reliable method for epithesis fixation. The continuous technical development of implant systems has led to almost minimally invasive surgical techniques, with ever increasing stability of the implants. Osseointegrated implants are a proven and durable solution in the rehabilitation of the patient with a defect in the craniofacial region. Overall complication rates are low. The design and mechanics of the implants, as well as the artificial body of the epithesis itself, are topics of current medical-technical research by anaplastologists and surgeons. Finally, functional prostheses, such as the tracheostomy epithesis, deserve particular attention.

An accelerated dose escalation with a grass pollen allergoid is safe and well-tolerated: a randomized open label phase II trial.

BACKGROUND: The number of injections in the dose escalation of subcutaneous immunotherapy (SCIT) is small for some currently used hypoallergenic allergoids, but can still be inconvenient to patients and can impair compliance. The aim of this trial was to compare safety and tolerability of an accelerated to the conventional dose escalation scheme of a grass pollen allergoid. METHODS: In an open label phase II trial, 122 patients were 1:1 randomized for SCIT using a grass pollen allergoid with an accelerated dose escalation comprising only 4 weekly injections (Group I) or a conventional dose escalation including 7 weekly injections (Group II). Safety determination included the occurrence of local and systemic adverse events. Tolerability was assessed by patients and physicians. RESULTS: Treatment-related adverse events were observed in 22 (36.1 %) patients in Group I and 15 (24.6 %) in Group II. Local reactions were reported by 18 patients in Group I and 11 in Group II. Five Grade 1 systemic reactions (WAO classification) were observed in Group I and 2 in Group II. Grade 2 reactions occurred 3 times in Group I and 2 times in Group II. Tolerability was rated as "good" or "very good" by 53 (86.9 %) patients in Group I and 59 (100 %) in Group II by investigators. Forty-eight patients in Group I (80.0 %) and 54 in Group II (91.5 %) rated tolerability as "good" or "very good". CONCLUSIONS: The dose escalation of a grass pollen allergoid can be accelerated with safety and tolerability profiles comparable to the conventional dose escalation.

[First experience in the thyroid and parathyroid surgery using the da Vinci® system]. / Erste Erfahrungen in der Schilddrüsen- und Nebenschilddrüsenchirurgie mit dem da Vinci®-System.

BACKGROUND: Endoscopic surgery for the treatment of thyroid and parathyroid pathologies is gaining increasing attention. The da Vinci® system has been already widely used in different fields of medicine including recently thyroid and parathyroid surgery. Herein we report our first experiences in endoscopic surgery of thyroid and parathyroid pathologies using the da Vinci® system. MATERIAL AND METHODS: 8 patients presenting with struma nodosa in 6 cases and parathyroid adenomas in 2 cases have been treated using the da Vinci® system at the ENT department of Homburg/Saar University. RESULTS: The skin incision to introduce the instruments with the da Vinci® system were axilar or at the lateral segment of the clavicle. The neurovascular structures like inferior laryngeal nerve as well as the pathologies were clearly 3-dimensional visualized in all 8 cases. No paralysis of the vocal cord was observed. All patients had in histological examination a benign pathology. CONCLUSIONS: The endoscopic surgery of the thyroid and parathyroid gland can be performed using the da Vinci® system and offers an excellent, intraoperative, 3-dimensional visualization of the neurovascular structures. Additionally the da Vinci® system enables skin incisions within considerable distance from the thyroid and parathyroid gland.

[Experience with individual obturators to treat nasal septum perforation]. / Erfahrungen mit individuellen Obturatoren zur Behandlung von Septumperforationen.

BACKGROUND: Individual septal buttons have gained more attention during the last years. However, experiences in patients being treated by an individual septal button are limited. Therefore, further evaluation of this treatment option is needed. MATERIAL AND METHODS: Records of 64 patients being treated by an individual septal button were evaluated retrospectively. As the silicon prints of the septum perforation were available size of the septal perforation were measured. Telephone interview were used to ask the patients about their general judgement and eff ect of the septal button on their different complaints. RESULTS: Septumplasty in 42 patients and a trauma in 10 patients had been documented prior to treatment. In 7 patients Wegner's granulomatosis had been proven by serological and histopathological analysis. Digital manipulation and nasal drop abuses were judged to be the reason of the septal perforation in 2 patients each. In one patient the etiology remained unknown. Size of the septal perforation ranged from 7.4 to 807 mm(2). Using visual analog scale 42 patients reported to be highly satisfied. A statistically significant improvement was reported for all symptoms. Respiratory noise and nasal obstruction were improved best followed by nasal bleeding, pain and crust formation. CONCLUSION: Treatment of septal perforations with individual septal buttons should be considered in treating septal perforations. Nasal obstruction and nasal bleeding were found to be improved best by this treatment option.

[First experience in endonasal surgery using a new 3D-Chipendoscope]. / Erste Erfahrungen in der endonasalen Chirurgie mit einem neuen 3D-Chipendoskop.

BACKGROUND: Endoscopic surgery for treatment of nasal, paranasal and anterior skull base pathologies is an established treatment modality. Available rigid endoscopes with angled views provide a 2-dimensional view with restriction of depth perception. In this study we report about our first experience with a new 3D-Chipendoscope in surgery at the nose, paranasal sinuses und anterior skull base. MATERIAL AND METHODS: 30 patients were enrolled in this study with chronic rhinosinusitis, inverted papilloma, frontal sinus mucocele, frontal sinus osteoma, chronic dacryocystitis and pituitary adenoma. All patients were subjected to standard endonasal endoscopic surgery using 3D-endoscopes. RESULTS: Surgery was performed by the use of the 3D-endoscope in all patients. The operative handling of the 3D-endoscopes was user friendly in regard to design and weight of the endoscopes. The problem of fogging during endoscopic surgery diminishing the quality of view was not observed. Blood crusts on the endoscope tip however was able to changed the 3D-view to a 2D-view. To close positioning of the 3D-endoscopes to the surgical field reduced image quality. The visualisation of the frontal sinus was limited. CONCLUSION: 3D-endoscopic surgery is an interesting development in endonasal surgery of pathologies at the nose, paranasal sinuses and anterior skull base.

[Endoscopic frontal sinus revision following transcutaneous endoscopic puncture and diaphanoscopy]. / Die endonasale Stirnhöhlenrevision nach transkutaner endoskopischer Punktion und Diaphanoskopie.

BACKGROUND: Endoscopic revision sinus surgery in case of frontal sinus pyocele may poses a great surgical challenge for various reasons. Due to the often troublesome anatomical changes caused by prior resection and findings of scaring with new bone formation, the identification of the frontal sinus in revision surgery is frequently a challenge for the surgeon. An easy endoscopic technique for a safe endonasal identification of the frontal sinus in revision surgery is therefore of major importance. MATERIAL AND METHODS: 4 patients (3 men, 1 female) were enrolled with an acute frontal pyocele following prior open frontal sinus surgery over an external access. All patients were subjected to standard endonasal endoscopic frontal sinus surgery. The frontal sinus was endonasally approached after endoscopic transcutaneous frontal sinus puncture through the pre-existing bone defect achieving a diaphanoscopy with endonasal identification of the frontal sinus floor. RESULTS: The external endoscopic puncture and illumination of the frontal sinus was performed in all 4 patients with a modular endoscopic system (Sinus View). A visual exploration of the frontal sinus was easily carried out after irrigation. A clear endonasal identification of the frontal sinus floor by diaphanoscopy was achieved in all patients and guided a direct opening of the frontal sinus. A stable frontal sinus drainage type IIb according to Draf was reached in all cases. CONCLUSION: Transcutaneous frontal sinus puncture with an modular endoscope allows not only to verify frontal sinus pyocele diagnosis, but also provides the option to open the frontal sinus directly guided by the diaphanoscopy at the frontal sinus floor even in situations of complex anatomy.

[Lacrimal systems endoscopy with a new endoscope system]. / Tränenwegsendoskopie mit einem neuen Endoskopiesystem.

BACKGROUND: Successful therapy of postsaccal stenosis in the lacrimal system can be done by an ENT Surgeon by endonasal dacryocystorhinostomy. It is desirable to have a good diagnostic method of the lacrimal system before undertaking surgery. This study describes the first experiences of endoscopic diagnostics of the lacrimal system with a new endoscope. MATERIAL AND METHODS: 24 patients (10 male and 14 female, between 3 and 65 years old) with epiphora and chronic lacrimal system infections were examined in the ENT Department Homburg/Saar with a 0.53 mm modular endoscope, between 11/2008 and 12/2009. The result were evaluated and analysed. RESULTS: The endoscopic lacrimal system examination was done in all 24 patients. 8 patients with high stenosis postsaccal and purulent epiphora had an endonasal dacryocystorhinostomie. 13 patients with prasaccal stenosis or stenosis in the ductus nasolacrimalis with clear epiphora were treated with irrigation, dilatation and U-intubation. The removal of the Endoscopic dilatation was undertaken in 3 children without using bicanicular intubation. CONCLUSION: Lacrimal system endoscopy with a modular endoscope with the possibility of interventional procedures is an efficient option in the widening diagnosis and therapy of the lacrimalm system disease. With this technique is it possible with selected patients to do interventional therapy. On the basis of the endoscopic findings an interventional therapy or an endonasal dacryocystorhinostomie can be done.

Surgery in patients with vascular malformations of the head and neck: value of coagulation disorders.

OBJECTIVES: The surgical treatment of congenital vascular malformations always bears the risk of severe bleeding. The aim of this study was to investigate the prevalence of haemostatic abnormalities in patients with congenital vascular malformations of the head and neck which could additionally complicate the complex surgery of vascular malformations. METHODS: Thirteen patients with congenital vascular malformations of the head and neck, who underwent scheduled surgery, were reviewed regarding their haemostatic tests, including prothrombin time, activated partial thromboplastin time, fibrinogen level, platelet count, platelet function analyzer-epinephrine (PFA-Epi) and -adenosine diphosphate (ADP) (PFA-100), von Willebrand factor (vWF) and D-dimers. RESULTS: In six of 13 patients an impaired primary haemostasis was detected by prolonged PFA-Epi and one of these patients also had a slightly prolonged PFA-ADP. Additionally, two of the patients showed mild coagulation factor deficiency. One patient had a mild vWF deficiency that was not detected by PFA-100. CONCLUSION: Prior to surgery of congenital vascular malformations of the head and neck, a detailed coagulation analysis is needed in order to identify those patients at increased risk of bleeding. This proceeding is supported by the fact that a relevant portion of the patients with congenital vascular malformations of the head and neck show an impaired primary haemostasis.

Transoral removal of submandibular stones.

OBJECTIVE: To assess transoral treatment of submandibular lithiasis. DESIGN: Study of a series of patients with submandibular stones undergoing transoral removal of the sialoliths. Duration of follow-up: 6 months to 7 years. SETTING: Department of Otorhinolaryngology, Head and Neck Surgery, University of Erlangen-Nuremberg, Erlangen, Germany, center for treatment of salivary stones. PATIENTS: Two hundred thirty-one patients (127 females, 104 males) suffering from submandibular lithiasis had a mean age of 41.7 years (age range, 12-86 years). Stone location was distal to the edge of the mylohyoid muscle in 115 patients and proximal to the gland in 102 patients (mean size of sialoliths, 6.3 mm [range, 2-30 mm]). Fourteen other patients had 2 separate stones, one within the hilum and a smaller more proximal one within the gland. INTERVENTIONS: Transoral removal of the stones under local anesthesia and preservation of the submandibular gland. MAIN OUTCOME MEASURES: Complete removal of the stones, complications, and recurrence of the stones. RESULTS: All 115 patients with distal stone location, 93 (91%) of 102 patients with stones of the perihilar region, and 9 (64%) of the 14 patients with 2 separate stones in the hilum and parenchyma were free of stones. Submandibulectomy had to be carried out in 4 patients (1.7%). Recurrence of lithiasis and damage to the lingual nerve remained below 1%. CONCLUSIONS: Transoral removal should be the treatment of choice in patients with submandibular stones that can be palpated bimanually and localized by ultrasound within the perihilar region of the gland.