Empfehlungen zur Überprüfung der Wirksamkeit und Verlaufsdokumentation von Mepolizumab bei chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) im deutschen Gesundheitssystem ­ Empfehlungen des Ärzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Halschirurgie (DGHNOKHC).

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the mucous membranes of the nose and sinuses. Eosinophilic inflammation is described as a common endotype. The anti-IL5 antibody mepolizumab was approved in November 2021 as an add-on therapy to intranasal glucocorticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps when systemic glucocorticosteroids or surgery do not provide adequate disease control. While national and international recommendations exist for the use of mepolizumab in CRSwNP, it has not yet been adequately specified how this therapy is to be monitored, what follow-up documentation is necessary, and when it should be terminated if necessary. METHODS: A literature search was performed to analyze previous data on the treatment of CRSwNP with mepolizumab and to determine the available evidence by searching Medline, Pubmed, the national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to and including 10/2022 were considered. RESULTS: Based on the international literature and previous experience by an expert panel, recommendations for follow-up, adherence to therapy intervals and possible therapy breaks, as well as termination of therapy when using mepolizumab for the indication CRSwNP in the German health care system are given on the basis of a documentation sheet. CONCLUSIONS: Understanding the immunological basis of CRSwNP opens up new non-surgical therapeutic approaches with biologics for patients with severe, uncontrolled courses. Here, we provide recommendations for follow-up, adherence to therapy intervals, possible therapy pauses, or discontinuation of therapy when mepolizumab is used as add-on therapy with intranasal glucocorticosteroids to treat adult patients with severe CRSwNP that cannot be adequately controlled with systemic glucocorticosteroids and/or surgical intervention.

Empfehlungen zur Überprüfung der Wirksamkeit und Verlaufsdokumentation von Dupilumab bei chronischer Rhinosinusitis mit Nasenpolypen (CRSwNP) im deutschen Gesundheitssystem.

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the nasal and paranasal mucosa. A Type-2 inflammation is described as the most common endotype. Since October 2019 the anti-IL-4/-IL-13 antibody dupilumab has been approved in Germany as an add-on therapy to intranasal corticosteroids for the treatment of adults with severe chronic rhinosinusitis with nasal polyps, when systemic corticosteroids alone or surgery do not provide adequate disease control. While recommendations for the use of dupilumab in CRSwNP exist at both national and international levels, until now it has not been adequately established, how therapy should be monitored and when it should be discontinued in the German Health Care System. METHODS: A literature search was performed analyzing previous data on the treatment of CRSwNP with dupilumab and to determine the available evidence by searching Medline, Pubmed, the national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to 05/2022 were included. RESULTS: Based on international literature and previous experience, recommendations are given by an expert panel for follow-up and possible therapy breaks, therapy intervals or termination of therapy when using dupilumab for the indication CRSwNP in the German health care system based on a documentation form. CONCLUSIONS: Understanding the immunological basis of CRSwNP opens new non-surgical therapy approaches with biologics for patients with severe courses. The authors give recommendations for follow-up, possible therapy breaks, therapy intervals and a termination for dupilumab treatment as add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP that cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.

Positionspapier: Empfehlungen zur Anwendung von Mepolizumab bei chronischer Rhinosinusitis mit Polyposis nasi (CRSwNP) im deutschen Gesundheitssystem ­ Empfehlungen des Ärzteverbandes Deutscher Allergologen (AeDA) und der AGs Klinische Immunologie, Allergologie und Umweltmedizin und Rhinologie und Rhinochirurgie der Deutschen Gesellschaft für HNO-Heilkunde, Kopf- und Hals-Chirurgie (DGHNO-KHC).

BACKGROUND: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a multifactorial inflammatory disease of the paranasal sinus mucosa with eosinophilic inflammation as the most common endotype. The anti-IL5 antibody mepolizumab was approved for the treatment of severe CRSwNP in the EU in November 2021. METHODS: A literature search was performed to analyze the immunology of CRSwNP and determine the available evidence by searching Medline, Pubmed, and the German national and international trial and guideline registries and the Cochrane Library. Human studies published in the period up to and including 12/2021 that investigated the effect of mepolizumab in CRSwNP were considered. RESULTS: Based on the international literature and previous experience, recommendations for the use of mepolizumab in CRSwNP in the German health care system are given by an expert panel on the basis of a documentation form. CONCLUSIONS: Understanding about the immunological basis of CRSwNP opens new non-surgical therapeutic approaches with biologics for patients with severe courses. Mepolizumab is approved since November 2021 for add-on therapy with intranasal corticosteroids for the treatment of adult patients with severe CRSwNP who cannot be adequately controlled with systemic corticosteroids and/or surgical intervention.

[New illuminated spectacles for vestibular diagnosis]. / Eine neue Leuchtbrille zur Vestibularisdiagnostik.

Frenzel's spectacles have been essential tools for the clinical examination of the vestibular system since 1925. However, they may lead to false-negative results because they enable the patient to fixate, or to false-positive results because they induce pseudospontaneous nystagmus. Both pitfalls originate from direct illumination of the patient's eyes, and we propose a new design using indirect illumination.

[Topical anesthesia of the tympanic membrane using DMSO and local anesthetics]. / Oberflächenanästhesie des Trommelfells mit DMSO und Lokalanästhetika.

A solution of 10% cocaine hydrochloride plus 10% water in 80% dimethyl sulfoxide (DMSO) or 5% tetracaine base in pure DMSO was topically applied to the eardrum in 112 and 52 cases respectively. Both preparations induced well-tolerated analgesia suitable for myringotomy with or without insertion of a grommet in the office environment. DMSO-tetracaine induced analgesia within ten, DMSO-cocaine within 30 minutes. This method has distinct advantages as compared to iontophoretically induced analgesia or topical agents with a destructive mode of action.

[Cefixime treatment in different bacterial infections in the ENT region]. / Cefiximbehandlung bei verschiedenen bakteriellen Infektionen im HNO-Bereich.

The clinical efficacy and tolerance of cefixime were evaluated in an open uncontrolled clinical trial including 37 patients suffering from ENT-infections. The MIC90 values of this new oral cephalosporin against gram-negative pathogens are less than 1 mg/l. The antibacterial activity of cefixime against gram-negative pathogens is stronger than that of other oral cephalosporins. Cefixime was administered for five to twelve days twice daily in a dose of 200 mg. In one patient the treatment with cefixime was discontinued after five days due to perioral dermatitis. In 33 of 36 patients cure or distinct improvement was observed after cefixime treatment, showing a clinical success rate of 91.7%. Causative organisms were isolated in 17 of 37 patients (47.2%). After the cefixime therapy the causative organisms were eradicated in 13 of 17 patients (76.5%). The tolerance of cefixime is comparable with that of other oral cephalosporins.

[Long-term results of gentamycin therapy of Menière's disease]. / Langzeitergebnisse der Gentamicin-Therapie des Morbus Ménière.

During the years 1976 to 1987, 82 patients with Ménière's disease received a tympanoclysis with gentamicin on a daily basis. Dosage was titrated up to the initial symptoms of vestibular or cochlear intoxication. Sixty-four patients filed for a complete follow-up examination; it was possible to interview 15, while three patients were lost. Vertigo was eliminated in 70 (89%) cases. Nine patients (11%) remained disabled, while demonstrating typical paroxysmal positional vertigo in three cases. Speech discrimination improved in 13%, stabilized in 54%, and deteriorated in 33%. Hearing improved significantly better if, preoperatively, there had been low frequency loss rather than a flat audiogram. HALLPIKE's caloric test demonstrated residual vestibular activity in 72 percent. In the author's opinion, tympanoclysis with gentamicin offers a technically simple, riskless, and effective method to rehabilitate patients with disabling Ménière's disease.

[Measures for reducing the rate of complications in endoscopic surgery of Zenker's diverticulum]. / Massnahmen zur Verringerung der Komplikationsrate bei der endoskopischen Operation des Zenkerschen Divertikels.

In the treatment of the pharyngeal pouch diverticulectomy and endoscopic diverticulotomy are generally accepted. The latter can lead to severe bleeding and mediastinitis. --Therefore the authors have extended the preoperative diagnostic procedure to include a DSA of the aortic arch. The simultaneous contrast filling of the pouch enables the exact position of the blood vessels relative to the bar to be established. --With the spreadable diverticuloscope developed by the authors, the use of a CO2 laser and an operating microscope, optimum endoscopic working conditions are assured. Postoperative sealing of the wound margin with fibrin reduces the likelihood of postoperative bleeding and mediastinitis, the risk of which have been further reduced by antibiotic prophylaxis and tube feeding for eight days. During and after the treatment of ten patients not a single complication has arisen.

[Conservative treatment of chronic sinusitis. Success of oral bacterial lysate therapy]. / Zur konservativen Therapie der chronischen Sinusitis. Erfolge einer oralen Bakterienlysat-Therapie.

In a multicenter randomized double-blind study, 284 patients with chronic purulent sinusitis were treated with an oral immunostimulant or placebo in addition to standard therapy (antibiotics, mucolytics, inhalants). Treatment lasted for three ten-day periods in three consecutive months. At the start and during the therapy as well as after six months, symptoms were assessed on the basis of a scoring system and the X-rays of the nasal sinuses evaluated. During the course of therapy and the follow-up period, improvement of the major symptoms headache, purulent nasal discharge, cough, and expectoration was statistically significant in the immunostimulant group as compared with the placebo group, objective evidence being provided by the X-ray examinations and the number of reinfections during the period of observation.

Clinical efficacy of Broncho-Vaxom in adult patients with chronic purulent sinusitis--a multi-centric, placebo-controlled, double-blind study.

This study was designed to test the clinical effectiveness of Broncho-Vaxom (an orally applicable bacterial lysate) in a large number of adult patients suffering from chronic purulent sinusitis. Broncho-Vaxom or placebo was administered to 284 patients presenting with chronic purulent sinusitis within the bounds of a multicentric, randomized double-blind study. Patients were clinically examined before admittance to the study and at 1, 2, 3 and 6 months after treatment initiation (one capsule daily for a period of 10 days per month during 3 consecutive months). The sinuses were x-rayed before and at 3 and 6 months after therapy began. Patients assessed the severity of their symptoms on a scale of 0 to 4: 0 = no symptoms, 1 = light symptoms, 2 = moderate symptoms, 3 = severe symptoms, 4 = very severe symptoms. The average severity score for coughing during the course of Broncho-Vaxom therapy decreased in the third month of treatment from 2.34 before treatment to 0.85, compared to placebo before treatment (2.41) and after treatment (1.24). The score decreased further to 0.61 in the sixth month after the initiation of Broncho-Vaxom therapy, with no further decrease as a result of placebo therapy (1.25). Comparable average score courses for expectorations and headache also occurred. In the first month of Broncho-Vaxom therapy, a decrease was already apparent in the severity of the main sinusitis symptom: purulent nasal discharge. The score was 1.55 in the first month of Broncho-Vaxom treatment compared to 1.80 in the placebo group.(ABSTRACT TRUNCATED AT 250 WORDS)