Nanofiltrated C1-esterase-inhibitor in the prophylactic treatment of bradykinin-mediated angioedema.

BACKGROUND: Patients suffering from bradykinin-induced angioedema show recurrent swelling of subcutaneous and submucosal structures. Increased bradykinin levels lead to an increase in vascular permeability and edema formation. Current therapy consists of B2 bradykinin receptor antagonists, C1-esterase-inhibitor (C1-INH) concentrate, or the kallikrein inhibitor ecallantide. In most cases the treatment of acute attacks is sufficient. Prophylactic therapy is recommended only in severe cases. C1-INHc has been shown a safe and efficient option. Its effect on the quality of life has not yet been analyzed. STUDY DESIGN AND METHODS: Patients with inadequate disease control despite an "on-demand therapy" including C1-INHc and/or the B2 receptor antagonist icatibant were switched to long-term prophylaxis consisting in an individual dose of intravenous C1-INHc (Cinryze). None of the patients had been previously treated with ecallantide. Disease-specific quality-of-life questionnaires and patient records were used for evaluation. Disease control, quality of life, adverse events, and administered dosage per month were compared for 6 months on on-demand therapy and the following 6 months under prophylactic therapy. RESULTS: Data of seven patients with hereditary angioedema (HAE) and one patient with acquired angioedema were evaluated. Prophylactic therapy with Cinryze led to a significant and clinically relevant reduction in the overall attack frequency from 6.7 to 2.3 per month without relevant side effects. The frequency of severe attacks was reduced by 89% and quality of life significantly improved. CONCLUSION: Prophylaxis with Cinryze led to a significantly improved quality of life in our cohort of patients with high-frequency bradykinin-induced angioedema attacks that were not sufficiently treated with on-demand medication.

Three different turbinoplasty techniques combined with septoplasty: Prospective randomized trial.

OBJECTIVES/HYPOTHESIS: Septal deviation and hypertrophic inferior turbinates are a frequent cause of nasal breathing disorders. The goal of this study was to prove the effectiveness and safety of three current turbinoplasty techniques. STUDY DESIGN: This is a prospective, three-arm, single-blinded, single-center, randomized controlled trial. METHODS: Sixty patients were randomly assigned to either anterior turbinoplasty (ATP) (n = 20), radiofrequency ablation (RFA) (n = 19; Celon Pro Breath), or novel submucous radial diode laser ablation (DLA) (n = 21; ELVeS Radial PainLess, wavelength = 1,470 nm), each in combination with standard septoplasty. Acoustic rhinometry, rhinomanometry, subjective nose questionnaire, and saccharin test served as outcome parameters for preoperative and 3-month, 1-year, and 2-year postoperative examinations. RESULTS: After 3 months 47/60 patients were evaluated, 28/60 patients were evaluated after 1 year, and 26/60 patients were evaluated in the 2-year follow-up visit. An improvement of nasal breathing was observed in all three groups in all follow-up visits. The increase of endonasal volume 2 (volume between the nasal valve and body of the inferior turbinate) was statistically significant in the ATP and RFA group after 3 months and 2 years, and in the RFA group also after 1 year. The DLA group failed to reach significance level in all follow-up visits. Subjective evaluation of nasal breathing improved in all three groups. CONCLUSIONS: In this trial, three different current techniques of turbinate surgery in combination with standard septoplasty were effective for the improvement of nasal breathing. The ATP and RFA techniques were more effective in the long term than DLA. LEVEL OF EVIDENCE: 1b. Laryngoscope, 2016 127:303-308, 2017.