Sino nasal inhalation of isotonic versus hypertonic saline (6.0%) in CF patients with chronic rhinosinusitis — Results of a multicenter, prospective, randomized, double-blind, controlled trial

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• 作者：Jochen G. Mainz^a ; ^{Jochen.Mainz@med.uni-jena.de} ; Ulrike Schumacher^b ; ^{Ulrike.Schumacher@med.uni-jena.de} ; Katja Schä ; dlich^a ; ^{Katja.Schaedlich@med.uni-jena.de} ; Julia Hentschel^a ; ^k ; ^{Julia.Hentschel@medizin.uniklinikum-leipzig.de} ; Christiane Koitschev^c ; ^{c.koitschev@klinikum-stuttgart.de} ; Assen Koitschev^c ; ^{a.koitschev@klinikum-stuttgart.de} ; Joachim Riethmü ; ller^d ; ^{Joachim.riethmueller@med.uni-tuebingen.de} ; Freerk Prenzel^e ; ^{freerk.prenzel@uniklinik-leipzig.de} ; Olaf Sommerburg^f ; ^{olaf.sommerburg@med.uni-heidelberg.de} ; Bä ; rbel Wiedemann^g ; ^{Baerbel.Wiedemann@tu-dresden.de} ; Doris Staab^h ; ^{doris.staab@charite.de} ; Wolfgang Gleiberⁱ ; ^{Wolfgang.Gleiber@kgu.de} ; Rainald Fischer^j ; ^{rainald.fischer@gmail.com} ; James F. Beck^a ; ^{James.Beck@med.uni-jena.de} ; Christin Arnold^a ; ^{Christin.Arnold@med.uni-jena.de} ; CooperatorsClaudia Schien¹ ; Anika Nader¹ ; Constance Henn² ; Christina Smaczny³ ; Claudius Werner⁴ ; Helge Hebestreit⁵ ; Hans Eberhard Heuer⁶ ; Sebastian Schmidt⁷ ; Corinna Eichhorn⁸ ; Isabella Schiller⁸ ; Andrea Roessler⁸ ; Ingo Baumann⁹
• 关键词：Hypertonic saline ; Sodium chloride ; Sino-Nasal Outcome Test-20 ; Rhinomanometry ; Nasal lavage ; Inflammation
• 刊名：Journal of Cystic Fibrosis
• 出版年：2016
• 出版时间：November 2016
• 年：2016
• 卷：15
• 期：6
• 页码：e57-e66
• 全文大小：792 K
• 卷排序：15

文摘

Chronic rhinosinusitis is a hallmark of Cystic fibrosis (CF) impairing the patients' quality of life and overall health. However, therapeutic options have not been sufficiently evaluated. Bronchial inhalation of mucolytic substances is a gold standard in CF therapy. Previously, we found that sinonasal inhalation of dornase alfa as vibrating aerosol reduces symptoms of chronic rhinosinusitis more effectively than NaCl 0.9% (net treatment benefit: − 5.87 ± 2.3 points, p = 0.017; SNOT-20 total score). This multicenter study compares the effect of NaCl 6.0% vs. NaCl 0.9% following the protocol from our preceding study with dornase alfa.MethodsSixty nine CF patients with chronic rhinosinusitis in eleven German CF centers were randomized to receive sinonasal vibrating inhalation of either NaCl 6.0% or NaCl 0.9% for 28 days. After 28 days of wash-out, patients crossed over to the alternative treatment. The primary outcome parameter was symptom score in the disease-specific quality of life Sino-Nasal Outcome Test-20 (SNOT-20). Additionally, pulmonary function was assessed, as well as rhinomanometry and inflammatory markers in nasal lavage (neutrophil elastase, interleukin (IL)-1β, IL-6, and IL-8) in a subgroup.ResultsBoth therapeutic arms were well tolerated and showed slight improvements in SNOT-20 total scores (NaCl 6.0%: − 3.1 ± 6.5 points, NaCl 0.9%: − 5.1 ± 8.3 points, ns).In both treatment groups, changes of inflammatory parameters in nasal lavage from day 1 to day 29 were not significant. We suppose that the irritating properties of NaCl 6.0% reduced the suitability of the SNOT-20 scores as an outcome parameter. Alternative primary outcome parameters such as MR-imaging or the quantity of sinonasal secretions mobilized with both saline concentrations were, however, not feasible.ConclusionSinonasal inhalation with NaCl 6.0% did not lead to superior results vs. NaCl 0.9%, whereas dornase alfa had been significantly more effective than NaCl 0.9%.