In vitro Comparison of Safety and Efficacy of Diluted Isotonic Seawater and Electrodialyzed Seawater for Nasal Hygiene.
electrolyte balance
homeostasis
medical device
nasal irrigation
nasal mucosa
Journal
Medical devices (Auckland, N.Z.)
ISSN: 1179-1470
Titre abrégé: Med Devices (Auckl)
Pays: New Zealand
ID NLM: 101566041
Informations de publication
Date de publication:
2020
2020
Historique:
received:
07
10
2020
accepted:
16
11
2020
entrez:
14
12
2020
pubmed:
15
12
2020
medline:
15
12
2020
Statut:
epublish
Résumé
Nasal irrigation is often used for managing sinonasal conditions and maintaining nasal hygiene, which is critical to overall nasal health and to provide protection against airborne contaminants and pathogens. However, studies comparing efficacies of different solutions are needed. This in vitro study evaluated the ionic balance of an isotonic diluted seawater solution (Stérimar Nasal Hygiene, SNH) and its safety and efficacy for regular nasal hygiene in comparison to electrodialyzed seawater (EDS). Ionic balance of SNH, EDS and pure seawater was measured by mass spectrometry and chromatography to be compared to the ionic balance of human plasma as reported in the literature. Safety was measured through cytotoxicity (lactate dehydrogenase release) and pro-inflammation (interleukin-8 secretion) assays using a 3D-reconstituted human nasal epithelium model. For efficacy, adenosine 5'-triphosphate (ATP) release assays, and histological (alcian blue) and immunohistochemical (aquaporin 3) stainings were performed on tissues under hypotonic challenge where saline solution was used as the negative control. Compared to EDS, the ionic balance of SNH was more similar to human plasma and pure seawater. SNH reduced hypotonic stress-associated ATP release and maintained tissue morphology more effectively and lastingly compared to EDS. Both solutions were safe to use on nasal epithelium, as neither of them caused cytotoxicity or induced (pro-) inflammation. In comparison to EDS, this study confirms the safety and efficacy of SNH in maintaining good nasal hygiene consistent with its benefits reported in clinical trials.
Sections du résumé
BACKGROUND
BACKGROUND
Nasal irrigation is often used for managing sinonasal conditions and maintaining nasal hygiene, which is critical to overall nasal health and to provide protection against airborne contaminants and pathogens. However, studies comparing efficacies of different solutions are needed.
PURPOSE
OBJECTIVE
This in vitro study evaluated the ionic balance of an isotonic diluted seawater solution (Stérimar Nasal Hygiene, SNH) and its safety and efficacy for regular nasal hygiene in comparison to electrodialyzed seawater (EDS).
MATERIALS AND METHODS
METHODS
Ionic balance of SNH, EDS and pure seawater was measured by mass spectrometry and chromatography to be compared to the ionic balance of human plasma as reported in the literature. Safety was measured through cytotoxicity (lactate dehydrogenase release) and pro-inflammation (interleukin-8 secretion) assays using a 3D-reconstituted human nasal epithelium model. For efficacy, adenosine 5'-triphosphate (ATP) release assays, and histological (alcian blue) and immunohistochemical (aquaporin 3) stainings were performed on tissues under hypotonic challenge where saline solution was used as the negative control.
RESULTS
RESULTS
Compared to EDS, the ionic balance of SNH was more similar to human plasma and pure seawater. SNH reduced hypotonic stress-associated ATP release and maintained tissue morphology more effectively and lastingly compared to EDS. Both solutions were safe to use on nasal epithelium, as neither of them caused cytotoxicity or induced (pro-) inflammation.
CONCLUSION
CONCLUSIONS
In comparison to EDS, this study confirms the safety and efficacy of SNH in maintaining good nasal hygiene consistent with its benefits reported in clinical trials.
Identifiants
pubmed: 33312003
doi: 10.2147/MDER.S285593
pii: 285593
pmc: PMC7726834
doi:
Types de publication
Journal Article
Langues
eng
Pagination
391-398Informations de copyright
© 2020 De Servi et al.
Déclaration de conflit d'intérêts
AS formerly worked as the EU Technology & Innovation Manager at Laboratoire Fumouze, who owns the Stérimar brand. AS has patents E3638257, EP2985027, and EP2985019 pending. The authors report no other conflicts of interest in this work.
Références
Toxicol Sci. 2018 Jul 1;164(1):21-30
pubmed: 29534242
J Physiol. 2007 Apr 15;580(Pt. 2):577-92
pubmed: 17317749
Am Fam Physician. 2009 Nov 15;80(10):1117-9
pubmed: 19904896
Arch Otolaryngol Head Neck Surg. 2008 Jan;134(1):67-74
pubmed: 18209140
Laryngoscope. 2006 Jun;116(6):878-82
pubmed: 16735920
Cell Res. 2005 Feb;15(2):111-9
pubmed: 15740640
Allergy. 2005 May;60(5):583-601
pubmed: 15813802
Chem Senses. 2008 Jun;33(5):481-8
pubmed: 18407959
Cochrane Database Syst Rev. 2010 Mar 17;(3):CD006821
pubmed: 20238351
J Allergy Clin Immunol. 2018 Jun;141(6):2074-2084
pubmed: 28797733
Clin Otolaryngol. 2013 Aug;38(4):297-305
pubmed: 23714166
Cochrane Database Syst Rev. 2016 Oct 17;10:CD009612
pubmed: 27748955
J Biol Chem. 2006 Aug 11;281(32):22992-3002
pubmed: 16754672
Rhinology. 2020 Feb 20;58(Suppl S29):1-464
pubmed: 32077450
Toxicol In Vitro. 2008 Jun;22(4):1099-106
pubmed: 18400464
Toxicol In Vitro. 2014 Mar;28(2):258-64
pubmed: 24216300
Physiol Rep. 2014 Feb 10;2(2):e00227
pubmed: 24744896
Acta Otolaryngol. 2004 Nov;124(9):1059-62
pubmed: 15513550
Am J Physiol. 1997 Nov;273(5):C1549-61
pubmed: 9374640
Ear Nose Throat J. 2005 Jul;84(7):426-30
pubmed: 16813032
Minerva Pediatr. 2010 Oct;62(5):499-505
pubmed: 20940683
J Laryngol Otol. 2014 Jan;128(1):73-7
pubmed: 24423751
Am J Respir Cell Mol Biol. 2001 Mar;24(3):224-34
pubmed: 11245621
Toxicol Sci. 2018 Mar 1;162(1):301-308
pubmed: 29182718
Eur Ann Otorhinolaryngol Head Neck Dis. 2015 Nov;132(5):281-5
pubmed: 26344138