| Safety and efficacy of Sofenz ceruminolytic solution. | |
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MedLine Citation:
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PMID: 16579195 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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We conducted an open-label study of 109 untreated patients who had excessive or impacted cerumen. Our goal was to evaluate the safety and efficacy of Sofenz Cerumenolytic Solution, a methyltrypsin-containing earwax removal solution. Each patient's external auditory canal was filled with Sofenz for 15 minutes. The primary measure of efficacy--visibility of the tympanic membrane--was assessed after the solution had been drained from the canal and again after the canal had been irrigated with lukewarm water. If the tympanic membrane was not completely visible following either application, the procedure was repeated. A safety examination was conducted 1 to 3 days after treatment. Secondary outcomes measures included relief of otologic symptoms (e.g., hearing loss, tinnitus, etc.) and patients'overall satisfaction with treatment. Immediately after treatment, we found that the external auditory canal was completely visible in 81 patients (74.3%) after 1 application of Sofenz and subsequent irrigation, and in 98 patients (89.9%) after 2 applications of each. At the safety follow-up visit, we determined that the number of otologic symptoms had declined by 93.2%. A self-reported assessment completed by each patient following the procedure revealed a high degree of satisfaction with treatment. A total of 58 adverse events were reported, but only 16 were directly related to treatment, and all were transient and either mild or moderate. We conclude that 1 or 2 applications of Sofenz followed by irrigation with lukewarm water is a safe, well-tolerated, and effective treatment for excessive or impacted cerumen in the external auditory canal. |
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Authors:
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Aiman Midani; Inez Carels; Michael Marks; Michael Wall; |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't |
Journal Detail:
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Title: Ear, nose, & throat journal Volume: 85 ISSN: 0145-5613 ISO Abbreviation: Ear Nose Throat J Publication Date: 2006 Feb |
Date Detail:
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Created Date: 2006-04-03 Completed Date: 2007-04-16 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 7701817 Medline TA: Ear Nose Throat J Country: United States |
Other Details:
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Languages: eng Pagination: 87-8, 90-2 Citation Subset: IM |
Affiliation:
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DocMidani@yahoo.co.uk |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Administration, Topical Adolescent Adult Aged Aged, 80 and over Cerumen / drug effects* Child Child, Preschool Female Humans Male Methylhistidines / administration & dosage, adverse effects, therapeutic use* Middle Aged Patient Satisfaction Treatment Outcome Trypsin / administration & dosage, adverse effects, therapeutic use* |
| Chemical | |
Reg. No./Substance:
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0/Methylhistidines; 0/N-(3-methylhistidinyl)-57-trypsin; EC 3.4.21.4/Trypsin |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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