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Plasminogen - safe for treatment of chronic tympanic membrane perforation: a phase 1 randomized, placebo-controlled study.
Sepehri, Elnaz; Tideholm, Bo; Hellström, Sten; Berglin, Cecilia Engmér.
Afiliación
  • Sepehri E; Division of Ear, Nose and Throat Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
  • Tideholm B; Division of Ear, Nose and Throat Diseases, Hearing and Balance, Karolinska University Hospital, Stockholm, Sweden.
  • Hellström S; Division of Ear, Nose and Throat Diseases, Department of Clinical Sciences, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden.
  • Berglin CE; Division of Ear, Nose and Throat Diseases, Hearing and Balance, Karolinska University Hospital, Stockholm, Sweden.
Acta Otolaryngol ; : 1-7, 2024 Sep 12.
Article en En | MEDLINE | ID: mdl-39262315
ABSTRACT

BACKGROUND:

There is a need for a simpler and accessible intervention to heal tympanic membrane perforations than myringoplasty that is todaýs golden standard. Experimental studies have identified plasminogen as a promising agent for medical treatment of chronic tympanic membrane perforation. AIMS/

OBJECTIVES:

This was a phase 1, prospective, randomized, placebo-controlled study with the main objective to evaluate the safety of injecting plasminogen in the vicinity of the tympanic membrane in subjects with chronic tympanic membrane perforation. MATERIAL AND

METHODS:

Adults diagnosed with a dry chronic tympanic membrane perforation were recruited for an injection schedule with Human plasminogen 10. Adverse events, audiometry, VAS fluctuations and size of perforation, were monitored throughout the length of the study.

RESULTS:

It was possible to perform the injections according to schedule in all subjects. None of the subjects experienced any severe adverse events. Most common adverse event was ear pain. No signs of ototoxicity were reported. CONCLUSIONS AND

SIGNIFICANCE:

This pilot study suggests that plasminogen injections close to the tympanic membrane as treatment for chronic tympanic membrane injections are safe and feasible, encouraging further dose-escalating studies.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Acta Otolaryngol Año: 2024 Tipo del documento: Article País de afiliación: Suecia Pais de publicación: Reino Unido
Texto completo
Añadir a Mi BVS
Imprimir
XML
PubMed Links
Buscar en Google

Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Idioma: En Revista: Acta Otolaryngol Año: 2024 Tipo del documento: Article País de afiliación: Suecia Pais de publicación: Reino Unido