Otology & neurotology : official publication of the American Otological Society, American Neurotology Society [and] European Academy of Otology and Neurotology · 2011
Regenerative treatment for tympanic membrane perforation.
СтатьяРандомизированное исследованиеПоддержка исследования: вне правительства СШАНазвание и аннотация: Перевод пока не подготовлен
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Kanemaru Shin-Ichi, Umeda Hiroo, Kitani Yoshiharu, Nakamura Tatsuo, Hirano Shigeru, Ito Juichi
Аннотация
OBJECTIVE: To establish a tissue engineering therapy for the treatment of large tympanic membrane perforation (TMP) without the need for conventional surgical therapy.
STUDY DESIGN: Randomized control trial.
SETTING: General hospital.
PATIENTS AND METHODS: A total of 63 chronic TMPs were randomly selected from outpatients.
INTERVENTION: Of the total 63 chronic TMPs, 53 were randomly assigned to the basic fibroblast growth factor (b-FGF) group and the remaining 10 were randomly assigned to the control group. Materials used for the TM repair were gelatin sponge and fibrin glue with/without b-FGF. After creating a mechanical disruption of the edge of the TMP, a gelatin sponge was immersed in b-FGF or saline (for the control group) and placed over the perforation. Fibrin glue was dripped over the sponge as a sealant.
MAIN OUTCOME MEASURES: The effectiveness of this therapy was evaluated by closure rates, hearing level, and sequelae 3 weeks after treatment. The treatment was repeated up to 4 times for cases in which complete closure of the TMP was not achieved after 1 round of treatment.
RESULTS: Complete closure of the TMP was achieved in more than 98.1% (52/53) of the patients in the b-FGF group and 10% (1/10) of the patients in the control group. The average hearing level of all patients with successful TM repair was improved. Serious sequelae were not observed in any patient.
CONCLUSION: This study demonstrates that a combination of gelatin sponge, b-FGF, and fibrin glue enables the regeneration of the TM without conventional operative procedures. This innovative regenerative therapy is an easy, safe, cost-effective, and minimally invasive outpatient treatment.
STUDY DESIGN: Randomized control trial.
SETTING: General hospital.
PATIENTS AND METHODS: A total of 63 chronic TMPs were randomly selected from outpatients.
INTERVENTION: Of the total 63 chronic TMPs, 53 were randomly assigned to the basic fibroblast growth factor (b-FGF) group and the remaining 10 were randomly assigned to the control group. Materials used for the TM repair were gelatin sponge and fibrin glue with/without b-FGF. After creating a mechanical disruption of the edge of the TMP, a gelatin sponge was immersed in b-FGF or saline (for the control group) and placed over the perforation. Fibrin glue was dripped over the sponge as a sealant.
MAIN OUTCOME MEASURES: The effectiveness of this therapy was evaluated by closure rates, hearing level, and sequelae 3 weeks after treatment. The treatment was repeated up to 4 times for cases in which complete closure of the TMP was not achieved after 1 round of treatment.
RESULTS: Complete closure of the TMP was achieved in more than 98.1% (52/53) of the patients in the b-FGF group and 10% (1/10) of the patients in the control group. The average hearing level of all patients with successful TM repair was improved. Serious sequelae were not observed in any patient.
CONCLUSION: This study demonstrates that a combination of gelatin sponge, b-FGF, and fibrin glue enables the regeneration of the TM without conventional operative procedures. This innovative regenerative therapy is an easy, safe, cost-effective, and minimally invasive outpatient treatment.