[Treatment of sudden hearing loss through Fibrinogen/LDL-apheresis. A prospective, randomized multicenter trial].
BACKGROUND
Sudden sensorineural hearing loss (SSHL) is thought to be of various origins. Disturbances of microcirculation, autoimmune pathology and viral infection are among the most likely causes. Acute reduction of plasma fibrinogen and serum LDL positively influences hemorheology and endothelial function and might thus be an effective therapy for SSHL.


OBJECTIVE
To test the hypothesis that fibrinogen/LDL-apheresis is as effective or superior to conventional therapy with plasma expanders and prednisolone in the treatment of SSHL.


METHODS
controlled, prospective, randomized, multicenter trial.


METHODS
201 patients were recruited from 01/2000 to 6/2001 at the University Clinics of Munich, Berlin, Hamburg and Bochum. Inclusion criteria was sudden sensorineural hearing loss of unknown origin within 6 days of onset.


METHODS
Single fibrinogen/ LDL-apheresis infusion of prednisolone (250 mg, tapered by 25 mg daily), hydroxyethyl starch (500 ml, 6%) and pentoxifylin (400 mg/day).


RESULTS
Improvement of pure tone thresholds 48 h after onset of therapy.


RESULTS
Over all improvement of pure tone thresholds in the fibrinogen/ LDL-apheresis treated patients is slightly but not significantly better than in the standard therapy group. After 48 h, 50% speech perception in the fibrinogen/ LDL-apheresis group (21.6+/-20.1 dB) is significantly (p<0.034) better than in the standard group (29.3+/-29.4 dB). Patients with plasma fibrinogen levels of more than 295 mg/dl have a substantial and significantly (p<0.005) better improvement of speech perception (15.3+/-17.3 dB) than standard treated patients (6.1+/-10.4 dB).


CONCLUSIONS
Fibrinogen/LDLapheresis is at least equally effective compared to prednisolone treatment in sudden hearing loss. Selected patients with plasma fibrinogen of more than 295 mg/dl improve significantly better when treated with fibrinogen/LDLapheresis.
Suckfüll
M
M
Klinik für Hals-Nasen-Ohrenheilkunde der Ludwig-Maximilians-Universität München, Klinikum Grosshadern, Marchioninistrasse 15, 81377 München, Germany. suckfuell@hno.med.uni-muenchen.de
Seidel
D
D
Thiery
J
J
Mazurek
B
B
Jaehne
M
M
Gronemeyer
J
J
Reichel
O
O
Sasama
J
J
Kichigina
S
S
Möller
M
M
Beil
F U
FU
Schrameyer-Wernecke
A
A
Kassner
U
U
Koch
M
M
Jaeger
B
B
Osterkorn
K
K
Osterkorn
D
D
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants / Q000627:therapeutic use; D001781:Blood Component Removal / Q000379:methods*; D011232:Chemical Precipitation; D005112:Extracorporeal Circulation / Q000379:methods*; D005260:Female; D005340:Fibrinogen / Q000302:isolation & purification*; D005500:Follow-Up Studies; D003639:Hearing Loss, Sudden / Q000175:diagnosis* / Q000188:drug therapy / Q000628:therapy*; D006493:Heparin / Q000627:therapeutic use*; D006801:Humans; D008077:Lipoproteins, LDL / Q000097:blood / Q000302:isolation & purification*; D008297:Male; D008875:Middle Aged; D011239:Prednisolone; D011446:Prospective Studies; D016896:Treatment Outcome
D000925:Anticoagulants; D008077:Lipoproteins, LDL; D005340:Fibrinogen; D006493:Heparin; D011239:Prednisolone