BORDERLINE PROBLEMS IN OTORHINOLARYNGOLOGY
PROCEEDINGS
OF THE Xlith WORLD CONGRESS OF OTORHINOLARYNGOLOGY
EWTEDBY L. SURJÁN GY. BODÓ
AKADÉNBAJ KIADÓ, BUDAPEST
Proc. XH th O R L World Congr., Budapest, Hungary 1981 L. Surjan, Gy. Bod6 (eds)
THE EFFECT OF IPRIFLAVON (YAMBOLAP) ON THE OTOSCLEROTIC PROCESS
O. RIBARI/ J.G. KISS/ I, TOMITY/ J. JORI AND Gy, STANZEL
D e p a r t m e n t o f O t o - R h i n o - L a r y n g o l o g y , S z e g e d U n i v e r s i t y o f M e d i c a l S c i e n c e s
6725 S z e g e d , H u n g a r y
According to statistics otosc lerosis is a disease effecting millions. The essence of the pathological process is in the reconstruction taking place in the labyrinthine capsule. T hrough the process the footplate of the stapes becomes fixed in the oval w i n d o w and as a result of this conductive hearing loss occurs which is co n t i nually increasing and in its ad vanced stage percep
tional disorder, the damage of the Corti-organ develops.
Vesti b u l a r disorders may be present, too and the only symptom is perceptive hearing damage in the cochlear appea r a n c e of the disease.
The aetiology of oto scler osi s is not exactly known yet. The results of the latest e xam inations suggest that the p a t h og eneti c base for the disease is the imbalance in the different enzymatic processes.
Presently, according to ex ami nations the
7 - i s o p r o p o x y - i s o f l a v o n , or by its man ufacturing name Y a m b o l a p , /pro d u c e d by C h i n o i n / has a favourable effect on the m itochondrial metabolism at the subcellular level.
The cell metabolism requires lower oxygen consumption due to Ipriflavon treatment and because of this reminer
ali z at i o n becomes more effective.
Based on the present knowledge of biology, biochem
istry and pharmacology, it may be supposed that Ipriflavon has a favourable effect / b e s i d e its other effects/ on every osteopathy which is in some way connected with disorders of m ineralization or remodelling.
We have tested the pre paration in the treatment of o to s cl e r os is at the Ear-, Nose- and Throat Clinic of Szeged University of Medical Sciences.
Case record and method
Examinations were carried out on 53 otosclerotic patients of both sexes who were otherwise found healthy.
Forty-three patients were treated by Yambolap with the dosage of 3x200 mg per day.
Stapedectomy was perf ormed on the patients within 3 months, as a general rule, following the treatment.
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We have examined the stapes of 20 patients hi s t o lo g ically.
Atomic absorption tests were done on auditory o s si cles of 23 patients for C a - , Z n - , and Cu-contents. For the purpose of comparison we determined components of the cortical bone-samples for the same patient.
Ten patients received placebo.
All patients had thorough otorhinolaryngologi c a l and a u d iological examinations, complete blood-counts, and urinanalysis.
These examinations were repeated after a period of 1 week, 1 month, 3 months and 6 months following the begin
ning of treatment.
R esults were compared to findings of untreated oto- sclerotic patients who were given placebo.
Results - Dis c u s s ion
We found S chwar tze -phen om enon in 11 cases which dis
a ppeared in 6 cases after 3 months of treatment by Yambolap, At the evaluation of the subjective complaints the most remarkable observation was the effectiveness of Y a m b o l a p upon tinnitus.
From the 43 patients treated with Ya m b o l a p 40 re
ported on a certain degree of tinnitus. After 3 months of treatment by Yambolap tinnitus in 12 patients / 3 0 % / dis
appeared, tinnitus in 16 patients / 4 0 % / decreased, com
plaints of 12 patients /3 0%/ were unchanged.
From the 1C patients taking placebo, the originally slight tinnitus in 1 patient disappeared, tinnitus in 1 patient decreased, complaints of 8 patients were unchanged.
C h anges in clear-tone hearing threshold
After 3 months of the treatment the hearing of 28 p atients / 6 5 % / did not change or improvement was shown only within the 5 dB limit of error, 12 patients /28%/
had a 10 dB or more improvement in hearing. The hearing of 3 patients /7% / deteriorated under the course of treatment.
The hearing of patients belonging to the control group had not improved, in fact, the hearing of 3 patients became worse under the time of examinations.
Ope r a t i ve findings
Operations were performed more easily on treated than on untreated patients. Bleeding has remained under the usual level during operations. In most of the treated cases the stapes could be removed intact while in cases of untreated patients the superst ructure was generally broken off and the footplate of the stapes could be lifted out only in fragments.
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H i s to l o g ic al examinations
C o m pared to untreated cases it seemed that the number of o s t e o cla sts decreased in the ot osc lerotic focuses. The mesenc h y m al cells became osteoblasts, then osteocytes.
C a l c i f i c a t i o n occurred at the per ivascular regions and at the pe r i me ter / e d g e / of the focuses. Therefore, Ipriflavon / Y a m b o l a p / promotes the deposition of lime salts in the
fibrous in ter stitial tissue of the focuses. Probably, the healing of the otosclerotic focuses was induced by a primary m e t a p l a s tic oste o g e n e s i s , a ls o preventing the progress of the disease.
Atomic a b s o rpt ion tests
The Ca-content of the c ortical bone has not changed by the treatment.
The Ca-content of the untreated otosclerotic stapes was usually lower than in the cortical bones serving as s tandard control. The Ca-c onten t of the auditory ossicles became definitely higher, often by more than 50 per cent, as a result of Ipriflavon treatment.
The Zn-content of the stapes was also higher than in the co r t ica l bone, and app rox imate ly a 5 per cent, and a 16 per cent increase could be detected in the cortical bone and auditory ossicles, respectively, in the cases of treated patients.
The Cu-content of the stapes was also higher than the C u - c onte nt measured in the c ortical bone. For the effect of treatment Cu-content increased by 32 per cent while i ncrease in the cortical bone was only 7 per cent.
We may conclude that there is a relation between the changes of Ca-, Zn- and Cu - c o n t e n t s in cases treated by Yambolap. The process taking place may be explained so that for the effect of Ya m b o l a p the activity of enzymes necessary to C a - i n c o r p o r a t i on increases /incr e a s e in Cu- and Z n - c o n t e n t s / which is resulting in a rise of the C a -l e v e l obser ved by us.
Summary
We have studied the effect of Ipriflavon / Y a m b o l a p / in 43 p a t ien ts who had s uff ered from otosclerosis.
It is evident that tinnitus, one of the most t o r me n t
ing symptoms of the disease, disappears or becomes m o d e r ated in the m ajority of cases. Also hearing impairment may be a r res ted at an early stage, in fact, hearing may even improve. C o nsiderin g the improvement of clinical symptoms /e.g. the disappearing of Schwartze-phenome no n , and tinnitus, improvement of hearing/, less bleeding at the operations, the easy removal of the footplate of the stapes, the results of histo log ic e xaminations and atomic abso r p t i on tests, we may come to the conclusion that the activity of the otosclerotic focuses decreases, and the process of remineraliza tion increases in the bone.
We have not found any h armful side effect of the drug beside the employed dosages.
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