Chinese Journal of Otology Vol. 8, No.1, (sudden sensorineural hearing loss, SSNHL) SSNHL, 50.0% 21.7%, (P = 0.041); 61.9%

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1 68 Chinese Journal of Otology Vol. 8 No (210008) 2 Hough (OK (sudden sensorineural hearing loss SSNHL) (10 ) SSNHL % 21.7% PTA 16.7 db 9.2 db (P = 0.041); % 21.7%PTA 20.2 db 9.2 db (P = P PTA = 0.011); (0.25 khz 0.5 khz) (1 khz 2 khz) (4 8 khz) 19.8 db 16.0 db 13.4 db (P = 0.046) SSNHL ; ; USA) R R452 A (2009) Revisiting efficacy of intratympanic methylprednisolone perfusion on hearing in refractory sudden sensorineural hearing loss: a prospective control study DAI Yan-hong 1 SHE Wan-dong 1 DU Xiao-ping 2 YU Chen-jie 1 CHEN Feng 1 WANG Jun-guo 1 QIN Xiao-ming 1 1 Department of Otolaryngology-Head and Neck Surgery the Affiliated Drum Tower Hospital Medical School of Nanjing University Nanjing PR China 2 Hough Ear Institute 3400 NW 56th street Oklahoma City OK 7311 USA Corresponding author: SHE Wan-dong shewandong@163.com Abstract Objective To investigate the effectiveness and safety of intratympanic methylprednisolone perfusion (IMP) through a micro-catheter in patients with sudden sensorineural hearing loss (SSNHL) who have failed conventional treatments. Methods This is prospective controlled clinical trial involving patients who failed at least 10-days of conventional treatments. A total 26 patients (study group) received a micro-catheter into the tympanum for methylprednisone perfusion once a day for 10 consecutive days in addition to simultaneous administration of a conventional treatment (no systemic steroid). Twenty three patients in a control group were treated with a second conventional treatment only (no systemic steroid). At 3-month follow-up the treatment response rate and improvement of pure-tone average (PTA) were compared. Results The treatment response rate was 50% and 21.7% and the mean PTA improvement was 16.7dB and 9.2 db for the study and control groups respectively. The difference in treatment response rate was statistically significant (P = 0.041). When the time period from disease onset to IMP was limited to 60 days the treatment response rate and PTA improvement in the study group were 61.9% and 20.2 db respectively both higher than the control group(p = and P = respectively). The mean PTA improvement at low frequencies (0.25 and 0.5 khz) middle frequencies (1 and 2 khz) and high frequencies (4 and 8 khz) after IMP were 19.8 db 16.0 db 13.4 db respectively. The mean : (YKK05098) : daiyanhong9@126.com : shewandong@163.com

2 PTA improvement at low frequencies was better than that at high frequencies (P = 0.046). Conclusion Daily IMP through a micro-catheter as a salvage treatment for refractory SSNHL is safe and effective. Its efficacy is better than that of the conventional treatment. IMP treatment should be recommended as early as possible when the patient has failed a conventional treatment. Key Words Intratympanic perfusion; Sudden sensorineural hearing loss; Methylprednisolone (sudden sensorineural hearing loss SSNHL) 60 DeKleyn CT / MRI ( ) [1] 10 - : (40 mg/ml) [2] : 0.5 ml 24 [2] ; ~ 0.6 ml 1 10 : [3] 10 ( / ) ( ) SSNHL ( ) 2008 / ( [4] 1.0 mm; (1) ( 1 2) [5] 2005 ; (2) 16 ~ 70 ; (3) (10 ) (pure-tone threshold average PTA) mm) 1 ml 30 < 15 db (4) 1.4

3 70 Chinese Journal of Otology Vol. 8 No [5] 2005 PTA 1.5 STATA x ± s t Mann-Whitney 2.1 t χ 2 P < (25 ) PTA PTA ; SSNHL (P = 0.004) + SSNHL 28 (28 ) ( 1) 1 1 ; (n=26) (n=23) P ( : ) 13:13 10:13 χ 2 = ( x ± s) 48.5 ± ± 16.7 t = ( : ) 12:14 7:16 χ 2 = χ 2 = χ 2 = Fisher PTA(dB x ± s) 86.2 ± ± 21.5 t = PTA(dB x ± s) 83.2 ± ± 20.4 t = ( x ± s) 43.6 ± ± 3.2 Z =

4 PTA PTA 20.2 ± 15.6 (db x± s) (db x± s) P (PTA) (n=26) (n=23) PTA 83.2 ± 12.9 PTA 16.7 ± % 3 PTA 16.7 db; % PTA 9.2 db (χ 2 = P = 0.041) PTA (P = 0.073)( 2) 79.3 ± ± 13.7 t = Z= %; PTA 20.2 db = 60 P (n = 21) (n = 23) 22.5 ± ±3.2 ( x± s) 9.2±13.7 t = Z= (4 khz 8 khz) ~ 8 khz 25 : (0.25 khz khz) (19.8 ± 20.3) db (1 khz 2 khz) (16.0 ± 19.1) db (4 khz 8 khz) (13.4 ± 17.3) db t (P = 0.004) : - : Z = P = (P = 0.008) 61.9% db (P PTA PTA ; P PTA = 0.011) 60 PTA ( 3) 4 (n=13) (n=13) P ( x ± s) 47.6 ± ± 14.8 t = ( : ) 5:8 8:5 χ 2 = χ 2 = Fisher Fisher ( x ± s) 23.4 ± ± 62.4 t = PTA(dB x ± s) 88.2 ± ± 10.8 t = PTA(dB x ± s) 84.0 ± ± 12.2 t = PTA (db x ± s) 4.1 ± ± 3.2 Z =

5 72 Chinese Journal of Otology Vol. 8 No PTA [13] [3] 0.23 ( 4) [14 15] SSNHL : (1) : 1 [16-19] 7 [20] [21] 1 ; 1 / (2) : 1 5 [22] [3] 5 (3) [22] : ; (4) + : 2 (5) : 3 SSNHL 10 shotgun [6] SSNHL 49% ~ PTA 89% ( 7) ; SSNHL 60 (n=21) ; (P = 0.008) PTA SSNHL [2 8 9] Kopke [23] [10-12] SSNHL 1 ; 6 : 3 Haynes [6]

6 SSNHL : (19.8 ± 20.3) db (16.0 ± 19.1) db (13.4 ± 17.3)dB (P = 0.046) (10 ) / [22] ( ) Fuse [24] / ; (GR) 7 ~ 10 GRα GRβ 3 2 [26] (resistant) Ito [25] 90 SSNHL : 2 SSNHL 2 ; 2 3 Lefebvre [7] 7 Xenellis [18] 1 Rauch SD. Intratympanic steroids for sensorineural hearing loss. Otolaryngol Clin N Am (5): Parnes LS Sun AH Freeman DJ. Corticosteroid pharmacokinetics PTA in the inner ear fluids: an animal study followed by clinical application. Laryngoscope 1999(7 Pt 2) 109: Plontke SK Salt AN. Simulation of application strategies for local PTA (4.1 ± 6.0) db (1.8 ± 3.2) db drug delivery to the inner ear. ORL J Otorhinolaryngol Relat Spec (6): (P = 0.115) (6): [3 9] ( ).. 5 ( ) ; (8): Haynes DS O Malley M Cohen S et al. Intratympanic dexa - SSNHL methasone for sudden sensorineural hearing loss after failure of systemic therapy. Laryngoscope (1): Lefebvre PP Staecker H. Steroid perfusion of the inner ear for Plontke [21] sudden sensorineural hearing loss after failure of conventional therapy: a pilot study. Acta Otolaryngol (7): ; Choung [19] 8 Salt AN Sirjani DB Hartsock JJ et al. Marker retention in the cochlea following injections through the round window membrane. SSNHL Hear Res (1-2): ( khz) ; Gouveris [10] 9 Plontke SK Biegner T Kammerer B et al. Dexamethasone concentration gradients along scala tympani after application to the 1.5 khz 3 khz round window membrane. Otol Neurotol (3): Gouveris H Selivanova O Mann W. Intratympanic dexamethasone (0.25 khz 0.5 khz) with hyaluronic acid in the treatment of idiopathic sudden sensorineural hearing loss after failure of intravenous steroid and (1 khz 2 khz) (4 khz 8 khz) va-

7 74 Chinese Journal of Otology Vol. 8 No soactive therapy. Eur Arch Otorhinolaryngol (2): Chandrasekhar SS. Intratympanic dexamethasone for sudden sensorineural hearing loss: clinical and laboratory evaluation. Otol Neurotol (1): Jackson LE Silverstein H. Chemical perfusion of the inner ear. Otolaryngol Clin N Am (3): Silverstein H Rowan PT Olds MJ et al. Inner ear perfusion and role of round window patency. Am J Otol (5): Lautermann J Sudhoff H Junker R. Transtympanic corticoid ther- 20 Silverstein H. Use of a new device the MicroWick TM to deliver medication to the inner ear. Ear Nose Throat J (8): Plontke SK L 觟 wenheim H Mertens Jet al. Randomized double blind placebo controlled trial on the safety and efficacy of continuous intratympanic dexamethasone delivered via a round window catheter for severe to profound sudden idiopathic sensorineural hearing loss after failure of systemic therapy. Laryngoscope (2): apy for acute profound hearing loss. Eur Arch Otorhinolaryngol (7): (4): Battista RA. Intratypanic dexamethasone for profound idiopathic sudden sensorineural hearing loss. Otolaryngol Head Neck Surg (6): Kopke RD Hoffer ME Wester D et al. Targeted topical steroid therapy in sudden sensorineural hearing loss. Otol Neurotol (4): Fuse T Aoyagi M Funakubo T et al. Short -term outcome and (5): prognosis of acute low-tone sensorineural hearing loss by adminis tration of steroid. ORL J Otorhi nolaryngol Relat Spec (1): (4): Ito S Fuse T Yokota M et al. Prognosis is predicted by early hearing improvement in patients with idiopathic sudden sensorineural 18 Xenellis J Papadimitriou N Nikolopoulos T et al. Intratypanic hearing loss. Clin Otolaryngol (6): steroid treatment in idiopathic sudden sensorineural hearing loss: a 26 Bamberger CM Bamberger AM de Castro M et al. Glucocorticoid control study. Otolaryngol Head Neck Surg (6): receptor beta a potential endogenous inhibitor of glucocorticoid action in humans. J Clin Invest (6): Choung YH Park K Shin YR et al. Intratympanic dexamethasone injection for refractory sudden sensorineural hearing loss. Laryngoscope ( : ) (5): MED-EL MED-EL I 10 : : ( ) ( ) :weijwu@163.com;xiaozian@sina.co