68 Chinese Journal of Otology Vol. 8 No.1 2010 1 1 2 1 1 1 1 1 (210008) 2 Hough (OK 73112 (sudden sensorineural hearing loss SSNHL) (10 ) SSNHL 10 + 3 26 23 50.0% 21.7% PTA 16.7 db 9.2 db (P = 0.041); 60 21 23 61.9% 21.7%PTA 20.2 db 9.2 db (P = 0.007 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) R764.437 R452 A 1672-2922(2009)03-068-07 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 Email: 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 = 0.007 and P = 0.011 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) : Email: daiyanhong9@126.com : Email: shewandong@163.com
2010 8 1 69 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] ; 9 0.4 ~ 0.6 ml 1 10 : [3] 10 ( / ) 1 7 3 2007 4 2009 3 ( ) 10 1.3 SSNHL ( ) 2008 / ( [4] 1.0 mm; 1 1.1 (1) ( 1 2) [5] 2005 ; (2) 16 ~ 70 ; (3) 45 30 (10 ) (pure-tone threshold average PTA) 1.2 1.4 mm) 1 ml 30 < 15 db (4) 1.4
70 Chinese Journal of Otology Vol. 8 No.1 2010 [5] 2005 PTA 1.5 STATA 8.0 2 x ± s t 26 23 Mann-Whitney 2.1 t χ 2 P < 0.05 2 2007 4 2009 3 53 25 (25 ) PTA PTA ; 43.6 13.6 SSNHL (P = 0.004) + SSNHL 28 (28 ) 2 5 6 ( 1) 1 1 ; 1 2.2 5 26 2 3 8 1 (n=26) (n=23) P ( : ) 13:13 10:13 χ 2 = 0.208 0.648 ( x ± s) 48.5 ± 14.2 46.2 ± 16.7 t = 0.521 0.605 ( : ) 12:14 7:16 χ 2 = 1.270 0.260 15 12 χ 2 = 0.150 0.698 25 20 χ 2 = 1.377 0.241 11 8 2 0 4 1 Fisher 0.562 13 10 PTA(dB x ± s) 86.2 ± 14.4 81.3 ± 21.5 t = 0.947 0.348 PTA(dB x ± s) 83.2 ± 12.9 79.3 ± 20.4 t = 0.809 0.422 ( x ± s) 43.6 ± 49.5 13.6 ± 3.2 Z = -2.905 0.004
2010 8 1 71 13 2 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 ± 15.9 50.0% 3 PTA 16.7 db; 23 3 2 18 21.7% PTA 9.2 db (χ 2 = 4.194 P = 0.041) PTA (P = 0.073)( 2) 79.3 ± 20.4 9.2 ± 13.7 t = 0.809 Z=1.794 0.422 0.073 21.7%; PTA 20.2 db = 60 P (n = 21) (n = 23) 22.5 ± 14.9 13.6±3.2 ( x± s) 9.2±13.7 t = 2.798 Z= 2.51 0.008 0.011 2.4 1 (4 khz 8 khz) 25 0.25 ~ 8 khz 25 : (0.25 khz 0.5 2.3 60 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 = 2.000 P = 0.046 60 21 2.5 23 (P = 0.008) 61.9% 13 9.2 db (P PTA PTA ; 0.007 P PTA = 0.011) 60 PTA ( 3) 4 (n=13) (n=13) P ( x ± s) 47.6 ± 14.2 49.5 ± 14.8 t = -0.334 0.741 ( : ) 5:8 8:5 χ 2 = 1.385 0.239 7 7 χ 2 = 0.000 1.000 13 12 Fisher 1.000 6 7 0 1 2 0 Fisher 0.508 6 4 ( x ± s) 23.4 ± 18.0 63.8 ± 62.4 t = -2.243 0.034 PTA(dB x ± s) 88.2 ± 17.5 84.3 ± 10.8 t = 0.684 0.501 PTA(dB x ± s) 84.0 ± 14.8 82.4 ± 12.2 t = 0.301 0.766 PTA (db x ± s) 4.1 ± 6.0 1.8 ± 3.2 Z = 1.577 0.115
72 Chinese Journal of Otology Vol. 8 No.1 2010 PTA [13] [3] 0.23 ( 4) [14 15] 2.6 28 SSNHL : (1) : 1 [16-19] 7 [20] [21] 1 ; 1 / 3 2 14 24 7 (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 26 23.4 63.8 SSNHL [2 8 9] Kopke [23] [10-12] 6 6 4 1 SSNHL 1 ; 6 : 3 Haynes [6]
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