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臭氧疗法治疗突发性感音神经性听力损失的随机、双盲、安慰剂对照临床试验。

Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss.

作者信息

Ragab A, Shreef E, Behiry E, Zalat S, Noaman M

机构信息

Department of ORL Head and Neck Surgery, Menofia University Hospital, Egypt.

出版信息

J Laryngol Otol. 2009 Jan;123(1):54-60. doi: 10.1017/S0022215108003770. Epub 2008 Oct 17.

DOI:10.1017/S0022215108003770
PMID:18925995
Abstract

OBJECTIVE

To investigate the safety and efficacy of ozone therapy in adult patients with sudden sensorineural hearing loss.

DESIGN

Prospective, randomised, double-blinded, placebo-controlled, parallel group, clinical trial.

SUBJECTS

Forty-five adult patients presented with sudden sensorineural hearing loss, and were randomly allocated to receive either placebo (15 patients) or ozone therapy (auto-haemotherapy; 30 patients). For the latter treatment, 100 ml of the patient's blood was treated immediately with a 1:1 volume, gaseous mixture of oxygen and ozone (from an ozone generator) and re-injected into the patient by intravenous infusion. Treatments were administered twice weekly for 10 sessions. The following data were recorded: pre- and post-treatment mean hearing gains; air and bone pure tone averages; speech reception thresholds; speech discrimination scores; and subjective recovery rates.

RESULTS

Significant recovery was observed in 23 patients (77 per cent) receiving ozone treatment, compared with six (40 per cent) patients receiving placebo (p < 0.05). Mean hearing gains, pure tone averages, speech reception thresholds and subjective recovery rates were significantly better in ozone-treated patients compared with placebo-treated patients (p < 0.05).

CONCLUSION

Ozone therapy is a significant modality for treatment of sudden sensorineural hearing loss; no complications were observed.

摘要

目的

探讨臭氧疗法对成人突发性感音神经性听力损失患者的安全性和有效性。

设计

前瞻性、随机、双盲、安慰剂对照、平行组临床试验。

研究对象

45例成人突发性感音神经性听力损失患者,随机分为两组,分别接受安慰剂治疗(15例)或臭氧疗法(自血疗法;30例)。对于后一种治疗方法,将100毫升患者血液立即与等体积的氧气和臭氧气体混合物(来自臭氧发生器)混合处理,然后通过静脉输注重新注入患者体内。每周治疗两次,共进行10次。记录以下数据:治疗前后的平均听力增益;气导和骨导纯音平均值;言语接受阈值;言语辨别分数;以及主观恢复率。

结果

接受臭氧治疗的23例患者(77%)有显著恢复,而接受安慰剂治疗的患者为6例(40%)(p<0.05)。与接受安慰剂治疗的患者相比,接受臭氧治疗的患者的平均听力增益、纯音平均值、言语接受阈值和主观恢复率均显著更好(p<0.05)。

结论

臭氧疗法是治疗突发性感音神经性听力损失的一种有效方法;未观察到并发症。

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