Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss
Randomised, double-blinded, placebo-controlled, clinical trial of ozone therapy as treatment of sudden sensorineural hearing loss
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DOI：
10.1017/s0022215108003770
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发表时间：
2009-01-01
影响因子：
1.7
通讯作者：
Noaman, M.
中科院分区：
文献类型：
--
作者：
Ragab, A.;Shreef, E.;Noaman, M.
目的：探讨臭氧治疗对突发感音神经性听力损失成人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。受试者：45 名突发感音神经性听力损失成年患者，随机分配接受安慰剂（15 名患者）或臭氧治疗（自体血液疗法；30 名患者）。对于后一种治疗，立即用1:1体积的氧气和臭氧的气态混合物（来自臭氧发生器）处理100毫升患者的血液，并通过静脉输注重新注射到患者体内。治疗每周两次，共 10 个疗程。记录以下数据：治疗前和治疗后平均听力增益；空气和骨纯音平均值；语音接收阈值；言语辨别分数；结果：接受臭氧治疗的 23 名患者（77%）观察到显着恢复，而接受安慰剂的患者为 6 名（40%）（p < 0.05）。与安慰剂治疗的患者相比，臭氧治疗的患者的平均听力增益、纯音平均值、言语接收阈值和主观恢复率明显更好（p < 0.05）。 结论：臭氧治疗是治疗突发感音神经性听力损失的重要方法；没有观察到并发症。
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.