Michel O, Matthias R
Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde der Universität zu Köln.
Laryngorhinootologie. 1991 May;70(5):255-9. doi: 10.1055/s-2007-998032.
A placebo-controlled, double-blind study with the stable prostacyclin analog Taprosten (CG4203, Grünenthal, Aachen, FRG) on the treatment of sudden hearing loss was conducted in 22 patients in the ENT Department of the University of Cologne. The hospital ethical committee gave permission for the trial. After informed consent had been obtained, the patients (13 male, 9 female, age 21-74 yrs.) were treated with Taprosten (25 ng/kg bodyweight/minute intravenously) or with 30 ml saline solution (NaCl 0.9%) for 6 hours during 5 days. Hearing thresholds were controlled by pure tone audiometry and speech discrimination test each day before and after treatment. All the data obtained (dB hearing loss) by pure tone audiometry was averaged for 7 frequencies. Differences were calculated between the hearing loss before and after treatment. Differences were considered significant if p less than or equal to 0.01. No significant difference could be seen in hearing recovery after Taprosten and placebo during the 5 days of treatment. Evaluation of the individual frequencies showed no prevalence of higher or lower frequencies. Although the impression was that hearing loss recovered better within the first days of treatment with Taprosten, no statistical proof could be found. In both groups the percentage of complete recovery did not differ (about 70%). The reason for the lack of significant statistical differences was the high standard deviation of the averaged hearing loss and the very high spontaneous recovery. Even if, in this placebo-controlled study, we could not prove the efficacy of a prostaglandin treatment for sudden hearing loss, the need for multicentred placebo-controlled studies with more patients is evident.
在科隆大学耳鼻喉科对22名患者进行了一项关于稳定前列环素类似物塔前列素（CG4203，德国亚琛格伦泰尔公司）治疗突发性听力损失的安慰剂对照双盲研究。医院伦理委员会批准了该试验。在获得知情同意后，患者（13名男性，9名女性，年龄21 - 74岁）接受塔前列素（25纳克/千克体重/分钟静脉注射）或30毫升生理盐水（0.9%氯化钠）治疗，持续5天，每天治疗6小时。每天在治疗前后通过纯音听力测定和言语辨别测试来控制听力阈值。将纯音听力测定获得的所有数据（听力损失分贝数）对7个频率进行平均。计算治疗前后听力损失的差异。如果p小于或等于0.01，则差异被认为具有统计学意义。在治疗的5天期间，塔前列素组和安慰剂组在听力恢复方面未见显著差异。对各个频率的评估显示，高频或低频并无优势。尽管感觉在使用塔前列素治疗的头几天听力损失恢复得更好，但未找到统计学证据。两组的完全恢复百分比没有差异（约70%）。缺乏显著统计学差异的原因是平均听力损失的标准差较高以及自发恢复率非常高。即使在这项安慰剂对照研究中，我们无法证明前列腺素治疗突发性听力损失的疗效，但显然需要进行更多患者参与的多中心安慰剂对照研究。
