Randomized placebo-controlled clinical trial investigating the effect of antioxidants and a vasodilator on overall safety and residual hearing preservation in cochlear implant patients
Randomized placebo-controlled clinical trial investigating the effect of antioxidants and a vasodilator on overall safety and residual hearing preservation in cochlear implant patients
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随机安慰剂对照临床试验，调查抗氧化剂和血管扩张剂对人工耳蜗植入患者整体安全性和残余听力保留的影响
DOI：
10.1186/s13063-020-04522-9
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发表时间：
2020
期刊：
影响因子：
2.5
通讯作者：
T. Lenarz
中科院分区：
文献类型：
--
作者：
V. Scheper;Melanie Schmidtheisler;Florian Lasch;H. E. von der Leyen;A. Koch;J. Schwieger;A. Büchner;A. Lesinski;T. Lenarz
背景感音神经性听力损失患者的标准治疗是人工耳蜗植入。将电极阵列插入到耳蜗中，伴随潜在的机械创伤和耳蜗内存在该异物，可能导致自由基形成和耳蜗的血液灌注减少，这可能导致残余听力丧失。研究表明，抗氧化剂维生素A、C和E以及血管扩张剂镁（合在一起：ACEMg）的特定组合可以保护残余听力。方法采用单中心、随机、安慰剂对照、双盲、II期临床试验，观察ACEMg对人工耳蜗植入术后患者残余听力的保护作用。植入不同FLEX电极阵列长度的MED-EL植入物的低频率有一定残余听力的CI候选人分别在术前2天和术后3个月接受ACEMg片剂或安慰剂治疗。研究目的是通过比较两个治疗组之间首次装配后3个月的听力损失（500 Hz时听力阈值相对于基线的变化），证明ACEMg在人工耳蜗植入期间保留残余听力方面比安慰剂更有效，并研究治疗的安全性。结果51例患者入组研究，由于一方伴侣的IMP再补给管理不当，在达到招募目标之前不得不终止研究。在意向治疗人群中，25例患者接受ACEMg治疗，24例患者接受安慰剂治疗。首次试戴后3个月，500 Hz时的平均听力损失为（± 15.84）30.21 dB（安慰剂组）或（± 17.56）26.00 dB（ACEMg组）。根据基线残余听力、计划电极长度和外科医生调整术后听力损失，与安慰剂治疗患者相比，ACEMg治疗患者的听力损失降低8.01 dB。安全性分析显示，ACEMg通常耐受良好，不良事件频率低于安慰剂水平。结论本研究是首次探讨药物对脑梗死患者残余听力影响的临床试验。这些首次人体试验数据可能表明，围手术期口服ACEMg是安全的，并可能为CI患者的残余听力提供保护。试验注册EU临床试验注册编号2012-005002-22。于2013年12月6日注册。资金来源：欧盟委员会FP 7-HEALTH-2012-INNOVATION-2。
Background The standard therapy for patients suffering from sensorineural hearing loss is cochlear implantation. The insertion of the electrode array into the cochlea, with potential mechanical trauma and the presence of this foreign body inside the cochlea, may lead to free radical formation and reduced blood perfusion of the cochlea which can result in a loss of residual hearing. Studies have suggested that a particular combination of the antioxidants vitamins A, C and E as well as the vasodilator magnesium (together: ACEMg) may protect the residual hearing. Methods The potential protective effect of ACEMg on residual hearing preservation in cochlear implant (CI) patients was investigated in a single-centre, randomized, placebo-controlled, double-blind phase II clinical trial. CI candidates with some residual hearing in low frequencies receiving MED-EL implants of different FLEX electrode array lengths were treated with ACEMg tablets or placebo respectively 2 days preoperatively and up to 3 months postoperatively. The study objective was to demonstrate that ACEMg is more efficacious than placebo in preserving residual hearing during cochlear implantation by comparing the hearing loss (change in hearing thresholds at 500 Hz from baseline) 3 months after the first fitting between the two treatment groups and to investigate the treatments’ safety. Results Fifty-one patients were included in the study, which had to be terminated before the recruitment goal was reached because of IMP-resupply mismanagement of one partner. In the intention-to-treat population, 25 patients were treated with ACEMg and 24 patients with placebo. The mean hearing loss at 500 Hz was (± 15.84) 30.21 dB (placebo) or (± 17.56) 26.00 dB (ACEMg) 3 months after the initial fitting. Adjusting the postoperative hearing loss for the baseline residual hearing, planned electrode length and surgeon results in 8.01 dB reduced hearing loss in ACEMg-treated patients compared to placebo-treated ones. The safety analysis revealed that ACEMg was generally well-tolerated with adverse event frequencies below the placebo level. Conclusion This is the first clinical trial investigating a drug effect on residual hearing in CI patients. These first-in-man data may suggest that a perioperative oral administration of ACEMg is safe and may provide protection of residual hearing in CI patients. Trial registration EU Clinical Trial Register No. 2012-005002-22 . Registered on 6 December 2013. Funding: European Commission FP7-HEALTH-2012-INNOVATION-2.
适合声加电听力联合治疗的患者低频残余听力的稳定性。
DOI：
10.1044/1092-4388(2006/077
发表时间：
2006
期刊：
Journal of speech, language, and hearing research : JSLHR
影响因子：
--
作者：
Yao,WaiNa;Turner,ChristopherW;Gantz,BruceJ
通讯作者：
Gantz,BruceJ