Injection, Intratympanic

  • 文章类型: Journal Article
    目的:本研究评估了鼓室内利多卡因对突发性耳聋(SSNHL)患者耳鸣缓解的疗效和安全性。
    方法:在一项双盲随机对照试验中,100例单侧耳鸣的SSNHL患者接受了鼓室内利多卡因或生理盐水以及常规护理。使用耳鸣障碍量表在1个月和3个月评估治疗效果,主观视觉模拟量表,纯音测听.
    结果:根据耳鸣障碍量表和视觉模拟量表,利多卡因组表现出明显的耳鸣缓解,在整个研究期间,没有纯音测听改善或严重不良事件。
    结论:鼓室内利多卡因提供了一种安全的,SSNHL耳鸣的有效治疗选择。由于SSNHL的异质性,进一步的研究应完善剂量和递送参数。
    OBJECTIVE: This study evaluates intratympanic lidocaine\'s efficacy and safety for tinnitus relief in sudden sensorineural hearing loss (SSNHL) patients.
    METHODS: In a double-blind randomized controlled trial, 100 SSNHL patients with unilateral tinnitus received either intratympanic lidocaine or saline plus usual care. Treatment impact was assessed at 1 and 3 months using the Tinnitus Handicap Inventory, subjective visual analog scale, pure-tone audiometry.
    RESULTS: The lidocaine group demonstrated significant tinnitus relief according to the Tinnitus Handicap Inventory and visual analog scale, without pure-tone audiometry improvement or serious adverse events throughout the study period.
    CONCLUSIONS: Intratympanic lidocaine provides a safe, efficacious treatment option for SSNHL tinnitus. Further studies should refine the dosage and delivery parameters because of SSNHL\'s heterogenous nature.
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    文章类型: Journal Article
    <b><br>简介:</b>特发性感音神经性听力损失超过30分贝(dB)或更多,在至少三个连续的听力频率上发作少于3天,被称为突发性感音神经性听力损失(ISSNHL),并被称为ENT(耳、鼻子,和喉咙)紧急情况。当病人的听力突然恶化,他们变得困惑,焦虑,和担心。突发性感觉神经性听力损失的主要治疗方法之一是鼓室内类固醇。鼓室内注射富血小板血浆(PRP)改善内耳毛细胞,这增强了听力。</br><b><br>目的:</b>旨在证明鼓内注射PRP在ISSNHL治疗中的安全性和有效性,与鼓内注射类固醇相比。</br><b><br>方法:</b>研究组由100名患者组成,这些患者在30天内经历了ISSNHL,没有耳蜗后病变,MRI扫描阴性。50名患者接受了6次鼓室类固醇注射,而其余50例患者间隔1周接受2次鼓室内注射PRP。</br><b><br>结果:</b>共39例PRP注射患者2周后听力改善25分贝,2个月后听力改善30分贝,2周后改善了26%的言语歧视,2个月后改善了28%。31名患者的鼓室内注射类固醇注意到他们的听力改善18分贝2周后和22分贝2个月后,2周后改善了21%的言语歧视,2个月后改善了24%。</br><b><br>结论:</b>PRP对于治疗ISSNHL是安全有效的,成本低,没有全身副作用,就像口服类固醇一样。因此,这样的研究应该继续下去。</br>.
    <b><br>Introduction:</b> Idiopathic sensorineural hearing loss of 30 decibels (dB) or more over at least three contiguous audiometric frequencies with an onset of less than 3 days is referred to as sudden sensorineural hearing loss (ISSNHL) and is known as an ENT (ear, nose, and throat) emergency. When a patient\'s hearing suddenly deteriorates, they become confused, anxious, and worried. One of the primary therapies for sudden sensorineural hearing loss is intratympanic steroids. Intratympanic injections of platelet-rich plasma (PRP) improve inner ear hair cells, which enhances hearing.</br> <b><br>Aim:</b> To show the safety and efficacy of intratympanic PRP injection in the management of ISSNHL in comparison with intratympanic steroid injection.</br> <b><br>Methods:</b> The study group was comprised of 100 patients who had experienced ISSNHL within 30 days with no retrocochlear pathology, as demonstrated by a negative MRI scan. 50 patients received 6 intratympanic steroid injections, while the remaining 50 patients received 2 intratympanic injections of PRP at a 1-week interval.</br> <b><br>Results:</b> A total of 39 patients with PRP injection noted an improvement in their hearing of 25 db after 2 weeks and of 30 db after 2 months, with improved speech discrimination of 26% after 2 weeks and of 28% after 2 months. 31 patients with intratympanic steroid injection noted an improvement in their hearing of 18 db after 2 weeks and of 22 db after 2 months, with improved speech discrimination of 21% after 2 weeks and of 24% after 2 months.</br> <b><br>Conclusions:</b> PRP appears safe and efficient for the treatment of ISSNHL, with a low cost and no systemic side effects, as with oral steroids. Therefore, such research should be continued.</br>.
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  • 文章类型: Journal Article
    目的:本研究旨在比较不同类固醇在鼓室注射(IT)中的副作用。
    方法:诊断为突发性感音神经性耳聋并接受IT的患者根据使用类固醇的类型或浓度分为四组(DM5组:5mg/ml地塞米松磷酸钠;DM10组:10mg/ml地塞米松磷酸钠;MP组:40mg/ml甲泼尼龙琥珀酸钠;BM组:4mg/ml乙米磷酸钠)。每组40名患者,所有参与者都收到了六次。该研究评估并比较了疼痛的程度和持续时间,头晕,和鼓膜损伤后。要求患者使用数字评定量表(NRS)报告他们感到的疼痛。
    结果:四组患者IT后疼痛的NRS评分有显著差异(p<0.001)。各组疼痛的平均NRS评分如下:DM5组:1.53±1.04;DM10组:1.45±1.30;MP组:4.33±2.22;BM组:6.03±1.46。IT后疼痛的持续时间在四组之间也表现出显着差异(p<0.001),在MP组中观察到的最长持续时间为31.93±15.20分钟。
    结论:不同类型的类固醇用于IT时会导致不同程度的疼痛。倍他米松可引起最严重的疼痛,甲基强的松龙可能导致最长的疼痛持续时间。
    OBJECTIVE: This study aimed to compare the side effects of different steroids used in the intratympanic injections (IT).
    METHODS: One hundred and sixty patients diagnosed with sudden sensorineural hearing loss and undergoing IT were assigned to four groups based on the type or concentration of steroids administered (Group DM5: 5 mg/ml Dexamethasone sodium phosphate; Group DM10: 10 mg/ml Dexamethasone sodium phosphate; Group MP: 40 mg/ml Methylprednisolone sodium succinate; Group BM: 4 mg/ml Betamethasone sodium phosphate). Each group comprised 40 patients, and all participants received IT six times. The study assessed and compared the degrees and duration of pain, dizziness, and tympanic membrane damage following IT. Patients were asked to report the pain they felt using the numeric rating scale (NRS).
    RESULTS: NRS scores for pain after IT showed significant differences among the four groups (p < 0.001). The average NRS scores for pain in each group were as follows: Group DM5: 1.53 ± 1.04; Group DM10: 1.45 ± 1.30; Group MP: 4.33 ± 2.22; Group BM: 6.03 ± 1.46. The durations of pain after IT also exhibited significant differences among the four groups (p < 0.001), with the longest duration observed in Group MP at 31.93 ± 15.20 min.
    CONCLUSIONS: Different types of steroids could lead to varying degrees of pain when used in IT. Betamethasone could cause the most severe pain, and methylprednisolone could result in the longest duration of pain.
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  • 文章类型: Journal Article
    背景:庆大霉素是一种前庭毒性抗生素,经常用于梅尼埃病患者的前庭消融作用。庆大霉素对水平半规管的影响并不总是与患者的眩晕控制程度相关;它对垂直半规管的影响仍然未知。我们试图通过视频头脉冲测试来检查鼓内庆大霉素对梅尼埃病患者垂直半规管功能的影响。
    方法:在三级学术中心进行了回顾性病例系列研究。包括2019-2022年接受>1次鼓室内庆大霉素注射并进行视频头部脉冲测试的梅尼埃病患者。感兴趣的结果是鼓室内庆大霉素后的垂直半规管功能,以及垂直半规管功能和水平半规管功能之间的相关性,以及注射后的残留症状。
    结果:10例患者符合纳入标准。20%在任何注射前都有异常的V-SCC功能,第一次注射后40%。首次鼓室内注射庆大霉素后,垂直和水平半规管功能异常之间存在关联,尽管这种关系没有达到统计学意义(p=0.058)。虽然第一次注射后垂直半规管功能异常的患者不太可能报告持续的眩晕发作,这种关系没有统计学意义(p=0.260).
    结论:鼓室内庆大霉素导致至少一部分梅尼埃病患者的垂直半规管功能改变。需要进一步的研究来更好地评估鼓内庆大霉素后垂直半规管功能与症状控制之间的相关性。
    BACKGROUND: Gentamicin is a vestibulotoxic antibiotic often used in patients with Ménière\'s disease for its vestibular ablative effects. Gentamicin\'s effect on the horizontal semicircular canal does not always correlate with the degree of vertigo control achieved by patients; its effect on the vertical semicircular canals remains unknown. We sought to examine the effect of intratympanic gentamicin on vertical semicircular canal function in patients with Ménière\'s disease using video head impulse testing.
    METHODS: A retrospective case series was carried out at a tertiary academic center. Patients with Ménière\'s disease who received ≥1 intratympanic gentamicin injection from 2019-2022 and had video head impulse testing performed were included. Outcomes of interest were vertical semicircular canal function following intratympanic gentamicin, correlations between vertical semicircular canal function and horizontal semicircular canal function, and residual symptoms following injection.
    RESULTS: Ten patients met inclusion criteria. Twenty percent had abnormal V-SCC function prior to any injection and 40% following the first injection. There was an association between abnormal vertical and horizontal semicircular canal function following the first intratympanic gentamicin injection, though the relationship did not reach statistical significance (p = 0.058). While patients with abnormal vertical semicircular canal function following the first injection were less likely to report ongoing vertigo attacks, the relationship was not statistically significant (p = 0.260).
    CONCLUSIONS: Intratympanic gentamicin leads to changes in vertical semicircular canal function in at least a proportion of patients with Ménière\'s disease. Further study is required to better assess correlations between vertical semicircular canal function and symptom control following intratympanic gentamicin.
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  • 文章类型: English Abstract
    Idiopathic sudden sensorineural hearing loss (ISSNHL) is one of the most common diseases in otolaryngology. Its etiology remains unknown. Furthermore, there is only a low level of evidence for the efficacy of established treatment modalities. In addition to systemic glucocorticoids, intratympanic corticosteroid treatment (ICT) has become increasingly important for treatment of ISSNHL. Different application strategies and treatment regimens have been described; however, uniform standards do not yet exist. ICT may be used for primary treatment as well as salvage therapy. Current data from meta-analyses show no benefit of intratympanic versus systemic primary therapy for sudden hearing loss (moderate evidence) but suggest a benefit of intratympanic secondary treatment over no treatment or placebo (high effect size, low evidence). Regarding combination of systemic and local glucocorticoid therapy in primary treatment of hearing loss, there may be a small benefit over systemic treatment alone (low effect size, low evidence).
    UNASSIGNED: Der Hörsturz zählt zu den häufigen Krankheitsbildern in der HNO-Heilkunde, seine Ursachen sind jedoch weitgehend unklar. Bislang etablierte Therapieverfahren weisen eine nur geringe Evidenz auf. Neben systemischen Glukokortikoiden hat die intratympanale „Cortison-Therapie“ (ITC) an Bedeutung gewonnen. Viele Applikationsformen und Therapieschemata wurden beschrieben. Einheitliche Standards für die ITC gibt es nicht. Die ITC kann zur Primär- sowie zur Rettungstherapie dienen. Aktuelle Metaanalysen zeigen keinen Nutzen der intratympanalen gegenüber systemischer Primärtherapie des Hörsturzes (moderate Evidenz), deuten aber auf einen Nutzen der intratympanalen Sekundärtherapie gegenüber keiner oder Placebotherapie hin (hohe Effektstärke, niedrige Evidenz). Für die Kombination aus systemischer und lokaler Glukokortikoidtherapie zur Primärtherapie des Hörsturzes besteht möglicherweise ein geringer Vorteil gegenüber alleiniger systemischer Behandlung (niedrige Effektstärke, niedrige Evidenz).
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  • 文章类型: Journal Article
    目的:经迷路切除前庭神经鞘瘤与急性前庭功能衰竭有关。术前鼓室注射庆大霉素(ITG)可以改善手术后的客观平衡功能,但其临床益处仍有待确定。
    方法:2014年1月至2018年2月期间接受经迷宫切除前庭神经鞘瘤的成年患者接受术前前庭功能检测。患者分为3组,接受ITG注射的前庭功能(VF)患者,那些有VF但没有收到ITG的人和那些没有VF的人。各组根据眩晕程度进行比较,逗留时间,无协助动员的时间,和术后止吐消耗。
    结果:46例患者注射了ITG(第1组),7有残余VF,但拒绝治疗(第2组),21没有VF(第3组)。随着时间的推移,第1组的眩晕得到了显着改善,而第2组和第3组则没有。与其他组相比,第1组和其他组之间的独立动员时间在统计学上显着减少了70%,第1组的住院时间减少了19%,尽管没有达到统计学意义。2例患者出现注射相关并发症。第1组比其他组使用更少的止吐药,但没有统计学意义。
    结论:术前鼓室内注射庆大霉素配合前庭康复锻炼与术后眩晕减少和术后活动提前相关。住院时间减少,止吐剂的消耗量减少,但由于未治疗组患者数量少,因此可能没有显着减少。
    方法:2喉镜,2024.
    OBJECTIVE: Translabyrinthine excision of a vestibular schwannoma is associated with acute vestibular failure. Preoperative intratympanic gentamicin (ITG) injections can improve objective balance function after surgery but its clinical benefits remain to be established.
    METHODS: Adult patients undergoing translabyrinthine removal of a vestibular schwannoma between January 2014 and February 2018 underwent preoperative vestibular function testing. Patients were divided in to 3 groups, those with vestibular function (VF) who received ITG injections, those with VF but did not receive ITG and those with no VF. Groups were compared according to degree of vertigo, length of stay, time to unassisted mobilization, and postoperative anti-emetic consumption.
    RESULTS: Forty six patients had ITG injections (Group 1), 7 had residual VF but refused treatment (Group 2), 21 had no VF (Group 3). Group 1 had a significant improvement in vertigo over time whereas groups 2 and 3 did not. There was a statistically significant 70% decrease in time to independent mobilization between Group 1 and other groups and a 19% decrease in length of stay in Group 1 compared to other groups although this did not reach statistical significance. Two patients had injection-related complications. Group 1 used less anti-emetics than other groups but this was not statistically significant.
    CONCLUSIONS: Preoperative intratympanic gentamicin injection with vestibular rehabilitation exercises is associated with less postoperative vertigo and earlier postoperative mobilization. There was reduced duration of hospitalization and decreased consumption of anti-emetic but not significantly so possibly because of low numbers of patients in the no treatment group.
    METHODS: 2 Laryngoscope, 134:3316-3322, 2024.
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  • 文章类型: Journal Article
    目的:鼓室内注射是安全的,由耳鼻喉科专家常规进行的耐受性良好的手术。鼓室内注射凝胶具有通过圆窗膜将治疗剂递送到耳蜗中的潜力,延长药物在内耳室中的释放。本综述的目的是总结通过鼓室内凝胶制剂测试内耳病变的药理学治疗的临床试验。
    方法:在线数据库(谷歌学者和PubMed)和寄存器(Clinicaltrials.gov和Euclinicaltrial)用于确定1990年至2022年进行的临床试验。
    方法:遵循PRISMA标准。包括测试通过局部鼓室内注射和靶向内耳疾病施用的凝胶制剂的临床试验。所有报告均由成对工作的作者确定,依次选择仅符合纳入标准的研究。
    结果:总共发现了45项临床研究;用于鼓内注射的凝胶是泊洛沙姆或透明质酸组合的形式;试验发现针对不同类型的内耳疾病:获得性稳定的SNHL,耳鸣,急性突发性SNHL,梅尼埃病,顺铂对人工耳蜗植入手术患者的耳毒性和听力保护。
    结论:列出的少数研究没有提供所使用的特定类型的凝胶制剂,而仅将鼓内给药载体报告为“凝胶”或“热凝胶”。多个临床研究已经通过通过泊洛沙姆和透明质酸制剂注射不同的化合物来靶向几种形式的内耳病症。需要更大和更高级的临床阶段来确认这些化合物的功效。
    OBJECTIVE: Intratympanic injections are a safe, well tolerated procedure routinely performed by ENT\'s specialists. Intratympanic injections of gels have the potential to deliver therapeutics into the cochlea through the round window membrane prolonging the release of drugs in the inner ear compartment. Aim of the present review is to summarize clinical trials testing pharmacological treatments for inner ear pathologies through intratympanic gel formulations.
    METHODS: Online databases (Google scholar and PubMed) and registers (Clinicaltrials.gov and Euclinicaltrial) were used to identify clinical trials performed between 1990 and 2022.
    METHODS: PRISMA criteria have been followed. Clinical trials testing gel formulations administered through local intratympanic injections and targeting inner ear disorders were included. All the reports were identified by the authors working in pairs sequentially selecting only studies respecting the inclusion criteria.
    RESULTS: A total of 45 clinical studies have been noticed; the gels for intratympanic injection are in the form of poloxamers or hyaluronic acid combinations; the trials found target different kind of inner ear disorders: acquired-stable SNHL, tinnitus, acute sudden SNHL, Meniere disease, cisplatin induced ototoxicity and hearing preservation in patients undergoing cochlear implant surgery.
    CONCLUSIONS: Few studies listed do not provide the specific kind of gel formulation used but only report the intratympanic delivery vehicle as \"gel\" or \"thermogel\". Multiple clinical studies have been targeting several forms of inner ear disorders by injecting different compounds through poloxamer and hyaluronic acid formulations. Larger and more advanced clinical stages are necessary to confirm the efficacy of these chemical compounds.
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  • 文章类型: Journal Article
    目的:鼓室内注射糖皮质激素(ITC)和庆大霉素治疗(ITG)是治疗梅尼埃病(MD)眩晕的广泛应用方法。尽管研究表明,与非MD组相比,MD患者在耳蜗植入(CI)后取得了良好的结果,没有迹象表明ITC和ITG在toCI之前对听力的影响。这项研究比较了患有和不患有MD的CI患者以及在toCI之前接受ITG或ITC的患者的术后听力。
    方法:在一项回顾性病例对照研究中,从2002年到2021年接受CI的成年MD患者与无MD的CI患者的匹配对照组进行比较.从MD组中提取具有先前ITC/ITG的患者。测量了术前听力学结果,并在打开时65分贝(WRS65CI)的术后单音节单词识别得分的趋势,3-6个月,对所有组的1年和最后一年的值进行分析。
    结果:将28只MD耳朵与33只对照耳朵进行了比较。来自MD的耳朵9在toCI之前接受了ITG和6ITC。WRS65CI在MD组和对照组随时间显著增加,但两组间WRS65CI无差异。ITG耳朵显示WRS65CI后波动,随时间无变化,而ITC耳部WRS65CI值随时间呈显著上升趋势。
    结论:MD和非MD患者在CI后表现出相当的听力结果。在MD患者中,先前的ITC可能会对CI后的听力保护产生积极影响,而ITG组表现出听力波动。
    OBJECTIVE: Intratympanic injection of corticosteroids (ITC) and gentamicin therapy (ITG) are widely used treatments for vertigo in Meniere\'s disease (MD). Even though studies show good results after cochlea implantation (CI) in MD patients when compared to non-MD groups, there is no indication on the effect of ITC and ITG prior to CI on hearing after CI. This study compares the post-operative hearing of CI patients with and without MD and patients who have received ITG or ITC prior to CI.
    METHODS: In a retrospective case control study, adult patients with MD who received CI from 2002 till 2021 were compared to a matched control group of CI patients without MD. Patients with prior ITC/ITG were extracted from MD group. Pre-operative audiological results were measured and trends across post-operative monosyllabic word recognition score at 65 decibels (WRS65CI) at switch-on, 3-6 months, 1 year and last yearly value were analyzed across all groups.
    RESULTS: 28 MD ears were compared with 33 control ears. From MD ears 9 had received ITG and 6 ITC prior to CI. WRS65CI increased significantly with time within MD and control groups, but no difference in WRS65CI was found between these 2 groups. ITG ears showed fluctuating WRS65CI after CI with no change across time, while ITC ears showed significant increase in trend of WRS65CI values across time.
    CONCLUSIONS: MD and non-MD patients showed comparable hearing results after CI. Prior ITC might positively influence hearing preservation after CI in MD patients whereas ITG group showed fluctuating hearing.
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  • 文章类型: Journal Article
    背景:鼓室内类固醇(ITS)治疗突发性感觉神经性听力损失(SSNHL)已变得越来越普遍。
    目的:本研究调查了ITS治疗与全身性类固醇(SS)联合治疗严重和严重SSNHL患者是否具有额外的益处。
    方法:将诊断为严重和深度SSNHL的患者分为两组:SS组和SS联合ITS组。在治疗完成前和治疗后三个月进行纯音测听。纯音平均(PTA),特定频率的听力增益,并比较各组间的平均值。
    结果:该研究包括57例患者(27例SS,30ITS),平均年龄50.09±15.56。治疗前:SSPTA84.40±15dBHL,ITS87.50±9.38dBHL(p=0.36)。治疗后:SS62.2±23.13dBHL,ITS65.17±12.19dBHL(p=0.55)。平均听力增益:SS22.19±13.81dBHL,ITS22.33±12.24dBHL(p=0.96)。频率特异性增益相似(p>0.05)。SS组:12略有改善,10没有改进,3部分,2完全恢复。ITS组:23略有改善,6没有改进,1部分。
    结论:在我们的研究中,将ITS与SS治疗相结合,在治疗严重和深度SSNHL方面没有额外的益处.
    BACKGROUND: Intratympanic steroids (ITS) in treating sudden sensorineural hearing loss (SSNHL) have become more widespread.
    OBJECTIVE: This study investigates whether ITS treatment provides additional benefits when combined with systemic steroids (SS) in patients with severe and profound SSNHL.
    METHODS: Patients diagnosed with severe and profound SSNHL were divided into two groups: SS group and SS combined with ITS group. Pure-tone audiometry was performed before and three months after treatment completion. The pure-tone average (PTA), frequency-specific hearing gains, and average values were compared between the groups.
    RESULTS: The study included 57 patients (27 SS, 30 ITS), with a mean age of 50.09 ± 15.56. Before treatment: SS PTA 84.40 ± 15 dB HL, ITS 87.50 ± 9.38 dB HL (p = 0.36). After treatment: SS 62.2 ± 23.13 dB HL, ITS 65.17 ± 12.19 dB HL (p = 0.55). Average hearing gain: SS 22.19 ± 13.81 dB HL, ITS 22.33 ± 12.24 dB HL (p = 0.96). Frequency-specific gains were similar (p > 0.05). SS group: 12 slight improvement, 10 no improvement, 3 partial, 2 complete recovery. ITS group: 23 slight improvement, 6 no improvement, 1 partial.
    CONCLUSIONS: In our study, combining ITS with SS treatment did not provide additional benefits in treating severe and profound SSNHL.
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  • 文章类型: Randomized Controlled Trial
    特发性突发性感音神经性听力损失(ISSNHL)的病理生理学和适当治疗是一个不断争论的话题。关于ISSNHL(特发性突发性感觉神经性听力损失),局部或全身使用皮质类固醇是最被接受的治疗药物。然而,尚无关于其有效性的有力证据或指南。在我们的未来,随机化,纳入对照试验78名参与者.患者根据入院日随机分为两组:SS组(n=43)接受静脉注射全身甲基强的松龙,CT组(n=35)接受鼓室地塞米松+全身甲基强的松龙。主要结果是比较不同治疗组之间的听力结果,广泛接受的类别(西格尔,Kanzaki,改进的Siegel和PTA4增益)。考虑到次要结果,我们研究了各种危险因素对听力改善的影响.两组之间在听力改善方面没有发现差异,基于任何标准[西格尔标准(p=0.604);Kanzaki标准(p=0.720);修改后的西格尔标准(p=0.524)和PTA4增益(p=0.569)]。然而,几个临床因素,如眩晕(p=0.039),发现心血管合并症(p=0.02)和初始听力损失的严重程度(p=0.033)对听力结果有重大影响。据我们所知,这是首个比较高剂量全身和联合糖皮质激素治疗ISSNHL患者的随机对照试验.我们的研究结果表明并存的心血管合并症,眩晕和初始听力损失的严重程度可能对听力改善产生明显更高的影响,而不是额外的鼓室内类固醇给药。所提出的试验已在欧盟药物监管机构临床试验数据库中注册(名称:特发性突发性感音神经性听力损失的全身和鼓室内类固醇联合治疗,不。:2017-000658-20),并获得美国国家药学与营养研究所(OGYÉI)的伦理批准(协议号:7621,于2017.02.16。).
    The pathophysiology and the proper treatment of idiopathic sudden sensorineural hearing loss (ISSNHL) are an ongoing subject of debate. Locally or systemic administered corticosteroids are the most accepted drugs of treatment in reference to ISSNHL (idiopathic sudden sensorineural hearing loss), however, no strong evidence nor guidelines regarding their effectiveness yet exists. In our prospective, randomized, controlled trial 78 participants were enrolled. Patients were randomly assigned based on the day of admission to two groups according to treatment: group SS (n = 43) received intravenous systemic methylprednisolone alone, and group CT (n = 35) received intratympanic dexamethasone + systemic methylprednisolone. The primary outcome was to compare the hearing outcomes between the treatment groups based on different, widely accepted categories (Siegel, Kanzaki, modified Siegel and PTA4 gain). In consideration of the secondary outcome, we examined the effect of the various risk factors on the hearing improvement. No differences were detected regarding hearing improvement between the two groups, based on any criteria [Siegel\'s criteria (p = 0.604); Kanzaki\'s criteria (p = 0.720); modified Siegel\'s criteria (p = 0.524) and PTA 4 gain (p = 0.569)]. However, several clinical factors such as vertigo (p = 0.039), or cardiovascular comorbidity (p = 0.02) and the severity of initial hearing loss (p = 0.033) were found to bear a significant impact upon the hearing outcome. To the best of our knowledge, this is the first randomized controlled trial comparing high dose systemic and combination corticosteroid therapy in ISSNHL patients. Our findings suggest coexisting cardiovascular comorbidity, vertigo and severity of the initial hearing loss may bear a significantly higher impact upon hearing improvement, than the additional intratympanic steroid administration. The presented trial was registered in the European Union Drug Regulating Authorities Clinical Trials Database (name: Combinated systemic and intratympanic steroid therapy in idiopathic sudden sensorineural hearing loss, No.: 2017-000658-20) and with the ethical approval of The National Institute of Pharmacy and Nutrition (OGYÉI) (protocol No.: 7621, on 2017.02.16.).
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