Qin Jiangyuan, Huang Geng, Lin Xiaoyu, Su Chang, Chen Lingkan, Liao Lanfang
The Third Department of Surgery, Guangxi Armed Police Corps Hospital, No. 46 Luban Road, Nanning, 530003, Guangxi Zhuang Autonomous Region, China.
Health Department, Guangxi Armed Police Corps Hospital, Nanning, 530003, China.
Eur J Med Res. 2025 Jul 2;30(1):547. doi: 10.1186/s40001-025-02771-5.
Sudden sensorineural hearing loss (SSNHL), is associated with significant inflammatory responses that can impair auditory function. Methylprednisolone sodium succinate (MPSS) is commonly used for its anti-inflammatory properties, while acoustic resonance therapy may enhance healing through improved microcirculation. This study aims to evaluate the combined effects of MPSS and acoustic resonance therapy on inflammatory response indicators and cerebral microcirculation in patients with SSNHL.
A double-blind, randomized, placebo-controlled trial was conducted with 256 participants aged 18 to 65 diagnosed with unilateral SSNHL. The study included three groups of patients: the MPSS group (n = 85), the combination therapy group (n = 86), and the placebo group (n = 85). Severe cases comprised 54.1% of the MPSS group, 57.0% of the combination therapy group, and 52.9% of the placebo group, while profound hearing loss was observed in 45.9%, 43.0%, and 47.1%, respectively. Word recognition scores at 80 dB varied, with median values of 16% (0-60) in the MPSS group, 22.5% (0-50) in the combination group, and 30% (0-70) in the placebo group. While the MPSS and placebo injections were administered under double-blind conditions, the acoustic resonance therapy component was not blinded due to the nature of the intervention. Key endpoints included changes in inflammatory markers [C-reactive protein (CRP), Interleukin 6 (IL-6), tumour necrosis factor alpha (TNF-a), and fibrinogen)], assessments of cerebral microcirculation, and hearing outcomes measured by pure-tone average (PTA) and word recognition scores (WRS).
Treatment effectiveness was assessed via PTA, hearing recovery, tinnitus severity, WRS, and inflammatory markers. At baseline, PTA values were similar (p = 0.802). By Day 30, PTA improved significantly (p = 0.022), with the greatest gains in the combination therapy group. By Day 60, PTA values were 45.0 ± 9.8 dB (MPSS), 48.0 ± 8.3 dB (combination therapy), and 31.0 ± 10.0 dB (placebo) (p = 0.031). The combination therapy group showed the most PTA improvement (16.0 ± 5.1 dB, p = 0.046) and highest complete recovery rate (46.5% vs. 29.4% MPSS, 9.4% placebo, p = 0.005). Tinnitus severity was similar at baseline (p = 0.236) but decreased significantly by Day 30. MPSS reduced to 4.0 ± 1.0, while combination therapy improved to 2.5 ± 0.9 (p < 0.001). By Day 60, combination therapy had the lowest severity (1.8 ± 0.7), confirming superior efficacy. WRS improved significantly, with combination therapy showing the most gains. By Day 60, WRS reached 45.0% ± 11.0% (MPSS), 60.0% ± 8.5% (combination therapy), and 42.0% ± 14.5% (placebo) (p < 0.001), supporting combination therapy's advantage. Inflammatory markers (CRP, IL-6, TNF-α, fibrinogen) dropped significantly in treatment groups. By Day 60, CRP fell to 5.2 ± 0.9 mg/L (MPSS) and 3.5 ± 0.8 mg/L (combination therapy) (p < 0.001). IL-6 dropped to 10.0 ± 2.0 pg/mL (MPSS) and 8.5 ± 1.8 pg/mL (combination therapy) (p < 0.001). TNF-α decreased to 38.5 ± 1.5 pg/mL (MPSS) and 34.0 ± 1.3 pg/mL (combination therapy), while fibrinogen was lowest in combination therapy (3.0 ± 0.2 g/L) (p < 0.001), demonstrating strong anti-inflammatory effects. Cerebral circulation improved significantly in all groups, with the greatest increase in blood flow (Qm) in combination therapy (9.00 ± 1.75 mL/s by Day 60) and enhanced cerebral perfusion (p < 0.05). While the placebo group showed moderate improvement, combination therapy consistently yielded the most substantial benefits in hearing, inflammation reduction, and circulation.
The findings suggest that the synergistic application of MPSS and acoustic resonance therapy effectively reduces inflammation and improves cerebral blood flow, leading to better auditory outcomes in patients with SSNHL. This research underscores the potential of integrated treatment approaches in managing SSNHL.
突发性感音神经性听力损失（SSNHL）与可损害听觉功能的显著炎症反应相关。琥珀酸甲泼尼龙（MPSS）因其抗炎特性而常用，而声共振疗法可通过改善微循环促进愈合。本研究旨在评估MPSS和声共振疗法联合应用对SSNHL患者炎症反应指标和脑微循环的综合影响。
对256名年龄在18至65岁、诊断为单侧SSNHL的参与者进行了一项双盲、随机、安慰剂对照试验。该研究包括三组患者：MPSS组（n = 85）、联合治疗组（n = 86）和安慰剂组（n = 85）。重度病例在MPSS组中占54.1%，联合治疗组中占57.0%，安慰剂组中占52.9%，而分别有45.9%、43.0%和47.1%的患者出现极重度听力损失。80 dB时的单词识别分数各不相同，MPSS组的中位数为16%（0 - 60），联合组为22.5%（0 - 50），安慰剂组为30%（0 - 70）。虽然MPSS和安慰剂注射是在双盲条件下进行的，但由于干预的性质，声共振治疗部分未设盲。主要终点包括炎症标志物[C反应蛋白（CRP）、白细胞介素6（IL - 6）、肿瘤坏死因子α（TNF - a）和纤维蛋白原]的变化、脑微循环评估以及通过纯音平均（PTA）和单词识别分数（WRS）测量的听力结果。
通过PTA、听力恢复、耳鸣严重程度、WRS和炎症标志物评估治疗效果。在基线时，PTA值相似（p = 0.802）。到第30天，PTA显著改善（p = 0.022），联合治疗组改善最大。到第60天，PTA值分别为45.0 ± 9.8 dB（MPSS）、48.0 ± 8.3 dB（联合治疗）和31.0 ± 10.0 dB（安慰剂）（p = 0.031）。联合治疗组的PTA改善最大（16.0 ± 5.1 dB，p = 0.046），完全恢复率最高（46.5%对比MPSS组的29.4%，安慰剂组的9.4%，p = 0.05）。耳鸣严重程度在基线时相似（p = 0.236），但到第30天显著降低。MPSS组降至4.0 ± 1.0，而联合治疗组改善至2.5 ± 0.9（p < 0.001）。到第60天，联合治疗组的严重程度最低（1.8 ± 0.7），证实了其卓越疗效。WRS显著改善，联合治疗组改善最大。到第60天，WRS分别达到45.0% ± 11.0%（MPSS）、60.0% ± 8.5%（联合治疗）和42.0% ± 14.5%（安慰剂）（p < 0.001），支持联合治疗的优势。治疗组的炎症标志物（CRP、IL - 6、TNF - α、纤维蛋白原）显著下降。到第60天，CRP降至5.2 ± 0.9 mg/L（MPSS）和3.5 ± 0.8 mg/L（联合治疗）（p < 0.001）。IL - 6降至10.0 ± 2.0 pg/mL（MPSS）和8.5 ± 1.8 pg/mL（联合治疗）（p < 0.001）。TNF - α降至38.5 ± 1.5 pg/mL（MPSS）和34.0 ± 1.3 pg/mL（联合治疗），而联合治疗组的纤维蛋白原最低（3.0 ± 0.2 g/L）（p < 0.001），显示出强大的抗炎作用。所有组的脑循环均显著改善，联合治疗组的血流量（Qm）增加最大（到第60天为9.00 ± 1.75 mL/s），脑灌注增强（p < 0.05）。虽然安慰剂组有中度改善，但联合治疗在听力、炎症减轻和循环方面始终产生最显著的益处。
研究结果表明，MPSS和声共振疗法的协同应用可有效减轻炎症并改善脑血流，从而使SSNHL患者获得更好的听觉结果。本研究强调了综合治疗方法在管理SSNHL方面的潜力。
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