Research on the prognosis and efficacy criteria of sudden sensorineural hearing loss
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摘要: 突发性聋是一种常见病、多发病。纵览国内外突发性聋诊治的疗效评估，各国在治疗疗效评估指标和标准方面各具特色，常用疗效判定的指标包括：①平均听阈；②受损频率听力提高的绝对值；③平均听阈提升的百分比；④言语识别率；⑤言语识别阈等。评估标准多以疗效分级或平均听阈的改善水平作为治疗有效的判定标准，缺乏统一标准，不利于全球突发性聋相关研究的同质化推进。本文系统回顾了多国突发性聋临床实践指南及质量较高的临床多中心研究中的疗效评估指标和标准，以便为我国突发性聋诊治效果评价改进提供参考。Abstract: Sudden sensorineural hearing loss is a common and frequently-occurring disease. Looking at the efficacy evaluation of the diagnosis and treatment of sudden sensorineural hearing loss at home and abroad, each country has its own characteristics in the indicators and criteria of the treatment efficacy evaluation, and the common indicators of efficacy evaluation include: average pure-tone hearing threshold, the absolute value of hearing improvement of impaired frequency, the percentage of average pure-tone hearing threshold increase, speech discrimination score, speech recognition threshold, etc. The evaluation criteria mostly take the efficacy grade or the improvement level of average hearing threshold as the criterion of effective treatment, and the lack of unified standards is not conducive to the homogenization of global research related to sudden sensorineural hearing loss. In order to provide reference for the clinical evaluation of sudden sensorineural hearing loss in China, this study systematically reviewed the clinical practice guidelines and the evaluation indexes and criteria of clinical efficacy in high quality clinical multicenter studies of the disease in many countries.
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Key words:
- sudden sensorineural hearing loss /
- efficacy assessment /
- index /
- criteria
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表 1 2015年突发性聋诊断和治疗指南
分级 疗效判定 PTA代表频率 痊愈 受损频率听力恢复至正常，或达健耳水平，或达此次患病前水平 受损频率 显效 受损频率听力平均提高30 dB以上 有效 受损频率听力平均提高15~30 dB 无效 受损频率听力平均提高不足15 dB 
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表 2 Siegel标准
分级 疗效判定 PTA代表频率 完全恢复 无论改善的大小，患者最终听力水平＜25 dB 500~2 000 Hz 部分恢复 听力改善>15 dB，最终听力水平在25~45 dB 轻微改善 听力改善>15 dB，但最终听力水平>45 dB 无改善 听力改善＜15 dB
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表 3 Wilson标准
分级 疗效判定 PTA代表频率 完全恢复 言语识别阈或纯音平均听阈恢复到听力损失前的10 dB以内 未明确 部分恢复 言语识别阈或纯音平均听阈恢复到听力损失前≥50% 未恢复 听力恢复百分比＜50%
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表 4 美国突发性聋临床实践指南
分级 疗效判定 PTA代表频率 完全恢复 患耳纯音听阈与健耳相差＜10 dB且言语识别率(WRS)与健耳相差＜5%~10% 500~4 000 Hz 部分恢复 ①对于因突发性聋而失去可用听力的患耳，如听力恢复到可用范围内，即为显著改善；②对于突发性聋后听力仍在可用范围内的患耳，PTA改善>10 dB或WRS提高≥10%视为部分恢复 未恢复 听力改善＜10 dB
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表 5 日本突发性聋疗效判断标准
分级 疗效判定 PTA代表频率 完全恢复或痊愈 患者250、500、1 000、2 000和4 000 Hz的阈值均恢复至20 dB以内或患耳听力损失恢复到与对侧健耳相同水平 250~4 000 Hz 显效 PTA改善≥30 dB 有效 PTA改善10~30 dB 无效 PTA改善＜10 dB(包括听力恶化)
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表 6 日本低频突发性聋疗效判断标准
分级 疗效判定 PTA代表频率 完全恢复 125~500 Hz 3个频率PTA≤20 dB，或恢复到与对侧健耳相同阈值水平 125~500 Hz 改善 PTA改善≥10 dB，但未达到完全恢复标准 无变化 PTA改善＜10 dB 恶化 除上述标准外的变化
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表 7 突发性聋多中心研究预后疗效评价指标及标准
作者 年份 样本量/例 疗效评价 Suckfüll，等 2002 201 主要疗效评价：治疗48 h后纯音恢复的百分比次要疗效评价：治疗后6周听力的改善，言语识别阈，耳鸣与不良反应发生率 Westerlaken，等 2007 81 主要疗效评价：发病12个月的PTA和WRS的改善次要疗效评价：耳鸣、眩晕、耳闷堵感等主观感觉的改善 Rauch，等 2011 250 主要疗效评价：治疗后2个月PTA的改善次要疗效评价：治疗后6个月时的PTA改善，2个月和6个月耳间差和WRS Nosrati-Zarenoe，等 2012 93 疗效评价：突发性聋3个月听力的改善 杨仕明，等 2013 1 024 主要疗效评价：结束治疗后听力改善水平次要疗效评价：耳鸣、眩晕或头晕、耳闷等因素的改善 Nakagawa，等 2014 120 主要疗效评价：治疗后8周的听力改善次要疗效评价：PTA随时间的变化和不良事件发生率 王秋菊，等 2015 76 主要疗效评价：治疗后第14天听力改善次要疗效评价：治疗后第14天WRS的改善 Tsounis，等 2018 102 疗效评价：治疗第90天PTA的改善
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表 8 突发性聋研究预后疗效评价指标和有效判定标准
评价指标 有效判定 PTA PTA改善>10 dB/PTA改善≥10 dB PTA改善>15 dB/PTA改善≥15 dB PTA改善≥20 dB PTA改善≥30 dB WRS WRS提升≥20%或WRS≥90% PTA+WRS PTA或SRT改善≥10 dB，WRS提升≥10% PTA改善>10 dB，WRS提升>12% PTA改善≥10 dB或WRS提升≥15% PTA改善20 dB或WRS提升20%
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