收稿日期: 2026-03-11
网络出版日期: 2026-06-15
基金资助
广东省自然科学基金项目(2023A1515010268)
Real-world study： Efficacy and safety analysis of butylphthalide combined with conventional therapy in the treatment of blast-induced deafness
Received date: 2026-03-11
Online published: 2026-06-15
目的 探讨在真实世界临床条件下，丁苯酞治疗爆震性聋的有效性及安全性。 方法 回顾性分析2020年1月至2025年4月就诊于南部战区总医院耳鼻咽喉头颈外科的爆震性聋患者临床资料。根据治疗过程中是否给予丁苯酞分为丁苯酞组（51例，66耳）与非丁苯酞组（54例，70耳）。纳入研究的所有患者均使用以糖皮质激素治疗为主，辅助使用改善微循环以及营养神经等药物的治疗方案。丁苯酞组患者在此基础上额外给予丁苯酞注射液，每天2次，连续7 d。通过比较两组患者治疗前后纯音听阈测定（PTA）结果，评估听力增益及治疗有效率（以听力增益≥ 15 dB为有效）。同时观察两组患者用药后的安全性。 结果 两组患者的基线资料差异无统计学意义（P > 0.05）。丁苯酞组PTA在250、500、1 000、2 000、4 000 Hz频率，听力增益均显著高于非丁苯酞组（均P < 0.05）。丁苯酞组在250、500、1 000、2 000、4 000 Hz的治疗总有效率分别为53.3%、68.1%、49.1%、47.4%、52.5%，显著高于非丁苯酞组的15.4%、14.9%、17.1%、22.0%、27.3%（均P < 0.05）。治疗期间发现轻微皮肤瘙痒2例、轻微头晕恶心1例，无丁苯酞相关的严重不良事件。 结论 在真实世界临床实践中，在常规治疗基础上联用丁苯酞，可显著改善爆震性聋患者的听力水平，且安全性良好，显示出重要的临床应用价值。
赵灿锋 , 任家平 , 欧阳铳 , 张梓敬 , 彭华 . 丁苯酞联合常规方案治疗爆震性聋的疗效与安全性分析：一项真实世界研究[J]. 实用医学杂志, 2026 , 42(11) : 2083 -2090 . DOI: 10.3969/j.issn.1006-5725.2026.11.025
Objective To investigate the effectiveness and safety of butylphthalide in treating sudden deafness under real-world clinical conditions. Methods A retrospective analysis was conducted on the clinical data of patients with blast-induced deafness admitted to the Department of Otorhinolaryngology Head and Neck Surgery， General Hospital of Southern Theater Command from January 2020 to April 2025. The patients were classified into a butylphthalide group （consisting of 51 patients with 66 affected ears） and a non-butylphthalide group （consisting of 54 patients with 70 affected ears） based on whether butylphthalide was administered during the treatment. All the patients included in the study received a therapeutic regimen centered on glucocorticoids， supplemented with drugs for improving microcirculation and nourishing nerves. On this basis， the patients in the butylphthalide group were additionally administered butylphthalide injection twice a day for 7 consecutive days. The hearing gain and treatment effective rate （defined as effective when the hearing gain was ≥ 15 dB） were assessed by comparing the results of pure-tone audiometry （PTA） before and after the treatment between the two groups. The safety of medication in both groups was also monitored. Results There were no statistically significant differences in baseline characteristics between the two groups. The butylphthalide group demonstrated significantly greater hearing gains in PTA thresholds at 250 Hz， 500 Hz， 1 000 Hz， 2 000 Hz， and 4 000 Hz when compared to the non-butylphthalide group （all P < 0.05）. The overall treatment effective rates in the butylphthalide group were 53.3%， 68.1%， 49.1%， 47.4%， and 52.5% at 250 Hz， 500 Hz， 1 000 Hz， 2 000 Hz， and 4 000 Hz， respectively. These rates were significantly higher than those in the non-butylphthalide group （15.4%， 14.9%， 17.1%， 22.0%， and 27.3%； all P < 0.05）. During treatment， mild pruritus was observed in 2 cases， and mild dizziness with nausea in 1 case. No serious adverse events associated with butylphthalide were reported during the treatment period. Conclusion In real-world clinical practice， the integration of butylphthalide into conventional therapy results in a substantial improvement in the hearing levels of patients with sudden deafness and demonstrates a favorable safety profile， which suggests significant clinical application value.
Key words： explosive deafness; butylphthalide; real-world study; therapeutic efficacy; safety
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