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

doi:10.3969/j.issn.1006-5725.2026.11.025

Abstract

Abstract:

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

CLC Number:

R764.43

Canfeng ZHAO,Jiaping REN,Chong OUYANG,Zijing ZHANG,Hua PENG. Real-world study： Efficacy and safety analysis of butylphthalide combined with conventional therapy in the treatment of blast-induced deafness[J]. The Journal of Practical Medicine, 2026, 42(11): 2083-2090.

Figures/Tables 4

Tab.1

Tab.2

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References 47

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项目	丁苯酞治疗组（n = 51）	非丁苯酞治疗组（n = 54）	χ²/Z值	P值
听力损失侧别			0.48	0.787 0
左	17（33.33）	21（38.89）
右	19（37.25）	17（31.48）
双	15（29.41）	16（29.63）
性别			0.01	0.928 5
男	46（90.20）	50（92.59）
女	5（9.80）	4（7.41）
年龄［M（P₂₅，P₇₅）］/岁	32.00（24.00， 34.00）	29.5（22.00， 34.50）	1.66	0.094 8
伴随症状
耳鸣	45（88.24）	49（90.74）	0.18	0.675 2
眩晕	4（7.84）	2（3.70）	0.20	0.656 2
耳痛	15（29.41）	12（22.22）	0.71	0.399 5
患耳/只	66	70	-	-
听力损失类型			0.11	0.737 3
高频	19（28.79）	22（31.42）
全频	47（71.21）	48（68.58）

频率	治疗前听力阈值		治疗后听力阈值
频率	丁苯酞组	非丁苯酞组	丁苯酞组	非丁苯酞组
250 Hz	45（35.0， 57.5）	40（30.0， 50.0）	32.87±14.28^####	35（30.0， 45.0）^##
500 Hz	45（35.0， 65.0）	45（35.0， 50.0）	30（20.0， 40.0）^{? ####}	40（30.0， 45.0）^###
1 000 Hz	55（45.0， 70.0）	50（45.0， 60.0）	42.50 ± 16.13^####	45（40.0， 55.0）^###
2 000 Hz	55（40.0， 65.0）	54.32 ± 16.33	43.86 ± 20.16^####	47.03 ± 18.46^####
4 000 Hz	64.92 ± 18.56	62.42 ± 16.23	52.12 ± 23.95^####	60（43.8， 70.0）^####
8 000 Hz	71.89 ± 17.84	68.00 ± 19.38	64.02 ± 19.58^####	65（50.0， 75.0）^####

项目	丁苯酞组	非丁苯酞组	Z值	P值
250 Hz	10.0（5.0， 15.0）	5.0（0， 10.0）	3.71	0.000 1
500 Hz	15.0（5.0， 20.0）	5.0（0， 5.0）	5.06	< 0.000 1
1 000 Hz	10.0（5.0， 20.0）	5.0（0， 10.0）	3.99	< 0.000 1
2 000 Hz	10.0（5.0， 17.5）	5.0（0， 10.0）	2.42	0.013 7
4 000 Hz	15.0（5.0， 20.0）	5.0（0， 15.0）	3.08	0.001 7
8 000 Hz	5.0（0， 10.0）	5.0（0， 10.0）	1.33	0.172 2

频率	组别	患耳数	痊愈	显效	有效	总有效/［例（%）］	χ²值	P值
250 Hz	丁苯酞组	45	11	3	10	24（53.3）	13.10	0.000 3
250 Hz	非丁苯酞组	39	2	2	2	6（15.4）	13.10	0.000 3
500 Hz	丁苯酞组	47	12	4	16	32（68.1）	27.39	< 0.000 1
500 Hz	非丁苯酞组	47	4	2	1	7（14.9）	27.39	< 0.000 1
1 000 Hz	丁苯酞组	53	8	5	13	26（49.1）	11.48	0.000 7
1 000 Hz	非丁苯酞组	51	2	2	5	9（17.1）	11.48	0.000 7
2 000 Hz	丁苯酞组	57	10	3	14	27（47.4）	8.24	0.004 1
2 000 Hz	非丁苯酞组	59	7	3	3	13（22.0）	8.24	0.004 1
4 000 Hz	丁苯酞组	59	7	4	20	31（52.5）	8.35	0.003 9
4 000 Hz	非丁苯酞组	66	5	2	11	18（27.3）	8.35	0.003 9
8 000 Hz	丁苯酞组	66	2	2	10	14（21.2）	0.15	0.699 6
8 000 Hz	非丁苯酞组	70	4	2	7	13（18.6）	0.15	0.699 6

Real-world study： Efficacy and safety analysis of butylphthalide combined with conventional therapy in the treatment of blast-induced deafness

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