鼻外神经刺激治疗干眼的疗效及安全性的临床研究
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曾庆延,女,博士,主任医师,副教授。 中国医 师协会眼科分会委员,湖北省眼科学会常务委员,中国非公医疗 眼科专业角膜病分委会副主任委员。 主要研究方向:角膜及眼表 疾病的临床与基础研究,尤其在圆锥角膜、干眼、角膜胶原交联等 领域取得系列创新成果。

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湖南省自然科学基金项目(编号:2025JJ90251); 武汉市卫生健康委科研项目(编号:WX23A20)


The efficacy and safety of external nasal nerve stimulation in the treatment of dry eye: a clinical trial
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    摘要:

    目的 评估鼻外神经刺激自身泪液促泌仪(iTEAR 睦沁?)在干眼患者中的疗效及安全性。 方法 于 2024 年 8 ~ 9 月招募成年干眼受试者 20 例,受试者使用 iTEAR 每日治疗 2 次,共 28 天。 在第 0、7、14、28、42 天进行随访。 其中前 4 个 时间点均进行使用前基础状态以及使用后即刻相关指标的采集。 采集指标包括眼表疾病指数( OSDI) 问卷、泪河高度 (TMH)、荧光素染色泪膜破裂时间(FBUT)、角膜荧光素染色评分、结膜增强荧光素染色评分、泪膜脂质层厚度( LLT)以及泪 液蕨类试验。 治疗结束后,通过问卷收集受试者对 iTEAR 的满意度和使用体验。 体征均只纳入右眼指标进行统计学分析。 结果 在第 7、14、28 及 42 天,OSDI 较第 0 天基线均明显下降(P<0. 01),FBUT 较第 0 天基线均明显上升(P<0. 01),角膜荧光 素染色评分较第 0 天基线均明显下降(P<0. 05),结膜增强荧光素染色评分较第 0 天基线呈下降趋势,但差异无统计学意义 (P>0. 05),泪膜脂质层厚度及泪液蕨类试验各时间点与第 0 天基线相比差异无统计学意义(P>0. 05)。 分层分析提示基线角 膜荧光素染色评分较高者泪膜稳定性改善更明显,TMH 较低患者眼表损伤的改善更为显著。 治疗期间受试者无严重不良反 应,对治疗设备总体满意度较高(40%比较满意,60%中立),90%受试者认为治疗有些不适,但适应后可接受。 结论 鼻外神 经刺激可快速有效改善干眼患者症状、泪膜稳定性及眼表损伤,且在停止治疗后疗效仍可持续,治疗可接受度及安全性良好。 提示鼻外神经刺激治疗干眼可能触发了具有持续性的中枢神经调节机制。

    Abstract:

    To evaluate the efficacy and safety of external nasal nerve stimulation auto-tear secretor ( iTEAR Muqin? ) in patients with dry eye. Methods From August to September, 2024, 20 adult subjects with dry eye were recruited. They were treated with iTEAR twice a day for a total of 28 days. Follow up was conducted on days 0, 7, 14, 28, and 42. Among them, the basic status before use and relevant indicators immediately after use were collected at the first 4 time points. The collected indicators included the ocular surface disease index (OSDI) questionnaire, tear meniscus height (TMH), fluorescein break-up time (FBUT), corneal fluorescein staining score, conjunctival enhanced fluorescein staining score, tear film lipid layer thickness (LLT) and tear ferning test. After treatment, subjects' satisfaction with iTEAR and experience were collected through questionnaires. Only data from the right eye were included for statistical analysis of clinical signs. Results On days 7, 14, 28, and 42, OSDI was decreased significantly compared with day 0 baseline (P<0. 01). FBUT was increased significantly compared with day 0 baseline (P<0. 01). Corneal fluorescein staining scores were decreased significantly compared with Day 0 baseline (P<0. 05). Conjunctival enhanced fluorescein staining scores showed a downward trend compared with Day 0 baseline, but the difference was not statistically significant (P>0. 05). There was no statistically significant difference between LLT and tear ferning test at each time point and the baseline on Day 0 (P>0. 05). Stratified analysis showed that those with higher baseline corneal fluorescein staining scores had a more significant improvement in tear film stability. Patients with lower TMH had a more significant improvement in ocular surface damage. During the treatment period, the subjects had no serious adverse reactions. The overall satisfaction with the treatment equipment was high (40% were satisfied and 60% were neutral). 90% of the subjects believed that the treatment was somewhat uncomfortable, but it was acceptable after adapting to it. Conclusions Extra nasal nerve stimulation can quickly and effectively improve the symptoms, tear film stability and ocular surface damage in patients with dry eye. The effect is sustainable after stopping treatment. The treatment has good acceptability and safety. These findings suggest that the stimulation of the external nasal nerve in the treatment of dry eye may trigger a sustained central nervous system regulatory mechanism

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李云婷,王浩宇,谌 丹,曾庆延.鼻外神经刺激治疗干眼的疗效及安全性的临床研究[J].实用医院临床杂志,2026,23(2):32-39

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  • 收稿日期:2026-02-13
  • 最后修改日期:2026-02-25
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  • 在线发布日期: 2026-04-14
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