从肝论治干眼症：以逍遥散类方为核心的临床研究进展

Clinical Advances in the Treatment of Dry Eye Disease from the Liver Perspective: A Review Focused on Xiao Yao San and Its Derivatives

摘要: 目的：系统综述中医“从肝论治”干眼症的理论基础，重点分析逍遥散及其加减方治疗干眼症的临床疗效与现代药理机制，为中医药规范化治疗干眼提供参考。方法：检索国内外相关文献，梳理从肝论治干眼症的理论溯源，归纳逍遥散原方及丹栀逍遥散、黑逍遥散等常见加减方的临床应用证据，总结其抗炎、抗氧化、免疫调节等现代作用机制。结果：纳入的11项临床研究显示，逍遥散类方联合西药治疗干眼症的总有效率为88.3%~93.3%，较单纯西药对照组提升15.0%~20.0%；可使泪膜破裂时间(BUT)延长1.76~2.33 s (均数差MD = 1.87~2.33 s，P均 < 0.05)，泪液分泌试验(SIT)增加2.76~3.53 mm/5 min (MD = 2.76~3.53 mm/5 min，P均 < 0.05)，同时显著降低角膜荧光素染色(FL)评分和中医证候积分。现有研究表明，逍遥散类方不仅能改善干眼症患者的主观症状和客观体征，还可通过多靶点调控炎症反应、保护眼表细胞、调节神经内分泌功能发挥治疗作用。结论：逍遥散类方治疗干眼症具有独特优势，但当前研究仍存在质量控制不统一、循证证据等级不足等问题，未来需开展高质量多中心随机对照试验，推动中医药治疗干眼的标准化与国际化。

Abstract: Objective: To systematically review the theoretical basis of treating dry eye disease (DED) from the liver perspective in Traditional Chinese Medicine (TCM), focus on analyzing the clinical efficacy and modern pharmacological mechanisms of Xiao Yao San (XYS) and its modified formulas in the treatment of DED, and provide a reference for the standardized TCM management of DED. Methods: Relevant domestic and international literature was retrieved to sort out the theoretical origin of treating DED from the liver, summarize the clinical application evidence of the original XYS formula and its common modified formulas including Danzhi Xiao Yao San (DZXYS) and Hei Xiao Yao San (HXYS), and conclude their modern mechanisms of action such as anti-inflammation, anti-oxidation and immunomodulation. Results: Eleven included clinical studies showed that the total effective rate of XYS-based formulas combined with Western medicine for DED ranged from 88.3% to 93.3%, which was 15.0% to 20.0% higher than that of the Western medicine monotherapy control group. The combined treatment prolonged tear film break-up time (BUT) by 1.76~2.33 seconds (mean difference, MD = 1.87~2.33 s, all P < 0.05), increased Schirmer I test (SIT) values by 2.76~3.53 mm/5 min (MD = 2.76~3.53 mm/5 min, all P < 0.05), and simultaneously significantly reduced corneal fluorescein staining (FL) scores and TCM syndrome scores. Existing evidence indicates that XYS-based formulas can not only improve the subjective symptoms and objective signs of DED patients, but also exert therapeutic effects through multi-target regulation of inflammatory responses, protection of ocular surface cells, and modulation of neuroendocrine functions. Conclusion: XYS-based formulas possess unique advantages in the treatment of DED. Nevertheless, current studies still have limitations including inconsistent quality control and insufficient evidence levels. In the future, high-quality multi-center randomized double-blind placebo-controlled trials should be carried out to promote the standardization and internationalization of TCM treatment for DED.