目的：探究当归饮子加味联合双氯芬酸钠滴眼液对过敏性结膜炎患者泪膜稳定性及泪液蛋白水平的影响。

方法：前瞻性研究，选取2021年3月至2024年8月于苏州市中西医结合医院就诊的过敏性结膜炎患者作为研究对象，将患者依据治疗方案划分为对照组(接受双氯芬酸钠滴眼液治疗)与观察组(接受当归饮子加味联合双氯芬酸钠滴眼液治疗)。采用倾向性评分对研究对象一般资料进行匹配分析。Log-binomial回归分析两组患者的不良反应发生风险。重复测量方差分析泪膜稳定性指标。双重差分(DID)模型评估联合治疗对泪液蛋白水平变化的净效果。

结果：校正匹配后最终纳入患者172例344眼，对照组与观察组各86例172眼。对照组男51例，女35例，平均年龄35.91±10.10岁； 观察组男49例，女37例，平均年龄37.87±8.09岁。治疗后两组患者各项症状积分较治疗前均呈下降趋势(均P<0.05)； 且观察组患者在治疗后2、4 wk的各项症状积分显著低于对照组(均P<0.05)。观察组总有效率(89.5%)较对照组(77.9%)显著提升(P<0.05)，总不良反应发生率(7.0%)较对照组(36.0%)显著降低(RR=0.133，P<0.001)。与治疗前相比，两组患者治疗后2、4 wk的BUT、SⅠt均上升，FL评分下降(均P<0.017)。治疗后2、4 wk，观察组的BUT和SⅠt水平显著高于对照组，FL评分显著低于对照组(均P<0.05)。DID模型显示观察组患者的乳铁蛋白、总蛋白质、分泌型免疫球蛋白A、溶菌酶较对照组分别多升高0.411 g/L，2.792 g/L，14.610 mg/L，0.419 g/L(均P<0.05)，且校正协变量后，仍高于对照组。

结论：当归饮子加味联合双氯芬酸钠滴眼液治疗可显著改善过敏性结膜炎患者的泪膜稳定性指标和泪膜蛋白水平，其治疗疗效较单纯双氯芬酸钠滴眼液治疗更好。

METHODS:Prospective study. Patients with allergic conjunctivitis who attended Suzhou Hospital of Integrated Traditional Chinese and Western Medicine from March 2021 to August 2024 were enrolled as study subjects. They were divided into two groups based on their treatment regimen: a control group(treated with diclofenac sodium eye drops alone)and an observation group(treated with modified Danggui Yinzi decoction combined with diclofenac sodium eye drops). Propensity score matching was used to balance baseline characteristics between the two groups. Log-binomial regression was performed to estimate the risk of adverse reactions. Repeated-measures analysis of variance(ANOVA)was used to assess tear film stability indicators. A difference-in-differences(DID)model was employed to assess the net effect of the combined therapy on changes in tear protein levels.

RESULTS:After propensity score matching, a total of 172 patients(344 eyes)were finally enrolled, with 86 patients(172 eyes)in each of the control and observation groups. In the control group, there were 51 males and 35 females, with a mean age of 35.91±10.10 y; in the observation group, there were 49 males and 37 females, with a mean age of 37.87±8.09 y. After treatment, symptom scores decreased in both groups compared with baseline(all P<0.05). At 2 and 4 wk after treatment, symptom scores in the observation group were significantly lower than those in the control group(all P<0.05). The overall response rate was significantly higher in the observation group(89.5%)than in the control group(77.9%)(P<0.05), while the incidence of total adverse reactions was significantly lower in the observation group(7.0%)than in the control group(36.0%)(RR=0.133, P<0.001). Compared with baseline, both groups showed increases in BUT and SⅠt, and a decrease in FL score at 2 and 4 wk after treatment(P<0.017). At 2 and 4 wk after treatment, the BUT and SⅠt levels in the observation group were higher than those in the control group, and the FL score was significantly lower(all P<0.05). The DID model showed that the observation group had greater increases than the control group in lactoferrin(0.411 g/L), total protein(2.792 g/L), secretory immunoglobulin A(14.610 mg/L), and lysozyme(0.419 g/L), respectively(all P<0.05), and these differences remained significant after adjusting for covariates.

CONCLUSION:Modified Danggui Yinzi decoction combined with diclofenac sodium eye drops significantly improves tear film stability indicators and tear protein levels in patients with allergic conjunctivitis, and its therapeutic efficacy is superior to that of diclofenac sodium eye drops alone.