【目的】 探讨加味引火归元化瘀方在糖尿病视网膜病变（DR）患者中的应用效果及其对核转录因子 κB（NF-κB）信号通 路的影响。【方法】 选取2019年1月～2020年4月衡水市第四人民医院眼科收治的阴虚血瘀型DR患者100例（200眼），采用随 机数字表法将患者随机分为对照组和观察组，每组各50例（100眼）。在积极控制血糖的基础上，对照组给予常规西药（卵磷 脂络合碘）治疗，观察组在对照组基础上联合加味引火归元化瘀方治疗，2组疗程均为 3个月。观察 2组患者治疗前、治疗 1 个月和3个月后中医证候积分、NF-κB信号通路关键因子[NF-κB p65、κB抑制性蛋白激酶（IkK）、抑制因子κB（IkB）]、新 生血管生成相关因子[成纤维细胞生长因子21（FGF21）、血管内皮生长因子（VEGF）、血管生成素2（Ang2）]、相关疗效性指标 [糖化血红蛋白（HbA1c）、空腹血糖（FBG）、胰岛素抵抗指数（HOMA-IR）、视野灰度值、最佳矫正视力（BCVA）]的变化情况， 评估2组患者的中医证候疗效和用药安全性。【结果】（1）疗效方面，治疗3个月后，观察组的总有效率为88.00%（44/50），对照 组为 70.00%（35/50），组间比较（χ2检验），观察组的中医证候疗效明显优于对照组（P＜0.05）。（2）中医证候积分方面，治疗 1 个月和 3 个月后，2 组患者的视物昏花、头晕耳鸣、腰膝酸软、五心烦热积分均较治疗前降低（P＜0.05）；且观察组在治 疗 1 个月和 3个月后对视物昏花、头晕耳鸣、腰膝酸软、五心烦热积分的降低幅度均明显优于对照组（P＜0.05）。（3）NF-κB 信号通路关键因子方面，治疗 1个月和 3个月后，2组患者的 NF-κB p65、IkK 蛋白表达水平均较治疗前降低（P＜0.05），IkB 蛋白水平均较治疗前升高（P＜0.05）；且观察组在治疗1个月和3个月后对NF-κB p65、IkK蛋白表达水平的降低幅度及对IkB 蛋白水平的升高幅度均明显优于对照组（P＜0.05）。（4）新生血管生成相关因子方面，治疗 1 个月和 3 个月后，2 组患者的 FGF21、Ang2、VEGF水平均较治疗前降低（P＜0.05）；且观察组在治疗 1 个月和 3 个月后对 FGF21、Ang2、VEGF 水平的降 低幅度均明显优于对照组（P＜0.05）。（5）相关疗效性指标方面，治疗 1 个月和3个月后，2组患者的HbA1c、FBG、HOMAIR、视野灰度值、BCVA值均较治疗前降低（P＜0.05）；且观察组在治疗1个月和3个月后对HbA1c、FBG、HOMA-IR、视野 灰度值、BCVA 值的降低幅度均明显优于对照组（P＜0.05）。（6）安全性方面，观察组的不良反应总发生率为 2.00%（1/50）， 对照组为 8.00%（4/50），组间比较，差异无统计学意义（P＞0.05）。【结论】 加味引火归元化瘀方能有效改善阴虚血瘀型DR 患者临床症状，调节新生血管生成相关因子及NF-κB信号通路关键因子，从而促进病情恢复，且安全性较高。

Objective To investigate the clinical efficacy of Modified Yinhuo Guiyuan Huayu Formula （MYGHF） in diabetic retinopathy （DR） patients with yin deficiency and blood stasis syndrome and to observe its regulatory effects on the nuclear factor κB （NF-κB） signaling pathway. Methods A total of 100 DR patients （200 eyes） with yin deficiency and blood stasis syndrome admitted to the Fourth People’s Hospital of Hengshui from January 2019 to April 2020 were equally randomized into a control group （50 cases，100 eyes） and an observation group （50 cases， 100 eyes） using a random number table. Both groups were required to conduct intensive glycemic control. The control group was treated with conventional western medicine of lecithin-bound iodine， while the observation group received additional MYGHF for 3 months. Parameters of traditional Chinese medicine （TCM） syndrome scores，key components of NF-κB signaling pathway [NF-κB p65，inhibitor of kappa B kinase （IKK），inhibitor kappa B （IκB）]，angiogenesis-related factors [fibroblast growth factor 21（FGF21），vascular endothelial growth factor （VEGF），angiopoietin 2（Ang2）]，and efficacy indicators [glycated hemoglobin （HbA1c），fasting blood glucose （FBG），homeostasis model assessment of insulin resistance （HOMA-IR），visual field grayscale value， and best-corrected visual acuity （BCVA）] in the two groups were evaluated before treatment and 1 and 3 month（s） after treatment. After treatment，the clinical efficacy and safety of the two groups were assessed. Results （1）After 3 months of treatment，the total effective rate was 88.00% （44/50） in the observation group versus 70.00% （35/50） in the control group，demonstrating significantly superior therapeutic effects of TCM syndrome differentiation in the observation group （tested by chi-square test，P＜0.05）.（2） At 1 and 3 month（s） after treatment，both groups showed reduced scores for TCM symptoms of blurred vision， dizziness and tinnitus， soreness and weakness of waist and knees，and feverish sensation in the palms and soles compared to the baseline levels （all P＜0.05）. The observation group exhibited significantly greater reductions in these symptom scores than the control group at both time points （all P＜0.05）.（3）The protein expression levels of NF- κB p65，IKK were decreased and IκB was increased in both groups at 1 and 3 month（s） after treatment compared to the baseline levels （all P＜0.05），and the observation group demonstrated more pronounced improvement of these key pathway components compared to the control group （all P＜0.05）.（4）The levels of angiogenesis-related factors of FGF21，Ang2，and VEGF were significantly reduced in both groups at 1 and 3 month（s） compared to the baseline levels （all P＜0.05），and the observation group showed superior decreases compared to the control group （all P＜0.05）.（5） The efficacy indicators of HbA1c，FBG，HOMA-IR，visual field grayscale values，and BCVA were improved in both groups at post-treatment 1 and 3 month（s） compared to the baseline levels （all P＜0.05），and the observation group achieved significantly superior improvement in all indicators compared to the control group （all P＜0.05）.（6）The total incidence of adverse reactions was 2.00% （1/50） in the observation group versus 8.00% （4/50） in the control group， with no statistically significant difference between groups （P＞0.05）. Conclusion MYGHF effectively alleviates clinical symptoms in patients with DR of yin deficiency and blood stasis type， and is effective on modulating angiogenesis-related factors and suppressing NF- κB signaling pathway activation， demonstrating satisfactory efficacy and good safety profile.

R276.7

国家自然科学基金项目（编号：81960179）；衡水市重点研发计划项目（编号：2023014067Z）