目的：分析益气养阴活血汤联合玻璃体腔内注射康柏西普治疗糖尿病性黄斑水肿(DME)疗效及对患者中医证候和血清血管内皮生长因子(VEGF)表达的影响。方法：前瞻性研究。选取2017-01/2019-06河南省中医院眼科门诊及住院诊断为DME患者60例60眼，采用随机数字表法分为两组，对照组30例30眼予以玻璃体腔内注射康柏西普治疗，观察组30例30眼在对照组基础上予以口服益气养阴活血汤治疗。比较两组患者中医症候积分及最佳矫正视力(BCVA)、黄斑中心凹视网膜厚度(CMT)、眼底荧光血管造影(FFA)下视网膜新生血管荧光素渗漏面积(RNV)、血清VEGF表达变化及并发症发生情况。结果：治疗3mo后观察组患者视物昏花、目睛干涩、倦怠乏力、腰膝酸软、口渴喜饮积分低于对照组(P<0.05)； 治疗前后两组患者BCVA、CMT、RNV、血清VEGF比较有差异(P<0.01)，观察组治疗1、3、6mo BCVA优于对照组(P<0.05)； 观察组治疗7、14d，1、3、6mo CMT、RNV、血清VEGF低于对照组(P<0.05)； 两组并发症发生率比较无差异(7% vs 10%，P>0.05)。结论：益气养阴活血汤联合玻璃体腔内注射康柏西普治疗DME疗效较单用康柏西普好，可明显改善患者BCVA、CMT，减少RNV，下调VEGF的表达，促进视网膜水肿吸收，且安全性好。

AIM: To analyze the effect of Yiqi Yangyin Huoxue Decoction combined with Conbercept on diabetic macular edema(DME), and the influence on TCM syndromes and serum vascular endothelial growth factor(VEGF)expression. METHODS: Between January 2017 and June 2019, 60 patients admitted to the ophthalmology department at Henan Province Hospital of Traditional Chinese Medicine were perspective enrolled in the study. They were divided into observation group and control group by random number table method, 30 cases with 30 eyes in each group. The control group were treated with intravitreal injection of Conbercept, while the observation group were treated with Yiqi Yangyin Huoxue Decoction combined with intravitreal injection of Conbercept. Changes in TCM symptom scores, the best corrected visual acuity(BCVA), central macular thickness(CMT), retinal neovascularization(RNV)fluorescein leakage area under fundus fluorescein angiography(FFA)and VEGF expression were compared between the two groups, and complications were recorded.RESULTS: Three months after treatment, the observation group had lower scores for blurred version, dry eyes, fatigue, soreness and weakness of waist and knees, and thirst than the control group(P<0.05). There were statistically significant differences in BCVA between the 2 groups before and after treatment(all P<0.01). The observation group had higher BCVA than the control group at 1mo, 3mo and 6mo(P<0.05). Differences in CMT between the 2 groups before and after treatment were statistically significant(all P<0.01). Besides, the observation group had smaller CMT than the control group at 7d, 14d, 1mo, 3mo and 6mo(P<0.05). There were statistically significant differences in RNV between the two groups before and after treatment(all P<0.01), and the observation group had smaller RNV than the control group at 7d, 14d, 1mo, 3mo and 6mo(P<0.05). Difference in VEGF between the 2 groups before and after treatment were statistically significant(all P<0.01). The VEGF expression level was lower in the observation group than in the control group at 7d, 14d, 1mo, 3mo and 6mo(P<0.05). No statistically significant difference was found in the incidence of complications between the two groups(7% vs 10%, P>0.05).CONCLUSION: Yiqi Yangyin Huoxue Decoction combined with intravitreal injection of Conbercept is more effective than Conbercept alone in the treatment of DME. The former can significantly improve the patient's vision and CMT, reduce leakage area, down regulate the expression of VEGF, and promote the absorption of retinal edema, with good safety.

河南省中医药科学研究专项课题(No.2016ZY2059)