目的 探讨双丹明目胶囊联合雷珠单抗治疗非增殖性糖尿病视网膜病变（肝肾阴虚证）的临床疗效。方法 纳入2023年1月—2023年12月在新乡医学院第一附属医院治疗的150例非增殖性糖尿病视网膜病变（肝肾阴虚证）患者，按照随机数字表法分为对照组和治疗组，每组各75例。对照组玻璃体腔内注射雷珠单抗注射液，0.5 mg/次，1次/月。治疗组在对照组基础上口服双丹明目胶囊，4粒/次，3次/d。两组患者均治疗4月。观察两组患者临床疗效，比较治疗前后两组患者血管渗漏面积、微血管瘤数、视网膜循环时间、眼压、最小分辨角对数（lgMAR）、黄斑中心凹视网膜厚度（CMT）、黄斑总体积（TMV），视网膜中央动脉收缩期最大流速、舒张末期血流速度和血管阻力指数，炎症因子血管内皮生长因子（VEGF）、白细胞介素-6（IL-6）和IL-1β表达水平。结果 治疗后，治疗组总有效率为92.00%，显著高于对照组总有效率78.67%，两组比较差异有统计学意义（P＜0.05）。治疗后，两组血管渗漏面积、微血管瘤数、视网膜循环时间、lgMAR、CMT、TMV、血管阻力指数、VEGF、IL-6和IL-1β水平均比治疗前显著降低（P＜0.05），而眼压、视网膜中央动脉收缩期最大流速及舒张末期血流速度均显著升高（P＜0.05），且与对照组相比，治疗组患者这些指标改善程度明显更好（P＜0.05）。结论 双丹明目胶囊联合雷珠单抗治疗非增殖性糖尿病视网膜病变（肝肾阴虚证）的临床疗效显著且安全性高，两者联合治疗后能显著提高患者视力，改善视网膜血流状态及降低机体的炎症因子的表达。

Objective To explore the clinical efficacy of Shuangdan Mingmu Capsules combined with ranibizumab in treatment of non-proliferative diabetic retinopathy (liver-kidney yin deficiency syndrome). Methods Patients (150 cases) with non-proliferative diabetic retinopathy (liver-kidney yin deficiency syndrome) in the First Affiliated Hospital of Xinxiang Medical University from January 2023 to December 2023 were divided into control and treatment group according to random number table method, and each group had 75 cases. Patients in the control group were iv administered with Ranibizumab Injections in the vitreous cavity, 0.5 mg/time, once monthly. Patients in the treatment group were po administered with Shuangdan Mingmu Capsules on the basis of the control group, 4 grains/time, three times daily. Patients in two groups were treated for 4 months. After treatment, the clinical evaluations were evaluated, and the vascular leakage area, number of microhemangiomas, retinal circulation time, intraocular pressure, lgMAR, CMT, TMV, the maximum systolic velocity, vascular resistance index, end-diastolic blood flow velocity of the central retinal artery, and the expression levels of VEGF, IL-6 and IL-1β in two groups before and after treatment were compared. Results After treatment, the total effective rate in the treatment group was 92.00%, which was significantly higher than the total effective rate in the control group (78.67%), and there was a statistically significant difference between two groups (P < 0.05). After treatment, the vascular leakage area, the number of microhemangioma, retinal circulation time, logMAR, CMT, TMV, vascular resistance index, VEGF, IL-6 and IL-1β expression levels were significantly reduced in two groups compared with before treatment (P < 0.05), while the intraocular pressure, the maximum systolic flow rate of the central retinal artery and the end diastolic blood flow rate were significantly increased (P < 0.05), and compared with the control group, the improvement of these indicators in the treatment group was significantly better (P < 0.05). Conclusion The clinical efficacy of Shuangdan Mingmu Capsules combined with ranibizumab in treatment of non-proliferative diabetic retinopathy (liver-kidney yin deficiency syndrome) is significant and the safety is high, which can significantly improve patient visual acuity, ameliorate retinal blood flow, and reduce systemic inflammatory factor expression.

R988.1

河南省医学科技攻关计划项目（LHGJ20220611）