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目的:观察益气养阴通络方联合西药治疗气阴两虚、络脉瘀阻型糖尿病视网膜病变患者的疗效。方法:选取116例气阴两虚、络脉瘀阻型糖尿病视网膜病变患者,随机分为对照组58例及研究组58例。2组均予常规治疗,研究组再予益气养阴通络方治疗。观察2组治疗前后血液流变学指标、肿瘤坏死因子-α(TNF-α)、血管内皮细胞生长因子(VEGF)、眼底检查评分、视力及中医证候评分的变化,并评估用药安全性。结果:总有效率对照组68.9%,研究组84.4%,2组比较,差异有统计学意义(P<0.01)。治疗后,对照组血浆黏度低于治疗前(P<0.05),研究组血浆黏度、红细胞压积、纤维蛋白原水平均低于治疗前(P<0.05),而红细胞变形指数高于治疗前(P<0.05);研究组血浆黏度、红细胞压积、纤维蛋白原水平均低于对照组(P<0.05),红细胞变形指数高于对照组(P<0.05)。治疗后,2组TNF-α、VEGF水平与眼底检查评分、中医证候评分均较治疗前降低(P<0.01,P<0.05),视力水平高于治疗前(P<0.05),研究组TNF-α、VEGF水平与眼底检查评分、中医证候评分均低于对照组(P<0.01,P<0.05),视力水平高于对照组(P<0.05)。2组患者在治疗过程中均未见严重不良反应事件,肝肾功能未见明显异常,均安全出组。结论:在常规治疗基础上加用益气养阴通络方治疗气阴两虚、络脉瘀阻型糖尿病视网膜病变患者安全有效,能有效改善患者的微循环,降低炎性反应,提高视力。
Objective: To observe the curative effect of Yiqi Yangyin Tongluo Recipe combined with western medicine in the treatment of Qi and Yin Deficiency and collaterals stasis type diabetic retinopathy. Methods: One hundred and sixty-six patients with Qi-Yin Deficiency Syndrome and Collaterals Stagnation Type Diabetic Retinopathy were randomly divided into control group (58 cases) and study group (58 cases). Both groups were given conventional treatment, and the study group was treated with Yiqi Yangyin Tongluo Formula. The changes of hemorheology index, tumor necrosis factor-α (TNF-α), vascular endothelial growth factor (VEGF), fundus examination score, visual acuity and TCM syndrome score were observed before and after treatment. The safety of medication was evaluated. Results: The total effective rate was 68.9% in the control group and 84.4% in the study group. There was significant difference between the two groups (P <0.01). After treatment, the plasma viscosity of the control group was lower than that before treatment (P <0.05). The plasma viscosity, hematocrit and fibrinogen levels of the control group were lower than those before treatment (P <0.05), while the erythrocyte deformability index <0.05). The plasma viscosity, hematocrit and fibrinogen in the study group were lower than those in the control group (P <0.05). The index of erythrocyte deformability was higher than that in the control group (P <0.05). After treatment, the levels of TNF-α, VEGF, fundus examination and TCM syndrome score in both groups were significantly lower than those before treatment (P <0.01, P <0.05) (P <0.01, P <0.05). The level of visual acuity was higher than that of the control group (P <0.05). Two groups of patients in the course of treatment were not serious adverse events, liver and kidney function no obvious abnormalities were safe out of the group. Conclusion: Based on routine treatment, Qi-Yin Yangyin Tongluo Recipe is used to treat both qi and yin deficiency. Collaterals and stasis-type diabetic retinopathy patients are safe and effective, which can effectively improve microcirculation, reduce inflammatory reaction and improve visual acuity.