目的 观察芪明颗粒联合胰激肽原酶肠溶片治疗2型糖尿病视网膜病变的临床疗效。方法 选择2018年5月-2020年12月河南科技大学第一附属医院接收的2型糖尿病视网膜病变患者100例(158眼),根据信封抽签法将患者分为对照组(50例, 76眼)和治疗组(50例, 82眼)。对照组患者口服胰激肽原酶肠溶片, 1片/次, 3次/d。治疗组在对照组的基础上温水冲服芪明颗粒, 1袋/次, 3次/d。两组均连续用药6个月。观察两组患者疗效,比较两组的视力情况、视网膜血流动力学、血清炎性因子、新生血管指标水平。结果 治疗后,对照组、治疗组的总有效率分别为50.00%、74.39%,组间比较差异有统计学意义(P<0.05)。治疗后,两组患者视野灰度值、视野平均缺损指数较治疗前下降,视力值较治疗前升高(P<0.05);并且治疗组的视野灰度值、视野平均缺损指数低于对照组,视力值高于对照组(P<0.05)。治疗后,两组眼动脉、视网膜中央动脉的阻力指数(RI)较治疗前下降,峰值血流速度(PSV)较治疗前升高(P<0.05);治疗组的眼动脉、视网膜中央动脉的RI低于对照组,眼动脉、视网膜中央动脉PSV高于对照组(P<0.05)。治疗后,两组血清白细胞介素-6(IL-6)、超敏C反应蛋白(hs-CRP)、肿瘤坏死因子-α(TNF-α)水平较治疗前下降(P<0.05);且治疗组的血清IL-6、hsCRP、TNF-α水平显著低于对照组(P<0.05)。治疗后,两组血清血管内皮生长因子(VEGF)、血管生成素-2(Ang-2)水平较治疗前下降(P<0.05),且治疗组的血清VEGF、Ang-2水平低于对照组(P<0.05)。结论 芪明颗粒联合胰激肽原酶肠溶片治疗2型糖尿病视网膜病变具有较好的临床疗效,可改善患者眼底微循环和视功能,降低机体炎症反应,减少血管的过度增生,且不增加不良反应发生。

Objective To observe the clinical effect of Qiming Granules combined with Pancreatic Kininogenase Enteric-coated Tablets in treatment of type 2 diabetic retinopathy.Methods Patients (100 cases, 158 eyes) with type 2 diabetic retinopathy in the First Affiliated Hospital of Henan University of Science and Technology from May 2018 to December 2020 were randomly divided into the control group (50 cases, 76 eyes) and the treatment group (50 cases, 82 eyes). Patients in the control group were po administered with Pancreatic Kininogenase Enteric-coated Tablets, 1 tablet/time, three times daily. Patients in the treatment group were po administered with Qiming Granules on the basis of the control group, 1 bag/time, three times daily. Patients in two groups were treated for 6 months. After treatment, the clinical efficacies were evaluated, and the visual acuity, retinal hemodynamics, serum inflammatory factors and neovascularization indexes in two groups were compared.Results After treatment, the total effective rates of the control group and the treatment group were 50.00% and 74.39%, respectively, and there was significant difference between two groups (P < 0.05). After treatment, the gray value of visual field and the average defect index of visual field in two groups were decreased, but the visual acuity in two groups were increased (P < 0.05). The gray value of visual field and the average defect index of visual field in the treatment group were lower than those in the control group, but the visual acuity in the treatment group was higher than that in the control group (P < 0.05). After treatment, the RI of ophthalmic artery and central retinal artery in two groups were decreased, but the PSV in two groups were increased (P < 0.05). The RI of ophthalmic artery and central retinal artery in the treatment group were lower than those in the control group, but the PSV of ophthalmic artery and central retinal artery in the treatment group were higher than those in the control group (P < 0.05). After treatment, the serum levels of IL-6, hs-CRP, and TNF-α in two groups were decreased compared with those before treatment (P < 0.05), and the serum levels of IL-6, hs-CRP, and TNF-α in the treatment group were significantly lower than those in the control group (P < 0.05). After treatment, the serum levels of VEGF and Ang-2 in two groups were decreased compared with those before treatment (P < 0.05), and the serum levels of VEGF and Ang-2 in the treatment group were lower than those in the control group (P < 0.05).Conclusion Qiming Granules combined with Pancreatic Kininogenase Entericcoated Tablets has clinical curative effect in treatment of type 2 diabetic retinopathy, can improve the fundus microcirculation and visual function, reduce the inflammatory reaction, reduce the excessive proliferation of blood vessels, and do not increase the incidence of adverse reactions.

R988.1

河南省医学科技攻关计划项目(2016020354)