和血明目片联合阿柏西普治疗糖尿病性黄斑水肿疗效观察

Effect Observation of Hexue Mingmu Tablet Combined with Aflibercept in the Treatment of Diabetic Macular Edema

[目的]观察和血明目片联合阿柏西普治疗糖尿病性黄斑水肿阴虚夹瘀证的临床疗效。[方法]选取糖尿病性黄斑水肿阴虚夹瘀证患者63例作为研究对象,随机分为观察组32例和对照组31例。两组均予阿柏西普玻璃体腔内注射,每眼每次0.05 ml,每月1次,连续治疗5个月。在此基础上,观察组同时予和血明目片常规剂量口服。比较两组临床疗效,治疗前后的中医症状及体征评分、最佳矫正视力、黄斑中心凹视网膜厚度、血清炎症因子水平、D-二聚体水平,随访1年内阿柏西普的注药次数。[结果]两组患者共脱落12例,最终观察组27例和对照组24例完成观察。观察组临床疗效优于对照组,差异有统计学意义(P<0.05)。治疗后两组视物模糊、眼前黑影、微血管瘤、眼底出血及眼底渗出均明显改善(P<0.05);观察组口渴多饮、心烦失眠、头晕目眩均明显改善(P<0.05),但对照组无明显改善(P>0.05);治疗后各项症状和体征评分观察组均优于对照组(P<0.05)。治疗后两组最佳矫正视力提高,黄斑中心凹视网膜厚度减小,且观察组显著优于对照组(P<0.05)。两组血清炎症因子、D-二聚体水平均较治疗前降低,且观察组显著低于对照组(P<0.05)。两组随访1年,观察组阿柏西普注药次数少于对照组,差异有统计学意义(P<0.05)。[结论]和血明目片联合阿柏西普治疗糖尿病性黄斑水肿阴虚夹瘀证患者,不仅能改善临床症状及体征,提高视力,促进黄斑水肿消退,改善血液高凝状态及抑制血清炎症因子,还可减少阿柏西普注药次数。

[Objective]To observe the effect of Hexue Mingmu tablet combined with Aflibercept in the treatment of diabetic macular edema(type of yin deficiency with blood stasis).[Methods]Sixty three patients with diabetic macular edema(type of yin deficiency with blood stasis)were selected and randomly divided into the observation group with 32cases and the control group with 31 cases.Both groups were given intravitreal injection of Aflibercept,0.05 ml per eye,once a month in 5 straight months.On this basis,the observation group was also given regular dose of Hexue Mingmu tablet orally.Then the clinical efficacy,the scoring of symptoms in TCM and physical sign,the best corrected visual acuity,the macular fovea retinal thickness,serum inflammatory factor level,D-dimer level before and after treatment,and the number of Aflibercept injection in 1-year follow-up in these two groups were compared.[Results]Due to the drop-out of 12 patients,27 in the observation group and 24 in the control group completed the observation.The clinical efficacy of the observation group was significantly better than that of the control group(P<0.05).Blurred vision,dark shadow,microhemangioma,fundus hemorrhage and exudation were improved in both groups(P<0.05).In the observation group,excessive thirst,insomnia with restlessness and dizziness were significantly improved(P<0.05),but there was no significant improvement in control group(P>0.05).After treatment,all symptoms and signs scoring in the observation group were better than those in the control group(P<0.05).The best corrected visual acuity was improved and the macular fovea retinal thickness was reduced after treatment in both groups compared to those before treatment,and these efficacy in the observation group was better than that of the control group(P<0.05).The levels of serum inflammatory factors and D-dimer in both groups were significantly decreased after treatment compared to those before treatment,and the levels in the observation group was lower than that of the control group(P<0.05).The number of Aflibercept injection in1-year follow-up in the observation group was significantly less than that in the control group(P<0.05).[Conclusion]Hexue Mingmu tablet combined with Aflibercept in the treatment of diabetic macular edema(type of yin deficiency with blood stasis)can not only effectively improve clinical symptoms and sighs,improve vision,promote the regression of macular edema,improve blood hypercoagulability and inhibit serum inflammatory factors,but also reduce the number of Aflibercept injection.