七叶皂苷钠片对糖尿病视网膜病变合并黄斑水肿患者的临床疗效

Clinical effects of Sodium Aescinate Tablets on patients with diabetic retinopathy complicated with macular edema

目的探讨七叶皂苷钠片对糖尿病视网膜病变合并黄斑水肿患者的临床疗效。方法320例(415只患眼)患者随机分为对照组(160例,203只患眼)和观察组(160例,212只患眼)。2组均给予常规治疗,同时对照组给予芪明颗粒,观察组在对照组基础上加用七叶皂苷钠片,疗程3个月。检测临床疗效、眼压、BCVA、logMAR、CMT、黄斑区渗漏、房水生物标志物(IL-1β、IL-6、sICAM-1、PEDF、TGF-β2)、黄斑区微循环指标(FAZ面积、SCP血流密度、DCP血流密度)、CVLQOL评分变化。结果观察组总有效率高于对照组(P<0.05),黄斑区渗漏改善情况更优(P<0.05)。治疗后,2组眼压、BCVA、logMAR、CMT、IL-1β、IL-6、sICAM-1、TGF-β2降低(P<0.05),PEDF、DCP血流密度、CVLQOL评分升高(P<0.05),以观察组更明显(P<0.05),而FAZ面积、SCP血流密度均无明显变化(P>0.05)。结论七叶皂苷钠片可调控糖尿病视网膜病变合并黄斑水肿患者房水IL-1β、IL-6、sICAM-1、PEDF、TGF-β2表达,减轻黄斑区水肿、渗漏,改善黄斑区微循环,提高视功能、生活质量。

AIM To explore the clinical effects of Sodium Aescinate Tablets on patients with diabetic retinopathy complicated with macular edema.METHODS Three hundred and twenty patients(415 affected eyes)were randomly assigned into control group(160 cases,203 affected eyes)for 3-month intervention of both Qiming Granules and conventional treatment,and observation group(160 cases,212 affected eyes)for 3-month intervention of Sodium Aescinate Tablets,Qiming Granules and conventional treatment.The changes in clinical efficacy,intraocular pressure,BCVA,logMAR,CMT,macular area leakage,aqueous humor biomarkers(IL-1β,IL-6,sicAM-1,PEDF,TGF-β2),macular area microcirculation indices(FAZ area,SCP blood flow density,DCP blood flow density)and CVLQOL score were detected.RESULTS The observation group demonstrated higher total effective rate than the control group(P<0.05),along with better improvement of macular area leakage(P<0.05).After the treatment,the two groups displayed decreased intraocular pressure,BCVA,logMAR,CMT,IL-1β,IL-6,sICAM-1,TGF-β2(P<0.05),and increased PEDF,DCP blood flow density,CVLQOL score(P<0.05),especially for the observation group(P<0.05),while no obvious changes in FAZ area and SCP blood flow density were observable(P>0.05).CONCLUSION For the patients with diabetic retinopathy complicated with macular edema,Sodium Aescinate Tablets can regulate aqueous humor IL-1β,IL-6,sicam-1,PEDF and TGF-β2 expressions,alleviate macular area edema and leakage,improve macular area microcirculation,and enhance visual functions and life quality.