羟苯磺酸钙治疗糖尿病视网膜病变黄斑水肿患者的临床研究  

Clinical trial of calcium dobesilate in the treatment of diabetic retinopathy patients with macular edema

作　　者：吴定勇 徐雅萍 李婉婷 WU Ding-yong;XU Ya-ping;LI Wan-ting(Department of Fundus Disease,Shangrao Aier Eye Hospital,Shangrao 334000,Jiangxi Province,China)

机构地区：[1]上饶爱尔眼科医院眼底病科,江西上饶334000

出　　处：《中国临床药理学杂志》2024年第20期2944-2948,共5页The Chinese Journal of Clinical Pharmacology

摘　　要：目的探究羟苯磺酸钙胶囊联合康柏西普眼用注射液治疗糖尿病视网膜病变黄斑水肿患者的临床疗效及安全性。方法将糖尿病视网膜病变黄斑水肿患者按队列法分为对照组和试验组。对照组给予玻璃体腔内注射康柏西普眼用注射液,每次50μL,每月1次;试验组在对照组治疗的基础上,给予羟苯磺酸钙胶囊,每次0.5 g,口服,tid。2组患者均治疗3个月。比较2组患者治疗后的临床疗效、眼部恢复指标[最佳矫正视力(BCVA)、黄斑中心凹视网膜厚度(CMT)]、房水促血管生成因子[血管内皮生长因子(VEGF)、基质细胞衍生因子1(SDF-1)]水平、房水低氧应答因子[促红细胞生成素(EPO)、缺氧诱导因子1α(HIF-1α)],并进行安全性评价。结果试验组和对照组分别纳入48例和56例。治疗3个月后,试验组和对照组总有效率分别为92.86%(52例/56例)和79.17%(38例/48例),在统计学上差异有统计学意义(P<0.05)。治疗3个月后,试验组和对照组BCVA分别为(0.58±0.14)和(0.45±0.12)logMAR,CMT分别为(281.22±37.68)和(329.52±46.74)μm,房水的VEGF表达量分别为(141.56±22.49)和(164.22±32.51)ng·L^(-1),房水的EPO表达量分别为(8.03±2.72)和(9.69±3.11)mU·mL^(-1),房水的HIF-1α表达量分别为(168.18±69.52)和(221.47±72.46)mg·L^(-1),房水的SDF-1表达量分别为(465.32±76.28)和(526.82±94.43)mg·L^(-1)。试验组的上述指标与对照组比较,在统计学上差异均有统计学意义(均P<0.05)。试验组和对照组发生的药物不良反应主要有一过性眼压升高、玻璃体积血、胃肠道反应。试验组和对照组的药物不良反应发生率分别为14.29%(8例/56例)和12.50%(6例/48例),在统计学上差异无统计学意义(P>0.05)。结论羟苯磺酸钙胶囊联合康柏西普眼用注射液治疗糖尿病视网膜病变黄斑水肿疗效确切,在提高视力、改善眼底微循环方面具有明显优势,且安全性较好。Objective To explore the clinical efficacy and safety of calcium dobesilate capsules combined with conbercept in the treatment of diabetic retinopathy with macular edema.Methods Patients with diabetic retinopathy complicated with macular edema were divided into control group and treatment group by cohort method.The control group was given intravitreal injection of conbercept ophthalmic injection 50μL every time once a month.On the basis of the treatment in the control group,the treatment group was orally treated with calcium dobesilate capsules 0.5 g three times a day.Both groups were treated for 3 months.The efficacy after treatment,and ocular recovery indexes[best corrected visual acuity(BCVA),central macular thickness(CMT)],aqueous humor proangiogenic factors[vascular endothelial growth factor(VEGF),stromal cell-derived factor 1(SDF-1)]and aqueous humor hypoxic response factors[erythropoietin(EPO),hypoxia-inducible factor-1α(HIF-1α)]were compared between two groups,and the safety of the two groups was evaluated.Results The treatment group and the control group were included in 48 cases and 56 cases,respectively.After 3 months of treatment,the total effective rates of the treatment group and the control group were 92.86%(52 cases/56 cases)and 79.17%(38 cases/48 cases),and the difference was statistically significant(P<0.05).After 3 months of treatment,the BCVA of the treatment group and the control group were(0.58±0.14)and(0.45±0.12)logMAR,respectively;the CMT were(281.22±37.68)and(329.52±46.74)μm,respectively;the expression of VEGF in aqueous humor were(141.56±22.49)and(164.22±32.51)ng·L^(-1),respectively;the expression of EPO in aqueous humor were(8.03±2.72)and(9.69±3.11)mU·mL^(-1),respectively;the expression levels of HIF-1αin aqueous humor were(168.18±69.52)and(221.47±72.46)mg·L^(-1),respectively;the expression levels of SDF-1 in aqueous humor were(465.32±76.28)and(526.82±94.43)mg·L^(-1),respectively.The above indexes in the treatment group were significantly different from those in the

关 键 词：羟苯磺酸钙胶囊 康柏西普眼用注射液 糖尿病视网膜病变 黄斑水肿 疗效 安全性 

分 类 号：R97[医药卫生—药品]