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OA北大核心CSTPCD
Clinical trial of calcium dobesilate in the treatment of diabetic retinopathy patients with macular edema
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50 μL,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 50 μL 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 pro-angiogenic factors[vascular endothelial growth factor(VEGF),stromal cell-derived factor 1(SDF-1)]and aqueous humor hypoxic response factors[erythropoietin(EPO),hypoxia-inducible factor-1 α(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-1α in 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 control group(all P＜0.05).The adverse drug reactions in the treatment group and the control group mainly included transient elevated intraocular pressure,vitreous hemorrhage,and gastrointestinal reactions.The incidence of adverse drug reactions in the treatment group and the control group were 14.29％(8 cases/56 cases)and 12.50％(6 cases/48 cases),respectively.There was no statistically significant difference(P＞0.05).Conclusion Calcium dobesilate capsules combined with conbercept ophthalmic injection has an exact efficacy in the treatment of diabetic retinopathy with macular edema.It has obvious advantages in improving visual acuity and fundus microcirculation,and has good safety.
吴定勇;徐雅萍;李婉婷
上饶爱尔眼科医院 眼底病科,江西 上饶 334000
药学
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
calcium dobesilate capsulesconbercept ophthalmic injectiondiabetic retinopathymacular edemaefficacysafety
《中国临床药理学杂志》 2024 (020)
2944-2948 / 5
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