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