康柏西普眼用注射液联合曲安奈德注射液治疗糖尿病性黄斑水肿的临床研究

Clinical trial of Conbercept Ophthalmic Injection combined with Triamcinolone Acetonide Injection in the treatment of the diabetic macular edema

目的研究康柏西普联合曲安奈德对糖尿病性黄斑水肿(DME)患者的血管内皮生长因子(VEGF)、基质细胞衍生囚子-1(SDF-1)和视功能的影响。方法按照随机数字表法将纳入患者分为对照组47例和试验组45例。对照组,取0.5%丙美卡因滴眼液表层麻醉,玻璃体腔内注射曲安奈德0.1 mL;在对照组基础上,试验组每次于玻璃体腔内注射康柏西普50μL,每月1次,持续3次。比较2组的临床疗效、VEGF与SDF-1水平、视功能和药物不良反应(ADR)发生情况。结果治疗后,试验组和对照组总有效率分别为78.72%(37例次/47例次)和95.56%(43例次/45例次);这2组的VEGF分别为(145.11±16.91)和(187.59±24.22)pg·mL^-1;这2组的SDF-1分别为(491.95±56.42)和(561.51±69.33)mg·L^-1;这2组的最佳矫正视力分别为0.55±0.11和0.44±0.08;这2组的黄斑中央凹视网膜厚度分别为(275.56±31.06)和(337.51±37.92)μm;这2组的平均黄斑容积分别为(7.48±0.89)和(8.35±1.15)mm^-3。上述指标:2组间比较差异均有统计学意义(均P<0.05)。2组ADR以一过性高眼压为主,试验组和对照组的发生率分别为2.22%和4.26%,组间比较差异无统计学意义(P>0.05)。结论康柏西普联合曲安奈德可提高DME的疗效,降低VEGF和SDF-1水平,改善视功能。

Objective To study on the effects of Conbercept Ophthalmic Injection(COI)combined with Triamcinolone Acetonide Injection(TAI)on vascular endothelial growth factor(VEGF),stromal cell derived prisoner-1(SDF-1)and visual function of diabetic macular edema(DME).Methods DME patients were divided into two groups:47 in control groups and 45 treatment groups by simple random number method.The control group was treated with 0.1 mL TAI each time,intravitreal injection was performed and topical anesthesia with 0.5%promecaine eye drops.The treatment group was treated with 50μL of COI on the basis of the control group,and injected into vitreous cavity once a month for 3 times.The clinical efficacy,VEGF,SDF-1,visual function and adverse drugs reaction(ADR)before and after treatment were compared between the two groups.Results After treatment,the total effective rates of the treatment group and the control group were 78.72%(37 cases/47 cases)and 95.56%(43 cases/45 cases);VEGF in the two groups were(145.1116.91)and(187.59±24.22)pg·mL^-1;SDF-1 in the two groups were(491.95±56.42)and(561.51±69.33)mg·L^-1;the best corrected visual acuity of the two groups were 0.55±0.11 and 0.44±0.08;the retinal thickness of fovea fovea in the two groups were(275.56±31.06)and(337.51±37.92)μm;the average macular volume in the two groups were(7.48±0.89)and(8.35±1.15)mm-3.The differences of the indicators between the two groups were statistically significant(all P<0.05).Transient ocular hypertension was the main complication in the two groups.The incidence of ADR in treatment group and control group were 2.22%and 4.26%,there was no significant difference between the two groups(P>0.05).Conclusion COI combined with TAI can improve the curative effect of DME,reduce the level of VEGF and SDF-1,and improve visual function.