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羟苯磺酸钙胶囊联合雷珠单抗治疗糖尿病视网膜病变黄斑水肿的临床研究
Clinical trial of calcium dobesilate capsules combined with ranibizumab in the treatment of macular edema of diabetic retinopathy
【摘要】 目的观察羟苯磺酸钙联合雷珠单抗治疗糖尿病视网膜病变黄斑水肿的临床疗效和安全性。方法将76例糖尿病视网膜病变黄斑水肿患者随机分为对照组和试验组,每组38例。对照组给予羟苯磺酸钙每次500 mg,每天3次,口服;试验组在对照组治疗的基础上,给予雷珠单抗每次0. 5 mg,玻璃体腔内注射,每隔4周重复注射1次,共治疗3次。比较2组患者的临床疗效、最佳矫正视力(BCVA)、黄斑中心厚度(CMT)及血清血管内皮生长因子(VEGF)、促血管生成素1(Ang-1)、促血管生成素2(Ang-2)和药物不良反应发生情况。结果治疗后,对照组总有效率为78. 95%(30例/38例),试验组为94. 74%(36例/38例),差异有统计学意义(P <0. 05)。治疗后,对照组和试验组血清VEGF分别为(125. 62±25. 67)和(92. 34±22. 79)μg·L-1,血清Ang-1分别为(10. 62±2. 37)和(13. 89±2. 58)μg·L-1,血清Ang-2分别为(5. 29±1. 05)和(4. 23±0. 94)μg·L-1,BCVA分别为0. 61±0. 16和0. 73±0. 15,CMT分别为(265. 41±62. 34)和(203. 17±54. 78)μm,差异均有统计学意义(均P <0. 05)。对照组的药物不良反应发生率为10. 53%(4例/38例),试验组为15. 79%(6例/38例),差异无统计学意义(P> 0. 05)。结论羟苯磺酸钙联合雷珠单抗对糖尿病视网膜病变黄斑水肿的临床疗效确切,有助于改善眼底循环,提高视力。
【Abstract】 Objective To observe the clinical efficacy and safety of calcium dobesilate combined with ranibizumab in the treatment of macular edema of diabetic retinopathy. Methods Seventy-six cases of macular edema of diabetic retinopathy patients were randomly divided into treatment group and control group,38 cases in each group. Control group was given calciumdobesilate 500 mg,tid,orally. Treatment group was given ranibizumab 0. 5 mg on the basis of control group,intravitreal injection,once every 4 weeks,3 times in total. The clinical efficacy,best corrected visual acuity( BCVA),central macular thickness( CMT),serum vascular endothelial growth factor( VEGF),angiopoietin-1( Ang-1),angiopoietin-2( Ang-2) and adverse drug reactions in two groups were observed. Results After treatment,the total effective rates of control group and treatment group were 78. 95%( 30 cases/38 cases),94. 74%( 36 cases/38 cases),with significant difference( P < 0. 05). After treatment,levels of serum VEGF in control group and treatment group were( 125. 62 ± 25. 67) and( 92. 34 ± 22. 79) μg·L-1,serum Ang-1 were( 10. 62 ± 2. 37) and( 13. 89 ± 2. 58)μg·L-1,serum Ang-2 were( 5. 29 ± 1. 05) and( 4. 23 ± 0. 94) μg·L-1,BCVA were 0. 61 ± 0. 16,0. 73 ± 0. 15,CMT were( 265. 41 ± 62. 34) and( 203. 17 ± 54. 78) μm,all with significant differences( all P < 0. 05). The incidence of adverse drug reactions in control group and treatment groups were 10. 53%( 4 cases/38 cases),15. 79%( 6 cases/38 cases),without significant difference( P > 0. 05). Conclusion Calcium dobesilate combined with ranibizumab is effective in macular edema of diabetic retinopathy,which can help improve the fundus circulation and vision.
【Key words】 calcium dobesilate capsule; ranibizumab; diabetic retinopathy; macular edema;
- 【文献出处】 中国临床药理学杂志 ,The Chinese Journal of Clinical Pharmacology , 编辑部邮箱 ,2018年23期
- 【分类号】R587.2;R774.1
- 【被引频次】24
- 【下载频次】217