中药联合玻璃体腔内注射雷珠单抗治疗糖尿病性黄斑水肿的疗效观察

Intravitreal Ranibizumab Injection Combining with TCM in Treating Diabetic Macular Edema

目的观察自拟益气活血利水方联合玻璃体腔内注射雷珠单抗治疗糖尿病性黄斑水肿(DME)的临床疗效。方法将58例(76眼)糖尿病性黄斑水肿患者随机分为治疗组和对照组,每组38眼。对照组给予玻璃体腔内注射雷珠单抗,每月1次,连续3月,治疗组在对照组治疗基础上加用自拟益气活血利水方,每日2次,疗程均为3月,观察治疗前后患者最佳矫正视力(BCVA)、黄斑中央视网膜厚度(CMT)及荧光素眼底血管造影(FFA)的改变,综合评价疗效。结果治疗后各时间点2组BCVA及CMT的改善程度均较治疗前显著好转(P<0.05),但至治疗后6月对照组BCVA呈现下降趋势,CMT呈现上升趋势,而治疗组疗效保持平稳,治疗后3月及6月2组间差异有统计学意义(P<0.05),治疗后6月对照组病例有效率为65.8%,治疗组有效率为86.8%,2组间比较差异有统计学意义(P<0.05)。结论采用自拟益气活血利水方联合玻璃体腔内注射雷珠单抗治疗糖尿病性黄斑水肿可有效减轻视网膜渗漏及黄斑水肿,更能稳定现存视力,推迟复发时间。

OBJECTIVE To investigate the clinical efficacy of intravitreal injection of Ranibizumab combined with Tradition- al Chinese Medicine in the treatment of diabetic macular edema. METHODS The 58 patients（76 eyes）with diabetic macular e- dema were randomly divided into two groups （treatment group and the control group）. The control group（n = 38）was treated with intravitreal injection of Ranibizumab, one time per month for three month. And the treatment group（n = 38）was treated with intravitreal injection of Ranibizumab combined with privately made Yiqihuoxuelishui Fang twice a day for three months. The changes of BCVA, CMT and FFA were observed to assess the effect. RESULTS The BCVA and CMT values of the two groups were significantly improved in each time period after treatment（P〈0.05）, but the BCVA presented down trend and the CMT presented up trend in the control group after 6 months of treatment, while they were both steady in the treatment group. There was statistically significant difference between the two groups after 3 and 6 months of treatment （P〈0.05）. The effec- tive rate was 65.8% in the control group after six months. The effective rate of treatment group was 86.8%. The difference is of statistical significance（P〈0.05）. CONCLUSION Intravitreal injection of Ranibizumab combined with privately made Yiqi- huoxuelishui Fang can effectively reduce the leakage of retina and macular edema, preserve existing visual acuity, delay the re- currence time.