三消内障方联合雷珠单抗玻璃体腔注射治疗糖尿病性黄斑水肿的疗效观察

Clinical observation on diabetic macular edema managed by Sanxiao Neizhang formula and ranibizumab in jection in vitreous chamber

目的观察三消内障方联合玻璃体腔注射雷珠单抗治疗糖尿病性黄斑水肿(DME)的临床疗效。方法中医辨证为气阴两虚证的DME患者78例(78只眼),随机分成两组。治疗组39例(39只眼),予以雷珠单抗0.5 mg玻璃体腔注射,同时从注射日开始口服三消内障方1个月;对照组39例(39只眼)仅行雷珠单抗0.5 mg玻璃体腔注射治疗。于注射前、注射后1个月进行最佳矫正视力(BCVA)及黄斑中心视网膜厚度(CMT)检查,比较两组视力及黄斑厚度变化并评价疗效。结果注射1个月后,两组的BCVA较治疗前都有所提高,黄斑视网膜厚度较治疗前都有所降低,治疗组两项指标改善更明显(P<0.05),且均优于对照组(P<0.05)。首次注射后,治疗组需再次注射者19只眼(19/39,48.72%),对照组为26只眼(26/39,66.67%),治疗组低于对照组,但组间差异无统计学意义(χ~2=2.574,P=0.109)。结论三消内障方联合雷珠单抗玻璃体腔注射治疗DME的疗效优于单纯玻璃体腔注射雷珠单抗。

OBJECTIVE To observe the clinical effect of combination of Sanxiao Neizhang formula and intravitreal injection of ranibizumab on diabetic macular edema（DME）. METHODS A total of 78 DME patients（78 eyes） with Qi-Yin deficiency syndrome were randomly divided into two groups. In the treatment group, 39 patients（39 eyes） were injected with 0.5 mg ranibizumab in vitreous chamber in the operating room, and taken Sanxiao Neizhang formula from the same day for 1 month. In the control group, 39 patients（39 eyes） received 0.5 mg ranibizumab vitreous injection alone. Best corrected visual acuity（BCVA） and central macular thickness（CMT） were examined before and 1 month after the injection. Changes in visual acuity and macular thickness were com-pared between the two groups and the curative effect was evaluated. RESULTS One month after injection, the BCVA of both groups were improved, and the difference of the treatment group was statistically significant（P〈0.05） and the result of treatment group was better than control group（P〈0.05）. The thickness of macular area decreased in both groups after treatment, and the difference of treatment groups was of statistical significance（P〈0.05）, moreover comparison between two groups showed the result of treatment group was better（P〈0.05）. Nineteen eyes（19/39, 48.72%） in the treatment group and 26 eyes（26/39, 66.67%） in the control group were injected again. The difference between two groups was not statistically significant（χ~2=2.574,P =0.109）. CONCLUSIONS The therapeutic effect of Sanxiao Neizhang formula combined with ranibizumab injection on DME was better than it of ranibizumab injection alone.