【目的】 探讨利水消肿颗粒联合康柏西普治疗糖尿病黄斑水肿（DME）患者的疗效。【方法】 选取2022年12月至2023年6月 佛山市中医院收治的46例（46眼）脾肾阳虚兼瘀阻目络证DME患者为研究对象，根据随机单盲原则，采用随机数字表法将患 者随机分为治疗组和对照组，每组各23例（23眼）。对照组给予康柏西普玻璃体腔注射治疗，治疗组在对照组的基础上给予 利水消肿颗粒口服治疗，疗程为 3 个月并随访至 6 个月。观察 2 组患者治疗前后中医证候积分、最佳矫正视力（BCVA， LogMAR）、黄斑中心视网膜厚度（CMT）、黄斑区浅层毛细血管（SCP）和深层毛细血管（DCP）的平均血流密度（VD）、多焦视网 膜电图（mf-ERG）R1环P1、N1波振幅密度和潜伏期的变化情况。【结果】（1）治疗 1、3、6 个月后，2组患者的BVCA均较前 1个观察时点改善（P＜0.05），且治疗组在治疗 1、3、6个月后对 BVCA 的改善作用均明显优于对照组（P＜0.01）。（2）治疗 1、 3、6个月后，2组患者的 CMT均较前 1个观察时点降低（P＜0.05），且治疗组在治疗 1、3、6个月后对 CMT的降低作用均明 显优于对照组（P＜0.01）。（3）治疗6个月后，2组患者的SCP-VD、DCP-VD均较治疗前无明显变化（P＞0.05），治疗后组间比 较，差异也均无统计学意义（P＞0.05）。（4）治疗 1、3、6 个月后，2 组患者 mf-ERG 检查 R1 环 P1 波和 N1 波振幅密度均较前 1个观察时点增加（P＜0.05），P1波和N1波潜伏期均较前1个观察时点缩短（P＜0.05），且治疗组对mf-ERG检查 R1环 P1波和 N1波振幅密度的增加作用及对 P1波和 N1波潜伏期的缩短作用均明显优于对照组（P＜0.01）。（5）治疗6个月后，治疗组患者 的中医证候积分较治疗前降低（P＜0.01），而对照组无明显降低（P＞0.05）；组间比较，治疗组对中医证候积分的降低作用明 显优于对照组（P＜0.01）。【结论】 利水消肿颗粒联合康柏西普治疗脾肾阳虚兼瘀阻目络证DME，虽然不能显著改善SCP-VD 和DCP-VD，但对于提高BCVA，改善黄斑水肿、黄斑区视网膜功能和全身症状有较好疗效。

Objective To investigate the efficacy of Lishui Xiaozhong Granules combined with Conbercept for the treatment of diabetic macular edema （DME）. Methods From December 2022 to June 2023，46 patients （46 eyes） with DME of spleen and kidney yang deficiency complicated with blood-stasis obstructing the eye collaterals syndrome admitted to Foshan Hospital of Traditional Chinese Medicine were selected as the study objects. According to the principle of single-blind randomized controlled trial， the patients were randomly divided into treatment group and control group by random number table method，with 23 cases （23 eyes） in each group. The control group was treated with intravitreal injection of Conbercept，and the treatment group was treated with oral use of Lishui Xiaozhong Granules on the basis of treatment for the control group. The course of treatment lasted 3 months and then a follow-up for 6 months was conducted. Before and after treatment， the two groups were observed int the changes of traditional Chinese medicine （TCM） syndrome score， best corrected visual acuity （BCVA，LogMAR），central macular thickness （CMT），mean vessel density （VD） of superficial capillary plexus （SCP） and deep capillary plexus （DCP） in macular area，and the amplitude density and the latency of P1 and N1 wave in the R1 ring of multifocal electroretinogram （mf-ERG）. Results （1）After 1， 3 and 6 month（s） of treatment，BVCA in the two groups was improved when compared with that at the previous observation time point （P＜0.05），and the improvement in the treatment group was superior to that in the control group after 1，3 and 6 month（s） of treatment （P＜0.01）.（2） After 1，3 and 6 month（s） of treatment，the CMT of the two groups was lowered as compared with that at the previous observation time point （P＜0.05），and the decrease in the treatment group was significantly superior to that in the control group （P＜0.01）.（3） After 6 months of treatment，SCP-VD and DCP-VD in the two groups showed no obvious changes when compared with those before treatment （P＞0.05）， the differences between the two groups after treatment were no statistically significant，either （P＞0.05）.（4） After 1，3 and 6 month（s） of treatment，the amplitude densities of P1 wave and N1 wave in the R1 ring of mf-ERG in the two groups were increased when compared with those at the previous observation time point （P＜0.05），and the latency of P1 wave and N1 wave was shortened when compared with that at the previous observation time point （P＜0.05），and the treatment group had stronger effect on increasing the amplitude densities and on shortening the latency than the control group （P＜0.01）.（5） After 6 months of treatment，the scores of TCM syndromes in the treatment group were lowered （P＜0.05） while the scores in the control group showed no obvious changes as compared with those before treatment. The intergroup comparison showed that the decrease of TCM syndrome score in the treatment group was significantly superior to that in the control group （P＜0.01）. Conclusion In the treatment of DME with spleen and kidney yang deficiency complicated with blood-stasis obstructing the eye collaterals syndrome，Lishui Xiaozhong Granules combined with Conbercept have no influence on improving the SCP-VD and DCP-VD， but the combined therapy exerts satisfactory efficacy on increasing BCVA and on improving macular oedema，retinal function in the macular area and systemic symptoms.

R259.872

广东省医学科研基金项目（编号：B2021340）；佛山市自筹经费类科技计划项目（编号：2220001004237）；国家中医药管理局 中医眼科专病（糖尿病性黄斑水肿）循证能力提升建设项目（编号：2019XZZX-YJ002）