目的：观察补阳还五汤加味治疗气阴两虚、络脉瘀阻型非增殖型糖尿病视网膜病变(NPDR)的临床疗效，并应用光学相干断层扫描血管成像(OCTA)定量分析治疗前后视盘旁血流密度的变化。

方法：采用前瞻性随机对照试验。收集2022-06/11期间我院收治的符合气阴两虚、络脉瘀阻型NPDR患者58例99眼，随机分为对照组29例48眼，采用2019年美国眼科学会发布的糖尿病视网膜病变推荐方案进行基础治疗(对于轻度NPDR患者进行控制血糖、糖尿病健康教育、定期随访； 中度NPDR患者必要时增加局部或格栅样激光光凝治疗)，观察组29例51眼在对照组的基础上加用补阳还五汤加味口服治疗1mo。比较两组患者治疗前后最佳矫正视力(BCVA)、中医证候疗效、视盘旁放射状毛细血管网血流密度(ppVD)及视盘旁视网膜神经纤维层(pRNFL)厚度变化。

结果：治疗1mo后观察组BCVA(LogMAR)为0.20(0.10，0.30)，较对照组0.30(0.20，0.40)明显改善(P<0.05)。治疗1mo后观察组中医证候疗效优于对照组(P<0.05)。观察组治疗1mo后各象限ppVD均较治疗前明显提高，且观察组各象限ppVD均高于对照组(P<0.05)。观察组治疗1mo后上方、颞侧象限及全周平均pRNFL厚度较治疗前升高，且观察组上方、颞侧、下方象限和全周平均pRNFL厚度均高于对照组(P<0.05)。

结论：气阴两虚、络脉瘀阻型NPDR患者服用补阳还五汤加味后可改善视力、提高中医证候疗效，可能与其能提高视盘旁放射状毛细血管网血流密度和减少视盘旁神经纤维层的损伤有关。

METHODS:A randomized controlled trial was used to collect a total of 58 patients(99 eyes)with qi and yin deficiency and stagnation of collaterals NPDR who visited our hospital from June 2022 to November 2022, and patients were randomly divided into an observation group(n=29, 51 eyes)and a control group(n=29, 48 eyes). The control group received basic treatment according to the recommendations for DR published by the American Academy of Ophthalmology in 2019(blood glucose control, diabetes health education, and regular follow-up for patients with mild NPDR; and add local/grid-like laser photocoagulation if necessary for patients with moderate NPDR), while the observation group received modified Buyang Huanwu Decoction in addition to the basic treatment for 1mo. The best-corrected visual acuity(BCVA), traditional Chinese medicine(TCM)efficacy, peripapillary telangiectasia vessel density(ppVD), and changes in peripapillary retinal nerve fiber layer(pRNFL)thickness were compared between the two groups before and after treatment.

RESULTS:The BCVA(LogMAR)of the observation group was 0.20(0.10, 0.30)after 1mo of treatment, which was significantly improved compared with that of the control group of 0.30(0.20, 0.40; P<0.05). The TCM efficacy in the observation group after 1mo of treatment was better than that in the control group(P<0.05). The ppVD in all quadrants of the observation group showed a significant improvement at 1mo after treatment, and the ppVD in all quadrants of the observation group was higher than that of the control group(P<0.05). The pRNFL thickness in the superior, temporal, and average peripapillary areas of the observation group increased after 1mo of treatment, and the pRNFL thickness in the superior, temporal, inferior quadrants, and average peripapillary area of the observation group was higher than that of the control group(P<0.05).

CONCLUSION:Modified Buyang Huanwu Decoction can improve visual acuity and enhance TCM efficacy in patients with NPDR of qi and yin deficiency and stagnation of collaterals. It may be related to its ability to improve ppVD and reduce damage to the pRNFL.