Abstract:

Objective　To explore the curative effect of Huayu Fuming Decoction combined with calcium oxybenzenesulfonate capsules for patients with diabetic retinopathy (DR). Methods　One hundred and four patients with DR treated at Ankang Hospital of Traditional Chinese Medicine from May 2020 to May 2023 were selected for the randomized control trial, and were divided into a control group (52 cases) and a treatment group (52 cases) by the random number table method. There 29 males and 23 females in the control group; they were (45.91±1.83) years old. There were 27 males and 25 females in the treatment group; they were (45.82±1.79) years old. The control group were treated with calcium oxybenzenesulfonate capsules,0.5 g each time, 3 times a day, and the treatment group with calcium oxybenzenesulfonate capsules and Huayu Fuming decoction, 200 ml was 1 dose, 1 dose per day, for 1 month. The Chinese medicine syndromes, scores of Chinese version of Quality of Life Scale for Low Vision (CLVQOL), macular thicknesses, blood spot areas, levels of blood glucose indicators, and serum levels of vascular endothelial growth factor (VEGF), platelet-derived growth factor (PDGF), and interleukin-1 (IL-1) were compared between the two groups before and after treatment. The efficacies the and adverse reactions in both groups were statistically analyzed. t and χ² tests were used for the statistical comparison. Results　The total effective rate of the treatment group was higher than that of the control group [96.15% (50/52) vs. (82.69% (43/52), with a statistical difference (χ²=4.98, P=0.026). After the treatment, the scores of traditional Chinese medicine syndrome and CLVQOL in the treatment group were better than those in the control group [(7.28±1.36) vs. (11.71±1.50) and (113.25±10.48) vs. (89.76±8.17)], with statistical differences (t=15.78 and 12.75; both P<0.05). After the treatment, the macular thickness and the area of blood stains decreased in both groups. After the treatment, the macular thickness and blood spot area in the treatment group were lower than those in the control group [(306.42±11.09) μm vs. (355.37±13.17) μm and (1.04±0.26) mm² vs. (1.85±0.37) mm²], with statistical differences (t=20.50 and 12.92; both P<0.001). After the treatment, the levels of fasting blood glucose (FBG), 2 h fasting blood glucose (2 hFBG), and glycosylated hemoglobin (HbAlc) in the treatment group were lower than those in the control group [(6.30±1.18) mmol/L vs. (7.35±1.24) mmol/L, (15.40±4.25) mmol/L vs. (17.35±4.32) mmol/L, and (3.76±0.95) μmol/L vs. (5.41±1.12) μmol/L], with statistical differences (t=4.42, 2.32, and 8.10; all P<0.05). After the treatment, the levels of VEGF, PDGF, and IL-1 in the treatment group were lower than those in the control group [(88.75±14.03) μg/L vs. (136.22±17.41) μg/L, (4.43±0.97) μg/L vs. (6.12±1.08) μg/L, (21.06±4.05) ng/L vs. (25.42±4.57) ng/L], with statistical differences (t=15.31, 8.40, and 3.97; all P<0.05). The incidence of adverse reactions in the treatment group was lower than that in the control group [3.85% (2/52) vs. 15.38% (8/52)], with a statistical difference (χ²=3.98; P<0.05). Conclusion　Huayu Fusing Decoction combined with calcium oxybenzenesulfonate capsules for patients with DR has ideal effect, and can improve their traditional Chinese medicine syndromes and quality of life, and reduce macular injury, blood glucose level, and serum levels of VEGF, PDGF, and IL-1, with a low incidence of adverse reactions and good safety, so it is worthy of promotion.

Key words:

Diabetic retinopathy, Vascular endothelial growth factor, Huayu Fuming Decoction, Calcium oxybenzenesulfonate, Platelet-derived growth factor

摘要：

目的　探讨化瘀复明汤联合羟苯磺酸钙治疗糖尿病视网膜病变（DR）患者的疗效。方法　前瞻性研究，按随机数字表法将安康市中医医院2020年5月至2023年5月收治的104例DR患者分为对照组（52例）与治疗组（52例）。对照组男29例，女23例，年龄（45.91±1.83）岁，给予羟苯磺酸钙胶囊治疗，0.5 g/次，3 次/d。治疗组男27例，女25例，年龄（45.82±1.79）岁，在对照组的基础上联合化瘀复明汤治疗，200 ml为1剂，每日1剂。两组均治疗１个月。比较两组治疗前、后中医证候及中文版低视力者生活质量量表（CLVQOL）评分、黄斑厚度、出血斑面积、各血糖指标、血清血管内皮生长因子（VEGF）、血小板衍生生长因子（PDGF）及白细胞介素-1（IL-1）水平变化，统计两组疗效与不良反应发生情况。统计学方法采用t检验、χ²检验。结果　治疗组总有效率高于对照组［96.15%（50/52）比82.69%（43/52）］，差异有统计学意义（χ²=4.98，P=0.026）。治疗后，治疗组中医证候积分低于对照组［（7.28±1.36）分比（11.71±1.50）分］，CLVQOL评分高于对照组［（113.25±10.48）分比（89.76±8.17）分］，差异均有统计学意义（t=15.78、12.75，均P<0.05）。治疗后，治疗组黄斑厚度、出血斑面积均低于对照组［（306.42±11.09）μm比（355.37±13.17）μm、（1.04±0.26）mm²比（1.85±0.37）mm²］，差异均有统计学意义（t=20.50、12.92，均P<0.001）。治疗后，治疗组空腹血糖（FBG）、2 hFBG、糖化血红蛋白（HbAlc）水平均低于对照组［（6.30±1.18）mmol/L比（7.35±1.24）mmol/L、（15.40±4.25）mmol/L比（17.35±4.32）mmol/L、（3.76±0.95）μmol/L比（5.41±1.12）μmol/L］，差异均有统计学意义（t=4.42、2.32、8.10，均P<0.05）。治疗后，治疗组VEGF、PDGF、IL-1水平均低于对照组［（88.75±14.03）μg/L比（136.22±17.41）μg/L、（4.43±0.97）μg/L比（6.12±1.08）μg/L、（21.06±4.05）ng/L比（25.42±4.57）ng/L］，差异均有统计学意义（t=15.31、8.40、3.97，均P<0.05）。治疗组不良反应发生率低于对照组［3.85％（2/52）比15.38％（8/52）］，差异有统计学意义（χ²=3.98，P<0.05）。结论　化瘀复明汤联合羟苯磺酸钙治疗DR患者疗效理想，能够改善中医证候、提升生活质量、减轻黄斑损伤和血糖水平，降低血清VEGF、PDGF及IL-1水平，不良反应发生率低，具备较好的安全性，值得推广。

关键词:

糖尿病视网膜病变, 血管内皮生长因子, 化瘀复明汤, 羟苯磺酸钙, 血小板衍生生长因子