Abstract:

Objective　To investigate the clinical effect of insulin degludec and liraglutide injection (IDegLira) combined with heptaphyllum saponin sodium tablets in the treatment of patients with diabetic retinopathy (DR) and macular edema (DME). Methods　One hundred and twenty patients with DR and DME treated at Yulin Traditional Chinese Medicine Hospital from January 2022 to May 2024 were selected for the randomized controlled trial, and were divided into a study group and a control group by the random number table method, with 60 cases in each group. There were 35 males and 25 females in the study group; they were (58.49±7.84) years old; their disease course was (14.39±2.05) years. There were 32 males and 28 females in the control group; they were (57.88±8.95) years old; their disease course was (14.52±2.10) years. Both groups received conventional treatment; the control group took heptaphyllum saponin sodium tablets; the study group took IDegLira and heptaphyllum saponin sodium tablets. Both groups were treated for 3 months. The blood glucose qualified rates and hypoglycemia incidence rates after the treatment were compared between the two groups. The logarithms of the minimum angle of resolution (logMAR), intraocular pressures, and retinal thicknesses of the macular center medulla (CMT) were compared between the two groups before and after the treatment. The macular penetration was compared between the two groups after the treatment. The levels of interleukin-6 (IL-6), vascular endothelial growth factor (VEGF), monocyte chemotactic protein (MCP-1), nitric oxide synthase (NOS), and soluble intercellular adhesion molecule-1 (sICAM-1) in atrial aqueous humor were compared between the two groups. The treatment efficacies and occurrence of adverse reactions were compared between the two groups. χ² and t tests were used for the statistical analysis. Results　The blood glucose qualified rate and the hypoglycemia incidence rate in the study group were better than those in the control group [85.00% (51/60) vs. 48.33% (29/60) and 6.67% (4/60) vs. 36.67% (22/60); both P<0.05]. Before the treatment, there were no statistical differences in logMAR, intraocular pressure, and CMT between the two groups (all P>0.05); after the treatment, the logMAR, intraocular pressure, and CMT in the study group were lower than those in the control group (all P<0.05). The rate of macular leakage regression in the study group was higher than that in the control group after the treatment [95.00% (57/60) vs. 80.00% (48/60); P=0.013]. Before the treatment, there were no statistical differences in the levels of IL-6, VEGF, NOS, MCP-1, and sICAM-1 between the two groups (all P>0.05); after the treatment, the levels of IL-6, VEGF, MCP-1, and sICAM-1 in the study group were lower than those in the control group, while the level of NOS was higher (all P<0.05). The total effective rate in the study group was higher than that in the control group [90.00% (54/60) vs. 71.67% (43/60); P=0.011]. No significant adverse reactions were observed in both groups; there was no statistical difference in the incidence rate of adverse reactions between the study group and the control gorup [3.33% (2/60) vs. 1.67 (1/60); P>0.05]. Conclusion　IDegLira combined with heptaphyllum saponin sodium tablets for patients with DR and DME can significantly improve their glycemic control, visual acuity, and atrial aqueous humor-related indicators and reduce the occurrence of hypoglycemic events and macular leakage, and is clinically effective and safe.

Key words:

Diabetes mellitus, Retinopathy, Macular edema, Insulin degludec and liraglutide injection, Heptaphyllum saponin sodium tablets

摘要：

目的　探讨德谷胰岛素利拉鲁肽注射液（IDegLira）联合七叶皂苷钠片治疗糖尿病视网膜病变（DR）合并黄斑水肿（DME）患者的临床效果。方法　选取榆林市中医医院2022年1月至2024年5月收治的DR合并DME患者120例进行随机对照试验。采用随机数字表法将其分为研究组与对照组，各60例。研究组男35例，女25例，年龄（58.49±7.84）岁，病程（14.39±2.05）年。对照组男32例，女28例，年龄（57.88±8.95）岁，病程（14.52±2.10）年。两组均接受常规治疗；对照组另给予七叶皂苷钠片治疗，研究组在对照组基础上联合IDegLira治疗。两组均治疗3个月。对比两组治疗后血糖达标率、低血糖发生率。比较两组治疗前后最小分辨角对数（logMAR）、眼压、黄斑中心凹视网膜厚度（CMT）。比较两组治疗后黄斑区渗透情况。比较两组治疗前后房水白细胞介素-6（IL-6）、血管内皮生长因子（VEGF）、单核细胞趋化蛋白（MCP-1）、一氧化氮合酶（NOS）、可溶性细胞间黏附分子-1 （sICAM-1）水平。比较两组治疗有效率和不良反应发生情况。采用χ²检验、t检验进行统计分析。结果　研究组血糖达标率高于对照组［85.00%（51/60）比48.33%（29/60），P<0.05］，低血糖发生率低于对照组［6.67%（4/60）比36.67%（22/60），P<0.05］。治疗前，两组logMAR、眼压、CMT比较，差异均无统计学意义（均P>0.05）；治疗后，研究组logMAR、眼压、CMT均低于对照组（均P<0.05）。治疗后，研究组黄斑区渗漏消退率高于对照组［95.00%（57/60）比80.00%（48/60），P=0.013］。治疗前，两组IL-6、VEGF、NOS、MCP-1、sICAM-1水平比较，差异均无统计学意义（均P>0.05）；治疗后，研究组IL-6、VEGF、MCP-1、sICAM-1水平均低于对照组，NOS水平高于对照组（均P<0.05）。研究组总有效率高于对照组［90.00%（54/60）比71.67%（43/60），P=0.011］。两组均未出现明显不良反应；研究组和对照组不良反应发生率差异无统计学意义［3.33%（2/60）比1.67（1/60），P>0.05］。结论　IDegLira联合七叶皂苷钠片治疗DR合并DME患者能改善其血糖控制，减少低血糖事件发生，还能有效减少黄斑区渗漏，改善患者视力及房水指标，临床总疗效更佳，且安全。

关键词:

糖尿病, 视网膜病变, 黄斑水肿, 德谷胰岛素利拉鲁肽注射液, 七叶皂苷钠片