明目地黄丸联合玻璃体腔内注射雷珠单抗治疗非增殖期糖尿病视网膜病变伴黄斑水肿临床研究
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R259;R276.7

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Clinical Study on Mingmu Dihuang Pills Combined with Intravitreal Injection of Ranibi⁃ zumab for Non-Proliferative Diabetic Retinopathy Complicated with Macular Edema
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    摘要:

    目的:观察明目地黄丸联合玻璃体腔内注射雷珠单抗治疗非增殖期糖尿病视网膜病变伴黄斑水肿 的临床疗效。方法:选取 90 例肝肾阴虚型非增殖期糖尿病视网膜病变伴黄斑水肿患者,随机分为对照组和观 察组各 45 例。对照组给予玻璃体腔内注射雷珠单抗治疗。观察组在对照组基础上加用明目地黄丸治疗。2 组 均治疗 3 个月。对比 2 组临床疗效,治疗前后评定中医证候积分,检测视功能、黄斑中心视网膜厚度、黄斑 视网膜体积、眼底检查相关指标、实验室检查指标[中性粒细胞/淋巴细胞比值 (NLR)、单核细胞趋化蛋 白-1(MCP-1)、血管内皮生长因子(VEGF)、晚期糖基化终末产物(AGEs)]。观察治疗期间患者的不良反 应发生情况。结果:治疗 3 个月后,临床疗效总有效率观察组 95.24%,对照组 80.95%,2 组总有效率比较, 差异均有统计学意义(P<0.05)。2 组中医证候积分均较治疗前降低(P<0.05),观察组中医证候积分低于对 照组(P<0.05)。2 组最佳矫正视力均较治疗前改善,黄斑视网膜体积、黄斑中心视网膜厚度值均较治疗前下 降(P<0.05),观察组最佳矫正视力、黄斑视网膜体积、黄斑中心视网膜厚度值均低于对照组 (P<0.05)。 2 组微血管瘤数均较治疗前减少,血管渗漏面积、毛细血管无灌注区面积均较治疗前缩小,视网膜循环时间均 较治疗前缩短,差异均有统计学意义(P<0.05)。观察组微血管瘤数少于对照组,血管渗漏面积、毛细血管无 灌注区面积均小于对照组,视网膜循环时间较对照组缩短,差异均有统计学意义 (P<0.05)。2 组 NLR、 MCP-1、AGEs、VEGF 水平均较治疗前降低(P<0.05),观察组 NLR、MCP-1、AGEs、VEGF 水平均低于对 照组(P<0.05)。2 组患者均未发生明显不良反应。结论:明目地黄丸联合玻璃体腔内注射雷珠单抗治疗肝肾 阴虚型非增殖期糖尿病视网膜病变伴黄斑水肿患者具有良好的临床疗效,能改善眼底状况,提高视功能,缓解 症状和体征,减轻炎症反应和氧化应激反应,安全性高。

    Abstract:

    Abstract:Objective:To observe the clinical effect of Mingmu Dihuang Pills combined with intravitreal injection of Ranibizumab on non- proliferative diabetic retinopathy complicated with macular edema. Methods:A total of 90 patients with non-proliferative diabetic retinopathy complicated with macular edema of liver- kidney yin deficiency type were selected and randomly divided into the control group and the observation group,with 45 cases in each group. The control group was given the intravitreal injection of Ranibizumab for treatment,and the observation group was additionally treated with Mingmu Dihuang Pills based on the treatment of the control group. The two groups were treated for 3 months. The clinical effects were compared between the two groups;before and after treatment,the traditional Chinese medicine (TCM) syndrome scores were evaluated; the visual function, the thickness of macular central retina, volume of macular retina,related indexes of fundus examination,and indexes of laboratory investigation, including neutrophil-to-lymphocyte ratio (NLR),monocyte chemoattractant protein-1 (MCP-1),vascular endothelial growth factor (VEGF) and advanced glycation end products (AGEs) were detected. The incidence of adverse reactions was observed during treatment. Results: After 3 months of treatment, the total effective rate was 80.95% in the control group and 95.24% in the observation group,differences being significant (P<0.05). The TCM syndrome scores in both groups were decreased when compared with those before treatment (P<0.05),and the TCM syndrome score in the observation group was lower than that in the control group (P<0.05). The best corrected vision in the two groups were improved when compared with those before treatment,and the thickness of macular central retina and volume of macular retina were decreased when compared with those before treatment (P<0.05);the best corrected vision,thickness of macular central retina and volume of macular retina in the observation group were lower than those in the control group (P<0.05). The number of microneurysms in the two groups were decreased when compared with those before treatment,the areas of vascular leakage and capillary non-perfusion were reduced when compared with those before treatment,and the retina circulation time were shortened when compared with those before treatment,differences being significant (P<0.05). The number of microneurysms in the observation group was lower than that in the control group,the areas of vascular leakage and capillary non- perfusion were smaller than those in the control group,and the retina circulation time was shorter than that in the control group,differences being significant (P<0.05). The levels of NLR,MCP-1,AGEs and VEGF in both groups were decreased when compared with those before treatment (P<0.05),and the above four levels in the observation group were lower than those in the control group (P<0.05). There were no significant adverse reactions in the two groups during treatment. Conclusion: The therapy of Mingmu Dihuang Pills combined with intravitreal injection of Ranibizumab has a good clinical effect on patients with non-proliferative diabetic retinopathy complicated with macular edema of liver-kidney yin deficiency type, which can improve the fundus state and visual function,mitigate the symptoms and signs and reduce the inflammatory responses and oxidative stress with good safety.

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王志勇,戚俊凯,罗顺利.明目地黄丸联合玻璃体腔内注射雷珠单抗治疗非增殖期糖尿病视网膜病变伴黄斑水肿临床研究[J].新中医,2023,55(14):82-87

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  • 在线发布日期: 2023-07-24
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