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Article(id=1322923880502932242, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923782029062261, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.06.047, pmid=null, cstr=null, oa=null, hot=null, price=null, onlineType=0, articleFormat=0, articleType=null, articleTypeStr=null, receivedDate=null, receivedDateStr=null, revisedDate=null, revisedDateStr=null, acceptedDate=null, acceptedDateStr=null, onlineDate=1793339231849, onlineDateStr=2026-10-30, pubDate=1749484800000, pubDateStr=2025-06-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793339231849, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793339231849, creator=13701087609, updateTime=1793339231849, updator=13701087609, issue=Issue{id=1322923782029062261, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='6', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1749484800000', pubDateStr='2025-06-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793339208371, creator='13701087609', updateTime=1793340556755, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322929437859258468, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923782029062261, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322929437859258469, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923782029062261, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=225, endPage=229, ext={EN=ArticleExt(id=1322923880704258835, articleId=1322923880502932242, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Effect of Modified Dihuang Pill（加味地黄丸）Combined with Anti-VEGF in Treatment of Proliferative Diabetic Retinopathy and Its Effect on Intraocular Inflammatory Factors, columnId=1256183365644968140, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Platform of Provincial Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To investigate effect of Modified Dihuang Pill（加味地黄丸）combined with anti-vascular endothelial growth factor（VEGF）in the treatment of proliferative diabetic retinopathy（DR）and its effect on intraocular inflammatory factors.

Methods

A total of 104 patients with proliferative DR admitted from January 2020 to June 2023 were prospectively selected and divided into study group and control group，52 in each.The control group was given anti-VEGF treatment，and the study group was given Modified Dihuang Pill on the basis of the control group.The effect of the two groups was observed for 3 months.TCM symptom scores，symptom improvement，vision-related indicators，curative effect，intraocular inflammatory factors and adverse reactions were compared in two groups.

Results

TCM syndrome scores after treatment was lower in the two groups than those before treatment（P<0.05），and those were significantly lower in the study group（P<0.05）.The absorption time，exudation absorption time and macular edema improvement time of the study group were lower（P<0.05）.After treatment，the thickness of macular fovea（CMT）and the gray value of visual field were lower than those before treatment，and the best corrected visual acuity（BCVA）was higher than that before treatment（P<0.05）.After treatment，CMT and the gray value of visual field of the study group were lower than those of the control group，BCVA was higher（P<0.05）.The total effective rate of the study group was higher（P<0.05）.The levels of VEGF，erythropoietin（EPO）and insulin-like growth factor-1（IGF-1）were all lower in two groups after treatment than those before treatment（P<0.05），and lower in the study group after treatment（P<0.05）.There was no significance in the incidence of total adverse reactions between two groups（P>0.05）.

Conclusion

Modified Dihuang Pill combined with anti-VEGF has significant efficacy in the treatment of proliferative DR，which can significantly improve the clinical symptoms and visual acuity of patients，regulate the expressions of intraocular inflammatory factors（VEGF，EPO and IGF-1），and is safe and reliable.

, authors=Xiaoli PENG, Yangming TANG, Yixia CHEN, authorsList=Xiaoli PENG, Yangming TANG, Yixia CHEN, authorCompany=null, correspAuthors=null, authorNote=null, correspAuthorsNote=null, copyrightStatement=null, copyrightOwner=null, extLink=null, articleAbsUrl=null, sourceXml=null, magXml=null, pdfUrl=null, pdf=null, pdfFileSize=null, pdfExtLink=null, richHtmlUrl=null, mobilePdfUrl=null, reviewReport=null, pdfFirstPage=null, abstractGraph=null, abstractGraphContent=null, abstractVideo=null, citation=null, cebUrl=null, magXmlContent=null, mapNumber=null, fund=null), CN=ArticleExt(id=1322923883946455847, articleId=1322923880502932242, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=加味地黄丸联合抗VEGF治疗增殖性糖尿病视网膜病变的疗效及对眼内炎症因子影响, columnId=1256183369033965799, journalTitle=中华中医药学刊, columnName=省级项目平台, runingTitle=null, highlight=null, articleAbstract=
目的

探讨加味地黄丸联合抗血管内皮生长因子（vascular endothelial growth factor，VEGF）治疗增殖性糖尿病视网膜病变（Diabetic retinopathy，DR）的疗效及对眼内炎症因子影响。

方法

前瞻性选取2020年1月—2023年6月收治的104例增殖性DR患者，随机数表法分为研究组、对照组，各52例。对照组给予抗VEGF治疗，研究组在对照组基础上给予加味地黄丸，两组治疗3个月观察效果。对比两组中医症状评分、症状改善情况、视力相关指标情况、疗效、眼内炎症因子及不良反应发生情况。

结果

两组治疗后中医证候评分低于治疗前（P<0.05），研究组治疗后更低（P<0.05）。研究组眼底出血吸收时间、渗出吸收时间、黄斑水肿改善时间低于对照组（P<0.05）。两组治疗后的黄斑中心凹厚度（central macular thickness，CMT）、视野灰度值低于治疗前，佳矫正视力（best corrected visual acuity，BCVA）高于治疗前（P<0.05）；研究组治疗后的CMT、视野灰度值均低于对照组，BCVA高于对照组（P<0.05）。研究组总有效率高于对照组（P<0.05）。两组治疗后的VEGF、促红细胞生成素（erythropoietin，EPO）、胰岛素样生长因子-1（insulin-like growth factor-1，IGF-1）均低于治疗前（P<0.05），研究组治疗后更低（P<0.05），两组总不良反应发生率对比差异无统计学意义（P>0.05）。

结论

加味地黄丸联合抗VEGF治疗增殖性DR疗效显著，可明显改善患者临床症状、视力，调控眼内炎症因子VEGF、EPO、IGF-1表达，安全可靠。

, authors=彭晓莉, 唐阳明, 陈亦霞, authorsList=彭晓莉, 唐阳明, 陈亦霞, authorCompany=null, correspAuthors=null, authorNote=

彭晓莉（1997-），女，江苏镇江人，副主任中医师，学士，研究方向：眼底病的中医治疗。

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彭晓莉（1997-），女，江苏镇江人，副主任中医师，学士，研究方向：眼底病的中医治疗。

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彭晓莉（1997-），女，江苏镇江人，副主任中医师，学士，研究方向：眼底病的中医治疗。

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Rom J Ophthalmol，2022，66（3）：265-270., articleTitle=Effect of pan-retinal laser photocoagulation on intravitreal vascular endothelial growth factor concentration in proliferative diabetic retinopathy, refAbstract=null), Reference(id=1322923889965282145, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, doi=null, pmid=null, pmcid=null, year=2021, volume=56, issue=6, pageStart=355, pageEnd=363, url=null, language=null, rfNumber=［17］, rfOrder=16, authorNames=YATESW B, MAMMO Z, SIMUNOVICM P, journalName=Can J Ophthalmol, refType=null, unstructuredReference=YATESW B，MAMMO Z，SIMUNOVICM P. Intravitreal anti-vascular endothelial growth factor versus panretinal LASER photocoagulation for proliferative diabetic retinopathy：a systematic review and meta-analysis［J］. 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JColl Physicians Surg Pak，2023，33（4）：380-384., articleTitle=Correlation of serum erythropoietin levels with different stages of diabetic retinopathy, refAbstract=null)], funds=[Fund(id=1322923888623104848, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, awardId=2019Z831, language=CN, fundingSource=江苏省自然科学基金项目(2019Z831), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1322923884269417256, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, xref=null, ext=[AuthorCompanyExt(id=1322923884282000169, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, companyId=1322923884269417256, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Ophthalmology Department of Zhenjiang Hospital of Traditional Chinese Medicine，Zhenjiang 212000，Jiangsu，China), AuthorCompanyExt(id=1322923884294583082, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, companyId=1322923884269417256, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=镇江市中医院，江苏 镇江 212000)])], figs=[ArticleFig(id=1322923885850669890, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数性别/（例）年龄/（岁，±s）体质量指数/（kg/m2，±s）糖尿病病程/（年，±s）增殖性DR分期/（例）
男女Ⅳ期Ⅴ期
对照组52302259.25±5.2923.14±1.529.23±1.593517
研究组52282460.49±5.3723.29±1.499.04±1.633220
t/χ2值2.4761.1860.5080.6020.378
P值0.1160.2380.6120.5490.539
), ArticleFig(id=1322923885951333187, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, language=CN, label=表1, caption=

两组糖尿病视网膜病变患者基本资料

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数性别/（例）年龄/（岁，±s）体质量指数/（kg/m2，±s）糖尿病病程/（年，±s）增殖性DR分期/（例）
男女Ⅳ期Ⅴ期
对照组52302259.25±5.2923.14±1.529.23±1.593517
研究组52282460.49±5.3723.29±1.499.04±1.633220
t/χ2值2.4761.1860.5080.6020.378
P值0.1160.2380.6120.5490.539
), ArticleFig(id=1322923886014247748, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别主症
例数视物昏花目睛干涩神疲乏力
治疗前治疗后治疗前治疗后治疗前治疗后
对照组523.87±0.511.59±0.25a3.69±0.541.46±0.23a3.98±0.461.38±0.23a
研究组523.71±0.521.42±0.21a3.58±0.531.28±0.21a4.05±0.431.19±0.19a
t值1.5843.7551.0484.1680.8024.593
P值0.1160.0000.2970.0000.4250.000
组别例数次症
五心烦热腰膝酸软口渴喜饮头晕耳鸣
治疗前治疗后治疗前治疗后治疗前治疗后治疗前治疗后
对照组522.21±0.210.97±0.16a2.24±0.321.02±0.17a2.29±0.311.02±0.18a2.05±0.311.03±0.18a
研究组522.19±0.230.89±0.14a2.19±0.340.93±0.15a2.21±0.320.93±0.14a2.02±0.320.95±0.16a
t值0.4632.7130.7722.8631.2952.8460.4862.395
P值0.6440.0080.4420.0050.1980.0050.6280.018
), ArticleFig(id=1322923886093939525, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, language=CN, label=表2, caption=

两组糖尿病视网膜病变患者中医证候评分（±s）

, figureFileSmall=null, figureFileBig=null, tableContent=
组别主症
例数视物昏花目睛干涩神疲乏力
治疗前治疗后治疗前治疗后治疗前治疗后
对照组523.87±0.511.59±0.25a3.69±0.541.46±0.23a3.98±0.461.38±0.23a
研究组523.71±0.521.42±0.21a3.58±0.531.28±0.21a4.05±0.431.19±0.19a
t值1.5843.7551.0484.1680.8024.593
P值0.1160.0000.2970.0000.4250.000
组别例数次症
五心烦热腰膝酸软口渴喜饮头晕耳鸣
治疗前治疗后治疗前治疗后治疗前治疗后治疗前治疗后
对照组522.21±0.210.97±0.16a2.24±0.321.02±0.17a2.29±0.311.02±0.18a2.05±0.311.03±0.18a
研究组522.19±0.230.89±0.14a2.19±0.340.93±0.15a2.21±0.320.93±0.14a2.02±0.320.95±0.16a
t值0.4632.7130.7722.8631.2952.8460.4862.395
P值0.6440.0080.4420.0050.1980.0050.6280.018
), ArticleFig(id=1322923886156854086, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数眼底出血吸收时间渗出吸收时间黄斑水肿改善时间
对照组524.03±0.7113.84±2.016.28±1.13
研究组523.41±0.5310.71±1.795.29±0.94
t值5.0468.3864.857
P值0.0000.0000.000
), ArticleFig(id=1322923886219768647, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, language=CN, label=表3, caption=

两组糖尿病视网膜病变患者症状改善情况（±s）

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数眼底出血吸收时间渗出吸收时间黄斑水肿改善时间
对照组524.03±0.7113.84±2.016.28±1.13
研究组523.41±0.5310.71±1.795.29±0.94
t值5.0468.3864.857
P值0.0000.0000.000
), ArticleFig(id=1322923887905878856, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923880502932242, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数CMT/（μm）视野灰度值BCVA
治疗前治疗后治疗前治疗后治疗前治疗后
对照组52425.98±42.31308.42±23.35a4.01±0.722.13±0.36a0.48±0.080.71±0.12a
研究组52429.87±41.08279.43±19.21a3.92±0.691.89±0.32a0.51±0.090.79±0.14a
t值0.4766.9140.6513.5931.7973.129
P值0.6350.0000.5170.0010.0750.002
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两组糖尿病视网膜病变患者视力相关指标改善情况（±s）

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组别例数CMT/（μm）视野灰度值BCVA
治疗前治疗后治疗前治疗后治疗前治疗后
对照组52425.98±42.31308.42±23.35a4.01±0.722.13±0.36a0.48±0.080.71±0.12a
研究组52429.87±41.08279.43±19.21a3.92±0.691.89±0.32a0.51±0.090.79±0.14a
t值0.4766.9140.6513.5931.7973.129
P值0.6350.0000.5170.0010.0750.002
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组别例数显效有效无效总有效
对照组5219（36.54）21（40.38）12（23.08）40（76.92）
研究组5225（48.08）23（44.23）4（7.69）48（92.31）
χ2值4.727
P值0.030
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两组糖尿病视网膜病变患者疗效比较

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组别例数显效有效无效总有效
对照组5219（36.54）21（40.38）12（23.08）40（76.92）
研究组5225（48.08）23（44.23）4（7.69）48（92.31）
χ2值4.727
P值0.030
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组别例数VEGF/（ng/L）EPO/（U/L）IGF-1/（ng/mL）
治疗前治疗后治疗前治疗后治疗前治疗后
对照组52602.37±94.64301.16±40.49a628.85±91.36351.47±42.81a38.62±5.1719.01±2.26a
研究组52597.48±91.47247.89±35.21a619.87±92.86320.46±36.19a39.81±5.3217.13±1.86a
t值0.2687.1590.4973.9891.1574.632
P值0.7890.0000.6200.0000.2500.000
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两组糖尿病视网膜病变患者眼内炎症因子情况（±s）

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组别例数VEGF/（ng/L）EPO/（U/L）IGF-1/（ng/mL）
治疗前治疗后治疗前治疗后治疗前治疗后
对照组52602.37±94.64301.16±40.49a628.85±91.36351.47±42.81a38.62±5.1719.01±2.26a
研究组52597.48±91.47247.89±35.21a619.87±92.86320.46±36.19a39.81±5.3217.13±1.86a
t值0.2687.1590.4973.9891.1574.632
P值0.7890.0000.6200.0000.2500.000
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组别例数结膜水肿异物感暂时性高眼压总不良反应
对照组521（1.92）2（3.85）1（1.92）4（7.69）
研究组522（3.85）1（1.92）2（3.85）5（9.62）
χ2值0.122
P值0.727
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两组糖尿病视网膜病变患者不良反应

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组别例数结膜水肿异物感暂时性高眼压总不良反应
对照组521（1.92）2（3.85）1（1.92）4（7.69）
研究组522（3.85）1（1.92）2（3.85）5（9.62）
χ2值0.122
P值0.727
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加味地黄丸联合抗VEGF治疗增殖性糖尿病视网膜病变的疗效及对眼内炎症因子影响
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彭晓莉 , 唐阳明 , 陈亦霞
中华中医药学刊 | 省级项目平台 2025,43(6): 225-229
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中华中医药学刊 |省级项目平台 2025 , 43 (6) : 225 -229
加味地黄丸联合抗VEGF治疗增殖性糖尿病视网膜病变的疗效及对眼内炎症因子影响
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彭晓莉, 唐阳明, 陈亦霞
作者信息
  • 镇江市中医院，江苏 镇江 212000
作者简介:

彭晓莉（1997-），女，江苏镇江人，副主任中医师，学士，研究方向：眼底病的中医治疗。

Effect of Modified Dihuang Pill（加味地黄丸）Combined with Anti-VEGF in Treatment of Proliferative Diabetic Retinopathy and Its Effect on Intraocular Inflammatory Factors
Xiaoli PENG, Yangming TANG, Yixia CHEN
Affiliations
  • Ophthalmology Department of Zhenjiang Hospital of Traditional Chinese Medicine，Zhenjiang 212000，Jiangsu，China
出版时间: 2025-06-10 doi: 10.13193/j.issn.1673-7717.2025.06.047
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摘要
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目的

探讨加味地黄丸联合抗血管内皮生长因子（vascular endothelial growth factor，VEGF）治疗增殖性糖尿病视网膜病变（Diabetic retinopathy，DR）的疗效及对眼内炎症因子影响。

方法

前瞻性选取2020年1月—2023年6月收治的104例增殖性DR患者，随机数表法分为研究组、对照组，各52例。对照组给予抗VEGF治疗，研究组在对照组基础上给予加味地黄丸，两组治疗3个月观察效果。对比两组中医症状评分、症状改善情况、视力相关指标情况、疗效、眼内炎症因子及不良反应发生情况。

结果

两组治疗后中医证候评分低于治疗前（P<0.05），研究组治疗后更低（P<0.05）。研究组眼底出血吸收时间、渗出吸收时间、黄斑水肿改善时间低于对照组（P<0.05）。两组治疗后的黄斑中心凹厚度（central macular thickness，CMT）、视野灰度值低于治疗前，佳矫正视力（best corrected visual acuity，BCVA）高于治疗前（P<0.05）；研究组治疗后的CMT、视野灰度值均低于对照组，BCVA高于对照组（P<0.05）。研究组总有效率高于对照组（P<0.05）。两组治疗后的VEGF、促红细胞生成素（erythropoietin，EPO）、胰岛素样生长因子-1（insulin-like growth factor-1，IGF-1）均低于治疗前（P<0.05），研究组治疗后更低（P<0.05），两组总不良反应发生率对比差异无统计学意义（P>0.05）。

结论

加味地黄丸联合抗VEGF治疗增殖性DR疗效显著，可明显改善患者临床症状、视力，调控眼内炎症因子VEGF、EPO、IGF-1表达，安全可靠。

加味地黄丸  /  抗血管内皮生长因子  /  增殖性糖尿病视网膜病变  /  疗效
Objective

To investigate effect of Modified Dihuang Pill（加味地黄丸）combined with anti-vascular endothelial growth factor（VEGF）in the treatment of proliferative diabetic retinopathy（DR）and its effect on intraocular inflammatory factors.

Methods

A total of 104 patients with proliferative DR admitted from January 2020 to June 2023 were prospectively selected and divided into study group and control group，52 in each.The control group was given anti-VEGF treatment，and the study group was given Modified Dihuang Pill on the basis of the control group.The effect of the two groups was observed for 3 months.TCM symptom scores，symptom improvement，vision-related indicators，curative effect，intraocular inflammatory factors and adverse reactions were compared in two groups.

Results

TCM syndrome scores after treatment was lower in the two groups than those before treatment（P<0.05），and those were significantly lower in the study group（P<0.05）.The absorption time，exudation absorption time and macular edema improvement time of the study group were lower（P<0.05）.After treatment，the thickness of macular fovea（CMT）and the gray value of visual field were lower than those before treatment，and the best corrected visual acuity（BCVA）was higher than that before treatment（P<0.05）.After treatment，CMT and the gray value of visual field of the study group were lower than those of the control group，BCVA was higher（P<0.05）.The total effective rate of the study group was higher（P<0.05）.The levels of VEGF，erythropoietin（EPO）and insulin-like growth factor-1（IGF-1）were all lower in two groups after treatment than those before treatment（P<0.05），and lower in the study group after treatment（P<0.05）.There was no significance in the incidence of total adverse reactions between two groups（P>0.05）.

Conclusion

Modified Dihuang Pill combined with anti-VEGF has significant efficacy in the treatment of proliferative DR，which can significantly improve the clinical symptoms and visual acuity of patients，regulate the expressions of intraocular inflammatory factors（VEGF，EPO and IGF-1），and is safe and reliable.

Modified Dihuang Pill（加味地黄丸）  /  anti-vascular endothelial growth factor  /  proliferative uropathy retinopathy  /  curative effect
彭晓莉, 唐阳明, 陈亦霞. 加味地黄丸联合抗VEGF治疗增殖性糖尿病视网膜病变的疗效及对眼内炎症因子影响. 中华中医药学刊, 2025 , 43 (6) : 225 -229 . DOI: 10.13193/j.issn.1673-7717.2025.06.047
Xiaoli PENG, Yangming TANG, Yixia CHEN. Effect of Modified Dihuang Pill（加味地黄丸）Combined with Anti-VEGF in Treatment of Proliferative Diabetic Retinopathy and Its Effect on Intraocular Inflammatory Factors[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (6) : 225 -229 . DOI: 10.13193/j.issn.1673-7717.2025.06.047
正文
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糖尿病患者长期高血糖状态会造成视网膜血管损伤，微血管病变可引发糖尿病视网膜病变（diabetic retinopathy，DR），导致视网膜内小血管的扩张、渗漏和闭塞，进而影响视网膜的正常结构和功能[1-2]。目前DR已成为全球范围内导致失明的主要原因之一，DR主要包括非增殖性、增殖性两种类型，与非增殖性DR相比，增殖性DR病情严重、病情进展迅速，异常血管新生速度快且解剖结构紊乱、脆弱，易发生新生血管渗漏及出血，短时间内导致黄斑水肿等严重的视网膜异常和视力损害[3-4]。目前，眼内注射抗血管内皮生长因子（vascular endothelial growth factor，VEGF）药物是西医治疗增殖性DR的重要手段之一，雷珠单抗是常用的抗VEGF药物之一，可抑制血管新生，减少异常血管生成及黄斑区域血管的通透性，从而减轻黄斑区域的渗漏和水肿，改善视力，但雷珠单抗药效持续时间有限，需多次注射以维持疗效[5-6]。
中医将DR归属于“消渴内障”“消渴目病”等范畴[7]，《外台秘要》言：“肾阴不足则阳亢进、燥热伤津，阴虚至，上荣不达至目失所养，气阴两虚贯穿始终。”六味地黄丸为滋阴补肾要方，目前研究已证实该方剂在改善DR病情方面具有一定优势[8-9]。笔者在多年临床工作中发现增殖性DR患者多为肾阴亏虚型，全身阴阳气血亏损，需更注重补肾阴，加味地黄丸适用于肾阴亏虚型增殖性DR，本研究将加味地黄丸联合抗VEGF药物雷珠单抗用于肾阴亏虚型增殖性DR患者，观察其对治疗效果及眼内炎症因子的影响，以便为临床治疗DR提供更多循证医学证据。
1　资料与方法
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1.1　一般资料
2020年1月—2023年6月医院收治的104例增殖性DR患者，随机数表法分为研究组、对照组，各52例。两组基本资料差异有统计学意义，具有可比性（P>0.05），见表1。本研究经医院医学伦理委员会审批通过（编号20200046）。
1.2　诊断标准
1.2.1　西医诊断标准
符合《我国糖尿病视网膜病变临床诊疗指南（2022年）》[10]中增殖性DR诊断标准。
1.2.2　中医辨证诊断标准
符合《中医眼科学》[11]中增殖性DR诊断标准，辨证肾阴亏虚型，主症：视物昏花、目睛干涩、神疲乏力，次症：五心烦热、腰膝酸软、口渴喜饮、头晕耳鸣，舌质黯淡或有瘀点，脉弦细或细数无力。
1.3　纳入与排除标准
纳入标准：①符合诊断标准；②双眼发病；③距上一次相关治疗时间间隔>6个月；④年龄>18岁；⑤黄斑中心凹厚度（central macular thickness，CMT）>250μm；⑥研究知情同意。
排除标准：①Ⅰ型糖尿病、甲亢者；②血液系统疾病；③伴精神性疾病；④伴其他类型眼科疾病；⑤屈光间质混浊影响眼底探查者；⑥渗出型年龄相关性黄斑变性；⑦基础疾病控制不佳、无法配合相关检查者；⑧既往有吸毒史、药物滥用史者；⑨对本研究药物过敏、自然失访者。
1.4　方法
两组均给予糖尿病健康教育、控制血糖等基础治疗。
对照组另给予抗VEGF治疗：患者眼部表面麻醉，常规消毒铺无菌巾，于颞上方距角巩膜缘4.0 mm 睫状体平坦部进针，向玻璃体腔内注射雷珠单抗0.05 mL，治疗后1、2个月再次注射。
研究组在对照组基础上给予加味地黄丸（包含熟地黄120 g，茯苓30 g，山茱萸60 g，泽泻30 g，牡丹皮15 g，山药60 g，麦冬10 g，五味子10 g，知母10 g，黄柏10 g共为细末，炼蜜为丸，6 g/丸）治疗，6 g/次，2次/d。
两组治疗3个月观察效果。
1.5　观察指标
1.5.1　中医证候评分
评估两组治疗前后中医证候评分，主症3项，每项0～6分；次症4项，每项0～3分；分数越高病情越严重[12]。
1.5.2　症状改善情况
统计两组眼底出血吸收时间、渗出吸收时间、黄斑水肿改善时间。
1.5.3　视力相关指标情况
于治疗前后，使用光学相干断层扫描仪（Spectralis HRA型，德国海德堡公司生产）测量患者CMT、视野灰度值，国际标准视力表（小数）测定患者最佳矫正视力（best corrected visual acuity，BCVA）。
1.5.4　疗效
显效：中医证候评分降低≥70%，眼底无纤维条索形成，视力提高≥2行，眼底视网膜水肿吸收和渗出吸收；有效：70%>中医证候评分降低≥40%，视力提高1行，眼底视网膜水肿和渗出情况减轻；无效：未达到上述标准或病情加重。总有效率＝显效率+有效率。
1.5.5　眼内炎症因子
治疗前后，分别采集患者玻璃体腔内组织液，离心分离（3500 r/min，10 min）收集上清液，酶联免疫吸附法检测玻璃体腔内VEGF、促红细胞生成素（erythropoietin，EPO）、胰岛素样生长因子-1（insulin-like growth factor-1，IGF-1）。
1.5.6　安全性
统计结膜水肿、异物感、结膜下出血、暂时性高眼压等不良反应。
1.6　统计学方法
SPSS18.0处理数据，计量资料以（）表示，t检验；计数资料以例（%）表示，χ2检验。P<0.05差异有统计学意义。
2　结果
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2.1　中医证候评分
两组治疗后主症、次症中医证候评分均低于治疗前（P<0.05），研究组治疗后更低（P<0.05）。见表2。
2.2　症状改善情况
研究组眼底出血吸收时间、渗出吸收时间、黄斑水肿改善时间低于对照组（P<0.05）。见表3。
2.3　视力相关指标情况
两组治疗后CMT、视野灰度值低于治疗前，BCVA高于治疗前（P<0.05）；研究组治疗后的CMT、视野灰度值均低于对照组，BCVA高于对照组（P<0.05）。见表4。
2.4　疗效
研究组总有效率高于对照组（P<0.05）。见表5。
2.5　眼内炎症因子情况
两组治疗后的VEGF、EPO、IGF-1均低于治疗前（P<0.05），研究组治疗后更低（P<0.05）。见表6。
2.6　不良反应
两组总不良反应发生率对比差异无统计学意义（P>0.05）。见表7。
3　讨论
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增殖性DR作为糖尿病最严重并发症之一，患者视网膜内静脉通路发生阻塞或狭窄风险较高，可导致血液回流受限，致使视网膜缺血和水肿，视网膜血管渗漏和损伤，为了弥补这种病理缺陷，机体可激活自身的修复机制，将通过多种途径诱导新血管的增生[13-14]。然而伴随异常新生血管的大量增生，可形成纤维增殖膜牵拉视网膜，诱导孔源性视网膜脱离，导致增殖性DR患者的视力严重下降，甚至发展至完全失明，严重威胁增殖性DR患者的眼部健康[15-16]。视网膜激光光凝术是临床治疗增殖性DR的常用手段，可通过激光器产生的高能光束，凝固和闭塞异常新生血管，抑制血管再生损伤新生血管，修复黄斑区域的血流紊乱，但激光光凝术视觉增益效果有限，还会导致视力发生不可逆损伤，并发症发生风险高，患者接受度有限[17]。目前药物治疗仍是多数增殖性DR患者的首要选择，雷珠单抗是其治疗的一线抗VEGF药物，但需多次治疗，因此临床医师一直致力于寻找有效药物辅助于雷珠单抗治疗增殖性DR，以便获得更加满意疗效。
本研究显示，加味地黄丸联合抗VEGF治疗增殖性DR疗效显著，可明显改善患者临床症状、视力。抗VEGF药物雷珠单抗能抑制新生血管生成，减少增殖性DR患者血管渗漏和黄斑水肿形成；雷珠单抗可通过抑制VEGF的活性来减少增殖性DR患者血管壁的通透性，降低液体和蛋白质的渗漏，改善临床症状，增强视力；雷珠单抗能够通过调节黄斑区域的血流，改善黄斑区域的营养供应和代谢状态，通过减少血管渗漏和炎症反应，有助于眼底组织恢复正常的血流动力学，从而改善临床症状，增强视力[18]。加味地黄丸由熟地黄、茯苓、山茱萸等多种药物精制而成，方中君药熟地黄具有滋阴补血、益肾养阴功效；山茱萸、山药为臣药，补养肝肾、健脾益气、补肾固精；泽泻利湿泄浊，泄肾浊以防熟地之腻；牡丹皮清泄相火，防治山茱萸温燥；茯苓健脾渗湿，配合山药运化，防熟地之腻；加入麦冬、五味子，既可润肺火，还能收涩肺肾之阴，使肾水更充足；加入知母、黄柏可滋阴降火，清上中下三焦之火，泻三焦湿热。诸药合用，共奏滋阴补肾、补中益气之功，进而改善增殖性DR患者临床症状，促进视力恢复，增强治疗效果。现代药理学研究显示，熟地黄及其有效成分具有抗氧化、抗炎症、降血糖、降血脂、调节机体代谢等多种作用[19]；山茱萸-牡丹皮可通过槲皮素、山柰酚、谷甾醇等活性成分作用于白细胞介素-6、P53、表皮生长因子受体等靶点调控眼部疾病信号通路传递[20]。
VEGF是调节血管生成、发育的重要因子，可通过与血管内皮细胞特异性受体结合，促进血管内皮细胞分裂，诱导VEGF受体细胞形成新生血管，增大血管通透性，被视为增殖性DR患者新生血管形成的主要调控因子。VEGF异常高表达可诱导视网膜血管过量生成，新生血管可自视网膜内向表面生长，可出现纤维膜，纤维膜牵拉可使视网膜损伤或脱离。DURAN G LER S等[21]研究指出，VEGF正常表达可促使视网膜血管生长至缺氧区与无血管区，VEGF异常高表达可损伤视网膜正常血管化过程，刺激新生血管过量生成，导致视网膜功能破坏。IGF-1主要由肝细胞、神经细胞等合成，可诱导细胞分化、有丝分裂，是VEGF的正向调节因子，具有广泛生物功能，可激活VEGF并诱导新生血管形成，进而介导视网膜血管生长发育及DR、视网膜增生等病理改变[22]。ZERTI D等[23]研究指出，靶向调控IGF-1表达能够促进高VEGF表达，抑制视网膜色素上皮ARPE-19细胞活性、促进细胞凋亡。EPO可通过促进红细胞生成和增加血红蛋白含量，提高增殖性DR患者血液的黏稠度，高黏稠度的血液会增加增殖性DR患者血管内膜受损风险，导致微循环障碍和血管损伤，从而加剧增殖性DR患者病情；EPO具有促进血管新生的作用，过度的血管新生可导致增殖性DR患者异常血管形成和渗漏，促进增殖性DR患者病情进展；炎症和氧化应激是DR的重要病理过程，EPO可通过激活炎症反应和氧化应激等机制导致视网膜细胞的损伤和凋亡[24]。MUHAMMAD T G等[25]研究指出，DR患者的血清EPO浓度随病情严重程度而升高。本研究显示，加味地黄丸联合抗VEGF治疗增殖性DR可抑制VEGF、EPO、IGF-1表达，研究组疗效更佳可能通过该途径发挥作用，但具体作用机制仍需后期进一步探讨。
综上所述，加味地黄丸联合抗VEGF治疗增殖性DR疗效显著，可明显改善患者临床症状、视力，调控眼内炎症因子VEGF、EPO、IGF-1表达，且安全可靠。本研究为单中心研究，样本量有限，后期仍需扩大样本量进一步验证本研究结论。
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doi: 10.13193/j.issn.1673-7717.2025.06.047
  • 首发时间：2026-10-30
  • 出版时间：2025-06-10
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    镇江市中医院，江苏 镇江 212000
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