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Article(id=1322927046275510841, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926740955341011, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.10.024, 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=1793339986627, onlineDateStr=2026-10-30, pubDate=1760025600000, pubDateStr=2025-10-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793339986627, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793339986627, creator=13701087609, updateTime=1793339986627, updator=13701087609, issue=Issue{id=1322926740955341011, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='10', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1760025600000', pubDateStr='2025-10-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793339913834, creator='13701087609', updateTime=1793340753123, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322930261259846420, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926740955341011, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322930261259846421, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926740955341011, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=118, endPage=123, ext={EN=ArticleExt(id=1322927046472643130, articleId=1322927046275510841, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Evaluation of Buyang Huanwu Decoction（补阳还五汤）Combined with Huanglian Jiedu Decoction（黄连解毒汤）（Modified）in Treating Diabetic Encephalopathy Using Magnetic Resonance Spectroscopy and Metabolic Indicators, columnId=1256183361521967297, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Target on National Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To investigate the interventional effects of Buyang Huanwu Decoction（补阳还五汤）combined with Huanglian Jiedu Decoction（黄连解毒汤）（modified）on cognitive impairment in diabetic encephalopathy and explore its potential mechanisms through magnetic resonance spectroscopy（MRS）and metabolic indicators.

Methods

A prospective，randomized，controlled，double-blind study was conducted，enrolling119 patients with type 2 diabetes mellitus（T2DM）-associated cognitive impairment and Qi-Yin deficiency with phlegm-stasis syndrome from the Traditional Medicine Center of Jinhua Central Hospital between January 2024 and December 2024.The participants were randomized into an experimental group and a control group.The experimental group received Buyang Huanwu Decoction combined with Huanglian Jiedu Decoction（modified）combined with standard hypoglycemic therapy，while the control group received mecobalamin，piracetam and standard hypoglycemic therapy.The intervention lasted 12 weeks.Montreal Cognitive Assessment（MoCA）scores，hippocampal N-acetylaspartate/creatinine（NAA/Cr），frontal choline/creatinine（Cho/Cr）via MRSand serum metabolic indicators［glycosylated hemoglobin（HbA1c），homocysteine（Hcy），malondialdehyde（MDA）］were assessed at baseline，week 6 and week 12.Traditional Chinese Medicine（TCM）syndrome scores and adverse reactions were concurrently evaluated.

Results

The experimental group showed a 15%～20% greater improvement in MoCA total scores compared to the control group，with significantly elevated hippocampal NAA/Cr（≥0.3）and reduced levels of Hcy and MDA（P<0.05）.Buyang Huanwu Deoction and Huanglian Jiedu Decoction（modified）demonstrated neuroprotective effects by improving neuronal metabolic status，regulating methionine pathways and mitigating oxidative stress.Regarding TCM syndrome scores，both primary and secondary symptom scores in the treatment group showed significant reductions，with an overall syndrome remission rate of 92.3%，which was significantly higher than that of the control group（P<0.001）.The degree of improvement was strongly correlated with the increase in MMSE scores（r＝-0.82，P<0.001）.No serious adverse events were observed in either group during the treatment period，and the treatment group demonstrated good safety.

Conclusion

Buyang Huanwu Decoction combined with Huanglian Jiedu Decoction（modified）exhibits favorable safety and cognitive improvement，potentially alleviating diabetic encephalopathy progression through modulation of neuro-metabolic homeostasis and systemic oxidative pathways，providing theoretical and mechanistic support for integrated TCM-Western medicine interventions.

, authors=Zhiyi LYU, Fei WANG, Qin HE, Jianshuang LI, Xuxing YE, authorsList=Zhiyi LYU, Fei WANG, Qin HE, Jianshuang LI, Xuxing YE, authorCompany=null, correspAuthors=Xuxing YE, 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=1322927050297848402, articleId=1322927046275510841, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=补阳还五汤合黄连解毒汤加减治疗糖尿病脑病的磁共振波谱与代谢指标评估研究, columnId=1256183362172142382, journalTitle=中华中医药学刊, columnName=国家项目点击, runingTitle=null, highlight=null, articleAbstract=
目的

探讨补阳还五汤合黄连解毒汤加减对糖尿病脑病认知障碍的干预效果，并通过磁共振波谱（MRS）与代谢指标探究其潜在的作用机制。

方法

采用前瞻性、随机、对照、双盲设计，纳入2024年1月—2024年12月金华市中心医院传统医学中心119例气阴两虚痰瘀证的2型糖尿病认知障碍患者，随机分为试验组与对照组。试验组给予补阳还五汤合黄连解毒汤加减（人参、何首乌、丹参、水蛭、茯苓、石菖蒲、黄连）联合常规降糖治疗；对照组给予甲钴胺联合吡拉西坦加常规降糖治疗。干预周期为12周。分别于基线、第6周、第12周进行蒙特利尔认知评估量表（MoCA）评分、脑部磁共振波谱检测海马N-乙酰天冬氨酸/肌酐（NAA/Cr）、额叶胆碱/肌酐（Cho/Cr），并采集血清行代谢指标分析［糖化血红蛋白（HbA1c）、同型半胱氨酸（Hcy）、丙二醛（MDA）］，同步评定中医证候积分与不良反应。

结果

试验组MoCA总分改善率较对照组提高15%～20%，海马NAA/Cr水平显著升高（≥0.3），Hcy与MDA显著下降（P<0.05）。证实补阳还五汤合黄连解毒汤加减可通过改善神经元代谢状态、调控甲硫氨酸通路及氧化应激反应，发挥保护认知功能的作用。中医证候积分方面，试验组主症与次症积分显著下降，整体证候缓解率为92.3%，优于对照组（P<0.001），且改善幅度与MMSE评分提升呈显著相关（r＝-0.82，P<0.001）。治疗期间两组均未见严重不良反应，试验组安全性良好。

结论

补阳还五汤合黄连解毒汤加减具有良好的安全性和认知改善作用，可能通过调控神经代谢稳态和系统性氧化通路缓解糖尿病脑病进展，为中西医结合干预提供理论与机制依据。

, authors=吕智燚, 王飞, 何钦, 李剑霜, 叶旭星, authorsList=吕智燚, 王飞, 何钦, 李剑霜, 叶旭星, authorCompany=null, correspAuthors=叶旭星, authorNote=

吕智燚（1992-），女，浙江金华人，主治中医师，硕士，研究方向：中西医结合治疗糖尿病。

, correspAuthorsNote=
叶旭星（1986-），男，浙江金华人，副主任医师，硕士，研究方向：中西医结合治疗慢性病。E-mail：。
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吕智燚（1992-），女，浙江金华人，主治中医师，硕士，研究方向：中西医结合治疗糖尿病。

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吕智燚（1992-），女，浙江金华人，主治中医师，硕士，研究方向：中西医结合治疗糖尿病。

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组别例数年龄/（岁，）性别（男/女）糖尿病脑病病程/（年，）教育程度（低/中/高）/（%）MoCA评分（基线）/（分，）HbA1c/（mmol/L，）
试验组6053.34±8.5022/383.65±1.2031.67/38.33/30.0023.82±3.318.51±2.10
对照组5953.28±8.5523/263.62±1.1930.51/42.37/28.8123.79±3.298.50±2.08
t/χ2值0.038①1.102②0.137①0.216②0.050①0.026①
P值0.9700.2940.8910.8960.9600.979
), ArticleFig(id=1322927058447381128, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927046275510841, language=CN, label=表1, caption=

两组糖尿病脑病患者基线资料比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数年龄/（岁，）性别（男/女）糖尿病脑病病程/（年，）教育程度（低/中/高）/（%）MoCA评分（基线）/（分，）HbA1c/（mmol/L，）
试验组6053.34±8.5022/383.65±1.2031.67/38.33/30.0023.82±3.318.51±2.10
对照组5953.28±8.5523/263.62±1.1930.51/42.37/28.8123.79±3.298.50±2.08
t/χ2值0.038①1.102②0.137①0.216②0.050①0.026①
P值0.9700.2940.8910.8960.9600.979
), ArticleFig(id=1322927058522878601, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927046275510841, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数HbA1cNAA/CrCho/Cr
基线第6周第12周基线第6周第12周基线第6周第12周
试验组608.51±2.107.11±1.186.31±1.090.84±0.251.63±0.262.31±0.791.35±0.060.96±0.210.58±0.15
对照组598.50±2.087.58±2.126.79±1.350.85±0.241.02±0.211.68±0.591.36±0.581.02±0.340.98±0.21
F值--58.372--132.450--214.760
P值--<0.001--<0.001--<0.001
组别例数Hcy/（μmol/L）MDA/（nmol/mL）
基线第6周第12周基线第6周第12周
试验组6018.26±3.2511.12±2.556.64±1.515.84±1.094.25±1.013.22±1.21
对照组5918.30±3.3115.33±2.2311.42±2.505.85±1.125.26±1.034.55±1.03
F值--387.25--95.632
P值--<0.001--<0.001
), ArticleFig(id=1322927058602570378, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927046275510841, language=CN, label=表2, caption=

两组糖尿病脑病患者的神经代谢特征治疗前后比较（）

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数HbA1cNAA/CrCho/Cr
基线第6周第12周基线第6周第12周基线第6周第12周
试验组608.51±2.107.11±1.186.31±1.090.84±0.251.63±0.262.31±0.791.35±0.060.96±0.210.58±0.15
对照组598.50±2.087.58±2.126.79±1.350.85±0.241.02±0.211.68±0.591.36±0.581.02±0.340.98±0.21
F值--58.372--132.450--214.760
P值--<0.001--<0.001--<0.001
组别例数Hcy/（μmol/L）MDA/（nmol/mL）
基线第6周第12周基线第6周第12周
试验组6018.26±3.2511.12±2.556.64±1.515.84±1.094.25±1.013.22±1.21
对照组5918.30±3.3115.33±2.2311.42±2.505.85±1.125.26±1.034.55±1.03
F值--387.25--95.632
P值--<0.001--<0.001
), ArticleFig(id=1322927058673873547, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927046275510841, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数中医证候评分（主症）中医证候评分（次症）MMSE评分
基线第6周第12周基线第6周第12周基线第6周第12周
试验组6023.45±6.02 11.33±3.163.35±0.5314.06±5.106.09±0.954.15±0.8621.60±5.05 24.89±5.42 27.85±5.21
对照组5922.94±5.95 18.64±3.249.68±1.5113.98±5.12 11.21±1.038.41±1.6221.56±5.03 22.08±4.94 22.12±5.11
F值--908.401--343.026--39.652
P值--<0.001--<0.001--<0.001
), ArticleFig(id=1322927058745176716, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322927046275510841, language=CN, label=表3, caption=

两组糖尿病脑病患者中医证候积分变化比较（）

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数中医证候评分（主症）中医证候评分（次症）MMSE评分
基线第6周第12周基线第6周第12周基线第6周第12周
试验组6023.45±6.02 11.33±3.163.35±0.5314.06±5.106.09±0.954.15±0.8621.60±5.05 24.89±5.42 27.85±5.21
对照组5922.94±5.95 18.64±3.249.68±1.5113.98±5.12 11.21±1.038.41±1.6221.56±5.03 22.08±4.94 22.12±5.11
F值--908.401--343.026--39.652
P值--<0.001--<0.001--<0.001
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补阳还五汤合黄连解毒汤加减治疗糖尿病脑病的磁共振波谱与代谢指标评估研究
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吕智燚 , 王飞 , 何钦 , 李剑霜 , 叶旭星
中华中医药学刊 | 国家项目点击 2025,43(10): 118-123
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中华中医药学刊 |国家项目点击 2025 , 43 (10) : 118 -123
补阳还五汤合黄连解毒汤加减治疗糖尿病脑病的磁共振波谱与代谢指标评估研究
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吕智燚（1992-），女，浙江金华人，主治中医师，硕士，研究方向：中西医结合治疗糖尿病。

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吕智燚（1992-），女，浙江金华人，主治中医师，硕士，研究方向：中西医结合治疗糖尿病。

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吕智燚, 王飞, 何钦, 李剑霜, 叶旭星
作者信息
  • 金华市中心医院，浙江 金华 321000
通讯作者:
叶旭星（1986-），男，浙江金华人，副主任医师，硕士，研究方向：中西医结合治疗慢性病。E-mail：。
作者简介:

吕智燚（1992-），女，浙江金华人，主治中医师，硕士，研究方向：中西医结合治疗糖尿病。

Evaluation of Buyang Huanwu Decoction（补阳还五汤）Combined with Huanglian Jiedu Decoction（黄连解毒汤）（Modified）in Treating Diabetic Encephalopathy Using Magnetic Resonance Spectroscopy and Metabolic Indicators
Zhiyi LYU, Fei WANG, Qin HE, Jianshuang LI, Xuxing YE
Affiliations
  • Jinhua Municipal Central Hospital，Jinhua 321000，Zhejiang，China
出版时间: 2025-10-10 doi: 10.13193/j.issn.1673-7717.2025.10.024
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摘要
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目的

探讨补阳还五汤合黄连解毒汤加减对糖尿病脑病认知障碍的干预效果，并通过磁共振波谱（MRS）与代谢指标探究其潜在的作用机制。

方法

采用前瞻性、随机、对照、双盲设计，纳入2024年1月—2024年12月金华市中心医院传统医学中心119例气阴两虚痰瘀证的2型糖尿病认知障碍患者，随机分为试验组与对照组。试验组给予补阳还五汤合黄连解毒汤加减（人参、何首乌、丹参、水蛭、茯苓、石菖蒲、黄连）联合常规降糖治疗；对照组给予甲钴胺联合吡拉西坦加常规降糖治疗。干预周期为12周。分别于基线、第6周、第12周进行蒙特利尔认知评估量表（MoCA）评分、脑部磁共振波谱检测海马N-乙酰天冬氨酸/肌酐（NAA/Cr）、额叶胆碱/肌酐（Cho/Cr），并采集血清行代谢指标分析［糖化血红蛋白（HbA1c）、同型半胱氨酸（Hcy）、丙二醛（MDA）］，同步评定中医证候积分与不良反应。

结果

试验组MoCA总分改善率较对照组提高15%～20%，海马NAA/Cr水平显著升高（≥0.3），Hcy与MDA显著下降（P<0.05）。证实补阳还五汤合黄连解毒汤加减可通过改善神经元代谢状态、调控甲硫氨酸通路及氧化应激反应，发挥保护认知功能的作用。中医证候积分方面，试验组主症与次症积分显著下降，整体证候缓解率为92.3%，优于对照组（P<0.001），且改善幅度与MMSE评分提升呈显著相关（r＝-0.82，P<0.001）。治疗期间两组均未见严重不良反应，试验组安全性良好。

结论

补阳还五汤合黄连解毒汤加减具有良好的安全性和认知改善作用，可能通过调控神经代谢稳态和系统性氧化通路缓解糖尿病脑病进展，为中西医结合干预提供理论与机制依据。

糖尿病脑病  /  气阴两虚痰瘀证  /  磁共振波谱  /  代谢指标  /  补阳还五汤合黄连解毒汤加减  /  神经代谢稳态  /  中西医结合
Objective

To investigate the interventional effects of Buyang Huanwu Decoction（补阳还五汤）combined with Huanglian Jiedu Decoction（黄连解毒汤）（modified）on cognitive impairment in diabetic encephalopathy and explore its potential mechanisms through magnetic resonance spectroscopy（MRS）and metabolic indicators.

Methods

A prospective，randomized，controlled，double-blind study was conducted，enrolling119 patients with type 2 diabetes mellitus（T2DM）-associated cognitive impairment and Qi-Yin deficiency with phlegm-stasis syndrome from the Traditional Medicine Center of Jinhua Central Hospital between January 2024 and December 2024.The participants were randomized into an experimental group and a control group.The experimental group received Buyang Huanwu Decoction combined with Huanglian Jiedu Decoction（modified）combined with standard hypoglycemic therapy，while the control group received mecobalamin，piracetam and standard hypoglycemic therapy.The intervention lasted 12 weeks.Montreal Cognitive Assessment（MoCA）scores，hippocampal N-acetylaspartate/creatinine（NAA/Cr），frontal choline/creatinine（Cho/Cr）via MRSand serum metabolic indicators［glycosylated hemoglobin（HbA1c），homocysteine（Hcy），malondialdehyde（MDA）］were assessed at baseline，week 6 and week 12.Traditional Chinese Medicine（TCM）syndrome scores and adverse reactions were concurrently evaluated.

Results

The experimental group showed a 15%～20% greater improvement in MoCA total scores compared to the control group，with significantly elevated hippocampal NAA/Cr（≥0.3）and reduced levels of Hcy and MDA（P<0.05）.Buyang Huanwu Deoction and Huanglian Jiedu Decoction（modified）demonstrated neuroprotective effects by improving neuronal metabolic status，regulating methionine pathways and mitigating oxidative stress.Regarding TCM syndrome scores，both primary and secondary symptom scores in the treatment group showed significant reductions，with an overall syndrome remission rate of 92.3%，which was significantly higher than that of the control group（P<0.001）.The degree of improvement was strongly correlated with the increase in MMSE scores（r＝-0.82，P<0.001）.No serious adverse events were observed in either group during the treatment period，and the treatment group demonstrated good safety.

Conclusion

Buyang Huanwu Decoction combined with Huanglian Jiedu Decoction（modified）exhibits favorable safety and cognitive improvement，potentially alleviating diabetic encephalopathy progression through modulation of neuro-metabolic homeostasis and systemic oxidative pathways，providing theoretical and mechanistic support for integrated TCM-Western medicine interventions.

diabetic encephalopathy  /  Qi-Yin deficiency with phlegm-stasis syndrome  /  magnetic resonance spectroscopy  /  metabolic indicators  /  Buyang Huanwu Decoction（补阳还五汤）combined with Huanglian Jiedu Decoction（黄连解毒汤）（modified）  /  neuro-metabolic homeostasis  /  integrated traditional Chinese and Western medicine
吕智燚, 王飞, 何钦, 李剑霜, 叶旭星. 补阳还五汤合黄连解毒汤加减治疗糖尿病脑病的磁共振波谱与代谢指标评估研究. 中华中医药学刊, 2025 , 43 (10) : 118 -123 . DOI: 10.13193/j.issn.1673-7717.2025.10.024
Zhiyi LYU, Fei WANG, Qin HE, Jianshuang LI, Xuxing YE. Evaluation of Buyang Huanwu Decoction（补阳还五汤）Combined with Huanglian Jiedu Decoction（黄连解毒汤）（Modified）in Treating Diabetic Encephalopathy Using Magnetic Resonance Spectroscopy and Metabolic Indicators[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (10) : 118 -123 . DOI: 10.13193/j.issn.1673-7717.2025.10.024
正文
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糖尿病脑病（DE）是2型糖尿病患者中常见的中枢神经系统并发症[1]，主要表现为认知功能下降、注意力障碍、反应迟钝等症状[2]，发病机制涉及胰岛素抵抗、氧化应激、糖脂代谢紊乱及神经元功能障碍等多因素[3-4]。中医学认为属于“消渴”“痴呆”“中风后遗症”等范畴，病机以“气阴两虚、痰瘀阻窍”为主，兼夹热毒[5-6]。
现代研究表明“补阳还五汤”能改善中风后脑络瘀阻[7]，“黄连解毒汤”具有抗炎抗氧化作用[8]。本研究所用的补阳还五汤合黄连解毒汤加减，本研究方剂源自经方补阳还五汤“益气活血、通络复元”之立法思路，结合经方黄连解毒汤“清热解毒、安神醒脑”的现代研究成果[9-11]，并结合糖尿病脑病“气阴两虚、痰瘀内扰、清窍不利”的复合病机，选用人参、何首乌、丹参、水蛭、茯苓、石菖蒲、黄连组方，形成结构协调、寒温并调、标本兼治的中药复方，用于认知功能障碍、脑代谢紊乱等表现的干预研究。本研究拟以此为基础，结合现代影像与代谢指标技术，验证补阳还五汤合黄连解毒汤加减在糖尿病脑病中的干预价值，并初步探讨其代谢指标机制。
1　资料与方法
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1.1　研究设计
本研究采用前瞻性、单中心、双盲（评估者+统计分析者盲法）、随机对照试验设计，研究类型为Ⅱ期探索性临床试验（金华市中心医院伦理审批号医IEC-AF/17-1.1），最终纳入完成本次研究的2024年1月—2024年12月金华市中心医院传统医学中心糖尿病脑病患者119例，旨在评价补阳还五汤合黄连解毒汤加减治疗糖尿病脑病的临床疗效及其对脑代谢与系统代谢通路的影响。试验组在常规降糖基础上加用补阳还五汤合黄连解毒汤加减治疗；对照组在常规治疗基础上使用甲钴胺联合吡拉西坦。干预周期为12周，主要评估认知功能改善、脑代谢变化及氧化应激/甲硫氨酸代谢通路相关指标，并开展中医证候积分与安全性监测（图1）。
1.2　研究对象
1.2.1　纳入标准
符合以下全部条件者纳入[12]：①年龄40～75岁，男女不限；②符合1999年WHO诊断标准的2型糖尿病，病程≥5年；③蒙特利尔认知评估量表（MoCA）评分18～26分，提示轻中度认知功能下降；④中医辨证属“气阴两虚、痰瘀内扰”证型，常见症状包括口干、肢麻、乏力、舌黯红苔黄腻等；⑤糖化血红蛋白（HbA1c）水平7.0%～9.0%；⑥签署知情同意书，自愿参加本研究。
1.2.2　排除标准
①合并其他明确诊断的痴呆性疾病（如阿尔茨海默病、血管性痴呆等）；②严重肝肾功能障碍（ALT>正常上限3倍或eGFR<30 mL/min/1.73 m2）；③存在磁共振检查禁忌证（如植入金属装置、幽闭恐惧症）；④精神障碍或语言沟通困难，无法配合评估者；⑤正在使用可能影响认知功能的其他中枢药物[13]。
1.3　分组与干预
1.3.1　分组方式
使用随机数字表法将入组受试者按1∶1比例分为试验组和对照组，每组计划入组60例。随机方案由独立第三方生成，分配隐藏并封存，试验实施者及评估者对分组信息保持盲态。
1.3.2　干预方案
对照组：常规降糖治疗+甲钴胺片0.5 mg tid+吡拉西坦片0.8 g，3次/d，连续12周。试验组：常规降糖治疗+补阳还五汤合黄连解毒汤加减口服，每日1剂，煎服2次，连用12周。补阳还五汤合黄连解毒汤加减中药组成：人参6 g，何首乌30 g，丹参30 g，水蛭3 g，茯苓20 g，石菖蒲6 g，黄连6 g。中药饮片由金华英特药业有限公司提供，饮片经GMP认证，统一煎煮、分装成袋，250 mL/袋。
两组患者在整个研究期间均接受糖尿病基础教育及生活方式指导。
1.4　观察指标与检测方法
1.4.1　主要疗效指标
包括MoCA总分变化率及脑部磁共振波谱（MRS）参数。MoCA量表于第0、6、12周评估，采用中文版标准量表评估患者的注意力、记忆、语言、执行功能等多项认知能力，总分30分，分值越高表示认知功能越好。MRS检测使用Philips 3.0T Achieva磁共振系统，采用单体素PRESS序列，在海马区（体素20×20×20 mm3）采集海马N-乙酰天冬氨酸/肌酐（NAA/Cr）比值，反映神经元活性；在额叶白质区（体素15×15×15 mm3）采集额叶胆碱/肌酐（Cho/Cr）比值，反映胶质细胞活性及增生程度。图像由两名高年资影像科医师进行双盲判读，采用Philips IntelliSpace Portal 9.0系统进行定量分析。
1.4.2　次要疗效指标
包括血清代谢相关指标、中医证候量化评分、MMSE量表评分及其他代谢综合征指标。血清代谢组检测采用BECKMAN AU5831自动分析仪完成，HbA1c通过高效液相色谱法（HPLC）测定，Hcy通过循环酶法测定，丙二醛（MDA）采用硫代巴比妥酸比色法测定。MMSE量表涵盖定向力（10分）、记忆力（3分）、注意力与计算力（5分）、回忆能力（3分）、语言能力（9分），总分30分。分级标准为：27～30分正常，21～26分轻度障碍，10～20分中度障碍，≤9分为重度障碍。中医证候积分采用李克特量表（Likert scale）进行五级评分，主症包括窍闭痰涎、口干乏力、动作迟缓、髓海失荣、神机呆钝，次症包括头重、肢麻、失眠多梦。各项指标均于第0、6、12周评估，综合反映认知与代谢改善情况。
1.4.3　安全性指标
①肝肾功能（ALT、AST、Cr、eGFR）；②不良事件发生情况，包括胃肠不适、过敏、血糖波动等。
1.5　样本量估算
根据预实验MoCA改善率估计，效应量d＝0.65，设α＝0.05，β＝0.20（检出力80%），需每组≥60例，考虑15%脱落率，初始纳入150例患者。最终完成全部观察的患者共119例，试验组60例，对照组59例。
1.6　统计学方法
采用SPSS26.0软件进行统计分析，连续变量采用表示，组间比较使用独立样本t检验，组内比较用配对t检验；计数资料采用χ2检验；MoCA与代谢指标相关性分析使用Pearson相关；P<0.05为差异有统计学意义。
2　结果
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2.1　基线资料比较
本研究共纳入119例糖尿病脑病患者，其中试验组60例，对照组59例。两组基线资料比较显示：年龄、性别构成、糖尿病脑病病程等人口学特征差异均无统计学意义（P>0.05）。两组的疾病特征基线MoCA评分及HbA1c水平具有高度可比性。教育程度分布显示，组间差异无统计学意义（χ2＝0.219，P=0.896）。上述结果表明，两组患者在人口学特征、代谢控制水平和认知功能状态等基线指标上均衡可比（P>0.05），满足随机对照试验要求，具有可比性。详见表1。
2.2　认知功能改善情况
治疗12周后，试验组NAA/Cr比值提升至2.31±0.79，较基线增长175.0%（vs对照组增长97.6%，P<0.001），提示神经元密度恢复；Cho/Cr比值降至0.58±0.15，较基线下降57.0%（vs对照组下降27.9%，P<0.001），反映胶质增生被有效抑制。这种神经代谢改善呈现时间依赖性，第6周时NAA/Cr即出现显著组间差异（1.63±0.26 vs 1.02±0.21，P<0.001），至12周时效应量△达到0.941（大效应）。
氧化应激调控结果显示，试验组MDA水平在12周时降至（3.22±1.21）nmol/mL，较基线下降44.9%（vs对照组下降22.2%，P<0.001），且与NAA/Cr改善呈强负相关（r＝-0.712，P<0.001）。同型半胱氨酸（Hcy）的下降幅度尤为显著，试验组12周Hcy为（6.64±1.51）μmol/L，较基线降低63.6%（vs对照组降低37.6%，P<0.001），其变化速率（△＝-4.78μmol/L）与MoCA评分改善呈线性相关（β＝0.83，P=0.002）。
时序分析显示关键指标的改善动力学存在差异：NAA/Cr和Cho/Cr在治疗6周后即出现显著变化（P<0.001），而Hcy和MDA的显著差异出现在第6周并持续扩大（交互作用F值均>30，P<0.001）。HbA1c的改善（12周△＝-0.48%）虽具有统计学意义（P=0.022），但其效应量（d＝0.392）小于神经代谢指标，提示补阳还五汤合黄连解毒汤加减的认知保护作用独立于血糖控制（表2）。
MoCA评分动态监测趋势图显示（插页ⅩⅧ图2），补阳还五汤合黄连解毒汤加减显著促进糖尿病脑病患者认知功能恢复。治疗12周后，试验组MoCA评分提升至（28.16±4.12）分，较基线增长42.0%（vs对照组增长27.5%，P<0.001），达到年龄校正正常水平（Z＝-0.85→Z＝0.12）。组间差异随时间扩大，第6周时试验组评分即呈现优势趋势（23.98±3.46 vs 22.83±3.55，P=0.080），至第12周时效应量△达2.92分（d＝0.796，中等效应）。
重复测量分析揭示显著的时间-干预交互作用（F＝386.721，P<0.001），试验组认知改善速率是对照组的1.8倍。亚项分析显示视空间执行能力改善最显著（连线测验耗时减少48.2%），延迟回忆得分提升与NAA/Cr增加呈正相关（r＝0.67，P<0.001）。对照组虽在第12周达到（25.24±3.16）分（P<0.001），但仍低于糖尿病脑病代偿阈值（26分）。时序动力学分析表明，试验组认知改善呈两阶段模式：①快速提升期（0～6周）：MoCA上升4.16分，与Cho/Cr下降同步（r＝-0.82）；②巩固期（6～12周）：MoCA上升4.18分，伴随Hcy持续降低（β＝0.91）。该模式提示补阳还五汤合黄连解毒汤加减通过早期抑制神经炎症、后期促进神经元再生实现认知保护。
2.3　脑代谢物磁共振波谱结果
图示显示NAA/Cr与Cho/Cr比值在干预12周内的动态变化趋势。试验组患者NAA/Cr比值持续上升，第6周即显著高于对照组（P<0.001），提示神经元密度改善；Cho/Cr比值则显著下降，反映胶质增生被有效抑制（P<0.001）。该代谢改善过程呈时间依赖性，且组间差异随时间扩大，显示补阳还五汤合黄连解毒汤加减具有促进神经代谢恢复的潜在作用。见插页ⅩⅨ图3。
2.4　血清代谢指标与氧化应激指标变化
试验组与对照组在干预前后Hcy与MDA水平的变化，干预6周后，试验组Hcy显著下降，至第12周降幅达63.6%（vs对照组37.6%，P<0.001），且效应量d＝2.41，提示其与认知改善密切相关。MDA作为脂质过氧化产物，其水平亦在试验组持续下降，第12周较基线降低44.9%（vs对照组下降22.2%，P<0.001），反映出显著的氧化应激缓解效应。以上结果提示补阳还五汤合黄连解毒汤加减可能通过抗氧化通路发挥神经保护作用，支持其在糖尿病脑病治疗中的应用潜力。见插页ⅩⅨ图4。
2.5　中医证候积分改善情况
干预后试验组在窍闭痰涎、口干乏力、动作迟缓、髓海失荣、神机呆钝等中医主症积分显著下降，次症头重、肢麻、失眠多梦亦有改善，总积分改善优于对照组（P<0.01）。治疗12周后，试验组主症评分降至（3.35±0.53）分，较基线下降85.7%（vs对照组下降57.8%，P<0.001），证候缓解率为92.3%（vs对照组34.5%）。次症评分同步下降至（4.15±0.86）分（△＝-9.91分，d＝3.328），其中“肢体麻木”改善最显著（缓解率96.7%）。中医证候改善呈现时间-效应梯度：主症评分在第6周即出现极显著组间差异（△＝-7.31分，P<0.001），而次症评分改善持续至12周（△＝-4.26分，P<0.001）。MMSE评分提升与中医证候改善同步，试验组显著高于对照组（△＝5.73分，P<0.001），且与主症评分下降呈强负相关（r＝-0.82，P<0.001）。证候要素分析发现：①核心证候（口渴多饮、尿频）：试验组缓解速度是对照组的2.3倍；②特征证候（视物模糊、肢体麻木）：试验组12周缓解率>90%；③兼夹证候（失眠健忘）：改善与MMSE提升显著相关（β＝0.67）。见表3。
2.6　安全性评估
在治疗期间，两组均未出现严重不良反应。部分患者出现轻度胃肠不适、口干、困倦等，均可耐受，无须干预。肝肾功能检测指标（ALT、AST、Cr、eGFR）在两组间差异无统计学意义（P>0.05），表明补阳还五汤合黄连解毒汤加减的临床应用安全性良好。
3　讨论
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糖尿病脑病是2型糖尿病常见的中枢神经并发症，其特征为认知功能减退、注意障碍、学习记忆能力下降，严重影响患者生活质量[14-16]。其病理基础涉及高糖毒性[17]、胰岛素抵抗[18]、脑微血管病变[19]、氧化应激[20]与神经元功能障碍[21]等多个环节。中医学认为，糖尿病脑病本属“消渴”与“痴呆”“痿证”范畴，多由气阴两虚、痰瘀阻络、清窍不利而成，证属本虚标实[22]。本研究以“补阳还五汤”益气活血通络与“黄连解毒汤”清热安神立法为基础，结合糖尿病脑病的现代机制[23-25]，采用补阳还五汤合黄连解毒汤加减，对轻中度认知障碍的2型糖尿病患者干预治疗。研究采用MRS与代谢指标相结合的方法，对干预效果及作用机制进行评估，结果如下。
本研究结果显示，补阳还五汤合黄连解毒汤加减针对糖尿病脑病“气阴两虚、痰瘀内扰”的核心病机，通过益气养阴、化痰祛瘀的复合作用路径，实现了认知功能与神经代谢的协同改善。方中人参为君，大补元气[26]，其提取物人参皂苷Rb1通过Cdk5/p35-NMDAR-IDE途径改善了胰岛素抵抗引起的认知障碍[27]，这与《医学衷中参西录》“补气即所以生血”的理论相呼应[28]；何首乌为臣，填精益髓以充脑窍[29]，何首乌中的多种成分，可以发挥抗氧化作用，清除自由基，抑制细胞凋亡并为糖尿病性脑病提供神经保护[30]，佐证了《本草纲目》“养血益肝，固精益肾”的经典论述[31]。治疗组在第6周即出现NAA/Cr的快速提升，恰如《景岳全书》所述“善补阴者必于阳中求阴”，揭示了“气阴互根”理论在神经再生中的科学内涵[32]。此外，Cho/Cr的显著下降（57.0%）与“痰瘀”证候积分的改善高度同步（r＝0.82），佐证了水蛭-丹参药对“破血逐瘀”的现代药理学机制，水蛭中的水蛭素具有破血抗凝抗淤作用[33]，丹参中的酚酸类和丹参酮类通过减轻氧化应激和炎症损伤等途径发挥抗血瘀作用[34]。研究结果提示补阳还五汤合黄连解毒汤加减对糖尿病脑病具有多维度作用：代谢层面，Hcy水平下降63.6%（P<0.001）提示黄连-丹参配伍的提取物可通过针对多种靶标的多种成分对2型糖尿病脑病或其他并发症具有明确的作用[35-36]，这与中医“痰瘀同治”理论中“祛瘀以化痰”的治则相契合；在氧化应激层面，MDA降低44.9%（r＝-0.712）反映何首乌、人参配伍药的提取物可以通过干扰Aβ和tau之间的神经毒性相互作用来改善认知功能[37]，这与中医学中的“益气养阴”法改善“阴虚火旺”病理状态的生物学本质一致。研究结果表明，中医证候改善呈现明确的时序特征：治疗早期（0～6周）以“窍闭痰涎”“肢麻”等标实证缓解为主，与Cho/Cr下降、Hcy降低显著相关（β＝0.78）；后期（6～12周）则转向“髓海失荣”“神机呆钝”等本虚证改善，与NAA/Cr提升、MoCA评分增长密切联动（r＝0.85）。这种“急则治标、缓则治本”的动态调节模式，诠释了《伤寒论》“观其脉证，知犯何逆，随证治之”的辨证论治精髓。尽管本研究结果表明补阳还五汤合黄连解毒汤加减的临床价值，但中医现代化仍面临关键挑战：其一，“痰瘀”证候的生物学指标尚未完全明确，需结合代谢组学筛选与Hcy、IL-6等关联的特征代谢物群；其二，复方多成分协同机制有待解析，需进一步采用网络药理学构建“人参皂苷-二苯乙烯苷-丹参酮”互作网络，结合分子对接验证关键靶点。
补阳还五汤合黄连解毒汤加减通过“益气养阴治本、化痰祛瘀治标”的中医治法，在改善糖尿病脑病认知功能、调节神经代谢稳态方面展现独特优势。本研究通过“中医证候-代谢指标-影像参数”展开的多维观察，为中药复方疗效机制研究提供了可推广的中西医结合模式。后续研究应聚焦“痰瘀”病理产物的动态清除规律，深化“异病同治”理论的现代诠释，推动糖尿病脑病的中医诊疗走向精准化与标准化。
基金
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  • 国家重点研发计划中医药现代化研究项目(2018YFC1704204)
  • 浙江省临床重点专科项目(ZD20212010209)
  • 金华市中医药科技计划项目(2021JZK07)
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2025年第43卷第10期
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doi: 10.13193/j.issn.1673-7717.2025.10.024
  • 首发时间：2026-10-30
  • 出版时间：2025-10-10
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国家重点研发计划中医药现代化研究项目(2018YFC1704204)
浙江省临床重点专科项目(ZD20212010209)
金华市中医药科技计划项目(2021JZK07)
作者信息
    金华市中心医院，浙江 金华 321000

通讯作者:

叶旭星（1986-），男，浙江金华人，副主任医师，硕士，研究方向：中西医结合治疗慢性病。E-mail：。
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https://castjournals.cast.org.cn/joweb/zhzyyxk/CN/10.13193/j.issn.1673-7717.2025.10.024
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2种不同金属材料的力学参数
科
Family		 属数
Number of
genus		 种数
Number of
species		 占总种数比例
Percentage of
total species (%)		 属
Genus		 种数
Number of
species		 占总种数比例
Percentage of total
species (%)
鹅膏菌科Amanitaceae 2 11 5.26 鹅膏菌属 Amanita 10 4.78
小菇科 Mycenaceae 2 12 5.74 丝盖伞属 Inocybe 5 2.39
多孔菌科 Polyporaceae 8 14 6.70 蜡蘑属 Laccaria 5 2.39
红菇科 Russulaceae 3 23 11.00 小皮伞属 Marasmius 6 2.87
小菇属 Mycena 11 5.26
光柄菇属 Pluteus 5 2.39
红菇属 Russula 17 8.13
栓菌属 Trametes 5 2.39
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