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Article(id=1322926690552394695, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926492627378659, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.09.046, 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=1793339901816, onlineDateStr=2026-10-30, pubDate=1757433600000, pubDateStr=2025-09-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793339901816, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793339901816, creator=13701087609, updateTime=1793339901816, updator=13701087609, issue=Issue{id=1322926492627378659, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='9', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1757433600000', pubDateStr='2025-09-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793339854628, creator='13701087609', updateTime=1793340762858, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322930302095590169, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926492627378659, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322930302095590170, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926492627378659, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=243, endPage=247, ext={EN=ArticleExt(id=1322926690770498504, articleId=1322926690552394695, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Influence of Huanglian Jiedu Decoction（黄连解毒汤）on Cognitive Function and Expressions of Serum Aβ1-42 and BK in Patients with Alzheimer’s Disease, columnId=1256183365644968140, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Platform of Provincial Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To study the influence of Huanglian Jiedu Decoction（黄连解毒汤）on cognitive function and expressions of serum human amyloid β-protein 1-42（Aβ1-42）and bradykinin（BK）in patients with Alzheimer’s disease（AD）.

Methods

A total of 120 patients with AD were selected and divided into western medicine group and Huanglian Jiedu Decoction group by adopting the random number table method，60 cases in each group. The western medicine group was treated with donepezil combined with memantine，while the Huanglian Jiedu Decoction group added Huanglian Jiedu Decoction on the basis of the western medicine group. The clinical efficacy，TCM symptoms scores，inflammatory factors［interleukin-1β（IL-1β），tumor necrosis factor-α（TNF-α）and interleukin-6（IL-6）］，serum proteins［Aβ1-42，BK and microtubule-associated protein（Tau）］and cognitive function［Chinese version of Alzheimer’s Disease Assessment Scale-Cognitive Subscale（ADAS-Cog）and Chinese version of Montreal Cognitive Assessment Scale（MoCA）］before and after treatmentwere compared between groups，and the adverse drug reactions were evaluated.

Results

The total effective rate in the Huanglian Jiedu Decoction group was 91.67% at3 months of treatment，which was higher than 78.33% in the western medicine group（P<0.05）. After treatment，the scores of TCM primary symptoms and the levels of inflammatory factors（IL-1β，TNF-αand IL-6）and serum proteins（Aβ1-42，BK and Tau）in Huanglian Jiedu Decoction group and western medicine group were decreased，and the scores and levels in Huanglian Jiedu Decoction group were lower than those in the western medicine group（P<0.05）. The ADAS-Cog score in the Huanglian Jiedu Decoction group and western medicine group after treatment were reduced while the MoCA score was increased，and the changes in Huanglian Jiedu Decoction group were higher than those in the western medicine group（P<0.05）. During treatment，there was no statistical significance in the incidence of adverse drug reactions between Huanglian Jiedu Decoction group and western medicine group（8.33% vs6.67%）（P>0.05）.

Conclusion

Huanglian Jiedu Decoction has an exact efficacy in the treatment of AD，and it can effectively alleviate the neuroinflammation，regulate the expressions of serum Aβ1-42 and BK，and improve the cognitive function，and it has good safety.

, authors=Yingkun HE1, Shijie LI2, Yujuan CHANG3, Chunjiang CAI1, Junna ZHANG1, authorsList=Yingkun HE, Shijie LI, Yujuan CHANG, Chunjiang CAI, Junna ZHANG, 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=1322926691504501709, articleId=1322926690552394695, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=黄连解毒汤对阿尔茨海默病患者认知功能及血清Aβ1-42、BK表达的影响观察, columnId=1256183369033965799, journalTitle=中华中医药学刊, columnName=省级项目平台, runingTitle=null, highlight=null, articleAbstract=
目的

研究黄连解毒汤对阿尔茨海默病（alzheimer＇s disease，AD）患者认知功能及血清β-淀粉样蛋白1-42（amyloid protein 1-42，Aβ1-42）、缓激肽（bradykinin，BK）表达的影响。

方法

选择120例AD患者，依据随机数表法分为单纯西药组和黄连解毒组各60例，单纯西药组采用多奈哌齐联合美金刚治疗，黄连解毒组在单纯西药组基础上加用黄连解毒汤治疗。比较两组临床疗效，治疗前后中医症状积分、炎性因子［白细胞介素1β（interleukin-1β，IL-1β）、肿瘤坏死因子-α（tumor necrosis factor，TNF-α）和白细胞介素6（interleukin-6，IL-6）］、血清蛋白［Aβ1-42、BK和微管相关蛋白（microtubule-associated protein tau，Tau）］和认知功能［中文版阿尔茨海默病认知功能量表（alzheimer＇s disease assessment scale-cognitive subscale，ADAS-Cog）和中文版蒙特利尔认知评估量表（Montreal cognitive assessment，Mo-CA）］，评估药物不良反应。

结果

黄连解毒组治疗3个月时总体有效率91.67%高于单纯医药组的78.33%（P<0.05）；治疗后，黄连解毒组与单纯西药组中医各主症状评分、炎性因子（IL-1β、TNF-α和IL-6）水平和血清蛋白（Aβ1-42、BK和Tau）水平均降低，且黄连解毒组低于单纯西药组（P<0.05）；治疗后，黄连解毒组与单纯西药组ADAS-Cog评分降低，MoCA评分提升，且黄连解毒组分值变化高于单纯西药组（P<0.05）；治疗期间，黄连解毒组与单纯西药组不良反应发生率比较（8.33% vs 6.67%）无统计学意义（P>0.05）。

结论

黄连解毒汤治疗AD疗效确切，可有效缓解神经炎症，调节血清Aβ1-42、BK表达，改善认知功能，安全性较好。

, authors=何瑛琨1, 李士杰2, 常玉娟3, 蔡春江1, 张军娜1, authorsList=何瑛琨, 李士杰, 常玉娟, 蔡春江, 张军娜, authorCompany=null, correspAuthors=null, authorNote=

何瑛琨（1987-），女，河北石家庄人，主治医师，博士，研究方向：中医脑病及心血管疾病。

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何瑛琨（1987-），女，河北石家庄人，主治医师，博士，研究方向：中医脑病及心血管疾病。

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何瑛琨（1987-），女，河北石家庄人，主治医师，博士，研究方向：中医脑病及心血管疾病。

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Genipin attenuates tau phosphorylation and aβlevels in cellular models of Alzheimer＇s disease［J］. Mol Neurobiol，2021，58（8）：4134-4144., articleTitle=Genipin attenuates tau phosphorylation and aβlevels in cellular models of Alzheimer＇s disease, refAbstract=null), Reference(id=1322926703135305767, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, doi=null, pmid=null, pmcid=null, year=2022, volume=14, issue=1, pageStart=20, pageEnd=null, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=DELABY C, ESTELLÉS T, ZHU N, journalName=Alzheimers Res Ther, refType=null, unstructuredReference=DELABY C，ESTELLÉS T，ZHU N，et al. The Aβ1-42/Aβ1-40 ratio in CSF ismore strongly associated to tau markers and clinical progression than Aβ1-42 alone［J］. 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组别例数临床痊愈显效好转无效有效率
单纯西药组608（13.33）27（45.00）12（20.00）13（21.67）47（78.33）
黄连解毒组6021（35.00）24（40.00）10（16.67）5（8.33）55（91.67）*
), ArticleFig(id=1322926697967924223, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=CN, label=表1, caption=

两组AD患者临床疗效比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数临床痊愈显效好转无效有效率
单纯西药组608（13.33）27（45.00）12（20.00）13（21.67）47（78.33）
黄连解毒组6021（35.00）24（40.00）10（16.67）5（8.33）55（91.67）*
), ArticleFig(id=1322926698047616000, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间迷蒙昏睡、寤寐颠倒激越攻击、谵语妄言便溺失禁、肢体失用躯体蜷缩、肢颤痫痉
单纯西药组60治疗前5.11±0.344.89±0.444.86±0.454.79±0.51
治疗后1.73±0.34#1.85±0.36#1.88±0.37#1.62±0.32#
黄连解毒组60治疗前5.14±0.354.93±0.414.80±0.434.72±0.48
治疗后1.24±0.23*#1.28±0.25*#1.11±0.21*#0.96±0.18*#
), ArticleFig(id=1322926698110529536, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=CN, label=表2, caption=

两组AD患者治疗前后中医症状积分比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间迷蒙昏睡、寤寐颠倒激越攻击、谵语妄言便溺失禁、肢体失用躯体蜷缩、肢颤痫痉
单纯西药组60治疗前5.11±0.344.89±0.444.86±0.454.79±0.51
治疗后1.73±0.34#1.85±0.36#1.88±0.37#1.62±0.32#
黄连解毒组60治疗前5.14±0.354.93±0.414.80±0.434.72±0.48
治疗后1.24±0.23*#1.28±0.25*#1.11±0.21*#0.96±0.18*#
), ArticleFig(id=1322926698181832705, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间IL-1β/（ng/L）TNF-α/（ng/L）IL-6/（pg/mL）
单纯西药组60治疗前30.07±5.146.68±1.149.86±1.45
治疗后23.67±4.11#5.36±0.93#8.18±1.07#
黄连解毒组60治疗前29.34±5.256.43±1.1810.08±1.63
治疗后20.24±3.36*#4.25±0.85*#7.11±1.02*#
), ArticleFig(id=1322926698248941570, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=CN, label=表3, caption=

两组AD患者治疗前后炎性因子比较（±s）

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间IL-1β/（ng/L）TNF-α/（ng/L）IL-6/（pg/mL）
单纯西药组60治疗前30.07±5.146.68±1.149.86±1.45
治疗后23.67±4.11#5.36±0.93#8.18±1.07#
黄连解毒组60治疗前29.34±5.256.43±1.1810.08±1.63
治疗后20.24±3.36*#4.25±0.85*#7.11±1.02*#
), ArticleFig(id=1322926698353799171, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间Aβ1-42/（ng/L）BK/（IU/L）Tau/（ng/L）
单纯西药组60治疗前220.87±16.5420.68±2.44229.86±15.59
治疗后206.67±12.11#15.87±1.73#216.49±11.71#
黄连解毒组60治疗前224.34±17.2520.13±2.38227.08±16.33
治疗后191.43±10.62*#14.12±1.65*#205.12±9.12*#
), ArticleFig(id=1322926698433490948, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=CN, label=表4, caption=

两组AD患者治疗前后血清蛋白水平比较（±s）

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间Aβ1-42/（ng/L）BK/（IU/L）Tau/（ng/L）
单纯西药组60治疗前220.87±16.5420.68±2.44229.86±15.59
治疗后206.67±12.11#15.87±1.73#216.49±11.71#
黄连解毒组60治疗前224.34±17.2520.13±2.38227.08±16.33
治疗后191.43±10.62*#14.12±1.65*#205.12±9.12*#
), ArticleFig(id=1322926698651594757, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间ADAS-CogMoCA
单纯西药组60治疗前61.27±5.5418.18±2.44
治疗后45.83±4.06#20.88±2.78#
黄连解毒组60治疗前60.34±5.3917.89±2.31
治疗后40.94±4.12*#23.63±2.85*#
), ArticleFig(id=1322926698731286534, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=CN, label=表5, caption=

两组AD患者治疗前后认知功能比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间ADAS-CogMoCA
单纯西药组60治疗前61.27±5.5418.18±2.44
治疗后45.83±4.06#20.88±2.78#
黄连解毒组60治疗前60.34±5.3917.89±2.31
治疗后40.94±4.12*#23.63±2.85*#
), ArticleFig(id=1322926698802589703, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数恶心呕吐头晕头痛失眠食欲不振总发生
单纯西药组602（3.33）1（1.67）1（1.67）0（0.00）4（6.67）
黄连解毒组601（1.67）1（1.67）1（1.67）2（3.33）5（8.33）
), ArticleFig(id=1322926698869698568, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926690552394695, language=CN, label=表6, caption=

两组AD患者不良反应比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数恶心呕吐头晕头痛失眠食欲不振总发生
单纯西药组602（3.33）1（1.67）1（1.67）0（0.00）4（6.67）
黄连解毒组601（1.67）1（1.67）1（1.67）2（3.33）5（8.33）
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黄连解毒汤对阿尔茨海默病患者认知功能及血清Aβ1-42、BK表达的影响观察
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何瑛琨 1 , 李士杰 2 , 常玉娟 3 , 蔡春江 1 , 张军娜 1
中华中医药学刊 | 省级项目平台 2025,43(9): 243-247
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中华中医药学刊 |省级项目平台 2025 , 43 (9) : 243 -247
黄连解毒汤对阿尔茨海默病患者认知功能及血清Aβ1-42、BK表达的影响观察
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何瑛琨1, 李士杰2, 常玉娟3, 蔡春江1, 张军娜1
作者信息
  • 1.河北省人民医院，河北 石家庄 050000
  • 2.河北以岭医院，河北 石家庄 050000
  • 3.石家庄市中医院，河北 石家庄 050000
作者简介:

何瑛琨（1987-），女，河北石家庄人，主治医师，博士，研究方向：中医脑病及心血管疾病。

Influence of Huanglian Jiedu Decoction（黄连解毒汤）on Cognitive Function and Expressions of Serum Aβ1-42 and BK in Patients with Alzheimer’s Disease
Yingkun HE1, Shijie LI2, Yujuan CHANG3, Chunjiang CAI1, Junna ZHANG1
Affiliations
  • 1.Hebei General Hospital，Shijiazhuang 050000，Hebei，China
  • 2.Hebei Yiling Hospital，Shijiazhuang 050000，Hebei，China
  • 3.Shijiazhuang Hospital of traditional Chinese Medicine，Shijiazhuang 050000，Hebei，China
出版时间: 2025-09-10 doi: 10.13193/j.issn.1673-7717.2025.09.046
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摘要
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目的

研究黄连解毒汤对阿尔茨海默病（alzheimer＇s disease，AD）患者认知功能及血清β-淀粉样蛋白1-42（amyloid protein 1-42，Aβ1-42）、缓激肽（bradykinin，BK）表达的影响。

方法

选择120例AD患者，依据随机数表法分为单纯西药组和黄连解毒组各60例，单纯西药组采用多奈哌齐联合美金刚治疗，黄连解毒组在单纯西药组基础上加用黄连解毒汤治疗。比较两组临床疗效，治疗前后中医症状积分、炎性因子［白细胞介素1β（interleukin-1β，IL-1β）、肿瘤坏死因子-α（tumor necrosis factor，TNF-α）和白细胞介素6（interleukin-6，IL-6）］、血清蛋白［Aβ1-42、BK和微管相关蛋白（microtubule-associated protein tau，Tau）］和认知功能［中文版阿尔茨海默病认知功能量表（alzheimer＇s disease assessment scale-cognitive subscale，ADAS-Cog）和中文版蒙特利尔认知评估量表（Montreal cognitive assessment，Mo-CA）］，评估药物不良反应。

结果

黄连解毒组治疗3个月时总体有效率91.67%高于单纯医药组的78.33%（P<0.05）；治疗后，黄连解毒组与单纯西药组中医各主症状评分、炎性因子（IL-1β、TNF-α和IL-6）水平和血清蛋白（Aβ1-42、BK和Tau）水平均降低，且黄连解毒组低于单纯西药组（P<0.05）；治疗后，黄连解毒组与单纯西药组ADAS-Cog评分降低，MoCA评分提升，且黄连解毒组分值变化高于单纯西药组（P<0.05）；治疗期间，黄连解毒组与单纯西药组不良反应发生率比较（8.33% vs 6.67%）无统计学意义（P>0.05）。

结论

黄连解毒汤治疗AD疗效确切，可有效缓解神经炎症，调节血清Aβ1-42、BK表达，改善认知功能，安全性较好。

阿尔茨海默病  /  黄连解毒汤  /  认知功能  /  血清人淀粉样蛋白1-42  /  血清缓激肽  /  疗效  /  安全性
Objective

To study the influence of Huanglian Jiedu Decoction（黄连解毒汤）on cognitive function and expressions of serum human amyloid β-protein 1-42（Aβ1-42）and bradykinin（BK）in patients with Alzheimer’s disease（AD）.

Methods

A total of 120 patients with AD were selected and divided into western medicine group and Huanglian Jiedu Decoction group by adopting the random number table method，60 cases in each group. The western medicine group was treated with donepezil combined with memantine，while the Huanglian Jiedu Decoction group added Huanglian Jiedu Decoction on the basis of the western medicine group. The clinical efficacy，TCM symptoms scores，inflammatory factors［interleukin-1β（IL-1β），tumor necrosis factor-α（TNF-α）and interleukin-6（IL-6）］，serum proteins［Aβ1-42，BK and microtubule-associated protein（Tau）］and cognitive function［Chinese version of Alzheimer’s Disease Assessment Scale-Cognitive Subscale（ADAS-Cog）and Chinese version of Montreal Cognitive Assessment Scale（MoCA）］before and after treatmentwere compared between groups，and the adverse drug reactions were evaluated.

Results

The total effective rate in the Huanglian Jiedu Decoction group was 91.67% at3 months of treatment，which was higher than 78.33% in the western medicine group（P<0.05）. After treatment，the scores of TCM primary symptoms and the levels of inflammatory factors（IL-1β，TNF-αand IL-6）and serum proteins（Aβ1-42，BK and Tau）in Huanglian Jiedu Decoction group and western medicine group were decreased，and the scores and levels in Huanglian Jiedu Decoction group were lower than those in the western medicine group（P<0.05）. The ADAS-Cog score in the Huanglian Jiedu Decoction group and western medicine group after treatment were reduced while the MoCA score was increased，and the changes in Huanglian Jiedu Decoction group were higher than those in the western medicine group（P<0.05）. During treatment，there was no statistical significance in the incidence of adverse drug reactions between Huanglian Jiedu Decoction group and western medicine group（8.33% vs6.67%）（P>0.05）.

Conclusion

Huanglian Jiedu Decoction has an exact efficacy in the treatment of AD，and it can effectively alleviate the neuroinflammation，regulate the expressions of serum Aβ1-42 and BK，and improve the cognitive function，and it has good safety.

Alzheimer’s disease  /  Huanglian Jiedu Decoction（黄连解毒汤）  /  cognitive function  /  serum human amyloid protein 1-42  /  serum bradykinin  /  efficacy  /  safety
何瑛琨, 李士杰, 常玉娟, 蔡春江, 张军娜. 黄连解毒汤对阿尔茨海默病患者认知功能及血清Aβ1-42、BK表达的影响观察. 中华中医药学刊, 2025 , 43 (9) : 243 -247 . DOI: 10.13193/j.issn.1673-7717.2025.09.046
Yingkun HE, Shijie LI, Yujuan CHANG, Chunjiang CAI, Junna ZHANG. Influence of Huanglian Jiedu Decoction（黄连解毒汤）on Cognitive Function and Expressions of Serum Aβ1-42 and BK in Patients with Alzheimer’s Disease[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (9) : 243 -247 . DOI: 10.13193/j.issn.1673-7717.2025.09.046
正文
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阿尔茨海默病（alzheimer＇s disease，AD）是一种以认知功能障碍、记忆力减退、生活能力下降和人格改变等为主要症状表现的神经退行性疾病[1]。其发病机制复杂，研究认为[2]，大脑中β-淀粉样蛋白（amyloid β-protein，Aβ）的异常沉积是AD病理进程中的核心事件，其通过引发一系列神经炎症反应，最终导致神经元死亡和认知功能受损；而缓激肽（bradykinin，BK）水平在对轻度认知功能障碍进展为AD临床预测中表现出良好的灵敏度和特异度。当前临床治疗AD主要通过药物治疗和非药物干预，常用的药物包括乙酰胆碱酯酶抑制剂和N-甲基-D天冬氨酸（N-methyl-D-aspartate，NMDA）受体拮抗剂，可通过增加胆碱能神经传递或调节谷氨酸受体，改善症状或延缓病情进展[3]。然西药治疗无法根治，且多需长期服用，药物不良反应风险较高。非药物治疗主要采用认知训练、行为干预等，但效果因人而异，且需长期坚持，依从性难以保证。
近年来，中医药在AD治疗中通过整体调节、辨证施治，逐渐显示出独特的疗效和潜力。AD属中医“痴呆”范畴，基本病机在于脑消髓减、神机失用，症见本虚标实、虚实夹杂，虚可见肾虚、心脾两虚证，实可见痰浊、毒损脑络证等，因肾虚而髓海不足，神明失养；脾虚受病，神明被阻，意舍不清，心神不宁，则使人健忘；肝阴不足，风阳上扰，神明被阻，则精神烦乱；三脏失常，致聚湿生痰，痰蒙清窍，则头晕、健忘、神疲，进展至晚期以毒损脑络、脑消髓减为主要病机[3]。中医强调辨证论治，针对中晚期AD毒盛虚极证，指南推荐以黄连解毒汤治疗，可达解毒通络、补肾固元之效[4]。研究发现[5]，黄连解毒汤可调节神经丝蛋白表达量干预AD的病理进程，改善患者认知功能，然其对于AD患者血清Aβ1-42、BK表达的影响尚不清晰。本研究旨在探究黄连解毒汤对AD患者认知功能以及血清Aβ1-42、BK表达的影响。
1　资料与方法
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1.1　一般资料
研究对象选择2020年6月—2023年12月接诊的120例AD患者，分组采用随机数表法，分为单纯西药组和黄连解毒组两组，每组60例。单纯西药组男33例，女27例，年龄范围60～78岁，平均（69.38±4.42）岁，发病时间7～11年，平均（9.22±1.13）年，高中及以上文化17例，初中文化24例，小学及以下文化19例。黄连解毒组男29例，女31例，年龄范围60～77岁，平均（68.45±4.17）岁，发病时间7～12年，平均（9.38±1.16）年，高中及以上文化15例，初中文化20例，小学及以下文化25例。两组就诊时基线资料比较无统计学意义（P>0.05）。本研究经我院医学伦理委员会审核批准（2024-LW-124）。
西医诊断参照我国AD诊治指南[6]中的诊断标准，符合痴呆（缓慢的智力减退、人格改变）标准，存在起病隐匿、进展恶化进程缓慢，经影像学和病理检查，确诊为AD。中医诊断参照《阿尔茨海默病的中医诊疗共识》[7]，毒盛虚极证，迷蒙昏睡、寤寐颠倒，激越攻击、谵语妄言，便溺失禁、肢体失用，躯体蜷缩、肢颤痫痉，具备症状组合之一者。纳入标准：①经西医、中医诊断确诊为AD、毒盛虚极证；②首次接受相关治疗者；③知情同意。排除标准：①合并有抑郁症、心脑血管病等疾病者；②因其他疾病或头部外伤导致痴呆者；③合并患有帕金森病者；④合并有其他影响认知功能的疾病者；⑤合并有视力、听力障碍者；⑥并有器官、组织功能障碍或疾病者；⑦对本研究药物或成分有禁忌者。
1.2　治疗方法
1.2.1　单纯西药组
采用盐酸多奈哌齐片（植恩生物技术股份有限公司，国药准字H20010723）每日睡前口服，5 mg/次，持续服用1个月无不良症状时，增加至10 mg/次；盐酸美金刚片（德国Rottendorf Pharma GmbH，注册证号H20120268）治疗首周5 mg/d晨服，次周增加至10 mg/d分为早晚服用，第3周增加至15 mg/d分为早晚服用，第4周增加至维持剂量20 mg/d早晚服用。持续服用3个月评估。
1.2.2　黄连解毒组
在单纯西药组基础上加用黄连解毒汤治疗，方剂组成：黄连9 g，黄芪、黄柏各6 g，栀子十四枚（擘）约9 g，加水1.2 L煎煮，浓缩至约400 mL，早晚两次温服。持续服用3个月评估。
1.3　观察指标
1.3.1　中医症状积分
中医症状参照《阿尔茨海默病的中医诊疗共识》[7]中毒盛虚极证，主症：迷蒙昏睡、寤寐颠倒，激越攻击、谵语妄言，便溺失禁、肢体失用，躯体蜷缩、肢颤痫痉，评分参照《中药新药临床研究指导原则》[8]，症状无、轻、中、重分别计分0、2、4、6分，得分越高症状越严重。
1.3.2　炎性因子
治疗前、治疗3个月后，采集患者空腹状态上肢静脉血5 mL，分离上层血清采用半径为10 cm的离心转子以2500 rpm转速离心10 min，白细胞介素1β（interleukin-1β，IL-1β）以酶联免疫吸附法测定，化学发光免疫分析法检测肿瘤坏死因子-α（tumor necrosis factor，TNF-α）和白细胞介素6（interleukin-6，IL-6）水平。
1.3.3　血清蛋白
治疗前、治疗3个月后，采用患者静脉血清，酶联免疫吸附法检测Aβ1-42、BK和微管相关蛋白（microtubule-associated protein tau，Tau）水平。
1.3.4　认知功能
治疗前、治疗3个月后，分别采用中文版阿尔茨海默病认知功能量表（alzheimer＇s disease assessment scale-cognitive subscale，ADAS-Cog）[9]，量表包含12条目，总分0～75分，分值越高认知受损越严重；中文版蒙特利尔认知评估量表（Montreal cognitive assessment，MoCA）[10]，包含8项认知领域的30题目，得分<16分为老年痴呆症，17～26分为轻度认知障碍，27～30分为正常。
1.3.5　不良反应
记录治疗期间发生的药物不良反应。
1.4　临床疗效标准[8]
临床痊愈：毒盛虚极证临床症状消失或基本消失，证候积分降低超95%；显效：临床症状改善，证候积分降低超70%；好转：临床症状好转，证候积分降低超30%；无效：未达上述标准。有效率为痊愈+显效+好转患者所占比例。
1.5　统计学方法
数据的统计学差异分析利用IBM SPSS 22.0，症状积分、实验室指标等连续性、符合正态分布的计量资料以均数±标准差描述，行t检验；疗效、不良反应计数资料比例以（%）表述，行χ2检验，差异以P<0.05描述统计学意义。
2　结果
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2.1　两组临床疗效比较
见表1。治疗3个月，黄连解毒组治疗有效55例，有效率为91.67%，高于单纯西药组的47例，有效率为78.33%（P<0.05）。
2.2　两组治疗前后中医症状积分比较
见表2。黄连解毒组与单纯西药组治疗前迷蒙昏睡、寤寐颠倒（5.14±0.35 vs 5.11±0.34），激越攻击、谵语妄言（4.93±0.41 vs 4.89±0.44），便溺失禁、肢体失用（4.80±0.43 vs 4.86±0.45），躯体蜷缩、肢颤痫痉（4.72±0.48 vs 4.79±0.51）评分比较均无统计学意义（P>0.05）；治疗后，黄连解毒组与单纯西药组各症状评分均降低，且黄连解毒组评分均低于单纯西药组（P<0.05）。
2.3　两组治疗前后炎性因子水平比较
见表3。黄连解毒组与单纯西药组治疗前在IL-1β（29.34±5.25 vs 30.07±5.14）、TNF-α（6.43±1.18 vs 6.68±1.14）和IL-6（10.08±1.63 vs 9.86±1.45）水平上比较均无统计学差异（P>0.05）；治疗后，黄连解毒组与单纯西药组各指标水平均有所下降，且黄连解毒组IL-1β、TNF-α和IL-6指标均低于单纯西药组（P<0.05）。
2.4　两组治疗前后血清蛋白水平比较
见表4。黄连解毒组与单纯西药组治疗前血清蛋白Aβ1-42（224.34±17.25 vs 220.87±16.54）、BK（20.13±2.38 vs 20.68±2.44）和Tau（227.08±16.33 vs 229.86±15.59）水平方面比较均无统计学差异（P>0.05）；治疗后，黄连解毒组与单纯西药组各蛋白水平均降低，且黄连解毒组Aβ1-42、BK和Tau指标水平均低于单纯西药组（P<0.05）。
2.5　两组治疗前后认知功能比较
见表5。治疗前，黄连解毒组与单纯西药组ADAS-Cog、MoCA评分比较无统计学意义（P>0.05）；治疗后，黄连解毒组与单纯西药组ADAS-Cog评分降低，MoCA评分提升，且黄连解毒组分值变化高于单纯西药组（P<0.05）。
2.6　两组不良反应比较
见表6。治疗期间，黄连解毒组与单纯西药组出现的恶心呕吐、头晕头痛、失眠和食欲不振等不良反应发生率分别为8.33%与6.67%，二者比较无统计学意义（P>0.05）。
3　讨论
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随着我国老龄化发展，AD成为当前继心脑血管病和癌症之后的第3大影响生命健康的疾病，该病发病隐匿，且进展缓慢，进展至晚期时脑神经功能多已发生不可逆损伤，西医药物治疗主要通过改善认知和痴呆精神行为症状群，指南推荐[4]胆碱酯酶抑制剂为改善AD患者认知功能和日常生活能力的一线药物，中-重度AD患者需联合采用NMDA受体拮抗剂治疗，可取得良好效果。现代医学研究发现[11-12]，AD发病或与递质系统功能异常引发的兴奋性神经毒素有关，中枢神经系统兴奋传递由NMDA型谷氨酸受体介导，其激活的NMDA受体和其他离子型谷氨酸受体在学习和记忆过程中起关键作用，当其水平异常提升时可导致NMDA受体的过度激活，产生兴奋性毒性，引发神经元损伤和凋亡，被认为是AD神经元损伤的重要机制之一。胆碱酶抑制剂可通过影响AD患者脑内胆碱合成功能缓解临床症状，多奈哌齐为其代表性第二代药物，可抑制乙酰胆碱水解，改善兴奋性神经递质功能活性，从而缓解疾病发展[13]；NMDA受体抑制剂代表药物为美金刚，可与不同谷氨酸受体亚型结合，阻断其介导的中枢神经系统兴奋度，缓解兴奋性神经毒性作用，同时能够调节钙离子内流，防止钙超载对神经元的毒性作用，从而减缓神经退化进程，缓解AD临床症状[14]。美金刚还具有一定神经保护作用，可改善患者语言、记忆等能力，在中-重度AD中的治疗效果已经临床证实[15]。然西药治疗多为缓解症状，无法逆转或根治疾病，且需长期服用，药物不良反应与耐药性问题不容忽视，近年来，随着中医药现代研究的深入，越来越多证据表明，中药在AD的预防和治疗中效果更佳。
AD归属中医“呆病”范畴，《黄帝内经》有云：“年高者，髓减脑消”，认为老年人由于精气不足、脏腑机能减退，导致脑髓亏虚，从而出现记忆力减退和认知功能障碍等症状[16]。中医认为，AD的发生与脏腑、气血、阴阳失调密切相关，脾虚多为AD发生因素，肾虚为其基础，气血生化不足，不能上荣于脑；肾虚则精气亏虚，脑髓失养；疾病进展，化生痰浊瘀血，久而化毒，毒袭经络，损伤气血，损伤脑络，加重髓减脑消，而神机失用[17]。早期治疗以补肾为主，晚期因痰、瘀、火化生毒浊而致毒盛虚极，形神衰败，治疗需补肾固元、解毒化浊。针对晚期毒盛虚极证，指南推荐采用黄连解毒汤，其为苦寒直折法代表方，出自晋代葛洪的《肘后备急方》，由黄连、黄芩、黄柏与栀子组成，其中黄连有清热燥湿、泻火解毒之效，为君药，可入上焦清泻心火，又可入中焦泻中焦之火；黄芩、黄柏皆有清热燥湿、泻火解毒之效，共为臣药，可清上焦、泻下焦之火，增强黄连清热泻火之效；栀子有泻火除烦、清热解毒之效，归心、肺、三焦经，可清泻三焦之火，导热下行，是为佐使药，诸药相伍，共奏清火解毒之效。本研究结果显示，治疗3个月后，黄连解毒组总体有效率高于医药组，中医各主症状评分低于医药组，表明黄连解毒汤在改善AD患者总体症状方面效果更好。现代药理学研究发现，黄连中的活性成分小檗碱可通上调微小RNA-137表达，下调淀粉样蛋白前体蛋白表达量，抑制Aβ诱导的人神经母细胞活力下降，逆转细胞凋亡，保护神经系统，从而达到治疗AD的目的[18]。黄芩中的活性成分黄芩素可减少脑内Aβ斑块沉积，缓解NLRP3炎症小体活化和神经元凋亡，并通过靶向HMOX1（Heme Oxygenase 1）/磷酸二酯酶-4D轴调节小胶质细胞极化，以抑制AD患者脑神经炎症和神经损伤而治疗AD[19]；黄芩苷可抑制NLRP3炎性小体和Toll样受体4/核转录因子-κB信号通路，进而减轻认知损伤、保护神经元免受小胶质细胞介导的神经炎症损伤[20]。黄柏活性成分黄柏苷可稳定地结合与炎症密切相关的细胞外信号调节激酶、应激激活蛋白激酶和p38丝裂原激活蛋白激酶，通过抑制MAPK信号通路中蛋白活化，抑制一氧化氮、TNF-α、IL-1β、IL-6等促炎介质的过度产生，缓解神经炎症，同时认知异常也与TNF-α和IL-1β等外周炎症信号变化相关[21]。Aβ纤维形成、Tau蛋白磷酸化、神经炎症、胆碱能神经递质调节、抗氧化应激和抗凋亡作用是栀子治疗AD的主要病理机制，其栀子苷可通过非经典雌激素通路，阻断原代培养海马中Aβ1-42介导的神经元死亡，从而缓解AD疾病的发生发展[22]；同时，栀子苷可通过抑制糖基化终末产物受体/细胞外信号调节激酶1/2-核因子κB、Toll样受体4/核转录因子-κB信号通路相关神经炎症通路，降低皮质和海马中炎症蛋白及促炎介质的表达和产生，进而减缓AD发展[23]。因而本研究结果显示，治疗3个月后，黄连解毒组IL-1β、TNF-α和IL-6水平低于单纯西药组，认知功能评分改善（ADAS-Cog评分降低，MoCA评分提升）优于单纯西药组，表明黄连解毒汤可更有效缓解AD患者神经炎症，改善认知功能。
Aβ1-42是血清Aβ代谢产物，其水平降低与突触功能受损有关，可反映认知障碍的严重程度，为当前AD诊断标志物之一，Aβ形成的可溶性低聚物具有高度的神经元毒性，可导致线粒体功能异常、膜结构损伤、神经突触功能减弱和神经元凋亡，在AD发展中起着关键作用[24]；Tau蛋白与神经轴突内微管功能的稳定性相关，AD患者Aβ表达量增加，可促进Tau蛋白的异常磷酸化，使其血清浓度提升，导致神经祖细胞纤维缠结的形成，失去对微管的稳定作用，引起神经纤维退化，进而使得神经功能失调[25-26]。BK增多被认为是AD病理生理学中的炎症诱因之一，在患有严重认知障碍的AD患者血浆中表达水平更高，且其释放量受血浆中Aβ调节，在存在Aβ42的情况下，血浆BK表达量可增加约2.6倍，BK可导致一氧化氮过量产生，从而引发神经炎症[26]。本研究结果显示，治疗后，黄连解毒组Aβ1-42、BK和Tau水平低于单纯西药组，表明黄连解毒汤调节AD相关血清蛋白表达效果更好。此外，本研究治疗期间，黄连解毒组药物不良反应发生与单纯西药组无显著差异，表明加用黄连解毒汤治疗不会增加不良反应，安全性较好。
综上所述，黄连解毒汤治疗AD疗效确切，可有效缓解神经炎症，调节血清Aβ1-42、BK表达，改善认知功能，安全性较好。
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  • 河北省中医药管理局科研计划项目(2020207)
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参考文献 引证文献
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2025年第43卷第9期
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doi: 10.13193/j.issn.1673-7717.2025.09.046
  • 首发时间：2026-10-30
  • 出版时间：2025-09-10
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河北省中医药管理局科研计划项目(2020207)
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    1.河北省人民医院，河北 石家庄 050000
    2.河北以岭医院，河北 石家庄 050000
    3.石家庄市中医院，河北 石家庄 050000
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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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