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Article(id=1322912407017882117, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322912162913596032, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.01.038, 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=1793336496357, onlineDateStr=2026-10-30, pubDate=1736438400000, pubDateStr=2025-01-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793336496357, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793336496357, creator=13701087609, updateTime=1793336496357, updator=13701087609, issue=Issue{id=1322912162913596032, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='1', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1736438400000', pubDateStr='2025-01-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793336438157, creator='13701087609', updateTime=1793340633627, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322929760048906989, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322912162913596032, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322929760048906990, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322912162913596032, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=214, endPage=217, ext={EN=ArticleExt(id=1322912407445701126, articleId=1322912407017882117, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Efficacy of Yishen Tiaogan Decoction（益肾调肝方）on Perimenopausal Women with Dry Eye of Kidney Deficiency and Liver Depression Syndrome and Its Influence on Early Changes in Ocular Surface, columnId=1256183365644968140, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Platform of Provincial Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the efficacy of Yishen Tiaogan Decoction（益肾调肝方）on perimenopausal women with dry eye of kidney deficiency and liver depression syndrome and its influence on early changes in ocular surface.

Methods

One hundred and twenty perimenopausal women with dry eye of kidney deficiency and liver depression syndrome admitted to the hospital from February 2021 to March 2023 were selected，and randomly assigned into two groups，each with 60 cases. The control group received sodium hyaluronate eye drops. Based on this，the study group was given Yishen Tiaogan Decoction. The treatment in both groups lasted for 4 weeks. Then the TCM symptom scores，ocular surface function［tear film break-up time（BUT），Schirmer I test（SIT），cornea corneal fluorescein（FL）staining］，clinical efficacy，the levels of inflammatory factors［interleukin（IL）-6，IL-33］and adverse reactions were compared between two groups after treatment.

Results

TCM syndrome scores showed a decline in both groups after treatment（P<0.05），and the score was（1.60±0.35）point in the study group，which was lower than that［（4.89±0.74）point］in the control group（P<0.05）. Therewas an improvement in BUT，SIT and FL score in both groups after treatment（P<0.05），and the three parameters were（10.08±1.29）s，（11.25±2.26）mm/5 min and（0.85±0.14）point in the study group，which were all better than those［（5.64±1.15）s，（7.76±1.35）mm/5 min and（2.38±0.49）point］in the control group，with statistical difference（P<0.05）. In the control group，15 cases were cured，24 cases were improved and 21 cases were ineffective. In the study group，35 cases were cured，22 cases were improved and 3 cases were ineffective. The efficacy grade distribution yielded statistical difference between two groups（Z＝-5.044，P<0.05）. The overall efficacy rate was 95.00%（57/60）in the study group，which was higher than that（65.00%，39/60）in the control group（P<0.05）. Serum levels of inflammatory factors showed a decrease in both groups after treatment（P<0.05）. The serum levels of IL-6 and IL-33 were（15.13±3.30）pg/mL and（10.30±1.85）pg/m L in the study group，which were lower than those［（17.26±3.71）pg/mL and（11.49±2.18）pg/mL］in the controlgroup（P<0.05）. During the treatment period，no adverse reactions were found in the control group，and one case of diarrhoea occurred in the study group，the symptoms were mild and could be relieved without any intervention. The adverse reaction rate yielded no statistical difference between two groups（χ2＝1.008，P>0.05）.

Conclusion

Yishen Tiaogan Decoction for perimenopausal women with dry eye of kidney deficiency and liver depression syndrome can effectively alleviate the clinical symptoms，improve ocular surface function and attenuate inflammation response with no significant adverse reactions，which is worthy of recommendation.

, authors=Qing LI1, Yuanlong ZHANG2, Guang YANG1, authorsList=Qing LI, Yuanlong ZHANG, Guang YANG, authorCompany=null, correspAuthors=Guang YANG, 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=1322912411119911440, articleId=1322912407017882117, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=益肾调肝方治疗围绝经期女性肾虚肝郁型干眼症疗效及对早期眼表变化的影响, columnId=1256183369033965799, journalTitle=中华中医药学刊, columnName=省级项目平台, runingTitle=null, highlight=null, articleAbstract=
目的

研究益肾调肝方治疗围绝经期女性肾虚肝郁型干眼症的疗效及对早期眼表变化的影响。

方法

选取2021年2月—2023年3月医院收治的120例围绝经期肾虚肝郁型干眼症女性患者，按随机数字表法分为对照组与研究组，各60例。对照组给予玻璃酸钠滴眼液治疗，研究组基于玻璃酸钠滴眼液给予益肾调肝方（生地黄15 g，白芍12 g，香附12 g，龟板10 g，山萸肉10 g，丹皮10 g，青皮10 g，泽泻10 g，枸杞子9 g，菊花5 g，沙参5 g，川楝子5 g）治疗，两组持续治疗4周。比较两组治疗后的中医症状评分，眼表功能［泪膜破裂时间（break-up time，BUT）、泪液基础分泌试验（Schirmer I test，SIT）、角结膜荧光素染色（fluorescent，FL）评分］，疗效，泪液炎症因子［白介素6（interleukin，IL）-6、IL-33］水平及不良反应情况。

结果

治疗后对照组中医症状评分为（4.89±0.74）分，研究组为（1.60±0.35）分，两组症状评分低于治疗前（P<0.05），且研究组症状评分低于对照组（P<0.05）。治疗后对照组BUT为（5.64±1.15）s、SIT为（7.76±1.35）mm/5 min、FL评分为（2.38±0.49）分，研究组分别为（10.08±1.29）s、（11.25±2.26）mm/5 min、（0.85±0.14）分，两组眼表功能优于治疗前（P<0.05），且研究组BUT、SIT高于对照组，FL低于对照组（P<0.05）。对照组治愈15例、好转24例、无效21例，研究组分别为35例、22例、3例，两组疗效等级分布有统计学意义（Z＝-5.044，P<0.05），研究组有效率（95.00%，57/60）高于对照组（65.00%，39/60）（P<0.05）。治疗后对照组泪液IL-6水平为（17.26±3.71）pg/mL、IL-33为（11.49±2.18）pg/mL，研究组分别为（15.13±3.30）pg/mL、（10.30±1.85）pg/mL，两组泪液因子水平低于治疗前（P<0.05），且研究组水平低于对照组（P<0.05）。治疗期间对照组未发现不良反应，研究组出现1例腹泻，症状较轻可自行缓解，两组不良反应无统计学意义（χ2＝1.008，P>0.05）。

结论

益肾调肝方能有效缓解围绝经期女性肾虚肝郁型干眼症患者临床症状，改善眼表功能，提高疗效，减轻泪液炎症水平，且无显著不良反应，可作为临床治疗首选方案之一。

, authors=李晴1, 张远龙2, 杨光1, authorsList=李晴, 张远龙, 杨光, authorCompany=null, correspAuthors=杨光, authorNote=

李晴（1986-），女，河北邢台人，主治医师，硕士，研究方向：中西医结合治疗眼底病。

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杨光（1956-），男，天津人，主任医师，硕士，研究方向：中药及针刺治疗眼病。E-mail：。
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李晴（1986-），女，河北邢台人，主治医师，硕士，研究方向：中西医结合治疗眼底病。

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李晴（1986-），女，河北邢台人，主治医师，硕士，研究方向：中西医结合治疗眼底病。

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unstructuredReference=张燕丽，田园，付起凤，等．白芍的化学成分和药理作用研究进展［J］．中医药学报，2021，49（2）：104-109., articleTitle=白芍的化学成分和药理作用研究进展, refAbstract=null), Reference(id=1322912809532653626, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, doi=null, pmid=null, pmcid=null, year=2020, volume=31, issue=4, pageStart=476, pageEnd=480, url=null, language=null, rfNumber=[28], rfOrder=27, authorNames=赵蒙蒙, 李建超, 金兰, journalName=海南医学, refType=null, unstructuredReference=赵蒙蒙，李建超，金兰，等．中医五联疗法治疗干眼症的疗效及对患者眼表功能的影响［J］．海南医学，2020，31（4）：476-480., articleTitle=中医五联疗法治疗干眼症的疗效及对患者眼表功能的影响, refAbstract=null), Reference(id=1322912809603956795, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, doi=null, pmid=null, pmcid=null, year=2022, volume=22, issue=3, pageStart=553, pageEnd=556, 481, url=null, language=null, rfNumber=[29], rfOrder=28, authorNames=沈柏宇, 杨丽芬, 刘娟, journalName=现代生物医学进展, refType=null, 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unstructuredReference=余秋燕，岳丽菁，唐敏．中药熏服治疗肝郁脾虚型干眼症的临床疗效观察［J］．广州中医药大学学报，2022，39（3）：551-555., articleTitle=中药熏服治疗肝郁脾虚型干眼症的临床疗效观察, refAbstract=null), Reference(id=1322912809809477694, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, doi=null, pmid=null, pmcid=null, year=2020, volume=29, issue=9, pageStart=1580, pageEnd=1582, url=null, language=null, rfNumber=[32], rfOrder=31, authorNames=丁勇, 常应, 胡晓莉, journalName=中国中医急症, refType=null, unstructuredReference=丁勇，常应，胡晓莉，等．补血润目汤眼部离子透入治疗干眼症（肝郁血虚证）的临床观察［J］．中国中医急症，2020，29（9）：1580-1582., articleTitle=补血润目汤眼部离子透入治疗干眼症（肝郁血虚证）的临床观察, refAbstract=null), Reference(id=1322912809893363775, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, doi=null, pmid=null, pmcid=null, year=2017, volume=46, issue=A03, pageStart=210, pageEnd=211, url=null, language=null, rfNumber=[33], rfOrder=32, authorNames=柴华, 刘宁州, 张丽霞, journalName=重庆医学, refType=null, 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组别例数治疗前治疗后
对照组6010.56±2.034.89±0.74*
研究组6010.63±2.111.60±0.35*
t值0.18531.132
P值0.853<0.001
), ArticleFig(id=1322912804780507159, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, language=CN, label=表1, caption=

两组围绝经期女性肾虚肝郁型干眼症患者中医症状评分比较（±s）

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组别例数治疗前治疗后
对照组6010.56±2.034.89±0.74*
研究组6010.63±2.111.60±0.35*
t值0.18531.132
P值0.853<0.001
), ArticleFig(id=1322912804851810328, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数BUT/（s）SIT/（mm/5 min）FL/（分）
治疗前治疗后治疗前治疗后治疗前治疗后
对照组603.74±0.625.64±1.15*5.27±1.047.76±1.35*4.90±0.652.38±0.49*
研究组603.70±0.5810.08±1.29*5.19±1.0611.25±2.26*4.94±0.600.85±0.14*
t值0.36519.9010.41710.2690.35023.256
P值0.716<0.0010.677<0.0010.727<0.001
), ArticleFig(id=1322912804998610969, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, language=CN, label=表2, caption=

两组围绝经期女性肾虚肝郁型干眼症患者眼表功能比较（±s）

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组别例数BUT/（s）SIT/（mm/5 min）FL/（分）
治疗前治疗后治疗前治疗后治疗前治疗后
对照组603.74±0.625.64±1.15*5.27±1.047.76±1.35*4.90±0.652.38±0.49*
研究组603.70±0.5810.08±1.29*5.19±1.0611.25±2.26*4.94±0.600.85±0.14*
t值0.36519.9010.41710.2690.35023.256
P值0.716<0.0010.677<0.0010.727<0.001
), ArticleFig(id=1322912805124440090, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数治愈好转无效总有效
对照组6015（25.00）24（40.00）21（35.00）39（65.00）
研究组6035（58.33）22（36.67）3（5.00）57（95.00）
Z/χ2值-5.04416.875
P值<0.001<0.001
), ArticleFig(id=1322912805208326171, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, language=CN, label=表3, caption=

两组围绝经期女性肾虚肝郁型干眼症患者疗效比较

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组别例数治愈好转无效总有效
对照组6015（25.00）24（40.00）21（35.00）39（65.00）
研究组6035（58.33）22（36.67）3（5.00）57（95.00）
Z/χ2值-5.04416.875
P值<0.001<0.001
), ArticleFig(id=1322912805308989468, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数IL-6IL-33
治疗前治疗后治疗前治疗后
对照组6018.65±4.4217.26±3.71*13.25±2.1911.49±2.18*
研究组6019.12±4.2715.13±3.30*13.84±2.3110.30±1.85*
t值0.5923.3231.4363.224
P值0.5550.0010.1540.002
), ArticleFig(id=1322912805392875549, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912407017882117, language=CN, label=表4, caption=

两组围绝经期女性肾虚肝郁型干眼症患者炎症指标比较（±s）

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组别例数IL-6IL-33
治疗前治疗后治疗前治疗后
对照组6018.65±4.4217.26±3.71*13.25±2.1911.49±2.18*
研究组6019.12±4.2715.13±3.30*13.84±2.3110.30±1.85*
t值0.5923.3231.4363.224
P值0.5550.0010.1540.002
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益肾调肝方治疗围绝经期女性肾虚肝郁型干眼症疗效及对早期眼表变化的影响
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李晴 1 , 张远龙 2 , 杨光 1
中华中医药学刊 | 省级项目平台 2025,43(1): 214-217
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中华中医药学刊 |省级项目平台 2025 , 43 (1) : 214 -217
益肾调肝方治疗围绝经期女性肾虚肝郁型干眼症疗效及对早期眼表变化的影响
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李晴1, 张远龙2, 杨光1
作者信息
  • 1．天津中医药大学第一附属医院，国家中医针灸临床医学研究中心，天津　300381
  • 2．天津市眼科医院，天津　300380
通讯作者:
杨光（1956-），男，天津人，主任医师，硕士，研究方向：中药及针刺治疗眼病。E-mail：。
作者简介:

李晴（1986-），女，河北邢台人，主治医师，硕士，研究方向：中西医结合治疗眼底病。

Efficacy of Yishen Tiaogan Decoction（益肾调肝方）on Perimenopausal Women with Dry Eye of Kidney Deficiency and Liver Depression Syndrome and Its Influence on Early Changes in Ocular Surface
Qing LI1, Yuanlong ZHANG2, Guang YANG1
Affiliations
  • 1.First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin 300381, China
  • 2.Tianjin Eye Hospital, Tianjin 300380, China
出版时间: 2025-01-10 doi: 10.13193/j.issn.1673-7717.2025.01.038
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摘要
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目的

研究益肾调肝方治疗围绝经期女性肾虚肝郁型干眼症的疗效及对早期眼表变化的影响。

方法

选取2021年2月—2023年3月医院收治的120例围绝经期肾虚肝郁型干眼症女性患者，按随机数字表法分为对照组与研究组，各60例。对照组给予玻璃酸钠滴眼液治疗，研究组基于玻璃酸钠滴眼液给予益肾调肝方（生地黄15 g，白芍12 g，香附12 g，龟板10 g，山萸肉10 g，丹皮10 g，青皮10 g，泽泻10 g，枸杞子9 g，菊花5 g，沙参5 g，川楝子5 g）治疗，两组持续治疗4周。比较两组治疗后的中医症状评分，眼表功能［泪膜破裂时间（break-up time，BUT）、泪液基础分泌试验（Schirmer I test，SIT）、角结膜荧光素染色（fluorescent，FL）评分］，疗效，泪液炎症因子［白介素6（interleukin，IL）-6、IL-33］水平及不良反应情况。

结果

治疗后对照组中医症状评分为（4.89±0.74）分，研究组为（1.60±0.35）分，两组症状评分低于治疗前（P<0.05），且研究组症状评分低于对照组（P<0.05）。治疗后对照组BUT为（5.64±1.15）s、SIT为（7.76±1.35）mm/5 min、FL评分为（2.38±0.49）分，研究组分别为（10.08±1.29）s、（11.25±2.26）mm/5 min、（0.85±0.14）分，两组眼表功能优于治疗前（P<0.05），且研究组BUT、SIT高于对照组，FL低于对照组（P<0.05）。对照组治愈15例、好转24例、无效21例，研究组分别为35例、22例、3例，两组疗效等级分布有统计学意义（Z＝-5.044，P<0.05），研究组有效率（95.00%，57/60）高于对照组（65.00%，39/60）（P<0.05）。治疗后对照组泪液IL-6水平为（17.26±3.71）pg/mL、IL-33为（11.49±2.18）pg/mL，研究组分别为（15.13±3.30）pg/mL、（10.30±1.85）pg/mL，两组泪液因子水平低于治疗前（P<0.05），且研究组水平低于对照组（P<0.05）。治疗期间对照组未发现不良反应，研究组出现1例腹泻，症状较轻可自行缓解，两组不良反应无统计学意义（χ2＝1.008，P>0.05）。

结论

益肾调肝方能有效缓解围绝经期女性肾虚肝郁型干眼症患者临床症状，改善眼表功能，提高疗效，减轻泪液炎症水平，且无显著不良反应，可作为临床治疗首选方案之一。

干眼症  /  围绝经期女性  /  肾虚肝郁  /  益肾调肝方  /  疗效  /  早期眼表变化
Objective

To explore the efficacy of Yishen Tiaogan Decoction（益肾调肝方）on perimenopausal women with dry eye of kidney deficiency and liver depression syndrome and its influence on early changes in ocular surface.

Methods

One hundred and twenty perimenopausal women with dry eye of kidney deficiency and liver depression syndrome admitted to the hospital from February 2021 to March 2023 were selected，and randomly assigned into two groups，each with 60 cases. The control group received sodium hyaluronate eye drops. Based on this，the study group was given Yishen Tiaogan Decoction. The treatment in both groups lasted for 4 weeks. Then the TCM symptom scores，ocular surface function［tear film break-up time（BUT），Schirmer I test（SIT），cornea corneal fluorescein（FL）staining］，clinical efficacy，the levels of inflammatory factors［interleukin（IL）-6，IL-33］and adverse reactions were compared between two groups after treatment.

Results

TCM syndrome scores showed a decline in both groups after treatment（P<0.05），and the score was（1.60±0.35）point in the study group，which was lower than that［（4.89±0.74）point］in the control group（P<0.05）. Therewas an improvement in BUT，SIT and FL score in both groups after treatment（P<0.05），and the three parameters were（10.08±1.29）s，（11.25±2.26）mm/5 min and（0.85±0.14）point in the study group，which were all better than those［（5.64±1.15）s，（7.76±1.35）mm/5 min and（2.38±0.49）point］in the control group，with statistical difference（P<0.05）. In the control group，15 cases were cured，24 cases were improved and 21 cases were ineffective. In the study group，35 cases were cured，22 cases were improved and 3 cases were ineffective. The efficacy grade distribution yielded statistical difference between two groups（Z＝-5.044，P<0.05）. The overall efficacy rate was 95.00%（57/60）in the study group，which was higher than that（65.00%，39/60）in the control group（P<0.05）. Serum levels of inflammatory factors showed a decrease in both groups after treatment（P<0.05）. The serum levels of IL-6 and IL-33 were（15.13±3.30）pg/mL and（10.30±1.85）pg/m L in the study group，which were lower than those［（17.26±3.71）pg/mL and（11.49±2.18）pg/mL］in the controlgroup（P<0.05）. During the treatment period，no adverse reactions were found in the control group，and one case of diarrhoea occurred in the study group，the symptoms were mild and could be relieved without any intervention. The adverse reaction rate yielded no statistical difference between two groups（χ2＝1.008，P>0.05）.

Conclusion

Yishen Tiaogan Decoction for perimenopausal women with dry eye of kidney deficiency and liver depression syndrome can effectively alleviate the clinical symptoms，improve ocular surface function and attenuate inflammation response with no significant adverse reactions，which is worthy of recommendation.

dry eye syndrome  /  perimenopausal women  /  kidney deficiency and liver depression  /  Yishen Tiaogan Decoction（益肾调肝方）  /  efficacy  /  early ocular surface changes
李晴, 张远龙, 杨光. 益肾调肝方治疗围绝经期女性肾虚肝郁型干眼症疗效及对早期眼表变化的影响. 中华中医药学刊, 2025 , 43 (1) : 214 -217 . DOI: 10.13193/j.issn.1673-7717.2025.01.038
Qing LI, Yuanlong ZHANG, Guang YANG. Efficacy of Yishen Tiaogan Decoction（益肾调肝方）on Perimenopausal Women with Dry Eye of Kidney Deficiency and Liver Depression Syndrome and Its Influence on Early Changes in Ocular Surface[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (1) : 214 -217 . DOI: 10.13193/j.issn.1673-7717.2025.01.038
正文
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干眼症为多种原因引发的泪液质、量及动力学异常等导致泪膜稳定性下降，且伴有眼部不适、眼表组织损伤的多种疾病总称[1-2]。围绝经期女性因卵巢功能衰退、体内激素水平下降，使泪膜结构与功能发生异常，进而促进发生干眼症[3-4]。该病在临床较为常见，主要表现为眼部干涩、视疲劳、灼烧感、充血等，治疗不及时可导致视力下降、角膜透明度下降，严重者可出现失明，对患者正常工作、生活有严重影响。故寻找有效预防干眼症疾病进展的治疗方式极为重要。目前临床对不同病因引发的干眼症治疗方式不一。研究显示[5]，干眼症与泪膜高渗透性、眼表面炎症等有关。部分干眼症治疗药物以控制角结膜炎症为主要目的，进而改善其症状。中医将干眼症归属于“白涩症、燥证、白眼痛”等范畴，研究显示，中药口服在临床治疗中有显著成效[6]。益肾调肝方中含有生地黄、龟板、白芍、枸杞子、山萸肉等成分，以调肝为主，具有滋阴生津、补肝益肾等功效[7]。为此，本研究通过益肾调肝方治疗围绝经期女性肾虚肝郁型干眼症的疗效及对早期眼表变化的影响，旨在为临床治疗提供更佳方案。
1　资料与方法
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1.1　一般资料
选取2021年2月—2023年3月我院收治的120例围绝经期肾虚肝郁型干眼症女性患者。西医诊断标准：符合《国际中医临床实践指南干眼》标准[8]：①眼部干燥、不适、有异物与灼烧感、视力波动等主观症状；②泪膜破裂时间（break-up time，BUT）不超过5 s或基础泪液分泌试验（Schirmer I test，SIT）每5 min不超过5 mm；③BUT在5～10 s（不包括5 s）或SIT在每5 min 5～10 mm（不包括5 mm），且角膜荧光色素染色（fluorescent，FL）呈阳性。中医诊断标准：参考《中医诊断学》[9]符合属肾虚肝郁证表现，双目干涩，酸困，不耐久视，甚则瞬目过频，羞明难睁，口干目赤，白睛干涩，黑睛星翳，伴腰膝酸软、五心烦热、失眠盗汗、易怒或情绪低落，便大干，舌红苔薄，脉细数。纳入标准：符合中西医诊断标准，中医证型为肾虚肝郁；双眼发病；围绝经期标准参考《临床内分泌学》[10]，停经时间不超过1年；年龄在45～55岁；患者知情同意。排除标准：合并角结膜炎、青光眼等其他眼疾病患者；严重肝肾功能障碍患者；严重心脑血管疾病患者；造血系统功能异常患者；思维障碍、意识模糊等精神类疾病患者；无法配合实验患者；依从性差患者。按随机数字表法分为对照组与研究组，各60例。对照组年龄为45～54岁，平均（48.98±1.24）岁；体质量指数（body mass index，BMI）为20～27 kg/m2，平均（24.88±1.03）kg/m2；病程在3～18个月，平均（11.53±2.38）个月。研究组年龄为46～55岁，平均（50.11±1.58）岁；BMI为20～28 kg/m2，平均（25.03±1.36）kg/m2；病程在3～17个月，平均（11.37±2.66）个月。两组基本资料比较差异无统计学意义（P>0.05）。本研究取得我院伦理委员会批准（批准号：TYLL2021［Y］字0013）。
1.2　方法
对照组行常规西医治疗，采用玻璃酸钠滴眼液［苏州欧康维视生物科技有限公司，国药准字H20223904，规格0.3%（0.4 mL∶1.2 mg）］滴眼，4次/d，1滴/次，根据患者症状适当增减，连续治疗4周。研究组基于玻璃酸钠滴眼液联合中医治疗，由我院中药房配制益肾调肝方，药方组成：生地黄15 g，白芍12 g，香附12 g，龟板10 g，山萸肉10 g，丹皮10 g，青皮10 g，泽泻10 g，枸杞子9 g，菊花5 g，沙参5 g，川楝子5 g。以上药材水煎取汁400 mL，分装两份于早晚2次服用，1剂/d，连续服用4周。
1.3　观察指标
中医证候积分：根据《中药新药临床研究指导原则》[11]，常见症状包括眼涩、视疲劳、异物感、白睛红赤、畏光等，按严重程度分为无症状、轻、中、重度，眼涩分别计0、2、4、6分，其余症状分别计0、1、2、3分，症状总分为各症状评分相加，分数与病情严重程度成正比。
眼表功能：①将荧光素钠眼科检测试纸在患者结膜囊内浸湿，嘱咐其轻眨眼数次，记录最后一次完全瞬目睁眼至泪膜上出现首个干燥斑时间，为BUT；②SIT：采用泪液检测滤纸条（来自天津晶明有限公司），将一端反折放在下睑结膜囊中外1/3交界部位，另一端自然下垂，嘱咐患者双眼闭合，5 min后取出滤纸，检测湿润长度；③FL评分：取荧光素钠滴入结膜囊中，嘱咐患者闭眼，5 s后眨眼，观察其染色阳性眼数，角膜分为4个象限，按染色面积与程度分别计0、1、2、3分，总分为12分。
疗效评估[12]：症状与FL消失，BUT超过10 s，多次SIT每5 min超过10 mm，视力提高超过0.1为治愈；症状明显缓解，FL减少，BUT延长，多次SIT泪液分泌量变多为好转；症状无显著变化，FL未减少或增多，BUT无变化，多次SIT未增加为无效。
炎症因子：于下眼睑皮肤涂抹少量清凉油，对眼部进行刺激使眼泪流出，用毛细管吸取收集外眦部泪液，离心处理后放于-20℃下冷冻保存；采用酶联免疫吸附法检测泪液白介素（interleukin，IL）-6、IL-33水平，严格按试剂盒说明书操作。
不良反应：统计患者治疗期间发生的不良反应情况，记录发生例数。
1.4　统计学方法
采用SPSS 20.0软件分析数据，症状评分、眼表功能指标、炎症水平以±s表示，t检验；有效率、不良反应发生率用（%）表示，χ2检验，等级资料采用秩和检验。P<0.05为差异有统计学意义。
2　结果
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2.1　中医症状评分比较
治疗前两组中医症状评分无统计学意义（P>0.05）。治疗后两组症状评分低于治疗前（P<0.05），且研究组症状评分低于对照组（P<0.05）。见表1。
2.2　眼表功能比较
治疗前两组眼表功能比较无统计学意义（P>0.05）。治疗后两组BUT、SIT高于治疗前，FL低于治疗前（P<0.05），且研究组BUT、SIT高于对照组，FL低于对照组（P<0.05）。见表2。
2.3　疗效比较
对照组治愈15例、好转24例、无效21例，研究组分别为35例、22例、3例，两组疗效等级分布有统计学意义（Z＝-5.044，P<0.05），研究组有效率（95.00%）高于对照组（65.00%）（P<0.05）。见表3。
2.4　炎症指标比较
治疗前两组泪液IL-6、IL-33水平差异无统计学意义（P>0.05）。治疗后两组泪液IL-6、IL-33水平低于治疗前（P<0.05），且研究组水平低于对照组（P<0.05）。见表4。
2.5　不良反应比较
治疗期间对照组未发现不良反应，研究组出现1例腹泻，症状较轻可自行缓解，两组不良反应无统计学意义（χ2 ＝1.008，P>0.05）。
3　讨论
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干眼症为临床中常见与多发疾病，发病与眼表面变化、体内性激素水平变化、细胞凋亡等因素有关。女性进入围绝经期后性激素水平下降，眼部为性激素作用靶器官之一，性激素持续下降导致机体无法维持正常泪膜结构与功能，进而引发干眼症[13-15]。当女性进入围绝经期后不仅体内激素水平紊乱，其睑板腺分泌泪液的脂质也减少，加上雌激素衰减，泪腺腺泡细胞破裂坏死，泪液减少，两者相互作用对干眼症发生发展具有促进作用[16-17]。治疗不及时可导致角结膜病变、视物模糊等，严重影响患者正常生活[18]。围绝经期干眼症治疗主要通过增加角膜浸润湿度，保留大量水分子在眼表面以提高泪膜稳定性[19]。人工泪液为西医治疗眼疾病的常用药物，可通过对角结膜进行润滑、湿润与营养，从而发挥类似天然泪液作用，有效缓解患者眼干症状[20-21]。但该方式的总体效果欠佳，需寻找更高效方式以提高患者疗效。
干眼症在中医中归属于白涩症范畴，该病发病原因主要为蒸发过快、泪液缺乏，前者与睑板腺功能障碍有关，后者称为sjogren综合征，与自身免疫疾病有关[22]。久病耗损、燥火伤肺阴，无法上荣于目而导致干眼。《素问》中记载“五脏化液，肝为泪”。《黄帝内经》中“肝开窍于目”。肾、肺为水之源，脾主运化水源，肾精、肺阴不足，久而目失津液，脾胃湿热而气运不畅、双目干燥[23]。五脏失调，双目缺乏津液滋养，久而引发干眼症。《灵枢》中记载“五脏六腑之津液，尽上渗于目”。阴津不足干眼症根本。泪为肝之液，肝失调和，泪液化生无源；肾主水液分布、代谢，肾气亏虚，津液无法上润于目，故治疗应从补肝益肾、养阴明目等方面入手[24-25]。益肾调肝方是从调肝汤基础上改良得到，功用补益肾水并平调肝气。方中生地黄能滋阴养肺、生津润燥，作为本方的君药；龟板具有滋阴潜阳、补肾健骨、养心安神功效；白芍能养血调经、柔肝止痛，与龟板共为臣药；山萸肉滋阴补益肝肾，白芍能养血柔肝；枸杞子能益肾填精[26-27]。纵观全方配伍滋而不腻、补而不燥，使肝肾得充，目得肝血能视，肾精上注明目，泪液生化有源而濡养目珠，进而改善眼干目涩等症状。
本研究结果显示，治疗后研究组中医症状评分低于对照组，说明基于常规西医治疗，对患者使用益肾调肝方能显著缓解患者症状。BUT、SIT、FL水平高低能反映泪腺分泌功能与分泌量，可代表角膜的稳定性，多用于临床中评估干眼症严重程度[28]。改善睑板腺功能对提高干眼症患者视功能、生活质量具有促进作用。本研究中治疗后研究组BUT、SIT高于对照组，FL低于对照组，说明益肾调肝方联合玻璃酸钠滴眼液能改善睑板腺功能，改善患者泪膜稳定性，增加其泪液分泌并减少角膜损伤。眼的约束在眼睑，肾为先天之本，脾为后天之本，眼表与肝、肾等有关，干眼症与不良生活习惯等有关，长期不良习惯导致肝肾阴虚症状，出现干眼症[29-30]。《素问·上古天真论篇》中指出“女子七岁，肾气盛……故形坏而无子也”，表明女子在中老年后肾气衰弱，阳气耗竭，冲任二脉虚弱，脏腑失养、功能失调易发生干眼症[31-32]。干眼病在中医中的病因病机较为复杂，治疗需辨证论治，以调理脏腑和经络功能为主，眼为标，标本兼治眼部炎症可进一步加重干眼症病情，IL-6、IL-33为疾病发病的常见炎症因子[33]。IL-6是由B细胞、T细胞等分泌而成，可调节炎症、免疫损伤的修复过程，在较多眼疾病中水平上升[34]。研究证实，IL-6水平上升为干眼症患者最先观察到的变化，与疾病严重程度有关[35]。IL-33是IL-1细胞因子新成员，由平滑肌、成纤维细胞等不同组织表达。研究显示，泪液IL-33水平上升与辅助型T细胞2（T helper 2 cell，Th2）细胞、干眼症严重程度有关。故IL-33在干眼症发病机制中可能发挥重要作用。本研究中经治疗后两组泪液IL-6、IL-33水平下降，但研究组水平低于对照组，提示益肾调肝方与玻璃酸钠滴眼液能减少IL-6、IL-33表达，对炎症发生有抑制作用[36-37]。两组治疗期间均未发现明显不良反应，说明益肾调肝方联合玻璃酸钠滴眼液的治疗安全性较好。
综上所述，益肾调肝方联合玻璃酸钠滴眼液能有效缓解围绝经期女性肾虚肝郁型干眼症患者临床症状，改善眼表功能，提高疗效，减轻泪液炎症水平，且无显著不良反应，可作为临床治疗首选方案之一。
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2025年第43卷第1期
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doi: 10.13193/j.issn.1673-7717.2025.01.038
  • 首发时间：2026-10-30
  • 出版时间：2025-01-10
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天津市中医药管理局中西医结合科研项目(2021066)
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    1．天津中医药大学第一附属医院，国家中医针灸临床医学研究中心，天津　300381
    2．天津市眼科医院，天津　300380

通讯作者:

杨光（1956-），男，天津人，主任医师，硕士，研究方向：中药及针刺治疗眼病。E-mail：。
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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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