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Article(id=1322924034194809386, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923782029062261, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.06.044, 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=1793339268491, onlineDateStr=2026-10-30, pubDate=1749484800000, pubDateStr=2025-06-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793339268491, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793339268491, creator=13701087609, updateTime=1793339268491, 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=213, endPage=216, ext={EN=ArticleExt(id=1322924034832343595, articleId=1322924034194809386, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Effect of Bailing Capsule（百令胶囊）Combined with Vitamin D Supplementation on Clinical Efficacy，Serum 25（OH）D and Th1/Th2 of Autoimmune Thyroiditis in Women of Childbearing Age, columnId=1256183365644968140, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Platform of Provincial Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the clinical efficacy of combined application of Bailing Capsule（百令胶囊）and vitamin D in the treatment of autoimmune thyroiditis in women of childbearing age，as well as the effects on serum 25（OH）D and Th1/Th2.

Methods

Ninety-four female patients with autoimmune thyroiditis of childbearing age admitted to the hospital from January 2020 to August 2022 were selected as the research subjects and randomly divided into a study group and a control group，with 47 cases in each group.The control group received thyroxine sodium tablets and vitamin D oral treatment，and the study group was combined with Bailing Capsule oral treatment on the basis of the control group.The treatment lasted for 6 months.The levels of free triiodothyronine（FT3），free thyroxine（FT4），thyroid stimulating hormone（TSH），thyroid stimulating hormone receptor antibody（TRAb），thyroid peroxidase antibody（TPO-Ab），25（OH）Dand Th1/Th2 were measured and compared in two groups at different stages.

Results

After 6 months of treatment，the levels of FT3 and FT4 in the study group were slightly lower than those in the control group（P>0.05），and the TSH level in the study group was significantly higher than that in the control group（P<0.05）.After 3 and 6 months of treatment，there was no significant difference in TRAb or TPO-Ab in the control group（P>0.05）.After 3 months of treatment，the levels of TRAb and TPO-Ab in the study group were significantly lower than those before treatment（P<0.05）.After 6 months of treatment，the levels of TRAb and TPO-Ab in the study group were significantly lower than those before treatment and after 3 months of treatment，and both were lower than those of the control group（P<0.01）.After 6 months of treatment，the serum 25（OH）D levels in the study group were significantly higher than those before treatment and those of the control group during the same period（P<0.05）.After 6 months of treatment，the levels of interferon（INF）-γmRNA and interleukin（IL）-10 mRNA in the study group were significantly higher than those in the control group，with statistically significant differences（P<0.01）.

Conclusion

The combination of Bailing Capsule and vitamin D can significantly improve the serum 25（OH）D levels and autoimmune antibody titers in women with autoimmune thyroiditis of childbearing age，providing an effective adjuvant therapy for autoimmune thyroiditis patients with low vitamin D levels.

, authors=Zongpan WANG, Wendong WANG, Yangqing WANG, Shaofang ZHOU, authorsList=Zongpan WANG, Wendong WANG, Yangqing WANG, Shaofang ZHOU, authorCompany=null, correspAuthors=Wendong WANG, 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=1322924035360825902, articleId=1322924034194809386, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=百令胶囊联合补充维生素D治疗对育龄期女性自身免疫性甲状腺炎临床疗效、血清（OH）D及Th1/Th2相关因子的影响分析, columnId=1256183369033965799, journalTitle=中华中医药学刊, columnName=省级项目平台, runingTitle=null, highlight=null, articleAbstract=
目的

探讨联合应用百令胶囊和维生素D治疗育龄期女性自身免疫性甲状腺炎的临床效果，以及对血清（OH）D和Th1/Th2相关因子的影响。

方法

纳入2020年1月—2022年8月在医院就诊的94例育龄期女性自身免疫性甲状腺炎患者，随机分为研究组和对照组，每组47例。对照组接受甲状腺素钠片和维生素D口服治疗，研究组在此基础上加用百令胶囊口服治疗，治疗持续6个月。测定并比较两组在不同时间点的FT3、FT4、TSH、TRAb、TPO-Ab、25（OH）D水平以及Th1/Th2相关因子。

结果

治疗6个月后，研究组的FT3和FT4水平略低于对照组，但差异无统计学意义（P>0.05）；研究组的TSH水平明显高于对照组（P<0.05）。治疗3、6个月后，对照组患者的TRAb和TPO-Ab水平与治疗前相比无显著差异（P>0.05）。然而，研究组在治疗3个月后TRAb和TPO-Ab水平显著降低，差异具有统计学意义（P<0.05）。治疗6个月后，研究组患者的TRAb和TPO-Ab水平明显低于同组治疗前及治疗3个月后，且均低于对照组（P<0.01）。此外，研究组患者的血清25（OH）D水平在治疗6个月后明显升高，与同期对照组和治疗前相比差异均具有统计学意义（P<0.05）。治疗6个月后，研究组的INF-γmRNA和IL-10mRNA水平显著优于对照组患者，两者差异具有统计学意义（P<0.01）。

结论

百令胶囊联合维生素D治疗可显著改善育龄期女性自身免疫性甲状腺炎患者的血清25（OH）D水平和自身免疫抗体滴度，为低维生素D水平的自身免疫性甲状腺炎患者提供了一种有效辅助治疗方案。

, authors=王宗攀, 王文栋, 王阳晴, 周少芳, authorsList=王宗攀, 王文栋, 王阳晴, 周少芳, authorCompany=null, correspAuthors=王文栋, authorNote=

王宗攀（1986-），男，河南禹州人，主治医师，硕士，研究方向：甲状腺、乳腺疾病。

, correspAuthorsNote=
王文栋（1980-），男，山东济南人，主任医师，博士，研究方向：甲状腺疾病。E-mail：。
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王宗攀（1986-），男，河南禹州人，主治医师，硕士，研究方向：甲状腺、乳腺疾病。

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王宗攀（1986-），男，河南禹州人，主治医师，硕士，研究方向：甲状腺、乳腺疾病。

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ACSOmega，2021，6（44）：29506-29515., articleTitle=Comparison of ergosterol and vitamin D2 in mushrooms agaricus bisporusand cordyceps militaris using ultraviolet irradiation directly on dry powder or in ethanol suspension, refAbstract=null)], funds=[Fund(id=1322924038141649498, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322924034194809386, awardId=2019ZB109, language=CN, fundingSource=浙江省中医药科技计划项目(2019ZB109), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1322924035574735407, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322924034194809386, xref=null, ext=[AuthorCompanyExt(id=1322924035587318320, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322924034194809386, companyId=1322924035574735407, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Quzhou Hospital Affiliated to Wenzhou Medical University，Quzhou People’s Hospital，Quzhou 324000，Zhejiang，China), AuthorCompanyExt(id=1322924035595706929, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322924034194809386, companyId=1322924035574735407, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=温州医科大学附属衢州医院（衢州市人民医院），浙江 衢州 324000)])], figs=[ArticleFig(id=1322924037495726674, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322924034194809386, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数FT3/（pg/mL）FT4/（pg/mL）TSH/（μIU/mL）
治疗前治疗后治疗前治疗后治疗前治疗后
研究组4713.96±2.382.17±0.41*10.79±0.241.28±0.51*0.14±0.022.31±0.23*
对照组4713.35±2.713.14±0.32*12.32±2.531.45±0.44*0.17±0.022.11±0.26*
t值0.5271.8780.7981.5821.3712.536
P值0.8980.0640.4250.1150.1710.028
), ArticleFig(id=1322924037571224147, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322924034194809386, language=CN, label=表1, caption=

两组自身免疫性甲状腺炎患者甲状腺激素水平比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数FT3/（pg/mL）FT4/（pg/mL）TSH/（μIU/mL）
治疗前治疗后治疗前治疗后治疗前治疗后
研究组4713.96±2.382.17±0.41*10.79±0.241.28±0.51*0.14±0.022.31±0.23*
对照组4713.35±2.713.14±0.32*12.32±2.531.45±0.44*0.17±0.022.11±0.26*
t值0.5271.8780.7981.5821.3712.536
P值0.8980.0640.4250.1150.1710.028
), ArticleFig(id=1322924037646721620, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322924034194809386, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数TRAb/（U/L）TPO-Ab/（U/mL）
治疗前治疗3个月治疗6个月治疗前治疗3个月治疗6个月
研究组474.21±1.323.12±0.79*0.56±0.38#87.45±15.8170.24±18.63*37.71±8.85#
对照组474.22±1.434.53±1.94*3.15±1.71*87.28±14.4481.41±13.57*74.41±19.91#
t值0.6692.6146.8220.5773.94212.121
P值0.5050.0410.0000.5650.0150.000
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两组自身免疫性甲状腺炎患者甲状腺自身抗体水平比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数TRAb/（U/L）TPO-Ab/（U/mL）
治疗前治疗3个月治疗6个月治疗前治疗3个月治疗6个月
研究组474.21±1.323.12±0.79*0.56±0.38#87.45±15.8170.24±18.63*37.71±8.85#
对照组474.22±1.434.53±1.94*3.15±1.71*87.28±14.4481.41±13.57*74.41±19.91#
t值0.6692.6146.8220.5773.94212.121
P值0.5050.0410.0000.5650.0150.000
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组别例数治疗前治疗后t值P值
研究组4710.16±2.1862.91±8.1331.5280.000
对照组4710.15±2.3231.79±3.163.6170.029
t值0.42328.814
P值0.4230.000
), ArticleFig(id=1322924037856436823, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322924034194809386, language=CN, label=表3, caption=

两组自身免疫性甲状腺炎患者血清25（OH）D水平比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数治疗前治疗后t值P值
研究组4710.16±2.1862.91±8.1331.5280.000
对照组4710.15±2.3231.79±3.163.6170.029
t值0.42328.814
P值0.4230.000
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组别例数INF-ymRNAIL-10mRNA
治疗前治疗3个月治疗6个月治疗前治疗3个月治疗6个月
研究组471.21±0.151.61±0.29*2.16±0.58#1.46±0.221.05±0.29*0.66±0.12#
对照组471.22±0.131.58±0.14*1.91±0.36*1.49±0.211.12±0.31*0.95±0.21#
t值0.1530.2535.9390.1140.4108.394
P值0.7550.5310.0030.8750.5350.001
), ArticleFig(id=1322924038020014681, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322924034194809386, language=CN, label=表4, caption=

两组自身免疫性甲状腺炎患者Th1/Th2细胞因子比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数INF-ymRNAIL-10mRNA
治疗前治疗3个月治疗6个月治疗前治疗3个月治疗6个月
研究组471.21±0.151.61±0.29*2.16±0.58#1.46±0.221.05±0.29*0.66±0.12#
对照组471.22±0.131.58±0.14*1.91±0.36*1.49±0.211.12±0.31*0.95±0.21#
t值0.1530.2535.9390.1140.4108.394
P值0.7550.5310.0030.8750.5350.001
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百令胶囊联合补充维生素D治疗对育龄期女性自身免疫性甲状腺炎临床疗效、血清（OH）D及Th1/Th2相关因子的影响分析
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王宗攀 , 王文栋 , 王阳晴 , 周少芳
中华中医药学刊 | 省级项目平台 2025,43(6): 213-216
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中华中医药学刊 |省级项目平台 2025 , 43 (6) : 213 -216
百令胶囊联合补充维生素D治疗对育龄期女性自身免疫性甲状腺炎临床疗效、血清（OH）D及Th1/Th2相关因子的影响分析
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王宗攀（1986-），男，河南禹州人，主治医师，硕士，研究方向：甲状腺、乳腺疾病。

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王宗攀（1986-），男，河南禹州人，主治医师，硕士，研究方向：甲状腺、乳腺疾病。

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王宗攀, 王文栋 , 王阳晴, 周少芳
作者信息
  • 温州医科大学附属衢州医院（衢州市人民医院），浙江 衢州 324000
通讯作者:
王文栋（1980-），男，山东济南人，主任医师，博士，研究方向：甲状腺疾病。E-mail：。
作者简介:

王宗攀（1986-），男，河南禹州人，主治医师，硕士，研究方向：甲状腺、乳腺疾病。

Effect of Bailing Capsule（百令胶囊）Combined with Vitamin D Supplementation on Clinical Efficacy，Serum 25（OH）D and Th1/Th2 of Autoimmune Thyroiditis in Women of Childbearing Age
Zongpan WANG, Wendong WANG , Yangqing WANG, Shaofang ZHOU
Affiliations
  • Quzhou Hospital Affiliated to Wenzhou Medical University，Quzhou People’s Hospital，Quzhou 324000，Zhejiang，China
出版时间: 2025-06-10 doi: 10.13193/j.issn.1673-7717.2025.06.044
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摘要
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目的

探讨联合应用百令胶囊和维生素D治疗育龄期女性自身免疫性甲状腺炎的临床效果，以及对血清（OH）D和Th1/Th2相关因子的影响。

方法

纳入2020年1月—2022年8月在医院就诊的94例育龄期女性自身免疫性甲状腺炎患者，随机分为研究组和对照组，每组47例。对照组接受甲状腺素钠片和维生素D口服治疗，研究组在此基础上加用百令胶囊口服治疗，治疗持续6个月。测定并比较两组在不同时间点的FT3、FT4、TSH、TRAb、TPO-Ab、25（OH）D水平以及Th1/Th2相关因子。

结果

治疗6个月后，研究组的FT3和FT4水平略低于对照组，但差异无统计学意义（P>0.05）；研究组的TSH水平明显高于对照组（P<0.05）。治疗3、6个月后，对照组患者的TRAb和TPO-Ab水平与治疗前相比无显著差异（P>0.05）。然而，研究组在治疗3个月后TRAb和TPO-Ab水平显著降低，差异具有统计学意义（P<0.05）。治疗6个月后，研究组患者的TRAb和TPO-Ab水平明显低于同组治疗前及治疗3个月后，且均低于对照组（P<0.01）。此外，研究组患者的血清25（OH）D水平在治疗6个月后明显升高，与同期对照组和治疗前相比差异均具有统计学意义（P<0.05）。治疗6个月后，研究组的INF-γmRNA和IL-10mRNA水平显著优于对照组患者，两者差异具有统计学意义（P<0.01）。

结论

百令胶囊联合维生素D治疗可显著改善育龄期女性自身免疫性甲状腺炎患者的血清25（OH）D水平和自身免疫抗体滴度，为低维生素D水平的自身免疫性甲状腺炎患者提供了一种有效辅助治疗方案。

自身免疫性甲状腺炎  /  百令胶囊  /  维生素D  /  女性  /  自身免疫性抗体  /  细胞因子
Objective

To explore the clinical efficacy of combined application of Bailing Capsule（百令胶囊）and vitamin D in the treatment of autoimmune thyroiditis in women of childbearing age，as well as the effects on serum 25（OH）D and Th1/Th2.

Methods

Ninety-four female patients with autoimmune thyroiditis of childbearing age admitted to the hospital from January 2020 to August 2022 were selected as the research subjects and randomly divided into a study group and a control group，with 47 cases in each group.The control group received thyroxine sodium tablets and vitamin D oral treatment，and the study group was combined with Bailing Capsule oral treatment on the basis of the control group.The treatment lasted for 6 months.The levels of free triiodothyronine（FT3），free thyroxine（FT4），thyroid stimulating hormone（TSH），thyroid stimulating hormone receptor antibody（TRAb），thyroid peroxidase antibody（TPO-Ab），25（OH）Dand Th1/Th2 were measured and compared in two groups at different stages.

Results

After 6 months of treatment，the levels of FT3 and FT4 in the study group were slightly lower than those in the control group（P>0.05），and the TSH level in the study group was significantly higher than that in the control group（P<0.05）.After 3 and 6 months of treatment，there was no significant difference in TRAb or TPO-Ab in the control group（P>0.05）.After 3 months of treatment，the levels of TRAb and TPO-Ab in the study group were significantly lower than those before treatment（P<0.05）.After 6 months of treatment，the levels of TRAb and TPO-Ab in the study group were significantly lower than those before treatment and after 3 months of treatment，and both were lower than those of the control group（P<0.01）.After 6 months of treatment，the serum 25（OH）D levels in the study group were significantly higher than those before treatment and those of the control group during the same period（P<0.05）.After 6 months of treatment，the levels of interferon（INF）-γmRNA and interleukin（IL）-10 mRNA in the study group were significantly higher than those in the control group，with statistically significant differences（P<0.01）.

Conclusion

The combination of Bailing Capsule and vitamin D can significantly improve the serum 25（OH）D levels and autoimmune antibody titers in women with autoimmune thyroiditis of childbearing age，providing an effective adjuvant therapy for autoimmune thyroiditis patients with low vitamin D levels.

autoimmune thyroiditis  /  Bailing Capsule（百令胶囊）  /  vitamin D  /  women  /  autoimmune antibodies  /  cell factor
王宗攀, 王文栋, 王阳晴, 周少芳. 百令胶囊联合补充维生素D治疗对育龄期女性自身免疫性甲状腺炎临床疗效、血清（OH）D及Th1/Th2相关因子的影响分析. 中华中医药学刊, 2025 , 43 (6) : 213 -216 . DOI: 10.13193/j.issn.1673-7717.2025.06.044
Zongpan WANG, Wendong WANG, Yangqing WANG, Shaofang ZHOU. Effect of Bailing Capsule（百令胶囊）Combined with Vitamin D Supplementation on Clinical Efficacy，Serum 25（OH）D and Th1/Th2 of Autoimmune Thyroiditis in Women of Childbearing Age[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (6) : 213 -216 . DOI: 10.13193/j.issn.1673-7717.2025.06.044
正文
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自身免疫性甲状腺炎（autoimmune thyroiditis，AITD），在中年女性中高发，其患病率相较男性高出6～10倍[1]。此病表现为甲状腺弥漫性轻至中度肿大，质地坚韧，临床症状主要包括体质量减轻、易饥饿、发热等，疼痛相对较少，局部症状罕见[2-3]。实验室检查显示患者甲状腺自身抗体阳性，包括TPO抗体或TG抗体，有时两者均呈阳性。甲状腺功能可能呈正常、亢进或减退[4-5]。治疗方面，左甲状腺素钠片是常规选择，但其疗效较为缓慢，且维持时间有限。百令胶囊属于一种免疫调节药物，具有消炎抗菌的作用，同时可调节免疫系统。维生素D，作为一种多效类固醇激素，既往研究表明自身免疫性甲状腺炎与维生素D缺乏密切相关[6-10]，低血清25（OH）D水平被认为是TPO-Ab阳性的独立危险因素。
尽管有研究对百令胶囊联合维生素D治疗AITD进行了评估，但研究数量相对较少且结论不一致。因此，本研究选取了47例育龄期女性AITD患者作为研究对象，旨在深入了解百令胶囊联合维生素D对甲状腺功能、自身免疫抗体水平、血清25（OH）D水平以及细胞因子水平的影响。通过这项研究，希望为育龄期女性AITD的治疗提供更全面、有效的参考依据。
1　对象和方法
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1.1　研究对象
将2020年1月—2022年8月衢州市人民医院收治的94例初期育龄期女性患者纳入研究，均确诊为自身免疫性甲状腺炎[11]，年龄21～43岁，病程（3.2±0.3）月，甲状腺无痛性弥漫性增大。以随机数字表法分为研究组（47例）和对照组（47例），研究组年龄（34.5±6.6）岁，病程（3.1±0.3）月，BMI（22.7±0.8）kg/m2。对照组年龄（35.2±7.8）岁，病程（3.2±0.2）月，BMI（23.1±0.9）kg/m2。两组基线差异无明显统计学意义（P>0.05）。本研究已获本院伦理委员会批准（ZRYY-LL-2019-17），患者均已签署知情同意书。
1.2　纳入及排除标准
纳入标准：①所有患者必须通过临床症状和甲状腺组织细针穿刺细胞学检查明确诊断，符合《中国甲状腺疾病诊治指南—甲状腺炎》对自身免疫性甲状腺炎的诊断标准。②入组前不能接受任何与研究相关的药物或手术治疗。排除标准：①合并急性感染性疾病的患者；②合并严重心血管、糖尿病、肾脏等慢性消耗性疾病，以及骨代谢性疾病、骨肿瘤等骨科疾病的患者及妊娠期妇女；③最近曾使用可能影响加甲状腺功能或维生素D代谢的药物的患者。
1.3　治疗方法
两组均低碘饮食。对照组予生活方式干预，外出日光照射和锻炼，30 min/d；口服甲状腺素钠片（国药准字H11020209），初始剂量20～25μg/次，每日1次，随医嘱调整剂量维持正常水平，连续干预6个月。期间，予维生素D（国药准字H20054433）口服治疗，每日1次，剂量5000单位。
对照组基础上，研究组予百令胶囊（国药准字Z10910036）口服，每次1 g，每日3次。持续干预6个月。
1.4　观察指标
治疗前后，采用化学发光法检测患者FT3、FT4和TSH水平，评估甲状腺功能。在干预前、3个月和6个月时，评估患者TRAb和TPO-Ab滴度。同时，使用罗氏cobas e601全自动电化学发光免疫分析仪及其相关试剂测定治疗前后25（OH）D水平。通过逆转录聚合酶链式反应（RT-PCR）提取患者RNA，分析Th1/Th2相关因子细胞水平表达，并利用试验图像分析仪比较治疗前后INF-γmRNA与IL-10 mRNA表达水平，评估治疗对这些细胞因子的影响。
1.5　统计学方法
以SPSS 22.0统计分析数据，计数资料以例数和%表示，χ2检验；计量资料以（）表示，正态分布，以t检验。P<0.05，差异有统计学意义。
2　结果
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2.1　甲状腺激素水平
干预前，组间差异不显著（P>0.05）。干预6个月后，两组FT3、FT4、TSH均较干预前显著改善（P<0.01），研究组TSH高于对照组（P<0.05）。此外，研究组FT3、FT4对于对照组，但差异不显著（P>0.05）。见表1。
2.2　甲状腺自身抗体水平
干预前，组间差异不显著（P>0.05）。干预3及6个月后，对照组TRAb、TPO-Ab略改善（P>0.05）。研究组干预3个月后，TRAb、TPO-Ab低于治疗前（P<0.05）。干预6个月后，研究组TRAb、TPO-Ab低于同组治疗前及治疗3个月后，且低于对照组（P<0.01）。见表2。
2.3　血清25（OH）D水平
干预前，组间差异不显著（P>0.05）。干预6个月后，对照组与治疗前比，差异显著（P<0.05）。研究组高于同组治疗前和同期对照组（P<0.01）。见表3。
2.4　Th1/Th2细胞因子比较
干预前，组间差异无统计学意义（P>0.05）。疗3、6个月后，两组INF-ymRNA与IL-10mRNA均改善，干预3个月后对比差异无统计学意义（P>0.05）。干预6个月后，研究组INF-ymRNA与IL-10mRNA明显优于对照组（P<0.01）。见表4。
3　讨论
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本研究通过随机对照试验评估了百令胶囊联合维生素D治疗对育龄期女性AITD患者甲状腺功能、自身免疫抗体、血清25（OH）D水平及Th1/Th2相关细胞因子的影响。结果显示，联合治疗显著降低了TRAb和TPO-Ab滴度，提升了血清25（OH）D水平，并调节了Th1/Th2细胞因子平衡。
甲状腺功能指标（FT3、FT4、TSH）的变化显示，治疗6个月后，研究组TSH水平显著高于对照组，而FT3、FT4差异无统计学意义。TSH升高可能与联合治疗对甲状腺功能的调节作用有关。传统观点认为，左甲状腺素钠通过负反馈抑制TSH分泌，但本研究中研究组TSH水平升高提示百令胶囊可能通过免疫调节间接影响甲状腺-垂体轴。Kasiyan等研究表明，甲状腺激素代谢与碘状态及免疫微环境密切相关，虫草类成分可能通过调节局部炎症反应影响甲状腺组织对激素的敏感性[18-19]。此外，维生素D受体（VDR）广泛分布于甲状腺滤泡细胞中，维生素D通过抑制甲状腺细胞凋亡和调节促炎因子分泌间接影响激素合成[23]。这一机制可能部分解释联合治疗对TSH的调控作用。
甲状腺自身抗体（TRAb、TPO-Ab）的变化是本研究的重要发现。研究组在治疗3个月后即出现TRAb和TPO-Ab显著下降，6个月后进一步降低至对照组的三分之一水平。这与Krysiak等研究结果一致，其发现维生素D补充可显著降低TPO-Ab滴度，尤其在基线维生素D缺乏患者中效果更显著[23]。百令胶囊中虫草多糖的免疫调节作用可能协同增强了这一效应。王兰英等研究证实，发酵虫草多糖可通过抑制NF-κB信号通路减少B淋巴细胞异常活化，从而降低自身抗体产生[24]。此外，ZHENG等采用益气化瘀法治疗桥本甲状腺炎的研究显示，中药复方可通过调节Th17/Treg平衡抑制自身免疫反应[16]。本研究中INF-γmRNA水平升高与IL-10mRNA下降提示Th1/Th2平衡向Th2偏移，这与虫草多糖通过调控树突状细胞成熟及T细胞分化相关的机制相符[25]。
血清25（OH）D水平在联合治疗组呈现显著提升，治疗后均值达到（62.91±8.13）ng/mL，显著高于对照组的（31.79±3.16）ng/mL。Holick指出，维生素D缺乏已成为全球性健康问题，其与自身免疫疾病的发生发展密切相关[21]。本研究中维生素D的高剂量补充（5000单位/d）突破了常规剂量限制，结合百令胶囊可能增强了维生素D的生物利用度。HU等研究发现，虫草类真菌中麦角固醇经紫外线照射可转化为维生素D2，提示中药成分可能通过多重途径影响维生素D代谢[28]。此外，Abali等发现GAD抗体阳性糖尿病患者常伴发维生素D缺乏，提示维生素D与自身免疫疾病的关联可能具有器官非特异性[15]。
Th1/Th2细胞因子谱的变化显示，研究组治疗后INF-γmRNA显著升高而IL-10mRNA下降，表明Th1反应增强与Th2反应抑制的双向调节。这一发现与Tsai等关于胃壁细胞抗体的研究形成对比，后者发现Th2优势反应与器官特异性自身免疫相关[12]。LUTFI等曾报道甲状腺炎患者存在Th1/Th2失衡，但未明确干预措施的影响[13]。本研究中，虫草多糖可能通过激活TLR4/MyD88信号通路促进IFN-γ分泌，同时抑制IL-10产生，这一机制在齐贺等的蛋白质组学研究中得到佐证[26]。维生素D则通过抑制DC细胞CD40、CD80等共刺激分子表达，阻碍Th2细胞分化，双重作用共同重塑免疫平衡[23]。
从临床疗效分析，联合治疗对育龄期女性的特殊意义值得关注。育龄期女性因雌激素水平波动更易出现免疫失衡，Reid等强调妊娠期甲状腺功能异常对母婴健康的深远影响[14]。本研究纳入对象平均年龄（34.5±6.6）岁，治疗期间血清25（OH）D水平提升至充足状态（>50 ng/mL），这为预防妊娠合并AITD提供了新思路。BUTT等关于幽门螺杆菌与自身免疫性胃炎的研究提示，黏膜免疫调节可能是多器官自身免疫疾病治疗的共同靶点[17]，而百令胶囊的抗炎作用可能对此具有协同效应。
在作用机制层面，维生素D与百令胶囊的协同效应可能涉及多重通路：①维生素D通过结合VDR抑制TRAF3泛素化，阻断NF-κB活化，减少促炎因子释放[23]；②虫草多糖激活Nrf2/ARE通路增强抗氧化能力，减轻甲状腺组织氧化损伤[24]；③联合治疗上调Foxp3表达促进Treg细胞分化，抑制Th17细胞增殖[16]；④调节肠道菌群-免疫轴，改善维生素D吸收及免疫耐受状态[22]。KAMJIO发现TSH受体阻断型抗体与刺激型抗体共存现象[25-28]，本研究中TRAb显著下降可能反映联合治疗对B细胞表位扩散的抑制作用。
与既往研究相比，本研究的创新性体现在：首次将虫草制剂与高剂量维生素D联合应用于AITD治疗；采用动态监测Th1/Th2相关因子mRNA表达水平；关注育龄期这一特殊生理阶段的治疗需求。然而，研究存在一定局限：①观察周期限于6个月，缺乏长期随访数据；②未检测维生素D受体基因多态性对疗效的影响；③Th细胞亚群分析局限于mRNA水平，缺乏蛋白表达验证。未来研究可结合单细胞测序技术深入解析免疫细胞亚群变化，并通过代谢组学探讨维生素D与虫草成分的相互作用机制。
综上所述，百令胶囊联合维生素D治疗通过多靶点调节自身免疫反应，包括抑制甲状腺特异性抗体产生、纠正Th1/Th2失衡、改善维生素D营养状态等。这一联合方案为低维生素D水平的育龄期AITD患者提供了新的治疗选择，其作用机制涉及免疫调节、抗氧化及内分泌代谢等多重通路。后续研究需进一步明确最佳剂量方案，并评估对卵巢功能及妊娠结局的潜在影响。
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2025年第43卷第6期
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doi: 10.13193/j.issn.1673-7717.2025.06.044
  • 首发时间：2026-10-30
  • 出版时间：2025-06-10
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浙江省中医药科技计划项目(2019ZB109)
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    温州医科大学附属衢州医院（衢州市人民医院），浙江 衢州 324000

通讯作者:

王文栋（1980-），男，山东济南人，主任医师，博士，研究方向：甲状腺疾病。E-mail：。
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2种不同金属材料的力学参数
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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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