Article(id=1322926729425203472, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926492627378659, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.09.043, 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=1793339911085, onlineDateStr=2026-10-30, pubDate=1757433600000, pubDateStr=2025-09-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793339911085, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793339911085, creator=13701087609, updateTime=1793339911085, 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=231, endPage=234, ext={EN=ArticleExt(id=1322926730142429457, articleId=1322926729425203472, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Curative Effect of Modified Gegen Qinlian Decoction(加味葛根芩连汤)and Its Influences on Immune Function in Patients with Recurrent Oral Ulceration, columnId=1256183365644968140, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Platform of Provincial Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the curative effect of Modified Gegen Qinlian Decoction(加味葛根芩连汤)and its influences on immune function in patients with recurrentoral ulceration(ROU).

Methods

According to simple randomization method,they were divided into observation group and control group,56 cases in each group. The control group was treated with Kangfuxin Solution,while the observation group was treated with Modified Gegen Qinlian Decoction for 8 weeks. The curative effect and the number of oralulceration in the two groups were recorded. The ulceration pain[Visual analogue scale(VAS)],the scores of TCM syndromes,the levels of inflammatory cytokines[Interleukin(IL)-1β,IL-17,IL-10,tumor necrosis factor-α(TNF-α)]in peripheral blood,cellular immune function(CD3+,CD4+,CD8+),quality of life[World health organization quality of life scale(WHOQOL-100)]and adverse reactions in the two groups were evaluated. All were followed up for 8 weeks after treatment to evaluate recurrence rates.

Results

The total response rate of the observation group was higher than that of the control group(P<0.05). After treatment,the scores of TCM syndromes and the number of ulceration in the observation group were lower than those in the control group(P<0.05). After 4 and 8 weeks of treatment,the levels of serum IL-1β,IL-17,IL-10 and TNF-α were decreased in both groups,which were lower in the observation group than those in the control group,and the above serum indexes were the lowest in the observation group after 8 weeks of treatment(P<0.05). After 4 and 8 weeks of treatment,the levels of CD3+and CD4+were increased,while CD8+levelwas decreased in both groups. The levels of CD3+and CD4+in the observation group were higher than those in the controlgroup,while CD8+level was lower than that in the control group. After8 weeks of treatment,the levels of CD3+ and CD4+ were the highest,while CD8+ level was the lowest in the observation group(P<0.05). As the treatment time changed,VAS score was gradually decreased,and WHOQOL-100 score was gradually increased in both groups. After 2,4,6 and 8 weeks of treatment,VAS scores in the observation group were lower than those in the control group,and WHOQOL-100 scores were higher than those in the control group(P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05). The recurrence rate in the observation group was lower than that in the control group(P<0.05).

Conclusion

Modified Gegen Qinlian Decoction can not only improve the clinical curative effect,relieve inflammatory response and pain,butalso improve the immune function and quality of life,and reduce the recurrence rate in ROU patients,with high safety.

, authors=Ru FENG1, Ning HAN2, Yufeng HUANG2, Zhe DONG1, Xiaodan ZHANG1, authorsList=Ru FENG, Ning HAN, Yufeng HUANG, Zhe DONG, Xiaodan ZHANG, authorCompany=null, correspAuthors=Xiaodan ZHANG, 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=1322926732134723870, articleId=1322926729425203472, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=加味葛根芩连汤治疗复发性口腔溃疡疗效及对免疫功能的影响, columnId=1256183369033965799, journalTitle=中华中医药学刊, columnName=省级项目平台, runingTitle=null, highlight=null, articleAbstract=
目的

探讨加味葛根芩连汤治疗复发性口腔溃疡(Recurrent oral ulceration,ROU)疗效及对免疫功能的影响。

方法

选取ROU患者112例,按1∶1简单随机法分为观察组与对照组,各56例。对照组予以康复新液,观察组予以加味葛根芩连汤,均持续治疗8周。记录两组疗效、口腔溃疡数量,评估两组溃疡疼痛[视觉模拟评分(Visual analogue scale,VAS)]、中医证候积分、外周血炎性细胞因子[白细胞介素(Interleukin,IL)-1β、IL-17、IL-10、肿瘤坏死因子(Tumor necrosis factor,TNF-α)]水平、细胞免疫功能(CD3+、CD4+、CD8+)水平、生存质量[世界卫生组织生存质量测定量表(World health organization quality of life scale,WHOQOL-100)]及不良反应。于治疗后随访8周评估复发率。

结果

相较于对照组,观察组总有效率更高(P<0.05)。治疗后观察组中医证候积分和溃疡数量低(少)于对照组(P<0.05)。与治疗前对比,两组治疗4、8周后的血清IL-1β、IL-17、IL-10和TNF-α水平均降低,且观察组均低于对照组,其中治疗8周后观察组血清指标最低(P<0.05)。与治疗前对比,两组治疗4、8周后的CD3+、CD4+水平均升高,CD8+水平均降低,且观察组CD3+、CD4+水平均高于对照组,CD8+水平低于对照组,其中治疗8周后观察组CD3+、CD4+水平最高,CD8+水平最低(P<0.05)。随治疗时间的变化,两组VAS评分逐渐下降,WHOQOL-100评分逐渐升高,且治疗2、4、6、8周后观察组VAS评分低于对照组,WHOQOL-100评分高于对照组(P<0.05)。两组不良反应发生率对比差异无统计学意义(P>0.05)。观察组复发率较对照组更低(P<0.05)。

结论

加味葛根芩连汤治疗ROU不仅利于提升患者临床疗效,减轻炎症反应和疼痛程度,还可提高免疫功能和生存质量,降低复发率,且安全性也较高。

, authors=冯茹1, 韩宁2, 黄宇峰2, 董哲1, 张晓丹1, authorsList=冯茹, 韩宁, 黄宇峰, 董哲, 张晓丹, authorCompany=null, correspAuthors=张晓丹, authorNote=

冯茹(1998-),女,江苏盐城人,硕士,研究方向:中医药防治老年病。

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张晓丹(1981-),女,浙江舟山人,主任医师,博士,研究方向:中医药防治老年病。E-mail:。
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冯茹(1998-),女,江苏盐城人,硕士,研究方向:中医药防治老年病。

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冯茹(1998-),女,江苏盐城人,硕士,研究方向:中医药防治老年病。

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注:*与对照组相比,P<0.05;#与同组治疗前相比,P<0.05。

, figureFileSmall=gnQU5I3JFsD+0o7aD3RQsA==, figureFileBig=7MjhtOA38JdmoOw7EUMC7g==, tableContent=null), ArticleFig(id=1322926736446468426, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926729425203472, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数治愈显效有效无效总有效
观察组5629(51.79)14(25.00)11(19.64)2(3.57)54(96.43)
对照组5617(30.36)11(19.64)20(35.71)8(14.29)48(85.71)
χ2值-----3.953
P值-----0.047
), ArticleFig(id=1322926736534548811, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926729425203472, language=CN, label=表1, caption=

两组复发性口腔溃疡患者临床疗效比较

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组别例数治愈显效有效无效总有效
观察组5629(51.79)14(25.00)11(19.64)2(3.57)54(96.43)
对照组5617(30.36)11(19.64)20(35.71)8(14.29)48(85.71)
χ2值-----3.953
P值-----0.047
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组别例数时间中医证候积分/(分)溃疡数量/(个)
观察组56治疗前19.34±3.065.12±1.23
治疗后8.70±2.17#&1.06±0.24#&
对照组56治疗前19.28±3.135.27±1.08
治疗后13.65±3.24#2.48±0.60#
), ArticleFig(id=1322926736698126669, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926729425203472, language=CN, label=表2, caption=

两组复发性口腔溃疡患者中医证候积分和溃疡数量对比(±s)

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组别例数时间中医证候积分/(分)溃疡数量/(个)
观察组56治疗前19.34±3.065.12±1.23
治疗后8.70±2.17#&1.06±0.24#&
对照组56治疗前19.28±3.135.27±1.08
治疗后13.65±3.24#2.48±0.60#
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组别例数时间IL-1βIL-17IL-10TNF-α
观察组56治疗前21.56±4.6937.67±4.9232.62±5.2819.33±3.41
治疗4周后16.85±3.24#a26.51±3.07#a23.37±3.06#a14.09±2.15#a
治疗8周后8.41±3.05#bc15.08±2.13#bc12.21±2.14#bc8.17±1.32#bc
对照组56治疗前21.79±4.8338.42±4.8033.15±5.1719.57±3.62
治疗4周后19.32±4.17#31.33±3.42#26.84±3.53#16.28±2.77#
治疗8周后14.19±2.66#c18.19±2.64#c16.60±2.76#c11.34±2.23#c
), ArticleFig(id=1322926736844927311, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926729425203472, language=CN, label=表3, caption=

两组复发性口腔溃疡患者血清炎症因子水平对比(±s)

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组别例数时间IL-1βIL-17IL-10TNF-α
观察组56治疗前21.56±4.6937.67±4.9232.62±5.2819.33±3.41
治疗4周后16.85±3.24#a26.51±3.07#a23.37±3.06#a14.09±2.15#a
治疗8周后8.41±3.05#bc15.08±2.13#bc12.21±2.14#bc8.17±1.32#bc
对照组56治疗前21.79±4.8338.42±4.8033.15±5.1719.57±3.62
治疗4周后19.32±4.17#31.33±3.42#26.84±3.53#16.28±2.77#
治疗8周后14.19±2.66#c18.19±2.64#c16.60±2.76#c11.34±2.23#c
), ArticleFig(id=1322926736933007696, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926729425203472, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间CD3+CD4+CD8+
观察组56治疗前55.64±5.7128.91±3.0535.92±3.41
治疗4周后60.23±6.14#a32.44±3.78#a26.13±2.40#a
治疗8周后68.70±6.82#bc39.52±3.62#bc23.50±2.49#bc
对照组56治疗前55.05±5.4328.63±3.3135.74±3.68
治疗4周后57.18±5.76#30.20±3.57#30.25±3.03#
治疗8周后62.56±6.35#c34.18±3.09#c28.61±2.57#c
), ArticleFig(id=1322926737004310865, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322926729425203472, language=CN, label=表4, caption=

两组复发性口腔溃疡患者免疫功能对比(±s)

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组别例数时间CD3+CD4+CD8+
观察组56治疗前55.64±5.7128.91±3.0535.92±3.41
治疗4周后60.23±6.14#a32.44±3.78#a26.13±2.40#a
治疗8周后68.70±6.82#bc39.52±3.62#bc23.50±2.49#bc
对照组56治疗前55.05±5.4328.63±3.3135.74±3.68
治疗4周后57.18±5.76#30.20±3.57#30.25±3.03#
治疗8周后62.56±6.35#c34.18±3.09#c28.61±2.57#c
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加味葛根芩连汤治疗复发性口腔溃疡疗效及对免疫功能的影响
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冯茹 1 , 韩宁 2 , 黄宇峰 2 , 董哲 1 , 张晓丹 1
中华中医药学刊 | 省级项目平台 2025,43(9): 231-234
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中华中医药学刊 |省级项目平台 2025 , 43 (9) : 231 -234
加味葛根芩连汤治疗复发性口腔溃疡疗效及对免疫功能的影响
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冯茹(1998-),女,江苏盐城人,硕士,研究方向:中医药防治老年病。

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冯茹1, 韩宁2, 黄宇峰2, 董哲1, 张晓丹1
作者信息
  • 1.上海中医药大学附属第七人民医院,上海 200137
  • 2.上海市东方医院,上海 200120
通讯作者:
张晓丹(1981-),女,浙江舟山人,主任医师,博士,研究方向:中医药防治老年病。E-mail:。
作者简介:

冯茹(1998-),女,江苏盐城人,硕士,研究方向:中医药防治老年病。

Curative Effect of Modified Gegen Qinlian Decoction(加味葛根芩连汤)and Its Influences on Immune Function in Patients with Recurrent Oral Ulceration
Ru FENG1, Ning HAN2, Yufeng HUANG2, Zhe DONG1, Xiaodan ZHANG1
Affiliations
  • 1.The Seventh People's Hospital Affiliated to Shanghai University of Traditional Chinese Medicine,Shanghai 200137,China
  • 2.Shanghai East Hospital,Shanghai 200120,China
出版时间: 2025-09-10 doi: 10.13193/j.issn.1673-7717.2025.09.043
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目的

探讨加味葛根芩连汤治疗复发性口腔溃疡(Recurrent oral ulceration,ROU)疗效及对免疫功能的影响。

方法

选取ROU患者112例,按1∶1简单随机法分为观察组与对照组,各56例。对照组予以康复新液,观察组予以加味葛根芩连汤,均持续治疗8周。记录两组疗效、口腔溃疡数量,评估两组溃疡疼痛[视觉模拟评分(Visual analogue scale,VAS)]、中医证候积分、外周血炎性细胞因子[白细胞介素(Interleukin,IL)-1β、IL-17、IL-10、肿瘤坏死因子(Tumor necrosis factor,TNF-α)]水平、细胞免疫功能(CD3+、CD4+、CD8+)水平、生存质量[世界卫生组织生存质量测定量表(World health organization quality of life scale,WHOQOL-100)]及不良反应。于治疗后随访8周评估复发率。

结果

相较于对照组,观察组总有效率更高(P<0.05)。治疗后观察组中医证候积分和溃疡数量低(少)于对照组(P<0.05)。与治疗前对比,两组治疗4、8周后的血清IL-1β、IL-17、IL-10和TNF-α水平均降低,且观察组均低于对照组,其中治疗8周后观察组血清指标最低(P<0.05)。与治疗前对比,两组治疗4、8周后的CD3+、CD4+水平均升高,CD8+水平均降低,且观察组CD3+、CD4+水平均高于对照组,CD8+水平低于对照组,其中治疗8周后观察组CD3+、CD4+水平最高,CD8+水平最低(P<0.05)。随治疗时间的变化,两组VAS评分逐渐下降,WHOQOL-100评分逐渐升高,且治疗2、4、6、8周后观察组VAS评分低于对照组,WHOQOL-100评分高于对照组(P<0.05)。两组不良反应发生率对比差异无统计学意义(P>0.05)。观察组复发率较对照组更低(P<0.05)。

结论

加味葛根芩连汤治疗ROU不仅利于提升患者临床疗效,减轻炎症反应和疼痛程度,还可提高免疫功能和生存质量,降低复发率,且安全性也较高。

葛根芩连汤  /  复发性口腔溃疡  /  疗效  /  炎症  /  免疫功能
Objective

To explore the curative effect of Modified Gegen Qinlian Decoction(加味葛根芩连汤)and its influences on immune function in patients with recurrentoral ulceration(ROU).

Methods

According to simple randomization method,they were divided into observation group and control group,56 cases in each group. The control group was treated with Kangfuxin Solution,while the observation group was treated with Modified Gegen Qinlian Decoction for 8 weeks. The curative effect and the number of oralulceration in the two groups were recorded. The ulceration pain[Visual analogue scale(VAS)],the scores of TCM syndromes,the levels of inflammatory cytokines[Interleukin(IL)-1β,IL-17,IL-10,tumor necrosis factor-α(TNF-α)]in peripheral blood,cellular immune function(CD3+,CD4+,CD8+),quality of life[World health organization quality of life scale(WHOQOL-100)]and adverse reactions in the two groups were evaluated. All were followed up for 8 weeks after treatment to evaluate recurrence rates.

Results

The total response rate of the observation group was higher than that of the control group(P<0.05). After treatment,the scores of TCM syndromes and the number of ulceration in the observation group were lower than those in the control group(P<0.05). After 4 and 8 weeks of treatment,the levels of serum IL-1β,IL-17,IL-10 and TNF-α were decreased in both groups,which were lower in the observation group than those in the control group,and the above serum indexes were the lowest in the observation group after 8 weeks of treatment(P<0.05). After 4 and 8 weeks of treatment,the levels of CD3+and CD4+were increased,while CD8+levelwas decreased in both groups. The levels of CD3+and CD4+in the observation group were higher than those in the controlgroup,while CD8+level was lower than that in the control group. After8 weeks of treatment,the levels of CD3+ and CD4+ were the highest,while CD8+ level was the lowest in the observation group(P<0.05). As the treatment time changed,VAS score was gradually decreased,and WHOQOL-100 score was gradually increased in both groups. After 2,4,6 and 8 weeks of treatment,VAS scores in the observation group were lower than those in the control group,and WHOQOL-100 scores were higher than those in the control group(P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups(P>0.05). The recurrence rate in the observation group was lower than that in the control group(P<0.05).

Conclusion

Modified Gegen Qinlian Decoction can not only improve the clinical curative effect,relieve inflammatory response and pain,butalso improve the immune function and quality of life,and reduce the recurrence rate in ROU patients,with high safety.

Gegen Qinlian Decoction(葛根芩连汤)  /  recurrent oral ulceration  /  curative effect  /  inflammation  /  immune function
冯茹, 韩宁, 黄宇峰, 董哲, 张晓丹. 加味葛根芩连汤治疗复发性口腔溃疡疗效及对免疫功能的影响. 中华中医药学刊, 2025 , 43 (9) : 231 -234 . DOI: 10.13193/j.issn.1673-7717.2025.09.043
Ru FENG, Ning HAN, Yufeng HUANG, Zhe DONG, Xiaodan ZHANG. Curative Effect of Modified Gegen Qinlian Decoction(加味葛根芩连汤)and Its Influences on Immune Function in Patients with Recurrent Oral Ulceration[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (9) : 231 -234 . DOI: 10.13193/j.issn.1673-7717.2025.09.043
复发性口腔溃疡(Recurrent oral ulceration,ROU)为口腔科常见疾病,好发于舌尖、唇内侧、舌缘及舌腹等部位,临床发病率超20%,具有复发性、周期性和自限性等特点[1-2]。本病发生后常表现为局部口腔黏膜溃烂,并伴进食疼痛,对患者生活质量造成极大影响。目前临床仍缺乏确切的根治药物,治疗多以止痛、消炎、贴敷、补充维生素、应用激素和免疫调节剂等为主,但因患者依从性不高,药物不良反应较多,使疗效欠佳,复发率较高[3]。近年因中医药理念的不断发展普及,其用于口腔疾病的防治已取得了显著成效[4-5]。中医认为ROU属“口疮”范畴,病位在口舌,与心脾关系最为密切,乃心脾积热,上炎于口所致。唐代王焘在《外台秘要》中也曾记载:“心脾中热,常患口疮”;杨士瀛在《仁斋直指方》中也提出:“口破生疮,盖心脾受热而致也”。由此可见ROU的病因在于心脾积热,治疗应遵循清心泻脾、清热解毒的原则。葛根芩连汤来源于张仲景《伤寒论》第34条,具清热解毒,发散郁火之效。以往葛根芩连汤常被应用于消化道疾病的治疗,尤其是炎症性肠病中,疗效显著[6]。而ROU作为炎症性肠病中最常见的肠外黏膜病变,其或与肠道病变存在相同的组织病理学变化和相同的免疫学机制。因此,本研究创新性地将加味葛根芩连汤用于治疗ROU,探讨其临床有效性及安全性。
选取2022年2月—2023年8月本院收治的ROU患者112例,按1∶1简单随机法分为观察组与对照组,每组56例。观察组男23例,女33例,年龄21~46岁,平均(33.51±4.62)岁,病程6~27个月,平均(16.38±3.06)个月,溃疡数量3~8个,平均(5.12±1.23)个;对照组男27例,女29例,年龄21~46岁,平均(33.19±4.25)岁,病程6~27个月,平均(16.70±3.18)个月,溃疡数量3~8个,平均(5.27±1.08)个。两组基线资料经对比,差异无统计学意义(P>0.05)。此研究已获得本院医院伦理委员会审批通过(伦理批号:2020-048)。
纳入标准:(1)西医:均符合《口腔黏膜病学》中ROU诊断标准[7];(2)中医[8]:证型:心脾积热型,主症:黄白色溃烂点,中央凹陷,周围黏膜鲜红,溃疡数目较多,局部灼热疼痛;次症:口渴饮冷,便秘,尿短黄。舌脉象:舌质红苔黄,脉数。同时有以上2项主症和1项次症、舌脉即可确诊;(3)ROU发病史半年以上;(4)患者年龄18~60岁,且均为自愿参与此次研究。
排除标准:(1)存在疱疹样ROU;(2)合并白塞病、克罗恩病者;(3)合并肝肾功能障碍者;(4)存在哺乳期和妊娠期妇女;(5)因身体原因不能承受2 h内禁食、禁水者;(6)需进行全口腔治疗者;(7)存在交流认知障碍者;(8)存在对本研究中药物过敏者;(9)近1个月内使用过抗生素、激素、免疫抑制剂等药物治疗者。
对照组:予以康复新液(湖南科伦制药有限公司,国药准字Z43020995,规格100 mL),含漱3 min后口服,2次/d,10 mL/次。观察组:予以加味葛根芩连汤,药用:葛根30 g,黄芩15 g,透骨草15 g,黄连6 g,甘草6 g,金蝉花12 g。由上海康桥中药有限公司代煎水剂,200 mL/次,2次/d,口服。两组均持续治疗8周。
观察比较两组治疗后临床疗效,治疗前后口腔溃疡数量、中医证候积分、外周血炎性细胞因子、细胞免疫功能、疼痛程度和生存质量变化情况及不良反应。同时随访8周,记录复发率。
(1)疗效评估[8]:治愈:经治疗后患者中医证候积分减少>95%,且口腔溃疡全部愈合,疼痛消失,随访期间未见复发;显效:中医证候积分减少70%~95%,口腔溃疡面愈合良好,疼痛缓解;有效:中医证候积分减少30%~69%,口腔溃疡愈合较好,轻微疼痛;无效:证候积分减少29%以下,口腔溃疡愈合时间慢,无变化甚至加重。总有效率为治愈、显效和有效例数之和/总例数×100%。(2)中医证候积分[9]:于治疗前和治疗结束时,对主症按无、轻、中和重记为0、2、4、6分,分数降低,提示症状好转。(3)炎性因子:均于治疗前和治疗4、8周后抽取患者空腹静脉血3 mL,经离心处理后取上层清液保存待检,采用酶联免疫吸附法检测白细胞介素(Interleukin,IL)-1β、IL-17、IL-10、肿瘤坏死因子(Tumor necrosis factor,TNFα)水平。(4)免疫功能:于治疗前和治疗4、8周后采用流式细胞法测定外周血T细胞亚群CD3+、CD4+、CD8+水平。(5)疼痛和生存质量:于治疗前和治疗2、4、6、8周后采用视觉模拟评分(Visual analogue scale,VAS)[10]评估两组疼痛程度,采用世界卫生组织生存质量测定量表(World health organization quality of life scale,WHOQOL-100)[11]评估生存质量。VAS总分0~10分,分高则疼痛越重,WHOQOL-100总分100分,分高则生活质量越好。(6)不良反应:记录用药期间不良反应发生率。(7)复发:随访8周记录复发率。复发率为复发例数/总有效例数×100%。
将SPSS 22.0作为数据处理软件,计量资料经检验均满足正态分布,以()表示,计数资料用例(%)表示,分别行t检验和χ2检验或Fisher精确概率,当P<0.05为差异有统计学意义。
相较于对照组,观察组总有效率更高(P<0.05)。见表1。
治疗后观察组中医证候积分和溃疡数量低(少)于对照组(P<0.05)。见表2。
与治疗前对比,两组治疗4周后、8周后的血清IL-1β、IL-17、IL-10和TNF-α水平均降低,且观察组均低于对照组,其中治疗8周后观察组血清指标最低(P<0.05)。见表3。
与治疗前对比,两组治疗4周后、8周后的CD3+、CD4+水平均升高,CD8+水平均降低,且观察组CD3+、CD4+水平均高于对照组,CD8+水平低于对照组,其中治疗8周后观察组CD3+、CD4+水平最高,CD8+水平最低(P<0.05)。见表4。
随治疗时间的变化,两组VAS评分逐渐下降,WHOQOL-100评分逐渐升高,且治疗2、4、6、8周后观察组VAS评分低于对照组,WHOQOL-100评分高于对照组(P<0.05),见插页ⅩⅩⅨ图1。
两组均无严重不良反应发生,仅对照组出现2例恶心呕吐。两组不良反应发生率比较无差异(Fisher精确概率=0.495)。随访8周后,对照组出现6例复发(12.50%,6/48),观察组出现1例复发(1.85%,1/54),经对比,观察组复发率低于对照组(χ2=4.508,P=0.034)。
祖国医学认为,口腔为手足阳明和足厥阴经循行之处,系肾经、脾经、心经,故而ROU的发生与脾胃关系密切,并可累及心肝肾等脏器,其中以心脾积热型最为多见。舌为心之苗也,诸痛痒疮皆属于心,心之络脉系舌本;脾开窍于口,足太阴脾经连舌本,系舌下,外邪化热,循经上炎,传于心脾,热气冲于口与舌而发病[12-14]。《圣济总录》中相关记载指出:“口疮者,由心脾有热,气冲上焦,熏发口舌,故作疮也”。《诸病源候论·口舌疮候》中也曾云:“心气通于舌,脾气通于口,热乘心脾,气冲于口与舌,故令口舌生疮也”。明确指出ROU与心脾热盛有关,因此应将清心泻脾,通腑解毒作为本病的主要治疗原则。
葛根芩连汤解表清里,发散郁火,主治表证未解,误用攻下,虚其里气,以致表热内陷阳明而下利不止的协热下利证。但葛根芩连汤的功效多样远不仅于治疗协热下利证,现代医家认为此方实为《内经》“火郁发之”之旨[15]。随着对葛根芩连汤研究的逐渐深入发现其治疗范围不断扩大,远超出原方之治,外邪误治郁闭化热,内热郁结不解,皆可采用“火郁发之”之法顺势而祛邪[16]。本研究基于前人研究结合临床诊治经验,经方新用,在经典药方中增加透骨草、金蝉花二味药物,一草一花可起到清热降火、开郁解毒的功效,组成加味葛根芩连汤。结果发现,观察组临床疗效高于对照组,中医证候积分低于对照组,溃疡数量少于对照组,提示加味葛根芩连汤的应用利于ROU患者临床疗效的提高和症状的缓解。考虑为加味葛根芩连汤中葛根解肌退热;黄连泻火燥湿、清热解毒;黄芩清热泻火,清心解毒;透骨草、金蝉花清热降火、开郁解毒;甘草清热益气、补脾解毒,调和诸药。共行健脾泻火,清热解毒的功效,以促使机体恢复正常,继而缓解症状,提高整体疗效。
既往研究指出[17-18],ROU为口腔溃疡的炎性反应,其中TNF-α的过度释放在溃疡疾病的进展过程中发挥重要作用,而TNF-α水平的提高增强了炎症反应,又可刺激促进IL-1β、IL-17、IL-10的表达,进而引起炎性损伤的级联反应,加重患者病情。本研究中两组治疗4周后、8周后的血清IL-1β、IL-17、IL-10和TNF-α水平均降低,且治疗8周后指标水平最低,表明两种治疗方法均可减轻ROU患者炎性反应,但观察组血清炎性因子水平改善程度较对照组更优,提示加味葛根芩连汤缓解ROU患者炎性反应的作用优于康复新液。可能与加味葛根芩连汤中各中药所含化学成分具有抗炎作用有关,如黄芩中的黄芩素有利于抑制促炎因子的合成和分泌,从而发挥抗炎作用,同时还具有抗氧化、调节免疫的作用[19];甘草中所含的甘草酸、多糖等均能起到抗炎、解毒的功效[20];葛根和透骨草中的黄酮类成分能够抑制炎症介质的释放,减轻炎症反应[21-22]。诸药合用,发挥药物协同作用,从而调节炎症因子表达,改善炎症状态。
近年来诸多研究认为免疫因素是ROU的主要发病机制之一,患者多表现为细胞和体液免疫功能失调,其中细胞免疫功能衰减更为显著[23]。任香英等[24]研究发现,ROU患者CD4+水平低于健康组,CD8+水平高于健康组,进一步证实了ROU患者存在细胞免疫功能失调情况。本研究中两组治疗4周后、8周后的CD3+、CD4+水平均升高,CD8+水平均降低,而观察组CD3+、CD4+水平均高于对照组,CD8+水平低于对照组,提示加味葛根芩连汤更利于提高ROU患者免疫功能。可能机制为加味葛根芩连汤可通过调控血清IL-1β、IL-17、IL-10和TNF-α水平而改善机体免疫功能失调状态,从而提高免疫力。杨艳玲等[25]研究也指出,加味葛根芩连汤可提高重度湿热型溃疡性结肠炎患者免疫功能,本研究与其部分类似,从侧面证实了加味葛根芩连汤利于免疫功能的提高。
本研究中治疗2、4、6、8周后观察组VAS评分均低于对照组,WHOQOL-100评分均高于对照组,提示加味葛根芩连汤在缓解ROU患者疼痛及提高生存质量方面的优势更为显著。可能与患者临床疗效、免疫力的提高和炎症反应的降低有关。此外,药方中的黄连、透骨草均具镇痛效应,对于缓解疼痛有重要作用,而疼痛的缓解使患者受到疾病的影响更小,故其生存质量也得以提高。本研究中还显示与对照组相比,观察组的复发率更低,进一步证实了加味葛根芩连汤治疗ROU切实可行,疗效显著。
综上所述,加味葛根芩连汤应用于ROU患者中可提升临床疗效,有利于减轻患者疼痛程度,降低炎症反应,提高免疫功能,且患者复发率也较低,并具安全性。
  • 上海市卫生健康委员会科研项目(202340155)
  • 上海市浦东新区卫生健康委员会卫生计生科研项目(PW2021A-16)
  • 上海市浦东新区卫生系统领先人才培养计划项目(PWRI2023-10)
  • 上海市浦东新区“中央财政支持中医药传承创新发展示范试点项目”临床特色学科项目(YC-2023-0611)
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doi: 10.13193/j.issn.1673-7717.2025.09.043
  • 首发时间:2026-10-30
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上海市卫生健康委员会科研项目(202340155)
上海市浦东新区卫生健康委员会卫生计生科研项目(PW2021A-16)
上海市浦东新区卫生系统领先人才培养计划项目(PWRI2023-10)
上海市浦东新区“中央财政支持中医药传承创新发展示范试点项目”临床特色学科项目(YC-2023-0611)
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    1.上海中医药大学附属第七人民医院,上海 200137
    2.上海市东方医院,上海 200120

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张晓丹(1981-),女,浙江舟山人,主任医师,博士,研究方向:中医药防治老年病。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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