Article(id=1322923093659885800, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923011518628427, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.03.046, 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=1793339044250, onlineDateStr=2026-10-30, pubDate=1741536000000, pubDateStr=2025-03-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793339044250, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793339044250, creator=13701087609, updateTime=1793339044250, updator=13701087609, issue=Issue{id=1322923011518628427, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='3', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1741536000000', pubDateStr='2025-03-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793339024666, creator='13701087609', updateTime=1793340602374, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322929628976906432, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923011518628427, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322929628981100737, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322923011518628427, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=235, endPage=238, ext={EN=ArticleExt(id=1322923095476019433, articleId=1322923093659885800, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Effects of Belling Capsule(百令胶囊)Combined with ARB Class Antihypertensive Drugs on Levels of TGF-β/Smad and p38MAPK in Diabetic Nephropathy, columnId=1256183365644968140, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Platform of Provincial Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To study the effect of Bailing Capsule(百令胶囊)combined with angiotensin Ⅱ receptor blocking agent resistance(ARB)class antihypertensive drugs in the treatment of diabetes nephropathy(DN)on serum levels of transforming growth factor-β(TGF-β)/Smad,p38 mitogen activated protein kinase(p38MAPK).

Methods

A total of 78 patients with DN admitted to the hospital from January 2020 to January 2022 were selected and divided into the control group(39 cases)and the observation group(39 cases)by random number method. The control group was given Candesartan Cilexetil Tablets and insulin. The observation group was added Belling Capsule on the basis of the control group,all of which were treated for 16 weeks. Before and after treatment,the levels of fasting plasma glucose(FPG),glycosylated hemoglobin(HbA1c),serum creatinine(SCr),urea nitrogen(BUN)and serum TGF-β,Smad1,Smad2,Smad3,p38MAPK,P-P38MAPK protein of two groups were compared. In addition,the adverse reaction incidence of the two groups were compared after treatment.

Results

The total effective rate was 87.74% in the observation group,significantly higher than that(69.23%)in the control group(P<0.05). The levels of FPG,HbA1c,SCr and BUN in the observation group were significantly lower than those before treatment and those in the control group after treatment(P<0.05). The protein levels of TGF-β,Smad1,Smad2 and Smad3 after treatment in the observation group were significantly lower than those before treatment and those in the control group after treatment(P<0.05). The serum levels of p38MAPK,p-p38MAPK and p-p38MAPK/p38MAPK in the observation group after treatment were significantly lower than those before treatment and those in the control group after treatment(P<0.05). There was no significant difference in the total incidence of adverse reactions between the two groups(41.03% vs 33.33%,P>0.05).

Conclusion

Belling Capsule combined with ARB class antihypertensive drugs in the treatment of DN can play a significant role in lowering blood glucose and improving renal function,and also can regulate the protein levels of TGF-β/Smad and p38MAPK,without significantly increasing the adverse reactions of drug treatment,which is worthy of clinical promotion and use.

, authors=Yinxi JI, Na XU, Yi JIN, Yuling LIN, Lin LIU, Zengyi LI, Runpeng DOU, Sheng CHENG, Junfeng ZENG, authorsList=Yinxi JI, Na XU, Yi JIN, Yuling LIN, Lin LIU, Zengyi LI, Runpeng DOU, Sheng CHENG, Junfeng ZENG, authorCompany=null, correspAuthors=Na XU, 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=1322923097728360690, articleId=1322923093659885800, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=百令胶囊联合ARB类降压药治疗糖尿病肾病对TGF-β/Smad、p38MAPK水平的影响, columnId=1256183369033965799, journalTitle=中华中医药学刊, columnName=省级项目平台, runingTitle=null, highlight=null, articleAbstract=
目的

研究百令胶囊联合血管紧张素Ⅱ受体拮抗剂(angiotensin Ⅱ receptor blocking agent resistance,ARB)类降压药治疗糖尿病肾病(diabetic nephropathy,DN)对血清转化生长因子(transforming growth factor-β,TGF-β)/Smad、p38丝裂原蛋白激酶(p38 mitogen-activated protein kinase,p38MAPK)水平的影响。

方法

选取2020年1月—2022年1月医院收治的DN患者78例,通过随机数字方法将78例患者分成对照组与观察组各39例,对照组给予坎地沙坦酯片和胰岛素,观察组在对照组的基础上加用百令胶囊,均治疗16周。比较两组疗效,比较两组患者治疗前后空腹血糖(fasting plasma glucose,FPG)、糖化血红蛋白(glycosylated hemoglobin,HbA1c)、肌酐(serum creatinine,SCr)、尿素氮(urea nitrogen,BUN)及血清TGF-β、Smad1、Smad2、Smad3、p38MAPK、p-p38MAPK蛋白水平差异,另外比较两组用药后的不良反应发生率。

结果

观察组患者总有效率87.74%显著高于对照组的69.23%,差异有统计学意义(P<0.05)。观察组治疗后FPG、HbA1c、SCr、BUN水平显著低于治疗前及对照组治疗后,差异有统计学意义(P<0.05)。观察治疗后TGF-β、Smad1、Smad2、Smad3蛋白水平显著低于治疗前及对照组治疗后,差异有统计学意义(P<0.05)。观察组治疗后血清p38MAPK、p-p38MAPK、p-p38MAPK/p38MAPK蛋白水平显著低于治疗前及对照组治疗后,差异有统计学意义(P<0.05)。两组不良反应的总发生率比较,差异无统计学意义(41.03% VS 33.33%,P>0.05)。

结论

百令胶囊联合ARB类降压药治疗DN可以起到明显的降血糖、改善肾功能的作用,同时还能调节TGF-β/Smad、p38MAPK蛋白水平,且不明显增加药物治疗的不良反应,值得临床推广使用。

, authors=籍胤玺, 徐娜, 金毅, 林玉玲, 刘琳, 李曾一, 窦润鹏, 程省, 曾俊风, authorsList=籍胤玺, 徐娜, 金毅, 林玉玲, 刘琳, 李曾一, 窦润鹏, 程省, 曾俊风, authorCompany=null, correspAuthors=徐娜, authorNote=

籍胤玺(1985-),男,河南南阳人,副主任医师,硕士,研究方向:糖尿病及相关并发症的诊治。

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徐娜(1973-),女,河南南阳人,主任医师,硕士,研究方向:糖尿病各种急慢性并发症。
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籍胤玺(1985-),男,河南南阳人,副主任医师,硕士,研究方向:糖尿病及相关并发症的诊治。

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籍胤玺(1985-),男,河南南阳人,副主任医师,硕士,研究方向:糖尿病及相关并发症的诊治。

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url=null, language=null, rfNumber=[17], rfOrder=16, authorNames=刘会敏, 谢辉, 万迅, journalName=中国卫生检验杂志, refType=null, unstructuredReference=刘会敏,谢辉,万迅,等. 渴络欣胶囊联合坎地沙坦酯对早期2型糖尿病肾病患者血清胱抑素C、同型半胱氨酸和炎性因子的影响[J]. 中国卫生检验杂志,2022,32(12):1430-1433., articleTitle=渴络欣胶囊联合坎地沙坦酯对早期2型糖尿病肾病患者血清胱抑素C、同型半胱氨酸和炎性因子的影响, refAbstract=null), Reference(id=1322923111468900682, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, doi=null, pmid=null, pmcid=null, year=2022, volume=7, issue=20, pageStart=142, pageEnd=145, url=null, language=null, rfNumber=[18], rfOrder=17, authorNames=任伟, 蔡东, journalName=临床医学研究与实践, refType=null, unstructuredReference=任伟,蔡东. 加味当归补血汤联合百令胶囊治疗糖尿病肾病的效果及对患者肾功能、免疫功能的影响[J]. 临床医学研究与实践,2022,7(20):142-145., articleTitle=加味当归补血汤联合百令胶囊治疗糖尿病肾病的效果及对患者肾功能、免疫功能的影响, refAbstract=null), Reference(id=1322923111540203851, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, doi=null, pmid=null, pmcid=null, year=2022, volume=24, issue=3, pageStart=8, pageEnd=11, url=null, language=null, rfNumber=[19], rfOrder=18, authorNames=李娟, 张学辉, 冯双双, journalName=湖北中医药大学学报, refType=null, unstructuredReference=李娟,张学辉,冯双双,等. 百令胶囊辅治对早期糖尿病肾病患者肾功能及血清胰岛素样生长因子和炎症因子水平的影响[J]. 湖北中医药大学学报,2022,24(3):8-11., articleTitle=百令胶囊辅治对早期糖尿病肾病患者肾功能及血清胰岛素样生长因子和炎症因子水平的影响, refAbstract=null), Reference(id=1322923111624089932, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, doi=null, pmid=null, pmcid=null, year=2020, volume=7, issue=38, pageStart=145, pageEnd=146, url=null, language=null, rfNumber=[20], rfOrder=19, authorNames=李丽燕, journalName=临床医药文献电子杂志, refType=null, unstructuredReference=李丽燕. 厄贝沙坦、百令胶囊、贝前列素钠联合治疗降低2型糖尿病肾病尿微量白蛋白排泄水平的疗效观察[J]. 临床医药文献电子杂志,2020,7(38):145-146., articleTitle=厄贝沙坦、百令胶囊、贝前列素钠联合治疗降低2型糖尿病肾病尿微量白蛋白排泄水平的疗效观察, refAbstract=null), Reference(id=1322923113280840014, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, doi=null, pmid=null, pmcid=null, year=2018, volume=24, issue=19, pageStart=221, pageEnd=228, url=null, language=null, rfNumber=[21], rfOrder=20, authorNames=吉晶, 何立群, journalName=中国实验方剂学杂志, refType=null, unstructuredReference=吉晶,何立群. 中西医防治肾纤维化的研究进展[J]. 中国实验方剂学杂志,2018,24(19):221-228., articleTitle=中西医防治肾纤维化的研究进展, refAbstract=null), Reference(id=1322923113343754575, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, doi=null, pmid=null, pmcid=null, year=2019, volume=59, issue=9, pageStart=106, pageEnd=109, url=null, language=null, rfNumber=[22], rfOrder=21, authorNames=陈方旭, 米焱, 王彩丽, journalName=山东医药, refType=null, unstructuredReference=陈方旭,米焱,王彩丽. TGF-β/Smad、p38MAPK及JNK/SAPK信号通路在糖尿病肾病发生发展中作用机制的研究进展[J]. 山东医药,2019,59(9):106-109., articleTitle=TGF-β/Smad、p38MAPK及JNK/SAPK信号通路在糖尿病肾病发生发展中作用机制的研究进展, refAbstract=null), Reference(id=1322923113427640656, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, doi=null, pmid=null, pmcid=null, year=2019, volume=30, issue=1, pageStart=117, pageEnd=122, url=null, language=null, rfNumber=[23], rfOrder=22, authorNames=谭菲, 盛瑶环, 何勇, journalName=中药新药与临床药理, refType=null, unstructuredReference=谭菲,盛瑶环,何勇. 尿毒清颗粒对糖尿病肾病大鼠肾脏抗炎抗氧化保护作用及对TGF-β1/p38MAPK信号通路影响的研究[J]. 中药新药与临床药理,2019,30(1):117-122., articleTitle=尿毒清颗粒对糖尿病肾病大鼠肾脏抗炎抗氧化保护作用及对TGF-β1/p38MAPK信号通路影响的研究, refAbstract=null), Reference(id=1322923113595412817, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, doi=null, pmid=null, pmcid=null, year=2018, volume=34, issue=11, pageStart=132, pageEnd=134, url=null, language=null, rfNumber=[24], rfOrder=23, authorNames=俞仲贤, 金仲达, 张文军, journalName=湖南中医杂志, refType=null, unstructuredReference=俞仲贤,金仲达,张文军,等. 百令胶囊干预糖尿病肾病模型大鼠炎症因子表达的实验研究[J]. 湖南中医杂志,2018,34(11):132-134., articleTitle=百令胶囊干预糖尿病肾病模型大鼠炎症因子表达的实验研究, refAbstract=null), Reference(id=1322923113708659026, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, doi=null, pmid=null, pmcid=null, year=2017, volume=34, issue=2, pageStart=21, pageEnd=23,28, url=null, language=null, rfNumber=[25], rfOrder=24, authorNames=韩坤, 郑亚萍, journalName=湖北民族学院学报(医学版), refType=null, unstructuredReference=韩坤,郑亚萍. 百令胶囊影响糖尿病肾病大鼠Caveolin-1蛋白表达机制探讨[J]. 湖北民族学院学报(医学版),2017,34(2):21-23,28., articleTitle=百令胶囊影响糖尿病肾病大鼠Caveolin-1蛋白表达机制探讨, refAbstract=null)], funds=[Fund(id=1322923109619212600, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, awardId=SBGJ202103108, language=CN, fundingSource=河南省卫生健康委员会项目(SBGJ202103108), fundOrder=null, country=null)], companyList=[AuthorCompany(id=1322923098172956915, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, xref=null, ext=[AuthorCompanyExt(id=1322923098181345524, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, companyId=1322923098172956915, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=Endocrinology Department of Nanyang Central Hospital,Nanyang 473000,Henan,China), AuthorCompanyExt(id=1322923098193928437, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, companyId=1322923098172956915, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=南阳市中心医院,河南 南阳 473000)])], figs=[ArticleFig(id=1322923106079220014, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数显效有效无效总有效
观察组3917(43.59)18(46.15)4(10.26)35(87.74)
对照组3915(38.46)12(30.77)12(30.77)27(69.23)
χ2值5.032
P值0.025
), ArticleFig(id=1322923106330878255, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=CN, label=表1, caption=

两组DN患者疗效比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数显效有效无效总有效
观察组3917(43.59)18(46.15)4(10.26)35(87.74)
对照组3915(38.46)12(30.77)12(30.77)27(69.23)
χ2值5.032
P值0.025
), ArticleFig(id=1322923106490261808, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数FPG/(mmol/L)HbA1c/(%)SCr/(μmol/L)BUN/(mmol/L)
治疗前治疗后治疗前治疗后治疗前治疗后治疗前治疗后
观察组3910.24±2.456.05±0.89①9.54±1.256.54±0.73①102.08±14.0064.09±11.62①8.43±1.575.12±0.77①
对照组3910.26±2.477.84±1.33①9.52±1.217.52±1.06①102.11±14.1182.22±10.93①8.43±1.596.54±1.05①
t值0.0366.9850.0724.7550.0097.0970.0004.654
P值0.9720.0000.9430.0000.9930.0001.0000.000
), ArticleFig(id=1322923106775474481, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=CN, label=表2, caption=

两组DN患者治疗前后血糖、肾功能指标比较()

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数FPG/(mmol/L)HbA1c/(%)SCr/(μmol/L)BUN/(mmol/L)
治疗前治疗后治疗前治疗后治疗前治疗后治疗前治疗后
观察组3910.24±2.456.05±0.89①9.54±1.256.54±0.73①102.08±14.0064.09±11.62①8.43±1.575.12±0.77①
对照组3910.26±2.477.84±1.33①9.52±1.217.52±1.06①102.11±14.1182.22±10.93①8.43±1.596.54±1.05①
t值0.0366.9850.0724.7550.0097.0970.0004.654
P值0.9720.0000.9430.0000.9930.0001.0000.000
), ArticleFig(id=1322923106934858034, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数TGFβ1/β-actinSmadl/β-actinSmxd2/β-actinSmad3/β-actin
治疗前治疗后治疗前治疗后治疗前治疗后治疗前治疗后
观察组390.79±0.370.41±0.14①0.73±0.290.48±0.14①0.69±0.300.34±0.08①0.85±0.360.39±0.07①
对照组390.81±0.350.57±0.11①0.75±0.260.55±0.13①0.70±0.280.43±0.08①0.93±0.220.54±0.09①
t值0.2455.6120.3212.2880.1524.9681.1848.216
P值0.8070.0000.7490.0250.8790.0000.2400.000
), ArticleFig(id=1322923107199099187, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=CN, label=表3, caption=

两组DN患者治疗前后血清TGF-β/Smad3蛋白水平比较()

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数TGFβ1/β-actinSmadl/β-actinSmxd2/β-actinSmad3/β-actin
治疗前治疗后治疗前治疗后治疗前治疗后治疗前治疗后
观察组390.79±0.370.41±0.14①0.73±0.290.48±0.14①0.69±0.300.34±0.08①0.85±0.360.39±0.07①
对照组390.81±0.350.57±0.11①0.75±0.260.55±0.13①0.70±0.280.43±0.08①0.93±0.220.54±0.09①
t值0.2455.6120.3212.2880.1524.9681.1848.216
P值0.8070.0000.7490.0250.8790.0000.2400.000
), ArticleFig(id=1322923108935541044, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数p38MAPKp-p38MAPKp-p38MAPK/p38MAPK
治疗前治疗后治疗前治疗后治疗前治疗后
观察组390.60±0.250.40+0.10①0.68±0.260.15+0.10①0.65±0.320.39+0.07①
对照组390.63±0.220.52+0.12①0.71±0.160.25+0.09①0.69±0.360.58+0.07①
t值0.5634.9910.6144.6420.51912.248
P值0.5750.0000.5410.0000.6060.000
), ArticleFig(id=1322923109166227765, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=CN, label=表4, caption=

两组DN患者治疗前后血清p38MAPK、p-p38MAPK蛋白水平比较()

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数p38MAPKp-p38MAPKp-p38MAPK/p38MAPK
治疗前治疗后治疗前治疗后治疗前治疗后
观察组390.60±0.250.40+0.10①0.68±0.260.15+0.10①0.65±0.320.39+0.07①
对照组390.63±0.220.52+0.12①0.71±0.160.25+0.09①0.69±0.360.58+0.07①
t值0.5634.9910.6144.6420.51912.248
P值0.5750.0000.5410.0000.6060.000
), ArticleFig(id=1322923109292056886, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数咽部不适咳嗽腹胀腹泻总发生
观察组393(7.69)5(12.82)3(7.69)5(12.82)16(41.03)
对照组392(5.13)3(7.69)4(10.26)4(10.26)13(33.33)
χ2值0.333
P值0.410
), ArticleFig(id=1322923109522743607, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322923093659885800, language=CN, label=表5, caption=

两组DN患者用药后的不良反应发生率对比

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数咽部不适咳嗽腹胀腹泻总发生
观察组393(7.69)5(12.82)3(7.69)5(12.82)16(41.03)
对照组392(5.13)3(7.69)4(10.26)4(10.26)13(33.33)
χ2值0.333
P值0.410
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百令胶囊联合ARB类降压药治疗糖尿病肾病对TGF-β/Smad、p38MAPK水平的影响
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籍胤玺 , 徐娜 , 金毅 , 林玉玲 , 刘琳 , 李曾一 , 窦润鹏 , 程省 , 曾俊风
中华中医药学刊 | 省级项目平台 2025,43(3): 235-238
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中华中医药学刊 |省级项目平台 2025 , 43 (3) : 235 -238
百令胶囊联合ARB类降压药治疗糖尿病肾病对TGF-β/Smad、p38MAPK水平的影响
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籍胤玺(1985-),男,河南南阳人,副主任医师,硕士,研究方向:糖尿病及相关并发症的诊治。

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籍胤玺, 徐娜, 金毅, 林玉玲, 刘琳, 李曾一, 窦润鹏, 程省, 曾俊风
作者信息
  • 南阳市中心医院,河南 南阳 473000
通讯作者:
徐娜(1973-),女,河南南阳人,主任医师,硕士,研究方向:糖尿病各种急慢性并发症。
作者简介:

籍胤玺(1985-),男,河南南阳人,副主任医师,硕士,研究方向:糖尿病及相关并发症的诊治。

Effects of Belling Capsule(百令胶囊)Combined with ARB Class Antihypertensive Drugs on Levels of TGF-β/Smad and p38MAPK in Diabetic Nephropathy
Yinxi JI, Na XU, Yi JIN, Yuling LIN, Lin LIU, Zengyi LI, Runpeng DOU, Sheng CHENG, Junfeng ZENG
Affiliations
  • Endocrinology Department of Nanyang Central Hospital,Nanyang 473000,Henan,China
出版时间: 2025-03-10 doi: 10.13193/j.issn.1673-7717.2025.03.046
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目的

研究百令胶囊联合血管紧张素Ⅱ受体拮抗剂(angiotensin Ⅱ receptor blocking agent resistance,ARB)类降压药治疗糖尿病肾病(diabetic nephropathy,DN)对血清转化生长因子(transforming growth factor-β,TGF-β)/Smad、p38丝裂原蛋白激酶(p38 mitogen-activated protein kinase,p38MAPK)水平的影响。

方法

选取2020年1月—2022年1月医院收治的DN患者78例,通过随机数字方法将78例患者分成对照组与观察组各39例,对照组给予坎地沙坦酯片和胰岛素,观察组在对照组的基础上加用百令胶囊,均治疗16周。比较两组疗效,比较两组患者治疗前后空腹血糖(fasting plasma glucose,FPG)、糖化血红蛋白(glycosylated hemoglobin,HbA1c)、肌酐(serum creatinine,SCr)、尿素氮(urea nitrogen,BUN)及血清TGF-β、Smad1、Smad2、Smad3、p38MAPK、p-p38MAPK蛋白水平差异,另外比较两组用药后的不良反应发生率。

结果

观察组患者总有效率87.74%显著高于对照组的69.23%,差异有统计学意义(P<0.05)。观察组治疗后FPG、HbA1c、SCr、BUN水平显著低于治疗前及对照组治疗后,差异有统计学意义(P<0.05)。观察治疗后TGF-β、Smad1、Smad2、Smad3蛋白水平显著低于治疗前及对照组治疗后,差异有统计学意义(P<0.05)。观察组治疗后血清p38MAPK、p-p38MAPK、p-p38MAPK/p38MAPK蛋白水平显著低于治疗前及对照组治疗后,差异有统计学意义(P<0.05)。两组不良反应的总发生率比较,差异无统计学意义(41.03% VS 33.33%,P>0.05)。

结论

百令胶囊联合ARB类降压药治疗DN可以起到明显的降血糖、改善肾功能的作用,同时还能调节TGF-β/Smad、p38MAPK蛋白水平,且不明显增加药物治疗的不良反应,值得临床推广使用。

糖尿病肾病  /  百令胶囊  /  ARB类降压药  /  TGF-β/Smad  /  p38MAPK
Objective

To study the effect of Bailing Capsule(百令胶囊)combined with angiotensin Ⅱ receptor blocking agent resistance(ARB)class antihypertensive drugs in the treatment of diabetes nephropathy(DN)on serum levels of transforming growth factor-β(TGF-β)/Smad,p38 mitogen activated protein kinase(p38MAPK).

Methods

A total of 78 patients with DN admitted to the hospital from January 2020 to January 2022 were selected and divided into the control group(39 cases)and the observation group(39 cases)by random number method. The control group was given Candesartan Cilexetil Tablets and insulin. The observation group was added Belling Capsule on the basis of the control group,all of which were treated for 16 weeks. Before and after treatment,the levels of fasting plasma glucose(FPG),glycosylated hemoglobin(HbA1c),serum creatinine(SCr),urea nitrogen(BUN)and serum TGF-β,Smad1,Smad2,Smad3,p38MAPK,P-P38MAPK protein of two groups were compared. In addition,the adverse reaction incidence of the two groups were compared after treatment.

Results

The total effective rate was 87.74% in the observation group,significantly higher than that(69.23%)in the control group(P<0.05). The levels of FPG,HbA1c,SCr and BUN in the observation group were significantly lower than those before treatment and those in the control group after treatment(P<0.05). The protein levels of TGF-β,Smad1,Smad2 and Smad3 after treatment in the observation group were significantly lower than those before treatment and those in the control group after treatment(P<0.05). The serum levels of p38MAPK,p-p38MAPK and p-p38MAPK/p38MAPK in the observation group after treatment were significantly lower than those before treatment and those in the control group after treatment(P<0.05). There was no significant difference in the total incidence of adverse reactions between the two groups(41.03% vs 33.33%,P>0.05).

Conclusion

Belling Capsule combined with ARB class antihypertensive drugs in the treatment of DN can play a significant role in lowering blood glucose and improving renal function,and also can regulate the protein levels of TGF-β/Smad and p38MAPK,without significantly increasing the adverse reactions of drug treatment,which is worthy of clinical promotion and use.

diabetic nephropathy  /  Bailing Capsule(百令胶囊)  /  ARB class antihypertensive drugs  /  TGF-β/Smad  /  p38MAPK
籍胤玺, 徐娜, 金毅, 林玉玲, 刘琳, 李曾一, 窦润鹏, 程省, 曾俊风. 百令胶囊联合ARB类降压药治疗糖尿病肾病对TGF-β/Smad、p38MAPK水平的影响. 中华中医药学刊, 2025 , 43 (3) : 235 -238 . DOI: 10.13193/j.issn.1673-7717.2025.03.046
Yinxi JI, Na XU, Yi JIN, Yuling LIN, Lin LIU, Zengyi LI, Runpeng DOU, Sheng CHENG, Junfeng ZENG. Effects of Belling Capsule(百令胶囊)Combined with ARB Class Antihypertensive Drugs on Levels of TGF-β/Smad and p38MAPK in Diabetic Nephropathy[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (3) : 235 -238 . DOI: 10.13193/j.issn.1673-7717.2025.03.046
糖尿病肾病(diabetic nephropathy,DN)是糖尿病的慢性并发症,该疾病的具体发病机制尚未明确,但较多临床医师认为可能与遗传、肾血流动力学异常、高血压病等有关,近年来随着人们生活方式的改变糖尿病人群愈发增多,导致DN患病群体也随之增多[1]。现阶段对于DN临床多使用血管紧张素Ⅱ受体拮抗剂(angiotensin Ⅱ receptor blocking agent resistance,ARB)类降压药进行治疗,如坎地沙坦酯,其治疗时药物不良反应少,有利于提高患者的治疗依从性,然而不足的是部分患者经治疗后效果并不明显,甚至还会进展为肾衰竭,因此临床仍需寻找其他有效的治疗方式用于DN患者[2-3]。百令胶囊是一种人工虫草药剂,近年来临床研究发现其对肾功能保护具有较好的作用,为寻找治疗DN的新方案[5-6],本次研究使用ARB类降压药治疗该疾病的同时加用百令胶囊,并对其临床治疗效果进行观察,以期为临床治疗工作提供新的思路,现报道如下。
选取2020年1月—2022年1月我院收治的DN患者78例纳入研究对象,通过随机数字方法将78例患者分成对照组与观察组各39例。对照组:男26例,女13例;年龄28~70岁,平均(52.34±3.12)岁;病程3~20年,平均(11.23±3.90)年;观察组:男24例,女15例;年龄30~68岁,平均(52.32±3.13)岁;病程3~20年,平均(11.24±3.91)年。两组临床资料对比,差异无统计学意义(P>0.05),具有可比性。本次研究开展前上报至我院伦理委员会,经批准后实施(伦理批号2019-22号)。
(1)所有患者参照《中国成人糖尿病肾脏病临床诊断的专家共识》[4]确诊;(2)年龄18~85岁;(3)研究对象均签署知情同意书。
(1)肝、肾、心功能严重不全;(2)其他原因造成的泌尿系统感染、肾小球疾病;(3)精神有障碍无法配合治疗、药物过敏等。
(1)对照组给予糖尿病教育、饮食控制和运动治疗;同时口服坎地沙坦酯片(国药准字H20052497,天津药物研究院药业有限责任公司,批号20150525)16 mg/次,1次/d。(2)观察组在对照组的基础上加用百令胶囊(国药准字Z10910036,杭州中美华东制药有限公司,批号20150407),每次口服5粒,每日3次。两组均治疗16周。
(1)两组疗效比较:分别在两组患者治疗16周后返院复查时评估,显效[5]:临床症状体征消失,24 h尿微量蛋白检测较治疗前减少40%以上;有效:临床症状体征消失,24 h尿微量蛋白较前减少10%~39%;无效:患者临床症状体征无变化,24 h尿微量蛋白较治疗前减少10%以下或上升;总有效率=(显效+有效)/总例数×100%。(2)两组治疗前后血糖、肾功能指标比较:分别在两组患者入院及治疗16周后返院复查时抽取清晨空腹静脉血3 mL,离心后检测空腹血糖(fasting plasma glucose,FPG)、糖化血红蛋白(glycosylated hemoglobin,HbA1c)、肌酐(serum creatinine,SCr)、尿素氮(urea nitrogen,BUN),FPG使用日立7600型生化分析仪以酶联比色法检测,HbA1c使用VA RIANTTM测定仪以高效液相法检测,SCr、BUN使用AU2700型分析仪以放免法检测。(3)比较两组治疗前后血清转化生长因子-β(TGF-β)/Smad3、p38丝裂原蛋白激酶(p38 mitogen-activated protein kinase,p38MAPK)、pp38MAPK蛋白水平:取血方式及时点同上,血清TGF-β、Smad1、Smad2、Smad3、p38MAPK、p-p38MAPK蛋白水平以酶联免疫吸附法检测,均以β-肌动蛋白(β-actin)相对表达表示。(4)统计并对比两组患者用药期间不良反应发生情况。
采用SPSS18.0统计软件进行数据分析,计量资料以()表示,组间比较采用t检验计数资料以率表示,采用χ2检验。P<0.05为差异有统计学意义。
观察组患者总有效率87.74%显著高于对照组的69.23%,差异有统计学意义(P<0.05)。见表1。
观察组治疗后FPG、HbA1c、SCr、BUN水平显著低于治疗前及对照组治疗后,差异有统计学意义(P<0.05)。见表2。
观察治疗后TGF-β、Smad1、Smad2、Smad3蛋白水平显著低于治疗前及对照组治疗后,差异有统计学意义(P<0.05)。见表3。
观察组治疗后血清 p38MAPK、p-p38MAPK、pp38MAPK/p38MAPK蛋白水平显著低于治疗前及对照组治疗后,差异有统计学意义(P<0.05)。见表4。
两组不良反应的总发生率比较,差异无统计学意义(41.03% VS33.33%,P>0.05)。见表5。
DN是由慢性高血糖引发的一种高危慢性疾病,发病后会为患者带来蛋白尿、水肿等诸多临床症状,若无法采取及时的治疗则会形成肾衰竭,较大地增加了患者的致残、病死率[7-9]。在DN的发病机制研究中,有学者发现此类患者存在细胞因子水平的改变,能够加剧患者肾功能的损失,如TGF-β/Smad、p38MAPK信号通路的激活[10-12]。其中TGF-β/Smads信号通路能够调节肾组织Ⅳ型胶原和FN蛋白的表达,影响肾小球基底膜的增殖和细胞外基质的合成与降解,在糖尿病肾病的发生发展中起重要作用,p38MAPK由360个氨基酸残基组成,相对分子质量为38 000,对肾脏炎症反应具有促进的作用[13-14]。坎地沙坦酯是现阶段治疗DN常用的ARB类降压药,虽然药物不良反应较少,但治疗效果并不满意,因此本次研究在DN的治疗中行百令胶囊联合坎地沙坦酯治疗,观察患者治疗后的临床疗效及TGF-β/Smad、p38MAPK蛋白水平变化,为DN的治疗工作提供帮助[15-17]。
本次研究结果显示,观察组患者总有效率87.74%显著高于对照组的69.23%,提示DN的治疗中行百令胶囊联合坎地沙坦酯治疗,能够提高临床治疗效果。坎地沙坦酯是既往临床治疗DN的常用药物,其具体的作用机制已有较多研究报道,在此笔者不再赘述。糖尿病在中医中属“消渴病”范畴,将其并发症称“消宵”,认为糖尿病肾病的基本病机为久病入络,消渴病久治不愈,伤阴耗气,津液亏耗,痰热郁瘀互结,阻于络脉,脾肾衰败,水湿潴留泛滥肌肤,遂发为水肿。百令胶囊中主要成分为发酵虫草菌粉,由冬虫夏草制得,冬虫夏草归肺、肾经,能够补肾益肺、止血化痰,具有补肺肾、益精气的效果。同时还含有腺苷、甘露醇、麦角醇等多种微量元素,其中腺苷具有清除氧自由基、降低脂质过氧化物的作用,对保护肾功能具有重要意义,同时还具有肾血流改善、血小板聚集抑制、促进肾功能恢复、抑制疾病进展的作用。因此观察组经联合治疗后能够获得更好地治疗效果[18-20]。同时在血糖及肾功能指标观察中,观察组治疗后FPG、HbA1c、SCr、BUN水平显著低于治疗前及对照组治疗后,可见坎地沙坦酯治疗DN时加用百令胶囊能够更好地发挥血糖控制及肾功能改善效果,笔者认为这与百令胶囊发挥肾功能保护及DN疾病进展抑制密切相关,能够与上述研究结果相互印证。吉晶等[21]在肾功能纤维化的防治中指出百令胶囊具有肾功能保护作用,与本次研究结果相符。
观察治疗后TGF-β、Smad1、Smad2、Smad3蛋白水平显著低于治疗前及对照组治疗后,且观察组治疗后血清p38MAPK、p-p38MAPK、p-p38MAPK/p38MAPK蛋白水平显著低于治疗前及对照组治疗后,提示RB类降压药治疗DN时加用百令胶囊能够更好地改善TGF-β/Smad、p38MAPK水平。TGFβ1、Smad1、Smad2和Smad3蛋白的表达水平上升会促进肾小管上皮细胞转分化,形成肾间质纤维化,可能导致疾病进展;p38MAPK、p-p38MAPK蛋白是p38MAPK信号通路上的重要效应蛋白,其能够影响炎症因子的释放和炎症细胞的聚集,可导致体内炎症式瀑布反应的激活,促进肾损伤的加剧。本次研究观察组治疗后TGF-β/Smad、p38MAPK水平显著降低,可能与百令胶囊、ARB类降压药改善肾血流,发挥肾功能保护作用有关[22-24]。同时其他研究[25]也证实在动物实验中证实百令胶囊能够对大鼠的TGF-β/Smad、p38MAPK蛋白水平进行改善,均能与本次研究结果相互印证。
另外在不良反应观察中,观察组不良反应总发生率(41.03%)略高于对照组(33.33%),但对比无显著差异,提示RB类降压药治疗DN时加用百令胶囊并不会明显地增加不良反应,可见临床应用百令胶囊治疗DN具有较高的安全性
综上,百令胶囊联合ARB类降压药治疗DN临床效果显著,能够改善患者肾功能,抑制血清TGF-β/Smad、p38MAPK蛋白水平,且不会明显增加药物治疗的不良反应,值得临床应用。
  • 河南省卫生健康委员会项目(SBGJ202103108)
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doi: 10.13193/j.issn.1673-7717.2025.03.046
  • 首发时间:2026-10-30
  • 出版时间:2025-03-10
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河南省卫生健康委员会项目(SBGJ202103108)
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    南阳市中心医院,河南 南阳 473000

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徐娜(1973-),女,河南南阳人,主任医师,硕士,研究方向:糖尿病各种急慢性并发症。
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