Article(id=1322928440726388856, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926985957221241, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.11.009, 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=1793340319090, onlineDateStr=2026-10-30, pubDate=1762704000000, pubDateStr=2025-11-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793340319090, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793340319090, creator=13701087609, updateTime=1793340319090, updator=13701087609, issue=Issue{id=1322926985957221241, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='11', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1762704000000', pubDateStr='2025-11-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793339972247, creator='13701087609', updateTime=1793340743335, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322930220201804556, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926985957221241, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322930220201804557, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322926985957221241, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=39, endPage=42, ext={EN=ArticleExt(id=1322928442567688314, articleId=1322928440726388856, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Clinical Study on Treatment of Non-alcoholic Fatty Liver Combined with Chronic Hepatitis B with Zhibitai Capsules(脂必泰胶囊), columnId=1256183361521967297, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Target on National Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To observe the efficacy and mechanism of Zhibitai Capsules(脂必泰胶囊)in the treatment of patients with non-alcoholic fatty liver disease and chronic hepatitis B.

Method

A random number grouping method was used to divide 100 patients with non-alcoholic fatty liver disease and hepatitis B who were hospitalized in the hospital from January 1,2022 to April 30,2023,into an observation group and a control group,with 50 patients in each group. The control group received tenofovir fumarate 25 mg once a day. Fifty cases in the observation group were given 0.24 g of Zhibitai Capsule twice a day for 2 months,during which both groups were given routine symptomatic treatment of western medicine. The liver function[alanine aminotransferase(ALT),asparagus cochinchinensis aminotransferase(AST),glutamyltransferase(γ-GT)],blood lipids[total cholesterol(TC),triglycerides(TG),high-density lipoprotein(HDL-C),low-density lipoprotein(LDL-C)],renal function[blood urea nitrogen(BUN),creatinine(Cr)],HBV-DNA amount and changes in TCM symptom scores of the two groups were compared before and after treatment.

Result

The trial has concluded with 10 ineffective patients in the control group and 3 ineffective patients in the observation group. The total effective rate of the observation group was 94%(47/50),which was higher than 80%(40/50)of the control group. Compared with those before treatment,the liver and kidney function,blood lipids and traditional Chinese medicine syndrome scores of HBV-DNA in both groups improved compared to those before treatment. The improvement of ALT,AST andγ-GT of the observation group was better than that of the control group(P<0.05). The reduction degree of TC,TG and LDL-C was higher than that of the control group,and the improvement degree of HDL-Cwas better(P<0.05). The TCM syndrome score significantly improved(P<0.05).

Conclusion

Zhibitai Capsules can effectively improve the blood lipid level,liver and kidney functions,assist in inhibiting the replication of HBV virus,delay the progression of the disease,and has a high factor of safety,which can provide an effective reference for the development of clinical treatment plans for the disease.

, authors=Wenfu ZHANG1, 2, Yiran CHEN3, Zhenchang WANG2, 4, Ming DAI3, 5, Jingjing HUANG1, 2, Jianlin LYU1, 2, authorsList=Wenfu ZHANG, Yiran CHEN, Zhenchang WANG, Ming DAI, Jingjing HUANG, Jianlin LYU, authorCompany=null, correspAuthors=Jianlin LYU, 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=1322928444073443459, articleId=1322928440726388856, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=脂必泰胶囊治疗非酒精性脂肪肝合并慢性乙型病毒性肝炎的临床研究, columnId=1256183362172142382, journalTitle=中华中医药学刊, columnName=国家项目点击, runingTitle=null, highlight=null, articleAbstract=
目的

观察脂必泰胶囊治疗非酒精性脂肪肝合并慢性乙型病毒性肝炎患者的疗效及作用机制。

方法

纳入非酒精性脂肪肝并乙型病毒性肝炎患者100例,采用随机数字分组法分为观察组和对照组各50例,对照组50例予富马酸替诺福韦25 mg,1次/d,观察组50例加予脂必泰胶囊0.24 g 2粒/次,2次/d,疗程2个月,期间两组均予西医常规对症治疗手段。比较两组治疗前后肝功能[丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、谷氨酰转移酶(γ-GT)]、血脂[总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)]、肾功能[尿素氮(BUN)、肌酐(Cr)]、HBV-DNA量、中医证候积分变化情况。

结果

试验结束后,观察组总有效率为94%(47/50),较对照组的80%(40/50)高;与治疗前相比,两组患者肝肾功能、血脂、HBV-DNA量中医证候积分均较治疗前有所改善。观察组ALT、AST、γ-GT改善程度较对照组优(P<0.05);TC、TG、LDL-C降低程度比对照组高、HDL-C改善程度较优(P<0.05);中医证候积分显著改善(P<0.05)。

结论

脂必泰胶囊可有效改善非酒精性脂肪肝合并肝硬化患者血脂水平、肝肾功能、协助抑制HBV病毒复制延缓病程进展且安全系数较高,可为该疾病临床治疗方案制定提供有效参考。

, authors=张文富1, 2, 陈毅然3, 王振常2, 4, 戴铭3, 5, 黄晶晶1, 2, 吕建林1, 2, authorsList=张文富, 陈毅然, 王振常, 戴铭, 黄晶晶, 吕建林, authorCompany=null, correspAuthors=吕建林, authorNote=

张文富(1984-),男(京族),广西防城人,副主任医师,硕士研究生导师,博士,研究方向:肝纤维化、肝硬化及其并发症基础与临床。

, correspAuthorsNote=
吕建林(1982-),男,湖北十堰人,主任医师,博士研究生导师,博士后,研究方向:中西医结合防治肝病研究。E-mail:。
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张文富(1984-),男(京族),广西防城人,副主任医师,硕士研究生导师,博士,研究方向:肝纤维化、肝硬化及其并发症基础与临床。

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张文富(1984-),男(京族),广西防城人,副主任医师,硕士研究生导师,博士,研究方向:肝纤维化、肝硬化及其并发症基础与临床。

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companyId=1322928444627091600, language=EN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=5.Guangxi Key Laboratory of Traditional Chinese Medicine Basic Research,Nanning 530299,Guangxi,China), AuthorCompanyExt(id=1322928444736143506, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, companyId=1322928444627091600, language=CN, country=null, province=null, city=null, postcode=null, companyName=null, departmentName=null, remark=5.广西中医基础研究重点实验室,广西 南宁 530299)])], figs=[ArticleFig(id=1322928448779452606, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, 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5018(36.00)29(58.00)3(6.00)47(94.00)
对照组504(8.00)36(72.00)10(20.00)40(80.00)#
), ArticleFig(id=1322928448859144383, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=CN, label=表1, caption=

两组非酒精性脂肪性肝病合并慢性乙型病毒性肝炎患者临床疗效比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数显效有效无效总有效
观察组5018(36.00)29(58.00)3(6.00)47(94.00)
对照组504(8.00)36(72.00)10(20.00)40(80.00)#
), ArticleFig(id=1322928448930447552, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数ALTASTγ-GT
治疗前治疗后治疗前治疗后治疗前治疗后
观察组50133.18±26.5664.06±14.40*#126.50±25.6558.20±14.22*#59.96±33.6234.16±18.10*#
对照组50131.48±25.1978.46±14.12*125.68±21.5773.06±15.00*55.60±30.3542.60±20.06*
), ArticleFig(id=1322928449001750721, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=CN, label=表2, caption=

两组非酒精性脂肪性肝病合并慢性乙型病毒性肝炎患者肝功能水平比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数ALTASTγ-GT
治疗前治疗后治疗前治疗后治疗前治疗后
观察组50133.18±26.5664.06±14.40*#126.50±25.6558.20±14.22*#59.96±33.6234.16±18.10*#
对照组50131.48±25.1978.46±14.12*125.68±21.5773.06±15.00*55.60±30.3542.60±20.06*
), ArticleFig(id=1322928449081442498, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数TGTCHDL-CLDL-C
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502.74±1.321.50±0.46*#6.41±1.064.96±0.60*#1.09±0.361.48±0.24*#3.12±0.802.33±0.38*#
对照组502.65±1.092.20±0.84*6.32±1.005.71±0.97*0.95±0.291.05±0.24*3.04±1.032.71±0.73*
), ArticleFig(id=1322928449173717187, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=CN, label=表3, caption=

两组非酒精性脂肪性肝病合并慢性乙型病毒性肝炎患者血脂水平比较(±s)

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数TGTCHDL-CLDL-C
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502.74±1.321.50±0.46*#6.41±1.064.96±0.60*#1.09±0.361.48±0.24*#3.12±0.802.33±0.38*#
对照组502.65±1.092.20±0.84*6.32±1.005.71±0.97*0.95±0.291.05±0.24*3.04±1.032.71±0.73*
), ArticleFig(id=1322928449253408964, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数Cr/(mmol/L)BUN/(μmol/L)
治疗前治疗后治疗前治疗后
观察组5095.56±13.1968.16±12.58*#9.52±3.376.25±1.93*#
对照组5095.09±17.1175.88±14.13*9.42±3.377.40±2.13*
), ArticleFig(id=1322928449328906437, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=CN, label=表4, caption=

两组非酒精性脂肪性肝病合并慢性乙型病毒性肝炎患者肾功能水平比较(±s)

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数Cr/(mmol/L)BUN/(μmol/L)
治疗前治疗后治疗前治疗后
观察组5095.56±13.1968.16±12.58*#9.52±3.376.25±1.93*#
对照组5095.09±17.1175.88±14.13*9.42±3.377.40±2.13*
), ArticleFig(id=1322928449500872902, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间HBV DNA载量/(UI/mL)
观察组50治疗前2.44±1.13×103
治疗后1.38±0.84×103*#
对照组50治疗前2.45±1.09×103
治疗后1.85±1.01×103*
), ArticleFig(id=1322928449601536199, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=CN, label=表5, caption=

两组HBV-DNA载量比较(±s)

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间HBV DNA载量/(UI/mL)
观察组50治疗前2.44±1.13×103
治疗后1.38±0.84×103*#
对照组50治疗前2.45±1.09×103
治疗后1.85±1.01×103*
), ArticleFig(id=1322928449693810888, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间证候积分
观察组50治疗前8.12±1.30
治疗后4.02±1.33*#
对照组50治疗前8.02±1.31
治疗后6.06±1.53*
), ArticleFig(id=1322928451367338185, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322928440726388856, language=CN, label=表6, caption=

两组非酒精性脂肪性肝病合并慢性乙型病毒性肝炎患者中医证候积分比较(±s)

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间证候积分
观察组50治疗前8.12±1.30
治疗后4.02±1.33*#
对照组50治疗前8.02±1.31
治疗后6.06±1.53*
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脂必泰胶囊治疗非酒精性脂肪肝合并慢性乙型病毒性肝炎的临床研究
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张文富 1, 2 , 陈毅然 3 , 王振常 2, 4 , 戴铭 3, 5 , 黄晶晶 1, 2 , 吕建林 1, 2
中华中医药学刊 | 国家项目点击 2025,43(11): 39-42
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中华中医药学刊 |国家项目点击 2025 , 43 (11) : 39 -42
脂必泰胶囊治疗非酒精性脂肪肝合并慢性乙型病毒性肝炎的临床研究
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张文富(1984-),男(京族),广西防城人,副主任医师,硕士研究生导师,博士,研究方向:肝纤维化、肝硬化及其并发症基础与临床。

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张文富(1984-),男(京族),广西防城人,副主任医师,硕士研究生导师,博士,研究方向:肝纤维化、肝硬化及其并发症基础与临床。

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张文富1, 2, 陈毅然3, 王振常2, 4, 戴铭3, 5, 黄晶晶1, 2, 吕建林1, 2
作者信息
  • 1.广西中医药大学第一附属医院,广西 南宁 530023
  • 2.广西高发传染病中西医结合转化医学重点实验室,广西 南宁 530299
  • 3.广西中医药大学,广西 南宁 530299
  • 4.广西国际壮医医院,广西 南宁 530201
  • 5.广西中医基础研究重点实验室,广西 南宁 530299
通讯作者:
吕建林(1982-),男,湖北十堰人,主任医师,博士研究生导师,博士后,研究方向:中西医结合防治肝病研究。E-mail:。
作者简介:

张文富(1984-),男(京族),广西防城人,副主任医师,硕士研究生导师,博士,研究方向:肝纤维化、肝硬化及其并发症基础与临床。

Clinical Study on Treatment of Non-alcoholic Fatty Liver Combined with Chronic Hepatitis B with Zhibitai Capsules(脂必泰胶囊)
Wenfu ZHANG1, 2, Yiran CHEN3, Zhenchang WANG2, 4, Ming DAI3, 5, Jingjing HUANG1, 2, Jianlin LYU1, 2
Affiliations
  • 1.The First Affiliated Hospital of Guangxi University of Traditional Chinese Medicine,Nanning 530023,Guangxi,China
  • 2.Guangxi Key Laboratory of Integrative Traditional Chinese and Western Medicine for Infectious Diseases,Nanning 530299,Guangxi,China
  • 3.Guangxi University of Traditional Chinese Medicine,Nanning 530299,Guangxi,China
  • 4.Guangxi International Zhuang Medical Hospital,Nanning530201,Guangxi,China
  • 5.Guangxi Key Laboratory of Traditional Chinese Medicine Basic Research,Nanning 530299,Guangxi,China
出版时间: 2025-11-10 doi: 10.13193/j.issn.1673-7717.2025.11.009
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目的

观察脂必泰胶囊治疗非酒精性脂肪肝合并慢性乙型病毒性肝炎患者的疗效及作用机制。

方法

纳入非酒精性脂肪肝并乙型病毒性肝炎患者100例,采用随机数字分组法分为观察组和对照组各50例,对照组50例予富马酸替诺福韦25 mg,1次/d,观察组50例加予脂必泰胶囊0.24 g 2粒/次,2次/d,疗程2个月,期间两组均予西医常规对症治疗手段。比较两组治疗前后肝功能[丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、谷氨酰转移酶(γ-GT)]、血脂[总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)]、肾功能[尿素氮(BUN)、肌酐(Cr)]、HBV-DNA量、中医证候积分变化情况。

结果

试验结束后,观察组总有效率为94%(47/50),较对照组的80%(40/50)高;与治疗前相比,两组患者肝肾功能、血脂、HBV-DNA量中医证候积分均较治疗前有所改善。观察组ALT、AST、γ-GT改善程度较对照组优(P<0.05);TC、TG、LDL-C降低程度比对照组高、HDL-C改善程度较优(P<0.05);中医证候积分显著改善(P<0.05)。

结论

脂必泰胶囊可有效改善非酒精性脂肪肝合并肝硬化患者血脂水平、肝肾功能、协助抑制HBV病毒复制延缓病程进展且安全系数较高,可为该疾病临床治疗方案制定提供有效参考。

非酒精性脂肪肝  /  慢性乙型病毒性肝炎  /  临床观察  /  脂必泰
Objective

To observe the efficacy and mechanism of Zhibitai Capsules(脂必泰胶囊)in the treatment of patients with non-alcoholic fatty liver disease and chronic hepatitis B.

Method

A random number grouping method was used to divide 100 patients with non-alcoholic fatty liver disease and hepatitis B who were hospitalized in the hospital from January 1,2022 to April 30,2023,into an observation group and a control group,with 50 patients in each group. The control group received tenofovir fumarate 25 mg once a day. Fifty cases in the observation group were given 0.24 g of Zhibitai Capsule twice a day for 2 months,during which both groups were given routine symptomatic treatment of western medicine. The liver function[alanine aminotransferase(ALT),asparagus cochinchinensis aminotransferase(AST),glutamyltransferase(γ-GT)],blood lipids[total cholesterol(TC),triglycerides(TG),high-density lipoprotein(HDL-C),low-density lipoprotein(LDL-C)],renal function[blood urea nitrogen(BUN),creatinine(Cr)],HBV-DNA amount and changes in TCM symptom scores of the two groups were compared before and after treatment.

Result

The trial has concluded with 10 ineffective patients in the control group and 3 ineffective patients in the observation group. The total effective rate of the observation group was 94%(47/50),which was higher than 80%(40/50)of the control group. Compared with those before treatment,the liver and kidney function,blood lipids and traditional Chinese medicine syndrome scores of HBV-DNA in both groups improved compared to those before treatment. The improvement of ALT,AST andγ-GT of the observation group was better than that of the control group(P<0.05). The reduction degree of TC,TG and LDL-C was higher than that of the control group,and the improvement degree of HDL-Cwas better(P<0.05). The TCM syndrome score significantly improved(P<0.05).

Conclusion

Zhibitai Capsules can effectively improve the blood lipid level,liver and kidney functions,assist in inhibiting the replication of HBV virus,delay the progression of the disease,and has a high factor of safety,which can provide an effective reference for the development of clinical treatment plans for the disease.

non-alcoholic fatty liver disease  /  chronic hepatitis B  /  clinical observation  /  Zhibitai Capsules(脂必泰胶囊)
张文富, 陈毅然, 王振常, 戴铭, 黄晶晶, 吕建林. 脂必泰胶囊治疗非酒精性脂肪肝合并慢性乙型病毒性肝炎的临床研究. 中华中医药学刊, 2025 , 43 (11) : 39 -42 . DOI: 10.13193/j.issn.1673-7717.2025.11.009
Wenfu ZHANG, Yiran CHEN, Zhenchang WANG, Ming DAI, Jingjing HUANG, Jianlin LYU. Clinical Study on Treatment of Non-alcoholic Fatty Liver Combined with Chronic Hepatitis B with Zhibitai Capsules(脂必泰胶囊)[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (11) : 39 -42 . DOI: 10.13193/j.issn.1673-7717.2025.11.009
非酒精性脂肪性肝病(NAFLD)与慢性乙型病毒性肝炎(CHB)两者皆可引起肝脏炎症反应可致肝细胞损伤改变组织生理结构及功能,CHB既往已经明确为肝癌发生的首要因素,两者叠加可引起或加剧包括肝纤维化、肝硬化、肝癌等发生[1]。流行病学调查显示,目前NAFLD全球正常人群发病率约25%,糖尿病患者发病率50% ~60%,近年全球NAFLD相关肝细胞癌及肝硬化相关病死率分别增加21.1%和2.7%[2]。多项研究证实,NAFLD以代谢功能障碍为始动因素,与肥胖、胰岛素抵抗、高脂血症相关,可通过影响肝外器官和调节途径引起多系统疾病的危险因素,增加2型糖尿病、心血管疾病和心脏病以及慢性肾脏疾病等患病风险[3]。本病病机复杂、症状隐匿、诊断困难,早期改善血脂代谢紊乱是有效延缓NAFLD进展及相关并发症发生的重要手段。虽然目前对于该疾病产生机制、治疗靶点、药物研发上有所进展,但仍存在重大挑战,尚未有特效药物,临床上主要应用他汀类药物主要通过减少胆固醇合成达到降脂作用,但单独使用疗效有限,且长期服用有诱导或加重肝功能、骨骼肌损害风险,对于已存在肝功能不全及他汀类不耐受患者须严格把握用药剂量及随访监测[4-5]。中成药脂必泰胶囊对血脂的影响已被证实与他汀类药物相接近,本研究通过脂必泰胶囊对NAFLD合并CHB患者疗效及安全性进行观察,为中西医联合治疗方案提供参考。
选取2020—2023年在广西中医药大学第一附属医院(东葛、仙葫院区)收治住院的100例NAFLD合并CHB患者。本研究已通过医院伦理委员会审批。
符合《非酒精性脂肪性肝病防治指南》中的诊断标准[6]:①无过量饮酒史(男性饮酒折合乙醇量<30 g/d,女性<20 g/d);②无其他可能导致脂肪肝的特定原因;③腹部CT、MRI或B超提示肝脏脂肪样变;④肝脏穿刺活检病理明确诊断。符合上述①、②和③或④项的患者。
符合《慢性乙型肝炎防治指南(2022年版)》中的诊断[7]:①有明确乙型肝炎流行病学史。②实验室检查:血清HBsAg(+)、HBeAg(+)或(-)、HBV DNA阳性(>E+03)。③血清HBsAg阴性,但血清和/或肝组织中HBV DNA阳性。
①既往有过量饮酒史;②存在严重的免疫缺陷或器官器质性病变;③严重肝肾功能损害;④其他病因类型导致的脂肪肝;⑤合并严重肿瘤性相关疾病;⑥合并其他类型肝炎病史;⑦肝硬化合并严重并发症(上消化道出血、肝性脑病)。
将符合标准的100例患者采用简单随机数字分类法进行1∶1随机分组,分为观察组和对照组各50例,两组观察期间均进行清淡饮食、营养均衡、适量运动等健康宣教,对照组50例予富马酸替诺福韦25 mg,1次/d或恩替卡韦胶囊0.5 mg,1次/d。观察组50例加予脂必泰胶囊(成都地奥九泓制药厂,国药准字Z51022196),用法0.24 g,2次/d,2次/d,疗程2个月。期间两组均予西医常规对症治疗手段。
参考《中药新药临床研究指导原则》[8],临床检验指标包括肝功能[丙氨酸氨基转移酶(ALT)、天门冬氨酸氨基转移酶(AST)、谷氨酰转移酶(γ-GT)]、血脂[总胆固醇(TC)、甘油三酯(TG)、高密度脂蛋白胆固醇(HDL-C)、低密度脂蛋白胆固醇(LDL-C)]、肾功能[尿素氮(BUN)、肌酐(Cr)]、HBV-DNA量。中医证候积分评定包括:痞满胀闷、食欲欠佳、肢体乏力、大便不调等症状由轻至重标记0~3分。
(1)显效:临床症状、体征明显改善,肝功能较前明显好转或恢复至正常、HBV-DNA持续低于检测值下限、血脂检验指标满足其中任意一项:TC下降≥20%、TG下降≥40%、LDC-C下降≥30%或HDL-C上升≥0.26 mmol·L-1;中医证候积分减少≥70%;(2)有效:临床症状、体征较前好转,肝功能较前下降,HBV-DNA检测值较前降低,血脂检验指标满足其中任意一项:TC下降≥10%、TG下降≥20%、LDC-C下降≥10%或HDL-C上升≥0.1 mmol·L-1。中医证候积分减少≥30%;(3)无效:临床症状、体征未见改善或较前加重,肝功能未见好转或加重,HBV-DNA检测值未见明显下降或较前增加,血脂检验指标未达上述标准,中医证候积分无明显改变。
本研究数据采用SPSS 26.0软件进行统计分析,计数资料采用卡方检验,以例数(%)表示。计量资料采用标记,数据符合正态分布采用t检验,不符合则使用秩和检验,当P<0.05,则证明差异具有统计学意义。有效率(%)=(显效例数+有效例数)/50×100%。
观察组总有效率为94.00%,高于对照组的80.00%。见表1。
两组肝功能(ALT、AST、γ-GT)水平比较,见表2。
两组血脂(TG、TC、HDL-C、LDL-C)水平比较,见表3。
两组肾功能(Cr、BUN)水平比较,见表4。
两组HBV-DNA载量比较,见表5。
两组中医证候积分比较,见表6。
两组患者在观察期间均未出现严重不良反应。
NAFLD被认为是复杂的代谢障碍性疾病中肝脏的表现,现代人不良的饮食习惯及运动的缺乏使代谢综合征人群(肥胖、血糖、血脂紊乱、高血压等)快速增长,伴随NAFLD发病率包括儿童在内急剧上升且日趋年轻化,预测将成为全球慢性肝病的主要病因[10]。NAFLD的发病机制尚未明确,与脂质代谢异常、PNPLA3基因遗传变异和微生物的影响,肝脏脂质累积后脂肪变性与胰岛素抵抗相互作用引起肝细胞氧化应激的“二次打击学说”被认为是加快NAFLD进展的重要原因[11-12]。慢性乙型肝炎病毒感染目前仍是全球范围内导致肝硬化、肝癌等严重肝脏疾病的首要病因,肝脏持续遭受HBV病毒打击,肝细胞功能受损,微循环障碍,加剧肝脏脂质代谢异常。抗HBV病毒作为基本治疗手段,当肝内脂质堆积缩小肝细胞与抗病毒药物接触面积,降低抗病毒预期的理想疗效[13]。因此改善机体脂质代谢,减轻细胞炎症反应产生是延缓NAFLD合并CHB进展的关键环节。他汀类药物可通过免疫调节、影响HBV转录、去胆固醇抑制HBV外膜形成等途径抑制HBV病毒复制。阿托伐他汀作为脂水溶双性他汀,通过抑制肝内HCM-CoA还原酶及胆固醇合成,增强肝脏对低密度脂蛋白的摄取和代谢,是心血管疾病预防和治疗一线用药,其调控血脂的作用受到广泛认可[14-16]。由于个体差异性,部分患者会出现他汀类不耐受,单一治疗疗效有限且长期服用有肝肾损害风险。现代药理学证实单味中药或复方治疗NAFLD可筛选出多个有效成分及靶点,应用中药制剂技术将复方各类中药有效活性成分进行提取,直接作用于靶点发挥功效,疗效显著。脂必泰胶囊治疗已通过前期分子机制研究发现治疗NAFLD多靶点、多通路可有效抑制肝细胞脂质堆积、胰岛素抵抗[17]。
NAFLD合并CHB患者早期无明显特定的疾病征象,多表现为胁肋胀闷不适、食欲不振、神疲乏力等肝郁脾虚之象,根据临床表现可纳入中医学“肝癖”“胁痛”“痞满”“积聚”等范畴。本病多从痰湿论述,湿热疫毒蕴结中焦,素体多痰湿或喜食肥腻之品,日久则正气受损,肝脾气机失调,致“阳气窒闭,浊阴凝痞”是关键病机,呈现出形体肥胖、痞满厌食、胸胁胀满等气滞血瘀、痰湿胶结标实之象,肝、脾、肾三脏本虚之征[18-19]。治疗讲究以“理气降浊,肝脾同调”为主,强调标本兼治的原则。痰从湿化,治疗关键在于利水,脂必泰胶囊是根据《金匮要略》经方“泽泻汤”衍生而来,在原方重用泽泻利水下行治其标,白术健脾化湿制其本的基础上,加入红曲、山楂组成的复方调脂制剂[20]。
脂质代谢异常是NAFLD发病的重要原因,内源性的脂质代谢受极低密度脂蛋白(VLDL-C)、低密度脂蛋白(LDLC)、高密度脂蛋白(HDL-C)水平影响。VLDL-C经肝脏合成转运内源性TG及TC,通过LDL-C输送至周围组织;HDL-C携带机体游离脂肪酸转运至肝脏通过摄取、氧化脂质,来维持脂质代谢的相对稳定[21]。本研究中,观察组服用脂必泰胶囊患者治疗2个月后,血脂中TC、TG、LDL-C较对照组降低,HDL-C改善优于对照组(P<0.05)。泽泻-白术作为治疗水湿内停的经典药对,药对核心活性成分泽泻醇A、24-乙酰泽泻醇A、泽泻醇B等三萜类成分及白术内酯Ⅲ等倍半萜类通过干预血清胆固醇代谢环节,促进其转运分解,抑制小肠酯化,发挥降脂作用[21];其中乙酰泽泻醇阿托伐他汀钙降脂作用机制相似,通过抑制HCM-CoA还原酶活性降低胆固醇[22]。HDL-C可通过胆固醇逆转运(RCT)使游离胆固醇分解胆汁酸,减轻机体脂质代谢负荷,吕昕儒等[23]研究发现泽泻-白术相配伍可促进APOE小鼠的ABCA1和LXRα分子的表达,加快RCT减少周围组织血管的脂质沉积,同时可抑制炎症因子TNF-α、IL-1β分泌发挥抗炎作用,在一定程度上可预防NASH的发生。红曲功擅消食活血,健脾燥胃,富含莫纳可林类、甾醇类、红曲色素类、有机酸类等多种有效活性成分,具有调脂、抗氧化、抗肿瘤等作用[24]。莫纳可林化合物可通过竞争性抑制HCM-CoA酶,减少内源性胆固醇生成,且生物利用度较精制洛伐他汀更高,不良反应更少[25]。有效成分红曲色素通过上调PPARα基因表达、激活AMPK途径刺激肝脏脂肪酸氧化,可显著降低高脂血症模型小鼠肝脏的TG、TC含量及ALT、AST水平[26];山楂归肝脾二经,可消食积,化瘀血,有效成分黄酮类、解脂酶对高脂血症疗效确切[27]。机体脂质代谢异常,巨噬细胞充分吞噬众多LDL,脂质过分沉积从而变为泡沫细胞是机体血管斑块形成的关键过程,山楂可通过参与肠道菌群调节下调巨噬细胞受体表达水平,抑制巨噬细胞泡沫化,调节血脂水平[28]。γ-GT参与谷胱甘肽代谢、LDL氧化,加强肝脏代谢各种体内外物质,对非酒精性脂肪性肝病的预测具有重要[29-30]。本研究中观察组患者治疗前后ALT、AST、γ-GT改善程度较对照组高(P<0.05),表明脂必泰胶囊可有效改善肝功能,降低肝外血管疾病危险因素的发生。既往研究表明慢性肝病患者容易合并急慢性肾脏的损伤,NAFLD是慢性肾脏病发展的独立危险因素,且合并CHB患者进展至肝硬化门静脉高压存在肾素-血管紧张素系统的激活、氧化应激、炎性因子等共同发病机制[31-32]。本研究中观察组患者肾功能改善水平较治疗组明显,可见脂必泰胶囊可有效维持肾功能稳定。
综上所述,本研究结果显示脂必泰胶囊可有效改善血脂水平、肝肾功能、降低HBV-DNA载量,同时观察组中医证候积分较对照组改善,均未出现不良反应,提示脂必泰胶囊临床治疗安全系数较高,可延缓脂肪肝合并慢性病毒性肝炎病程的进展,减少肝外疾病危险因素的发生,为临床治疗方案制定提供有效参考。
  • 国家自然科学基金项目(81860839; 81960910)
  • 中国博士后科学基金面上项目(2023MD734157)
  • 广西自然科学基金项目(2022GXNSFAA035446)
  • 广西重点研发计划项目(桂科AB23026137)
  • 戴铭广西名中医工作室建设项目(2023017-05-09)
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2025年第43卷第11期
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doi: 10.13193/j.issn.1673-7717.2025.11.009
  • 首发时间:2026-10-30
  • 出版时间:2025-11-10
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基金
国家自然科学基金项目(81860839; 81960910)
中国博士后科学基金面上项目(2023MD734157)
广西自然科学基金项目(2022GXNSFAA035446)
广西重点研发计划项目(桂科AB23026137)
戴铭广西名中医工作室建设项目(2023017-05-09)
作者信息
    1.广西中医药大学第一附属医院,广西 南宁 530023
    2.广西高发传染病中西医结合转化医学重点实验室,广西 南宁 530299
    3.广西中医药大学,广西 南宁 530299
    4.广西国际壮医医院,广西 南宁 530201
    5.广西中医基础研究重点实验室,广西 南宁 530299

通讯作者:

吕建林(1982-),男,湖北十堰人,主任医师,博士研究生导师,博士后,研究方向:中西医结合防治肝病研究。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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