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Article(id=1322912280257638828, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322912162913596032, articleNumber=null, orderNo=null, doi=10.13193/j.issn.1673-7717.2025.01.034, 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=1793336466134, onlineDateStr=2026-10-30, pubDate=1736438400000, pubDateStr=2025-01-10, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1793336466134, onlineIssueDateStr=2026-10-30, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1793336466134, creator=13701087609, updateTime=1793336466134, updator=13701087609, issue=Issue{id=1322912162913596032, tenantId=1146029695717560320, journalId=1255847919539208197, year='2025', volume='43', issue='1', pageStart='1', pageEnd='258', issueExtLink='null', onlineDate='null', pubDate='1736438400000', pubDateStr='2025-01-10', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=0, createTime=1793336438157, creator='13701087609', updateTime=1793340633627, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1322929760048906989, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322912162913596032, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1322929760048906990, tenantId=1146029695717560320, journalId=1255847919539208197, issueId=1322912162913596032, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=196, endPage=199, ext={EN=ArticleExt(id=1322912280488325549, articleId=1322912280257638828, tenantId=1146029695717560320, journalId=1255847919539208197, language=EN, title=Clinical Effect and Safety of Qijia Lifei Capsule（芪甲利肺胶囊）Combined with Entecavir in Treatment of Primary Positive Pulmonary Tuberculosis Complicated with Hepatitis B, columnId=1256183365644968140, journalTitle=Chinese Archives of Traditional Chinese Medicine, columnName=Platform of Provincial Project, runingTitle=null, highlight=null, articleAbstract=
Objective

To explore the clinical effect and safety of Qijia Lifei Capsule（芪甲利肺胶囊）combined with entecavir in the treatment of primary positive pulmonary tuberculosis complicated with hepatitis B.

Methods

A total of 102 patients with newly treated bacteriopositive pulmonary tuberculosis combined with hepatitis B（admitted from January 2022 to November 2022）were included in this study. According to the random number table method，they were divided into observation group and control group，with 51 patients in each group，including 1 patient felling out in the control group and 2 patients felling out in the observation group. The control group（50 cases）were given entecavir treatment. The observation group（49 cases）were treated with entecavir combined with Qijia Lifei Capsule，and the data of each group［efficacy，changes of TCM symptom scores（afternoon tidal fever，shortness of breath and low voice，night sweats and spontaneous sweating，phlegm，cough，etc.），changes of inflammatory response indexes and immune indexes，liver function indexes and incidence of liver function damage and improvement rate of quality of life］was observed.

Results

Compared with that in the observation group，the total effective rate of the control group was lower（P<0.05）. Before treatment，TCM syndrome scores（afternoon tidal fever，shortness of breath and low voice，night sweats and spontaneous sweating，phlegm，cough，etc.），the levels of tumor necrosis factor-α（TNF-α），C-reactive protein（CRP），white blood cell count（WBC），immunoglobulin A/G/M（IgA/IgG/IgM），serum total bilirubin（TBiL），aspartate aminotransferase（AST），glutamyl transpeptidase（GGT），alkaline phosphatase（ALP），alanine aminotransferase（ALT）and other liver function indexeswere not significant（P>0.05）. After treatment，TCM syndrome scores（afternoon tidal fever，shortness of breath and low voice，nightsweats and spontaneous sweating，phlegm，cough，etc.），the levels of TNF-α，CRP，WBC，IgA/IgG/IgM，TBiL，AST，GGT，ALP，ALT and other indexes in observation group were better than those in the control group（P<0.05）. Compared with that in the controlgroup，the incidence of liver function impairmentwas lower in the observation group after treatment，and the improvement rate of life quality was higher（P<0.05）.

Conclusion

Qijia Lifei Capsule combined with entecavir has significant clinical effect in the treatment of primary bacteriopositive pulmonary tuberculosis complicated with hepatitis B，which can better improve the condition，immune function and quality of life of the patients to a certain extent and reduce the liver damage，and the treatment is safe and reliable.

, authors=Zhenhua CHEN, Lin WANG, Xiang MEI, Fangfang ZOU, Shenghui XU, authorsList=Zhenhua CHEN, Lin WANG, Xiang MEI, Fangfang ZOU, Shenghui XU, authorCompany=null, correspAuthors=Shenghui 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=1322912281528512950, articleId=1322912280257638828, tenantId=1146029695717560320, journalId=1255847919539208197, language=CN, title=芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙型肝炎临床效果及安全性观察, columnId=1256183369033965799, journalTitle=中华中医药学刊, columnName=省级项目平台, runingTitle=null, highlight=null, articleAbstract=
目的

探究芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙型肝炎（乙肝）临床效果及安全性。

方法

研究总计纳入初治菌阳肺结核合并乙肝患者102例（2022年1月—2022年11月收治）进行试验，根据随机数字表法将其分为观察组和对照组，各组51例，对照组患者脱落1例，观察组患者脱落2例，给予对照组患者（50例）恩替卡韦治疗，给予观察组患者（49例）恩替卡韦结合芪甲利肺胶囊治疗，各组数据观察：疗效、中医证候积分变化（午后潮热、气短声低、盗汗与自汗并见、咳痰、咳嗽等）、机体炎症反应指标变化与免疫指标变化、肝功能指标及肝功能损害发生率、生活质量提升率。

结果

与观察组患者治疗总有效率比较，对照组更低（P<0.05）；各组患者治疗前中医证候积分（午后潮热、气短声低、盗汗与自汗并见、咳痰、咳嗽等）、肿瘤坏死因子α（tumour necrosis factor-α，TNF-α）、C反应蛋白（C-reactive protein，CRP）、白细胞计数（white blood cell，WBC）等炎症反应指标、免疫球蛋白A/G/M（immunoglobulin A/immunoglobulin G/immunoglobulin M，IgA/IgG/IgM）等免疫指标、血清总胆红素（total bilirubin，TBiL）、谷草转氨酶（aspartate transaminase，AST）、谷氨酰转肽酶（gamma glutamyl transferase，GGT）、碱性磷酸酶（alkaline phosphatase，ALP）、谷丙转氨酶（glutamic pyruvic transaminase，ALT）等肝功能指标比较（P>0.05），而观察组患者治疗后中医证候积分（午后潮热、气短声低、盗汗与自汗并见、咳痰、咳嗽等）、TNF-α、CRP、WBC、IgA/IgG/IgM、TBiL、AST、GGT、ALP、ALT等指标均优于对照组患者（P<0.05）；较对照组，观察组患者治疗后肝功能损害发生率更低，生活质量提升率更高（P<0.05）。

结论

芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙肝临床效果显著，可较好改善患者病情，一定程度提升机体免疫功能及生活质量，减少肝损伤，较为安全可靠。

, authors=陈振华, 王林, 梅湘, 邹芳芳, 徐胜辉, authorsList=陈振华, 王林, 梅湘, 邹芳芳, 徐胜辉, authorCompany=null, correspAuthors=徐胜辉, authorNote=

陈振华（1979-），男（苗族），湖南沅陵人，副主任医师，硕士，研究方向：结核病及肝病学。

, correspAuthorsNote=
徐胜辉（1970-），女，湖南新宁人，主任医师，学士，研究方向：结核病及非结核分枝杆菌病。E-mail：。
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陈振华（1979-），男（苗族），湖南沅陵人，副主任医师，硕士，研究方向：结核病及肝病学。

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陈振华（1979-），男（苗族），湖南沅陵人，副主任医师，硕士，研究方向：结核病及肝病学。

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journalId=1255847919539208197, articleId=1322912280257638828, doi=null, pmid=null, pmcid=null, year=2022, volume=44, issue=5, pageStart=500, pageEnd=504, url=null, language=null, rfNumber=[23], rfOrder=22, authorNames=费婉婉, 鹿振辉, 黄星, journalName=中国防痨杂志, refType=null, unstructuredReference=费婉婉，鹿振辉，黄星，等．基于“肺与大肠相表里”探讨肠道菌群与肺结核关系的研究进展［J］．中国防痨杂志，2022，44（5）：500-504., articleTitle=基于“肺与大肠相表里”探讨肠道菌群与肺结核关系的研究进展, refAbstract=null), Reference(id=1322912742830637665, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, doi=null, pmid=null, pmcid=null, year=2022, volume=41, issue=3, pageStart=231, pageEnd=237, url=null, language=null, rfNumber=[24], rfOrder=23, authorNames=蔡剑飞, 刘忠达, 徐磊, journalName=上海针灸杂志, refType=null, unstructuredReference=蔡剑飞，刘忠达，徐磊，等．穴位贴敷联合中西药治疗老年复治肺结核阴虚火旺证的临床观察［J］．上海针灸杂志，2022，41（3）：231-237., articleTitle=穴位贴敷联合中西药治疗老年复治肺结核阴虚火旺证的临床观察, refAbstract=null), Reference(id=1322912742893552226, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, doi=null, pmid=null, pmcid=null, year=2022, volume=29, issue=2, pageStart=309, pageEnd=311, url=null, language=null, rfNumber=[25], rfOrder=24, authorNames=沈炜, 黄晓菁, journalName=中国中医药科技, refType=null, unstructuredReference=沈炜，黄晓菁．保真汤加减配合常规疗法治疗肺结核的疗效观察及对免疫功能的影响［J］．中国中医药科技，2022，29（2）：309-311., articleTitle=保真汤加减配合常规疗法治疗肺结核的疗效观察及对免疫功能的影响, refAbstract=null), Reference(id=1322912742956466787, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, doi=null, pmid=null, pmcid=null, year=2022, volume=42, issue=9, pageStart=123, pageEnd=143, url=null, language=null, rfNumber=[26], rfOrder=25, authorNames=王沛珊, journalName=中国社会科学院大学学报, refType=null, unstructuredReference=王沛珊．从“肺结核”病名演变看中国近代医学知识的多元汇通［J］．中国社会科学院大学学报，2022，42（9）：123-143., articleTitle=从“肺结核”病名演变看中国近代医学知识的多元汇通, refAbstract=null), Reference(id=1322912743015187044, tenantId=1146029695717560320, journalId=1255847919539208197, 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组别例数治愈显效有效无效总有效
对照组5011（22.00）14（28.00）11（22.00）14（28.00）36（72.00）
观察组4928（57.14）10（20.41）7（14.29）4（8.16）45（91.84）
χ2值6.546 1
P值0.010 5
), ArticleFig(id=1322912734307811899, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=CN, label=表1, caption=

两组初治菌阳肺结核合并乙型肝炎患者疗效比较

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组别例数治愈显效有效无效总有效
对照组5011（22.00）14（28.00）11（22.00）14（28.00）36（72.00）
观察组4928（57.14）10（20.41）7（14.29）4（8.16）45（91.84）
χ2值6.546 1
P值0.010 5
), ArticleFig(id=1322912737822638652, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间午后潮热气短声低盗汗与自汗并见咳痰咳嗽
对照组50治疗前2.06±0.241.96±0.322.11±0.262.34±0.222.26±0.20
治疗后0.69±0.130.72±0.110.69±0.150.76±0.110.70±0.14
观察组49治疗前2.02±0.281.99±0.382.15±0.292.38±0.202.29±0.18
治疗后0.36±0.08a0.39±0.06a0.40±0.05a0.40±0.06a0.37±0.08a
), ArticleFig(id=1322912737948467773, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=CN, label=表2, caption=

两组初治菌阳肺结核合并乙型肝炎患者中医证候积分比较（±s）

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组别例数时间午后潮热气短声低盗汗与自汗并见咳痰咳嗽
对照组50治疗前2.06±0.241.96±0.322.11±0.262.34±0.222.26±0.20
治疗后0.69±0.130.72±0.110.69±0.150.76±0.110.70±0.14
观察组49治疗前2.02±0.281.99±0.382.15±0.292.38±0.202.29±0.18
治疗后0.36±0.08a0.39±0.06a0.40±0.05a0.40±0.06a0.37±0.08a
), ArticleFig(id=1322912738019770942, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间TNF-α/（pg/mL）CRP/（mg/L）WBC/（×109/L）
对照组50治疗前6.87±0.5691.65±8.4219.56±1.56
治疗后3.99±0.3855.45±4.3213.25±1.06
观察组49治疗前6.92±0.5991.68±8.4619.63±1.60
治疗后2.03±0.38a35.42±3.75a10.05±0.98a
), ArticleFig(id=1322912738091074111, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=CN, label=表3, caption=

两组初治菌阳肺结核合并乙型肝炎患者TNF-α、CRP、WBC指标比较（±s）

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组别例数时间TNF-α/（pg/mL）CRP/（mg/L）WBC/（×109/L）
对照组50治疗前6.87±0.5691.65±8.4219.56±1.56
治疗后3.99±0.3855.45±4.3213.25±1.06
观察组49治疗前6.92±0.5991.68±8.4619.63±1.60
治疗后2.03±0.38a35.42±3.75a10.05±0.98a
), ArticleFig(id=1322912738162377280, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间IgAIgGIgM
对照组50治疗前1.03±0.256.20±1.061.01±0.46
治疗后1.22±0.206.97±0.761.30±0.48
观察组49治疗前1.01±0.236.21±1.041.00±0.44
治疗后1.49±0.19a8.59±0.55a1.59±0.21a
), ArticleFig(id=1322912738229486145, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=CN, label=表4, caption=

两组初治菌阳肺结核合并乙型肝炎患者IgA/IgG/IgM指标比较（±s）

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组别例数时间IgAIgGIgM
对照组50治疗前1.03±0.256.20±1.061.01±0.46
治疗后1.22±0.206.97±0.761.30±0.48
观察组49治疗前1.01±0.236.21±1.041.00±0.44
治疗后1.49±0.19a8.59±0.55a1.59±0.21a
), ArticleFig(id=1322912738309177922, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间TBiL/（μmol/L）AST/（U/L）GGT/（U/L）ALP/（U/L）ALT/（U/L）
对照组50治疗前13.21±3.2629.45±5.4379.65±7.65159.65±8.8533.76±6.23
治疗后16.76±3.5236.54±6.54114.4±10.65185.65±9.5441.23±5.33
观察组49治疗前13.19±3.2429.48±5.6179.69±7.68159.68±8.8633.72±5.99
治疗后21.56±4.23a49.36±4.21a178.54±9.65a255.32±7.54a56.54±6.23a
), ArticleFig(id=1322912738376286787, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=CN, label=表5, caption=

两组初治菌阳肺结核合并乙型肝炎患者治疗前后肝功能指标（TBiL、AST、GGT、ALP、ALT）变化比较（±s）

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数时间TBiL/（μmol/L）AST/（U/L）GGT/（U/L）ALP/（U/L）ALT/（U/L）
对照组50治疗前13.21±3.2629.45±5.4379.65±7.65159.65±8.8533.76±6.23
治疗后16.76±3.5236.54±6.54114.4±10.65185.65±9.5441.23±5.33
观察组49治疗前13.19±3.2429.48±5.6179.69±7.68159.68±8.8633.72±5.99
治疗后21.56±4.23a49.36±4.21a178.54±9.65a255.32±7.54a56.54±6.23a
), ArticleFig(id=1322912738460172868, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数轻度损害中度损害重度损害总损害
对照组506（12.00）5（10.00）3（6.00）14（28.00）
观察组491（2.04）1（2.04）0（0.00）2（4.08）
χ2值10.448 8
P值0.001 2
), ArticleFig(id=1322912738527281733, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=CN, label=表6, caption=

两组初治菌阳肺结核合并乙型肝炎患者肝功能损害发生率比较

, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数轻度损害中度损害重度损害总损害
对照组506（12.00）5（10.00）3（6.00）14（28.00）
观察组491（2.04）1（2.04）0（0.00）2（4.08）
χ2值10.448 8
P值0.001 2
), ArticleFig(id=1322912738606973510, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=EN, label=null, caption=null, figureFileSmall=null, figureFileBig=null, tableContent=
组别例数生活质量提升例数/（例）生活质量提升率/（%）
对照组501530.00
观察组492857.14
χ2值7.420 9
P值0.006 4
), ArticleFig(id=1322912738674082375, tenantId=1146029695717560320, journalId=1255847919539208197, articleId=1322912280257638828, language=CN, label=表7, caption=

两组初治菌阳肺结核合并乙型肝炎患者生活质量提升率比较

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组别例数生活质量提升例数/（例）生活质量提升率/（%）
对照组501530.00
观察组492857.14
χ2值7.420 9
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芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙型肝炎临床效果及安全性观察
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陈振华 , 王林 , 梅湘 , 邹芳芳 , 徐胜辉
中华中医药学刊 | 省级项目平台 2025,43(1): 196-199
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中华中医药学刊 |省级项目平台 2025 , 43 (1) : 196 -199
芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙型肝炎临床效果及安全性观察
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陈振华, 王林, 梅湘, 邹芳芳, 徐胜辉
作者信息
  • 湖南省胸科医院，湖南　长沙　410013
通讯作者:
徐胜辉（1970-），女，湖南新宁人，主任医师，学士，研究方向：结核病及非结核分枝杆菌病。E-mail：。
作者简介:

陈振华（1979-），男（苗族），湖南沅陵人，副主任医师，硕士，研究方向：结核病及肝病学。

Clinical Effect and Safety of Qijia Lifei Capsule（芪甲利肺胶囊）Combined with Entecavir in Treatment of Primary Positive Pulmonary Tuberculosis Complicated with Hepatitis B
Zhenhua CHEN, Lin WANG, Xiang MEI, Fangfang ZOU, Shenghui XU
Affiliations
  • Hunan Chest Hospital, Changsha 410013, Hunan, China
出版时间: 2025-01-10 doi: 10.13193/j.issn.1673-7717.2025.01.034
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摘要
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目的

探究芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙型肝炎（乙肝）临床效果及安全性。

方法

研究总计纳入初治菌阳肺结核合并乙肝患者102例（2022年1月—2022年11月收治）进行试验，根据随机数字表法将其分为观察组和对照组，各组51例，对照组患者脱落1例，观察组患者脱落2例，给予对照组患者（50例）恩替卡韦治疗，给予观察组患者（49例）恩替卡韦结合芪甲利肺胶囊治疗，各组数据观察：疗效、中医证候积分变化（午后潮热、气短声低、盗汗与自汗并见、咳痰、咳嗽等）、机体炎症反应指标变化与免疫指标变化、肝功能指标及肝功能损害发生率、生活质量提升率。

结果

与观察组患者治疗总有效率比较，对照组更低（P<0.05）；各组患者治疗前中医证候积分（午后潮热、气短声低、盗汗与自汗并见、咳痰、咳嗽等）、肿瘤坏死因子α（tumour necrosis factor-α，TNF-α）、C反应蛋白（C-reactive protein，CRP）、白细胞计数（white blood cell，WBC）等炎症反应指标、免疫球蛋白A/G/M（immunoglobulin A/immunoglobulin G/immunoglobulin M，IgA/IgG/IgM）等免疫指标、血清总胆红素（total bilirubin，TBiL）、谷草转氨酶（aspartate transaminase，AST）、谷氨酰转肽酶（gamma glutamyl transferase，GGT）、碱性磷酸酶（alkaline phosphatase，ALP）、谷丙转氨酶（glutamic pyruvic transaminase，ALT）等肝功能指标比较（P>0.05），而观察组患者治疗后中医证候积分（午后潮热、气短声低、盗汗与自汗并见、咳痰、咳嗽等）、TNF-α、CRP、WBC、IgA/IgG/IgM、TBiL、AST、GGT、ALP、ALT等指标均优于对照组患者（P<0.05）；较对照组，观察组患者治疗后肝功能损害发生率更低，生活质量提升率更高（P<0.05）。

结论

芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙肝临床效果显著，可较好改善患者病情，一定程度提升机体免疫功能及生活质量，减少肝损伤，较为安全可靠。

初治菌阳肺结核合并乙肝  /  芪甲利肺胶囊  /  恩替卡韦  /  疗效  /  安全性  /  中医证候积分  /  生活质量
Objective

To explore the clinical effect and safety of Qijia Lifei Capsule（芪甲利肺胶囊）combined with entecavir in the treatment of primary positive pulmonary tuberculosis complicated with hepatitis B.

Methods

A total of 102 patients with newly treated bacteriopositive pulmonary tuberculosis combined with hepatitis B（admitted from January 2022 to November 2022）were included in this study. According to the random number table method，they were divided into observation group and control group，with 51 patients in each group，including 1 patient felling out in the control group and 2 patients felling out in the observation group. The control group（50 cases）were given entecavir treatment. The observation group（49 cases）were treated with entecavir combined with Qijia Lifei Capsule，and the data of each group［efficacy，changes of TCM symptom scores（afternoon tidal fever，shortness of breath and low voice，night sweats and spontaneous sweating，phlegm，cough，etc.），changes of inflammatory response indexes and immune indexes，liver function indexes and incidence of liver function damage and improvement rate of quality of life］was observed.

Results

Compared with that in the observation group，the total effective rate of the control group was lower（P<0.05）. Before treatment，TCM syndrome scores（afternoon tidal fever，shortness of breath and low voice，night sweats and spontaneous sweating，phlegm，cough，etc.），the levels of tumor necrosis factor-α（TNF-α），C-reactive protein（CRP），white blood cell count（WBC），immunoglobulin A/G/M（IgA/IgG/IgM），serum total bilirubin（TBiL），aspartate aminotransferase（AST），glutamyl transpeptidase（GGT），alkaline phosphatase（ALP），alanine aminotransferase（ALT）and other liver function indexeswere not significant（P>0.05）. After treatment，TCM syndrome scores（afternoon tidal fever，shortness of breath and low voice，nightsweats and spontaneous sweating，phlegm，cough，etc.），the levels of TNF-α，CRP，WBC，IgA/IgG/IgM，TBiL，AST，GGT，ALP，ALT and other indexes in observation group were better than those in the control group（P<0.05）. Compared with that in the controlgroup，the incidence of liver function impairmentwas lower in the observation group after treatment，and the improvement rate of life quality was higher（P<0.05）.

Conclusion

Qijia Lifei Capsule combined with entecavir has significant clinical effect in the treatment of primary bacteriopositive pulmonary tuberculosis complicated with hepatitis B，which can better improve the condition，immune function and quality of life of the patients to a certain extent and reduce the liver damage，and the treatment is safe and reliable.

initial treatment of positive pulmonary tuberculosis with hepatitis B  /  Qijia Lifei Capsule（芪甲利肺胶囊）  /  entecavir  /  curative effect  /  security  /  TCM symptom score  /  quality of life
陈振华, 王林, 梅湘, 邹芳芳, 徐胜辉. 芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙型肝炎临床效果及安全性观察. 中华中医药学刊, 2025 , 43 (1) : 196 -199 . DOI: 10.13193/j.issn.1673-7717.2025.01.034
Zhenhua CHEN, Lin WANG, Xiang MEI, Fangfang ZOU, Shenghui XU. Clinical Effect and Safety of Qijia Lifei Capsule（芪甲利肺胶囊）Combined with Entecavir in Treatment of Primary Positive Pulmonary Tuberculosis Complicated with Hepatitis B[J]. Chinese Archives of Traditional Chinese Medicine, 2025 , 43 (1) : 196 -199 . DOI: 10.13193/j.issn.1673-7717.2025.01.034
正文
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肺结核是临床常见疾病，是由结核分枝杆菌导致的一种慢性传染病，乙肝即慢性乙型肝炎，为乙型肝炎病毒所致的病毒性肝炎，肺结核与乙肝均为对人体伤害较大的疾病，通常两种疾病独立存在，少数患者出现两种疾病合并，一旦患者出现肺结核合并乙肝，危害较大。抗结核治疗方案对患者肝功能具有损害，加重乙肝病情，故而采取何种方法安全治疗肺结核合并乙肝成为临床关注的重点与难点[1-3]。恩替卡韦属于鸟嘌呤核苷类似物，可较好抑制鸟嘌呤核苷类似物，达到抗病毒作用，该药还可清除肝脏内沉积胶原纤维，利于肝细胞再生，改善肝功能，治疗乙肝及抗肺结核治疗肺损伤影响效果较好[4-5]。中医药治疗肺结核合并乙肝具有一定效果，临床经验发现，初治菌阳肺结核合并乙肝患者应用芪甲利肺胶囊取得较好治疗效果，值得深入观察。故而本次纳入102例初治菌阳肺结核合并乙肝患者进行分组观察，研究芪甲利肺胶囊与恩替卡韦结合治疗效果，报道如下。
1　资料与方法
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1.1　一般资料
研究纳入我院2022年1月—2022年11月收治的102例初治菌阳肺结核合并乙肝患者进行本次试验，根据随机数字表法将其平均分为两组，对照组研究过程中脱落1例，观察组脱落2例。对照组50例，男17例，女33例；年龄26～69岁，平均（48.65±3.12）岁；病程为1～9个月，平均（4.65±0.54）个月。观察组49例，男18例，女31例；年龄25～68岁，平均（48.69±3.16）岁；病程为1～10个月，平均（4.68±0.58）个月。观察组与对照组患者资料比较，P>0.05。
1.2　诊断标准
西医参照《WS288-2017》[6]诊断初治菌阳肺结核合并乙肝：患者咳嗽咳痰、咯血、胸痛、发热、恶心、身体乏力、腹胀等临床症状，CT与X线检查提示患者胸部结核病灶，痰涂片结果显示结核分枝杆菌阳性。中医诊断参照《中医内科常见病诊疗指南中医病证部分》[7]中气阴两虚型初治菌阳肺结核合并乙肝诊断：午后潮热、气短声低、盗汗与自汗并见、咳痰、咳嗽、神疲乏力、畏风怕冷、纳呆、舌光淡、脉细弱等。
1.3　纳入排除标准
纳入标准：①患者符合初治菌阳肺结核合并乙肝诊断；②患者知情，自愿加入研究；③患者可接受本次研究治疗方案。排除标准：①合并肿瘤与脏器疾病患者；②肝硬化和肝癌患者；③合并严重心脑血管疾病患者；④合并肺外结核患者；⑤精神疾病与心理障碍患者等；⑥无法配合研究进行与取得数据患者等。本研究经伦理委员会批准，伦理编号：LS2023100803
1.4　治疗方法
入组患者均采取标准抗结核方案进行治疗。强化期：患者采取异烟肼（临汾宝珠制药有限公司；国药准字H14022499）治疗，每次0.3 g，每日1次；利福平（湖南洞庭药业股份有限公司；国药准字H43020585）治疗，每日1次，每次0.45 g；乙胺丁醇（上海华源安徽锦辉制药有限公司；国药准字H34020957）治疗，每日1次，每次0.75 g；吡嗪酰胺，每日2次，每次0.75 g。持续服药2个月。巩固期：每日1次，口服异烟肼，每次0.3 g；利福平，每日1次，每次0.45 g。治疗4个月。并采取还原性谷胱甘肽（重庆药友制药有限责任公司；国药准字H20050667）保肝治疗，每日3次，每次0.4 g，治疗6个月。对照组患者同时口服恩替卡韦片治疗，每日1次，每次服药0.5mg，治疗6个月。观察组：患者在对照组治疗基础上结合芪甲利肺胶囊（哈尔滨奇达制药有限公司；国药准字Z20050779）治疗，每日服药3次，每次服药3粒，治疗6个月。
1.5　观察指标
（1）患者治疗效果评估[8]：治愈：患者症状和体征消失，证候积分减少率高达90%以上；显效：患者症状和体征改善，证候积分减少率为70%～90%；有效：患者症状和体征好转，证候积分减少率为30%～70%；无效：未达到以上标准。总有效率＝治愈率+显效率+有效率。（2）各组患者中医证候积分评估[9]：午后潮热、气短声低、盗汗与自汗并见、咳痰、咳嗽等证候采取四级评分法，0分无症状，1分轻度，2分中度，3分重度，分值越高证候越严重。（3）机体炎症反应指标变化测定[10]：采取酶联免疫吸附法测定各组治疗前后肿瘤坏死因子α（tumour necrosis factor-α，TNF-α）、C反应蛋白（C-reactive protein，CRP）、白细胞计数（white blood cell，WBC）指标。（4）免疫指标变化测定[11]：采取酶联免疫吸附法测定各组治疗前后免疫球蛋白A/G/M（immunoglobulin A/immunoglobulin G/immunoglobulin M，IgA/IgG/IgM）指标。（5）肝功能指标测定[12]：采取全自动生化分析仪测定各组患者治疗前后血清总胆红素（total bilirubin，TBiL）、谷草转氨酶（aspartate transaminase，AST）、谷氨酰转肽酶（gamma glutamyl transferase，GGT）、碱性磷酸酶（alkaline phosphatase，ALP）、谷丙转氨酶（glutamic pyruvic transaminase，ALT）等指标。（6）比较各组肝功能损害发生率，分为轻度、中度、重度。（7）生活质量提升率采取SF-36量表进行评估，量表分值0～100分，患者分值上升提示生活质量提升[13]。
1.6　统计学方法
采用SPSS 26.0软件处理各组数据，进行χ2与t检验，P<0.05，差异具有统计学意义。
2　结果
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2.1　效果比较
与观察组比较，对照组总有效率较低，P<0.05。见表1。
2.2　中医证候积分变化
各组患者治疗前中医证候积分比较，P>0.05，观察组患者治疗后中医证候积分各项均低于对照组患者（P<0.05）。见表2。
2.3　机体炎症反应指标（TNF-α、CRP、WBC）变化
各组患者治疗前机体炎症反应指标（TNF-α、CRP、WBC）比较，P>0.05，观察组患者治疗后机体炎症反应指标（TNF-α、CRP、WBC）比对照组患者更低（P<0.05）。见表3。
2.4　免疫指标（IgA/IgG/IgM）变化
各组患者治疗前免疫指标（IgA/IgG/IgM）比较，P>0.05，观察组患者治疗后免疫指标（IgA/IgG/IgM）比对照组患者更佳（P<0.05）。见表4。
2.5　肝功能指标（TBiL、AST、GGT、ALP、ALT）指标比较
治疗前，各组患者肝功能指标（TBiL、AST、GGT、ALP、ALT）变化比较，P>0.05，观察组患者治疗后肝功能指标（TBiL、AST、GGT、ALP、ALT）均优于对照组患者（P<0.05）。见表5。
2.6　肝功能损害发生率比较
较对照组，观察组患者肝功能损害发生率更低（P<0.05）。见表6。
2.7　生活质量提升率比较
观察组患者生活质量提升率高于对照组，P<0.05。见表7。
3　讨论
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肺结核与乙肝疾病均属于我国较为常见的传染病，数据显示，近年我国肺结核、乙肝疾病发病率处于上升阶段[14-16]。肺结核合并乙肝疾病较为少见，一旦发病，对患者造成较大影响，其治疗难度大，引起临床重视[17-19]。目前，临床治疗初治菌阳肺结核多采取用异烟肼、利福平、乙胺丁醇、吡嗪酰胺等，杀灭结核菌效果较好，可达到治疗效果[20-21]。但以上治疗药物对患者肝脏损伤较大，可能导致药物性肝损伤，合并乙肝的肺结核患者采取该方法治疗存在较大危险，故而需积极探究有效的治疗方案[22]。恩替卡韦为鸟嘌呤核苷类似物，可较好抑制鸟嘌呤核苷类似物，抗病毒效果显著，该药还可较好清除肝脏内沉积胶原纤维，利于肝细胞的再生，改善肝功能，治疗乙肝疗效佳，还可缓解药物肝损伤[23]。为了进一步提升初治菌阳肺结核合并乙肝治疗效果，本次研究给予患者标准化抗结核药物与恩替卡韦治疗同时，给予患者中医药治疗，以促进患者病情好转[24]。
中医将肺结核归属于“肺疳”“肺痨”“痨瘵”等范畴[25-26]。《诸虫飞尸鬼注》记载：“肺虫居肺叶之内，蚀人肺系，故成擦疾，咯血声嘶。”中医认为，肺痨是由于痨虫侵蚀肺叶所导致，由内外原因引起，外因为痨虫感染，内因为机体虚弱，导致外邪入侵[27]。《医学正传·劳极》记载：“治之之法，一则杀其虫，以绝其根本；一则补其虚，以复其真元。”可见治疗肺结核当以补虚与杀虫为主，即为增强机体正气，祛邪外出。气阴两虚型肺痨较为多见，正气亏损、痨虫感染，日久伤肺阴，阴虚愈盛，病久伤脾，气阴两伤，故而治疗可采取滋阴润肺与止咳化痰之法[28]。中医将乙肝归属于“肝着”“胁痛”等范畴[29]。中医认为，正气不足，湿热疫毒侵袭肝脏，阻滞气机，损伤肝络，导致发病。故而治疗当以益气补肝之法。本次给予初治菌阳肺结核合并乙肝患者芪甲利肺胶囊治疗，取得显著临床疗效[30]。芪甲利肺胶囊属于中成药，临床应用较多，疗效良好，该中成药是由黄芪、鳖甲、黄芩、地骨皮、蛤蚧、冬虫夏草、珍珠、白及、连翘、乌梢蛇、夏枯草、川贝母、百部、鱼腥草等中药组成，其中黄芪具有补气、解毒、利尿消肿等功效；鳖甲可滋阴潜阳、软坚散结、退热除蒸；黄芩可清热燥湿、泻火解毒；地骨皮可清肺降火、凉血；蛤蚧可补肺益肾、纳气定喘、助阳益精；冬虫夏草可补肾益肺、化痰；珍珠可镇心安神、清热熄风、养肝；白及可补肺消肿；连翘可消肿散结、清热解毒、利尿；乌梢蛇可祛风止痉、通络；夏枯草可清肝泻火、散结消肿；川贝母可清热润肺、化痰止咳、散结消痈；百部可润肺止咳、杀虫灭虱；鱼腥草可清热祛火、杀菌、利尿、健体。诸药配伍，具有较好益气养阴及退热抗痨功效，对初治菌阳肺结核合并乙肝患者具有积极影响，治疗效果甚佳。本次研究数据显示，与观察组比较，对照组总有效率更低（P<0.05），数据提示芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙肝临床效果显著。观察组患者治疗后中医证候积分（午后潮热、气短声低、盗汗与自汗并见、咳痰、咳嗽等）低于对照组患者（P<0.05），提示芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙肝可较好改善患者的临床证候，促进患者病情好转。肺结核疾病是由于肺部病菌感染导致机体免疫能力降低，大量结核菌繁殖，使得机体发生炎症反应。而WBC为了解机体细菌感染重要指标，细菌感染后，机体WBC水平显著上升。而TNF-α、CRP可反映机体炎症严重程度。本次治疗后发现，初治菌阳肺结核合并乙肝患者经芪甲利肺胶囊结合恩替卡韦治疗后，机体WBC、TNF-α、CRP水平显著下降，可见本次治疗方法可较好抑制机体炎症反应，帮助患者机体逐渐恢复，可能与芪甲利肺胶囊具有较好抗炎与抑菌作用相关。观察组患者治疗后IgA/IgG/IgM指标优于对照组患者（P<0.05），现代药理指出，芪甲利肺胶囊具有较好改善机体免疫功能作用，可较好改善初治菌阳肺结核合并乙肝患者免疫功能。观察组患者治疗后TBiL、AST、GGT、ALP、ALT等指标均优于对照组患者，且肝功能损害发生率低于对照组患者（P<0.05），提示芪甲利肺胶囊结合恩替卡韦可较好减轻及改善初治菌阳肺结核合并乙肝患者肝功能损伤。观察组患者的生活质量提升率更高，可见本次治疗对患者生活质量具有较大影响，可提升患者生活质量。
综上所述，芪甲利肺胶囊结合恩替卡韦治疗初治菌阳肺结核合并乙肝效果佳，患者症状改善，免疫功能与生活质量均提升，还可改善患者肝功能，保证患者安全，值得应用。
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  • 湖南省卫生健康委员会项目(202103082480)
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2025年第43卷第1期
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doi: 10.13193/j.issn.1673-7717.2025.01.034
  • 首发时间：2026-10-30
  • 出版时间：2025-01-10
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湖南省卫生健康委员会项目(202103082480)
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    湖南省胸科医院，湖南　长沙　410013

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徐胜辉（1970-），女，湖南新宁人，主任医师，学士，研究方向：结核病及非结核分枝杆菌病。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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