Article(id=1321425679304995057, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, articleNumber=null, orderNo=null, doi=10.20251/j.cnki.1003-3734.2026.09.012, 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=1746633600000, acceptedDateStr=2025-05-08, onlineDate=1792982032847, onlineDateStr=2026-10-26, pubDate=1778774400000, pubDateStr=2026-05-15, doiRegisterDate=null, doiRegisterDateStr=null, onlineIssueDate=1792982032847, onlineIssueDateStr=2026-10-26, onlineJustAcceptDate=null, onlineJustAcceptDateStr=null, onlineFirstDate=null, onlineFirstDateStr=null, sourceXml=null, magXml=null, createTime=1792982032847, creator=13701087609, updateTime=1792982032847, updator=13701087609, issue=Issue{id=1321425625915707977, tenantId=1146029695717560320, journalId=1235980733773295621, year='2026', volume='35', issue='9', pageStart='897', pageEnd='1008', issueExtLink='null', onlineDate='null', pubDate='1778774400000', pubDateStr='2026-05-15', beforeIssueId=null, nextIssueId=null, price=null, status=1, issueComplete=1, articleOrder=1, issueType=-1, specialIssue=null, createTime=1792982020119, creator='13701087609', updateTime=1792983090252, updator='13701087609', preIssue=null, nextIssue=null, articleTotal=null, ext={EN=IssueExt(id=1321430114441745406, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=EN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=), CN=IssueExt(id=1321430114441745407, tenantId=1146029695717560320, journalId=1235980733773295621, issueId=1321425625915707977, language=CN, specialIssueTitle=, coverIllustrator=null, specialIssueEditor=, specialIssueAbout=)}, issueFiles=null, downloadFileDto=null}, startPage=986, endPage=993, ext={EN=ArticleExt(id=1321425679552458994, articleId=1321425679304995057, tenantId=1146029695717560320, journalId=1235980733773295621, language=EN, title=Rationality and effectiveness of hepatoprotective drugs in clinical practice: a single-center retrospective study based on 732 hospitalized patients, columnId=null, journalTitle=Chinese Journal of New Drugs, columnName=null, runingTitle=null, highlight=null, articleAbstract=
Objective:

To analyze the rationality and effectiveness of hepatoprotective drugs in clinical practice and explore the evidence-based basis for off-label use, as well as the clinical value of prophylactic use and combination therapies.

Methods:

Clinical data of 732 hospitalized patients treated with hepatoprotective drugs from January 2023 to December 2024 were collected. Rationality was evaluated based on drug labels, domestic and international guidelines, and expert consensus. Effectiveness was assessed by comparing liver function indicators before and after treatment.

Results:

A total of 732 patients were included. Rational use of hepatoprotective drugs was observed in 592 cases (80.87%), while 140 cases (19.12%) were categorized as irrational use. Rational use was subcategorized into label-compliant use (252 cases, 34.43%) and off-label use (340 cases, 46.45%). Off-label use cases were further classified as guideline-supported (91 cases, 12.43%) and consensus-supported (249 cases, 34.02%). Irrational use primarily included non-indicated prescriptions (58 cases, 7.92%), prophylactic use (43 cases, 5.87%), and redundant combinations (20 cases, 2.73%). Significant reduction in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBIL) levels was observed after treatment (all P<0.001). The effective rate was significantly higher in the label-compliant group than in the inappropriate-use group (72.62% vs 53.57%, P<0.05). No statistically significant differences were found among monotherapy, dual therapy, and triple-or-more therapy groups (62.54% vs 69.31% vs 62.79%, P>0.05).

Conclusion:

Clinical application of hepatoprotective drugs should strictly adhere to instructions and authoritative guidelines, and avoid non-indicated prescriptions or combination therapy. This study provides a reference for rational clinical medication use and clinical pharmacist interventions.

, authors=Chen PAN1, Xiao-dong LIU1, Yong-qi XIE2, Yi WU1, Ran-jia LIU1, Zhen-huan WANG1, Xiang-li CUI1, *, authorsList=Chen PAN, Xiao-dong LIU, Yong-qi XIE, Yi WU, Ran-jia LIU, Zhen-huan WANG, Xiang-li CUI, authorCompany=null, correspAuthors=Xiang-li CUI, 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=1321425679925752051, articleId=1321425679304995057, tenantId=1146029695717560320, journalId=1235980733773295621, language=CN, title=保肝药临床应用合理性与有效性分析:一项基于732例住院患者的单中心回顾性研究, columnId=1236331163573342670, journalTitle=中国新药杂志, columnName=药物安全与合理应用, runingTitle=null, highlight=null, articleAbstract=
目的:

分析保肝药临床使用的合理性和有效性,探讨超说明书用药的循证依据、预防用药及联合用药的临床价值。

方法:

收集2023年1月—2024年12月住院使用保肝药患者数据,依据药品说明书、国内外指南及专家共识评价用药合理性,并通过住院期间使用保肝药前后肝功能指标变化评估有效性。

结果:

共纳入732例使用保肝药患者,保肝药合理用药592例(80.87%),不合理用药共140例(19.12%)。合理用药分为符合说明书用药(252例,34.43%)和超说明书用药(340例,46.45%),超说明书用药进一步分为符合用药指南(91例,12.43%)和符合专家共识(249例,34.02%)。不合理用药类型主要包括无肝病诊断用药58例(7.92%)、预防用药43例(5.87%)及重复用药20例(2.73%)。患者使用保肝药后谷丙转氨酶(alanine aminotransferase, ALT)、谷草转氨酶(aspartate aminotransferase, AST)、总胆红素(total bilirubin, TBIL)水平显著降低(均P<0.001);符合说明书用药组有效率显著高于不合理用药组(72.62% vs 53.57%,P<0.05);单独用药组、二联用药组和三联及以上用药组有效率无显著差异(62.54% vs 69.31% vs 62.79%,P>0.05)。

结论:

保肝药临床应用需严格遵循说明书及权威指南,避免无指征用药及联用;本研究为临床合理用药和临床药师干预方向提供了参考。

, authors=潘晨1, 刘晓冬1, 谢永琦2, 武一1, 刘冉佳1, 王震寰1, 崔向丽1, *, authorsList=潘晨, 刘晓冬, 谢永琦, 武一, 刘冉佳, 王震寰, 崔向丽, authorCompany=null, correspAuthors=崔向丽, authorNote=

潘晨,女,硕士研究生,主要从事医院药学研究。联系电话:(010)80838614,E-mail: 。

, correspAuthorsNote=
* 崔向丽,女,硕士生导师,教授,主要从事医院药学研究。联系电话:(010)80838614,E-mail: 。
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潘晨,女,硕士研究生,主要从事医院药学研究。联系电话:(010)80838614,E-mail: 。

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潘晨,女,硕士研究生,主要从事医院药学研究。联系电话:(010)80838614,E-mail: 。

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保肝药临床应用合理性与有效性分析:一项基于732例住院患者的单中心回顾性研究
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潘晨 1 , 刘晓冬 1 , 谢永琦 2 , 武一 1 , 刘冉佳 1 , 王震寰 1 , 崔向丽 1, *
中国新药杂志 | 药物安全与合理应用 2026,35(9): 986-993
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中国新药杂志 |药物安全与合理应用 2026 , 35 (9) : 986 -993
保肝药临床应用合理性与有效性分析:一项基于732例住院患者的单中心回顾性研究
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潘晨,女,硕士研究生,主要从事医院药学研究。联系电话:(010)80838614,E-mail: 。

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100050)])])]
潘晨1 , 刘晓冬1, 谢永琦2, 武一1, 刘冉佳1, 王震寰1, 崔向丽1, *
作者信息
  • 1首都医科大学附属北京友谊医院药剂科,北京 100050
  • 2北京城市学院,北京 100191
通讯作者:
* 崔向丽,女,硕士生导师,教授,主要从事医院药学研究。联系电话:(010)80838614,E-mail: 。
作者简介:

潘晨,女,硕士研究生,主要从事医院药学研究。联系电话:(010)80838614,E-mail: 。

Rationality and effectiveness of hepatoprotective drugs in clinical practice: a single-center retrospective study based on 732 hospitalized patients
Chen PAN1 , Xiao-dong LIU1, Yong-qi XIE2, Yi WU1, Ran-jia LIU1, Zhen-huan WANG1, Xiang-li CUI1, *
Affiliations
  • 1Department of Pharmacy, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
  • 2Beijing City University, Beijing 100191, China
出版时间: 2026-05-15 doi: 10.20251/j.cnki.1003-3734.2026.09.012
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目的:

分析保肝药临床使用的合理性和有效性,探讨超说明书用药的循证依据、预防用药及联合用药的临床价值。

方法:

收集2023年1月—2024年12月住院使用保肝药患者数据,依据药品说明书、国内外指南及专家共识评价用药合理性,并通过住院期间使用保肝药前后肝功能指标变化评估有效性。

结果:

共纳入732例使用保肝药患者,保肝药合理用药592例(80.87%),不合理用药共140例(19.12%)。合理用药分为符合说明书用药(252例,34.43%)和超说明书用药(340例,46.45%),超说明书用药进一步分为符合用药指南(91例,12.43%)和符合专家共识(249例,34.02%)。不合理用药类型主要包括无肝病诊断用药58例(7.92%)、预防用药43例(5.87%)及重复用药20例(2.73%)。患者使用保肝药后谷丙转氨酶(alanine aminotransferase, ALT)、谷草转氨酶(aspartate aminotransferase, AST)、总胆红素(total bilirubin, TBIL)水平显著降低(均P<0.001);符合说明书用药组有效率显著高于不合理用药组(72.62% vs 53.57%,P<0.05);单独用药组、二联用药组和三联及以上用药组有效率无显著差异(62.54% vs 69.31% vs 62.79%,P>0.05)。

结论:

保肝药临床应用需严格遵循说明书及权威指南,避免无指征用药及联用;本研究为临床合理用药和临床药师干预方向提供了参考。

保肝药  /  合理用药  /  超说明书用药  /  联合用药  /  有效性
Objective:

To analyze the rationality and effectiveness of hepatoprotective drugs in clinical practice and explore the evidence-based basis for off-label use, as well as the clinical value of prophylactic use and combination therapies.

Methods:

Clinical data of 732 hospitalized patients treated with hepatoprotective drugs from January 2023 to December 2024 were collected. Rationality was evaluated based on drug labels, domestic and international guidelines, and expert consensus. Effectiveness was assessed by comparing liver function indicators before and after treatment.

Results:

A total of 732 patients were included. Rational use of hepatoprotective drugs was observed in 592 cases (80.87%), while 140 cases (19.12%) were categorized as irrational use. Rational use was subcategorized into label-compliant use (252 cases, 34.43%) and off-label use (340 cases, 46.45%). Off-label use cases were further classified as guideline-supported (91 cases, 12.43%) and consensus-supported (249 cases, 34.02%). Irrational use primarily included non-indicated prescriptions (58 cases, 7.92%), prophylactic use (43 cases, 5.87%), and redundant combinations (20 cases, 2.73%). Significant reduction in alanine aminotransferase (ALT), aspartate aminotransferase (AST) and total bilirubin (TBIL) levels was observed after treatment (all P<0.001). The effective rate was significantly higher in the label-compliant group than in the inappropriate-use group (72.62% vs 53.57%, P<0.05). No statistically significant differences were found among monotherapy, dual therapy, and triple-or-more therapy groups (62.54% vs 69.31% vs 62.79%, P>0.05).

Conclusion:

Clinical application of hepatoprotective drugs should strictly adhere to instructions and authoritative guidelines, and avoid non-indicated prescriptions or combination therapy. This study provides a reference for rational clinical medication use and clinical pharmacist interventions.

hepatoprotective drugs  /  rational drug use  /  off-label use  /  combination therapy  /  effectiveness
潘晨, 刘晓冬, 谢永琦, 武一, 刘冉佳, 王震寰, 崔向丽. 保肝药临床应用合理性与有效性分析:一项基于732例住院患者的单中心回顾性研究. 中国新药杂志, 2026 , 35 (9) : 986 -993 . DOI: 10.20251/j.cnki.1003-3734.2026.09.012
Chen PAN, Xiao-dong LIU, Yong-qi XIE, Yi WU, Ran-jia LIU, Zhen-huan WANG, Xiang-li CUI. Rationality and effectiveness of hepatoprotective drugs in clinical practice: a single-center retrospective study based on 732 hospitalized patients[J]. Chinese Journal of New Drugs, 2026 , 35 (9) : 986 -993 . DOI: 10.20251/j.cnki.1003-3734.2026.09.012
  • 国家卫生健康委员会医院药学高质量发展研究项目(NIHAYS2302)
  • 北京慢性病防治与健康教育研究会2024年药学专项科研课题资助项目(MBZX0082024001)
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doi: 10.20251/j.cnki.1003-3734.2026.09.012
  • 首发时间:2026-10-26
  • 出版时间:2026-05-15
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  • 录用日期:2025-05-08
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国家卫生健康委员会医院药学高质量发展研究项目(NIHAYS2302)
北京慢性病防治与健康教育研究会2024年药学专项科研课题资助项目(MBZX0082024001)
作者信息
    1首都医科大学附属北京友谊医院药剂科,北京 100050
    2北京城市学院,北京 100191

通讯作者:

* 崔向丽,女,硕士生导师,教授,主要从事医院药学研究。联系电话:(010)80838614,E-mail: 。
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