Welcome to visit Zhongnan Medical Journal Press Series journal website!
Zhongnan Medical Journal Press Series of Journals Center for Evidence-Based and Translational Medicine of Wuhan University

The title
  • The title
  • The keywords
  • The author
Submit
Home Articles Vol 35,2026 No.5 Detail

Visualization analysis of off-label drug use of Chinese patent medicine based on CiteSpace software

Published on May. 28, 2026Total Views: 61 times Total Downloads: 18 times Download Mobile

Author: SONG Yifei 1 WANG Hui 2 YANG Wenbao 2 CHEN Xin 3 JIA Shengwei 4 ZHANG Huiyue 5

Affiliation: 1. Clinical Pharmaceutics Room, Shandong University of Traditional Chinese Medicine Affiliated Ophthalmology Hospital, Jinan 250001, China 2. Department of Pharmacy, Jinan Shizhong District People's Hospital, Jinan 250001, China 3. Department of Pharmacy, The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250001, China 4. Department of Pharmacy, Neck, Shoulder, Waist and Leg Pain Hospital of Shandong First Medical University, Jinan 250002, China 5. Department of Pharmacy, Shandong Second Provincial General Hospital, Jinan 250000, China

Keywords: Chinese patent medicine Off-label use Bibliometrics Visual analysis Rational drug use

DOI: 10.12173/j.issn.1005-0698.202508017

Reference: Song YF, Wang H, Yang WB, et al. Visualization analysis of off-label drug use of Chinese patent medicine based on CiteSpace software[J]. Chinese Journal of Pharmacoepidemiology, 2026, 35(5): 563-570. DOI: 10.12173/j.issn.1005-0698.202508017. [Article in Chinese]

  • Abstract
  • Full-text
  • References
Abstract

Objective  To explore the current research status, research hotspots and future research directions of off-label use of Chinese patent medicine.

Methods  Related literature reports on off-label drug use of Chinese patent medicine published before July 2025 were retrieved from CNKI, WanFang, VIP database, and PubMed, then CiteSpace 6.4.R1 was used to make a visual analysis of the issue time, author, institution, keywords, literature type and other aspects.

Results  A total of 58 relevant articles were ultimately included, the earliest of which was published in 2006; 182 scholars and 84 institutions contributed to research in this field, with the articles primarily published in 37 journals. The literature on off-label use of Chinese patent medicine involved 78 keywords, with "rational drug use" being the most frequently occurring and clustering keyword. The literature was divided into six main types: hospital medication data analysis, literature data analysis of off-label use, expert consensus on off-label use, clinical research on off-label use, literature review on off-label use, and other types.

Conclusion  The current research in the field of off-label use of Chinese patent medicines remains weak, characterized by a minimal number of publications, highly con-centrated geographical distribution, and predominantly single-center retro-spective prescription analyses, lacking high-quality clinical efficacy and safety evidence. Systematic research framework and management standards have yet to be established in this field, urgently requiring a shift from "phenomenon description" to "evidence construction". Multicenter collaborative research and the development of a characteristic evidence-based evaluation system of traditional Chinese medicine should be encouraged to promote rational clinical medication.

Full-text
Please download the PDF version to read the full text: download
References

1. 国家基本药物临床应用指南和处方集编委会. 国家基本药物处方集临床应用指南(中成药)2018版[M]. 人民卫生出版社, 2019.

2. 张镭, 谭玲, 陆进. 超说明书用药专家共识[J].药物不良反应杂志, 2015, 17(2): 101-110. DOI: 10.3760/cma.j.issn.1008-5734. 2015.02.011.

3. 陈绍辉, 毛颖婕. 关于超说明书用药的法律性质[J]. 医学与法学, 2014, 6(3):19-24. [Chen SH, Mao YJ. On the legal nature of off-label use of drugs[J]. Medicine & Jurisprudence, 2014, 6(3):19-24.].http://yxyfx.swmu.edu.cn/#/digest?ArticleID=286.

4. 钱燕飞, 郑儿, 柯灵飞. 某妇幼保健专科医院妇产科中成药超说明书用药分析[J]. 中医药管理杂志, 2021, 29(19): 112-114. DOI: 10.16690/j.cnki.1007-9203.2021.19.052.

5. Stafford RS. Regulating off-label drug use--rethinking the role of the FDA[J]. N Engl J Med, 2008, 358(14): 1427-1429. DOI:10.1056/NEJMp0802107.

6. Fairman KA, Curtiss FR. Regulatory actions on the off-label use of prescription drugs: ongoing controversy and contradiction in 2009 and 2010[J]. J Manag Care Pharm, 2010,16(8): 629-639. DOI: 10.18553/jmcp.2010.16.8.629.

7. 薛丽萍, 汪琪. 儿科超药品说明书用药的调查分析[J]. 中国药房, 2008, 19(4): 315-316. [Xue LP, Wang Q. Survey and analysis of drug use that goes beyond the scope of package inserts in pediatrics[J]. China Pharmacy, 2008, 19(4): 315-316.].https://www.cnki.com.cn/Article/CJFDTotal-ZGYA200804034.htm.

8. 菅凌燕, 何晓静, 汪珊. 国内外超说明书用药的现状及其启示[J]. 中华医院管理杂志, 2015, 31(1): 46-49. [Jian LY, He XJ, Wang S. Current situation of off-label drug use in China and abroad and its inspirations[J]. Chiinese Journal f Hospital Administration, 2015, 31(1): 46-49.] DOI: 10.3760/cma.j.issn.1000-6672.2015.01.014.

9. 许俐娜, 陈昱, 罗卉, 等. 复方半边莲注射液不良反应文献分析[J]. 药品评价, 2023, 20(9):1108-1111. [Xu LN, Chen Y, Luo H, et al. Literature analysis of adverse drug reactions of compound banbianlian injection[J]. Drug Evaluation, 2023, 20(9):1108-1111.] DOI: 10.19939/j.cnki.1672-2809.2023.09.16.

10. 张丽, 王瑞杰, 王吉全, 等. 中药注射剂临床应用ADR分析[J]. 甘肃科技, 2021, 37(23): 125-128. DOI: 10.3969/j.issn.1000-0952.2021.23.036.

11. 薛建忠, 于芝颖, 李玉珍. 门诊中成药处方调查与分析[J]. 中国医院药学杂志, 2010, 30(24): 2116-2117. https://www.cnki.com.cn/Article/CJFDTotal-ZGYZ201024022.htm.

12. 刘家平, 李木水. 我院门诊中药注射剂应用分析[J].中国药物滥用防治杂志, 2010, 16(2): 117-119. [Liu JP, Li MS. Utilization analysis of outpatient Chinese medicine injection in our hospital[J]. Chinese Journal of Drug Abuse Prevention and Treatment, 2010, 16(2): 117-119.] DOI: 10.15900/j.cnki.zylf1995.2010.02.005.

13. 金锐, 王宇光, 薛春苗, 等. 中成药处方点评的标准与尺度探索(八):疗程与用药时长问题[J]. 中国医院药学杂志, 2015, 35(22): 1979-1985. [Jin R, Wang YG, Xue CM, et al. Exploration on criteria and compromise in prescription review of Chinese patent medicines Ⅷ: course of treatment[J]. Chinese Journal of Hospital Pharmacy, 2015, 35(22): 1979-1985.] DOI: 10.13286/j.cnki.chinhosppharmacyj.2015.22.01.

14. 金锐, 王宇光, 薛春苗, 等. 中成药处方点评的标准与尺度探索(一):超说明书剂量用药[J]. 中国医院药学杂志, 2015, 35(6): 473-477.[Jin R, Wang YG, Xue CM, et al. The exploration on the creteria and compromise of prescription review of Chinese patent medicines Ⅰ: the overdose medication[J]. Chinese Journal of Hospital Pharmacy, 2015, 35(6): 473-477.] DOI: 10.13286/j.cnki.chinhosppharmacyj.2015.06.01.

15. 金锐, 王宇光, 薛春苗, 等. 中成药处方点评的标准与尺度探索(四):适应证不适宜[J]. 中国医院药学杂志, 2015, 35(13): 1161-1167.[Jin R, Wang YG, Xue CM, et al. Exploration on criteria and compromise of prescription review of Chinese patent medicinesⅣ: inappropriate indications for drug use[J]. Chinese Journal of Hospital Pharmacy, 2015, 35(13): 1161-1167.] DOI: 10.13286/j.cnki.chinhosppharmacyj.2015.13.01.

16. 李焕, 张四喜, 张杰, 等. 老年住院患者使用肾康注射液超说明书用药情况分析[J]. 实用药物与临床, 2019, 22(8): 867-870.[Li H, Zhang SX, Zhang J, et al. Analysis on the off-label use of Kidney Rehabilitation Injection in elderly inpatients[J]. Practical Pharmacy and Clinical Remedies, 2019, 22(8): 867-870.] DOI: 10.14053/j.cnki.ppcr.201908020.

17. 李岩, 张四喜, 张杰, 等. 我院老年肿瘤患者中药注射剂超说明书用药调查[J]. 药物流行病学杂志, 2018, 27(12): 811-814, 818.[Li Y, Zhang SX, Zhang J, et al. Investigation of off-label drug use in traditional Chinese medicine injections for elderly cancer patients in our hospital[J]. Chinese Journal of Pharmacoepidemiology, 2018, 27(12):811-814, 818.] DOI: 10.19960/j.cnki.issn1005-0698.2018.12.007.

18. 刘莹, 商洪才. 心血管中成药超说明书用药循证评价方法和程序的建立[J]. 世界中医药, 2017, 12(6): 1253-1257. [Liu Y, Shang HC. The methods of evidence-based evaluation on off-label drug use of cardiovascular proprietary Chinese medicine[J]. World Chinese Medicine, 2017, 12(6): 1253-1257.] DOI: 10.3969/j.issn.1673-7202.2017.06.010.

19. 史楠楠, 申长春, 曾宪涛, 等. 《中成药超说明书使用循证评价》技术操作规范[J]. 中国研究型医院, 2017, 17(4): 56-61.[Shi NN, Shen CC, Zeng XT, et al. Technical specification for evidence-based evaluation on off-label drug using[J]. Chinese Research Hospitals, 2017, 17(4): 56-61.] DOI: 10.19450/j.cnki.jcrh.2017.04.012.

Popular papers
Last 6 months