Application and development of real-world study on Chinese patent medicine

Ze Yu, Fang Kou, Xin Hao, Fei Gao, Hai Wei, Wan-yu Feng

PDF(396 KB)
PDF(396 KB)
Intelligent Pharmacy ›› 2023, Vol. 1 ›› Issue (1) : 11-16. DOI: 10.1016/j.ipha.2023.04.002
Orginal Article

Application and development of real-world study on Chinese patent medicine

Author information +
History +

Abstract

Objective: This paper aims to summarize the development status and clinical application of Chinese patent medicine (CPM) in real-world study (RWS), and provide references for the use of real-world evidence (RWE) in the field of CPM.

Methods: By searching keywords, we searched relevant literature in CNKI, Wanfang Data, PubMed and other databases, and summarized the application and development of RWS in CPM field.

Results and conclusion: Currently, RWS has been frequently used in wide aspects of CPM field, mainly in observational study, including evaluation of effectiveness, safety and economics of CPM based on RWE. This paper reviews the applications above, which will help researchers to have an in-depth understanding of the development status and application characteristics of RWS in CPM field, and express views on the challenges and solutions facing the RWS of CPM, in order to guide and promote the development of the re-evaluation of CPM after marketing.

Keywords

Chinese patent medicine / Real world study / Effectiveness / Safety / Economics

Cite this article

Download citation ▾
Ze Yu, Fang Kou, Xin Hao, Fei Gao, Hai Wei, Wan-yu Feng. Application and development of real-world study on Chinese patent medicine. Intelligent Pharmacy, 2023, 1(1): 11‒16 https://doi.org/10.1016/j.ipha.2023.04.002

References

[1]
Sherman RE, Anderson SA, Dal Pan GJ, et al. Real-world evidence - what is it and what can it tell us? N Engl J Med. 2016; 375 (23): 2293- 2297.
[2]
Center for Drug Evaluation, State Medical Products Administration. Notice on the public solicitation of opinions on "basic considerations for real-world evidence to support drug development"[EB/OL]. 2019-05-29. http://www.cde.org.cn/news.do?method=viewInfoCommon&id=314865
[3]
Yang Yiheng. Overview of real-world studies and post-marketing re-evaluation of danshen polyphenol salts for injection. Symposium Evidence Based Med Practical Res Methodol 2012. 2012: 92.
[4]
Xing Dongmei, Li Chunxiao, Liu Xincan, et al. Problems and countermeasures in real-world research in the field of traditional Chinese medicine. Chin J Traditional Chin Med. 2021; 36 (4): 4.
[5]
Ma Xiaofan, Cui Weifeng, Fan Junming, et al. Effect of Jiangyabao series of Chinese patent medicine on blood pressure progression in patients with hypertension in the real world. Liaoning J Traditional Chin Med. 2019; (10): 7.
[6]
Chinese expert committee on real-world research implementation standards for clinical medicine norms for real-world research in clinical medicine in China. Chin J Exp Clin Infectious Diseases. 2017; 11 (6): 521.
[7]
Robson C. Real World Research. 3rd ed. United Kingdom: John Wiley & Sons Ltd; 2011.
[8]
Ji Dan. The Effect of Real-World Soft Liver Pills Combined with Traditional Chinese Medicine in the Treatment of HBC and the Correlation between Traditional Chinese Medicine Symptom Type and Liver Reserve Function and Portal Hypertension[D]. Henan University of Chinese Medicine.
[9]
Wang Hui, Hu Haiyin, Zhaochen Ji, et al. Analysis of real-world research status of traditional Chinese medicine based on clinical trial registration information. World Chin Med. 2019.
[10]
The first world conference on science and technology of traditional Chinese medicine and the international contribution award of traditional Chinese medicine (science and technology progress award) award presentation conference were held in hangzhou-focusing on scientific and technological innovation and international cooperation of traditional Chinese medicine in the new era. World J Traditional Chin Med. 2019; 14 (1): 4- 7.
[11]
Wang Xue. The real world research professional committee of China association of traditional Chinese materia medica[EB/OL]. 2019-10-17. http://www.Xinhuanet.com//video/2019-10/17/c1210316160htm
[12]
Sun Xin, Zhang Junhua, Wang Wen, et al. Formulate technical guidelines for real-world research of CPM to promote the transformation of clinical research of CPM into decision-making evidence. Chin J Evidence-Based Med. 2020; 20 (9): 7- 13.
[13]
Song Mei. Masa the proper meaning of real-world research on CPM. J Med Econ. 2019: 8.
[14]
Fu Ling, Zhou Xueping, Guochun LI. Real-world research"-New ideas of traditional Chinese medicine scientific research. J Zhejiang University Chinese Med. 2013; (9): 1127- 1129.
[15]
Zhang Junhua, Li Youping, Zhang Boli. Evidence-based Chinese medicine: theory and practice. China J Chin Mater Med. 2018; 43 (1): 7.
[16]
Li Xintao, Cui Weifeng, Fan Junming. A real-world study of the characteristics of Chinese patent medicine application in hospitalized patients with cerebral infarction. Shizhen Chin Medicine Med. 2020; 31 (8): 1925- 1927.
[17]
Tang Bin, Wei J, Gao Yun, et al. Analysis of the use of Chinese patent medicine in cervical radiculopathy in real life. World Sci Technol: Modernization Traditional Chin Med. 2018; 20 (6): 6.
[18]
Yue Teng, Jing Zhiwei, Wang Lianxin, et al. Clinical medication characteristics of 12385 patients using Qingkailing injection based on the real world. J Tradit Chin Med. 2018; 59 (3): 5.
[19]
Zhao Fengying, Zhu Jian, Zhang Lidan, et al. A real-world study of the precise population and medication characteristics of Honeysuckle Miyanling Tablets for urinary tract obstruction. World J Traditional Chin Med. 2022; 17 (4): 6.
[20]
Yang Huisheng, Xie Yanming, Chen Cen, et al. Study on the characteristics of the combination of traditional Chinese and Western medicines in the treatment of lung cancer by "real-world" compound Kushen injection based on association rule analysis. China J Chin Mater Med. 2018; 43 (8): 6.
[21]
Zhang Yan, Chen Mei, Hua Huilian. Clinical application of Xueshuantong for injection based on real-world data of hospital information system. Chin Pharmaceutical Econ. 2021; 16 (5): 5.
[22]
Wang Ziyan, Zhang Yili, Xie Yanming, et al. Based on "real-world" HIS data, analysis of the combined use of Chinese and Western medicines in minors' Maixuekang capsules. Shizhen Chin Medicine Med. 2019; (3): 4.
[23]
Sun J, Li Yuanyuan, Xie Yanming, et al. Clinical characteristics and combination rules of 16856 elderly patients who applied Suxiao Jiuxin pills in a real-world study. China J Chin Mater Med. 2020; 45 (10): 8.
[24]
Aii Yingna, Gao An, Zhang Junru. Clinical application analysis of Danshen Ligustrazine injection based on HIS "real world". Hainan Med J. 2019; 30 (23): 5.
[25]
Xue Chunmiao, Wang Yanmei, Wang Ying, et al. Clinical application investigation of Pudilan anti-inflammatory oral liquid based on real-world prescription information. J Clin Pharmacotherapy. 2019; 17 (5): 4.
[26]
Zhang Q, Li YX, Liu Y, et al. Effects of adjuvant Chinese patent medicine therapy on prevention of variceal rebleeding: a retrospective cohort study. Chin J Integr Med. 2021; 27 (8): 8.
[27]
Meng Fanchao, Li Haisong, Zhao Qi, et al. Efficacy of Lingze tablets in the treatment of benign prostatic hyperplasia in the real world. Chin J Andrology. 2021; 35 (4): 5.
[28]
Xu Y, Wang Y, Gou XJ, Wang M. Comparative efficacy of Chinese patent medicines for clearing heat and dampness in the treatment of NAFLD: a network meta-analysis of real-world evidence, 2022 Jul 31 Evid Based Complement Alternat Med. 2022, 4138555.
[29]
Pan Li, Lin Jing, Xie Yanming, et al. Clinical effectiveness of Danshen Ligustrazine injection in the treatment of orthopedic diseases based on propensity score. World J Traditional Chin Med. 2022; 17 (12): 5.
[30]
Wang L, Jia K, Li F, et al. Comparison of improvement in 2-year survival rate of patients with stage II-III non-small cell lung cancer treated with different durations of Chinese patent medicine: a retrospective cohort study. Front Pharmacol. 2021Sep 2; 12, 719802.
[31]
Bao H, Liu J, Liu , et al. Correlation analysis between Zilongjin tablets based on electronic medical record data and the diagnosis and treatment outcomes of lung tumor surgery patients. Chin Tradit Herb Drugs. 2021; 52 (22): 6.
[32]
Yu Mingwei, Liu Qiang, Wu Wanyin, et al. Survival analysis of Zilongjin tablets adjuvant therapy for lung cancer based on multicenter real-world data. Chin Tradit Herb Drugs. 2022; (12): 53.
[33]
Pang Bo, Zheng Wenke, Zhang Junhua, et al. Application scenarios of real-world research of traditional Chinese medicine. World J Traditional Chin Med. 2019; 14 (12): 3115- 3118, 3122.
[34]
Yang Wei, Xie Yanming. Exploring the safety evaluation method of post-marketing Chinese patent medicine based on HIS "real world" data warehouse. China J Chin Mater Med. 2011; 36 (20): 4.
[35]
Yan LI. Research on the Status Quo and Safety Re-evaluation of Drug Use of Danhong Injection in Sichuan Province Based on the Real World. Beijing: University of Electronic Science and Technology of China; 2019.
[36]
Wang Mingxia, Wang Shumei, Liu Ming, et al. Use and safety evaluation of 30012 cases of Shenmai injection in real world. Chin J Evidence-Based Med. 2021; 21 (2): 6.
[37]
Xing Liao, Yu Dandan, Xie Yanming, et al. Post-marketing safety monitoring of Diemailing Kudiezi Injection: a real-world registry study of 30233 cases. China J Chin Mater Med. 2017; 42 (15): 7.
[38]
Xiang Jiaojiao, Yao Siyun, Xie Yanming, et al. Research on the safety of real-world Dengzhanxixin injection. Guangdong Med J. 2018; 39 (3): 5.
[39]
Guo Xin, Pei Guizhen, Lu Ningjie, et al. Signal mining of adverse reactions of Danshen Ligustrazine injection based on real-world Danshen. Anhui Med. 2020; 24 (2): 4.
[40]
Jiang Junjie, Yang Zhixin, Xie Yanming, et al. Real-world study on the application of Shuxuetong injection in the elderly and its adverse reaction characteristics. J Cardiovascular Cerebrovascular Dis Integrated Traditional Western Med. 2016; 14 (21): 2476- 2480.
[41]
Li Xiaoxiao, Lin ZHUO, Yang Yiheng, et al. Post-marketing safety re-evaluation of Tanreqing injection in elderly patients: a real-world study. Chin J Integr Med. 2019; 39 (8): 6.
[42]
Li Xiaoxiao, Lin ZHUO, Yang Yiheng, et al. Real-world study on the re-evaluation of the safety of Tanreqing injection in children. Chin J Epidemiol. 2017; 38 (2): 5.
[43]
Zhang Guanghui, Lv Jian, Wu Xianwen, et al. Effect of real-world injectable breviscapine on liver function. Liaoning J Traditional Chin Med. 2021; 48 (5): 6.
[44]
Wang Ting, Yang Jing, Xie Yanming, et al. Effect of real-world Xiyanping injection on alanine aminotransferase and aspartate aminotransferase. Chin J Chin Materia Medica. 2016; 31 (7): 5.
[45]
Yue Teng, Jing Zhiwei, Wang Lianxin, et al. Study on the influencing factors related to suspected allergic reactions in Qingkailing injection in real world. Chin J Basic Med Traditional Chin Med. 2019; (4): 4.
[46]
Cheng Feng, Jingming XIE Yanming, Wang Lianxin, Li Yuanyuan, Yang Xiaochen. A real-world study on the influencing factors of suspected allergic reaction of breviscapine for injection. J Tradit Chin Med. 2020; 61 (24): 5.
[47]
Li Yannan, Xie Yanming, Zhang Yin, et al. Clinical effectiveness of real-world Xianlinggubao capsules on liver function based on electronic medical data. Liaoning J Traditional Chin Med. 2018; 45 (12): 6.
[48]
Cheng Jingming, Wang Lianxin, Xie Yanming, et al. Research on the effect of real-world Mailuo Shutong pills on liver function indexes. Chin Tradit Herb Drugs. 2022; (11): 53.
[49]
Peng Shiyu, Xie Yanming, Wang Zhifei, et al. Analysis of adverse reaction characteristics of Xianlinggubao preparation based on real-world SRS data[J]. China J Chin Mater Med. 2020; 45 (10): 6.
[50]
Zhang Junhua, Sun Xin, Li Youping, et al. The present and future of evidence-based Chinese medicine. Chin J Evidence-Based Med. 2019; 19 (5): 6.
[51]
Tang Xianshuai, Zheng Lei, Zhang Mingzhu, et al. Comprehensive clinical evaluation of CPM based on evidence-based medical evidence and pharmacoeconomic model. China Pharm. 2022; (15): 33.
[52]
Xie Yanming, Wang Xin, Wang Nuo, et al. Technical specification for post-marketing pharmacoeconomic evaluation of traditional Chinese medicines (draft for comments). China J Chin Mater Med. 2013; 38 (18): 2925- 2929.
[53]
Cui Xin, Han Sheng, Zheng Liu, et al. Cost-effect analysis of Qilong capsules in the treatment of ischemic stroke based on a prospective real-world cohort study. China J Chin Mater Med. 2022; 47 (11): 7.
[54]
Tao Jiaona, Qu Xiaoyu, Song Yanqing, et al. Cost and effect analysis of real-world injectable salvianolic acid in the treatment of ischemic stroke. China Med Insurance. 2019; (9): 5.
[55]
Xu D, Luo Weihua, Wang Yuwei, et al. Construction of pharmacoeconomic evaluation system for the prevention and treatment of major chronic diseases of Chinese patent medicine. China Pharm. 2022; (17): 33.

RIGHTS & PERMISSIONS

2023 2023 The Authors. Publishing services by Elsevier B.V. on behalf of KeAi Communications Co. Ltd. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
AI Summary AI Mindmap
PDF(396 KB)

Accesses

Citations

Detail

Sections
Recommended

/