Landscape of DILI-related adverse drug reaction in China Mainland

Wang, Jiabo; Song, Haibo; Ge, Fei-Lin; Xiong, Peng; Jing, Jing; He, Tingting; Guo, Yuming; Shi, Zhuanghua; Zhou, Chao; Han, Zi-Xin; Han, Yanzhong; Niu, Ming; Bai, Zhaofang; Luo, Guangbin; Shen, Chuanyong; Xiao, Xiaohe

doi:10.1016/j.apsb.2022.04.019

Cited by 24 publications

(16 citation statements)

References 20 publications

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“…However, researchers pointed that implicated drug categories adopted in this study might seriously influence the reliability of conclusions ( Cong et al, 2019 ). A latest study screened 94,593 DILI reports from 308 medical centers across the China mainland between 2012 and 2016, and found that TCM herbs only accounted for 4.5% of the DILI reports ( Wang et al, 2022 ). The main challenge facing the application of TCM for the treatment of sepsis in drug safety aspect is how to identify the scattered categories of drug that are potentially harmful to the organ function, and the assessment of risk/benefit ratio.…”

Section: Discussion and Perspectivesmentioning

confidence: 99%

Traditional Chinese medicine for treatment of sepsis and related multi-organ injury

2023

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Sepsis is a common but critical illness in patients admitted to the intensive care unit and is associated with high mortality. Although there are many treatments for sepsis, specific and effective therapies are still lacking. For over 2,000 years, traditional Chinese medicine (TCM) has played a vital role in the treatment of infectious diseases in Eastern countries. Both anecdotal and scientific evidence show that diverse TCM preparations alleviate organ dysfunction caused by sepsis by inhibiting the inflammatory response, reducing oxidative stress, boosting immunity, and maintaining cellular homeostasis. This review reports on the efficacy and mechanism of action of various TCM compounds, herbal monomer extracts, and acupuncture, on the treatment of sepsis and related multi-organ injury. We hope that this information would be helpful to better understand the theoretical basis and empirical support for TCM in the treatment of sepsis.

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Section: Discussion and Perspectivesmentioning

confidence: 99%

Traditional Chinese medicine for treatment of sepsis and related multi-organ injury

2023

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“…The analysis showed that 26 of 21,470 patients (0.12%) had liver injury, and the specific manifestation was that the ALT level was higher than the normal level ( 20 ). According to the data of 6,673 million ADR reports from the China National ADR Monitoring System from 1 January 2012 to 31 December 2016, Jiabo Wang et al found that the proportion of herb and traditional medicines-related ADR reports to the total reports was 4.5% ( 21 ). Future clinical research on new drugs should focus on conducting placebo-controlled, randomized, double-blind clinical trials to further confirm the effectiveness of TCM in treating various diseases and to evaluate adverse drug reactions.…”

Section: Discussionmentioning

confidence: 99%

Characteristic analysis of clinical trials for new traditional Chinese medicines in mainland China from 2013 to 2021

Zhou

Yang²,

He³

et al. 2022

Front. Med.

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ObjectiveBased on the clinical trials registered on the platform for the registry and publicity of clinical drug trials of the National Medical Products Administration (NMPA), the registration and approval of clinical trials of traditional Chinese medicines (TCMs) in mainland China from 2013 to 2021 were reviewed.MethodsClinical trials of new TCMs published in Chinese were retrieved from the platform for the registry and publicity of clinical drug trials. The number of registered trials and approved trials, status of clinical trials, therapeutic area of clinical trials for the treatment of diseases, type of trial design, sample size, sponsors, and leading clinical trial centers were evaluated.ResultsFrom 2013 to 2021, a total of 965 clinical trials of new drugs applied in TCM were registered on the aforementioned NMPA platform, comprising 117 phase I trials, 586 phase II trials, 174 phase III trials, 40 phase IV trials, and 48 other clinical trials. The treatment fields included the respiratory system, alimentary tract and metabolism, genetic system and reproductive hormones, and cardiovascular system. Among the 760 phase II and phase III trials, 98.9% were randomized, 95.4% were double-blind, and 98.2% were parallel controlled trials, and the proportion of placebo-controlled trials increased year by year from 2013 to 2021. From 2013 to 2021, 123 new TCMs were approved in mainland China.ConclusionFrom 2015 to 2021, the number of registered clinical trials of new TCMs remained low. The approval rate was also low, but the clinical trial design was greatly improved.

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“…Therefore, the severity of safety problems such as liver injury caused by Chinese medicine should not be exaggerated, but at the same time, it should not be underestimated. [89,90]…”

Section: Methods and Conclusionmentioning

confidence: 99%

Top 10 academic progress on traditional Chinese medicine in 2022

2023

Sci Tradit Chin Med

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Background To implement the spirit of the 20th National Congress of the Communist Party of China and the Opinions on Promoting the Inheritance, Innovation, and Development of Traditional Chinese Medicine (TCM), regularly summarize the research results of TCM, present the academic progress on TCM dynamically, and fully leverage the academic leadership of academic groups, the China Association of Chinese Medicine organized the selection of the top 10 academic progress on TCM in 2022. The selection process adhered to 4 orientations, eliminated any biases, highlighted the solutions to clinical problems, answered scientific questions, and led the industry’s development. It reflected an exploratory and forward-looking approach, emphasizing innovation and breakthroughs. The selection focused on new laws, new discoveries, new methods, new products, and new theories in the field of basic research and applied basic research in TCM. Through a process of dynamic collection, preliminary examination, review, and final judgment, the top 10 academic progress of TCM in 2022 were determined.

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Landscape of DILI-related adverse drug reaction in China Mainland

Cited by 24 publications

References 20 publications

Traditional Chinese medicine for treatment of sepsis and related multi-organ injury

Traditional Chinese medicine for treatment of sepsis and related multi-organ injury

Characteristic analysis of clinical trials for new traditional Chinese medicines in mainland China from 2013 to 2021

Top 10 academic progress on traditional Chinese medicine in 2022

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