1.Liver and Kidney Safety Assessment of Chinese Herbal Compound in Treatment of Gastric Cancer Based on Real-World Data
Yumiao SHEN ; Xiaohong ZHU ; Yi WANG ; Ya'nan ZHANG ; Ruohan ZHAO ; Fangqi MA ; Yan XU ; Lin ZENG ; Mingjie CHEN ; Aiguang ZHAO
China Cancer 2025;34(5):408-415
[Purpose]To evaluate the liver and kidney safety of traditional Chinese medicine(TCM)compounds in the treatment of gastric cancer.[Methods]The clinical data of gastric cancer patients who attended in Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2012 to February 2022 were collected.The results of liver and renal func-tion tests were rated according to National Cancer Institute-Common Terminology Criteria for Ad-verse Events(NCI-CTCAE)V5.0.The patients were divided into 4 groups:TCM group,TCM+chemotherapy/targeted/antivascular therapy group,TCM+TCM preparation group and TCM+chemotherapy/targeted/antivascular therapy+TCM preparation group,and the effects of TCM on liver and renal functions were analyzed.[Results]A total of 7 943 patients were included in the analysis,of which 2 941 cases receiving TCM ≥12 months,1 468 months ≥36 months,and 687 months≥60 months.The highest incidence rate of liver function abnormality was 13.71%,the highest in-cidence rate of grade 3/4 abnormality was 2.58%;the highest incidence of creatinine abnormality was 2.32%,the highest incidence rate of grade 3/4 abnormality was 0.37%in patients with differ-ent duration of taking TCM.Most of liver and renal function abnormalities occurred in the early stage of drug taking.The incidence of liver and renal function abnormalities in the TCM group was lower than that of the other three groups.The incidence of grade 3/4 abnormality for direct biliru-bin(DBIL)in the TCM group was 0.14%,for aspartate transaminase(AST)was 0.11%,for alka-line phosphatase(ALP)was 0.16%,for alanine aminotransferase(ALT)was 0.06%and for total bilirubin(TBIL)was 0.07%,and there was no grade 3/4 creatinine abnormality observed.The ab-normal liver and renal function indexes were not increased with the increase of the length of herbal medicine taking.[Conclusion]The study shows that long term taking TCM drugs and stan-dardized prescriptions for gastric cancer patients are safe.
2.Evidence-based Optimization of Acupuncture Timing Strategies for Ischemic Stroke
Gezhi ZHANG ; An LI ; Weixuan BAI ; Xue CHEN ; Fangqi LIU ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):144-152
ObjectiveTo investigate the impacts of three types of acupuncture timing factors, including intervention initiation time, needle retention duration, and treatment intervals, on the treatment efficacy of ischemic stroke (IS) and provide evidence-based support for optimizing acupuncture timing strategies. MethodsA systematic search was conducted in both Chinese and English databases, including CNKI, Wanfang Data, VIP, CBM, PubMed, Web of Science, Cochrane Library, and Embase. The randomized controlled trials involving multiple acupuncture intervention time groups were included to reduce inter-study heterogeneity. A network meta-analysis model was constructed to compare the effects of different intervention initiation time, needle retention duration, and treatment intervals on primary IS outcomes, including total clinical response rate, neurological and limb function scores, quality of life score, and hemorheological parameters. Adverse events were also assessed. ResultsA total of 32 studies were included. The results showed that early acupuncture intervention (1-3 days and 4-7 days after onset) outperformed late intervention (>14 days) in terms of response rate, neurological function improvement, and quality of life (P<0.05, P<0.01). Extending needle retention time to 40-60 min was associated with improved response rates and hemorheological parameters (P<0.01). No significant differences were observed among different treatment intervals. The evidence of key outcomes showed high overall certainty, with low heterogeneity and inconsistency. Sensitivity analyses and publication bias assessments indicated the stability of the main results and a low risk of publication bias. No significant adverse reaction was reported. ConclusionDifferent timing factors significantly influence the efficacy of acupuncture treatment for IS. Early intervention and appropriately extended needle retention time result in better clinical outcomes, while treatment interval has no significant effect on efficacy. The inclusion of studies with multiple acupuncture timing groups helps control methodological heterogeneity and enhances the robustness of the analysis, providing evidence-based guidance for optimizing acupuncture timing strategies in IS management.
3.Preliminary Construction of Comprehensive Evaluation System for TCM Clinical Practice Guidelines Based on Bibliometric Analysis and Core Element Extraction
Xue CHEN ; Gezhi ZHANG ; Danping ZHENG ; Fangqi LIU ; An LI ; Junjie JIANG ; Nannan SHI ; Wei YANG ; Xinghua XIANG ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(24):209-219
ObjectiveTo construct a comprehensive evaluation indicator system for clinical practice guidelines of traditional Chinese medicine (TCM) that is scientific, systematic, and reflects the characteristics of TCM. MethodsA systematic search was conducted in Chinese and English databases, including CNKI, Wanfang, VIP, SinoMed, PubMed, Embase, and Cochrane Library, to include literature on domestic and international guideline evaluation tools and TCM-related research. Document analysis and CiteSpace were utilized for keyword co-occurrence and clustering analysis. ResultsA total of 65 relevant studies were included, from which seven core thematic domains were identified. Based on the research objectives, a two-step construction strategy was adopted: first, an external evaluation framework was established by referencing international tools to cover methodological rigor and procedural standardization; second, an internal evaluation framework was developed to reflect the distinctive features of TCM clinical practice, including syndrome differentiation and efficacy feedback. Through expert consensus, the indicator system was refined, resulting in a dual-layered structure comprising 8 primary indicators, 22 secondary indicators, and 62 evaluation criteria. ConclusionThe comprehensive evaluation system for TCM clinical practice guidelines, based on bibliometric analysis and core element extraction, integrates both theoretical integrity and practical applicability. This study provides a preliminary research foundation for further optimization, validation, and development of a refined comprehensive evaluation system.
4.Liver and Kidney Safety Assessment of Chinese Herbal Compound in Treatment of Gastric Cancer Based on Real-World Data
Yumiao SHEN ; Xiaohong ZHU ; Yi WANG ; Ya'nan ZHANG ; Ruohan ZHAO ; Fangqi MA ; Yan XU ; Lin ZENG ; Mingjie CHEN ; Aiguang ZHAO
China Cancer 2025;34(5):408-415
[Purpose]To evaluate the liver and kidney safety of traditional Chinese medicine(TCM)compounds in the treatment of gastric cancer.[Methods]The clinical data of gastric cancer patients who attended in Longhua Hospital Affiliated to Shanghai University of Traditional Chinese Medicine from January 2012 to February 2022 were collected.The results of liver and renal func-tion tests were rated according to National Cancer Institute-Common Terminology Criteria for Ad-verse Events(NCI-CTCAE)V5.0.The patients were divided into 4 groups:TCM group,TCM+chemotherapy/targeted/antivascular therapy group,TCM+TCM preparation group and TCM+chemotherapy/targeted/antivascular therapy+TCM preparation group,and the effects of TCM on liver and renal functions were analyzed.[Results]A total of 7 943 patients were included in the analysis,of which 2 941 cases receiving TCM ≥12 months,1 468 months ≥36 months,and 687 months≥60 months.The highest incidence rate of liver function abnormality was 13.71%,the highest in-cidence rate of grade 3/4 abnormality was 2.58%;the highest incidence of creatinine abnormality was 2.32%,the highest incidence rate of grade 3/4 abnormality was 0.37%in patients with differ-ent duration of taking TCM.Most of liver and renal function abnormalities occurred in the early stage of drug taking.The incidence of liver and renal function abnormalities in the TCM group was lower than that of the other three groups.The incidence of grade 3/4 abnormality for direct biliru-bin(DBIL)in the TCM group was 0.14%,for aspartate transaminase(AST)was 0.11%,for alka-line phosphatase(ALP)was 0.16%,for alanine aminotransferase(ALT)was 0.06%and for total bilirubin(TBIL)was 0.07%,and there was no grade 3/4 creatinine abnormality observed.The ab-normal liver and renal function indexes were not increased with the increase of the length of herbal medicine taking.[Conclusion]The study shows that long term taking TCM drugs and stan-dardized prescriptions for gastric cancer patients are safe.
5.Role and mechanism of XPOT inhibition by atractylenolide I in gastric cancer cells
Yi ZHANG ; Fangqi MA ; Siyuan WEI ; Xuejun LI
The Journal of Practical Medicine 2024;40(14):1928-1934
Objective This study aimed to investigate the role and mechanism of atractylenolide Ⅰ in inhibiting XPOT proliferation and invasion in gastric cancer cells.Methods This study included exploration of XPOT expression in gastric cancer tissues,analysis of gene expression data from GC patients in TCGA and GEO databases,as well as various cellular assays to detect the ability of cancer cells to proliferate,migrate,and invade.Protein expression levels of XPOT,SKP2,CyclinA,and P27 mRNA were also detected by qPCR and Western Blot.Results Analysis confirmed that XPOT was highly expressed in gastric cancer tissues,indicating a poor prognosis.In vitro studies revealed that AT-1 inhibits the proliferation and invasion ability of GC cells;XPOT down-regulation also inhibits these abilities.Furthermore,AT-1 down-regulates the expression of XPOT which then regulates SKP2,P27,and CyclinA-ultimately inhibiting the proliferation and invasion of gastric cancer cells through the regulation of the XPOT pathway.Conclusion The overexpression of XPOT in gastric cancer tissues can indicate a poor prognosis.Atractylenolide Ⅰ down-regulates the XPOT-regulated ubiquitination-proteasome pathway to inhibit proliferation and invasion of gastric cancer cells.
6.Characteristics of Emergency Health Systems Guidance Based on AGREE-HS
Danping ZHENG ; Wei YANG ; Nannan SHI ; Dongfeng WEI ; An LI ; Gezhi ZHANG ; Xue CHEN ; Fangqi LIU ; Zhaoshuai YAN ; Weixuan BAI ; Xinghua XIANG ; Yaxin TIAN ; Mengyu LIU ; Huamin ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):137-148
This study used the Appraisal of Guidelines Research & Evaluation-Health Systems (AGREE-HS) to demonstratively compare 34 global coronavirus disease-2019 (COVID-19) health systems guidance documents (HSGs) and 6 World Health Organization (WHO) standard HSGs. The comparison involved topic, participants, methods, recommendations, and implementability, with the aim of exploring the characteristics of emergency HSGs. The results showed that the emergency HSGs had an overall average score of 49%, with topic having the highest score, recommendations having the second highest score, and participants having the lowest score. The standard HSGs had an overall average score of 79%, with high scores in all items. The emergency HSGs had lower scores in participants, methods, recommendations, and implementability than the standard HSGs (P<0.001), while the COVID-19 emergency HSGs developed by the WHO had higher score in topic than the standard HSGs (P<0.05). Compared with those released by countries, the COVID-19 emergency HSG developed by the WHO showed superiority in all items and overall scores (P=0.000 2). This indicates that emergency HSGs, represented by the COVID-19 emergency HSG, place equal emphasis on topic and recommendations as standard HSGs but have low requirements in terms of expert participation, evidence support, and comprehensive consideration in the time- and resource-limited context. They have the characteristics of prominent topics, clear purposes, orientation to demand, keeping up with the latest evidence, flexible adjustment, and timeliness, emphasizing immediate implementation effects, weakening long-term effects, and focusing on comprehensive benefits. Additionally, developers, types, and report completeness are important influencing factors.
7.Characteristics of Developing Methods for Emergency Health Systems Guidance Based on AGREE-HS
Danping ZHENG ; Wei YANG ; Dongfeng WEI ; Nannan SHI ; Lin TONG ; An LI ; Gezhi ZHANG ; Xue CHEN ; Fangqi LIU ; Weixuan BAI ; Xinghua XIANG ; Mengyu LIU ; Huamin ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):149-156
The scientific rigor and efficacy of methodologies employed in drafting emergency health systems guidance documents (HSGs) are paramount in guaranteeing the quality, reliability, and applicability of HSGs. According to the Appraisal of Guidelines for Research and Evaluation- Health Systems (AGREE-HS), we demonstratively assessed both global coronavirus disease-2019 (COVID-19) emergency HSGs and World Health Organization (WHO) standard HSGs to uncover the core attributes of methods employed in the development of emergency HSGs. Our evaluation findings revealed that across the five assessment items of AGREE-HS, methods in the 34 emergency HSGs evaluated ranked third, trailing behind topic and recommendations. Notably, criterion 2 (the best available and most contextually relevant evidence is considered) received the highest score, whereas criterion 5 (evidence of cost and cost-effectiveness of the potential options is described) scored the lowest. Compared with the WHO standard HSGs, the COVID-19 emergency HSGs exhibited low scores in methods (P<0.05), which was reflected in nine criteria (P<0.05), especially in criteria 1 (systematic and transparent methods are used to identify and review the evidence) and 9 (systematic and transparent methods are used to agree upon the final recommendations). Among the COVID-19 emergency HSGs, that developed by the WHO achieved higher scores in eight out of all nine criteria, excluding criterion 8 (P<0.05). The clinically relevant emergency HSGs had higher scores in the criteria 3 (the evidence base is current) and 8 (the rationale behind the recommendations is clear) than other types of emergency HSGs. Collectively, the methodology for developing emergency HSGs, represented by the COVID-19 emergency HSG, underscores evidence orientation and integrates expert consensus. It is characterized by adaptable evidence synthesis strategies, streamlined evidence review protocols, and contextual relevance, all of which are influenced by external, internal, and implementation-specific factors.
8.Characteristics of Participants for Developing Emergency Health Systems Guidance Based on AGREE-HS
An LI ; Gezhi ZHANG ; Xue CHEN ; Fangqi LIU ; Danping ZHENG ; Weixuan BAI ; Wei YANG ; Dongfeng WEI ; Nannan SHI ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):157-163
The formulation method of emergency health systems guidance (HSG) is crucial, directly impacting the efficiency and effectiveness of responses in emergencies. A scientifically sound, systematic, and easily executable guidance document can assist health institutions at all levels in quickly coordinating resources, standardizing emergency response processes, and safeguarding public health. This study employed the Appraisal of Guidelines for Research and Evaluation for Health Systems (AGREE-HS) to analyze the characteristics of participants in developing emergency HSGs represented by the COVID-19 emergency HSG. The results showed that in the 34 HSGs included in this study, the item participants received the lowest score. Within this item, criterion 1 (diversity of development group) scored the highest (3.13±1.55), while criterion 5 (prevention of funding agency influence) scored the lowest (1.21±0.47). There were differences (P<0.05) in measures taken to mitigate funding agency influence between the six standard HSGs developed by the World Health Organization (WHO) and the four emergency HSGs. Additionally, differences (P<0.05) existed in the development group members, background, conflicts of interest, and preventive measures between the six WHO standard HSGs and the 34 emergency HSGs, as well as between the HSGs developed by the WHO and those developed by countries. The participants in developing emergency HSGs were influenced by various factors, including limited time for guideline development, modes of participation, scarce evidence, and uncertainties in expected outcomes. There is a need to downplay extensive requirements concerning the composition of group members, institutional diversity, and conflicts of interest, emphasizing the roles of key participants like government officials and professionals who can provide rapid, practical guidance in emergency situations.
9.Characteristics of Recommendations for Emergency Health Systems Guidance Based on AGREE-HS
Gezhi ZHANG ; Cuifang LIU ; Danping ZHENG ; Xue CHEN ; An LI ; Fangqi LIU ; Dongfeng WEI ; Wei YANG ; Nannan SHI ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):164-170
Recommendations, consensus-based syntheses of the best available evidence, constitute the core content of a guideline. This paper analyzes the characteristics of emergency health systems guidance documents (HSGs), represented by the coronavirus disease-2019 (COVID-19) emergency HSG, regarding the item "recommendations" and its eight evaluation criteria in the Appraisal of Guidelines for Research and Evaluation for Health Systems (AGREE-HS). The World Health Organization (WHO) standard HSGs were used as reference to explore the characteristics of emergency HSGs that are different from non-emergency HSGs. The results showed that the “recommendations” scored second after “topic” among the five items. Criterion 7 relating to operability scored higher than others among the eight criteria, and criterion 3 dealing with ethical principles scored lower than other criteria. Compared with the standard HSGs, the emergency HSGs showed decreased scores (P<0.05) of the item recommendations and the criteria of this item except criterion 4 concerning equity promotion. Among the HSGs with different developers, those developed by the WHO had higher (P<0.05) scores of recommendations than nationally developed HSGs, as evidenced by criterion 4, criterion 5 involving acceptability to and alignment with sociocultural and political interests, and criterion 8 for updating plans. The HSGs regarding global or country strategy scored higher (P<0.05) on criterion 2 relating to comprehensiveness than those involving specific guidance on clinical or material issues. Overall, the emergency HSGs, represented by the COVID-19 emergency HSGs, differ from the standard HSGs in a number of ways in terms of their recommendations. Emergency HSGs have more condensed content and weaker articulation of expected outcomes. They incline to put more emphasis on updating plans, rather than comprehensiveness or integrative requirements in terms of ethics, equity, and sociocultural and political interests.
10.Characteristics of Topic for Emergency Health Systems Guidance Based on AGREE-HS
Xue CHEN ; An LI ; Fangqi LIU ; Danping ZHENG ; Gezhi ZHANG ; Nannan SHI ; Wei YANG ; Dongfeng WEI ; Mengyu LIU
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(22):171-177
The clear definition of the topic in emergency health systems guidance (HSG) ensures the relevance, scientific rigor, and practicality of the guidance, providing a clear direction and a framework for a rapid and effective public health response. This study used the Appraisal of Guidelines for Research & Evaluation-Health Systems (AGREE-HS) to demonstratively evaluate the global COVID-19 emergency HSGs and World Health Organization (WHO) standard HSGs, aiming to explore the characteristics of topic in emergency HSGs. The results showed that in the 34 HSGs included, the item topic received the highest score. Specifically, criterion 4 relating to relevant and applicable factors scored the highest (5.59), while criterion 3 concerning the prioritization of health system challenges scored the lowest (2.76). There were differences (P<0.05) in criterion 1 between standard HSGs and overall emergency HSGs, as well as between WHO and national emergency HSGs. Criterion 3 also showed differences (P<0.05) between standard HSGs and emergency HSGs, as well as between WHO and national emergency HSGs. Criterion 4 displayed differences (P<0.000 1) between WHO and national emergency HSGs. No differences were observed in intra-group or inter-group comparisons of different emergency HSG subcategories (P<0.05). Overall, emergency HSGs represented by the COVID-19 emergency HSG focus on detailing the challenges faced by the health system, including the natures of challenges, affected populations, and other relevant and applicable factors, while aligning with stakeholder concerns. The prioritization is downplayed, with emphasis placed on rapid responses to and flexible handling of urgent issues. Influenced by factors such as the evidence base, phase timing, and effectiveness, the topic setting shows variations.

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