1.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
3.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
4.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
5.Development of a Diagnostic Scale for Qi-Yin Deficiency with Blood Stasis Syndrome in Diabetic Macrovascular Disease
Qingzhi LIANG ; Ting LUO ; Yi SU ; Xiaoqin LIU ; Hong GAO ; Hongyan XIE ; Chunguang XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(11):225-234
ObjectiveTo construct a standardized diagnostic scale for Qi-Yin deficiency with blood stasis syndrome in diabetic macrovascular disease. MethodsLiterature related to Qi-Yin deficiency with blood stasis syndrome in diabetic macrovascular disease was retrieved from CNKI, VIP, and Wanfang databases. Diagnostic information from four diagnostic methods was extracted and standardized, with items having a frequency of ≥15 included in the item pool. A three-round Delphi expert consultation was conducted, screening items using support degree, mean score, rank sum, and coefficient of variation. Item weights were determined using analytic hierarchy process (AHP), gactor analysis (FA), and combined weighting method (CWM). The optimal weighting method was selected by comparing the area under the receiver operating characteristic (ROC) curve (AUC). The Youden index was calculated to establish the diagnostic cutoff value, which was proportionally scaled. ResultsA total of 102 studies were included. Thirty-five items were incorporated into the item pool. The authority coefficients for the three Delphi rounds were 0.82, 0.85, and 0.86, with coordination coefficients of 0.648, 0.538, and 0.506, respectively. Fifteen items were retained after screening. ROC curve analysis showed the AUC ranking as FA > CWM > AHP. The maximum Youden index was 0.814, corresponding to a diagnostic cutoff of 8.361 (scaled to 40 points). The final scale adopted a structured diagnostic framework: the symptom dimension requires at least 2 items, and the tongue or pulse dimension requires at least 1 category. ConclusionThis study developed a standardized diagnostic scale for Qi-Yin deficiency with blood stasis syndrome in diabetic macrovascular disease. Core items were screened via the Delphi method, with factor analysis identified as the optimal weighting method through AUC comparison. The diagnostic threshold (40 points) and structured diagnostic framework provide a quantitatively clear, clinically practical tool.
6.Analysis of barriers to physical activity behavior among overweight and obese children and adolescents
HUANG Daohua, FANG Miaomiao, XIE Qinglei, WAN Hongyan, ZHANG Yumei
Chinese Journal of School Health 2026;47(5):642-645
Objective:
To explore the barriers to physical activity behavior among overweight and obese children and adolescents, so as to provide evidence for developing physical activity intervention programs.
Methods:
From March to April 2025, 13 overweight or obese children and adolescents from one primary school and one secondary school in Nanjing were selected by purposive sampling for semi structured interviews. Guided by the capability, opportunity and motivation-behavior model, data were coded, categorized and analyzed using content analysis.
Results:
A total of 13 interviews were completed, with a cumulative duration of 358 minutes. Three themes and eight subthemes were identified:capability factors, including physical discomfort and limited physical fitness, weak exercise skills and insufficient behavioral regulation ability, and insufficient psychological capability; opportunity factors, including insufficient family support and negative influence, pressure from school and peer environments, and limited time resources and exercise conditions; and motivation factors, including low self efficacy and situations prone to giving up, and insufficient positive feedback and lack of attractiveness of exercise forms.
Conclusions
Barriers to physical activity among overweight and obese children and adolescents result from the combined effects of capability, opportunity and motivation. It is necessary to lower the threshold for initiating exercise, strengthen positive experiences and feedback, and build integrate family-school support environments to promote the initiation and maintenance of physical activity behaviors in children and adolescents.
7.Establishment and Evaluation of Diabetic Macrovascular Atherosclerosis Model with Qi and Yin Deficiency Syndrome
Ting LUO ; Qingzhi LIANG ; Xi PENG ; Yi SU ; Hongyan XIE ; Chunguang XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(13):86-98
ObjectiveTo explore the establishment of a rat model of diabetic macrovascular atherosclerosis (DMA) with Qi and Yin deficiency syndrome induced by high-fat diet, streptozotocin (STZ), and Yin-depleting herbs, and to evaluate its biological characteristics. MethodsForty SD rats were randomly divided into a blank group (n=10) and a modeling group (n=30). Except for the blank group, rats in the model group were fed a high-fat diet for 4 weeks, followed by intraperitoneal injection of STZ (30 mg·kg-1) to establish a diabetic model. Twenty-four successfully modeled diabetic rats were randomly divided into a model group (n=7), a Qi and Yin deficiency syndrome group (n=8), and a counter-syndrome group (n=9). Except for the model group, rats received intragastric administration of Yin-depleting herbs (1.2 g·kg-1) for 8 weeks. The counter-syndrome group was further treated with Shenqi compound formula (1.69 g·kg-1) for an additional 8 weeks. General condition and body weight were recorded, and syndrome-related indicators were assessed, including precordial temperature, skin moisture content, grip strength, open-field test performance, and tongue appearance. Serum levels of vascular endothelial growth factor (VEGF), endothelin-1 (ET-1), vascular cell adhesion molecule-1 (VCAM-1), insulin-like growth factor-1 (IGF-1), and monocyte chemotactic protein-1 (MCP-1) were measured by enzyme-linked immunosorbent assay (ELISA). Fasting blood glucose, blood lipids, hemorheological parameters, and coagulation function were analyzed using an automatic biochemical analyzer. Vascular ultrasound and hematoxylin-eosin (HE) staining were used to evaluate vascular lesions. ResultsIn terms of syndrome manifestations, compared with the blank group, body weight increased rapidly during the first 5 weeks in the model, Qi and Yin deficiency, and counter-syndrome groups. After STZ injection combined with Yin-depleting herbal administration at week 5, body weight decreased significantly (P<0.01) and continued to decline until the end of the experiment. Rats exhibited decreased activity, irritability, coarse and yellowish fur with obvious shedding, polydipsia, polyphagia, frequent urination, and dry stools, which were most pronounced in the Qi and Yin deficiency group. Grip strength decreased, peak activity time occurred earlier, total distance in the open-field test was reduced, and residence time was prolonged. Precordial temperature decreased (P<0.01), while paw temperature increased (P<0.05), and skin moisture and oil content were reduced (P<0.05, P<0.01). In terms of disease-related indicators, compared with the blank group, fasting blood glucose was significantly increased (>16.7 mmol·L-1) in the model and Qi and Yin deficiency groups, and blood lipid levels were significantly elevated (P<0.05). Vascular-related factors ET-1, MCP-1, VCAM-1, and VEGF were significantly increased (P<0.05,P<0.01), while IGF-1 was significantly decreased (P<0.01). Pathological examination of the aortic valve showed valvular thickening and structural disorganization. Carotid artery examination revealed discontinuity of the intima, foam cell accumulation beneath the intima, disordered smooth muscle arrangement, and widened intercellular spaces. Compared with the model group, ET-1, MCP-1, and VEGF levels were significantly decreased in both the Qi and Yin deficiency group and the counter-syndrome group. The reductions in ET-1 and MCP-1 were more pronounced in the Qi and Yin deficiency group (P<0.01), while the decrease in VCAM-1 was more significant in the counter-syndrome group (P<0.05). Compared with the blank group, the Qi and Yin deficiency group showed significantly prolonged activated partial thromboplastin time (APTT), thrombin time (TT), and prothrombin time (PT) (P<0.01). The erythrocyte deformability index (TK), erythrocyte sedimentation rate, erythrocyte electrophoresis index, and whole blood low-shear viscosity all showed increasing trends. Vascular ultrasound revealed reduced arterial blood flow velocity, increased vascular resistance, and intimal thickening without plaque formation. The aortic intima showed no obvious overall thickening, with only occasional localized thickening and foam cell presence, and carotid artery injury was observed. ConclusionA rat model of DMA with Qi and Yin deficiency syndrome was successfully established using high-fat diet feeding combined with STZ injection and Yin-depleting herbal administration. Shenqi compound formula effectively alleviated Qi and Yin deficiency syndrome, regulated glucose and lipid metabolism, improved hemorheological and coagulation function, reduced vascular lesion severity, and demonstrated potential for early prevention and treatment of DMA.
8.TCM Research of Theories and Prescriptions on Blood Glucose Fluctuation in Diabetes Mellitus: A Review
Yongjiang ZHU ; Xiaoxu FU ; Hongyan XIE ; Chunguang XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):303-310
A systematic review of the traditional Chinese medicine (TCM) literatures published over the past decade on blood glucose fluctuations in diabetes mellitus was conducted to summarize related TCM research progress of theories and prescriptions, so as to provide references for future TCM theoretical exploration, basic research, and clinical prevention and treatment. Blood glucose fluctuation is an independent risk factor for chronic complications of diabetes mellitus, with significant progress made in TCM theories and prescription studies targeting this condition. The TCM theories include "spleen-pancreas homology", "liver controlling dispersion", "small intestine transforming qi and separating purity from turbidity", "Yi Qi Zhou Liu theory", "Xuan Fu Qi Ye theory", "Yin-fire theory" and so on, all of which emphasize "Qi". Prescription studies primarily utilize clinical trials, which evaluate plentiful indexes of blood glucose fluctuation such as the mean amplitude of glycemic excursion. Classical and self-formulated prescriptions are widely used, with various dosage forms such as decoctions, granules and capsules. "Qi-Yin deficiency" is the main syndrome of blood glucose fluctuation. Basic research focuses on mechanisms that improve blood glucose fluctuation and reduce chronic complications, such as the renin-angiotensin system regulating islet β cell's function, and the transforming growth factor-β1 inhibiting organ fibrosis. However, there are still some deficiencies in the evidential support and syndrome study of TCM theories, in the high-level evidence-based evaluation, efficacy comparison among multiple dosage forms, and the integration of TCM theories with prescription's clinical research, in the quantities, multi-level verifications, blood glucose fluctuation model establishment and intervention criteria as well as prescription-syndrome correspondence of prescription's basic research, and in the collaboration between clinical and basic research. Despite these challenges, TCM offers a promising approach to improving blood glucose fluctuation and reducing chronic complications in diabetes mellitus, with its rich theories, diverse methods, and proven efficacy.
9.Mechanisms of Intestinal Microecology in Hyperuricemia and Traditional Chinese Medicine Intervention:A Review
Mingyuan FAN ; Jiuzhu YUAN ; Hongyan XIE ; Sai ZHANG ; Qiyuan YAO ; Luqi HE ; Qingqing FU ; Hong GAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(5):329-338
In recent years, hyperuricemia (HUA) has shown a rapidly increasing incidence and tends to occur in increasingly young people, with a wide range of cardiac, renal, joint, and cancerous hazards and all-cause mortality associations. Western medicine treatment has limitations such as large liver and kidney damage, medication restriction, and easy recurrence. The intestine is the major extra-renal excretion pathway for uric acid (UA), and the intestinal microecology can be regulated to promote UA degradation. It offers great potential to develop UA-lowering strategies that target the intestinal microecology, which are promising to provide safer and more effective therapeutic approaches. Traditional Chinese medicine (TCM) can treat HUA via multiple targets and multiple pathways from a holistic view, with low toxicity and side effects. Studies have shown that intestinal microecology is a crucial target for TCM in the treatment of HUA. However, its specific mechanism of action has not been fully elucidated. Focusing on the key role of intestinal microecology in HUA, this review explores the relationship between intestinal microecology and HUA in terms of intestinal flora, intestinal metabolites, intestinal UA transporters, and intestinal barriers. Furthermore, we summarize the research progress in TCM treatment of HUA by targeting the intestinal microecology, with the aim of providing references for the development of TCM intervention strategies for HUA and the direction of future research.
10.Comparative study of incremental dosimetry of HSRT on target area of large volume brain metastases between IMRT and VMAT
Haipeng LYU ; Xiao LIU ; Jiawei CHEN ; Mingming SHI ; Hongyan XU ; Xiaowei HOU ; Chuanbin XIE
China Medical Equipment 2025;22(4):6-12
Objective:To compare the dosimetric parameters under different incremental modes between intensity-modulated radiation therapy(IMRT)and volume rotation intensity-modulated therapy(VMAT)for the target area of large volume brain metastases(BMs),and to explore the better way of treating BMs based on hypofractionated stereotactic radiotherapy(HSRT)of linear accelerator.Methods:A total of 30 BMs patients who underwent IMRT at The 971th Hospital of Navy of the CPLA from 2020 to 2023 were selected.In the treatment planning system(TPS),three types of IMRT plans and VMAT plans were designed,which included uniformity plan(Planuniformity)of target area dose,uniform increased plan(Planuniform increased-dose)and incremental plan(Planincremental)within target area.In the inside of the target area,the target area of high dose(GTVh)was set,and Planuniform increased-dose and Planincremental were designed to aim at GTVh.The differences of the doses of three types of treatment plans included Planuniformity,Planuniform increased-dose and Planincremental,which were respectively designed by using IMRT and VMAT,were analyzed.The mean dose(Dmean)of the target area,the 50%and 2%exposed doses(D50%and D2%)of the target area were observed and compared.The conformity index(CI),homogeneity index(HI),gradient index(GI),and the volume percentage(V10 Gy-V40 Gy)that normal brain tissue received 10 Gy-40 Gy also were observed and compared.Results:Compared with Planuniformity of IMRT,the Dmean of GTV of Planuniform increased-dose and Planincremental of IMRT increased by 10.13%and 17.9%,with statistically significant differences(t=13.680,12.771,P<0.05).D50%increased by 8.9%and 10.8%,with statistically significant differences(t=15.190,9.929,P<0.05).D2%increased by 15.2%and 46.4%,with statistically significant differences(t=52.320,8.746,P<0.05).There were no statistically significant differences in normal brain tissue V10 Gy-V40 Gy among Planuniformity,Planuniform increased-dose and Planincremental of IMRT(P>0.05).Compared with Planuniformity of VMAT,the Dmean of GTV of Planuniform increased-dose and Planincremental of VMAT increased by 10.53%and 21.23%,with statistically significant differences(t=18.641,15.461,P<0.05),and D50%increased by 9.1%and 13.4%,with statistically significant differences(t=11.382,10.952,P<0.05),and D2%increased by 16.4%and 48.8%,with statistically significant differences(t=56.471,8.685,P<0.05),respectively.There were no statistically significant differences in normal brain tissue V10 Gy-V40 Gy among Planuniformity,Planuniform increased-dose and Planincremental of VMAT(P>0.05).The normal brain tissue V20 Gy,V30 Gy and V40 Gy of Planuniform increased-dose and Planincremental of IMRT were respectively less than those of VMAT,and the differences of them between IMRT and VMAT were significant(tPlan uniform increased-dose=2.112,2.215,2.444,tPlan incremental=2.323,2.939,3.145,P<0.05).There were no statistically significant difference in D2%,Dmean,and D50%between IMRT and VMAT(P>0.05).Conclusion:On the premise of ensuring the safety of normal brain tissue at the edge of the target area,the synchronously increasing of the central dose of the target area will not significantly increase the dose for normal brain tissue.Both IMRT and VMAT can meet the requirements of increment in the inside of the target area,and VMAT has slightly better increment and higher efficiency within target area.The incremental of VMAT target area is slightly better,which also has better efficiency,while the enhancement effect of the dose of target area of Planincremental is better than that of the Planuniform increased-dose.The Plan incremental of VMAT is more suitable for HSRT treatment for BMs.


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