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.Exploring Role of Energy Dyshomeostasis in Metabolic Dysfunction-associated Fatty Liver Disease Panvasculopathy from Theory of Liver Being Substantial Yin and Functional Yang
Jing CUI ; Qian XU ; Wenting WANG ; Mengmeng ZHU ; Yanfei LIU ; Yue LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):227-233
Liver being substantial Yin and functional Yang maintain normal function of Qi, blood and meridians. In clinical practice, it is often found that pan-vascular lesions with atherosclerosis as the predominant pathological change often co-occur with metabolic dysfunction-associated fatty liver disease(MAFLD). MAFLD leads to increased risk and worse prognosis for many pan-vascular diseases, including cardiovascular disease. Dysregulation of energy homeostasis disrupts the hepatic homeostasis of body use, and representative drugs to improve metabolism, such as metformin, sodium-glucose co-transporter 2 inhibitors, and glucagon-like peptide-1 agonists, not only have a clear cardiovascular benefit, potential improvement of MAFLD has also been demonstrated. The liver stores blood and the heart pumps blood, and liver diseases affect the heart, that's why the unsmoothness of vessels appears. So the treatment should from the standpoint of liver, restoring liver function, soothing the liver and nourishing heart, activating blood and dredging meridian. It is of great significance to explore in depth the pathogenesis and treatment of pan-vascular lesions caused by MAFLD, and to restore the energy homeostasis by adjusting the balance of liver Yin and Yang.
6.Exploring Role of Energy Dyshomeostasis in Metabolic Dysfunction-associated Fatty Liver Disease Panvasculopathy from Theory of Liver Being Substantial Yin and Functional Yang
Jing CUI ; Qian XU ; Wenting WANG ; Mengmeng ZHU ; Yanfei LIU ; Yue LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(17):227-233
Liver being substantial Yin and functional Yang maintain normal function of Qi, blood and meridians. In clinical practice, it is often found that pan-vascular lesions with atherosclerosis as the predominant pathological change often co-occur with metabolic dysfunction-associated fatty liver disease(MAFLD). MAFLD leads to increased risk and worse prognosis for many pan-vascular diseases, including cardiovascular disease. Dysregulation of energy homeostasis disrupts the hepatic homeostasis of body use, and representative drugs to improve metabolism, such as metformin, sodium-glucose co-transporter 2 inhibitors, and glucagon-like peptide-1 agonists, not only have a clear cardiovascular benefit, potential improvement of MAFLD has also been demonstrated. The liver stores blood and the heart pumps blood, and liver diseases affect the heart, that's why the unsmoothness of vessels appears. So the treatment should from the standpoint of liver, restoring liver function, soothing the liver and nourishing heart, activating blood and dredging meridian. It is of great significance to explore in depth the pathogenesis and treatment of pan-vascular lesions caused by MAFLD, and to restore the energy homeostasis by adjusting the balance of liver Yin and Yang.
7.Advances in mechanisms of damage to cardiovascular system by exposure to micro-nano plastics
Guangzhen LU ; Xiaoting WANG ; Xinye WANG ; Hong ZHUANG ; Mengmeng CUI ; Gang ZHAO
Journal of Environmental and Occupational Medicine 2025;42(10):1260-1267
This review described the potential health threats to the cardiovascular system from micro-nano plastics (MNPs) and their multifaceted toxicity mechanisms. The article reviewed the environmental distribution of MNPs, exposure pathways, and their toxic effects on the cardiovascular system, and summarized the specific mechanisms of MNPs involving oxidative stress, inflammatory response, mitochondrial damage, apoptosis, pyroptosis, and autophagy dysregulation. Meanwhile, the combined toxic effects of MNPs with other environmental pollutants (e.g., heavy metals and polycyclic aromatic hydrocarbons), including synergistic, antagonistic, and dual effects, were analyzed, and the potential risks of MNPs as carriers of microorganisms and toxic chemicals were pointed out. The widespread presence of MNPs and their complex toxicity mechanisms may make them important triggers for cardiovascular diseases, but current research still suffers from unbalanced studies across environmental systems, incomplete understanding of plastic properties, and limited knowledge of long-term biological effects. Future research should focus on the long-term effects of MNPs, the joint toxicity mechanisms with other pollutants, and the differential effects across population subgroups. It is suggested to accelerate plastic recycling technology innovation, promote biodegradable materials, and optimize waste treatment process to mitigate the potential threat of MNPs pollution to human health. Through multidisciplinary collaboration and in-depth research, combining innovative concepts from toxicology, public health policy, and environmental science, it is expected to provide new methods and approaches for the prevention and treatment of cardiovascular diseases associated with MNPs.
8.Proportion and clinical characteristics of metabolic-associated fatty liver disease and associated liver fibrosis in an urban Chinese population.
Mengmeng HOU ; Qi GU ; Jiawei CUI ; Yao DOU ; Xiuhong HUANG ; Jie LI ; Liang QIAO ; Yuemin NAN
Chinese Medical Journal 2025;138(7):829-837
BACKGROUND:
Metabolic-associated fatty liver disease (MAFLD) is the predominant form of chronic liver disease worldwide. This study was designed to investigate the proportion and characteristics of MAFLD within the general Chinese population and to identify the contributory risk factors for liver fibrosis among MAFLD individuals.
METHODS:
The participants were recruited from a cohort undergoing routine health evaluations at the Third Hospital of Hebei Medical University between May 2019 and March 2023. The diagnosis of MAFLD was based on the established clinical practice guidelines. The fibrosis-4 index score (FIB-4) was employed to evaluate hepatic fibrosis, with a FIB-4 score of ≥1.3 indicating significant fibrosis. Binary logistic regression analyses were used to determine risk factors associated with significant hepatic fibrosis in MAFLD.
RESULTS:
A total of 22,970 participants who underwent comprehensive medical examinations were included in the analysis. The overall proportion of MAFLD was 28.77% (6608/22,970), with 16.87% (1115/6608) of these patients showing significant fibrosis as assessed using FIB-4. Independent risk factors for significant liver fibrosis in MAFLD patients were male (odds ratio [OR] = 0.676, 95% confidence interval [CI]: 0.558-0.821), hepatitis B surface antigen (HBsAg) positivity (OR = 2.611, 95% CI: 1.557-4.379), body mass index ≥23.00 kg/m 2 (OR = 0.632, 95% CI: 0.470-0.851), blood pressure ≥130/85 mmHg (OR = 1.885, 95% CI: 1.564-2.272), and plasma glucose ≥5.6 mmol/L (OR = 1.815, 95% CI: 1.507-2.186) (all P <0.001).
CONCLUSIONS
The proportion of MAFLD in an urban Chinese population is 28.77%. About 16.87% of MAFLD patients presented with significant liver fibrosis. Independent risk factors for significant liver fibrosis in MAFLD patients should be noticed.
Humans
;
Male
;
Female
;
Liver Cirrhosis/pathology*
;
Middle Aged
;
Risk Factors
;
Adult
;
Fatty Liver/pathology*
;
Aged
;
China/epidemiology*
;
Logistic Models
;
Urban Population
;
East Asian People
9.Expert consensus on the diagnosis and treatment of cemental tear.
Ye LIANG ; Hongrui LIU ; Chengjia XIE ; Yang YU ; Jinlong SHAO ; Chunxu LV ; Wenyan KANG ; Fuhua YAN ; Yaping PAN ; Faming CHEN ; Yan XU ; Zuomin WANG ; Yao SUN ; Ang LI ; Lili CHEN ; Qingxian LUAN ; Chuanjiang ZHAO ; Zhengguo CAO ; Yi LIU ; Jiang SUN ; Zhongchen SONG ; Lei ZHAO ; Li LIN ; Peihui DING ; Weilian SUN ; Jun WANG ; Jiang LIN ; Guangxun ZHU ; Qi ZHANG ; Lijun LUO ; Jiayin DENG ; Yihuai PAN ; Jin ZHAO ; Aimei SONG ; Hongmei GUO ; Jin ZHANG ; Pingping CUI ; Song GE ; Rui ZHANG ; Xiuyun REN ; Shengbin HUANG ; Xi WEI ; Lihong QIU ; Jing DENG ; Keqing PAN ; Dandan MA ; Hongyu ZHAO ; Dong CHEN ; Liangjun ZHONG ; Gang DING ; Wu CHEN ; Quanchen XU ; Xiaoyu SUN ; Lingqian DU ; Ling LI ; Yijia WANG ; Xiaoyuan LI ; Qiang CHEN ; Hui WANG ; Zheng ZHANG ; Mengmeng LIU ; Chengfei ZHANG ; Xuedong ZHOU ; Shaohua GE
International Journal of Oral Science 2025;17(1):61-61
Cemental tear is a rare and indetectable condition unless obvious clinical signs present with the involvement of surrounding periodontal and periapical tissues. Due to its clinical manifestations similar to common dental issues, such as vertical root fracture, primary endodontic diseases, and periodontal diseases, as well as the low awareness of cemental tear for clinicians, misdiagnosis often occurs. The critical principle for cemental tear treatment is to remove torn fragments, and overlooking fragments leads to futile therapy, which could deteriorate the conditions of the affected teeth. Therefore, accurate diagnosis and subsequent appropriate interventions are vital for managing cemental tear. Novel diagnostic tools, including cone-beam computed tomography (CBCT), microscopes, and enamel matrix derivatives, have improved early detection and management, enhancing tooth retention. The implementation of standardized diagnostic criteria and treatment protocols, combined with improved clinical awareness among dental professionals, serves to mitigate risks of diagnostic errors and suboptimal therapeutic interventions. This expert consensus reviewed the epidemiology, pathogenesis, potential predisposing factors, clinical manifestations, diagnosis, differential diagnosis, treatment, and prognosis of cemental tear, aiming to provide a clinical guideline and facilitate clinicians to have a better understanding of cemental tear.
Humans
;
Dental Cementum/injuries*
;
Consensus
;
Diagnosis, Differential
;
Cone-Beam Computed Tomography
;
Tooth Fractures/therapy*
10.Efficacy of selective expansive opendoor laminoplasty in the treatment of multisegmental cervical spondylotic myelopathy
Zehua JIANG ; Boyu ZHANG ; Hongjie ZHANG ; Haojun CUI ; Zhishuai REN ; Hao YU ; Mengmeng ZHOU ; Rusen ZHU
Tianjin Medical Journal 2025;53(7):719-724
Objective To evaluate the clinical efficacy of selective expansive open-door laminoplasty(SEOLP)with preservation of C7 spinous process in the treatment of multisegmental cervical spondylotic myelopathy and its impact on changes in sagittal parameters of cervical spine.Methods A retrospective analysis was conducted on the clinical data and radiological information of 73 patients who underwent expansive open-door laminoplasty(EOLP)for cervical spondylotic myelopathy in our department between March 2018 and June 2022.Patients were divided into the SEOLP group(n=35)and the EOLP group(n=38)based on the surgical method.Follow-up was conducted for one year.The operation time,blood loss,axial symptom scores,JOA scores,VAS scores and neck disability index(NDI)were recorded in two groups of patients.Radiological data were also recorded for both groups during the perioperative period,and the C2-7 Cobb angle,C2-7 SVA and T1 slope were measured.The cervical curvature index(CCI)and cervical range of motion(ROM)were calculated.The perioperative clinical outcomes and changes in cervical sagittal parameters were observed,and their correlations were analyzed.Results There were no significant differences in blood loss,operation time,JOA scores at various follow-up time points between the two groups(P>0.05).During postoperative follow-up,axial symptoms were observed in 5 patients in SEOLP group and 14 patients in EOLP group.There were statistically significant differences in axial symptom scores,incidence and severity of axial symptoms between the two groups(P<0.05).The NDI indices at one year after operation were 21.1±2.3 for SEOLP group and 24.8±3.5 for EOLP group respectively(P<0.01).There were no statistically significant differences in T1 slope and C2-7 Cobb angle at various follow-up time points after surgery between the two groups(P>0.05).One year after operation,CCI indices for two groups were(13.4±2.7)and(12.1±2.4),respectively,with a statistically significant difference(t=2.178,P<0.05).The C2-C7 SVA values for two groups at one year after operation were(22.4+3.8)mm and(26.7±5.9)mm,respectively(t=3.667,P<0.01).The results of the correlation analysis showed that there was a significant negative correlation between clinical functional improvement(NDI)and changes of the radiological parameter C2-C7 SVA in both groups of patients.Conclusion After SEOLP,the recovery of C2-C7 SVA is faster and has less impact on cervical spine function,and the occurrence degree and incidence of axial symptoms are lower.

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