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.Research on hybrid brain-computer interface based on imperceptible visual and auditory stimulation responses.
Zexin PANG ; Yijun WANG ; Qingpeng DONG ; Zijian CHENG ; Zhaohui LI ; Ruoqing ZHANG ; Hongyan CUI ; Xiaogang CHEN
Journal of Biomedical Engineering 2025;42(4):660-667
In recent years, hybrid brain-computer interfaces (BCIs) have gained significant attention due to their demonstrated advantages in increasing the number of targets and enhancing robustness of the systems. However, Existing studies usually construct BCI systems using intense auditory stimulation and strong central visual stimulation, which lead to poor user experience and indicate a need for improving system comfort. Studies have proved that the use of peripheral visual stimulation and lower intensity of auditory stimulation can effectively boost the user's comfort. Therefore, this study used high-frequency peripheral visual stimulation and 40-dB weak auditory stimulation to elicit steady-state visual evoked potential (SSVEP) and auditory steady-state response (ASSR) signals, building a high-comfort hybrid BCI based on weak audio-visual evoked responses. This system coded 40 targets via 20 high-frequency visual stimulation frequencies and two auditory stimulation frequencies, improving the coding efficiency of BCI systems. Results showed that the hybrid system's averaged classification accuracy was (78.00 ± 12.18) %, and the information transfer rate (ITR) could reached 27.47 bits/min. This study offers new ideas for the design of hybrid BCI paradigm based on imperceptible stimulation.
Brain-Computer Interfaces
;
Humans
;
Evoked Potentials, Visual/physiology*
;
Acoustic Stimulation
;
Photic Stimulation
;
Electroencephalography
;
Evoked Potentials, Auditory/physiology*
;
Adult
6.Quercetin ameliorates myocardial injury in diabetic rats by regulating L-type calcium channels.
Hongyan SUN ; Guoqing LU ; Chengwen FU ; Mengwen XU ; Xiaoyi ZHU ; Guoquan XING ; Leqiang LIU ; Yufei KE ; Lemei CUI ; Ruiyang CHEN ; Lei WANG ; Pinfang KANG ; Bi TANG
Journal of Southern Medical University 2025;45(3):531-541
OBJECTIVES:
To investigate the effects of quercetin on cuproptosis and L-type calcium currents in the myocardium of diabetic rats.
METHODS:
Forty SD rats were randomized into control group and diabetic model groups. The rat models of diabetes mellitus (DM) induced by high-fat and high-sugar diet combined with streptozotocin (STZ) injection were further divided into DM model group, quercetin treatment group, and empagliflozin treatment group (n=10). Blood glucose and body weight were measured every other week, and cardiac function of the rats was evaluated using echocardiography. HE staining, Sirius red staining, and wheat germ agglutinin (WGA) analysis were used to observe the changes in myocardial histomorphology, and serum copper levels and myocardial FDX1 expression were detected. In cultured rat cardiomyocyte H9c2 cells with high-glucose exposure, the effects of quercetin and elesclomol, alone or in combination, on intracellular CK-MB and LDH levels and FDX1 expression were assessed, and the changes in L-type calcium currents were analyzed using patch-clamp technique.
RESULTS:
The diabetic rats exhibited elevated blood glucose, reduced body weight, impaired left ventricular function, increased serum copper levels and myocardial FDX1 expression, decreased L-type calcium currents, and prolonged action potential duration. Quercetin and empagliflozin treatment significantly lowered blood glucose, improved body weight, and restored cardiac function of the diabetic rats, and compared with empagliflozin, quercetin more effectively reduced serum copper levels, downregulated FDX1 expression, and enhanced myocardial L-type calcium currents in diabetic rats. In H9c2 cells, high glucose exposure significantly increased myocardial expressions of FDX1, CK-MB and LDH, which were effectively lowered by quercetin treatment; Elesclomol further elevated FDX1, CK-MB and LDH levels in the exposed cells, and these changes were not significantly affected by the application of quercetin.
CONCLUSIONS
Quercetin ameliorates myocardial injury in diabetic rats possibly by suppressing myocardial cuproptosis signaling and restoring L-type calcium channel activity.
Animals
;
Quercetin/pharmacology*
;
Calcium Channels, L-Type/metabolism*
;
Diabetes Mellitus, Experimental/metabolism*
;
Rats, Sprague-Dawley
;
Rats
;
Myocytes, Cardiac/drug effects*
;
Myocardium/pathology*
;
Male
7.Evaluation of neoadjuvant chemotherapy curative effect in patients with breast cancer by MRI
Liangfeng YAO ; Baoliang GUO ; Hongyan HE ; Xulong FAN ; Cuishan LIANG ; Gan TIAN ; Yunneng CUI
Journal of Practical Radiology 2025;41(5):767-770
Objective To analyze the value of MRI in evaluating the treatment efficacy of neoadjuvant chemotherapy(NAC)in breast cancer patients.Methods The clinical data of 130 patients with breast cancer were analyzed retrospectively.All patients under-went 4-8 cycles of NAC,with MRI examinations was performed before and after NAC treatment.Based on postoperative response eval-uation criteria in solid tumors(RECIST),the patients were categorized into effective and ineffective groups.The MRI related param-eters,early enhancement parameters and peak enhancement parameters before and after NAC were observed to evaluate the efficacy of MRI in evaluating the treatment efficacy of NAC in breast cancer.Results The sensitivity,specificity,and accuracy of MRI in evalua-ting the treatment efficacy of NAC in breast cancer were 96.74%,89.47%,and 94.62%,respectively.The Kappa value for consis-tency analysis between MRI and postoperative pathology reached 0.869,indicating good agreement.Receiver operating characteristic(ROC)curve analysis showed that the area under the curve(AUC)for MRI in predicting the treatment efficacy of NAC in breast cancer was 0.935[95% confidence interval(CI)0.831-0.981].Significant differences were observed between the effective and ineffec-tive groups in early and peak enhancement parameters before and after NAC(P<0.05).Conclusion MRI can effectively assesses the treatment efficacy of NAC in breast cancer patients,demonstrating high value in clinical applications.
8.Intracranial mesenchymal tumors with FET::CREB fusion: a clinicopathological analysis of six cases
Peizhu HU ; Li CUI ; Weiwei WANG ; Xiaoyu WU ; Wencai LI ; Hongyan ZHANG
Chinese Journal of Pathology 2025;54(1):41-45
Objective:To investigate the clinicopathological and molecular genetic characteristics of intracranial mesenchymal tumors with FET::CREB fusion transcript.Methods:The clinical and imaging data of 6 cases of intracranial mesenchymal tumors with FET::CREB fusion from December 2018 to December 2023 were collected at the First Affiliated Hospital of Zhengzhou University. Their histological features, immunophenotype and molecular characteristics were analyzed.Results:Among the 6 patients, 4 were males and 2 were females, and the median age was 20 years. The clinical symptoms were increased intracranial pressure in 5 cases and epilepsy in 1 case. The lesion sites were cerebellum (2 cases), frontal lobe (2 cases), parietal lobe (1 case), and cranioorbital communication (1 case). The radiological features mainly showed solid or cystic components, with obvious annular enhancement on MRI. The histopathological features showed a wide spectrum of morphology, clear boundaries and fibrous pseudocapsule. The tumor cells were arranged in a lamellar or nodular pattern, and some in cord or loose network. The tumor cells were spindle, oval, epithelioid or stellate. The stroma was collagenous or mucin-rich, and accompanied by abundant lymphocytes and plasma cells infiltration. By immunohistochemical staining, desmin, CD99 and EMA were expressed in 6 cases, CD68 in 1 case, MUC4 in 1 case, synaptophysin in 2 cases, and ALK in 1 case. The Ki-67 proliferation index was between 1%-15%. Molecular analysis showed EWSR1::ATF1 fusion in 3 cases, EWSR1::CREB1 fusion in 2 cases, and EWSR1::CREM fusion in 1 case.Conclusions:Intracranial mesenchymal tumors with FET::CREB fusion are relatively rare and typically occur in children and younger adults. These tumors have a broad morphological spectrum and often express desmin, CD99 and EMA. The molecular characteristics are the gene fusions of FET family (mainly EWSR1, FUS) with CREB family transcription factors (ATF1, CREB1 or CREM). It is necessary to distinguish these tumors from meningiomas and solitary fibrous tumors, and the combination of immunohistochemical staining and molecular genetic testing can effectively help identify these tumors.
9.The research progress of neutrophil extracellular traps in antiphospholipid syndrome
Hongyan ZHONG ; Xiaohui CHEN ; Liyan CUI
Chinese Journal of Laboratory Medicine 2025;48(6):770-773
Antiphospholipid syndrome (APS) is a systemic autoimmune disease caused by antiphospholipid antibodies. Recent studies have found that neutrophil extracellular traps (NET) play an important role in the pathogenesis of APS. This article mainly introduces the formation, detection and research progress of NET in APS. Additionally, it summarizes the relevant drug targets for APS treatment based on NET, aiming to provide a reference for further research on APS.
10.Abnormalities of cerebellar-cerebral circuits and social impairment in ASD
Wenjing HU ; Tingli HE ; Zhe ZHANG ; Hongyan XU ; Zhangying ZHOU ; Xinxin CUI ; Danmeng CHENG ; Yanan HAN ; Xianwen DONG ; Anqin DONG
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(4):328-333
Autism spectrum disorder(ASD) is a neurodevelopmental disorder, and social impairment was one of the core symptoms of ASD, which can seriously affects the social life of patients.The pathogenesis of social impairment in ASD is unclear and it may involves many brain abnormalities.The related theories and hypotheses are numerous and there is no unified conclusion. Studies have shown that the cerebellum has extensive connections with brain networks and is involved in the regulation of social cognition, but its role in ASD has not been fully emphasized.The structural and functional abnormalities of the cerebellar-cortex (CC) loop in ASD patients can lead to language communication disorders, empathy disorders, difficulties in interpreting social cues, abnormal social reward processing and emotional regulation disorders, which are closely related to ASD social impairment. Noninvasive brain stimulation of the superficial cerebellum can improve the abnormal CC circuit in ASD patients, and the cerebellum can be considered as a target for the treatment of social disorders in ASD in the future.Based on the clinical and basic researches on social impairment in ASD in recent years, this article reviews the relevant manifestations of disorders which cerebellar and CC circuit involved, aiming to promote the development of related research in the future.

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