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.Relationship between heart failure and blood pressure variability in patients with hypertension and unstable angina pectoris
Jing ZHANG ; Lingyan SU ; Hongyan CUI
Journal of Public Health and Preventive Medicine 2026;37(4):81-85
Objective To investigate the relationship between occurrence of heart failure (HF) and blood pressure variability in patients with hypertension complicated with unstable angina pectoris (UA). Methods The data of 385 patients with hypertension and UA admitted to the Nantong Third People's Hospital from January 2022 to January 2024 were collected and analyzed. After discharge, the enrolled patients were followed up for 1 year via outpatient visits or telephone calls. The study endpoint was new-onset HF. The relationship of blood pressure variability with new-onset HF was analyzed. Results According to the clinical risk stratification of UA, the blood pressure variability in the high-risk group was higher than that in the low-risk group and the medium-risk group (P<0.05). There were 46 cases (11.94%) of new-onset HF among 385 UA patients with hypertension. After adjusting for confounding factors, the risk of new-onset HF in UA patients with hypertension was increased with the increases of 24 h systolic blood pressure standard deviation (24 h SSD) [HR (95% CI)=4.20 (2.33-14.79)] and nighttime systolic blood pressure standard deviation (nSSD) [HR (95% CI)=1.94 (1.53-2.46)] (P<0.05). Receiver operating characteristic (ROC) curve indicated that the AUCs of Model 1 and Model 2 in predicting new-onset HF were 0.776 and 0.869, and 95% CI values were 0.707-0.844 and 0.820-0.918, respectively. The AUC of Model 2 was higher than that of Model 1 (Z/P=3.734/<0.001). Conclusion For patients with hypertension complicated with unstable angina pectoris, the blood pressure variability indicators at admission have high predictive value on new-onset heart failure.
6.Prognosis and its influencing factors in patients with hypertension complicated with heart failure
Jun QIU ; Hongyan CUI ; Lingyan SU
Journal of Public Health and Preventive Medicine 2026;37(4):173-176
Objective To investigate the prognosis and its influencing factors in patients with hypertension complicated with heart failure (HF). Methods A total of 381 patients with hypertension and HF who were treated in our hospital from March 2022 to April 2025 were chosen. The patients were followed up for the prognosis within 6 months and split into good prognosis group (n=266) and poor prognosis group (n=115). The clinical data of the two groups were compared and analyzed. Multivariate Logistic regression analysis was used to determine the influencing factors of poor prognosis. Results The group with poor prognosis had higher proportions of atrial fibrillation and New York Heart Association (NYHA) Class III-IV, as well as increased left ventricular end-diastolic diameter (LVED), left ventricular end-systolic diameter (LVES), interventricular septum thickness (IVS), and left ventricular posterior wall thickness (LVPW) compared to the group with good prognosis (P<0.05). Additionally, levels of systolic blood pressure (SBP), N-terminal pro-B-type natriuretic peptide (NT-proBNP), total cholesterol (TC), low-density lipoprotein (LDL), creatinine (Cr) were elevated (P<0.05), while left ventricular ejection fraction (LVEF) was decreased (P<0.05). NYHA classification, LVEF, LVED, LVPW, NT-proBNP were independent influencing factors of poor prognosis in patients with hypertension complicated with HF (P<0.05). Conclusion NYHA classification, LVEF, LVED, LVPW and NT-proBNP are closely related to the poor prognosis of patients with hypertension and HF.
7.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
8.Quality control of pediatric musculoskeletal ultrasound
Tao CHEN ; Ligang CUI ; Jia'an ZHU ; Li QIU ; Li YUAN ; Hongyan WANG ; Jianchu LI
Chinese Journal of Medical Imaging Technology 2025;41(8):1354-1360
Quality control of pediatric musculoskeletal ultrasound(MSKUS)must be integrated throughout the entire diagnostic process.Its core lies in a thorough understanding of the growth,development,and pathophysiological characteristics of the pediatric musculoskeletal system,mastery of MSKUS examination techniques,and the establishment of a systematic and comprehensive diagnostic framework.This review focuses on the core aspects of pre-examination,during examination,and post-examination to describe the quality control points and strategies for pediatric MSKUS.
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.Neuroprotective effect of Tibetan medicine 70 Wei Pearl Pill on 6-OHDA Parkinson's disease model rats
Haiyan CUI ; Dan SONG ; Hongyan LI ; Jie LI ; Xinjie ZHAO ; Jianli ZHAO ; Mengru ZHANG ; Yong CHENG
Journal of Xi'an Jiaotong University(Medical Sciences) 2025;46(1):190-196
Objective To investigate the neuroprotective effect of Tibetan medicine 70 Wei Pearl Pill(RNSP)on 6-hydroxydopamine(6-OHDA)induced Parkinson's disease model rats and its related mechanism.Methods Totally 48 male SD rats were randomly divided into control group,model group,model plus low-dose RNSP group(90 mg/kg),model plus medium-dose RNSP group(180 mg/kg),model plus high-dose RNSP group(360 mg/kg),and model plus madopar group(50 mg/kg),with 8 rats in per group.Except for the control group,the other rats were treated with 6-OHDA single injection into the striatum to establish the PD model.Each group was given intragastric administration after modeling and the control group and model group were given an equal volume of saline once a day for 4 weeks.The rats were subjected to apomorphine-induced rotation,experiments at the 2nd and 4th week after the completion of modeling,and the open field experiment was conducted the next day after the last rotation experiment to observe the animal behavior.After the behavioral experiment,the rats were stained with tyrosine hydroxylase(TH)in the substantia nigra pars compacta by immunohistochemical method and the positive neurons were counted.The protein levels of Bcl-2,BAX,Caspase-3 in substantia nigra and P38,P-P38,ERK,P-ERK,JNK,P-JNK in the striatum were detected by Western blotting.Results Compared with the control group,the rotation frequency and percentage of rotating rats in the model group increased significantly at the 2nd and 4th weeks after modeling;the open field active distance,average speed and times of crossing the grid were significantly decreased;and the rest time was significantly increased.While the number of TH positive neurons in the substantia nigra was significantly decreased,the BAX and Caspase-3 protein levels were increased significantly,Bcl-2 was decreased significantly,the ratios of P-P38/P38,P-JNK/JNK and P-ERK/ERK in the striatum were significantly increased in PD group.Compared with the model group,the rotation frequency and percentage of rotating rats in the low-,medium-and high-dose groups of RNSP had no significant changes after 2 weeks of administration,the rotation frequency in the high-dose group and percentage of rotating rats in the low-and medium-dose RNSP groups significantly decreased after 4 weeks of administration.The open field active distance,average speed,and times of crossing the grid were significantly increased;the rest time was significantly decreased.The number of TH positive neurons in the substantia nigra was significantly increased,the Bax and Caspase-3 protein levels were decreased significantly while the Bcl-2 was significantly increased.The ratios of P-P38/P38,P-JNK/JNK and P-ERK/ERK in the striatum were significantly decreased.Conclusion Tibetan medicine RNSP can improve the motor ability and reduce the loss of DA neurons in PD rats,and its mechanism may be related to inhibiting P38/JNK/ERK signaling pathway and reducing the apoptosis of midbrain neurons.


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