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.The mediating role of fear of missing out between the dark triad and smartphone addiction in college students
Fang CHEN ; Mengmeng ZHAO ; Ruixin WANG ; Zhenyu ZHAO ; Jiale ZHAO ; Xinyue YIN ; Chunjuan NIU ; Lina LI
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(9):835-839
Objective:To explore the relationship between the dark triad, fear of missing out and smartphone addiction, as well as the mediating role of fear of missing out between the dark triad and smartphone addiction.Methods:A total of 408 college students were assessed using dirty dozen, fear of missing out scale, and mobile phone addiction index. SPSS 24.0 software was used for common method bias tests, descriptive statistical analysis, and correlation analysis. Mplus 8.3 software was employed to construct a structural equation model, and the Bootstrap method was used for mediation effect analysis.Results:The dark triad (36.14±9.06) was positively correlated with fear of missing out (22.55±6.60) and smartphone addiction (46.77±13.62) ( r=0.48, 0.45, both P<0.01). Fear of missing out was also positively correlated with smartphone addiction ( r=0.54, P<0.01). Fear of missing out played a partial mediating role in the relationship between the dark triad and smartphone addiction, with a total effect value of 0.495 and a mediating effect value of 0.217. Conclusion:Fear of missing out partially mediates the relationship between the dark triad and smartphone addiction. The dark triad not only directly predicts smartphone addiction but also indirectly influences smartphone addiction through fear of missing out.
6.The impact of insomnia on suicidal behavior among college students: the mediating role of depression and the moderating role of sense of meaning in life
Wei LIU ; Ruixin WANG ; Mengmeng ZHAO ; Yuxuan ZHENG ; Ying ZHANG ; Lina LI
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(8):727-732
Objective:To explore the relationship between insomnia, depression, sense of meaning in life and suicidal behavior among college students.Methods:A cross-sectional survey was conducted among 7 260 college students at a university in Hebei Province from September to November 2024. The insomnia severity index (ISI), patient health questionnaire(PHQ-9), meaning in life questionnaire(MLQ), and suicide behavior questionnaire-revised (SBQ-R) were used for assessment. Structural equation modeling test was conducted by Mplus 8.0 to test the mediating effect of depression and the moderating effect of sense of meaning in life.Results:(1) The scores of insomnia (6.00 (4.00, 8.00)), depression (2.50 (0, 2.00)), and suicidal behavior (4.00 (3.00, 4.00)) were significantly and positively correlated with each other ( r=0.51-0.66, all P<0.01). The sense of meaning in life (47.80 (39.00, 58.00)) was negatively correlated with insomnia, depression, and suicidal behavior ( r=-0.04--0.22, all P<0.01). (2) Insomnia could positively predict suicidal behavior among college students ( β= 0.15, P<0.01). (3) Depression played a partial mediating role between insomnia and suicidal behavior, with a mediating effect value of 0.40 (95% CI= 0.37-0.43), accounting for 72.73%(0.40/0.55) of the total effect. Conclusion:Depression plays a partial mediating role between insomnia and suicidal behavior among college students. The sense of meaning in life can moderate the impact of insomnia on depression and suicidal behavior.
7.Clinical analysis of the use of carglumic acid to treat organic acidemia-induced neonatal hyperammonemia in 6 cases
Caijun WANG ; Mengchen CAO ; Mengmeng CHEN ; Xiaoyuan ZHANG ; Yingyuan WANG ; Yanmei ZHAO ; Yongxing CHEN ; Wenqing KANG
Chinese Journal of Applied Clinical Pediatrics 2025;40(8):625-629
Objective:To analyze the clinical efficacy and safety of carglumic acid in the treatment of neonatal hyperammonemia caused by organic acidemia.Methods:A case summary was made.Six cases of neonatal hyperammonemia caused by organic acidemia treated at the Neonatal Intensive Care Unit of Henan Children′s Hospital from March to September in 2024 were included.They received comprehensive ammonia-lowering treatment in combination with oral carglumic acid dispersible tablets.The clinical data of the children were collected and analyzed retrospectively.Changes in blood ammonia levels, blood gas parameters, and complete blood count before and after treatment with carglumic acid were analyzed using the Wilcoxon test.The incidence of adverse reactions and clinical regression during the treatment with carglumic acid was observed.Results:There were 2 females and 4 males in the 6 patients included.Four children suffered from isolated methylmalonic acidemia caused by MUT gene mutations, and the other 2 had propionic acidemia.The clinical manifestations were poor breastfeeding in 6 cases, vomiting in 2 cases, poor response in 6 cases, weight loss in 6 cases, and convulsions in 3 cases.Acute metabolic decompensation abnormalities were presented in all children, such as metabolic acidosis, hyperammonemia, leukopenia and thrombocytopenia.The first dose of carglumic acid was 62-255 mg/kg, the second dose was 75-172 mg/kg.The blood ammonia level decreased from 411.7 (339.7, 623.8) μmol/L before treatment to 108.1 (35.5, 229.1) μmol/L after 48 hours of treatment, showing a statistically significant reduction ( Z=2.20, P<0.05).Three cases with a blood ammonia level higher than 400 μmol/L, it was effectively reduced after treatment with carglumic acid.Two cases did not undergo hemodialysis or peritoneal dialysis.One case underwent hemodialysis but died after withdrawing the treatment.After administration of carglumic acid, metabolic acidosis was corrected in all children, and 2 patients ultimately died after discontinuing the treatment.No causal relationship was identified between adverse events and carglumic acid treatment.The examinations at discharge and during the follow-up period (2-7 months) showed that most laboratory abnormalities (including leukopenia, anemia, thrombocytopenia, hyperlactatemia, hyponatremia, hyperkalemia, elevated myocardial enzymes, and hyperbilirubinemia) returned to normal. Conclusions:Carglumic acid can effectively reduce neonatal hyperammonemia caused by organic academia, improve metabolic disorders, and reduce the need for blood purification or peritoneal dialysis, with good safety.
8.SNG162 activates the estrogen signaling pathway at the membrane initiation of glioblastoma by upregulating ER-α36 ex-pression
Entong ZHAO ; Xin GUAN ; Hongyan LI ; Yunting QIU ; Bingqiang ZHANG ; Mengmeng CHEN ; Wei ZOU ; Chao QU
Practical Oncology Journal 2025;(3):177-183
Objective The aim of this study was to explore the effects of changes in the estrogen receptor alpha 36(ER-α36)expression on the proliferation and membrane-initiated estrogen signaling in glioblastoma U251 cells.Methods The expression and localization of ER-α36 and EGFR glioblastoma U87 cells and U251 cells were determined by immunofluorescence,qRT-PCR and Western blot.The effect of upregulating ER-α 36 on U251 cell proliferation and estrogen signaling pathway activity by low con-centrations of 100 pmol/L icariin isomer(SNG162)was detected by MTT assay and Western blot.Results ER-α36 and EGFR were co-expressed in the cell membrane of glioblastoma.Compared with DMSO(control group),the expression ER-α36(P<0.01)and EG-FR increased in U251 cells treated with SNG162(P<0.05);Further experments also found that low concentrations of SNG162 in-creased the expression of cycle related proteins-cyclin D1,cyclin B,cyclin E and CDK4(P<0.01),and enhanced the proliferative a-bility of U251 cells(P<0.05).Conclusion The low concentration of SNG162 upregulates the expression of ER-α36,activates the estrogen-mediated ERK1/2 MAPK,p38 MAPK,and EGFR/Src signaling pathways,promotes glioblastoma proliferation,and activates the membrane initialized estrogen signaling pathway.
9.The mediating role of fear of missing out between the dark triad and smartphone addiction in college students
Fang CHEN ; Mengmeng ZHAO ; Ruixin WANG ; Zhenyu ZHAO ; Jiale ZHAO ; Xinyue YIN ; Chunjuan NIU ; Lina LI
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(9):835-839
Objective:To explore the relationship between the dark triad, fear of missing out and smartphone addiction, as well as the mediating role of fear of missing out between the dark triad and smartphone addiction.Methods:A total of 408 college students were assessed using dirty dozen, fear of missing out scale, and mobile phone addiction index. SPSS 24.0 software was used for common method bias tests, descriptive statistical analysis, and correlation analysis. Mplus 8.3 software was employed to construct a structural equation model, and the Bootstrap method was used for mediation effect analysis.Results:The dark triad (36.14±9.06) was positively correlated with fear of missing out (22.55±6.60) and smartphone addiction (46.77±13.62) ( r=0.48, 0.45, both P<0.01). Fear of missing out was also positively correlated with smartphone addiction ( r=0.54, P<0.01). Fear of missing out played a partial mediating role in the relationship between the dark triad and smartphone addiction, with a total effect value of 0.495 and a mediating effect value of 0.217. Conclusion:Fear of missing out partially mediates the relationship between the dark triad and smartphone addiction. The dark triad not only directly predicts smartphone addiction but also indirectly influences smartphone addiction through fear of missing out.
10.The impact of insomnia on suicidal behavior among college students: the mediating role of depression and the moderating role of sense of meaning in life
Wei LIU ; Ruixin WANG ; Mengmeng ZHAO ; Yuxuan ZHENG ; Ying ZHANG ; Lina LI
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(8):727-732
Objective:To explore the relationship between insomnia, depression, sense of meaning in life and suicidal behavior among college students.Methods:A cross-sectional survey was conducted among 7 260 college students at a university in Hebei Province from September to November 2024. The insomnia severity index (ISI), patient health questionnaire(PHQ-9), meaning in life questionnaire(MLQ), and suicide behavior questionnaire-revised (SBQ-R) were used for assessment. Structural equation modeling test was conducted by Mplus 8.0 to test the mediating effect of depression and the moderating effect of sense of meaning in life.Results:(1) The scores of insomnia (6.00 (4.00, 8.00)), depression (2.50 (0, 2.00)), and suicidal behavior (4.00 (3.00, 4.00)) were significantly and positively correlated with each other ( r=0.51-0.66, all P<0.01). The sense of meaning in life (47.80 (39.00, 58.00)) was negatively correlated with insomnia, depression, and suicidal behavior ( r=-0.04--0.22, all P<0.01). (2) Insomnia could positively predict suicidal behavior among college students ( β= 0.15, P<0.01). (3) Depression played a partial mediating role between insomnia and suicidal behavior, with a mediating effect value of 0.40 (95% CI= 0.37-0.43), accounting for 72.73%(0.40/0.55) of the total effect. Conclusion:Depression plays a partial mediating role between insomnia and suicidal behavior among college students. The sense of meaning in life can moderate the impact of insomnia on depression and suicidal behavior.

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