1.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.
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.Construction of the Diagnosis and Treatment System of "Sinew Prescription Correspondence" under the Guidance of Systematic Dialectical Sphygmology
Feng ZHANG ; Baoqiang DONG ; Xingxing LIN ; Yapeng LIU ; Lujia XIAO ; Bodong XING ; Yiyun CAO ; Wenhui ZHANG ; Wenqian QI
Journal of Traditional Chinese Medicine 2026;67(10):1038-1043
"Sinew prescription correspondence" is the principle of selecting prescriptions for channel sinew diseases. On the basis of the theory of syndrome differentiation and treatment, the pulse manifestation corresponds to the channel sinew syndrome, which can improve the flexibility and standardization of clinical prescriptions. From the perspective of systematic dialectical sphygmology, this paper explains the dialectical relationship between channel sinew theory and pulse body elements, pulse wall elements, pulse elements and blood flow elements, and clarifies the internal relationship between pulse manifestation and prescriptions at the level of channel sinew disease. The prescription is derived from the method, while the method is established with the syndrome, and the prescription is unified by the method. According to the theory of "sinew prescription correspondence", the treatment ideas of channel sinew diseases were analyzed from the perspective of channel sinew distribution, functional characteristics and structural changes. On this basis, the diagnosis of channel sinew disease and the application of prescriptions are expanded, and the research on the internal treatment and diagnosis mode of "pulse manifestation-channel sinew-zang fu (脏腑)" is prospected, so as to expand the differentiation and treatment methods of channel sinew theory.
4.Advances in the Study of Varenicline Combined with Nicotine Patches for the Treatment of Tobacco Dependence
Qiuqi WEI ; Wenqian ZHAO ; Ling LIU
Journal of Kunming Medical University 2025;46(4):157-162
China has the highest number of smokers in the world with more than 1 million tobacco-related deaths each year.Smoking cessation is a feasible intervention to reduce the prevalence of smoking-related diseases and premature deaths.The smoking cessation therapies approved for use in China are ineffective for some tobacco dependent patients.In order to further improve the rate of smoking cessation,a combination of medications can be chosen,including varenicline combined with nicotine replacement therapy.However,there are conflicting evaluation conclusions on the effectiveness and safety of combination therapy.This article aims to review the mechanism of action,efficacy,and safety of varenicline combined with nicotine replacement therapy in the treatment of tobacco dependence,aiming to provide a basis for this combination therapy.
5.Impact of health literacy on self-management in postoperative chemotherapy patients with colorectal cancer: the chain-mediated effects of coping style and fear of progression
Yue SUN ; Dequan WU ; Wenqian CAI ; Bo LIU ; Jiao CHEN
Chinese Journal of Practical Nursing 2025;41(15):1129-1136
Objective:To explore the mediating role of coping style and fear of disease progression between health literacy and self-management in postoperative chemotherapy patients with colorectal cancer. It provided a theoretical basis for improving the self-management ability of postoperative chemotherapy patients with colorectal cancer.Methods:Convenience sampling method was used to select postoperative chemotherapy patients with colorectal cancer admitted to the Second Affiliated Hospital of Anhui Medical University from October 2023 to May 2024, and a cross-sectional survey was conducted using Health Literacy Management Scale, Medical Coping Modes Scale, Fear of Progression Questionnaire-Short Form, and Cancer Patient Self-Management Assessment Scale.Results:A total of 229 questionnaires were distributed, of which 220 were returned as valid questionnaires, including 142 males and 78 females, aged (60.05 ± 10.14) years. The total health literacy score was (85.30 ± 9.45) points and self-management score was (150.36 ± 14.10) points among patients undergoing postoperative chemotherapy for colorectal cancer. Self-management was positively correlated with health literacy and facing ( r=0.576, 0.525, both P<0.01), while negatively correlated with avoidance, yielding, and fear of disease progression ( r=-0.660, -0.616, -0.566, all P<0.01). The mediation model showed that facing coping style and fear of disease progression had a chained mediation effect of 0.050 between health literacy and self-management, accounting for 8.36% of the total effect. Conclusions:Self-management in patients with postoperative chemotherapy for colorectal cancer was moderately low. The chain mediating role of coping style and fear of disease progression between health literacy and self-management in postoperative chemotherapy patients with colorectal cancer was established. Nursing staff should strengthen health education for postoperative chemotherapy patients with colorectal cancer, guide patients to face the disease positively, reduce fear, and promote patient self-management.
6.Aerobic exercise activates SLC7A11/GPx4 pathway to inhibit mitochondrial ferroptosis and prevent sarco-penia in aging mice
Haitao WANG ; Wenqian YANG ; Yuqian LIU
Chinese Journal of Rehabilitation Medicine 2025;40(4):501-507
Objective:To elucidate the role of solute carrier protein 7,family member 11(SLC7A11)/Glutathione peroxi-dase 4(glutathione peroxidase 4,GPx4)regulated ferroptosis pathway in the improvement of sarcopenia through aerobic exercise,and to identify a new target for the prevention and treatment of sarcopenia with exercise.Method:Twenty 52-week-old Specific pathogen Free(SPF)C57BL/6 male mice were randomly divided into the old control group(OC)and the old exercise group(OE).There were 10 mice in each group.Following one week of adaptive exercise,moderate-intensity exercise with incremental load was implemented as follows:14 m/min at 1-2 weeks,15 m/min at 3-4 weeks,16m/min at 5-10weeks,17m/min at 11-16weeks,60min/d,all with a slope of 0°.Gastrocnemius was harvested for ultrathin electron microscope sections.The levels of Glutathione(GSH),muscle glycogen and non-heme iron(non-heme iron)were measured by spectro-photometer.The serum ferritin(SF),mitochondrial 8-hydroxy-2 deoxyguanosine(8-OHdG)and 4-Hydroxynone-na(4-HNE)were measured by enzyme-linked immunosorbent assay(ELISA).Western blot was used to detect the expression of iron metabolism-related proteins,such as GPx4,SLC7A11,ferroportin 1(FPN1)and ferri-tin heavy chain 1(FTH1)in gastrocnemius muscle.Result:①Compared with OC,the wet weights of quadriceps femoris and gastrocnemius in OE were signifi-cantly increased(P<0.01).In the exercise group,mitochondrial cristae arranged neatly and densely,and the light and dark bands of myofilaments were clear.In the aged control group,the mitochondrial cristae of gas-trocnemius muscle were disrupted,vacuolated or pyknotic,showing typical features of ferroptosis.② The SF and the iron content of gastrocnemius muscle were decreased in OE(P<0.01).③ The levels of 4-HNE and 8-OHdG in gastrocnemius muscle of OE were significantly lower than those of OC(P<0.01).The GSH content in gastrocnemius of OE was significantly higher than that of OC(P<0.01).④ The expressions of SLC7A11,GPx4,FPN1 and FTH1 in gastrocnemius muscle of OE were significantly higher than those of OC(P<0.01).Conclusion:Moderate aerobic exercise can prevent age-related sarcopenia by activating the SLC7A11/GPx4 pathway and inhibiting mitochondrial ferroptosis.
7.Construction of Nomogram prediction model for pulmonary infection in patients after aortic dissection surgery
Wenqian CAI ; Dequan WU ; Wenjing LYU ; Bo LIU ; Yue SUN
Chinese Journal of Practical Nursing 2025;41(28):2161-2168
Objective:To construct Nomogram prediction model for pulmonary infection in patients after aortic dissection surgery, so as to provide reference for early screening of high-risk groups and carrying out preventive nursing measures.Methods:This was a retrospective case-control study. The case data of patients after aortic dissection surgery in the Second Affiliated Hospital of Anhui Medical University from January 2020 to October 2023 were selected by convenient sampling method and divided into pulmonary infection group and non-pulmonary infection group according to whether pulmonary infection occurred within one week after surgery. The risk factors of pulmonary infection after aortic dissection surgery were analyzed by Logistic regression and the Nomogram prediction model was constructed by R4.3.3.The model was evaluated by area under the receiver operating characteristic curve, calibration curve and decision curve analysis.Results:A total of 324 patients with aortic dissection were collected, and the incidence of postoperative pulmonary infection was 26.9%(87/324). There were 87 cases in pulmonary infection group, including 65 males and 22 females, with a median age of 58.0 years. There were 237 cases in non-pulmonary infection group, including 180 males and 57 females, with a median age of 60.0 years. Finally, operation time ( OR=1.015, 95% CI 1.007-1.022), intraoperative blood transfusion ( OR=1.001, 95% CI 1.000-1.022), mechanical ventilation time ( OR=7.624, 95% CI 2.679-21.692), postoperative invasive operation ( OR=6.310, 95% CI 1.545-25.778) and postoperative renal insufficiency ( OR=6.723, 95% CI 1.219-37.063) were independent risk factors for pulmonary infection after aortic dissection surgery. The area under the receiver operating characteristic curve of the model was 0.978, sensitivity of 93.7%, and specificity of 90.8%. The calibration curve showed good consistency, and the decision curve analysis curve showed good net benefit. Conclusions:Operation time, intraoperative blood transfusion, mechanical ventilation time, postoperative invasive operation and postoperative renal insufficiency are high-risk factors of pulmonary infection after aortic dissection surgery and the constructed predictive model has predictive value.
8.Investigation on the Role of Medical Recombinant Human-Derived Collagen Functional Dressings in Wound Healing.
Xiaoxiao GAI ; Xiaoxia SUN ; Wenqian MA ; Zhenhua LIN ; Xinyuan LI ; Chenghu LIU
Chinese Journal of Medical Instrumentation 2025;49(4):415-422
OBJECTIVE:
To investigate the biological effect of medical recombinant human-derived collagen functional dressings in wound healing.
METHODS:
MTT assay and RTCA assay were used to detect cell toxicity and proliferation. Scratch assay and Transwell cell migration assay were used to detect cell motility and migration ability. Enzyme-linked immunosorbent assay was used to detect the contents of vascular endothelial growth factor (VEGF), fibroblast growth factor (FGF), and platelet-endothelial cell adhesion molecule (CD31) in the supernatant of four types of cells. After animal surgery, the surgical wound was taken at 1 week, 4 weeks and 13 weeks, respectively, for hematoxylin eosin (HE) staining and immunohistochemistry to observe the inflammatory response and CD31 expression of the wound.
RESULTS:
Medical recombinant human-derived collagen functional dressing promotes cell proliferation and migration, enhances wound angiogenesis by upregulating the expression of VEGF, FGF, and CD31 in human dermal vascular endothelial cells (HDVEC) and human vascular endothelial cells (HVEC), thereby improving local blood supply to the wound, regulating the inflammatory response of the wound, and accelerating wound healing.
CONCLUSION
Recombinant type Ⅲ humanized collagen plays an important role in wound healing.
Humans
;
Wound Healing/drug effects*
;
Recombinant Proteins/pharmacology*
;
Animals
;
Cell Proliferation
;
Cell Movement
;
Collagen/pharmacology*
;
Vascular Endothelial Growth Factor A/metabolism*
;
Bandages
;
Platelet Endothelial Cell Adhesion Molecule-1/metabolism*
;
Endothelial Cells
;
Fibroblast Growth Factors/metabolism*
9.Study on the correlation between the expression of inflammatory cytokines in cerebrospinal fluid and the severity and prognosis of spontaneous intracerebral hemorrhage
Jianqiang WEI ; Jing YIN ; Ming-yan HONG ; Jianzhong CUI ; Kaijie WANG ; Hongyu WANG ; Xinwang CAI ; Wenqian ZHANG ; Huan LIU
The Journal of Practical Medicine 2025;41(22):3558-3565
Objective To examine the expression levels of inflammatory factors,including IL-6,IL-10,MMP-9,IL-17A,and LDH,in the cerebrospinal fluid(CSF)of patients with spontaneous intracerebral hemor-rhage(sICH),and to investigate their associations with disease severity and clinical outcomes.Methods A total of 168 patients with sICH admitted to Tangshan GongRen Hospital between January 2023 and January 2025 were prospectively enrolled as the study group,while 30 non-sICH patients who underwent lumbar puncture during the same period served as the control group.Levels of inflammatory factors in CSF were compared between the two groups.Spearman's rank correlation analysis was performed to assess the association between inflammatory factor levels and clinical severity in sICH patients.Binary logistic regression analysis was conducted to identify independent predictors of sICH prognosis.Receiver operating characteristic(ROC)curve analysis was employed to evaluate the prognostic value of these inflammatory factors in sICH.Results The levels of IL-6,IL-10,MMP-9,IL-17A,and LDH in the CSF of patients with sICH were significantly higher than those in non-sICH patients(all P<0.05).Furthermore,among sICH patients,these biomarker levels exhibited a graded increase according to disease severity:severe>moderate>mild(all P<0.05).Spearman correlation analysis revealed significant positive correlations between CSF levels of IL-6,IL-10,MMP-9,IL-17A,and LDH and the NIHSS scores,with correlation coefficients(r)of 0.686,0.553,0.685,0.593,and 0.695,respectively(all P<0.05).When comparing the prognoses of sICH patients,hematoma size,NIHSS score,and CSF levels of IL-6,IL-10,MMP-9,IL-17A,and LDH were significantly higher in the deceased group than in the survival group(P<0.05),whereas ApoA1 levels were lower in the deceased group(P<0.05).Logistic regression analysis revealed that hematoma size,NIHSS score,and elevated CSF levels of IL-6,IL-10,MMP-9,IL-17A,and LDH were independent risk factors for mortality in sICH patients(P<0.05).ROC curve analysis showed that the AUC values for CSF IL-6,IL-10,MMP-9,IL-17A,and LDH in predicting sICH prognosis were 0.794,0.754,0.670,0.717,and 0.683,respectively.Notably,the combination of CSF inflammatory markers with hematoma size and NIHSS score yielded an AUC of 0.993,demonstrating significantly greater predictive accuracy than CSF inflammatory markers alone(P<0.05).Conclusions The levels of inflammatory factors in the CSF,including IL-6,IL-10,MMP-9,IL-17A,and LDH,were elevated in patients with sICH and positively correlated with disease severity.Combining CSF inflammatory markers with the NIHSS score and hematoma size improved the predictive accuracy for sICH prognosis.
10.Key questions of translational research on international standards of acupuncture-moxibustion techniques: an example from the WFAS Technical Benchmark of Acupuncture and Moxibustion: General Rules for Drafting.
Shuo CUI ; Jingjing WANG ; Zhongjie CHEN ; Jin HUO ; Jing HU ; Ziwei SONG ; Yaping LIU ; Wenqian MA ; Qi GAO ; Zhongchao WU
Chinese Acupuncture & Moxibustion 2025;45(8):1159-1165
OBJECTIVE:
To provide the experience and demonstration for the transformation of acupuncture-moxibustion techniques standards from Chinese national standards to international standards.
METHODS:
Questionnaire research, literature research, semi-structured interviews and expert consultation were used.
RESULTS:
The safety of acupuncture-moxibustion techniques was evaluated through literature research, and based on the results of the questionnaire survey, expert interviews, and expert consultation, 11 main bodies and structure of the former Chinese national standard, Technical Benchmark of Acupuncture and Moxibustion: General Rules for Drafting, were adjusted and optimized in accordance with the requirements of international standard (including the language, normative references, purpose, scope, applicable environment, target population, work team, terms and definitions, general principles and basic requirements, structural elements and text structure, and compilation process); and the first international standard, World Federation of Acupuncture-Moxibustion Societis (WFAS) Technical Benchmark of Acupuncture and Moxibustion: General Rules for Drafting was formulated to specify the general rules for drafting.
CONCLUSION
The 3 key questions, "international compatibility", "technical operability" and "safety" should be solved technically on the basis of explicit international requirements. It is the core technical issue during transforming the national standards of technical benchmark of acupuncture and moxibustion into international standards.
Moxibustion/methods*
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Acupuncture Therapy/methods*
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Humans
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Translational Research, Biomedical/standards*
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Surveys and Questionnaires
;
China
;
Benchmarking/standards*

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