The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

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.

The Guidelines for Construction of Traditional Chinese Medicine Pharmacovigilance Systems in Medical Institutions （T/CACM 1563.2-2024） were the first special guideline in China to systematically assist medical institutions in establishing a pharmacovigilance system tailored to the characteristics of traditional Chinese medicine （TCM）. This guideline was jointly developed with 23 authoritative medical and research institutions in China， under the lead of the Institute of Basic Clinical Medicine， China Academy of Chinese Medical Sciences. The purpose of this guideline was to standardize pharmacovigilance work throughout the entire lifecycle of TCM （including research and development， marketing， and application） and to establish a four-dimensional framework of "organizational structure， institutional system， information platform， and vigilance activities". Key components included the establishment of a TCM Safety Committee， the construction of nine core systems， the development of an information platform that complies with International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use （ICH） E2B standards， alongside the risk monitoring， identification， assessment， and control during clinical trials and post-marketing phases. Therefore， this guideline filled a significant gap in the systemic standards for TCM safety management within medical institutions. Strictly adhering to domestic and international laws and regulations， the guideline compilation involved multiple rounds of expert interviews， systematic evidence integration， and broad consensus. This guideline was specified to be applicable to medical institutions at all levels， primarily addressing core issues， including the difficulty in adverse reaction identification， low reporting rates， and incomplete risk management chains due to the complex composition and diverse application of TCM. The compilation process was scientific and rigorous， ensuring alignment with current national laws and regulations， and was registered internationally. In the future， implementation will be promoted through standardized training， tiered dissemination， as well as a post-effect evaluation and dynamic revision mechanism starting two years after publication. All these aimed to enhance medical institutions' proactive capabilities in preventing and controlling TCM safety risks， ensure patient medication safety， and promote the high-quality development of TCM.

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.

To explore the advantages of traditional Chinese medicine （TCM） and integrative TCM-Western medicine approaches in the treatment of diabetic microvascular complications （DMC）， refine key pathophysiological insights and treatment principles， and promote academic innovation and strategic research planning in the prevention and treatment of DMC. The 38th session of the Expert Salon on Diseases Responding Specifically to Traditional Chinese Medicine， hosted by the China Association of Chinese Medicine， was held in Beijing， 2024. Experts in TCM， Western medicine， and interdisciplinary fields convened to conduct a systematic discussion on the pathogenesis， diagnostic and treatment challenges， and mechanism research related to DMC， ultimately forming a consensus on key directions. Four major research recommendations were proposed. The first is addressing clinical bottlenecks in the prevention and control of DMC by optimizing TCM-based evidence evaluation systems. The second is refining TCM core pathogenesis across DMC stages and establishing corresponding "disease-pattern-time" framework. The third is innovating mechanism research strategies to facilitate a shift from holistic regulation to targeted intervention in TCM. The fourth is advancing interdisciplinary collaboration to enhance the role of TCM in new drug development， research prioritization， and guideline formulation. TCM and integrative approaches offer distinct advantages in managing DMC. With a focus on the diseases responding specifically to TCM， strengthening evidence-based support and mechanism interpretation and promoting the integration of clinical care and research innovation will provide strong momentum for the modernization of TCM and the advancement of national health strategies.

Childhood simple obesity has become a significant public health issue in China. Modern medicine primarily relies on lifestyle interventions and often suffers from poor long-term compliance， while pharmacological options are limited and associated with potential adverse effects. Traditional Chinese Medicine （TCM） has a long history in the prevention and management of this condition， demonstrating eight distinct advantages， including systematic theoretical foundation， diversified therapeutic approaches， definite therapeutic efficacy， high safety profile， good patient compliance， comprehensive intervention strategies， emphasis on prevention， and stepwise treatment protocols. Additionally， TCM is characterized by six distinctive features： the use of natural medicinal substances， non-invasive external therapies， integration of medicinal dietetics， simple exercise regimens， precise syndrome differentiation， and diverse dosage forms. By combining internal and external treatments， TCM facilitates individualized regimen adjustment and holistic regulation， demonstrating remarkable effects in improving obesity-related metabolic indicators， regulating constitutional imbalance， and promoting healthy behaviors. However， challenges remain， such as inconsistent operational standards， insufficient high-quality clinical evidence， and a gap between basic research and clinical application. Future efforts should focus on accelerating the standardization of TCM diagnosis and treatment， conducting multicenter randomized controlled trials， and fostering interdisciplinary integration， so as to enhance the scientific validity and international recognition of TCM in the prevention and treatment of childhood obesity.

OBJECTIVE The emergence of evolving variants of Coronavirus disease 2019(COVID-19)has fostered the need for change of newer and adaptive treatments for these infections.During the COVID-19 pandemic and persists,traditional Chinese medicine(TCM)herbs exhibit significant bioactivity and therapeutic effect.This study is aimed to evaluate the efficacy of four TCM preparations on 28-day mortality risk of patients and changes of the laboratory indicators.METHODS The retrospective cohort study included patients with COVID-19 who were admitted to the Jiangsu Province Hospital of Chinese Medicine from December 15,2022 to January 15,2023,and those died within 48 hours of admission or cannot be tracked for outcomes were excluded.The pri-mary outcome was survival status in 28 days(death or survival)starting from the day of admission.The second outcomes were labora-tory indicators,including absolute lymphocyte count,lactate dehydrogenase,creatinine,and blood urea nitrogen.Binary logistic re-gressions were used to estimate the effect of TCM preparations on the primary and secondary outcomes in main analysis.Meanwhile,heterogeneity and robustness of results from main analysis were assessed by subgroup analyses and multiple sensitivity analyses.RESULTS 1 816 eligible patients were included in analysis dataset,including 573 patients received standard care(control group)and 1 243 patients received TCM preparations(hospital preparation group).The 28-day mortality rate of hospital preparation group was lower than that of control group(4.75%vs.14.83%),and the difference was statistically significant(χ2=54.666,P<0.001).The risk of 28-day mortality was 0.535 times lower in the hospital preparation group as compared with the control group(OR=0.46,95%CI:0.305-0.708,P<0.001)showed by multivariable binary logistic regressions.Subgroup analyses showed that taking TCM preparations reduced the 28-day mortality risk.Sensitivity analyses demonstrated that the results of the main analysis for primary outcomes were robust.For secondary outcomes,the risk of abnormal absolute lymphocyte counts at discharge in the hospital prepara-tion group decreased by 0.284 times(OR=0.703,95%CI:0.515-0.961,P=0.027).CONCLUSION Compared with standard of care,taking four hospital preparations including Kanggan Heji,Feining Heji,Qishen Gubiao Keli,and Qianghuo Qushi Qingwen Heji decreased risk of 28-day mortality among hospitalized COVID-19 patients.TCM therapy achieves adequate therapeutic effects in COVID-19.

Objective To investigate the effectiveness and safety of electroconvulsive therapy(ECT)in reducing suicidal ideation and depressive symptoms of major depressive disorder patients,as well as its effect on cognitive function.Methods A total of 160 adolescent patients with major depressive disorder were recruited for this study.The ECT group(n=81)received conventional antidepressant medication combined with 8 sessions of electroconvulsive therapy,and the control group(n=79)received conventional antidepressant medication only.Depressive symptoms,suicidal ideation,and cognitive functioning were assessed using 17-item Hamilton rating scale for depression(HAMD-17)and self-rating idea of suicide scale(SIOSS),at baseline(before ECT),after ECT,and at 2 and 6 weeks after treatment.The Montreal cognitive assessment(MoCA)was used to evaluate the cognitive function of the patients,and the patients were followed up for side effects such as dizziness and nausea.Results Generalized estimating equation(GEE)analysis of HAMD-17 and SIOSS scores showed significant group×time interaction effects(P<0.01).Both groups exhibited a reduction in HAMD-17 scores before and after treatment(scores at four time points:ECT group 24.59±4.56 vs.13.25±4.32 vs.6.20±1.95 vs.3.62±2.04,control group 23.48±3.66 vs.15.42±3.11 vs.10.10±2.05 vs.4.68±2.01;P<0.01).The mean difference in HAMD-17 scores before and after treatment was-9.62±3.13 in the ECT group,and was-8.16±1.71 in the control group.Additionally,suicidal ideation reduced in both groups after treatment(SIOSS scores at four time points:ECT group 18.57±2.85 vs.10.93±3.52 vs.8.02±2.79 vs.3.70±1.96,control group 18.97±3.03 vs.15.51±2.98 vs.11.11±2.18 vs.6.44±1.78;P<0.01).For cognitive function scores,there was no interaction between group and time(P=0.21),the difference in the change in MoCA scores at different follow-up time points was significant(P<0.01),and the difference in the change in MoCA scores between the two groups was not significant(P=0.05),and the cognitive functions of the two groups could be restored to the baseline level at 6 weeks after treatment.No severe side effects were reported in either group of patients during the study.Conclusions Our findings confirm that ECT is effective and safe for improving suicidal ideation and depressive symptoms in adolescents with major depressive disorder.The impairment of cognitive function by ECT in adolescent patients with major depressive disorder is reversible.

Objective To develop a Knowledge-Attitude-Practice Questionnaire for Nursing Assistants on Humanistic Care and test its reliability and validity,in order to provide a valid tool for evaluating their humanistic care competence.Methods Based on the theory of knowledge,attitude and practice,the first draft of the questionnaire was developed through literature review,semi-structured interviews,2 rounds of Delphi expert consultation,and pre-surveys.All nursing assistants from 4 tertiary hospitals in Hubei Province were investigated by convenient sample,and the reliability and validity were tested from May to July,2024.Results 412 questionnaires were distributed and 399 valid questionnaires were recovered,with a valid questionnaire recovery rate of 96.84％.The final knowledge-attitude-practice questionnaire include 3 dimensions of knowledge,attitude and practice,with a total of 24 items and cumulative contribution rate was 65.338％.The CVI of each item in the questionnaire ranged from 0.800 to 1.000,with an average of 0.981.The confirmatory factor analysis showed that the scale model had a good fit.The total Cronbach's α coefficient of the questionnaire was 0.941,and the test-retest reliability coefficient of the questionnaire after 2 weeks was 0.923.Conclusion The knowledge-attitude-practice questionnaire has good reliability and validity,and it can be used as a valid tool for evaluating the competence of humanistic care of nursing assistants.

OBJECTIVE To explore the potential mechanism of ketamine-induced cognitive impairment in mice based on metabolomics.METHODS Male C57BL/6 mice were randomly divided into control group and ketamine group(25 mg/kg),with 12 mice in each group.Each group of mice was intraperitoneally injected with normal saline or corresponding drugs,4 times a day,for 10 consecutive days.On the last 2 days of drug administration,the cognitive behavior was evaluated by Y maze and novel object recognition test,and the histopathological changes in the prefrontal cortex(PFC)were observed.Ultra-high performance liquid chromatography-tandem mass spectrometry technology was used to analyze the changes of metabolites in PFC,screen for differential metabolites,and perform pathway enrichment analysis.RESULTS Compared with the control group,the morphology of PFC neurons in the ketamine group of mice was inconsistent.There were cavities around the nucleus,and the number of deeply stained cells increased.The mean optical density value of the Nissl staining positive area was significantly reduced,and the alternation rate and discrimination index were significantly reduced(P＜0.05 or P＜0.01).In the PFC tissue samples of mice of the two groups,there were a total of 114 differential metabolites,including 73 up-regulated and 41 down-regulated metabolites,including glutamine,succinic acid,ketoglutarate,and choline,etc.The differential metabolites mentioned above were mainly enriched in metabolism of alanine,aspartate and glutamate,metabolism of arginine and proline,γ aminobutyric acid synapses,pyrimidine metabolism,cholinergic synapses pathways,etc.CONCLUSIONS Ketamine can induce cognitive impairment in mice.Its neurotoxicity is related to abnormal synaptic transmission and energy metabolism,and neuroimmune regulation disorders.