[Clinical comprehensive evaluation of Jiangzhi Tongluo Soft Capsules for treating hyperlipidemia (syndrome of blood stasis and Qi stagnation)].

This study provides a systematic review of existing evidence concerning the efficacy of Jiangzhi Tongluo Soft Capsules(JTSC) in treating hyperlipidemia(syndrome of blood stasis and Qi stagnation), following the Guidelines for clinical evidence and value assessment of drugs. The qualitative and quantitative methods were integrated, including questionnaire surveys, evidence-based medicine, and pharmacoeconomic evaluation. Multi-criteria decision analysis(MCDA) model was used for comprehensive assessment of the clinical evidence and value of JTSC for hyperlipidemia in "6+1" dimensions: safety, effectiveness, cost-effectiveness, innovation, suitability, accessibility, and traditional Chinese medicine(TCM) characteristics.

[Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration].

The group standard Pharmacovigilance guidelines for clinical application of Chinese patent medicines for mucosal administration was released on January 16, 2024, on the national group standards information platform by the Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences and School and Hospital of Stomatology of Peking University, under the centralized management by the China Association of Chinese Medicine. The standard number is T/CACM 1563.6-2024.

[Pharmacovigilance guidelines for clinical application of Chinese patent medicines for external use].

There are many kinds and dosage forms of Chinese patent medicines for external use on the market, which are widely used in clinical departments. The common adverse reactions of Chinese patent medicines for external use are skin reactions, and those for the rare severe diseases include palpitation, chest tightness, dyspnea, and anaphylactic shock. At present, World Health Organization(WHO), International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH),the United States, the European Union, and Asia-Pacific countries(such as Japan and South Korea) have not issued any pharmacovigilance guideline of Chinese patent medicines for external use.

[Guidelines for construction of traditional Chinese medicine pharmacovigilance system in medical institutions].

The group standard Guidelines for construction of traditional Chinese medicine(TCM) pharmacovigilance system in medical institutions, managed by Chinese Association of Chinese Medicine and led by the Institute of Basic Research in Clinical Medicine,China Academy of Chinese Medical Sciences and Dongfang Hospital of Beijing University of Chinese Medicine, was announced on National Group Standard Information Platform on January 16, 2024, with the standard number T/CACM 1563. 2-2024. According to EU pharmacovigilance regulations and the second-level guidance principles of International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use(ICH), the unique characteristics of TCM were fully considered, and the relevant systems and procedures for constructing TCM pharmacovigilance systems in medical institutions were clearly defined.

[Prospective,multi-center,and large-scale hospital centralized monitoring of clinical safety of Reduning Injection in 100249 children cases].

This study utilized a prospective, large-sample, multi-center, and registered key specialty approach of hospitals to monitor the application of Reduning Injection. A total of 100 249 adolescent patients aged 14 years and below who received Reduning Injection were monitored, resulting in 83 cases of adverse events, with 76 of them being classified as adverse drug reaction(ADR). The calculated incidence rate of ADR for Reduning Injection was 0.

[Clinical comprehensive evaluation of Ginkgolide Injection in treatment of cerebral infarction].

This clinical value-oriented comprehensive evaluation of drugs was carried out in accordance with Guidelines for Management of Comprehensive Clinical Evaluation of Drugs(trial version 2021), with the qualitative and quantitative evaluation methods adopted. Based on the evidence-based medicine, epidemiology, clinical medicine, pharmacoeconomics, mathematical statistics, and health technology evaluation(HTA), the clinical value of Ginkgolide Injection was evaluated from the "6+1" dimension by giving weight to the criterion level and index level and calculating with multi-criteria decision analysis(MCDA) model and CSC v2.0.

[Clinical comprehensive evaluation of Diemailing~® Kudiezi Injection in treatment of cerebral infarction].

Clinical comprehensive evaluation was conducted in "6+1" dimensions(safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine) to reflect the advantages and characteristics of Diemai-ling~® Kudiezi Injection in the treatment of cerebral infarction. This study adopted a combination of qualitative and quantitative evaluation methods. Based on the methodologies of evidence-based medicine, epidemiology, clinical medicine, evidence-based pharmacy, pharmacoeconomics, mathematical statistics, and health technology assessment(HTA), experts gave weight to the criterion layer and index layer, and multi-criteria decision analysis(MCDA) model and CSC v2.

[Clinical comprehensive evaluation of Mudan Granules in treatment of diabetic peripheral neuropathy with Qi-deficiency and collateral stagnation syndrome].

This study explored the clinical comprehensive evaluation of Mudan Granules, aiming to promote the safe, effective and rational use of Mudan Granules, reflect its clinical value and provide a basis for medical decision-making. The safety, effectiveness, economy, innovation, suitability, accessibility, and characteristics of traditional Chinese medicine of Mudan Granules were combed, and the multi-criteria decision analysis(MCDA) model was used to carry out comprehensive evaluation on each dimension. In terms of safety, multiple sources of evidence showed that the adverse reactions of Mudan Granules mainly involved gastrointestinal system, with controllable safety risk rated as grade B.

[Report standards for clinical comprehensive evaluation of Chinese patent medicine].

The clinical comprehensive evaluation of drugs is an important basis for the return of clinical value, decision-making of medical and health authorities, and allocation of medical resources. In July 2021, the National Health Commission issued the Guidelines for the Management of Clinical Comprehensive Evaluation of Drugs(trial version 2021), which required the evaluation to be implemented from the six dimensions(safety, effectiveness, economy, innovation, suitability, and accessibility), and made detailed arrangements for the clinical comprehensive evaluation of drugs. As Chinese patent medicine differs from chemical medicines in terms of effective components and action modes, the clinical comprehensive evaluation of Chinese patent medicine should highlight the characteristics and advantages of traditional Chinese medicine(TCM) on the basis of general requirements of comprehensive clinical evaluation of drugs.

[Early detection and risk control of safety signals of Chinese medicine].

The safety of modern Chinese medicine has attracted increasing attention from society. Experts and scholars have carried out extensive in-depth research on the safety of commonly used Chinese medicines from various aspects such as safety monitoring, clinical research, and experimental analysis. The findings in the safety performance of Chinese medicines can inspire the mining and analysis of relevant signals in the drug safety alerts.

[Study of integrative evidence chain in clinical trial of Guizhi Fuling Capsules based on "Yibing Tongzhi" in clinical applications].

Guizhi Fuling Capsules is a new-type traditional Chinese medicine preparation made by modern process method. It was widely used to treat uterine fibroids, pelvic inflammation, dysmenorrhea, endometriosis, mammary gland hyperplasia and other gynecological diseases. Under the combination of disease and syndrome, the diagnosis and treatment model of "Yizheng Tongbing, Yibing Tongzhi" with Chinese patent medicine has been widely used in clinical practice.

[TCR immune repertoire characteristics of patients with drug-induced liver injury due to Polygonum multiflorum preparations].

To explore the immune status of patients with drug-induced liver injury caused by Polygonum multiflorum preparations,and analyze their immune characteristics. Case-control design was used to collect the cases of drug-induced liver injury caused by P. multiflorum preparations through key specialized surveillance.

[Post-marketing surveillance on Guizhi Fuling Jiaonang based on literature review].

To systemically evaluate the post-marketing safety of Guizhi Fuling Jiaonang. Computer retrieval was conducted in Medline, EMbase, the Web of Science, Clinical Trials. Gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM to collect relevant information.

[Systematic review on safety of Xianling Gubao capsule].

To systemically evaluate the safety of Xianling Gubao capsule after launching. Computer retrieval of Medline, EMbase, the Web of Science, Clinical Trials. gov, the Cochrane Library, CNKI, VIP, WanFang Data and CBM was conducted to collect information on all the research types of Xianling Gubao capsule.

EGCG decreases the expression of HIF-1α and VEGF and cell growth in MCF-7 breast cancer cells.

Purpose: To investigate the effects of epigallocatechin-3-gallate (EGCG) on the expression of HIF-1α and vascular endothelial growth factor (VEGF) and cell growth in MCF-7 breast cancer cells.

Methods: MCF-7 human breast cancer cells were pretreated with different concentrations of EGCG (25, 50, 100 mg/L) for 48 h. The growth and proliferation of cells were analyzed by trypan blue staining in the pretreated MCF-7 cells.

Construction and identification of the recombinant lentiviral expression vector targeting human BAX inhibitor-1 gene.

Purpose: The aim of this study was to construct a recombinant lentiviral expression vector targeting human BAX inhibitor- 1(BI-1) gene and observe its expression in NIH3T3 cells.

Methods: Human BI-1 gene was amplified by polymerase chain reaction (PCR), and then cloned into the vector pLCMV- IG using DNA recombinant technique. After the inserted sequences in the recombinant plasmids were identified by PCR, and double digesting and DNA sequencing analysis, the recombinant lentivirus was packaged and administered into NIH3T3 cells.