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.

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 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.

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.

ObjectiveTo investigate whether Huanglian Jiedutang （HLJD） and its major active constituents （geniposide， baicalin， and berberine） can inhibit the inflammatory response of BV2 cells under lipopolysaccharide （LPS） stimulation via the high-mobility group protein B1 （HMGB1）/Toll-like receptor 4 （TLR4）/nuclear factor-κB （NF-κB） signaling pathway， and to explore differences in therapeutic efficacy among the three monomers， their combined formula， and HLJD under equal content ratios. MethodsBV2 microglial cells were used as the primary experimental model. Cell viability was assessed using the cell counting kit-8 （CCK-8） method to examine the effects of different concentrations of dimethyl sulfoxide （DMSO， 0.8%， 0.4%， 0.2%， 0.1%， and 0.05%） on cell viability. IncuCyte was employed to monitor the growth of cells under different concentrations of HLJD （200， 100， 50， 25， 12.5， 6.25 mg·L^-1）. Nitric oxide （NO） assay was used to screen the optimal HLJD concentration. High-performance liquid chromatography （HPLC） determined the content of geniposide， baicalin， and berberine in HLJD， and experimental groups were subsequently established according to the relative proportions of these constituents. CCK-8 assay evaluated cell viability under different treatments. Enzyme-linked immunosorbent assay （ELISA） measured levels of inflammatory factors （TNF-α， IL-1β， IL-6， IL-10） in the supernatant. Flow cytometry assessed the effects of treatments on M1-type polarization of BV2 cells. Western blot determined the expression levels of HMGB1， TLR4， and NF-κB-related proteins. ResultsCompared with the blank group， DMSO at concentrations ≤0.2% did not affect cell viability within 48 h. BV2 cell growth plateaued at 24 h after treatment with 200 mg·L^-1 HLJD. Under stimulation with 2 mg·L^-1 LPS， this concentration of HLJD effectively reduced NO release， and 6 h pre-treatment had a stronger inhibitory effect on NO than direct administration. HPLC results showed that 1 mg of HLJD freeze-dried powder contained approximately 24 μg of geniposide， 15 μg of baicalin， and 30 μg of berberine. Based on these ratios， experimental groups were blank， LPS （2 mg·L^-1）， HLJD （200 mg·L^-1）， monomer combination， geniposide （4.8 mg·L^-1）， baicalin （3 mg·L^-1）， and berberine （6 mg·L^-1）. The monomer combination group consisted of all three active constituents dissolved together. LPS and HLJD or its active constituents did not affect cell viability compared with the blank group. LPS significantly increased TNF-α， IL-1β， IL-6， and IL-10 in the supernatant （P<0.01）. HLJD and its active constituents significantly reduced pro-inflammatory factors TNF-α， IL-1β， and IL-6 （P<0.05， P<0.01） while upregulating anti-inflammatory IL-10 （P<0.01）， with the monomer combination showing the strongest effect （P<0.05， P<0.01）. Compared with the blank group， LPS significantly increased the proportion of CD80⁺CD86⁺ （M1-type） BV2 cells （P<0.01）. HLJD and its constituents partially inhibited M1 polarization （P<0.05， P<0.01）， with the monomer combination exhibiting the most pronounced effect （P<0.05， P<0.01）. Compared with the blank group， LPS upregulated HMGB1， TLR4， and NF-κB-related proteins （P<0.01）， whereas HLJD and its active constituents significantly reduced their expression （P<0.05， P<0.01）， with the monomer combination having the strongest regulatory effect （P<0.05， P<0.01）. ConclusionHLJD and its major active constituents （geniposide， baicalin， berberine） can inhibit LPS-induced inflammatory responses in BV2 cells. The combination of the three active constituents demonstrates the most potent anti-inflammatory effect， significantly attenuating M1-type polarization of BV2 cells via the HMGB1/TLR4/NF-κB signaling pathway.

Objective:This study aims to provide insights into the clinical features of anti-melanoma differentiation-associated protein-5(MDA5)-positive dermatomyositis (MDA5-DM) patients with fatal outcomes, leveraging pathogenic microbiota metagenomic analysis, to guide the clinical assessment and treatment choices.Methods:From January 2020 to August 2023, deceased patients diagnosed with MDA5-DM were identified at the Department of Rheumatology and Immunology, the Second Affiliated Hospital of Xi ′an Jiaotong University. Clinical data were retrospectively collected and analyzed using Mann Whitney U test and Fisher ′s exact test to summarize risk factors and treatment assessment for MDA5-DM patients with fatal outcomes. Results:①The proportion of male patients was higher than females among MDA5-DM patients with fatal outcomes, which differed from the incidence pattern, possibly associated with smoking and gender proportions (6/11 vs. 0/7, P=0.037). ②94%(17/18) patients presented initially with elevated ferritin levels [(1 350±942)ng/ml] and CRP [(47±36)mg/L]. ③All patients (18/18) exhibited early involvement of the upper lung lobes, including multiple nodules in 9/18, ground-glass opacities in 5/18, and solitary nodules in 4/18. ④Metagenomic next-generation sequencing (mNGS) of bronchoalveolar lavage fluid was negative in 4/16 cases, with cytomegalovirus and pneumocystis jirovecii being the most commonly detected pathogens in 5/16 cases each. ⑤89%(16/18) of patients continued to have lymphocyte counts persistently <0.5×10 9/L irrespective of treatment. Conclusion:Smoking may have adverse effects on male MDA5 patients. Early involvement of the upper lobe of the lungs is more common in MDA5 antibody positive deaths, and persistent lymphocyte depletion is an important factor in poor response. Enhancing mNGS analysis of bronchoalveolar lavage fluid and vigilance towards cytomegalovirusand Pneumocystis jirovecii could provide valuable clinical guidance.

Objective To investigate the influence of remifentanil infusion at different speed on propofol injection pain.Methods Totally 200 patients who accepted elective surgery under general anesthesia with tracheal intubation were selected.The patients were divided into C group,R2 group,R3 group,R4 group and R5 group by random number table method,with 40 patients in each group,and they were injected with remifentanil at a constant rate of 0 μg·kg-1·min-1,0.2 μg·kg-1·min-1,0.3 μg·kg-1·min-1,0.4 μg·kg-1·min-1,and 0.5 μg·kg-1·min-1,respectively.After 2 minutes of remifentanil infusion,a target controlled infusion of propofol at an effect-site concentration of 2.5 μg/mL was initiated.The incidence of propofol injection pain,the severity of injection pain,heart rate and mean arterial pressure before remifentanil infusion and before tracheal intubation were compared among the 5 groups.The incidence of complications such as hypotension,bradycardia and chest wall stiffness of patients was recorded.Results The incidence and the severity of propofol injection pain of patients in R2 group,R3 group,R4 group and R5 group were significantly lower than those in C group(P<0.05).The incidence of propofol injection pain of patients in R4 group was significantly lower than those in R2 group and R3 group,and the severity of propofol injection pain of patients in R4 group was significantly lower than that in R2 group(P<0.05).The incidence and the severity of propofol injection pain of patients in R5 group was significantly lower than those in R2 group and R3 group(P<0.05).However,there were no statistically significant differences in the incidence or severity of injection pain between R2 group and R3 group,and between R4 group and R5 group(P>0.05).None of the patients in each group had complications such as hypotension,bradycardia,decreased pulse oxygen saturation,and chest wall stiffness that required drug treatment.And there was no adverse reactions such as pain,edema,redness at the injection site occurred within 24 hours after operation.Conclusion Remifentanil infused at a constant rate of 0.4 μg·kg-1·min-1 and 0.5 μg·kg-1·min-1 starting at 2 minutes before propofol administration is effective in reducing propofol injection pain without causing serious complications.

One-day-old AA broilers were divided into five groups(15 chickens each,5 replicates per group):control(basic diet),three groups with low,medium,and high doses of crude extract of Flos sophorae and Fructus sophorae(100,150,200 mg/kg),and one group with Macleaya cordata extract(300 mg/kg).The 42-day trial measured intestinal enzyme activity,morphology,antioxidant and immune capacity,barrier function,and microbiota structure and diversity.Compared to the control and Macleaya cordata groups,the high-dose crude extract of Flos sophorae and Fructus sophorae group significantly increased trypsin activity in the duodenum,jejunum,and ileum(P＜0.05).It also reduced reactive oxygen species and malondialdehyde levels,increased glu-tathione peroxidase activity,reduced tumor necrosis factor-α,increased interleukin-10,and elevated mRNA expression of tight junction protein-1 and mucin-2 in the jejunum(P＜0.05).Microbial di-versity analysis showed higher Shannon index,increased Firmicutes and Bacteroidetes,decreased Proteobacteria,and more beneficial bacteria in the high-dose group(P＜0.05).Supplementing 200 mg/kg of crude extract of Flos sophorae and Fructus sophorae enhances intestinal morpholo-gy and function,and promotes intestinal health,thereby increasing farming efficiency.