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.

Objective:To evaluate the expression of tertiary lymphoid structures (TLS) in renal tissues, and the relationship between TLS and clinicopathological changes and prognosis in idiopathic membranous nephropathy (IMN) patients.Methods:It was a single center retrospective study. The patients with IMN diagnosed by renal biopsy at Shengjing Hospital Affiliated to China Medical University from January 2018 to December 2020 were enrolled, and their clinicopathological data were collected. Immunohistochemistry was used to evaluate the expression of TLS in renal tissues. According to whether TLS expression in renal tissues was positive or not, the patients were divided into TLS-positive group and TLS-negative group, and the baseline differences in clinicopathological data between the two groups were compared. The clinical remission included complete remission and partial remission. Logistic regression analysis was used to analyze the correlation between serum phospholipase A2 receptor (PLA2R) antibody titer and positive TLS expression in renal tissues. Kaplan-Meier survival curve and log-rank test were performed to analyze the differences of proteinuria remission rates between TLS-positive and TLS-negative groups. Cox regression analysis was employed to identify the related factors of proteinuria remission. The receiver operating characteristic (ROC) curve was used to evaluate the value of TLS in predicting proteinuria remission.Results:A total of 120 IMN patients were included in this study, with age of 50.00 (40.00, 57.75) years and 78 (65.00%) males. The 24-hour urinary protein was (7.54±4.14) g, 89 (74.17%) patients were positive for serum PLA2R antibody, and the serum PLA2R antibody titer was 90.49 (48.88, 155.33) RU/ml. Immunohistochemical results showed that TLS was mainly distributed in the renal cortex glomeruli or around renal blood vessels in renal tissues. There were 43 patients in the TLS-positive group and 77 patients in the TLS-negative group. The positive rate of serum PLA2R antibody in the TLS-positive group was 83.72% (36/43). Compared with the TLS-negative group, the TLS-positive group had lower serum albumin ( t=-3.474, P<0.001) and estimated glomerular filtration rate ( Z=-2.076, P=0.045), while serum creatinine ( t=2.006, P=0.028), 24-hour urinary protein ( t=4.140, P<0.001), serum PLA2R antibody titer ( Z=4.628, P=0.001), glomerulosclerosis degree ( Z=2.403, P=0.019), and proportions of hypertension ( χ2=6.511, P=0.011), renal interstitial fibrosis ( χ2=4.088, P=0.043), renal interstitial inflammatory cell infiltration ( χ2=9.261, P=0.002), tubular atrophy ( χ2=4.936, P=0.026) and extremely high-risk of kidney disease progression ( χ2=9.352, P=0.002) were higher. Multivariate logistic regression analysis showed that serum PLA2R antibody titer was an independent factor correlated with positive TLS expression in renal tissues ( OR=1.014, 95% CI 1.007-1.021). The median follow-up time was 18.00 (95% CI 16.07-19.93) months. Kaplan-Meier survival curve showed that the proteinuria remission rate in the TLS-positive group was lower than that in the TLS-negative group (Log-rank χ2=9.339, P=0.002). Cox regression analysis showed that positive TLS expression was an independent factor correlated with proteinuria remission ( HR=0.228, 95% CI 0.177-0.297). ROC curve showed that TLS had a certain clinical predictive value for proteinuria remission ( AUC=0.703, 95% CI 0.608-0.798). Conclusions:IMN patients with positive TLS expression in renal tissues have a lower proteinuria remission rate, more severe pathological damage, and a higher risk of disease progression. TLS is expected to become a pathological marker for predicting the severity and prognosis of IMN.

Arachidonic acid can be transformed into a variety of metabolites that trigger an inflammatory response through cyclooxygenase, lipoxygenase, cytochrome P450 enzymes, and other metabolic pathways. Moreover, it plays a key role in the occurrence and development of inflammatory diseases. In recent years, multi-target drugs based on the arachidonic acid metabolic pathway have become an important direction of anti-inflammatory drug research. This article summarizes the opportunities and challenges of arachidonic acid metabolic pathways as well as their interference in the development of anti-inflammatory drugs, reviews the research progress of multi-target drug design, synthesis, and anti-inflammatory activity based on the arachidonic acid metabolic pathway, and discusses the difficulties and prospects of multi-target drugs based on metabolic pathways in anti-inflammatory drug development, aiming to provide some reference and inspiration for the study of multi-target anti-inflammatory drugs based on the arachidonic acid metabolic pathway.

Objective To explore the effect of Echinetin(ECH)pretreatment on alleviating intestinal bar-rier dysfunction caused by severe acute pancreatitis(SAP).Methods Totally 36 rats were randomly divided into Sham group,SAP group and SAP+ECH group,with 12 rats in each group.Pancreatitis was induced by retrograde injection of 3％sodium taurocholate into pancreatic duct.Histological examination was performed on the pancreas of experimental rats to determine whether the pancreatitis model of rats was successfully con-structed.Intestinal barrier function was evaluated by intestinal pathological scores,serum diamine oxidase(DAO)activity and endotoxin levels,and bacterial translocation in mesenteric lymph nodes.The mRNA and protein expression levels of tight junction proteins ZO-1 and occludin were detected by quantitative fluorescent PCR(qPCR)and Western blot,and the protein expression levels of high mobility frame-1 protein(HMGB1),Toll-like receptor 4(TLR4)and protein kinase R(PKR)were detected by Western blot.Results ECH had no significant effect on the histological changes of pancreas,but could improve the intestinal mucosal barrier damage and membrane permeability associated with SAP.Although ECH does not affect the mRNA expres-sion levels of ZO-1 and occludin in ileum of SAP rats,it could significantly increase the expression levels of ZO-1 and occludin,and ECH treatment could significantly reduce the expression levels of HMGB1,TLR4 and PKR in ileum of SAP rats.Conclusion ECH can reduce the intestinal barrier dysfunction induced by SAP,and its effect on intestinal barrier function may be related to the inhibition of the HMGB1/TLR4/PKR pathway.

Objective To investigate the value of gut metabolites in predicting the development of severe acute pancreatitis(SAP),myocardial injury,and adverse outcomes in patients with acute pancreatitis(AP).Methods A total of 80 SAP patients admitted to Cangzhou Hospital of Integrated Chinese and Western Medicine from April 2023 to April 2024 were selected as the severe group,and 80 non-severe AP patients were selected as the non-severe group.The levels of serum amylase,lipase,acetic acid,propionic acid,butyric acid,and total short-chain fatty acids(SCFAs)in feces,serum bile acid(BA),trimethylamine n-oxide(TMAO),myocardial injury-related indicators[creatine kinase isoenzymes(CK-MB),cardiac troponin T(cTnT),N-terminal pro-b-type natriuretic peptide(NT-proBNP)],C-reactive protein(CRP),acute physiology and chronic health evaluation II(APACHE II)and bedside index for severity in acute pancreatitis(BISAP)were compared between the two groups at admission.Patients in the severe group were followed up for 30 days and divided into a survival subgroup(n=61)and a non-survival subgroup(n=19)based on their prognosis.The levels of total SCFAs,BA,and TMAO were compared between these two subgroups.Spearman correlation analysis was used to analyze the correlation of serum amylase,lipase,total SCFAs,BA,and TMAO levels with myocardial injury-related indicators and disease severity scores in all patients.Multivariate logistic regression analysis was used to identify the influencing factors for the occurrence of SAP.Receiver operating characteristic(ROC)curve analysis was used to evaluate the predictive value of total SCFAs,BA,TMAO,and their combination for the occurrence of SAP.Results Compared with the non-severe group,the severe group had significantly lower levels of acetic acid,propionic acid,butyric acid,and total SCFAs(P<0.01),and significantly higher levels of BA,TMAO,CK-MB,cTnT,NT-proBNP,CRP,and APACHE II and BISAP scores.Within the severe group,the non-survival subgroup had significantly lower levels of total SCFAs(P<0.05)and significantly higher levels of BA and TMAO(P<0.05)compared to the survival subgroup.Spearman analysis showed that the levels of CK-MB,cTnT,NT-proBNP,CRP,and the APACHE II and BISAP scores were negatively correlated with total SCFAs levels and positively correlated with BA and TMAO levels(P<0.001).Multivariate logistic regression analysis revealed that total SCFAs,BA,and TMAO were independent influencing factors for the occurrence of SAP(P<0.05).ROC curve analysis showed that the area under the curve(AUC)for total SCFAs,BA,TMAO,and their combination in predicting the occurrence of SAP were 0.951,0.797,0.790,and 0.974,respectively(P<0.001).The AUC for the combination of the three markers was larger than that of any single marker,indicating good predictive efficacy.Conclusion The levels of gut metabolites SCFAs,BA,and TMAO in SAP patients are independent factors associated with myocardial injury and prognosis.