1.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
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.
2.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
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.
3.The role of establishing the concept of"liver and pancreas co-management"in the treatment of pancreatic diseases
Kongyuan WEI ; Canitano NICOLA ; Shuo WANG ; Zipeng LU ; Kuirong JIANG ; Zhenhua MA ; Zheng WU ; Qingyong MA ; Marchegiani GIOVANNI ; Hackert THILO ; Zheng WANG
Chinese Journal of Surgery 2026;64(1):79-82
With the continuous development of new surgical technology, new equipment and new concepts, the research focused in the field of surgery is also in constant change. Among them, there are still confusion and controversies in the current clinical practice when facing the one-stop proposition of benefit population screening, advantageous surgical indication decision-making, surgical intervention timing selection, postoperative complication prediction and management. Therefore, our team tries to analyze whether the concept of"co-management of liver and pancreas"exists in clinical practice from the aspects of anatomy, physiology, histology and embryology of liver and pancreas, as well as the interaction between liver and pancreas, and explore the relationship between liver and pancreas in anatomy and tissue embryonic development, and the relationship between the concept of"co-management of liver and pancreas"and pancreatitis and pancreatic tumors as well as the concept of “co-management of liver and pancreas” applied in neoadjuvant chemoradiotherapy, and attempts to establish a new treatment pathway for pancreatic diseases based on this concept, in order to provide a new idea, new scheme and new possibility for the clinical research of pancreatic diseases and pancreatic surgery.
4.The role of establishing the concept of"liver and pancreas co-management"in the treatment of pancreatic diseases
Kongyuan WEI ; Canitano NICOLA ; Shuo WANG ; Zipeng LU ; Kuirong JIANG ; Zhenhua MA ; Zheng WU ; Qingyong MA ; Marchegiani GIOVANNI ; Hackert THILO ; Zheng WANG
Chinese Journal of Surgery 2026;64(1):79-82
With the continuous development of new surgical technology, new equipment and new concepts, the research focused in the field of surgery is also in constant change. Among them, there are still confusion and controversies in the current clinical practice when facing the one-stop proposition of benefit population screening, advantageous surgical indication decision-making, surgical intervention timing selection, postoperative complication prediction and management. Therefore, our team tries to analyze whether the concept of"co-management of liver and pancreas"exists in clinical practice from the aspects of anatomy, physiology, histology and embryology of liver and pancreas, as well as the interaction between liver and pancreas, and explore the relationship between liver and pancreas in anatomy and tissue embryonic development, and the relationship between the concept of"co-management of liver and pancreas"and pancreatitis and pancreatic tumors as well as the concept of “co-management of liver and pancreas” applied in neoadjuvant chemoradiotherapy, and attempts to establish a new treatment pathway for pancreatic diseases based on this concept, in order to provide a new idea, new scheme and new possibility for the clinical research of pancreatic diseases and pancreatic surgery.
5.Effects of Pulsatilla decoction on 5-HT signaling system in the hippocampus of rats with damp-heat diarrhea
Yunqi QU ; Shengming JIANG ; Shuo FENG ; Chenying WANG ; Siyue LAI ; Qi MA
Chinese Journal of Veterinary Science 2025;45(3):559-567
This study aims to investigate the effects of Pulsatilla decoction(PD)on the 5-HT sig-naling system in the hippocampus of damp-heat diarrhoea(DHD)rats.Twenty-four male SD rats were randomly divided into four groups including the blank group,the model group,the PD group and the self-healing group.Except for the blank group,the rats in each group were induced by"high sugar and high fat,high temperature and high humidity,and E.coli poisoning"to establish a of rat model DHD,and were treated by gavage with PD.Changes in body weight,temperature,food intake and water intake,routine blood tests and histopathological changes in the colon were recor-ded to comprehensively determine the modelling condition of rats with DHD;histopathological changes in the hippocampus of rats were observed,and real-time fluorescence PCR was used to de-termine the expression of IL-1β3,IL-6,TNF-α,IFN-γ and TPH1 mRNA in the hippocampus;West-ern blot and immunohistochemistry were used to detect the protein expression of tryptophan hydroxylase 1(TPH1),receptors(5-HT3R,5-HT4R,5-HT7R)in 5-HT signaling pathway in the hippocampus.The results showed that:PD significantly regulated the abnormal changes of body weight,food and water intake and blood routine indexes in rats with DHD,and significantly im-proved the pathological damage of colonic tissues;PD significantly lowered the expression of in-flammatory cytokines IL-1β,IL-6,IFN-γ,and TNF-α in hippocampus of rats with DHD(P<0.05),and significantly reduced the expression of TPH1 mRNA in hippocampus of rats with DHD(P<0.05).PD could increased the expression of 5-HT4R and 5-HT7R in the hippocampus of rats with DHD;reduced the expression of 5-HT3R and TPH in the hippocampus,among which 5-HT3R expression was significantly reduced.This study suggests that PD can affect the function of hippocampus in rats with DHD by regulating the 5-HT signaling pathway.
6.Effects of Pulsatilla powder on intestinal flora and tryptophan metabolism in co-lon of piglets with diarrhea
Shuo FENG ; Lifang ZHANG ; Yufei XIE ; Shengming JIANG ; Liting CAO ; Shicheng BI ; Qi MA
Chinese Journal of Veterinary Science 2025;45(3):568-579
This study aims to investigate the effects of Pulsatilla powder(PP)on colonic intestinal flora and tryptophan metabolism in piglets with diarrhea.Twenty-four weaned piglets were ran-domly divided into the normal control group,model group,self-healing group,and PP group.The model of piglet diarrhea was established by the compound factor of external evil+internal injury+epi-demic virus,and treated with PP.During the modeling period,the body weight,mental status and fecal patterns of piglets were monitored daily.After the experiment,the colon tissues were collect-ed for histopathological observation,and the inflammatory factors IL-1β and IL-6 in the colon tis-sue was detected by ELISA,16S rRNA was used to analyze colonic intestinal flora and RT-qPCR was used to determine the expression of genes related to tryptophan metabolism in the colon.The results showed that,compared with the model group,PP significantly improved the pathological status of the colon in piglets with diarrhea,with elevated body mass and a significant increase in goblet cells(P<0.05);and significantly reduced the levels of IL-1β and IL-6 in the colon of diar-rhea piglets(P<0.05).The results of intestinal flora showed that PP increased the abundance of Firmicutes(P<0.01),Spirochaeota(P<0.01)and Lactobacillus(P<0.05),reduced the abun-dance of Bacteroidota(P<0.05)、Prevotella_NK3B31_group(P<0.05)and Clostridium_sensu_stricto 1(P<0.01).Meanwhile,PP significantly reduced the expression level of TPH1 mRNA(P<0.05),increased the expression levels of AhR(P<0.05)and IL-22 mRNA in the co-lon of diarrhea piglets.These results indicates that PP may alleviate diarrhea in piglets by regula-ting colonic intestinal flora and genes related to intestinal tryptophan metabolism.This study pro-vides data support for the subsequent investigation of piglet diarrhea prevention and treatment.
7.Comparison of efficacy of different biological scaffolds for pulp regeneration therapy in immature permanent teeth:a Bayesian network meta-analysis
Kaigang WANG ; Dongsheng HAO ; Pei MA ; Shuo ZHOU ; Ruimin LI
Chinese Journal of Tissue Engineering Research 2025;29(34):7447-7460
OBJECTIVE:There are many kinds of biological scaffolds used for pulp revascularization in clinical practice,and the difference of efficacy between different scaffolds is controversial.The efficacy of nine kinds of biological scaffolds in endodontic revascularization was evaluated by Bayesian network meta-analysis.METHODS:The computer was used to search the literature in CNKI,VIP,WanFang,China Biomedical Literature Service System,PubMed,Cochrane Library,Web of Science,Embase,and Scopus databases.Randomized controlled trials of different biological scaffolds for the treatment of pulp revascularization in young permanent teeth meeting inclusion criteria were collected from each database up to April 1,2024.Two researchers sifted through the literature,data collection,sorting and extraction were completed independently,and the quality of the included literature was assessed for risk of bias.A network meta-analysis was performed using BUGSnet1.1.1 package of R4.2.0 software.RESULTS:A total of 22 studies with 926 affected teeth and 9 different interventions were included in this study.The results of network meta-analysis showed that:(1)Clinical success rate(primary goal):platelet-rich fibrin was superior to blood clot[OR=1.45,95%CI(0.32,2.69)],and the top three ranking results were:concentrated growth factor(82.77%)>platelet-rich fibrin(75.38%)>modified platelet-rich fibrin(62.39%).(2)Increased root length(secondary goal):There was no difference among the 7 biological scaffolds at 1-6 months of follow-up(P>0.05),the top 3 ranking results of rank probability were:concentrated growth factor(86.25%)>platelet-rich plasma(53.76%)>platelet-rich fibrin(51.11%).When followed up for>6 months and<12 months,concentrated growth factor was superior to blood clot[MD=9.59,95%CI(0.52,18.40)],the top 3 ranking results of rank probability were:concentrated growth factor(92.42%)>platelet-rich plasma(56.03%)>platelet-rich fibrin(55.76%).When followed up for more than 12 months,concentrated growth factor was superior to modified platelet-rich fibrin[MD=11.01,95%CI(0.02,22.72)],the top 3 ranking results of rank probability were:concentrated growth factor(86.95%)>platelet-rich fibrin(68.61%)>blood clot combined with collagen(52.5%).(3)Increased root wall thickness(secondary goal):at 1-6 months of follow-up,platelet-rich fibrin was superior to blood clot[MD=11.37,95%CI(4.74,17.71)],the top 3 ranking results of rank probability were:platelet-rich fibrin(93.66%)>concentrated growth factor(63.11%)>modified platelet-rich fibrin(50.48%).At>6 months and<12 months of follow-up,there was no difference among the 6 biological scaffolds(P>0.05),the top 3 ranking results of rank probability were:modified platelet-rich fibrin(73.63%)>platelet-rich fibrin(62.36%)>concentrated growth factor(56.25%).When followed up for more than 12 months,there was no difference among the 9 biological scaffolds(P>0.05),and the top 3 ranking results of rank probability were:blood clot combined with collagen(81.9%)>platelet-rich plasma(62.67%)>modified platelet-rich fibrin(59.49%).(4)Pulp vitality(third-level goal):there was no difference among the 6 biological scaffolds(P>0.05),and the top 3 ranking results of rank probability were:blood clot combined with collagen(84.22%)>concentrated growth factor(67.71%)>platelet-rich fibrin(48.79%).CONCLUSION:Existing evidence shows that the clinical success rate of different scaffolds is higher in pulp revascularization,among which platelet-rich fibrin is better than blood clots.In terms of comprehensive comparison of root length and root wall thickness increase,concentrated growth factor performs best in the follow-up period of 1-6 months and>6 months and<12 months,while blood clot combined with collagen performs best after follow-up of more than 12 months;concentrated growth factor performs outstandingly in all levels of goals,and may be more conducive to the continued development of the tooth root than other scaffolds,and has great potential in pulp regeneration treatment.Limited by the quality and quantity of literature,the above conclusions still need to be verified by more high-quality studies.
8.The predictive value and model establishment of body composition in the long-term prognosis of patients after rectal cancer surgery
Shuo LIU ; Yun LU ; Jilin HU ; Wenchang YANG ; Rizhi ZHAO ; Wenda XU ; Hanyu YANG ; Zechen LU ; Zheng MA ; Zhaolin DU ; Yunzhi GAO ; Yuan GAO
China Oncology 2025;35(7):672-684
Background and Purpose:Previous studies have investigated the prognostic significance of skeletal muscle and adipose tissue composition and distribution in colorectal cancer patients,yet most have not differentiated between rectal and colon cancer patient cohorts.This study aimed to explore the relationship between body composition and long-term prognosis,and to develop a postoperative predictive model.Methods:Clinical data of rectal cancer patients who underwent surgical treatment at Qingdao University Affiliated Hospital from January 2018 to December 2021 were retrospectively collected.Inclusion criteria:①Age>18 years;② Preoperative colonoscopy and pathological diagnosis of colorectal cancer;③ Complete surgical resection;④Abdominal computed tomography(CT)scan 1 month before surgery.Exclusion criteria:① Clinical data is missing;② Multiple metastases of tumors;③ Tumor T stage 0 or carcinoma in situ;④ Severe artifacts lead to poor quality CT imaging,making it difficult to distinguish between fat and muscle;⑤ Inability to obtain follow-up results.This study has been approved by the Medical Ethics Committee of the Affiliated Hospital of Qingdao University(approval number:QYFYWZLL30313),and informed consent has been waived in the ethical approval process.The skeletal muscle index(SMI)and subcutaneous adipose tissue index(SATI)were calculated by dividing the areas of skeletal muscle and subcutaneous fat observed on CT scans by the square of the patient's height.Univariate and multivariate COX regression analyses were conducted to identify risk factors influencing recurrence-free survival(RFS)and overall survival(OS)in rectal cancer patients.Based on the results of the multivariate analysis,a nomogram prediction model was developed,its predictive power and accuracy were assessed using the receiver operating characteristic(ROC)curve,calibration plots and decision curve analysis(DCA),and internal validation was conducted.Results:A total of 696 patients were included in this study,with 96(13.8%)patients experiencing postoperative recurrence and 89(12.8%)patients dying.Multivariate COX regression analysis showed that SMI,SATI,tumor T stage and N stage were independent factors affecting the postoperative RFS and OS of patients.Nomogram prediction models for RFS and OS in rectal cancer patients were constructed based on the above independent predictors.The area under ROC curve(AUC)for 3-,4-and 5-year RFS was 0.862,0.846 and 0.824,respectively;the AUC for 3-,4-and 5-year OS was 0.886,0.898 and 0.875,respectively.The models were evaluated using calibration curves and decision curves,and internal validation was performed,which showed that the prediction accuracy of the models was good.Conclusion:CT body composition is an independent predictor of RFS and OS in rectal cancer patients,and the nomogram model developed based on these factors demonstrates good predictive value for patient prognosis.
9.Application and pregnancy outcomes analysis of hysteroscopy combined with hysterosalpingo-contrast sonography in intrauterine insemination
Liang LIANG ; Shuo YANG ; Liying WANG ; Yun REN ; Haiyan WANG ; Caihong MA ; Rong LI
Chinese Journal of Obstetrics and Gynecology 2025;60(10):772-781
Objective:To compare pregnancy outcomes between patients undergoing combined hysteroscopy and hysterosalpingo-contrast sonography (HyCoSy) versus hysteroscopy alone prior to intrauterine insemination, and to evaluate the safety and clinical value of the combined procedure in the diagnosis and treatment of infertility.Methods:A retrospective analysis was conducted on clinical data from 385 patients who underwent hysteroscopy at Peking University Third Hospital between October 1, 2020 and September 30, 2022, and subsequently received their first cycle of artificial insemination with donor sperm (AID) within six months. Pregnancy outcomes were compared between the group receiving combined hysteroscopy with four-dimensional HyCoSy (hysteroscopy+4D-HyCoSy group) and the group receiving hysteroscopy alone (hysteroscopy group). Multivariate logistic regression was used to analyze factors influencing pregnancy outcomes after AID.Results:Among the 385 patients included, 79 achieved clinical pregnancy. The clinical pregnancy rate (24.9%, 53/213) and live birth rate (21.1%, 45/213) in the hysteroscopy+4D-HyCoSy group were significantly higher than those in the hysteroscopy group [15.1% (26/172) and 12.8% (22/172), respectively; all P<0.05]. There was no significant difference in tubal patency between the two groups ( P>0.05); however, the time interval from tubal patency assessment to intrauterine insemination was significantly longer in the hysteroscopy group compared to the hysteroscopy+4D-HyCoSy group (median: 4.0 vs 2.0 months; P<0.001). Multivariate analysis showed that double insemination significantly increased clinical pregnancy rate compared to single insemination ( OR=2.42, 95% CI: 1.02-5.72; P=0.044). An interval exceeding 6 months between tubal patency assessment and intrauterine insemination was identified as a risk factor for reduced clinical pregnancy ( OR=0.35, 95% CI: 0.14-0.92; P=0.047). Additionally, neither the time interval from hysteroscopy to intrauterine insemination nor hysteroscopic findings and pathological diagnoses had significant effects on clinical pregnancy rates (all P>0.05). Conclusions:The combination of hysteroscopy and HyCoSy provides a safe and efficient approach for fertility assessment in infertile patients and improves clinical pregnancy rate and live birth rate in intrauterine insemination cycles. Hysteroscopy is recommended for patients with suspected endometrial or intrauterine abnormalities. If no previous tubal patency assessment has been performed or the last assessment was more than six months prior, combined hysteroscopy and HyCoSy may be considered to enhance the likelihood of clinical pregnancy.
10.Research progress in mechanisms of traditional Chinese medicine polysaccharides in prevention and treatment of alcoholic liver disease.
Yu-Fan CHEN ; He JIANG ; Qing MA ; Qi-Han LUO ; Shuo HUANG ; Jiang QIU ; Fu-Zhe CHEN ; Zi-Yi SHAN ; Ping QIU
China Journal of Chinese Materia Medica 2025;50(2):356-362
Alcoholic liver disease(ALD), a major cause of chronic liver disease worldwide, poses a serious threat to human health. Despite the availability of various drugs for treating ALD, their efficacy is often uncertain, necessitating the search for new therapeutic approaches. Traditional Chinese medicine polysaccharides have garnered increasing attention in recent years due to their versatility, high efficiency, and low side effects, and they have demonstrated significant potential in preventing and treating ALD. Emerging studies have suggested that these polysaccharides exert their therapeutic effects through multiple mechanisms, including the inhibition of oxidative stress and the regulation of lipid metabolism, gut microbiota, and programmed cell death. This review summarizes the recent research progress in the pharmacological effects and regulatory mechanisms of traditional Chinese medicine polysaccharides in treating ALD, aiming to provide a scientific basis and theoretical support for their application in the prevention and treatment of ALD.
Humans
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Liver Diseases, Alcoholic/metabolism*
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Polysaccharides/administration & dosage*
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Drugs, Chinese Herbal/administration & dosage*
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Animals
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Oxidative Stress/drug effects*
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Medicine, Chinese Traditional
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Gastrointestinal Microbiome/drug effects*
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Lipid Metabolism/drug effects*

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