1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Utility of upper urinary tract video urodynamics in recurrent symptoms and equivocal hydronephrosis after ureteral reconstruction: A retrospective cohort study.
Xinfei LI ; Yiming ZHANG ; Liqing XU ; Chen HUANG ; Zhihua LI ; Kunlin YANG ; Hua GUAN ; Jing LIU ; Peng ZHANG ; Hongjian ZHU ; Liqun ZHOU ; Xuesong LI
Chinese Medical Journal 2025;138(18):2350-2352
3.Traditional Chinese Medicine Intervention in Diarrhea-predominant Irritable Bowel Syndrome Based on Gut-brain Axis: A Review
Jinchan PENG ; Jinxiu WEI ; Zhu LIU ; Lijian LIU ; Liqun LI ; Chengning YANG ; Guangwen CHEN ; Jianfeng LI ; Sheng XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):311-319
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a common digestive system disease with high prevalence and recurrence rates for years, high treatment costs, and serious impacts on patients' quality of life and economic burden. Therefore, it is important to explore new and safe treatment methods. The pathogenesis of IBS-D is complex, in which the gut-brain axis is a key factor. The gut-brain axis, a bidirectional signaling pathway connecting the gastrointestinal tract and the central nervous system, regulates gastrointestinal motility, secretion, and immune responses, playing a key role in the occurrence and development of IBS-D. Up to now, antidiarrheal agents, probiotics, and neurotransmitter modulators are the main methods for the clinical treatment of IBS-D. Although they can partially curb the progression of this disease, the therapeutic effects remain to be improved. Studies have confirmed that traditional Chinese medicine (TCM) has significant advantages in the treatment of IBS-D since it can regulate the gut-brain axis via multiple pathways and targets to improve the gastrointestinal motility and strengthen immune defenses. However, there is a lack of systematic reviews on the regulation of the gut-brain axis by TCM in the treatment of IBS-D. Based on the review of IBS-D-related articles published in recent years, this paper systematically summarized the relationship between the gut-brain axis and IBS-D and the role of TCM in the treatment, providing new ideas for the treatment of IBS-D.
4.Summary of best evidence for early rehabilitation management of hand function in patients with hand burns
Xueqin YAN ; Songmei CAO ; Fangfang ZHOU ; Liqun ZHU ; Cheng CHEN ; Mengxue ZHU ; Yanhong ZHANG ; Yiqing LIANG ; Suping BAI
Chinese Journal of Nursing 2025;60(8):998-1004
Objective To summarize the best evidence of early rehabilitation management of hand function in patients with hand burn,and provide basis for medical personnel to carry out early rehabilitation management of hand burn.Methods According to the 5S model,all evidence on early rehabilitation management of hand function in patients with hand burns was retrieved from databases and websites including UpToDate,BMJ Best Practice,NICE,RNAO,GIN,and so on.The retrieved evidence included clinical decisions,guidelines,evidence summaries,expert consensuses,systematic reviews,Meta analysis.The search period of the summary of best evidence,expert concensus and guidelines are from the establishment of the database to December 20,2024,and the search period of the systematic reviews is from January 1,2019 to December 20,2024.Quality evaluation of literature,evidence extraction and summary were conducted.The evidence was graded according to JBI evidence pre-grading system 2014.Results Totally 17 pieces of the literature were included,including 1 clinical decision,4 guidelines,6 evidence summaries,3 expert consensus articles,and 3 systematic reviews.Totally pieces of best evidence were summarized,including 7 aspects of assessment,hand positioning,treatment of edema,dressing,use of orthotics,joint mobility training,and health education.Conclusion This study summarized the best evidence of early rehabilitation management of hand function in patients with hand burn,and provided evidence-based evidence for clinical rehabilitation management plan.According to the clinical situation,the medical staff can apply the evidence to clinical practice,so as to improve the hand function and quality of life of patients.
5.Analysis of factors influencing the deterioration of nutritional status after radiotherapy/radiochemotherapy for esophageal cancer
Liqun CAO ; Panpan GAN ; Heling ZHU ; Han CHEN ; Nalin SUN ; Lihao CHEN ; Jiawen YU
Academic Journal of Naval Medical University 2025;46(5):674-680
Objective To analyze the factors influencing the deterioration of nutritional status after radiotherapy/radiochemotherapy for esophageal cancer,so as to provide reference for nutritional management during antitumor therapy.Methods A total of 106 patients with esophageal cancer who received radiotherapy or radiochemotherapy at Anqing First People's Hospital of Anhui Medical University from Dec.2017 to Dec.2023 were enrolled.Patients'gender,age,surgical history,timing of radiotherapy intervention,synchronous chemoradiotherapy,radiotherapy dose,clinical stage,initial nutritional status,and performance status score were collected.The patient generated subjective global assessment scale(PG-SGA)scores were monitored before and after antitumor treatment.According to the nutritional status at the beginning of enrollment and at the end of radiotherapy,the patients were assigned to deterioration group or non-deterioration(stable or improved)group.The clinical characteristics of the 2 groups were compared.The factors influencing the deterioration of nutritional status were screened by logistic regression analysis.The correlation between nutritional status deterioration and adverse reactions(radiation esophagitis,pulmonary infection,neutropenia,thrombocytopenia,and elevated aminotransferase)was analyzed by Spearman correlation analysis.Results There were no significant differences in gender,radiotherapy dose,initial nutritional status,or performance status score between the 2 groups for the deterioration of nutritional status after radiotherapy(all P>0.05).The proportions of patients with previous surgical history of esophageal cancer,synchronous chemoradiotherapy,initiation of radiotherapy at less than 90%of target calorie requirement,and clinical stage Ⅳ were significantly higher in the deterioration group than those in the non-deterioration group(all P<0.05).Logistic regression analysis showed that clinical stage Ⅳ(odds ratio[OR]=4.684,95%confidence interval[CI]1.252-17.519,P=0.022)and previous surgical history of esophageal cancer(OR=7.338,95%CI 1.878-28.666,P=0.004)were the independent adverse risk factors for the deterioration of nutritional status after radiotherapy/radiochemotherapy.The timing of radiotherapy intervention was also an independent risk factor for the deterioration of nutritional status,and taking the tolerance of 70%-90%target energy as the reference level,starting radiotherapy when the tolerance of 90%-100%target energy had the optimal protection of nutritional status(OR=0.166,95%CI 0.050-0.551,P=0.003).Spearman correlation analysis showed that the deterioration of nutritional status was positively correlated with elevated transaminases after radiotherapy(rs=0.283,P=0.003),while it was not correlated with the other adverse reactions(all P>0.05).Conclusion Under the standard nutritional intervention model,patients with previous surgery and recurrent metastatic esophageal cancer who receive radiotherapy/chemoradiotherapy are still at risk of nutritional status deterioration.Tolerance to 90%-100%target energy requirement may be a more appropriate timing for radiotherapy intervention.When the nutritional status deteriorates during treatment,it is necessary to be alert to the elevated transaminases.
6.Traditional Chinese Medicine Treats Sepsis by Regulating PI3K/Akt Pathway: A Review
Zhu LIU ; Jiawei WANG ; Jing YAN ; Jinchan PENG ; Mingyao XU ; Liqun LI ; Sheng XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):314-322
Sepsis is a systemic inflammatory response syndrome caused by the invasion of pathogenic microorganisms such as bacteria. In addition to the manifestations of systemic inflammatory response syndrome and primary infection lesions, critical cases often have manifestations of organ hypoperfusion. The morbidity and mortality of sepsis have remained high in recent years, which seriously affect the quality of life of the patients. The pathogenesis of sepsis is complicated, in which uncontrollable inflammation is a key mechanism. The phosphatidylinositol 3-kinase/protein kinase B (PI3K/Akt) signaling pathway plays a key role in mediating inflammation in sepsis. The available therapies of sepsis mainly include resuscitation, anti-infection, vasoactive drugs, intensive insulin therapy, and organ support, which show limited effects of reducing the mortality. Therefore, finding new therapeutic drugs is a key problem to be solved in the clinical treatment of sepsis. In recent years, studies have shown that traditional Chinese medicine (TCM) can regulate the PI3K/Akt pathway via multiple pathways, multiple effects, and multiple targets to inhibit inflammation and curb the occurrence and development of sepsis, which has gradually become a hot spot in the prevention and treatment of sepsis. Moreover, studies have suggested that TCM has unique advantages in the treatment of sepsis. TCM can regulate the PI3K/Akt signaling pathway to inhibit inflammation, reduce oxidative stress, and control apoptosis in the prevention and treatment of sepsis. Despite the research progress, a systematic review remains to be performed regarding the TCM treatment of sepsis by regulating the PI3K/Akt signaling pathway. After reviewing relevant papers published in recent years, this study systematically summarizes the relationship between PI3K/Akt pathway and sepsis and the role of TCM in the treatment of sepsis, aiming to provide new ideas for the potential treatment of sepsis and the development of new drugs.
7.Quality Evaluation of Cisatracurium Besilate Injection
Jing FANG ; Xinying YU ; Kai DUO ; Biwei BAI ; Yu HAN ; Kexin XIAO ; Xinying MA ; Liqun LIU ; Jialiang ZHU
Herald of Medicine 2025;44(1):31-38
Objective To evaluate the quality of cisatracurium besilate injection produced by domestic manufacturers.Methods A comprehensive evaluation of 104 batches of samples was carried out using statutory testing methods combined withexploratory research,including related substances,1,5-pentanediol diacrylate,residual solvents,genotoxic impurities of benzenesulfonate esters,infrared spectrum,and endotoxin examination.The quality of domestic products and the controllability of current specifications were comprehensively evaluated.Results According to the statutory tests,the qualified rate of 104 batches of samples was 100.0%.The exploratory research showed that the results of related substances in the samples produced by 6 manufacturers were far below the limit,and no genotoxic impurities of benzenesulfonate esters were detected.However,the results showed that there was variability in 1,5-pentanediol diacrylate,as well as residual solvents.Conclusions The quality of the cisatracurium besilate injection is good,and the current specifications should be further improved and unified.It was proposed that the infrared spectrum,related substance,and 1,5-pentanediol diacrylate method be added or revised,and the limit of endotoxin strictly controlled.It was proposed that manufacturers pay attention to the quality of API and control injection production.
8.Analysis of the influencing factors of health-related quality of life in community-dwelling elderly with mild cognitive impairment from the perspective of health ecology
Jiayi LIN ; Yanbo ZHU ; Jiameng JIA ; Yuhao LUO ; Jiaju REN ; Jianni CONG ; Yueheng LOU ; Liqun LONG ; Rui CAO ; Pu GE
Chinese Journal of Behavioral Medicine and Brain Science 2025;34(3):245-251
Objective:To analyze the current situation of health-related quality of life (HRQOL) and its influencing factors among community-dwelling elderly with mild cognitive impairment (MCI) based on the health ecology model (HEM).Methods:From December 2023 to September 2024, a cross-sectional survey was conducted among 997 community-dwelling elderly in Beijing, Shandong, Chongqing and other regions. The EuroQol five-dimensional questionnaire 5 level (EQ-5D-5L), the Montreal cognitive assessment (MoCA), and the Pittsburgh sleep quality index (PSQI) were used to assess the subjects.Descriptive analysis, Mann-Whitney U test, Kruskal-Wallis test, and Tobit regression analysis were performed using Stata 18.0 software. Results:A total of 324 valid samples were finally obtained, and the health utility value of MCI elderly was 0.842(0.815, 0.951). Tobit regression analysis showed that ≥80 years old( β=-0.121, 95% CI=-0.193--0.050) in individual traits level, don't exercise( β=-0.196, 95% CI=-0.255--0.137) and poor quality of sleep ( β=-0.064, 95% CI=-0.116--0.013) in behavior characteristics level, and poor subjective economic status( β=-0.153, 95% CI=-0.261--0.045) in living and working conditions level were risk factors for the health utility value of the elderly with MCI. Drinking( β=0.096, 95% CI=0.022-0.171) in behavior characteristics level and participating in social activities( β=0.126, 95% CI=0.062-0.190) in interpersonal network level were protective factors for the health utility value of the elderly with MCI. Conclusions:The HRQOL of the community-dwelling elderly with MCI in China is low, and its influencing factors are multi-level. HEM should be combined to strengthen the intervention and management of the elderly with MCI from personal constitution to policy environment to improve their HRQOL.
9.Research on Analysis Method of Ketoconazole Related Substancse Based on National Drug Sampling and Testing
Changying XIN ; Yanbin XUN ; Xinying YU ; Yu HAN ; Qiong WU ; Longshan ZHAO ; Liqun LIU ; Jialiang ZHU
Herald of Medicine 2025;44(10):1611-1617
Objective To establish the HPLC analysis method for ketoconazole related substances,and to provide technical support for the improvement of the quality standard and the purity of ketoconazole.Methods Gradient elution conditions were optimized based on the chromatographic parameters outlined in the 2024"British Pharmacopoeia"for ketoconazole cream.A C18 column(4.6 mm×150 mm,3 μm)was used to facilitate the elution process using a gradient of acetonitrile and acetate buffer,and detection performed at a wavelength of 230 nm.Results The known impurities and potentially genotoxic impurities in the material drugs of ketoconazole can be more effectively separated using the established methods,which are both robust and highly sensitive.The content of the two potentially geno toxic impurities,six known impurities and unknown impurities in the 21 batches of ketoconazole sourced from five raw material pharmaceutical companies is below the specified limit requirements.Conclusion This method contributes to improving the quality of ketoconazole ingredients,ensuring the safety of ketoconazole preparations,and better supporting the regulatory supervision.
10.Construction of review indicators and analysis of obstacles and promoting factors for long-term oral anticoagulant management in patients with atrial fibrillation
Jun LIU ; Xiaoyan ZHAO ; Songmei CAO ; Liqun ZHU ; Jiaojiao JIANG ; Chengjie DONG ; Fang WANG
Chinese Journal of Practical Nursing 2025;41(6):452-458
Objective:To evaluate the clinical status of long-term oral anticoagulant management in patients with atrial fibrillation, and to analyze the obstacles and promoting factors in the implementation of evidence, so as to provide evidence for clinical transformation.Methods:This study was a cross-sectional study. Through the evidence-based nursing method, guided by the Ottawa Model, the review indicators and review methods were developed based on the best evidence. The clinical status review of 100 patients who met the inclusion criteria in the Department of Cardiology, Affiliated Hospital of Jiangsu University was conducted from August to November 2022 using a convenience sampling method, and based on the results of the review, an analysis of obstacles and promoting factors was carried out to develop a clinical response.Results:This study included 100 patients with atrial fibrillation, 60 males and 40 females, aged (70.14 ± 10.39) years. Totally 26 best items were included, and 24 review indicators were developed, among which only 4 indicators had a compliance rate of 100% , 2 indicators had a compliance rate of >60% , 5 indicators had a compliance rate of <60% , and 13 indicators had a compliance rate of 0. According to the results of the review, a comprehensive and systematic analysis was conducted from the three dimensions of system, practitioners, patients and family members. For each dimension, obstacles and promoting factors were analyzed in depth from evidence-based change, potential adopters and practical environment.Conclusions:There is a gap between the best evidence and clinical status of long-term oral anticoagulant management in patients with atrial fibrillation. In-depth analysis of obstacle factors, formulate countermeasures, and promote the efficient implementation of evidence in clinical practice.


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