1.Development and Application of the Evidence Quality Rating Scale for Ancient Classical Prescriptions in Traditional Chinese Medicine
Juwen ZHANG ; Jianping LIU ; Xiangfei SU ; Wei WEI ; Xiaolan SU ; Xue FENG ; Fanya YU ; Xudong ZHANG ; Junhong YU ; Wei CHEN
Journal of Traditional Chinese Medicine 2025;66(8):804-810
		                        		
		                        			
		                        			ObjectiveTo develop the Evidence Grading Scale for Ancient classical prescriptions in Traditional Chinese medicine, assess its reliability and validity, and apply it in practice to provide multi-source evidence for clinical practice guidelines development. MethodsLiterature retrieval was conducted to extract and screen existing evaluation dimensions, then the initial items were summarized using thematic analysis. Experts in the clinical medicine, medical history and literature participated in the Delphi questionnaire survey to evaluate and refine the items. An expert consensus meeting was conducted to finalize the included items, refine the method for items evaluation and evidence grading. The evidence quality rating scale for ancient classical traditional Chinese medicine (TCM) prescriptions was then established and tested for reliability and validity. ResultsThrough literature review, extraction, screening and summarization, a total of 3 dimensions and 12 initial items were formed. Questionnaires were sent to 69 experts to evaluate the initial items, with a questionnaire response rate of 100% and an expert authority coefficient of 0.92. All 12 items were retained for they had importance scores above 4. The Evidence Grading Scale on Ancient classical prescriptions in Traditional Chinese medicine includes 3 dimensions with 12 items. The 3 dimensions includes ancient evidence, inheritance status, and modern application. Each dimension contains 4 items, and each item has a full score of 5 points. The evidence was rated as high-level, moderate-level, and low-level according to the final scores. The content validity index (CVI) of the 12 items was >0.9, the average CVI of the scale was 0.98, and the intraclass correlation coefficient (ICC) was 0.90. ConclusionThe Evidence Grading Scale on Ancient classical prescriptions in Traditional Chinese medicine has good reliability and validity, which is practical for use in the development of TCM clinical guidelines and can better support clinical decision-making. 
		                        		
		                        		
		                        		
		                        	
2.A Review and Comment of Animal Models of Spleen Deficiency Syndrome
Mengxiong LU ; Hong XUE ; Beihua ZHANG ; Xudong TANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2024;26(3):652-658
		                        		
		                        			
		                        			The field of traditional Chinese medicine has a long history of applying modern science method in related research,and has made significant achievements in the field of disease and syndrome animal models.This paper reviewed the development history of the animal model of spleen deficiency syndrome,summarized and commented the modeling method,animal selection,evaluation index,digestive system disease and syndrome combination model.Small rodents,such as rats,are commonly used as representative animal models in research.Currently,the academic community mostly focuses on etiology and pathogenesis modeling,with limited use of chemical drugs and physical factors for modeling.The most common approach is the complex factor modeling method.Evaluation indicators include traditional Chinese medicine syndrome indicators,quantitative indicators related to"spleen"function and characteristics,as well as prescription counter-indicators.The focus of current research is the combination of disease patterns related to spleen deficiency,such as functional diarrhea/dyspepsia.The research on animal models of spleen.
		                        		
		                        		
		                        		
		                        	
3.Construction and identification of multiple epitope antigens of norovirus based on bioinformatics
Xue DU ; Yinzhen ZHAO ; Yiqing ZHANG ; Xiaojun WANG ; Xudong WANG ; Lanying GUO ; Yunlong WANG
Chinese Journal of Immunology 2024;40(11):2391-2398
		                        		
		                        			
		                        			Objective:To design a multi-epitope antigen of norovirus(NoV)based on bioinformatics technology and to pre-pare and characterize it.Methods:Bioinformatics methods were used to construct and analyze the NoV multi-epitope antigen NoV-ZH.Recombinant proteins were prepared and characterized by prokaryotic expression system,and monoclonal antibodies were prepared by animal immunization and hybridoma technology,and initially applied in colloidal gold platform.Results:The designed multi-epitope antigen had a large proportion of random curls in the secondary structure,with theoretical molecular mass and isoelectric point(PI)of 13.1 ku and 7.16,which were stable and hydrophilic.It had good immunogenicity and could activate humoral and cellular immune re-sponses.The proteins prepared by ligating pET-28a(+)and pET-32a vectors with antigenic sequences were expressed as inclusion body proteins and soluble proteins,respectively.A pair of paired antibodies was obtained by animal immunization and hybridoma tech-nique,and applied to colloidal gold test strips with a sensitivity of 0.5 ng/ml,and the test strips could specifically bind two genotypes of NoV recombinant capsid proteins.Conclusion:The successful preparation and characterization of multi-epitope antigen of norovirus provides a reference for the subsequent exploration of NoV universal detection targets and the development of diagnostic raw materials.
		                        		
		                        		
		                        		
		                        	
4.Research Process of Polysaccharide and Triterpenoids in Large Varieties of Poria cocos with Homology of Medicine and Food
Xuemei PU ; Xue LI ; Xudong HE ; Jinbiao HE ; Zhibo LIU ; Dan XU ; Xiaojiao CHEN ; Fan ZHANG ; Jie YU
World Science and Technology-Modernization of Traditional Chinese Medicine 2023;25(7):2561-2573
		                        		
		                        			
		                        			Poria cocos is a classic Chinese medicine with homology of food and medicine,which is beneficial to water infiltration,spleen and stomach,calming the heart and calming the mind,etc.It is known as"nine Poria cocos in ten prescriptions".Poria cocos contains polysaccharide,triterpenoids and steroids,among them polysaccharide and triterpenoid are considered as the main active components.Modern studies have shown that Poria cocos polysaccharide triterpenes display pharmacological activities such as anti-tumor,immunomodulatory and anti-oxidation.The dissolution rate of poria cocos and triterpenes was low in the traditional decocting process,and the oral absorption rate of poria cocos was low,but the activity of poria cocos and triterpenes was still very good,indicating the high activity of poria cocos and triterpenes.Therefore,this paper systematically reviews the extraction and separation,structural identification,content determination,structural modification,biosynthesis,pharmacological activity and potential product development value of Poria cocos polysaccharide and triterpenoids,in order to provide literature reference for the development of Poria cocos grand health industry.
		                        		
		                        		
		                        		
		                        	
5.Guideline for the diagnosis and treatment of chronic refractory wounds in orthopedic trauma patients (version 2023)
Yuan XIONG ; Bobin MI ; Chenchen YAN ; Hui LI ; Wu ZHOU ; Yun SUN ; Tian XIA ; Faqi CAO ; Zhiyong HOU ; Tengbo YU ; Aixi YU ; Meng ZHAO ; Zhao XIE ; Jinmin ZHAO ; Xinbao WU ; Xieyuan JIANG ; Bin YU ; Dianying ZHANG ; Dankai WU ; Guangyao LIU ; Guodong LIU ; Qikai HUA ; Mengfei LIU ; Yiqiang HU ; Peng CHENG ; Hang XUE ; Li LU ; Xiangyu CHU ; Liangcong HU ; Lang CHEN ; Kangkang ZHA ; Chuanlu LIN ; Chengyan YU ; Ranyang TAO ; Ze LIN ; Xudong XIE ; Yanjiu HAN ; Xiaodong GUO ; Zhewei YE ; Qisheng ZHOU ; Yong LIU ; Junwen WANG ; Ping XIA ; Biao CHE ; Bing HU ; Chengjian HE ; Guanglin WANG ; Dongliang WANG ; Fengfei LIN ; Jiangdong NI ; Aiguo WANG ; Dehao FU ; Shiwu DONG ; Lin CHEN ; Xinzhong XU ; Jiacan SU ; Peifu TANG ; Baoguo JIANG ; Yingze ZHANG ; Xiaobing FU ; Guohui LIU
Chinese Journal of Trauma 2023;39(6):481-493
		                        		
		                        			
		                        			Chronic refractory wound (CRW) is one of the most challengeable issues in clinic due to complex pathogenesis, long course of disease and poor prognosis. Experts need to conduct systematic summary for the diagnosis and treatment of CRW due to complex pathogenesis and poor prognosis, and standard guidelines for the diagnosis and treatment of CRW should be created. The Guideline forthe diagnosis and treatment of chronic refractory wounds in orthopedic trauma patients ( version 2023) was created by the expert group organized by the Chinese Association of Orthopedic Surgeons, Chinese Orthopedic Association, Chinese Society of Traumatology, and Trauma Orthopedics and Multiple Traumatology Group of Emergency Resuscitation Committee of Chinese Medical Doctor Association after the clinical problems were chosen based on demand-driven principles and principles of evidence-based medicine. The guideline systematically elaborated CRW from aspects of the epidemiology, diagnosis, treatment, postoperative management, complication prevention and comorbidity management, and rehabilitation and health education, and 9 recommendations were finally proposed to provide a reliable clinical reference for the diagnosis and treatment of CRW.
		                        		
		                        		
		                        		
		                        	
6.Clinical Evidence of Treatment of Constipation with Oral Chinese Patent Medicine: A Scoping Review
Simin XU ; Zeqi DAI ; Miaomiao LI ; Xue WU ; Xudong TANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(20):144-153
		                        		
		                        			
		                        			This study systematically and comprehensively sorted out the application status of Chinese patent medicines for the treatment of constipation in the clinic, to provide scientific evidence for future research directions and clinical drug use in this field. Based on the method of scoping review, the Chinese patent medicines for the treatment of constipation were retrieved from three drug lists to obtain the medicines that needed to be evaluated. A comprehensive and systematic search was carried out on the included studies on the treatment of constipation by Chinese patent medicines through eight Chinese and English databases, and the included studies were integrated and analyzed. The results were displayed in combination with charts. Thirty-four Chinese patent medicines and 118 studies were included in this study. According to the efficacies, Chinese patent medicines were divided into 4 categories, namely eliminating accumulation, purging fire, promoting Qi, and moistening bowels, involving 125 Chinese medicines. The overall attention of constipation research is on the rise. Marenwan (granules or soft capsules) gained the highest attention, with 42 studies, followed by Qirong Runchang oral liquid, with 21 studies, and Biantong tablets (capsules), with 19 studies. There are 10 studies on Congrong Tongbian oral liquid. Seventeen Chinese patent medicines had no corresponding clinical research. There were 8 study design types, and all drugs were mainly randomized controlled trials except Danggui Longhui pill. Among the intervention types, the comparison between Chinese patent medicines and western medicines was the most. The highest outcome indicators were efficacy, safety evaluation, and main symptoms or scores, and there was a lack of a unified core outcome indicator set. There were few studies on adverse reactions and the economy. Only 11.86% of the studies were funded. Clinically, Chinese patent medicines are widely used in the treatment of constipation, and the amount of related research shows an increasing trend. However, some Chinese patent medicines lack corresponding clinical evidence, and the published research has problems such as unrigorous design, ununified criteria for efficacy evaluation, lack of comprehensive evidence studies, and insufficient funds. It is hoped that more investment will be made in this field in the future, and more attention will be paid to drugs with relatively blank research and constipation syndromes with few treatments. Comprehensive evidence studies such as systematic reviews should be carried out actively. And the study design should be standardized to provide reliable evidence for the treatment of constipation with Chinese patent medicines. 
		                        		
		                        		
		                        		
		                        	
7.Four Oral Chinese Patent Medicines for Treatment of Functional Dyspepsia: A Rapid Health Technology Assessment
Miaomiao LI ; Hui ZHAO ; Zeqi DAI ; Xue WU ; Simin XU ; Xudong TANG ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2022;28(20):161-169
		                        		
		                        			
		                        			ObjectiveTo evaluate the safety, efficacy, and economy of the four Chinese patent medicines (CPMs), including Simotang oral liquid, Liuwei Anxiao capsule, Baohe pill, and Jianwei Xiaoshi oral liquid in the treatment of functional dyspepsia (FD) by a rapid health technology assessment (RHTA), thus providing evidence support for clinical decision making. MethodChina National Knowledge Infrastructure (CNKI), WanFang Database, VIP Chinese Technology Periodical Database (VIP), China Biology Medicine disc (CBMdisc), PubMed, EMBASE, Cochrane Library, and Web of Science were searched by computer from inception to March 2022. After literature screening, data extraction, and quality evaluation, the descriptive analysis of the results combined with visual charts was performed. Nineteen studies were included, involving 18 randomized controlled trials (RCTs) and 1 Meta-analysis. Neither economic studies nor health technology assessment (HTA) reports were retrieved. ResultThe four CPMs were safe and effective in the treatment of FD, but economic research was lacking. Among them, Simotang oral liquid could be used for children with FD and FD caused by qi and food stagnation, liver and spleen disharmony, and liver and spleen stagnation. Liuwei Anxiao capsule could be used for adult patients with FD caused by food stagnation. Baohe pill could be used for the elderly with FD. Jianwei Xiaoshi oral liquid could be used for children with FD caused by spleen and stomach weakness. ConclusionThe four CPMs have their advantages in the treatment of FD. Among them, the clinical universality of Simotang oral liquid is higher. However, the quality of clinical evidence is generally low, and comparative analysis among drug dosage forms is lacking. In the future, it is necessary to improve, apply, and promote RHTA for rapid evidence production while carrying out a more standardized and scientific evidence-based demonstration of the comprehensive clinical efficacy of CPMs. 
		                        		
		                        		
		                        		
		                        	
8.Status of HVPG clinical application in China in 2021
Wen ZHANG ; Fuquan LIU ; Linpeng ZHANG ; Huiguo DING ; Yuzheng ZHUGE ; Jitao WANG ; Lei LI ; Guangchuan WANG ; Hao WU ; Hui LI ; Guohong CAO ; Xuefeng LU ; Derun KONG ; Lin SUN ; Wei WU ; Junhui SUN ; Jiangtao LIU ; He ZHU ; Dongliang LI ; Wuhua GUO ; Hui XUE ; Yu WANG ; Jiancuo GENGZANG ; Tian ZHAO ; Min YUAN ; Shirong LIU ; Hui HUAN ; Meng NIU ; Xin LI ; Jun MA ; Qingliang ZHU ; Wenbo GUO ; Kunpeng ZHANG ; Xiaoliang ZHU ; Birun HUANG ; Jianan LI ; Weidong WANG ; Hongfeng YI ; Qi ZHANG ; Long GAO ; Guo ZHANG ; Zhongwei ZHAO ; Kai XIONG ; Zexin WANG ; Hong SHAN ; Mingsheng LI ; Xueqiang ZHANG ; Haibin SHI ; Xiaogang HU ; Kangshun ZHU ; Zhanguo ZHANG ; Hong JIANG ; Jianbo ZHAO ; Mingsheng HUANG ; Wenyong SHEN ; Lin ZHANG ; Feng XIE ; Zhiwei LI ; Changlong HOU ; Shengjuan HU ; Jianwei LU ; Xudong CUI ; Ting LU ; Shaoqi YANG ; Wei LIU ; Junping SHI ; Yanming LEI ; Jinlun BAO ; Tao WANG ; Weixin REN ; Xiaoli ZHU ; Yong WANG ; Lei YU ; Qiang YU ; Huiling XIANG ; Wenqiang LUO ; Xiaolong QI
Chinese Journal of Hepatology 2022;30(6):637-643
		                        		
		                        			
		                        			Objective:The investigation and research on the application status of Hepatic Venous Pressure Gradient (HVPG) is very important to understand the real situation and future development of this technology in China.Methods:This study comprehensively investigated the basic situation of HVPG technology in China, including hospital distribution, hospital level, annual number of cases, catheters used, average cost, indications and existing problems.Results:According to the survey, there were 70 hospitals in China carrying out HVPG technology in 2021, distributed in 28 provinces (autonomous regions and municipalities directly under the central Government). A total of 4 398 cases of HVPG were performed in all the surveyed hospitals in 2021, of which 2 291 cases (52.1%) were tested by HVPG alone. The average cost of HVPG detection was (5 617.2±2 079.4) yuan. 96.3% of the teams completed HVPG detection with balloon method, and most of the teams used thrombectomy balloon catheter (80.3%).Conclusion:Through this investigation, the status of domestic clinical application of HVPG has been clarified, and it has been confirmed that many domestic medical institutions have mastered this technology, but it still needs to continue to promote and popularize HVPG technology in the future.
		                        		
		                        		
		                        		
		                        	
9.Targeted immunotherapy efficacy analysis in patients with relapsed/refractory B cell acute lymphocytic leukemia
Yan SU ; Shen BAO ; Yuping WEI ; Lijun SONG ; Yimiao XUE ; Xudong WEI ; Yongping SONG ; Qingsong YIN
Chinese Journal of Hematology 2022;43(11):946-951
		                        		
		                        			
		                        			Objective:Comparison of conventional chemotherapy and immunotargeted therapy efficacy in patients with relapsed/refractory (R/R) acute B cell leukemia (B-ALL) .Methods:The clinical data of 212 patients with R/R B-ALL in the Affiliaed Cancer Hospital of Zhengzhou University from January 2008 to July 2020 were analyzed retrospectively to compare the response rate and survival time difference between conventional chemotherapy and immunotargeted therapies (antiCD19 CAR-T and CD3CD19 bi-specific antibody blinatumomab) , and to explore the related factors affecting prognosis.Results:The CR rate of patients with R/R B-ALL treated with anti-CD19 CAR-T cells was 80.4% , patients treated with blinatumomab was 62.5% , and patients treated with chemotherapy was 38.6% . There was significant difference in the CR rate among the three therapies ( P<0.001) . CAR-T cells 1-year OS rate was 41.5% , which was significantly higher than that of the chemotherapy group (10.3% ) ( P<0.001) . The 1-year PFS rate of CAR-T cells (30.1% ) was also significantly higher than that of the chemotherapy group (9.7% ) ( P<0.001) . The median OS of patients with bridging allo-HSCT after CR treatment by CAR-T cells was 18.5 months, which was higher than that of patients without allo-HSCT (8 months) ( P=0.027) . The median PFS of patients with allo-HSCT was 17 months, which was higher than that of patients without allo-HSCT (4 months) ( P=0.001) . The 1-year OS rate of patients treated with blinatumomab was 14.3% , which was higher than that of the chemotherapy group (10.3% ) ( P=0.018) . The 1-year PFS rate (14.6% ) was also higher than that of the chemotherapy group (9.7% ) ( P=0.046) . The median OS and median PFS of patients with bridging allo-HSCT were 13 and 11 months, respectively, which was higher than that of patients without allo-HSCT (9.5 and 6 months) . The cytokine release syndrome (CRS) incidence in patients with R/R B-ALL treated with anti-CAR-T cells was 89.8% . Grades 3-4, grade 2, and grade 1 CRS were experienced by 30.2% , 11.3% and 58.5% patients, respectively. Only three patients (37.5% ) with blinatumomab developed CRS, all of which were grade 1. Conclusion:The response rate and survival rate of patients with R/R B-ALL treated with CD19 CAR-T cells and blinatumomab were significantly better than those treated with conventional chemotherapy.
		                        		
		                        		
		                        		
		                        	
10.Efficacy and safety of endoscopic papillectomy of major duodenal papilla neoplasms
Jian WANG ; Shun HE ; Jiqing ZHU ; Liyan XUE ; Lan AN ; Yueming ZHANG ; Lizhou DOU ; Yong LIU ; Yan KE ; Xudong LIU ; Yumeng LIU ; Hairui WU ; Pingping LIU ; Huaying XUN ; Xue ZHANG ; Xinzhang JIA ; Guiqi WANG
Chinese Journal of Oncology 2021;43(3):329-334
		                        		
		                        			
		                        			Objective:To discuss the efficacy and safety of endoscopic papillectomy of major duodenal papilla neoplasms.Methods:The clinical-pathological data of 21 patients who were admitted to the Department of Endoscopy, Cancer Hospital, Chinese Academy of Medical Sciences and underwent endoscopic papillectomy of major duodenal papilla neoplasms from January 2014 to January 2020 were retrospectively studied, their postoperative outcomes and complication were also analyzed.Results:Tweenty-one patients were successfully performed endoscopic papillectomy of major duodenal papilla neoplasms. The resected lesions varied between 0.5-2.8 cm. Completed lesion was resected in 19 cases and lesion blocks in 2 cases. The incidence of postoperative complication was 52.4% (11/21), including 8 cases of postoperative bleeding (38.1%). Five patients stopped bleeding after endoscopic hemostasis and 3 patients stopped after interventional embolization. Two patients experienced perforation (9.5%) and recovered after conservative treatment including anti-inflammatory treatment and abdominal drainage. Five patients had pancreatitis (23.8%) and recovered after treatment with pre-somatostatin and anti-inflammatory rectal suppository. Preoperative pathological results of 21 patients suggested that 11 were high-grade intraepithelial neoplasia and 8 were low-grade intraepithelial neoplasia, and 2 were chronic inflammation. Postoperative pathological results suggested that 4 were adenocarcinoma, and the rest 17 were adenoma. The coincidence rate of preoperative biopsy results and postoperative pathology was 38.1%(8/21), and underestimate of the pathological stage occurred in 11 patients (52.4%) during the preoperative biopsy, overestimate occurred in two patients (9.5%). Four cases had a positive incisal margin. All patients had good prognoses and no death event occurred during the follow-up period.Conclusions:Early-stage major duodenal papilla neoplasms should be treated with aggressive resection. Endoscopic papillectomy of duodenal papilla neoplasms is safe, effective, and can be recommended as the preferred procedure for major duodenal papilla neoplasms.
		                        		
		                        		
		                        		
		                        	
            
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