1.Methodology for the Development of Clinical Practice Guideline for Chinese Patent Medicine(Part 1): Development Status and Characteristics
Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Fuqiang ZHANG ; Ziteng HU ; Yaxin CHEN ; Huizhen LI ; Haili ZHANG ; Zhao CHEN ; Yin JIANG ; Bin LIU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):44-49
		                        		
		                        			
		                        			The irrational use of Chinese patent medicines (CPM) is becoming more and more prominent, which makes the demand for clinical practice guidelines of CPM gradually increase. In order to make domestic scholars understand the latest developments and existing problems of the CPM guidelines, and promote its development, this paper introduced the concept of CPM guidelines, summarized the characteristics of the two development modes, namely “taking CPM as the key” and “taking disease/syndrome as the key”, and analyzed the current methodological status of developing and reporting CPM guidelines. Based on the existed problems, three suggestions have been put forward to optimize the quality of CPM guidelines, which were clarifying the target users and scope of CPM guidelines, establishing an open and transparent mechanism of the personnel involvement and process steps, and formulating implementable and operable recommendations for the use of CPM. 
		                        		
		                        		
		                        		
		                        	
2.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine(Part 3): Identification of Clinical Questions
Ziteng HU ; Ning LIANG ; Lijiao YAN ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Zhao CHEN ; Yin JIANG ; Cuicui CHENG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):55-59
		                        		
		                        			
		                        			The identification of clinical questions for clinical practice guidelines of Chinese patent medicine (CPM) is important for subsequent evidence retrieval, evaluation of evidence quality, formation of recommendations. This paper described a methodological proposal for the identification of clinical questions for CPM guidelines to highlight the characteristics of Chinese patent medicine and reflect its effect in specific stage of the disease. Considering four aspects, namely, the drug of Chinese patent medicine (D), the specific disease stage (S), comparison (C), and specific outcome (O), DSCO framework has been proposed to formulate the clinical questions. Multi-source information through scientific research, policy or standard documents, and clinical data are suggested for collecting clinical questions, and clear selection criteria should be set to finalize the clinical questions to be addressed by the guideline. In addition, the above process needs to be transparently and publicly reported in order to ensure the clarity and completeness of the guidelines. 
		                        		
		                        		
		                        		
		                        	
3.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine(Part 4): Evidence Retrieval and Evaluation
Fuqiang ZHANG ; Lijiao YAN ; Ziteng HU ; Yujing ZHANG ; Yaxin CHEN ; Xingyu ZONG ; Zhao CHEN ; Weili WANG ; He LI ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(1):60-65
		                        		
		                        			
		                        			The retrieval and evaluation of evidence is the basis for the development of clinical practice guidelines for Chinese patent medicine. As traditional Chinese medicine has a different development trajectory and utilization characteristics from modern medicine, there is certain differences in terms of evidence composition, retrieval and integration.This paper discussed multi-source body of evidence on Chinese patent medicine based on modern evidence-based medicine and ancient medical literature, and summarized the retrieval strategy as well as the possible problems and solving methods. For different types of evidence on Chinese patent medicine, the corresponding evaluation tools have been recommended, and the order to integrate the evidence based on the quality of the evidence from high to low is suggested. Finally, a multi-source based evidence retrieval-evaluation-integration scheme for Chinese patent medicine has been formed, which will provide a methodological reference for practitioners in the development of clinical practice guidelines for Chinese patent medicine. 
		                        		
		                        		
		                        		
		                        	
4.Methodology for the Development of Clinical Practice Guidelines for Chinese Patent Medicine (Part 6): Formation and Presentation of Recommendations
Yujing ZHANG ; Ning LIANG ; Lijiao YAN ; Ziteng HU ; Yaxin CHEN ; Fuqiang ZHANG ; Qianzi CHE ; Zhao CHEN ; Yuqi LIU ; Dingyi WANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(2):172-177
		                        		
		                        			
		                        			Recommendation formation is a key component of clinical practice guidelines for Chinese patent medicine (CPM), and should encompass the determination of the strength and direction of the recommendation, the rationale for the recommendation, and the methodology for implementing the recommendation. Recommendations can be formed through formal consensus and informal consensus. The strength and direction of recommendations for CPM guidelines should be determined by considering the quality of evidence for CPMs, the priority of the clinical questions, the pros and cons of efficacy and adverse effects, patient acceptance, the feasibility of the recommendation and the availability of resources, social fairness, economic benefits, and other influencing factors. In order to better guide guideline developers to consider these factors more rationally, this article provideed a detailed explanation of each factor in the context of the characteristics of TCM. 
		                        		
		                        		
		                        		
		                        	
5.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 1):Concept and Current Practice
Lijiao YAN ; Ning LIANG ; Ziteng HU ; Yujing ZHANG ; Yaxin CHEN ; Fuqiang ZHANG ; Xiaoling LI ; Wenjie CAO ; Chen ZHAO ; Cheng LYU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(3):269-274
		                        		
		                        			
		                        			Rapid and living guidelines are those developed in response to public health emergencies in a short period of time using a scientific and standardized approach. Subsequently, they provide timely and credible recommendations for decision makers through regular and frequent updates of clinical evidence and recommendations. In this paper, we introduced the definition of rapid and living guideline as well as analyzed the basic characteristics of eight rapid and living guidelines in the field of traditional Chinese medicine (TCM) published till 2023 June, summarizing three core methodological issues in relation to how to rapidly develop guidelines, how to formulate recommendations when there is lack of evidence, and how to ensure the timeliness of guidelines. Based on the analysis of current rapid and living guidelines, it is implicated that there is necessity to carry out rapid and living guideline in the field of TCM, and the methodology of rapid integration of multivariate evidence in the field of TCM needs to be further explored; furthermore, it is necessary to further explore the obstacles of implementation of guidelines and promote timely updating, all of which provide certain theoretical references for relevant guideline developers and researchers. 
		                        		
		                        		
		                        		
		                        	
6.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 3): Rapid Evidence Collection, Integration and Recommendation Formation
Ziteng HU ; Lijiao YAN ; Yujing ZHANG ; Yaxin CHEN ; Xiaoling LI ; Haili ZHANG ; Huizhen LI ; Jingya WANG ; An LI ; Zhao CHEN ; Ning LIANG ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(3):281-286
		                        		
		                        			
		                        			The lack of direct evidence is an important problem faced in the formation of recommendations in rapid living guidelines of traditional Chinese medicine under public health emergencies, and the supplementation of indirect evidence can be a key method to solve this problem. For the collection of evidence, the type of evidence required, including direct and indirect evidence, should be clarified, and ‘direct first’ principle for selecting evidence can be set to standardize and accelerate the guideline development. When integrating evidence, recommendations can be formed directly if there is sufficient direct evidence, while regarding insufficient direct evidence, recommendations need to be supplemented and improved by integrating indirect evidence. In addition, when the body of evidence contains evidence from multiple sources, it is suggested to rate the evidence according to “higher rather than lower” principle. Finally, when forming recommendations, the level of evidence, safety and economic efficiency should be taken into consideration to determine the strength of the recommendation. 
		                        		
		                        		
		                        		
		                        	
7.Methodology for Developing Rapid and Living Guidelines of Traditional Chinese Medicine (RALIG-TCM) (Part 4): Evidence Monitoring and Dynamic Updates
Lijiao YAN ; Ning LIANG ; Yujing ZHANG ; Ziteng HU ; Yaxin CHEN ; Xiaoling LI ; Wenjie CAO ; Huizhen LI ; Xingyu ZONG ; Chen ZHAO ; Cheng LYU ; Nannan SHI ; Yanping WANG
Journal of Traditional Chinese Medicine 2024;65(3):287-291
		                        		
		                        			
		                        			In developing rapid and living guidelines of traditional Chinese medicine (TCM) in response to public health emergencies, it is important that evidence continue to be reviewed, and clinical questions and recommendations updated if necessary, due to the rapid changes in disease progression and the continuous generation of relevant research evidence. This paper proposed that the updating scope in dynamic mode should first be identified; then evidence monitoring should be carried out in four aspects, including clinical research, related guidelines or laws and regulations, disease progression, as well as clinical use of recommendations and clinical needs; finally, based on the results of the evidence monitoring, different options should be made, including revising the clinical questions, updating the evidence and recommendations, and withdrawing the guideline. 
		                        		
		                        		
		                        		
		                        	
8.Effects of chlorogenic acid on the proliferation, migration and invasion of renal carcinoma A498 and 769-P cells
Haibin CHEN ; Lijiao WANG ; Jianjun ZHAO ; Chao TAN
Journal of Modern Urology 2023;28(5):436-440
		                        		
		                        			
		                        			【Objective】 To investigate the effects of chlorogenic acid on the proliferation, migration and invasion of renal carcinoma A498 and 769-P cells and the possible molecular mechanism. 【Methods】 Human renal carcinoma A498 and 769-P cells were divided into control group and chlorogenic acid group (2 μL,1 μmol/L) and cultured for 72 h. The cell proliferation, invasion and migration were detected with MTT assay, Transwell assay and scratch test, respectively. The expressions of IL-1β, EPAS-1 and AKT/P65 signaling pathway related proteins were detected with ELISA, qRT-PCR and Western blot, respectively. 【Results】 Chlorogenic acid inhibited the proliferation, invasion and migration of renal carcinoma A498 and 769-P cells, and reduced the IL-1β level in the cell supernatant. Anti-IL-1β reduced the protein and mRNA expressions of EPAS-1, p-AKT and p-P65. Compared with the control group, the chlorogenic acid group had reduced mRNA and protein expressions of EPAS-1, p-AKT and p-P65 (P<0.05). 【Conclusion】 Chlorogenic acid can inhibit the invasion and metastasis of renal carcinoma cells, and its mechanism may be related to inhibiting the secretion of IL-1β, thereby inhibiting the AKT/P65/EPAS-1 pathway.
		                        		
		                        		
		                        		
		                        	
9.Relationship between 18F-FDG PET/CT Lugano lymphoma response evaluation criteria and prognosis at the end of chemotherapy for diffuse large B-cell lymphoma
Fengchun WU ; Zhaoqi ZHANG ; Xinming ZHAO ; Lijiao ZENG ; Kun WANG
Chinese Journal of Nuclear Medicine and Molecular Imaging 2022;42(4):209-215
		                        		
		                        			
		                        			Objective:To investigate the relationship between 18F-FDG PET/CT Lugano lymphoma response evaluation criteria and prognosis of patients with diffuse large B-cell lymphoma (DLBCL) at the end of chemotherapy. Methods:A total of 131 patients with DLBCL (63 males, 68 females, age (50.3±17.0) years) who underwent 18F-FDG PET/CT at the end of chemotherapy in the Fourth Hospital of Hebei Medical University from July 2013 to January 2021 were analyzed retrospectively. 18F-FDG PET/CT Lugano lymphoma response evaluation criteria was used to evaluate the response (complete remission (CR), partial remission (PR), stable disease (SD) and progressive disease (PD)). Progression-free survival (PFS) and overall survival (OS) were followed up. Kaplan-Meier survival analysis was used for univariate analysis of clinical parameters and imaging parameters, and Cox proportional hazards regression model was used for multivariate analysis to explore related factors affecting the prognosis of patients with DLBCL. Results:The median follow-up time was 35.47 months for 131 patients with DLBCL. The 5-year PFS rate was 57.3%(75/131), and the 5-year OS rate was 84.0%(110/131). There were 74 cases of CR, 37 cases of PR and 20 cases of PD. Univariate analysis showed that the Lugano lymphoma response evaluation criteria was the influencing factor of PFS and OS (PFS, χ2=72.25, P<0.001; OS, χ2=11.97, P=0.003). Deauville score (DS) of patients with DLBCL was also the influencing factor for PFS ( χ2=62.46, P<0.001) and OS ( χ2=19.95, P<0.001). Ann Arbor stage, Eastern Cooperative Oncology Group physical state (ECOG PS) score and international prognostic index (IPI) were the influencing factors for PFS ( χ2 values: 10.31-15.80, all P<0.05). Ann Arbor stage, ECOG PS score, number of extranodal organ involved, β 2 microglobulin, and IPI were the influencing factors for OS ( χ2 values: 4.97-30.57, all P<0.05). Cox multivariate analysis showed that Lugano lymphoma response evaluation criteria, Ann Arbor stage and ECOG PS score were independent prognostic factors for PFS (relative risk ( RR) and 95% CI: 8.841(4.764-16.405), 1.434(1.111-1.852), 2.125(1.205-3.746), P values: <0.001, 0.006, 0.009) and OS ( RR(95% CI): 3.276(1.304-8.235), 9.728(2.216-42.669), 2.506(1.040-6.039), P values: 0.012, 0.003, 0.041). Conclusion:18F-FDG PET/CT Lugano lymphoma response evaluation criteria can precisely evaluate the prognosis of patients with DLBCL at the end of chemotherapy.
		                        		
		                        		
		                        		
		                        	
10.Clinical efficacy of angiotensin-receptor neprilysin inhibitors in the treatment of maintenance hemodialysis with heart failure
Changli SUN ; Yang DONG ; Lijiao WANG ; Xindi ZHAO ; Zhu ZHANG ; Fengmin SHAO
Chinese Journal of Nephrology 2022;38(1):15-22
		                        		
		                        			
		                        			Objective:To observe the clinical efficacy of angiotensin-receptor neprilysin inhibitors (ARNI) in the treatment of maintenance hemodialysis (MHD) with heart failure.Methods:The clinical data of heart failure patients who accepted MHD in Central China Fuwai Hospital were retrospectively collected. All patients accepted regular treatments of heart failure, and then the treatment group was treated with ARNI, while the control group was treated with valsartan. The treatment course was 6 months. The cardiac parameters: left ventricular ejection fraction (LVEF), left ventricular end-diastolic dimension (LVEDD), left ventricular end-systolic dimension (LVESD), pulmonary artery pressure, right ventricular end-diastolic dimension (RVED), right atrial end-diastolic dimension (RAED), N-terminal pro-B-type natriuretic peptide (NT-pro BNP), and serum potassium were collected and compared between the two groups. Multivariate ordered logistic regression analysis was adopted to analyze the influencing factors of treatment effect.Results:A total of 60 MHD patients with heart failure were enrolled with age of (53.92±11.88) years old, 37 males (61.7%), dialysis age of (27.83±12.92) months, and blood pressure of (154.22±15.27) mmHg/(85.43±12.31) mmHg. (1) There was no significant difference of the clinical data and cardiac parameters between the treatment group ( n=30) and the control group ( n=30) before treatment (all P>0.05); (2) After treatment of 6 months, the total effective rate [28/30(93.3%)] in the treatment group was significantly higher than that in the control group [20/30(66.7%)] and the rehospitalization rate [2/30(6.7%)] in the treatment group was significantly lower than that in the control group [10/30(33.3%)] (both P<0.05); (3) After treatment of 6 months, LVEF, LVEDD, LVESD, pulmonary artery pressure, RVED, RAED, NT-pro BNP, and blood pressure were all improved significantly compared with the baseline in both groups (all P<0.05) and there was no significant difference of serum potassium and body weight before and after treatment in the two groups (all P>0.05); (4) After treatment of 6 months, LVEF in the treatment group was higher than that in the control group and LVEDD, LVESD, pulmonary artery pressure, NT-pro BNP, and blood pressure in the treatment group were lower than those in the control group (all P<0.05). There was no significant difference of RVED, RAED, serum potassium and body weight between the two groups after treatment (all P>0.05); (5)The difference values before and after treatment of LVEF, LVEDD, LVESD, NT-pro BNP, body weight, systolic blood pressure, and diastolic blood pressure were different between the two groups (all P<0.05); (6)Therapy method ( β=-1.863, 95% CI -2.948-0.777, P=0.001) and residual urine ( β=-1.686, 95% CI -3.079- -0.293, P=0.018) were independent influencing factors of treatment effect (the treatment effect of ARNI was better than that of valsartan; the treatment effect of patients with normal urine volume was better than that of patients with oliguria and anuria). Conclusions:ARNI can effectively improve cardiac function in MHD patients with heart failure, inhibit ventricular remodeling, and improve disease prognosis.
		                        		
		                        		
		                        		
		                        	
            
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