1.Promoting Innovative Development of Traditional Chinese Medicine Case Report Based on China Clinical Cases Library of Traditional Chinese Medicine
Kaige ZHANG ; Hongcai SHANG ; Yong ZHU ; Weijun HUANG ; Xiaoxiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(6):190-195
		                        		
		                        			
		                        			China Clinical Cases Library of Traditional Chinese Medicine is built to promote the establishment of a scientific and technological talent evaluation system oriented on innovative value, ability and contribution in the backgroud of breaking the four only and setting new standards required by the document jointly issued by several national administrations and commissions. In the process of the construction, in order to further consolidate the foundation and ensure the quality and authority of case reports, we need to fully understand the origin and development of Chinese medical cases. Therefore, we clarified the development situation of Chinese medical cases by combing the characteristics of ancient and modern case reports, comparing the differences between Chinese and western medical case reports in terms of content and writing requirements, finally formed the main points of systematic case report norms and quality evaluation system, aiming to fully explore the unique advantages of Chinese medical cases in the fields of discipline development, scientific research innovation, clinical practice and guidance, talent evaluation and training, so as to promote its innovative development in a broader direction. 
		                        		
		                        		
		                        		
		                        	
2.Multi-evidence Integration Methodology for Traditional Chinese Medicine: the MERGE Framework
Honghao LAI ; Zhe WANG ; Ying LI ; Wenjing TANG ; Beibei WANG ; Peidong SUN ; Mingyao SUN ; Jiajie HUANG ; Zhipan XIAO ; Ying LI ; Chen ZHAO ; Hongcai SHANG ; Kehu YANG ; Jie LIU ; Long GE
Medical Journal of Peking Union Medical College Hospital 2024;15(1):172-182
		                        		
		                        			
		                        			In the era of evidence-based medicine, it is necessary to explore the unique advantages of traditional Chinese medicine (TCM) based on standardized technical methods and operating procedures in order to achieve the modernization and internationalization of TCM and benefit all humanity. The proposal of a three-pronged evidence system combining TCM theory, human experience and experimental evidence marks an important progress in the thinking method of the TCM evaluation system. The multi-evidence body integrated through appropriate methods provides a strong support for the clinical guideline recommendations and evidence-based health decision-making in TCM. Based on the current methodological progress of international evidence synthesis and grading, this paper proposes a novel approach for integrating multi-evidence in TCM: the MERGE framework. The aim is to establish a solid foundation for the development of this methodology and provide guidance for the advancement of evidence-based medicine framework in TCM.
		                        		
		                        		
		                        		
		                        	
3.Promoting Reform of Talent Evaluation Based on China Clinical Cases Library of Traditional Chinese Medicine
Kaige ZHANG ; Yong ZHU ; Jisheng WANG ; Liangzhen YOU ; Weijun HUANG ; Jie YANG ; Candong LI ; Genping LEI ; Chuan ZHENG ; Shuzhen GUO ; Longtao LIU ; Zhining TIAN ; Xinping QIU ; Wenli SU ; Zuo LI ; Wei YAN ; Hongcai SHANG ; Xiaoxiao ZHANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(17):220-226
		                        		
		                        			
		                        			Talents are the main force for the development of traditional Chinese medicine(TCM), and the construction of TCM talents and the reformation of talent evaluation system are essential to promote the inheritance and innovation of TCM. At present, we are still exploring and developing in the fields of the formulation, implementation and evaluation indicators of TCM talent evaluation system. However, there are shortcomings and difficulties. For instance, insufficient stratification in the evaluation, excessive emphasis on the quantity of achievements, neglecting the quality of the achievements and the actual contribution, imperfect assessment indicators, and the weak characteristics of TCM. Therefore, national ministries and commissions have jointly issued a document requesting to break the four only and set a new standard, in order to promote the construction of a scientific and technological talent evaluation system oriented by innovation value, ability and contribution. For the evaluation of TCM clinical talents, China Association for Science and Technology commissioned China Association of Chinese Medicine to build the China Clinical Cases Library of TCM(CCCL-TCM), which aims at collecting the most authoritative and representative TCM clinical cases and exploring the advantages of applying clinical cases as masterpiece of achievement in TCM clinical talents evaluation. CCCL-TCM can promote the construction of a talent evaluation system that is more in line with the development characteristics of TCM industry, and to carry out relevant pilot in TCM colleges and institutions across the country in order to promote the reformation of TCM talent evaluation system. 
		                        		
		                        		
		                        		
		                        	
4.Exploration of the Method of Developing Core Data Sets for Post-marketing Clinical Safety Evaluation of Chinese Proprietary Medicine
Ruijin QIU ; Min LI ; Jiayuan HU ; Ya HUANG ; Tianmai HE ; Songjie HAN ; Rui ZHENG ; Xiaoyu ZHANG ; Manke GUAN ; Jing CHEN ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1723-1728
		                        		
		                        			
		                        			The insufficient reporting of adverse reactions of Chinese proprietary medicines is common. In addition, there is a lack of safety information in the specifications of Chinese proprietary medicines, which led to less evidence for clinical safety of Chinese proprietary medicines in clinical practice. It is urgent to carry out post-marketing clinical safety re-evaluation of Chinese proprietary medicine. Developing a clinical safety evaluation data set for Chinese proprietary medicine may reduce the insufficient reporting of safety information and the inconsistency of data reporting in similar studies, as well as include more studies in systematic reviews, so that they can provide higher-level evidence for clinical safety of Chinese proprietary medicine. This paper proposes a method for developing core data set of clinical safety evaluation of Chinese proprietary medicine: firstly, the application scope of core data set for clinical safety evaluation was determined according to the characteristics of diseases, population, research objectives, administration methods, evaluation methods, etc. Systematic reviews and semi-structured interviews should be conducted to develop the list of original items for clinical safety evaluation. Based on the list, Delphi surveys can be developed in different stakeholders. Then the final core data set can be developed via consensus meetings.
		                        		
		                        		
		                        		
		                        	
5.Clinical Evidence Evaluation and Mechanism Exploration of Xinxuening in Cardiovascular Disease Treatment
Zhaofeng SHI ; Songjie HAN ; Ya HUANG ; Tianmai HE ; Asiyamu·mushajiang ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1745-1753
		                        		
		                        			
		                        			Objective: To refine and evaluate the clinical evidence, and provide proof and reference for Xinxuening's clinical program establishment from the perspective of evidence-based medicine through screening the clinical studies of cardiovascular disease by Xinxuening.s treatment. Method: The included and excluded criteria was established before the setting of search terms, eligible databases (PubMed, Web of Science, Ovid, Embase, Cochrane, CNKI, CBM, Wanfang and Vip) were searched and the quality evaluation and evidence classification was conducted for eligible documents. The software RevMan was used to evaluate the clinical evidence of Xinxuening in the treatment of cardiovascular disease (primary hypertension, coronary heart disease, heart failure and hyperlipidemia) and to explore the specific mechanism.Results: A total of 16 suitable studies were included, of which 15 were RCTs and 1 was observation study. 9 of the 16 studies were the C level evidence and 7 were the D level. The included studies were all low quality. The outcome indicators of clinical treatment for cardiovascular disease were: the efficacy of hypertension therapy, the level of systolic and diastolic blood pressure after therapy, the efficacy of angina pectoris and hyperlipidemia treatment, and the total cholesterol and triglyceride levels after treatment. The results showed that Xinxuening could significantly reduce the level of blood pressure for patients with hypertension, improve the symptoms of angina pectoris in patients with coronary heart disease, and reduce the levels of blood lipids (triglycerides and total cholesterol) . The results have statistical differences (P < 0.05) . However, it the specific mechanism of Xinxuening in the treatment of cardiovascular disease was not found.Conclusion: Xinxuening has higher clinical effect on the treatment of some cardiovascular diseases compared with some western drugs and other proprietary Chinese medicine. However, it still needs further exploration of the specific clinical mechanism and to conduct high-quality clinical research.
		                        		
		                        		
		                        		
		                        	
6.Clinical Evidence Evaluation and Effect Characteristics of Shuxuening Injection
Ya HUANG ; Tianmai HE ; Songjie HAN ; Qianqian DAI ; Manke GUAN ; Changming ZHONG ; Zhaofeng SHI ; Huichan YUAN ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1754-1760
		                        		
		                        			
		                        			Objective: To summarize the clinical effects of Shuxuening Injection on diseases and evaluate the quality of evidence to provide reference for the clinical application of Shuxuening Injection. Methods: Journal articles and conference papers were retrieved from the databases CNKI, Wanfang, VIP, CBM, EMbase, Pubmed and Cochrane with thematic word"Shuxuening"in Chinese and English, then all forms of clinical studies were screened and the disease types and frequency were analyzed, the dominant disease types of Shuxuening Injection were identified. Futhermore, RCT was extracted, and the literature quality was graded using the cochrane manual recommendation method, and its effectiveness and safety were evaluated. Results: All clinical research results show that Shuxuening Injection to treat disease with as many as 74 kinds of varieties, mainly circulation system disease and neural system disease, followed by endocrine disease, respiratory disease, scattered remaining research in ten other system diseases. These researches appeared with the highest frequency of the three diseases were cerebral infarction and its aftermath, angina pectoris and coronary heart disease, diabetes mellitus and its complication. A total of 337 RCT articles were included, all of which were of poor quality. In general, the efficiency of Shuxuening Injection treatment group was significantly higher than that of the control group, with a total efficiency of 84.48%. There were 21.96% references to adverse reactions, but all of them were minor adverse reactions, such as pruritus, which generally got better by itself or after treatment. Conclusion:Shuxuening Injection has a wide range of clinical application and remarkable effect, especially for the ischemic diseases of cardiovascular and cerebrovascular diseases with good efficacy, less adverse reactions and safety. However, the quality of evidence is generally poor, which needs further study.
		                        		
		                        		
		                        		
		                        	
7.The Clinical Study of Wenxin Keli in the Treatment of Atrial Fibrillation: a Systematic Review
Min LI ; Ruijin QIU ; Yang SUN ; Xiaoyu ZHANG ; Rui ZHENG ; Jiayuan HU ; Chengyu LI ; Shiqi CHEN ; Yin JIANG ; Xinyu YANG ; Zhaofeng SHI ; Songjie HAN ; Tianmai HE ; Ya HUANG ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1761-1771
		                        		
		                        			
		                        			Objective: To conduct a comprehensive and systematic review of the efficacy and safety of Wenxin Keli (WXKL) in the treatment of atrial fibrillation (AF) . Methods: Seven databases (PubMed, The Cochrane Library, Web ofScience, CNKI, Wanfang Database, VIP and SinoMed) were searched to identify relevant randomized controlled trials (RCTs) from inceptions to 1 October, 2018. Two review authors independently assessed the methodological quality andanalyzed data by Cochrane handbook and the Rev Man 5.3 software. Begg.s test was conducted to assess publication biasvia Stata 14 software. Results: Twenty-four RCTs with 2246 patients were included in this review. Compared with blankcontrol, placebo or western medicine alone, WXKL alone or combined with western medicine could effectively reducerapid ventricular rate (MD=-7.14, 95%CI:-8.42——5.87), the frequency and duration of AF. It could also shorten thesinus rhythm conversion time (MD=-3.04, 95%CI:-3.47——2.61), increase the sinus rhythm conversion rate (RR=1.19, 95% CI: 1.09~1.29) and decrease recurrence rate of AF (RR=0.28, 95% CI: 0.13-0.59) . Besides, WXKL alone orcombined with western medicine was beneficial for improving the left ventricular ejection fraction (LVEF) (MD=3.44, 95% CI: 0.87-6.01), left ventricular end diastolic diameter (LVEDD) (MD=-2.47, 95% CI:-2.86——2.08), left atrialdiameter (LAd) (MD=-0.91, 95%CI:-1.58——0.25) and P wave dispersion (Pd) (MD=-4.04, 95%CI:-4.15——3.93) .WXKL combined with low-dose amiodarone was superior to conventional-dose amiodarone alone in improving themaximum P wave (Pmax) (MD=-8.25, 95% CI:-10.33——6.17), and WXKL combined with conventional-doseamiodarone is more effective (MD=-13.10, 95%CI:-13.65——12.55) . Compared with the control group, the treatmentgroup had fewer adverse reactions, and the Begg.s test did not find any publication bias. Conclusion: WXKL alone orcombined with western medicine exhibited better therapeutic effects in the treatment of AF, but these results still needhigh-quality evidence to verify.
		                        		
		                        		
		                        		
		                        	
8.Systematic Review of Danhong Injection on Endothelial Function after Percutaneous Coronary Intervention in Patients with Coronary Heart Disease
Tianmai HE ; Xinyu YANG ; Ruijin QIU ; Songjie HAN ; Ya HUANG ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(12):2126-2133
		                        		
		                        			
		                        			Objective: To evaluate the effect of Danhong injection on endothelial function after percutaneous coronaryintervention (PCI) in coronary heart disease (CHD) . It provides the basis for further research and design. Methods: Sevendatabases of CNKI, VIP, Wanfang Data, CBM, PubMed, The Cochrane Library, Embase and others were searched bycomputer cents with coronary heart disease treated by Danhong injection combined with conventional drugs. Twoevaluators independently sifted the literature, extracted the data and evaluated the bias risk in the study. The data werestatistically analyzed by RevMan 5.3 software. Results: A total of 12 RCTs, involving 1325 patients were included. Metaanalysis showed that the treatment group (Danhong injection combined with routine therapy) was superior to the controlgroup in improving the endothelium index after operation. The index NO[MD=9.57, 95%CI (8.22, 10.93), P < 0.00001], vWF [MD=-31.60, 95%CI (-41.47, -21.72), P < 0.00001], ET-1 [MD=-2.19, 95%CI (-3.11, -1.27), P < 0.00001], ET[SMD=-0.92, 95%CI (-1.49, -0.35), P < 0.01], FMD[MD = 1.81, 95%CI (1.26, 2.37), P < 0.00001]. There was statisticalsignificance between each index. Conclusion: Danhong injection combined with conventional therapy can improveendothelial function after PCI. However, due to the low quality of included studies and the problem of heterogeneity, these conclusions need to be further verified by high quality multicenter, large sample and double blind randomizedcontrolled trials.
		                        		
		                        		
		                        		
		                        	
9.Study of the clinical value of medical history and clinical manifestation-based protocol for the diagnosis of spontaneous coronary artery dissection using intravascular ultrasound
Yanwei LI ; Lingqiu KONG ; Pan ZHANG ; Lincen ZOU ; Dajun HUANG ; Zhou WU ; Hongcai ZHANG ; Jue ZHAO ; Yong XU
Chinese Journal of Ultrasonography 2017;26(7):553-557
		                        		
		                        			
		                        			Objective To investigate the feasibility and clinical value of medical history and clinical manifestation-based protocol(MHCMP) for the diagnosis of spontaneous coronary artery dissection(SCAD)using intravascular ultrasound (IVUS).Methods Based on the MHCMP designed in our centre,intraoperative sequential analysis was performed in patients with acute coronary syndrom and clinical tip of SCAD,SCAD and its classification were defined according to the result of IVUS.Results Of the 37 patients admitted with ACS at the Cardiology Service,29 patients had SCAD as the cause(78.4 %).All the patients underwent coronary angiography and IVUS,of which 9 patiens were type I (24.3 %),15 patients were type Ⅱ (40.5%) and 5 patients were type Ⅲ (13.5%).The left anterior descending artery was the most frequently affected (16 patients),followed by the the right coronary artery (7 patients),while 5 patients had dissection of the circumflex artery and 1 patient had dissection of the left main coronary artery.Type I (evident arterial wall stain):this was the pathognomonic angiographic appearance of SCAD with contrast dye staining of the arterial wall with multiple radiolucent lumens.Type Ⅱ (diffuse stenosis of varying severity):this angiographic appearance was not well appreciated and was often missed or misdiagnosed.SCAD commonly involved the mid to distal segments of coronary arteries,and could be so extensive that it reached the distal tip.There was an appreciable (often subtle) abrupt change in arterial caliber,with demarcation from normal diameter to diffuse narrowing.This diffuse and usually smooth narrowing could vary in severity from inconspicuous mild stenosis to complete occlusion.Type Ⅲ (mimic atherosclerosis):this appearance was the most challenging to differentiate from atherosclerosis and most likely to be misdiagnosed,while IVUS was helpful for the differential diagnosis.Conclusions MHCMP is able to screen out all kinds of SCAD and guide the treatment decisions making.
		                        		
		                        		
		                        		
		                        	
10.Clinical observation of ureteroscopy and minimally invasive percutaneous nephrolithotomy in the treatment of ;124 urinary calculi patients with acute renal dysfunction
Yuefu HAN ; Xinhua YAO ; Cuifen JIANG ; Hongcai HUANG ; Chaosheng ZHANG ; Zhengguo CAO ; Jianxin LI ; Xiaojian ZHONG ; Chao TIAN
Chinese Journal of Primary Medicine and Pharmacy 2013;20(z2):4-6
		                        		
		                        			
		                        			Objective To explore the clinical value of ureteroscopy and minimally invasive percutaneous nephrolithotomy ( MPCNL) in the treatment of ureteral calculi patients with acute renal dysfunction .Methods Clini-cal data of 124 ureteral calculi patients with acute renal dysfunction were retrospectively analyzed .86 cases were trea-ted with holmium-laser lithotripsy under ureteroscope .38 cases were treated with MPCNL under the guide of ultra-sound.Results Three months after operation ,the stone clearance rate was 100%,and no severe complications were observed.The renal function decreased to normal levels in 102 cases(82.3%).Conclusion The holmium laser lith-otripsy under ureteroscope and MPCNL can deal with double sites of ureteral calculi ,and offer advantages with less in-vasion,safety and efficiency ,which can be the first choice for the ureteral calculi combined with acute renal dysfunc -tion.
		                        		
		                        		
		                        		
		                        	
            
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