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."High detective rate of""metabolic inflammatory syndrome""in patients with type 2 diabetes"
Renming HU ; Ying XIE ; Bin LU ; Fengling CHEN ; Lianxi LI ; Ying HUANG ; Qin LI ; Weiwei YE ; Zhaoyun ZHANG ; Linuo ZHOU ; Min HE ; Weihu FAN ; Jie LIU ; Jie WENG ; Lili CHEN ; Yehong YANG ; Yiming LI ; Xixing ZHU
Chinese Journal of Endocrinology and Metabolism 2016;(1):27-32
Objective Metabolites produced by metabolic imbalance such as free fatty acids and lipopolysaccharides can result in a state of chronic low-grade inflammation, or metabolic inflammation, which plays an important role in the pathogenesis of atherosclerosis, type 2 diabetes, non-alcoholic fatty liver disease, and obesity. The above metabolic disorders are closely related with the metabolic inflammation, which always coexist. Therefore, we proposed the concept ofmetabolic inflammatory syndrome ( MIS). According to our study, patients with two or more metabolic disorders above could be diagnosed as MIS. The current research is aimed to investigate the prevalence of MIS and its components, and to compare the clinical values of MIS and metabolic syndrome ( MS) . Methods 2 001 in patients with type 2 diabetes from 6 hospitals in Shanghai were recruited in the current multi-center cross-sectional study. The diagnostic rates of MIS and MS and their components of both syndromes were compared. Results In the patients with type 2 diabetes, the detective rate of MIS was 96. 2%, which was higher than that of MS (71. 3%). Among 4 components of MIS, atherosclerosis showed the highest detective rate (75.6%). MIS[OR=2.252(95%CI1.026-4.942),P=0.043],atherosclerosis[OR=2.726(95% CI1.953-3. 804),P<0. 001], and MS[OR=1. 915 (95%CI 1. 444-2. 540),P<0. 01] were the risk factors of coronary heart disease. Conclusion With atherosclerosis, type 2 diabetes mellitus, non-alcoholic fatty liver disease, and obesity as its 4 components, MIS has a high detective rate in patients with metabolic disorders, and seems to be more sensitive than MS to distinguish inflammation-related metabolic diseases. The concept of MIS will promote the screening and prevention of atherosclerosis in its early stage.
3.A comparison of efficacy and tolerance of nateglinide and acarbose monotherapy in type 2 diabetes mellitns
Changyu PAN ; Yan GAO ; Guangwei LI ; Xixing ZHU ; Xin GAO ; Xin LIU
Chinese Journal of Internal Medicine 2009;48(4):304-307
Objective To compare the efficacy and tolerability of nateglinide with those of acarbose in Chinese type 2 diabetes mellitus (T2DM) patients.Methods This multi-center,randomized,double-blind,parallel-arm study compared the efficacy and tolerability of nateglinide( 120 mg,3/d,n = 119) and those of acarbose( 100 mg,3/d,n = 118) during a 12-week treatment in T2DM patients uncontrolled by diet with glycosylated haemoglobin (HbA1c) 6.5% - 11.0% .Results Monotherapy with nateglinide (120 mg,3/d)or acarbose (100 mg,3/d)decreased HbA1c to a similar extent during 12-week treatment.The mean change from baseline to end-point in HbAlc was ( -0.90±0.98)% and ( -0.83±0.81 )% in patients receiving nateglinide and acarbose,respectively,with no significant difference between the two groups (P>0.05).The decrease in fasting plasma glucose (FPG)was similar between nateglinide and acarbose (P > 0.05).The mean change in 2-hour postprandial plasma glucose ( PG2h ) was ( - 1.45 ± 2.74) mmol/L and ( -2.20±2.21 ) mmol/L in patients receiving nateglinide and acarbose(P =0.0017).Body weight was significantly decreased in both groups at the end-point ( P < 0.05 ),although the decrease was more with acarbese than nateglinide [( -0.66±1.79)kg vs (-2.06±2.00) kg,P=0.0000].And the proportion of patients experiencing any presumed drug related adverse events was not significantly different between the two groups.Conclusions Nateglinide ( 120 mg,3/d) is effective and well tolerated in T2DM patients uncontrolled by diet,demonstrating similar HbA1c reductions as compared with acarbose (100 mg,3/d).
4.Clinical diagnosis of 5 cases of pituitary stalk interruption syndrome
Hongying YE ; Qinghua LI ; Xi WU ; Yehong YANG ; Jie WEN ; Bin LU ; Linuo ZHOU ; Yiming LI ; Yiming ZHOU ; Zhenwei YAO ; Xixing ZHU ; Renming HU
Chinese Journal of Endocrinology and Metabolism 2008;24(5):483-485
Objective To raise the level of clinical diagnosis for the patients with pituitary stalk interruption syndrome (PSIS). Methods Five patients (4 males) with PSIS were retrospectively analyzed with respects to the clinical features, endocrine status and image characteristics. Magnetic resonance imaging (MRI) scan was performed at hypothalamic-pituitary region. Results The clinical manifestations of all patients consisted of growth retardation and delayed puberty without polyuria. Deficiency of multiple anterior pituitary hormones was revealed in all patients by the evaluation of endocrine status. The features of MRI included a lack of visible pituitary stalk, absence of posterior lobe hypersignal in the sella turcica and a hyperintense spot in the region of the thalamus opticus. Conclusion The clinical characteristics of patients with PSIS are growth retardation and delayed puberty. The evaluation of anterior pituitary function is necessary. The detection of an anatomical abnormality around hypothalamic-pituitary region by MRI is important diagnostic evidence.
5.Analysis of treatment outcomes for patients diagnosed with type 2 diabetes in Jiangninglu Neighborhood of downtown Shanghai
Wen XU ; Jingjun JIN ; Linlin GONG ; Bin LU ; Renming HU ; Xixing ZHU
Chinese Journal of General Practitioners 2008;7(9):596-598
Objective To understand treatment outcomes of patients diagnosed with type 2 diabetes aged over 30 years in Jiangninglu Neighborhood of downtown Shanghai. Methods Total 642 patients diagnosed as type 2 diabetes aged over 30 were investigated by cluster sampling in Jiangninglu Neighborhood of downtown Shanghai. Status of optimal control of diabetes in them was analyzed based on the recommendations proposed by International Diabetes Federation (IDF) for Western Pacific Region. Results and serum level of glycosylated hemoglobin Alc (HbAlc) of less than 6.5% was achieved in 37.5% (241/were achieved in 23.8% (153/642) and 18.1% (116/642) of them, respectively, and beth systolic and mmol/L was achieved in 21.7% (139/642) of all the participants investigated, triglyceride of less than 1.5 mmol/L in 46.6% (299/642), low-deusity lipoprotein-cholesterol (LDL-C) of less than 2.5 mmol/L in 23.7% (152/642) and high-density lipoprotein-cholesterol of greater than 1.1 mmol/L in 62.1% (399/of their blood glucose, blood pressure and serum LDL-C (defined as HbAlc less than 6.5%, blood pressure less than 130/80 mm Hg and LDL-C less than 2.5 retool/L). Conclusions Only 2.6% of all the patients diagnosed with diabetes aged over 30 in downtown Shanghai get optimal control of their blood glucose, blood pressure and serum lipid, so comprehensive prevention and control for diabetes shall be strengthened for them at community-level of urban areas.
6.Astragalus Polysaccharide Prevent Type 1 Diabetes in Nonobese Diabetic Mice
Wei CHEN ; Fang LIU ; Maohua YU ; Qiuyu ZHU ; Xixing ZHU
Fudan University Journal of Medical Sciences 2001;28(1):57-60
Purpose To observe the effects of the intervention or prevention of astragalus polysaccharide(APS)on type 1 diabetes in non-obese diabetic(NOD) mice. Methods the APS group was compared withthe normal solution(NS)group by the incidence of diabetes, the serum C-peptide levels and GAD-Ab levels,the proportion of CD4 or CD8 T subsets in splencytes, pancreatic histopathology and immunocyto-chemistry.Results It shows that the APS group has lower incidence of diabetes, higher serum C-P levels, decreaseddegree of the lymphocytic inflammation of pancreatic islets, stronger proliferation of CD8 T subsets and lowerratio of CD4/CD8 subgroup in splencytes than those of the NS group. Conclusions It proves thepreventive effects of APS on the onset of type 1 diabetes in NOD mice.
7.Effect of Gasoline on Barrier Function of Skin
Li YOU ; Maohua YU ; Hongying YE ; Xiufang YANG ; Songguo ZHENG ; Xixing ZHU
Fudan University Journal of Medical Sciences 2000;27(3):192-193
PurposeTo investigate the effect of gasoline on the skin barrier function.MethodsA rat skin model in vitro was used in this study. The amount of 3H-water penetrated throught the skin was applied as the index of evaluating the barrier function.ResultsThe results showed that the amount of 3H-water was not obviously increased in those exposed to gasoline for 0.5,1 and 2 h(P > 0.05), but the 3H-water penetration amount through the skin increased linearly with the time. In the group exposed to gasoline 4 h, the 3H-water penetration amount through the skin was significantly higher than that in the control group (P 0.05). The skin barrier function of the group (expopsed to gasoline 4 h) was disrupted.Conclusions Gasoline may disrupt the skin barrier function. Gasoline would remove the lipids within the intercellular domains of the stratum corneum and then lead to damage the skin.
8.Efficacy and safety of orlistat in Chinese obese patients
Yifan SHI ; Guangwei LI ; Xixing ZHU
Chinese Journal of Endocrinology and Metabolism 2000;0(06):-
Objective To evaluate the clinical efficacy and safety of orlistat in Chinese overweight and obese patients. Methods In six research centers, 444 overweight and obese patients (body mass index 25~40 kg/m 2) were divided into orlistat group (296 patients) and placebo group (148 patients) with a low-energy diet for 24 weeks by a randomized, double-blinded, placebo-controlled study. Results For intent-to-treat analysis, 286 orlistat-treated and 142 placebo-treated subjects were evaluated. After 24 weeks, orlistat-treated patients lost more weight 〔(6.1?3.6)kg,( x ?s)〕 than placebo-treated patients did (3.0?3.5)kg (P
9.Effect of diet with various fatty acid composition on insulin resistance in male OLETF rats
Hongli SHI ; Zhaozeng LU ; Jingchong FANG ; Hechen ZHU ; Xixing ZHU ;
Chinese Journal of Endocrinology and Metabolism 2000;0(06):-
The effect of diet with various fatty acid composition on insulin resistance in male OLETF ratswas observed. The results showed that it was beneficial to insulin sensitivity in rats fed with ? 3 polyunsaturated fatty acid rich food.
10.Lipoprotein (a) concentration and apolipoprotein (a) phenotype in subjects with type 2 diabetes mellitus
Hongli SHI ; Jingchong FANG ; Xiufang YANG ; Zhizhou SHEN ; Xixing ZHU
Chinese Medical Journal 1998;111(11):1013-1017
Objective To investigate the apolipoprotein (a) [apo(a)] polymorphism in the patients with type 2 diabetes mellitus and its relationship with complications.Methods In this study, we tested apo(a) phenotype via modified Utermann and Guo method in the 40 non-diabetic controls and 176 subjects with type 2 diabetes and analyzed the relationship between apo(a) phenotypes and micro- and macrovascular complications, including nephropathy, neuropathy, retinopathy, hypertension, coronary heart disease and cerebral infarction.Results Among the 40 non-diabetic controls, the frequencies of S3S2, S4 and S4S2 were 20%, 70% and 10% respectively and the serum lipoprotein(a) [Lp(a)] level was 0.08±0.07 mg/L. While the frequencies of S2, S3, S3S2, S4, S4S2, S4S3 were 18.18%, 20.45%, 17.05%, 34.09%, 4.55% and 5.68% in the diabetics and the Lp(a) concentration was 0.13±0.11 mg/L, with significant difference between the diabetics and non-diabetic controls. In comparison with the diabetics without complications, the frequency of apo(a) phenotype significantly differed in patients with nephropathy, nephropathy, hypertension, coronary heart disease and cerebral infarction except for diabetic retinopathy. In comparison with patients with S2 phenotype, the levels of fasting plasma glucose (FPG), 2-hour postprandial plasma glucose (2hPG) and glycated hemoglobin A1c (HbA1c) were lower in patients with S4 phenotype. The concentration of Lp(a) and urine albumin index (Alb/Cr) were significantly different among diabetics with different apo(a) phenotype, the highest being in patients with S2, secondly S3, and the lowest S4.Conclusion There were significant differences in the frequency of apo(a) phenotype between subjects with type 2 diabetes and non-diabetic controls, and also in diabetics with or without microvascular and macrovascular diseases. The underlying linkage might be microalbuminuria and insulin resistance.


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