1.Exploring on Quality Evaluation Methods of Clinical Case Reports in Traditional Chinese Medicine Based on China Clinical Cases Library of Traditional Chinese Medicine
Kaige ZHANG ; Feng ZHANG ; Bo ZHOU ; Haimin CHEN ; Yong ZHU ; Changcheng HOU ; Liangzhen YOU ; Weijun HUANG ; Jie YANG ; Guoshuang ZHU ; Shukun GONG ; Jianwen HE ; Yang YE ; Yuqiu AN ; Chunquan SUN ; Qingjie YUAN ; Buman LI ; Xingzhong FENG ; Kegang CAO ; Hongcai SHANG ; Jihua GUO ; Xiaoxiao ZHANG ; Zhining TIAN
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(1):271-276
As the core vehicle for preserving and transmitting traditional Chinese medicine(TCM) academic thought and clinical experience, the establishment of a robust quality evaluation system for TCM clinical case reports is a crucial component in the current standardization and modernization of TCM. Based on the practical experience of constructing the China Clinical Cases Library of Traditional Chinese Medicine by the China Association of Chinese Medicine, this study conducted a comprehensive analysis of critical challenges, including insufficient authenticity and unfocused evaluation criteria. It proposed a three-dimensional evaluation framework grounded in the structure-process-outcome logic, encompassing three dimensions of authenticity and standardization, characteristics and advantages, application and translational impact. This framework integrated 12 key evaluation indicators in a systematic manner. The model preserved the academic characteristics of TCM syndrome differentiation and treatment, while aligning with modern scientific research standards, achieving a balance between individualized TCM experience and standardized evaluation. Concurrently, this study provided theoretical foundations and methodological guidance for evaluating the quality of TCM clinical cases, contributing significantly to the inheritance of TCM knowledge, evidence-based practice, and the reform of talent evaluation mechanisms.
2.Application of dense fine speckled antinuclear antibodies in the diagnosis of autoimmune diseases
Hongcai LI ; Yuan LIU ; Mengyuan SUN ; Lin WANG ; Yuanqing QU ; Yugang LIU
International Journal of Laboratory Medicine 2025;46(19):2353-2357
Objective To investigate the distribution of dense fine speckled(DFS)antinuclear antibody(ANA)in different ages,genders,and diseases,and to explore its clinical significance in the diagnosis of auto-immune disease(AID).Methods A retrospective summary was conducted on the clinical basic data of 53520 patients who visited the hospital from January 2022 to April 2024,as well as the results of indirect immunoflu-orescence(IIF)ANA fluorescence karyotype and titer,and immunoblotting ANA spectrum,and the relation-ship between DFS positivity and AID was analyzed.Results Of the 53 520 serum samples,the rate of ANA fluorescence positivity was 32.40%,with DFS-positive samples accounting for 1.18%of all ANA fluores-cence-positive samples.The male-to-female ratio of DFS positives was 1∶1.94,with the highest percentage of 51.9%in the 21-40 age group.Among DFS positive individuals,only 12.14%were clinically diagnosed with AID disease,significantly lower than other ANA fluorescent karyotype positive individuals(23.31%,P<0.001).The overall positivity rate of ANA spectra using immunoblotting in DFS-positive individuals was 23.54%,which was significantly lower than that in other fluorescent karyotype positive ANA individuals(73.26%,P<0.001).Moreover,DFS positive individuals were mainly accompanied by antibody positivity such as anti-Ro52 antibodies,which had no diagnostic specificity in AID diagnosis.When comparing DFS posi-tive individuals with similar fluorescence morphology to those with homogeneous nuclear granules and nuclei,at an ANA titer of 1∶100,the proportion of AID patients in homogeneous nuclear granules and nuclei was 20.04%,significantly higher than the proportion of AID patients in DFS positive individuals(9.44%,P=0.001).With the increase of ANA titer,the proportion of AID diseases significantly increased in both karyo-type samples.When the ANA titer of DFS positive samples was increased to ≥ 1∶320,the proportion of AID diseases significantly increased to 30.77%(P=0.002).Conclusion DFS is a rare ANA fluorescent karyo-type,and DFS positive individuals are mainly found in females aged 21-40,mostly non AID patients.Howev-er,high titers of DFS cannot rule out the possibility of AID.In clinical work,special attention should be paid to distinguishing it from the homogeneous nuclear granule type to avoid misdiagnosis.
3.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.
4.Constitution identification model in traditional Chinese medicine based on multiple features
Anying XU ; Tianshu WANG ; Tao YANG ; Xiao HAN ; Xiaoyu ZHANG ; Ziyan WANG ; Qi ZHANG ; Xiao LI ; Hongcai SHANG ; Kongfa HU
Digital Chinese Medicine 2024;7(2):108-119
Objective To construct a precise model for identifying traditional Chinese medicine(TCM)constitutions,thereby offering optimized guidance for clinical diagnosis and treatment plan-ning,and ultimately enhancing medical efficiency and treatment outcomes. Methods First,TCM full-body inspection data acquisition equipment was employed to col-lect full-body standing images of healthy people,from which the constitutions were labelled and defined in accordance with the Constitution in Chinese Medicine Questionnaire(CCMQ),and a dataset encompassing labelled constitutions was constructed.Second,heat-suppres-sion valve(HSV)color space and improved local binary patterns(LBP)algorithm were lever-aged for the extraction of features such as facial complexion and body shape.In addition,a dual-branch deep network was employed to collect deep features from the full-body standing images.Last,the random forest(RF)algorithm was utilized to learn the extracted multifea-tures,which were subsequently employed to establish a TCM constitution identification mod-el.Accuracy,precision,and F1 score were the three measures selected to assess the perfor-mance of the model. Results It was found that the accuracy,precision,and F1 score of the proposed model based on multifeatures for identifying TCM constitutions were 0.842,0.868,and 0.790,respectively.In comparison with the identification models that encompass a single feature,either a single facial complexion feature,a body shape feature,or deep features,the accuracy of the model that incorporating all the aforementioned features was elevated by 0.105,0.105,and 0.079,the precision increased by 0.164,0.164,and 0.211,and the F1 score rose by 0.071,0.071,and 0.084,respectively. Conclusion The research findings affirmed the viability of the proposed model,which incor-porated multifeatures,including the facial complexion feature,the body shape feature,and the deep feature.In addition,by employing the proposed model,the objectification and intel-ligence of identifying constitutions in TCM practices could be optimized.
5.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.
6.An experimental study of a novel transjugular intrahepatic portosystemic shunt puncture set in animals
Yingen LUO ; Jingui LI ; Yawei LI ; Chao YANG ; Tianhao CONG ; Ruilin TIAN ; Hongcai YANG ; Yujie LI ; Mingchen SANG ; Xiao LI
Chinese Journal of Radiology 2023;57(11):1246-1251
Objective:To evaluate the feasibility and safety of a novel transjugular intrahepatic portosystemic shunt (TIPS) puncture set for transjugular intrahepatic portal puncture in swine.Methods:Thirteen domestic swine were randomly divided into experimental group ( n=7) and control group ( n=6) and received transjugular intrahepatic portal puncture with the novel puncture set and the R?sch-Uchida Transjugular Liver Access Set (RUPS-100), respectively. Three swines in each group were randomly selected and sacrificed immediately after the procedure and the rest were sacrificed 1 week later. The intraoperative technical success rate, puncture attempts, procedure time, fluoroscopy time, vital signs and occurrence of complications related to the procedure as well as the changes of liver and kidney function before, immediately after and 1 week after the procedure were compared between two groups. Independent sample t test, paired t test, Mann-Whitney U test, chi-square test or Fisher′s exact test were performed to compare the differences between groups. Results:The technical success rate was 100% for both groups. No significant difference in portal puncture attempts [2.0 (1.0, 5.0) vs. 2.0(1.0, 5.5), P>0.999], procedure time [(47.7±20.6) vs. (52.5±28.0)min, P=0.729] and fluoroscopy time [(725.1±489.2) vs. (763.7±562.4)s, P=0.897] was observed between two groups. In addition, no significant difference of the major liver and kidney function between two groups before, immediately after and 1 week after procedure ( P>0.05 at all time points). No significant difference of the major liver and kidney function change in two groups during perioperative period was identified (all P>0.05). Furthermore, no significant difference of non-target puncture occurrence was observed between two groups ( P>0.999). In the meantime, no significant difference of occurrence of small hematomas around hepatic hilar was discovered among swine sacrificed immediately after procedure between two groups ( P>0.999). No other major complications were identified in either group. Conclusion:The novel TIPS puncture set is feasible and safe to perform transjugular intrahepatic portal puncture in swine.
7.Cardioprotective mechanism of SGLT2 inhibitor against myocardial infarction is through reduction of autosis.
Kai JIANG ; Yue XU ; Dandan WANG ; Feng CHEN ; Zizhuo TU ; Jie QIAN ; Sheng XU ; Yixiang XU ; John HWA ; Jian LI ; Hongcai SHANG ; Yaozu XIANG
Protein & Cell 2022;13(5):336-359
Sodium-glucose cotransporter 2 (SGLT2) inhibitors reduce cardiovascular mortality in patients with diabetes mellitus but the protective mechanism remains elusive. Here we demonstrated that the SGLT2 inhibitor, Empagliflozin (EMPA), suppresses cardiomyocytes autosis (autophagic cell death) to confer cardioprotective effects. Using myocardial infarction (MI) mouse models with and without diabetes mellitus, EMPA treatment significantly reduced infarct size, and myocardial fibrosis, thereby leading to improved cardiac function and survival. In the context of ischemia and nutritional glucose deprivation where autosis is already highly stimulated, EMPA directly inhibits the activity of the Na+/H+ exchanger 1 (NHE1) in the cardiomyocytes to regulate excessive autophagy. Knockdown of NHE1 significantly rescued glucose deprivation-induced autosis. In contrast, overexpression of NHE1 aggravated the cardiomyocytes death in response to starvation, which was effectively rescued by EMPA treatment. Furthermore, in vitro and in vivo analysis of NHE1 and Beclin 1 knockout mice validated that EMPA's cardioprotective effects are at least in part through downregulation of autophagic flux. These findings provide new insights for drug development, specifically targeting NHE1 and autosis for ventricular remodeling and heart failure after MI in both diabetic and non-diabetic patients.
Animals
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Diabetes Mellitus
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Diabetes Mellitus, Type 2/drug therapy*
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Glucose
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Humans
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Mice
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Myocardial Infarction/metabolism*
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Sodium-Glucose Transporter 2 Inhibitors/therapeutic use*
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Ventricular Remodeling
8.A multicenter prospective cohort study of Xuebijing injection in the treatment of severe coronavirus disease 2019
Xuesong LIU ; Yuanlin SONG ; Weijie GUAN ; Haibo QIU ; Bin DU ; Yimin LI ; Yan LIU ; Hongcai SHANG ; Nanshan ZHONG
Chinese Critical Care Medicine 2021;33(7):774-778
Objective:To evaluate the effect of Xuebijing injection on the improvement of pneumonia severity index (PSI) and prognosis in patients with severe coronavirus disease 2019 (COVID-19).Methods:A multicenter prospective cohort study was designed. Adult patients with COVID-19 admitted to the intensive care unit (ICU) of 28 designated COVID-19 hospitals in 15 provinces and cities of China from January to March 2020 were enrolled. All patients were treated according to the standard treatment plan of COVID-19 issued by the National Health Commission of the People's Republic of China. They were divided into Xuebijing group and standard treatment group according to whether they received Xuebijing injection or not. In the standard treatment group, routine medical care measures such as antiviral, respiratory support, circulatory support and symptomatic treatment were taken. In the Xuebijing group, on the basis of standard treatment, Xuebijing was used within 12 hours of admission to the ICU, 100 mL each time, twice daily. The minimum duration of Xuebijing administration was 1 day. The improvement rate of PSI risk rating on the 8th day and clinical outcome on the 28th day were recorded.Results:A total of 276 COVID-19 patients were screened continuously, and the data of 144 severe patients who met PSI risk rating Ⅲ-Ⅴ were analyzed. Seventy-two cases were involved each in standard treatment group and Xuebijing group. The average age of the standard treatment group and Xuebijing group were (65.7±7.9) years old and (63.5±10.9) years old, and male accounted for 75.0% (54/72) and 70.8% (51/72), respectively. There were no significant differences in general conditions, comorbidities, PSI risk rating and score, sequential organ failure assessment (SOFA) score, oxygenation index (PaO 2/FiO 2), respiratory support mode and other baseline indicators between the two groups. Compared with the standard treatment group, the improvement rate of PSI risk rating in Xuebijing group on the 8th day after admission was significantly improved [56.9% (41/72) vs. 20.8% (15/72), between-group difference and 95% confidence interval (95% CI) was 36.1% (21.3% to 50.9%), P < 0.01], PSI score, SOFA score and PaO 2/FiO 2 were significantly improved [PSI score: 83.7±34.8 vs. 108.2±25.6, between-group difference (95% CI) was -24.5 (-34.9 to -14.1); SOFA score: 2.0 (1.0, 4.0) vs. 7.0 (4.0, 10.0), between-group difference (95% CI) was -3.5 (-5.0 to -2.0); PaO 2/FiO 2 (mmHg, 1 mmHg = 0.133 kPa): 289.4±111.6 vs. 188.5±98.1, between-group difference (95% CI) was 100.9 (65.3 to 136.5); all P < 0.01]. The 28-day discharge rate of Xuebijing group was 44.5% higher than that of standard treatment group [66.7% (48/72) vs. 22.2% (16/72), P < 0.01], and the 28-day survival rate was 9.8% [91.7% (66/72) vs. 81.9% (59/72), P < 0.01]. There was no significant difference in the combination of antiviral drugs, antibiotics, anticoagulants and vasopressor drugs between the two groups. There was no significant difference in the incidence of adverse events between the Xuebijing group and standard treatment group [41.7% (30/72) vs. 43.1% (31/72), P > 0.05], and no serious adverse events and adverse reactions of Xuebijing were reported. Conclusion:Standard treatment combined with Xuebijing injection can significantly improve the PSI risk score and clinical prognosis of patients with severe COVID-19 without increasing drug safety risk.
9.Effect of Xuebijing Injection on differentiation of bone marrow hematopoietic stem cells in septic mice
Jun WANG ; Ping WANG ; Ying HAO ; Xiaorui LI ; Yaru FENG ; Lan WANG ; Hongcai SHANG ; Jianxun WANG
Chinese Journal of Integrated Traditional and Western Medicine in Intensive and Critical Care 2019;26(5):539-542
Objective To investigate the intervention effect of Xuebijing Injection on the differentiation of bone marrow hematopoietic stem cells (HSC) in septic mice. Methods Fifty-four male C57BL/6N mice were randomly divided into three groups: normal control group, model group and Xuebijing group, each group with 18 mice. The mouse models of sepsis were duplicated by intra-peritoneal injection of 10 mg/kg E. coli lipopolysaccharide (LPS) method. Starting from the day of modeling, Xuebijing Injection 20 mL/kg was intravenously injected into the tail vein in Xuebijing group, once a day for consecutive 4 days; the normal control and model groups were intravenously injected with normal saline at the same dose and site for 4 days. The bone marrow cells of the femur and tibia of the mice were isolated after 4 days of various treatments in the three groups, and the proportions of bone marrow HSC Lin-Sca-1+c-Kit+ (LSK) and hematopoietic progenitor cells Lin-Sca-1-c-Kit+ (LS-K) of each group were detected by flow cytometry. Results Finally, 14 mice were included in the normal control group, 17 in the model group, and 12 in the Xuebijing group. With the prolongation of time, the body weight of the normal control group gradually increased, the body masses of the model group and the Xuebijing group were decreased first and then increased, reaching a peak at 96 hours after the model was established, but they were still significantly lower than the body mass of normal control group (g: 19.81±0.27, 19.58±0.39 vs. 22.23±0.30, both P < 0.05). Compared with the normal control group, the proportions of LSK, LS-K, long-term HSC (LT-HSC), and megakaryocyte-erythroid progenitor cells (MEP) were all significantly increased in the model group [LSK: (16.62±1.28)% vs. (12.89±0.83)%, LS-K: (44.77±1.77)% vs. (30.34±0.90)%, LT-HSC: (6.88±0.48)% vs. (1.83±0.24)%, MEP: (13.89±1.26)% vs. (9.38±0.66)%, all P < 0.05], the proportion of multipotential progenitor cells (MPP) was significantly decreased [(2.41±0.34)% vs. (5.99±0.59)%, P < 0.05]. Compared with the model group, the LSK and myeloid progenitor (CMP) of the Xuebijing group were significantly reduced [LSK: (12.25±0.69)% vs. (16.62±1.28)%, CMP :(0.31±0.05)% vs. (0.55±0.13)%, both P < 0.05], and LS-K, LT-HSC, MEP showed a decreasing trend [LS-K: (42.75±2.48)% vs. (44.77±1.77)%, LT-HSC:(5.98±0.70)% vs. (6.88±0.48)%, MEP: (10.94±1.36)% vs. (13.89±1.26) %], but the differences were not statistically significant (all P > 0.05). There were no significant differences in the proportions of short-term HSC (ST-HSC) and granulocyte-macrophage progenitor cells (GMP) among the three septic groups (all P > 0.05). Conclusion Xuebijing Injection can improve the differentiation function of bone marrow cells in septic mice, which may be possibly related to the inhibition of pathological proliferation of bone marrow hematopoietic stem cells and progenitor cells in septic mice by Xuebijing Injection.
10.Problems of Using Traditional Chinese Medicine Injections in Clinical Practice and the Suggestions about Making the Package Inserts
Shiqi CHEN ; Rui ZHENG ; Youping LI ; Hongcai SHANG
World Science and Technology-Modernization of Traditional Chinese Medicine 2018;20(10):1718-1722
In clinical practice, the application of Traditional Chinese Medicine injections (TCMIs) has several problems, for example, at some time, the components are complicated, the ingredients and pyrogen are uncontrollable, the usage, the dosage, and the drug interactions are unclear and the method of application is also ambiguous and non-standard. The factors have restricted the development of TCMIs. Based on the policies of the TCMI package inserts since 2006, this paper takes consideration of the problems and gives suggestions of making strict, normal and evidence-based TCMI package inserts.

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