1.Current Status and Reflections on Key Technologies and Methods for Clinical Research Design and Evaluation of Traditional Chinese Medicine in Spleen and Stomach Diseases
Fang LU ; Ping WANG ; Liqun BIAN ; Lin LYU ; Mengli XIAO ; Tai ZHANG ; Xudong TANG
Journal of Traditional Chinese Medicine 2026;67(5):498-503
Clinical trials represent a pivotal stage in the development of pharmaceutical drugs. Nevertheless, given the unique characteristics of traditional Chinese medicine (TCM) and the diagnostic and treatment principle of syndrome differentiation and treatment in TCM, the clinical evaluation techniques and methods that can comprehensively reflect the characteristics of TCM and are tailored to its specificities are still in need of refinement and innovation. This paper systematically summarizes the key techniques and methods for designing and evaluating the clinical research on the treatment of the spleen and stomach diseases with TCM from three aspects including clinical research design, evaluation, and platform construction, compares domestic and international research landscapes, and proposes for future directions. It is suggested that a multidimensional evaluation system integrating modern medicine and TCM theory should be established, and further innovation is needed in TCM research design and methodologies, leveraging intelligent devices and technologies powered by next-generation information technology to transform clinical data into high-quality TCM evidence. Moreover, standardized and shared platforms for TCM clinical data should be accelerated, so as to provide references for the design, implementation, and evaluation of future clinical research on the treatment of the spleen and stomach diseases with TCM.
2.Mechanism of Shengmai Injection Against Cerebral Ischemia Based on Proteomics
Jingtong LIU ; Shaowei HU ; Mengli CHANG ; Jing XU ; Qingqing CAI ; Xinghong LI ; Liying TANG ; Huanhuan WANG ; Hongwei WU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(9):57-67
ObjectiveTo evaluate pharmacological effects of Shengmai injection(SMI)on cerebral ischemia and study its neuroprotective mechanism. MethodsMale specific pathogen-free (SPF) Sprague-Dawley (SD) rats were randomly divided into a sham group, a model group, a low-dose SMI group(3 mL·kg-1), a middle-dose SMI group(6 mL·kg-1), a high-dose SMI group(12 mL·kg-1), and a Ginaton group(4 mL·kg-1)according to the random number table method, with 12 rats in each group. The rat model of cerebral ischemia-reperfusion(MCAO/R)was prepared via the suture method. The administration groups were intraperitoneally injected with corresponding concentrations of SMI or Ginaton injection after reperfusion, which was conducted for 3 consecutive days. The sham group and model group were administered the equivalent volume of physiological saline. The pharmacological effects of SMI on brain injury in MCAO/R rats were evaluated by neurological function scores, cerebral infarction area, hematoxylin-eosin (HE) staining, Nissl staining, terminal deoxynucleotidyl transferase dUTP nick-end labeling (TUNEL) staining, and Western blot. The dominant link and key protein of SMI treating cerebral injury were explored using proteomic analysis. The related mechanisms of SMI were further validated using enzyme-linked immunosorbent assay (ELISA), Western blot, and chloride ion fluorescence probe with oxygen-glucose deprivation/reoxygenation(OGD/R)-treated PC12 cells and MCAO/R rats. ResultsCompared with the sham group, the model group showed significantly increased neurological function scores, cerebral infarction area, neuronal apoptosis rate, and expression levels of apoptosis related proteins (P<0.05, P<0.01)and significantly decreased density of Nissl bodies and neurons(P<0.01). Compared with the model group, the SMI groups exhibited significantly decreased neurological function scores, cerebral infarction area, neuronal apoptosis rate, and expression levels of apoptosis related proteins (P<0.05, P<0.01)and significantly increased density of Nissl bodies and neurons (P<0.05). The proteomic analysis results showed that oxidative stress and inflammatory response were important processes of SMI intervening in MCAO/R injury, and the chloride intracellular channel protein 1 (CLIC1) was one of key proteins in its action network. The levels of representative indicators of oxidative stress and inflammatory response in the MCAO/R rats of the SMI groups were significantly reduced, compared with those in the model group(P<0.05, P<0.01), and the expression levels of CLIC1 and downstream NOD-like receptor protein 3 (NLRP3) decreased (P<0.01). In addition, the experimental results based on the OGD/R PC12 cells showed that SMI significantly increased the cell survival rate(P<0.01) and significantly decreased the intracellular chloride ion concentration(P<0.05). ConclusionSMI has neuroprotective effects. Oxidative stress and inflammatory response are key processes of SMI intervening in MCAO/R injury. The potential mechanism is closely related to the regulation of CLIC1.
3.Epidemiological characteristics of myopia and pre-myopia among preschool children aged 5-6 years in ten provinces of China
Mengli TANG ; Yang LIU ; Ran QIN ; Xin GUO ; Hongtian LI
Journal of Peking University(Health Sciences) 2025;57(3):442-447
Objective:To describe the prevalence of myopia and pre-myopia among preschool children aged 5-6 years in ten provinces or municipalities(hereinafter referred to as province)of China,and to provide a reference for the prevention and control of myopia,and the allocation of related health re-sources.Methods:Convenience sampling was used to select preschool children aged 5-6 years from 21 cities in 10 provinces(including 8 provinces and 2 municipalities)in China.Cycloplegic autorefraction was conducted.The distribution of myopia and pre-myopia was described using frequencies and percenta-ges.The Chi-square test was used to compare the differences in the prevalence of myopia and pre-myopia between regions with different varying economic development levels and between boys and girls,with a significance level of α=0.05.Results:A total of 12 926 preschool children aged 5-6 years were sur-veyed.The myopia prevalence was 5.5%,and the overall prevalence of myopia and pre-myopia was 43.4%.Boys had higher rates of myopia and overall prevalence of myopia and pre-myopia than girls(5.7%vs.5.2%,46.4%vs.40.1%),though the difference in myopia prevalence was not statistical-ly significant.Stratified analysis by the province,there was no statistically significant differences in the prevalence of myopia between boys and girls in any province(P>0.05),but in 8 provinces,the preva-lence of myopia in boys was slightly higher than in girls.The overall prevalence of myopia and pre-myopia in boys was higher than in girls across all the 10 provinces,with 5 provinces showing statistically signifi-cant differences(P<0.05).The investigated areas were divided into two categories,relatively more-developed areas and relatively less-developed areas,based on per capita gross domestic product(GDP).In 6 provinces,there was no statistically significant difference in the prevalence of myopia between the two categories of areas.In 2 provinces,the prevalence was higher in relatively more-developed areas,and in 2 provinces,it was higher in relatively less-developed areas.In 4 provinces,there was no statisti-cally significant difference in the overall prevalence of myopia and pre-myopia between the two categories of areas with relatively more-developed and relatively less-developed areas.In 3 provinces,the preva-lence was higher in relatively more-developed areas,and in 3 provinces,it was higher in relatively less-developed areas.Conclusion:The prevalence of myopia and pre-myopia among preschool children aged 5-6 years is relatively high.Boys show higher overall prevalence of myopia and pre-myopia than girls,but there is no significant difference in the prevalence of myopia.There is no consistent association be-tween the level of economic development and the incidence of myopia and pre-myopia in each province.
4.Epidemiological characteristics of myopia and pre-myopia among preschool children aged 5-6 years in ten provinces of China
Mengli TANG ; Yang LIU ; Ran QIN ; Xin GUO ; Hongtian LI
Journal of Peking University(Health Sciences) 2025;57(3):442-447
Objective:To describe the prevalence of myopia and pre-myopia among preschool children aged 5-6 years in ten provinces or municipalities(hereinafter referred to as province)of China,and to provide a reference for the prevention and control of myopia,and the allocation of related health re-sources.Methods:Convenience sampling was used to select preschool children aged 5-6 years from 21 cities in 10 provinces(including 8 provinces and 2 municipalities)in China.Cycloplegic autorefraction was conducted.The distribution of myopia and pre-myopia was described using frequencies and percenta-ges.The Chi-square test was used to compare the differences in the prevalence of myopia and pre-myopia between regions with different varying economic development levels and between boys and girls,with a significance level of α=0.05.Results:A total of 12 926 preschool children aged 5-6 years were sur-veyed.The myopia prevalence was 5.5%,and the overall prevalence of myopia and pre-myopia was 43.4%.Boys had higher rates of myopia and overall prevalence of myopia and pre-myopia than girls(5.7%vs.5.2%,46.4%vs.40.1%),though the difference in myopia prevalence was not statistical-ly significant.Stratified analysis by the province,there was no statistically significant differences in the prevalence of myopia between boys and girls in any province(P>0.05),but in 8 provinces,the preva-lence of myopia in boys was slightly higher than in girls.The overall prevalence of myopia and pre-myopia in boys was higher than in girls across all the 10 provinces,with 5 provinces showing statistically signifi-cant differences(P<0.05).The investigated areas were divided into two categories,relatively more-developed areas and relatively less-developed areas,based on per capita gross domestic product(GDP).In 6 provinces,there was no statistically significant difference in the prevalence of myopia between the two categories of areas.In 2 provinces,the prevalence was higher in relatively more-developed areas,and in 2 provinces,it was higher in relatively less-developed areas.In 4 provinces,there was no statisti-cally significant difference in the overall prevalence of myopia and pre-myopia between the two categories of areas with relatively more-developed and relatively less-developed areas.In 3 provinces,the preva-lence was higher in relatively more-developed areas,and in 3 provinces,it was higher in relatively less-developed areas.Conclusion:The prevalence of myopia and pre-myopia among preschool children aged 5-6 years is relatively high.Boys show higher overall prevalence of myopia and pre-myopia than girls,but there is no significant difference in the prevalence of myopia.There is no consistent association be-tween the level of economic development and the incidence of myopia and pre-myopia in each province.
5.Regulatory Effect of Naoxintong Capsules on Short-chain Fatty Acids in Mice with Cerebral Ischemia-reperfusion Injury Based on LC-MS/MS
Jing ZHANG ; Yu LI ; Yuxin LEI ; Mengli CHANG ; Yanan WANG ; Jing XU ; Shihuan TANG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(23):141-148
ObjectiveTo explore the mechanism of Naoxintong capsules' intervention in cerebral ischemia-reperfusion by building a mouse cerebral ischemia-reperfusion model based on short-chain fatty acids. MethodC57BL/6J male mice were randomly divided into the sham group, model group, Naoxintong group (158.9 mg∙kg-1), and Ginaton group (12.1 mg∙kg-1) according to the random number table method. The model of cerebral ischemia-reperfusion (MCAO/R) was prepared via the filament occlusion method. The effect of Naoxintong capsules on brain injury in MCAO/R mice was evaluated by the neuroethological score, cerebral infarction area determination, Nissl staining, and immunofluorescence staining. Hematoxylin-eosin (HE) staining and Western blot were employed to evaluate the effect of Naoxintong capsules on the intestinal barrier in MCAO/R mice. The content of short-chain fatty acids in mouse feces was detected by LC-MS/MS. ResultCompared to the sham group, the model group exhibited significant increases in the cerebral infarction area, neuroethological score, and cell apoptosis rate (P<0.01), with a notable decrease in the number of Nissl bodies (P<0.01). The protein expression levels of Claudin-1 and Occludin were significantly reduced (P<0.05). Compared with the model group, the intervention of Naoxintong capsules significantly decreased the cerebral infarction area (P<0.05) and improved the neuroethological score (P<0.01) and cell apoptosis rate (P<0.01), with the number of Nissl bodies (P<0.01) and expression levels of Claudin-1 and Occludin proteins (P<0.01) increased. LC-MS/MS results showed that compared to the sham group, the model group featured a significantly reduced content of acetic acid, propionic acid, and butyric acid in feces (P<0.01), while valeric acid, isovaleric acid, and isobutyric acid levels were increased (P<0.01). The intervention of Naoxintong capsules notably lowered the content of valeric acid, isovaleric acid, and isobutyric acid (P<0.01). ConclusionNaoxintong capsules can improve brain and intestinal barrier damage and play a protective role in cerebral ischemia-reperfusion by regulating the content of short-chain fatty acids.
6.Quantitative Analysis on Health Care Industry Policy Text of the Yangtze River Delta Based on a Two Dimensional Framework of"Policy Tool-Health Care Industry Format"
Chinese Health Economics 2024;43(9):12-17
Objective:Using quantitative analysis to explore the health care industry policy documents of the Yangtze River Del-ta,reveal the exising policies problems,and provide scientific references for the healthy development of the health care industry.Methods:It uses the open coding method of qualitative research to code health care industry policy texts of Zhejiang,Jiangsu,Anhui and Shanghai,and carries out quantitative analysis based on the policy tool and health care format.Results:The policies and measures related to the health care industry in the Yangtze River Delta are scattered in the policy documents such as health pen-sion,health care,health care travel,etc.There is no special policy to guide the overall development of the health care industry.In the use of policy tools,there is a shortage of environmental tools,supply tools and demand tools,and there is an imbalance in the internal structure of various policy sub-tools;In terms of industrial format,the Yangtze River Delta can develop the advanta-geous format of health care industry based on local resource endowment,but there was insufficient attention to health and culture.Conclusion:The Yangtze River Delta should speed up the formulation of special policies for health care industry,strengthen the construction of health care service standards and product quality evaluation system,increase the proportion of demand-oriented tools,increase the supply of health care and culture policies,and promote the development of health care industry.
7.Quantitative Analysis on Health Care Industry Policy Text of the Yangtze River Delta Based on a Two Dimensional Framework of"Policy Tool-Health Care Industry Format"
Chinese Health Economics 2024;43(9):12-17
Objective:Using quantitative analysis to explore the health care industry policy documents of the Yangtze River Del-ta,reveal the exising policies problems,and provide scientific references for the healthy development of the health care industry.Methods:It uses the open coding method of qualitative research to code health care industry policy texts of Zhejiang,Jiangsu,Anhui and Shanghai,and carries out quantitative analysis based on the policy tool and health care format.Results:The policies and measures related to the health care industry in the Yangtze River Delta are scattered in the policy documents such as health pen-sion,health care,health care travel,etc.There is no special policy to guide the overall development of the health care industry.In the use of policy tools,there is a shortage of environmental tools,supply tools and demand tools,and there is an imbalance in the internal structure of various policy sub-tools;In terms of industrial format,the Yangtze River Delta can develop the advanta-geous format of health care industry based on local resource endowment,but there was insufficient attention to health and culture.Conclusion:The Yangtze River Delta should speed up the formulation of special policies for health care industry,strengthen the construction of health care service standards and product quality evaluation system,increase the proportion of demand-oriented tools,increase the supply of health care and culture policies,and promote the development of health care industry.
8.Quantitative Analysis on Health Care Industry Policy Text of the Yangtze River Delta Based on a Two Dimensional Framework of"Policy Tool-Health Care Industry Format"
Chinese Health Economics 2024;43(9):12-17
Objective:Using quantitative analysis to explore the health care industry policy documents of the Yangtze River Del-ta,reveal the exising policies problems,and provide scientific references for the healthy development of the health care industry.Methods:It uses the open coding method of qualitative research to code health care industry policy texts of Zhejiang,Jiangsu,Anhui and Shanghai,and carries out quantitative analysis based on the policy tool and health care format.Results:The policies and measures related to the health care industry in the Yangtze River Delta are scattered in the policy documents such as health pen-sion,health care,health care travel,etc.There is no special policy to guide the overall development of the health care industry.In the use of policy tools,there is a shortage of environmental tools,supply tools and demand tools,and there is an imbalance in the internal structure of various policy sub-tools;In terms of industrial format,the Yangtze River Delta can develop the advanta-geous format of health care industry based on local resource endowment,but there was insufficient attention to health and culture.Conclusion:The Yangtze River Delta should speed up the formulation of special policies for health care industry,strengthen the construction of health care service standards and product quality evaluation system,increase the proportion of demand-oriented tools,increase the supply of health care and culture policies,and promote the development of health care industry.
9.Quantitative Analysis on Health Care Industry Policy Text of the Yangtze River Delta Based on a Two Dimensional Framework of"Policy Tool-Health Care Industry Format"
Chinese Health Economics 2024;43(9):12-17
Objective:Using quantitative analysis to explore the health care industry policy documents of the Yangtze River Del-ta,reveal the exising policies problems,and provide scientific references for the healthy development of the health care industry.Methods:It uses the open coding method of qualitative research to code health care industry policy texts of Zhejiang,Jiangsu,Anhui and Shanghai,and carries out quantitative analysis based on the policy tool and health care format.Results:The policies and measures related to the health care industry in the Yangtze River Delta are scattered in the policy documents such as health pen-sion,health care,health care travel,etc.There is no special policy to guide the overall development of the health care industry.In the use of policy tools,there is a shortage of environmental tools,supply tools and demand tools,and there is an imbalance in the internal structure of various policy sub-tools;In terms of industrial format,the Yangtze River Delta can develop the advanta-geous format of health care industry based on local resource endowment,but there was insufficient attention to health and culture.Conclusion:The Yangtze River Delta should speed up the formulation of special policies for health care industry,strengthen the construction of health care service standards and product quality evaluation system,increase the proportion of demand-oriented tools,increase the supply of health care and culture policies,and promote the development of health care industry.
10.Quantitative Analysis on Health Care Industry Policy Text of the Yangtze River Delta Based on a Two Dimensional Framework of"Policy Tool-Health Care Industry Format"
Chinese Health Economics 2024;43(9):12-17
Objective:Using quantitative analysis to explore the health care industry policy documents of the Yangtze River Del-ta,reveal the exising policies problems,and provide scientific references for the healthy development of the health care industry.Methods:It uses the open coding method of qualitative research to code health care industry policy texts of Zhejiang,Jiangsu,Anhui and Shanghai,and carries out quantitative analysis based on the policy tool and health care format.Results:The policies and measures related to the health care industry in the Yangtze River Delta are scattered in the policy documents such as health pen-sion,health care,health care travel,etc.There is no special policy to guide the overall development of the health care industry.In the use of policy tools,there is a shortage of environmental tools,supply tools and demand tools,and there is an imbalance in the internal structure of various policy sub-tools;In terms of industrial format,the Yangtze River Delta can develop the advanta-geous format of health care industry based on local resource endowment,but there was insufficient attention to health and culture.Conclusion:The Yangtze River Delta should speed up the formulation of special policies for health care industry,strengthen the construction of health care service standards and product quality evaluation system,increase the proportion of demand-oriented tools,increase the supply of health care and culture policies,and promote the development of health care industry.

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