1.Randomized Controlled Clinical Observation on the Treatment of Lumbar Disc Herniation of Cold-Dampness Obstruction Type with Hot Ironing of Haitongpi Formula (海桐皮方) Combined with Three Movements Technique of Qinggong Spinal Manipulation
Fajie LI ; Yue ZHANG ; Tianhao WAN ; Manhong YANG ; Di XIA ; Qing ZHANG
Journal of Traditional Chinese Medicine 2025;66(10):1023-1030
ObjectiveTo observe the clinical efficacy and safety of hot ironing with Haitongpi Formula (海桐皮方, HF) in the treatment of lumbar disc herniation (LDH) of cold-dampness obstruction type. MethodsA total of 70 patients with cold-dampness obstruction type LDH were randomly divided into a treatment group and a control group, with 35 cases in each group. Both groups received three movements technique of Qinggong Spinal Manipulation (QSM) as the basis for treatment. In addition, the treatment group received hot ironing with HF, while the control group applied Diclofenac Sodium Gel externally. The treatment duration for both groups was 14 days. The clinical efficacy was compared between groups. Japanese Orthopedic Association (JOA) score, visual analog scale (VAS) for pain, pain pressure threshold (PPT) for lumbar positive response points, and traditional Chinese medicine (TCM) symptom scores were compared, on day 7, and day 14 of treatment, as well as on day 7 and day 14 of follow-up. The lumbar curvature index (LCI) was also compared before treatment and on day 14 of treatment. Adverse reactions during the study were recorded for both groups. ResultsA total of 35 patients in the treatment group and 34 patients in the control group were included for final analysis. The clinical total effective rate of the treatment group (91.43%, 32/35) was significantly higher than that of the control group (82.35%, 28/34, P<0.05). Both the JOA score and PPT of the two groups increased on day 7 and day 14 of treatment, and on day 7 and day 14 of follow-up. VAS scores and TCM symptom scores both decreased. The LCI of both groups increased on day 14 of treatment (P<0.01). Compared with the control group at the same time points, on day 14 of treatment and day 7 and day 14 of follow-up, the treatment group had higher JOA scores and PPT, and lower VAS scores and TCM symptom scores. The LCI of the treatment group increased on day 14 of treatment (P<0.05 or P<0.01). One case in the control group showed mild skin allergy, with no other adverse reactions observed in either group. ConclusionBased on three movements technique of QSM, hot ironing with HF shows better clinical efficacy than external Diclofenac Sodium Gel in the treatment of cold-dampness obstruction type LDH. It can significantly reduce lumbar pain, increase pain pressure threshold, improve clinical symptoms, lumbar function, and lumbar curvature, with good safety.
2.Analysis of Clinical Diagnosis and Traditional Chinese Medicine Medication Rule of Children with Nephrotic Syndrome in Single Center
Tingting XU ; Xia ZHANG ; Ying DING ; Long WANG ; Shanshan XU ; Yijin WANG ; Yue WANG ; Feiyu YAO ; Chundong SONG ; Wensheng ZHAI ; Xianqing REN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):176-184
ObjectiveTo analyze the clinical treatment plan and traditional Chinese medicine (TCM) medication rule of children with primary nephrotic syndrome (PNS) in the First Affiliated Hospital of Henan University of Chinese Medicine. MethodsThe gender and age of children firstly diagnosed with nephrotic syndrome in the pediatric nephrology department of the First Affiliated Hospital of Henan University of Chinese Medicine from November 2019 to December 2022 were collected, and the use of immunosuppressive agents and related frequencies were counted. According to the inclusion and exclusion criteria, an independent TCM prescription database for children with nephrotic syndrome was established. Excel was used to analyze the relevant information of the literature. The frequency counting, association rule analysis, and cluster analysis were carried out on TCM in the prescription, and the high-frequent drugs were analyzed. Results(1) General information: A total of 711 children were included, consisting of 522 males (73.42%) and 189 females (26.58%). The ratio of male to female was about 2.76∶1. The disease mainly occurred in infants and preschool age, and the average age of onset was (4.74 ± 3.48) years old. (2) Clinical treatment plan and use of immunosuppressive agents: Of the 711 children with PNS, 237 were treated with hormone alone (32.33%), and 474 (66.67%) received immunosuppressive agents combined with hormones. In the initial treatment, hormone combined with Tacrolimus (TAC) was the preferred treatment (32.91%). For children with refractory PNS who exhibited poor clinical efficacy, Rituximab (RTX) was mostly used for treatment, with a ratio of up to 23.63%. (3) TCM syndrome and medication rule: In PNS syndrome differentiation, Qi and Yin deficiency was identified as the main syndrome. This involved a total of 477 cases, accounting for 67.09%. Yang deficiency of spleen and kidney was observed in 118 cases, accounting for 16.60%. A total of 711 children were included, of which 706 children were treated with TCM. This involved a total of 706 prescriptions, 226 TCM, and 9 793 frequencies. There were 30 herbs used more than 95 times. The top five TCM were Radix et Rhizoma Glycyrrhizae (81.16%), Radix Astragali (71.81%), Poria (68.84%), Rhizoma Atractylodis Macrocephalae (63.60%), and Fructus Corni (57.37%). The drug association rules and network diagram showed that the combination of ''Radix Astragali-Rhizoma Atractylodis Macrocephalae-Poria'' was the closest, and five types of combinations were obtained by cluster analysis. ConclusionIn the diagnosis and treatment of PNS in children, TAC combined with hormones shows good clinical efficacy and high safety. For children with refractory PNS, RTX combined with hormones can be used. TCM medication for PNS should follow the basic principles of strengthening the body and vital Qi and make good use of drugs such as Radix Astragali, Poria, Rhizoma Atractylodis Macrocephalae, and cornus to regulate the Yin and Yang balance and achieve better clinical efficacy.
3.Analysis of Clinical Diagnosis and Traditional Chinese Medicine Medication Rule of Children with Nephrotic Syndrome in Single Center
Tingting XU ; Xia ZHANG ; Ying DING ; Long WANG ; Shanshan XU ; Yijin WANG ; Yue WANG ; Feiyu YAO ; Chundong SONG ; Wensheng ZHAI ; Xianqing REN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(12):176-184
ObjectiveTo analyze the clinical treatment plan and traditional Chinese medicine (TCM) medication rule of children with primary nephrotic syndrome (PNS) in the First Affiliated Hospital of Henan University of Chinese Medicine. MethodsThe gender and age of children firstly diagnosed with nephrotic syndrome in the pediatric nephrology department of the First Affiliated Hospital of Henan University of Chinese Medicine from November 2019 to December 2022 were collected, and the use of immunosuppressive agents and related frequencies were counted. According to the inclusion and exclusion criteria, an independent TCM prescription database for children with nephrotic syndrome was established. Excel was used to analyze the relevant information of the literature. The frequency counting, association rule analysis, and cluster analysis were carried out on TCM in the prescription, and the high-frequent drugs were analyzed. Results(1) General information: A total of 711 children were included, consisting of 522 males (73.42%) and 189 females (26.58%). The ratio of male to female was about 2.76∶1. The disease mainly occurred in infants and preschool age, and the average age of onset was (4.74 ± 3.48) years old. (2) Clinical treatment plan and use of immunosuppressive agents: Of the 711 children with PNS, 237 were treated with hormone alone (32.33%), and 474 (66.67%) received immunosuppressive agents combined with hormones. In the initial treatment, hormone combined with Tacrolimus (TAC) was the preferred treatment (32.91%). For children with refractory PNS who exhibited poor clinical efficacy, Rituximab (RTX) was mostly used for treatment, with a ratio of up to 23.63%. (3) TCM syndrome and medication rule: In PNS syndrome differentiation, Qi and Yin deficiency was identified as the main syndrome. This involved a total of 477 cases, accounting for 67.09%. Yang deficiency of spleen and kidney was observed in 118 cases, accounting for 16.60%. A total of 711 children were included, of which 706 children were treated with TCM. This involved a total of 706 prescriptions, 226 TCM, and 9 793 frequencies. There were 30 herbs used more than 95 times. The top five TCM were Radix et Rhizoma Glycyrrhizae (81.16%), Radix Astragali (71.81%), Poria (68.84%), Rhizoma Atractylodis Macrocephalae (63.60%), and Fructus Corni (57.37%). The drug association rules and network diagram showed that the combination of ''Radix Astragali-Rhizoma Atractylodis Macrocephalae-Poria'' was the closest, and five types of combinations were obtained by cluster analysis. ConclusionIn the diagnosis and treatment of PNS in children, TAC combined with hormones shows good clinical efficacy and high safety. For children with refractory PNS, RTX combined with hormones can be used. TCM medication for PNS should follow the basic principles of strengthening the body and vital Qi and make good use of drugs such as Radix Astragali, Poria, Rhizoma Atractylodis Macrocephalae, and cornus to regulate the Yin and Yang balance and achieve better clinical efficacy.
4.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.
5.Meteorological factor-driven prediction of high-use days of budesonide: construction and comparison of ensemble learning models
Qitao CHEN ; Yue ZHOU ; Xiaojun ZHANG ; Jingwen NI ; Guoqiang SUN ; Fenfei GAO ; Lizhen XIA ; Zihao LI
China Pharmacy 2025;36(21):2723-2726
OBJECTIVE To construct ensemble learning models for predicting high-use days of budesonide based on meteorological factors, thereby providing reference for hospital pharmacy management. METHODS Meteorological data for 2024 and outpatient budesonide usage data from the jurisdiction of Sanming Hospital of Integrated Traditional Chinese and Western Medicine were collected. High-use days were defined as the 75th percentile of outpatient budesonide usage, and a corresponding dataset was established. The prediction task was formulated as a classification problem, and three ensemble learning models were developed: Random Forest, Extreme Gradient Boosting (XGBoost), and Histogram-based Gradient Boosting Classifier. Model performance was evaluated using accuracy, precision, recall, F1-score, and log-loss. Model interpretability was analyzed using Shapley Additive Explanations (SHAP). RESULTS The Histogram-based Gradient Boosting Classifier achieved the best performance (accuracy=0.75, F1-score=0.48), followed by XGBoost (accuracy=0.74, F1-score=0.43) and Random Forest (accuracy=0.72, F1-score=0.22). SHAP results suggested that the prediction results of the last two models have the highest correction. CONCLUSIONS Ensemble learning models can effectively predict high-use days of budesonide, with the Histogram- based Gradient Boosting Classifier demonstrating the best predictive performance. Low temperature, high humidity, and low atmospheric pressure show significant positive impacts on the prediction of daily budesonide usage.
6.Research and development of sterile electrode acupuncture needle for single use based on medicine-engineering integration and its clinical application.
Wanying XIA ; Tianxin LI ; Lingli QIN ; Yue GAO ; Hanxi DAI ; Jie ZHANG ; Jinsheng YANG ; Lu ZHANG
Chinese Acupuncture & Moxibustion 2025;45(10):1527-1532
The sterile electrode acupuncture needle for single use is an innovative product that combines traditional acupuncture with modern electronic technology, and it has obtained Class Ⅱ medical device registration certificate. This acupuncture device consists of a needle body and a handle. The diameter of the needle body ranges from 0.16 mm to 0.55 mm, and the length from 7 mm to 150 mm. The spiral spray technology is adopted to modify the micron-level insulating coat on stainless steel needle body. The needle holder is connected to the electroacupuncture device (conductive), the micro-film insulated needle body (non-conductive) and the membrane-free needle tip (conductive) can provide a precise electrical stimulation for different tissue layers of acupoints (such as deep nerves and fascia). The intradermal stimulation test, cytotoxicity test and hypersensitivity reaction test have showed a favorable biocompatibility, laying a solid and reliable safety for clinical application. This acupuncture device is suitable for the in-depth invasive stimulation at the sites of human body surface in combination with electroacupuncture equipment in medical institutions.
Humans
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Needles
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Acupuncture Therapy/instrumentation*
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Electrodes
;
Equipment Design
;
Electroacupuncture/instrumentation*
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Acupuncture Points
;
Animals
7.Construction of oleanolic acid-producing Saccharomyces cerevisiae cells.
Yue ZHANG ; Xue-Mi HAO ; Cai-Xia WANG ; Long-Shan ZHAO
China Journal of Chinese Materia Medica 2025;50(9):2365-2372
In this study, Saccharomyces cerevisiae R0 was used as the chassis cell to synthesize oleanolic acid from scratch through the heterologous expression of β-amyrin synthase(β-AS) from Glycyrrhiza uralensis, cytochrome P450 enzyme CYP716A154 from Catharanthus roseus, and cytochrome P450 reductase AtCPR from Arabidopsis thaliana. The engineered strain R1 achieved shake flask titres of 5.19 mg·L~(-1). By overexpressing enzymes in the pentose phosphate pathway(PPP)(ZWF1, GND1, TKL1, and TAL), the NADH kinase gene in the mitochondrial matrix(POS5), truncated 3-hydroxy-3-methylglutaryl-CoA reductase(tPgHMGR1) from Panax ginseng, and farnesyl diphosphate synthase gene(SmFPS) from Salvia miltiorrhiza, the precursor supply and intracellular reduced nicotinamide adenine dinucleotide phosphate(NADPH) supply were enhanced, resulting in an 11.4-fold increase in squalene yield and a 3.6-fold increase in oleanolic acid yield. Subsequently, increasing the copy number of the heterologous genes tPgHMGR1, β-AS, CYP716A154, and AtCPR promoted the metabolic flow towards the final product, oleanolic acid, and increased the yield by three times. Shake flask fermentation data showed that, by increasing the copy number, precursor supply, and intracellular NADPH supply, the final engineered strain R3 could achieve an oleanolic acid yield of 53.96 mg·L~(-1), which was 10 times higher than that of the control strain R1. This study not only laid the foundation for the green biosynthesis of oleanolic acid but also provided a reference for metabolic engineering research on other pentacyclic triterpenoids in S. cerevisiae.
Oleanolic Acid/biosynthesis*
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Saccharomyces cerevisiae/metabolism*
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Industrial Microbiology
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Microorganisms, Genetically-Modified/metabolism*
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Plants/enzymology*
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Fermentation
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Metabolic Engineering
8.Effects of Saccharomyces cerevisiae chassis cells with different squalene content on triterpenoid synthesis.
Feng ZHANG ; Kang-Xin HOU ; Yue ZHANG ; Hong-Ping HOU ; Yue ZHANG ; Chao-Yue LIU ; Xue-Mi HAO ; Jia LIU ; Cai-Xia WANG
China Journal of Chinese Materia Medica 2025;50(8):2130-2136
Many triterpenoid compounds have been successfully heterologously synthesized in Saccharomyces cerevisiae. To increase the yield of triterpenoids, various metabolic engineering strategies have been developed. One commonly applied strategy is to enhance the supply of precursors, which has been widely used by researchers. Squalene, as a precursor to triterpenoid biosynthesis, plays a crucial role in the synthesis of these compounds. This study primarily investigates the effect of different squalene levels in chassis strains on the synthesis of triterpenoids(oleanolic acid and ursolic acid), and the underlying mechanisms are further explored using real-time quantitative PCR(qPCR) analysis. The results demonstrate that the chassis strain CB-9-5, which produces high levels of squalene, inhibits the synthesis of oleanolic acid and ursolic acid. In contrast, chassis strains with moderate to low squalene production, such as Y8-1 and CNPK, are more conducive to the synthesis of oleanolic acid and ursolic acid. The qPCR analysis reveals that the expression levels of ERG1, βAS, and CrCYP716A154 in the oleanolic acid-producing strain CB-OA are significantly lower than those in the control strains C-OA and Y-OA, suggesting that high squalene production in the chassis strains suppresses the transcription of certain genes, leading to a reduced yield of triterpenoids. Our findings indicate that when constructing S. cerevisiae strains for triterpenoid production, chassis strains with high squalene content may suppress the expression of certain genes, ultimately lowering their production, whereas chassis strains with moderate squalene levels are more favorable for triterpenoid biosynthesis.
Squalene/analysis*
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Saccharomyces cerevisiae/genetics*
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Triterpenes/metabolism*
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Metabolic Engineering
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Oleanolic Acid/biosynthesis*
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Ursolic Acid
9.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
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Humans
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Consensus
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Drugs, Chinese Herbal/therapeutic use*
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Surveys and Questionnaires
10.Application of motor behavior evaluation method of zebrafish model in traditional Chinese medicine research.
Xin LI ; Qin-Qin LIANG ; Bing-Yue ZHANG ; Zhong-Shang XIA ; Gang BAI ; Zheng-Cai DU ; Er-Wei HAO ; Jia-Gang DENG ; Xiao-Tao HOU
China Journal of Chinese Materia Medica 2025;50(10):2631-2639
The zebrafish model has attracted much attention due to its strong reproductive ability, short research cycle, and ease of maintenance. It has always been an important vertebrate model system, often used to carry out human disease research. Its motor behavior features have the advantages of being simpler, more intuitive, and quantifiable. In recent years, it has received widespread attention in the study of traditional Chinese medicine(TCM)for the treatment of sleep disorders, neurodegenerative diseases, fatigue, epilepsy, and other diseases. This paper reviews the characteristics of zebrafish motor behavior and its applications in the pharmacodynamic verification and mechanism research of TCM extracts, active ingredients, and TCM compounds, as well as in active ingredient screening and safety evaluation. The paper also analyzes its advantages and disadvantages, with the aim of improving the breadth and depth of zebrafish and its motor behavior applications in the field of TCM research.
Zebrafish/physiology*
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Medicine, Chinese Traditional
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Drugs, Chinese Herbal/therapeutic use*
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Disease Models, Animal
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Drug Evaluation, Preclinical/methods*
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Animals
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Sleep Wake Disorders/physiopathology*
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Epilepsy/physiopathology*
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Neurodegenerative Diseases/physiopathology*
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Fatigue/physiopathology*
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Behavior, Animal/physiology*
;
Motor Activity/physiology*


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