1.Treatment Principles and Paradigm of Diabetic Microvascular Complications Responding Specifically to Traditional Chinese Medicine
Anzhu WANG ; Xing HANG ; Lili ZHANG ; Xiaorong ZHU ; Dantao PENG ; Ying FAN ; Min ZHANG ; Wenliang LYU ; Guoliang ZHANG ; Xiai WU ; Jia MI ; Jiaxing TIAN ; Wei ZHANG ; Han WANG ; Yuan XU ; .LI PINGPING ; Zhenyu WANG ; Ying ZHANG ; Dongmei SUN ; Yi HE ; Mei MO ; Xiaoxiao ZHANG ; Linhua ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(5):272-279
To explore the advantages of traditional Chinese medicine (TCM) and integrative TCM-Western medicine approaches in the treatment of diabetic microvascular complications (DMC), refine key pathophysiological insights and treatment principles, and promote academic innovation and strategic research planning in the prevention and treatment of DMC. The 38th session of the Expert Salon on Diseases Responding Specifically to Traditional Chinese Medicine, hosted by the China Association of Chinese Medicine, was held in Beijing, 2024. Experts in TCM, Western medicine, and interdisciplinary fields convened to conduct a systematic discussion on the pathogenesis, diagnostic and treatment challenges, and mechanism research related to DMC, ultimately forming a consensus on key directions. Four major research recommendations were proposed. The first is addressing clinical bottlenecks in the prevention and control of DMC by optimizing TCM-based evidence evaluation systems. The second is refining TCM core pathogenesis across DMC stages and establishing corresponding "disease-pattern-time" framework. The third is innovating mechanism research strategies to facilitate a shift from holistic regulation to targeted intervention in TCM. The fourth is advancing interdisciplinary collaboration to enhance the role of TCM in new drug development, research prioritization, and guideline formulation. TCM and integrative approaches offer distinct advantages in managing DMC. With a focus on the diseases responding specifically to TCM, strengthening evidence-based support and mechanism interpretation and promoting the integration of clinical care and research innovation will provide strong momentum for the modernization of TCM and the advancement of national health strategies.
2.Pharmacological Mechanism of Huanglian Jiedutang: A Review
Duojing LI ; Yongfa XING ; Baohe WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):275-283
Huanglian Jiedutang (HLJDT), a traditional Chinese herbal formula, is known for its heat-clearing and detoxifying effects. This article reviewed the material basis, pharmacological mechanism of action, and research on HLJDT. Modern research has shown that HLJDT is rich in alkaloids, flavonoids, glycosides, and other active ingredients. In terms of pharmacological mechanisms of action, HLJDT has anti-inflammatory and antibacterial effects, and it can regulate intestinal flora and cell disorder, improve iron metabolism disorder, control glucose and lipid metabolism, and exert vascular endothelial functions, with anti-tumor effects, thus improving cerebral ischemia and reducing liver damage. Its therapeutic actions are multi-layered, multi-faceted, and multi-targeted, showing significant efficacy in treating various diseases. Interdisciplinary research, such as the combined application of network pharmacology with molecular docking technology, as well as metabolomics with proteomics, has revealed the potential mechanism of HLJDT in treating various diseases. However, the research on HLJDT still faces some challenges, including the need for an in-depth exploration of its complex pharmacological mechanism of action, evaluation of its efficacy and safety across different diseases and populations, and quality control of traditional Chinese medicine. Future research should integrate modern scientific and technological approaches with traditional Chinese medicine principles to further investigate HLJDT's complex pharmacological mechanism of action, providing theoretical and practical support for its clinical use.
3.Pharmacological Mechanism of Huanglian Jiedutang: A Review
Duojing LI ; Yongfa XING ; Baohe WANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):275-283
Huanglian Jiedutang (HLJDT), a traditional Chinese herbal formula, is known for its heat-clearing and detoxifying effects. This article reviewed the material basis, pharmacological mechanism of action, and research on HLJDT. Modern research has shown that HLJDT is rich in alkaloids, flavonoids, glycosides, and other active ingredients. In terms of pharmacological mechanisms of action, HLJDT has anti-inflammatory and antibacterial effects, and it can regulate intestinal flora and cell disorder, improve iron metabolism disorder, control glucose and lipid metabolism, and exert vascular endothelial functions, with anti-tumor effects, thus improving cerebral ischemia and reducing liver damage. Its therapeutic actions are multi-layered, multi-faceted, and multi-targeted, showing significant efficacy in treating various diseases. Interdisciplinary research, such as the combined application of network pharmacology with molecular docking technology, as well as metabolomics with proteomics, has revealed the potential mechanism of HLJDT in treating various diseases. However, the research on HLJDT still faces some challenges, including the need for an in-depth exploration of its complex pharmacological mechanism of action, evaluation of its efficacy and safety across different diseases and populations, and quality control of traditional Chinese medicine. Future research should integrate modern scientific and technological approaches with traditional Chinese medicine principles to further investigate HLJDT's complex pharmacological mechanism of action, providing theoretical and practical support for its clinical use.
4.Clinical Evidence Profile of Eleven Expensive Chinese Patent Medicines: A Scoping Analysis
Yajing LI ; Miaomiao LI ; Le ZHANG ; Wenya WANG ; Hui ZHAO ; Xing LIAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(2):227-238
ObjectiveThis study employed the scoping review method to systematically retrieve and analyze the basic information and clinical research evidence of expensive Chinese patent medicines (CPMs), aiming to provide a basis for future related research and clinical applications. MethodsEight Chinese and English databases were systematically searched for the clinical research evidence on expensive CPMs. ResultsEleven expensive CPMs (Angong Niuhuang Wan, Jufang Zhibao Wan, Suhexiang Wan, Pien Tze Huang, Niuhuang Qingxin Wan, Qinggong Shoutao Wan, Compound Realgar Natural Indigo Tablets, Xihuang Wan, Dingkun Wan, Babao Wan, and Guilingji Capsules) were selected. A total of 365 related studies were included in this review, comprising 331 clinical studies (of which 291 were randomized controlled trials), 30 systematic reviews and Meta-analyses, 3 expert consensus, and 1 rapid health technology assessment. Among the 11 CPMs, 2(Angong Niuhuang Wan and Jufang Zhibao Wan) had a daily price over 500 yuan. The famous and precious Chinese medicinal materials involved included Moschus (frequency of 7), Bovisc Alculus (7), and Borneol (5). The dosage forms included pills, capsules, oral liquid, tablets, and lozenges. The diseases treated by these CPMs mainly included malignant tumors, cerebrovascular diseases, gynecological diseases, and hepatobiliary system diseases. The sample sizes of the clinical studies were mainly concentrated within the range of 51-100 cases, and the main control form was CPM + basic Western medicine treatment vs. basic Western medicine treatment. The 331 clinical studies reported a total of 44 adverse events occurred, of which 36 were determined to be adverse reactions. ConclusionThe scarcity of raw materials leads to the high prices of expensive CPMs. The difficulty of conducting clinical research and the critical and severe cases treated lead to a lack of clinical research evidence with large sample sizes. The uneven distribution of existing studies, incomplete information on medicine package, and non-standard clinical research designs remain to be addressed in the future.
5.Clinical Efficacy of Tangning Tongluo Tablets for Nonproliferative Diabetic Retinopathy
Fuwen ZHANG ; Junguo DUAN ; Wen XIA ; Tiantian SUN ; Yuheng SHI ; Shicui MEI ; Xiangxia LUO ; Xing LI ; Yujie PAN ; Yong DENG ; Chuanlian RAN ; Hao CHEN ; Li PEI ; Shuyu YANG
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(3):132-139
ObjectiveTo observe the clinical efficacy and safety of Tangning Tongluo tablets in the treatment of nonproliferative diabetic retinopathy (DR). MethodsFourteen research centers participated in this study, which spanned a time interval from September 2021 to May 2023. A total of 240 patients with nonproliferative DR were included and randomly assigned into an observation group (120 cases) and a control group (120 cases). The observation group was treated with Tangning Tongluo tablets, and the control group with calcium dobesilate capsules. Both groups were treated for 24 consecutive weeks. The vision, DR progression rate, retinal microhemangioma, hemorrhage area, exudation area, glycosylated hemoglobin (HbA1c) level, and TCM syndrome score were assessed before and after treatment, and the safety was observed. ResultsThe vision changed in both groups after treatment (P<0.05), and the observation group showed higher best corrected visual acuity (BCVA) than the control group (P<0.05). The DR progression was slow with similar rates in the two groups. The fundus hemorrhage area and exudation area did not change significantly after treatment in both groups, while the observation group outperformed the control group in reducing the fundus hemorrhage area and exudation area. There was no significant difference in the number of microhemangiomas between the two groups before treatment. After treatment, the number of microhemangiomas decreased in both the observation group (Z=-1.437, P<0.05) and the control group (Z=-2.238, P<0.05), and it showed no significant difference between the two groups. As the treatment time prolonged, the number of microhemangiomas gradually decreased in both groups. There was no significant difference in the HbA1c level between the two groups before treatment. After treatment, the decline in the HbA1c level showed no significant difference between the two groups. The TCM syndrome score did not have a statistically significant difference between the two groups before treatment. After treatment, neither the TCM syndrome score nor the response rate had significant difference between the two groups. With the extension of the treatment time, both groups showed amelioration of TCM syndrome compared with the baseline. ConclusionTangning Tongluo tablets are safe and effective in the treatment of nonproliferative DR, being capable of improving vision and reducing hemorrhage and exudation in the fundus.
6.Survey on the perception and current status of drug risk management in medical institutions
Xuelin SUN ; Mingqing XING ; Zixuan ZHANG ; Wenjing ZHAO ; Dongfang QIAN ; Yan LIANG ; Li XU ; Pengfei JIN ; Yatong ZHANG
China Pharmacy 2025;36(1):7-12
OBJECTIVE To know about the perception and current status of drug risk management among pharmacists in Chinese medical institutions, providing insights and recommendations for enhancing the drug risk management system in medical institutions. METHODS A questionnaire survey was conducted across 28 provinces, cities, and autonomous regions; stratified radom sampling was employed to study the population of medical workers and pharmaceutical professionals in medical institutions nationwide. The survey included information on the survey population, the current status of drug risk management implementation in medical institutions, the cognition, definition and process of drug risk management related concepts, and the content and mode of drug risk management work in medical institutions. Finally, suggestions were collected from various medical institutions on the system construction of drug risk management. Descriptive statistical analysis was adopted to summarize the obtained data. RESULTS A total of 446 questionnaires were collected in this survey, including 420 valid questionnaires and 26 invalid questionnaires. The questionnaire collection rate was 100%,and the effective rate was 94.17%. 51.19% of the respondents No.2020YFC2009001)。 based their understanding of drug risk management on Management Measures for Adverse Drug Reaction Reports and Monitoring, while 87.38% recognized the need for drug risk management throughout the drug use process. 63.33% of the participants stated that their medical institutions had dedicated positions related to drug risk management, with the highest proportion (72.17%) was in third-grade class A medical institutions. 66.43% reported implementing risk management across all drug use stages. Suggestions for the development of drug risk management systems in medical institutions by the research participants focused on enhancing guiding documents, clarifying concepts, establishing information-sharing mechanisms. CONCLUSIONS The overall awareness of drug risk management in China’s medical institutions is high, with practices in place across various stages in multiple forms. However, there remains a need to strengthen institutional documents, management regulations, system development, and information-sharing mechanisms to improve collaborative governance, improve drug management levels, and ensure patient safety.
7.Effect and mechanism of compatibility of Astragali Radix-Puerariae Lobatae Radix on ferroptosis in T2DM insulin resistance rats
Shuang WEI ; Feng HAO ; Wenchun ZHANG ; Zhangyang ZHAO ; Ji LI ; Dongwei HAN ; Huan XING
China Pharmacy 2025;36(1):57-63
OBJECTIVE To explore the effect and potential mechanism of the compatibility of Astragali Radix-Puerariae Lobatae Radix on ferroptosis of liver cells in type 2 diabetes mellitus (T2DM) insulin resistance (IR) rats. METHODS Sixty male SD rats were randomly divided into control group (12 rats) and modeling group (48 rats). The modeling group was fed with a high- fat diet for 4 consecutive weeks and then given a one-time tail vein injection of 1% streptozotocin to establish T2DM IR model. The model rats were randomly divided into model group, the compatibility of Astragali Radix-Puerariae Lobatae Radix group [QG group, 4.05 g/(kg·d), intragastric administration], ferroptosis inhibitor ferrostatin-1 group [Fer-1 group, 5 mg/kg by intraperitoneal injection, once every other day], the compatibility of Astragali Radix-Puerariae Lobatae Radix+ferroptosis inducer erastin group [QG+erastin group, 4.05 g/(kg·d) by intragastric administration+erastin 10 mg/(kg·d), intraperitoneal injection]. After 4 weeks of intervention, serum fasting blood glucose (FBG) and fasting insulin (FINS) were measured in each group of rats, and homeostasis model assessment of insulin resistance (HOMA-IR) and the natural logarithm of insulin action index(IAI) were calculated; the serum levels of total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), aspartate transaminase (AST) and alanine transaminase (ALT), Fe2+ and Fe content, glutathione (GSH), malondialdehyde (MDA) and superoxide dismutase (SOD) levels, NADP+/NADPH ratio and reactive oxygen species (ROS) were determined. The pathological morphology of its liver tissue was observed; the protein expressions of glutathione peroxidase 4 (GPX4), ferritin heavy chain 1 (FTH1), long-chain acyl-CoA synthetase 3 (ACSL3), ACSL4, ferritin mitochondrial (FTMT), and cystine/glutamate anti-porter (xCT) in the liver tissue of rats were detected. RESULTS Compared with control group, the liver cells in the model group of rats showed disordered arrangement, swelling, deepened nuclear staining, and more infiltration of inflammatory cells, as well as a large number of hepatocyte vacuoles and steatosis; FBG (after medication), the levels of TC, TG, LDL-C, AST, ALT, FINS, MDA and ROS, HOMA-IR, Fe2+ and Fe content, NADP+/NADPH ratio and protein expression of ACSL4 were significantly increased or up-regulated, while the levels of HDL-C, GSH and SOD, IAI, protein expressions of GPX4, FTH1, ACSL3, FTMT and xCT were significantly reduced or down-regulated (P<0.01). Compared with the model group, both QG group and Fer-1 group showed varying degrees of improvement in pathological damage of liver tissue and the levels of the above indicators, the differences in the changes of most indicators were statistically significant (P<0.01 or P<0.05). Compared with QG group, the improvement of the above indexes of QG+erastin group had been reversed significantly (P<0.01). CONCLUSIONS The compatibility decoction of Astragali Radix-Puerariae Lobatae Radix can reduce the level of FBG in T2DM IR rats, and alleviate IR degree, ion overload and pathological damage of liver tissue. The above effects are related to the inhibition of ferroptosis.
8.Practical exploration of ethical review in decentralized drug clinical trials
Xu ZUO ; Yingshuo HUANG ; Yue LI ; Lihan XING ; Chunxiu YANG ; Yan CUI
Chinese Medical Ethics 2025;38(1):40-45
ObjectiveTo explore the process and guidelines for ethical review in decentralized drug clinical trials, promote clinical trial progress, and ensure drug development progress. MethodsThe key points of the ethical review were summarized by studying the relevant laws and regulations on decentralized drug clinical trials, analyzing the advantages and challenges of decentralized drug clinical trials, and combining the experience of the ethics committee of the institution in reviewing decentralized drug clinical trials. ResultsRelevant laws and regulations were the basis for the ethical review, and the ethics committee should adopt appropriate review methods based on regulations and hospital ethical standard operating procedures. The ethics committee should focus on the feasibility, applicability, and rationality, the adequacy of informed consent, the protection of rights and interests and privacy of subjects, as well as the qualification and standard operating procedures of electronic platforms for conducting decentralized drug clinical trials. ConclusionDecentralized drug clinical trials are in their early stages and urgently require guidance from relevant laws and regulations. Ethical review is also constantly being refined through exploration. It is necessary to supervise the implementation of responsibilities by all parties, pay attention to the rights and interests of subjects, and gradually promote the implementation of decentralized drug clinical trials.
9.Effect of Tongmai Kaiqiao Pills on Mitochondrial Biogenesis of Hippocampal Neurons in Rats with Vascular Cognitive Impairment Based on AMPK/PGC-1α Signaling Pathway
Luyao MA ; Yanjie LI ; Haoyuan LIU ; Yanjie BAI ; Ruoxing XING
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(8):125-134
ObjectiveTo observe the effects of Tongmai Kaiqiao pills on AMP-activated protein kinase (AMPK)/peroxisome proliferator-activated receptor gamma coactivator-1α (PGC-1α) signaling pathway and mitochondrial biogenesis in hippocampal tissue of rats with vascular cognitive impairment (VCI) and to investigate the potential mechanism of Tongmai Kaiqiao pills in improving cognitive impairment in rats with VCI. MethodsTwelve of 72 male SD rats were selected as the sham operation group, and the remaining rats were modelled using the modified 2VO method. The rats that were successfully modelled were divided into the model group, the high-dose group of Tongmai Kaiqiao pills (27.6 g·kg-1), the low-dose group of Tongmai Kaiqiao pills (13.8 g·kg-1), the combination group (27.6 g·kg-1 Tongmai Kaiqiao pills + 25 mg·kg-1 dorsomorphin), and the donepezil hydrochloride group (0.45 g·kg-1) according to the random number table method. After four weeks of continuous intraperitoneal injection of the corresponding drugs, the Morris water maze test was used to test the learning and memory ability of rats. Hematoxylin-eosin (HE) staining and Nissl staining were used to detect pathological changes in the hippocampus of the rats. The content of mitochondrial adenosine triphosphate (ATP) in the brain hippocampus was detected by colorimetry, and reactive oxygen species (ROS) level was detected in rat mitochondria by MitoSOX Red assay. Mitochondrial DNA copy number was detected by real-time fluorescent quantitative PCR (Real-time PCR). Pathological changes in mitochondria were observed by transmission electron microscopy (TEM), and AMPK, PGC-1α, phosphorylated AMP-activated protein kinase (p-AMPK), nuclear respiratory factor 1 (Nrf1), and mitochondrial transcription factor A (TFAM) protein expression in the hippocampus of the rats were detected by Western blot. ResultsCompared with those in the sham operation group, rats in the model group had a reduced number of platform crossings (P<0.01), significantly prolonged evasion latency (P<0.01), disorganized neuronal arrangement in the hippocampal region, widened gaps, and blurred nucleus membrane and nucleolus boundaries. The emergence of necrotic cells was visible. The color of the nissl bodies was light, and the number was reduced with severe loss. Mitochondria were atrophied, and cristae were lost. Severe damage was observed. The content of ROS was increased, and the level of ATP was decreased. mtDNA copy number decreased significantly (P<0.01), and the protein expression of p-AMPK, PGC-1α, Nrf1, and TFAM decreased (P<0.05, P<0.01). Compared with those in the model group, rats in the high-dose group of Tongmai Kaiqiao pills and donepezil hydrochloride group showed a shorter time to find the platform (P<0.01), increased number of platform crossings (P<0.01), restored mitochondrial morphology and structure of the hippocampal neurons, alleviated neuronal death, increased number of nissl bodies, weaken degree of injury, lower content of ROS, and significantly increased levels of ATP and number of copies of mtDNA (P<0.05, P<0.01). In addition, there was increased protein expression of p-AMPK, PGC-1α, Nrf1, and TFAM (P<0.05, P<0.01). Compared with the model group, the evasion latency was shortened in the low-dose group of Tongmai Kaiqiao pills (P<0.01), and the number of platform crossings was increased, but the difference was not statistically significant. The mitochondria were swollen and deformed, and the cristae became shorter and partially disappeared. The degree of damage did not improve significantly, and the number of nissl bodies was increased but not statistically significant. The ROS content decreased (P<0.01), but there was no significant difference in ATP level and mtDNA copy number. The protein expression of PGC-1α was increased (P<0.05), but there was no significant difference in the protein expression of p-AMPK, Nrf1, and TFAM, and the results were not statistically significant. Compared with the donepezil hydrochloride group, there was no significant change in the results of each assay in the high-dose group of Tongmai Kaiqiao pills, and the difference was not statistically significant. Compared with the high-dose group of Tongmai Kaiqiao pills, rats in the combination group had a significantly lower number of platform crossings (P<0.01), a significantly longer evasion latency (P<0.01), a reduced number of neuronal cells, disorganized tissue structure, swollen and blurred cell outlines, a significant reduction in the number of nissl bodies. Moreover, there was an increase in the content of ROS, a decrease in the level of ATP and the number of mtDNA copies (P<0.01), and a decrease in the expression of p-AMPK, PGC-1α, Nrf1, and TFAM (P<0.05). ConclusionTongmai Kaiqiao pills is able to improve cognitive function in rats by activating the AMPK/PGC-1α signaling pathway, promoting mitochondrial biogenesis, and attenuating pathological damage to neurons in the hippocampal region, thereby demonstrating its therapeutic potential.
10.Correlation between brain white matter lesions and insulin resistance in non-diabetic elderly individuals based on magnetic resonance imaging
Mei LI ; Fang YUAN ; Xizi XING ; Feng XIE ; Hua ZHANG
Chinese Journal of Radiological Health 2025;34(1):96-101
Objective To investigate the relationship between brain white matter lesions (WML) and triglyceride glucose (TyG) index in non-diabetic elderly individuals based on magnetic resonance imaging. Methods A total of 523 non-diabetic elderly individuals aged ≥ 60 years were selected from Jinan, Shandong Province, China from June 2018 to December 2019. According to the quartiles of TyG index, there were 133 participants in the first quartile (Q1) group, 127 in the second quartile (Q2) group, 132 in the third quartile (Q3) group, and 131 in the fourth quartile (Q4) group. All participants underwent brain magnetic resonance imaging to evaluate paraventricular, deep, and total WML volumes, as well as Fazekas scores. Results Compared with Q1, Q2, and Q3 groups, Q4 group showed significant increase in periventricular, deep, and total WML volumes (P < 0.05). The proportion of participants with a Fazekas score ≥ 2 in the periventricular, deep, and total WML was higher in the Q4 group compared with the Q1 and Q2 groups (P < 0.05). The proportion of participants with a Fazekas score ≥ 2 in deep WML was higher in Q4 group than in Q3 group (P < 0.05). TyG index was significantly positively correlated with periventricular, deep, and total WML volumes (r = 0.401, 0.405, and 0.445, P < 0.001). After adjusting for confounding factors, TyG index was still significantly positively correlated with periventricular, deep, and total WML volumes (P < 0.001). Logistic regression analysis showed that compared with Q1 group, the risk of Fazekas score ≥ 2 in periventricular WML was 1.950-fold (95% confidence interval [CI]: 1.154-3.294, P = 0.013) in Q3 group and 3.411-fold (95% CI: 1.984-5.863, P < 0.001) in Q4 group, the risk of Fazekas score ≥ 2 in total WML was 2.529-fold (95%CI: 1.444-4.430, P = 0.001) in Q3 group and 4.486-fold (95%CI: 2.314-8.696, P < 0.001) in Q4 group. The risk of Fazekas score ≥ 2 in deep WML was 2.953-fold (95%CI: 1.708-5.106, P < 0.001) in Q4 group compared with Q1 group. Conclusion Increased TyG index is an independent risk factor for WML in non-diabetic elderly individuals.

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