OBJECTIVES: To explore the efficacy of DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy for management of cancer pain and provide reference for its standardized clinical application. Methods and. RESULTS: Recommendations were formulated based on literature review and expert group discussion, and consensus was reached following expert consultation. The consensus recommendations are comprehensive, covering the entire treatment procedures from preoperative assessment and preparation, surgical operation process, postoperative management and traditional Chinese medicine treatment to individualized treatment planning. The study results showed that the treatment plans combining traditional Chinese with Western medicine effectively alleviated cancer pain, reduced the use of opioid drugs, and significantly improved the quality of life and enhanced immune function of the patients. Postoperative follow-up suggested good treatment tolerance among the patients without serious complications. CONCLUSIONS The formulated consensus is comprehensive and can provide reference for clinicians to use DSA-guided intrathecal drug delivery system combined with Zi Wu Liu Zhu Acupoint Therapy. The combined treatment has a high clinical value with a good safety profile for management of cancer pain.
Humans ; Medicine, Chinese Traditional ; Cancer Pain/therapy* ; Drugs, Chinese Herbal/therapeutic use* ; Drug Delivery Systems ; Pain Management/methods* ; China

OBJECTIVES: To investigate the therapeutic mechanism of Qingshen Granules (QSG) in patients with chronic kidney disease (CKD) damp-heat syndrome. METHODS: The regulatory targets of QSG were retrieved and mapped using TCMSP and UniProt. Small RNA sequencing technology was used to screen the target genes of chronic renal failure damp-heat syndrome to construct the "active ingredients-intersection targets-diseases" network, followed by KEGG pathway enrichment analysis and molecular docking of the core targets. Sixty patients with CKD (stage 3-5) presenting with damp-heat syndrome and not undergoing dialysis were randomized equally into two groups for conventional Western medicine treatment (control group) and additional treatment with QSG (observation group) for 8 weeks, with 20 healthy individuals as the normal control group. The expression levels of miR-23b-5p, Nrf2 and HO-1 protein in peripheral blood mononuclear cells (PBMC), renal function indicators (Scr and eGFR), and serum ROS, AOPP and PON-1 levels were compared among the 3 groups after the treatments. RESULTS: Six main active ingredients of QSG were identified, and their key targets included ACTB, JUN, PTEN, ESR1, GSK3B, PPARG, PIK3CA, APP, PIK3R1, and BECN1. MiR-23b-5p expression was significantly up-regulated in CKD damp-heat syndrome, in which the Nrf2 pathway abnormality played an important pathogenic role. Molecular docking results suggested good binding activity of the core targets with the active ingredients of QSG, and NFE2L2 had the strongest binding with luteolin. In patients with CKD damp-heat syndrome, QSG treatment significantly decreased serum Scr, ROS and AOPP levels, obviously improved eGFR, and increased serum PON-1 levels, expression levels of Nrf2 and HO-1 proteins in PBMCs, and the expression level of miR-23b-5p. CONCLUSIONS QSG can improve the renal function in patients with CKD damp-heat syndrome possibly by up-regulating miR-23b expression, activating the Nrf2 antioxidant pathway, and reducing oxidative stress levels.
Humans ; Renal Insufficiency, Chronic/metabolism* ; Drugs, Chinese Herbal/therapeutic use* ; NF-E2-Related Factor 2/metabolism* ; MicroRNAs/genetics* ; Signal Transduction ; Male ; Medicine, Chinese Traditional ; Adult ; Middle Aged ; Female

Immune suppression in the tumor microenvironment (TME) is closely related to abnormal glycolysis. Tumor cells gain metabolic advantages and suppress immune responses through the "Warburg effect". Traditional Chinese medicine (TCM) has been shown to regulate key glycolysis enzymes (such as HK2 and PKM2), metabolic signaling pathways (such as PI3K/AKT/mTOR, HIF-1α) and non-coding RNAs at multiple targets, thus synergistically inhibiting lactate accumulation, improving vascular abnormalities, and relieving metabolic inhibition of immune cells. Studies have shown that TCM monomers and formulas can promote immune cell infiltration and functions, improve metabolic microenvironment, and with the assistance by the nano-delivery system, enhance the precision of treatment. However, the dynamic mechanism of the interaction between TCM-regulated glycolysis and TME has not been fully elucidated, for which single-cell sequencing and other technologies provide important technical support to facilitate in-depth analysis and clinical translational research. Future studies should be focused on the synergistic strategy of "metabolic reprogramming-immune activation" to provide new insights into the mechanisms of tumor immunotherapy.
Humans ; Tumor Microenvironment/immunology* ; Glycolysis/drug effects* ; Neoplasms/drug therapy* ; Medicine, Chinese Traditional ; Signal Transduction ; Drugs, Chinese Herbal/pharmacology*

According to the principle and current domestic and international construction processes of core outcome set(COS) and the characteristics of post-stroke aphasia, this study built COS with evidence-based support for traditional Chinese medicine(TCM) treatment of post-stroke aphasia. Firstly, a comprehensive review was conducted on the articles about the TCM treatment of post-stroke aphasia that were published in the four major Chinese databases, three major English databases, and three clinical registration centers over the past five years. The articles were analyzed and summarized, on the basis of which the main part of the COS for clinical research on the TCM treatment of post-stroke aphasia was formed. Secondly, clinical doctors and related nursing personnel were interviewed, and important outcome indicators in the clinical diagnosis and treatment process were supplemented to form a pool of core outcome indicators. Two rounds of Delphi surveys were carried out to score the importance of the core outcome indicators in the pool. Finally, a consensus meeting of experts was held to establish the COS for clinical research on the TCM treatment of post-stroke aphasia. The final COS included a total of 268 studies [236 randomized controlled trials(RCTs), 21 Meta-analysis, and 11 clinical registration protocols] and 20 open questionnaire survey results. After two rounds of Delphi surveys, a total of 14 outcome indicators and their corresponding measurement tools were included in the expert consensus meeting. The final expert consensus meeting determined the COS for post-stroke aphasia, which included 9 indicator domains and 12 outcome indicators.
Humans ; Aphasia/therapy* ; Stroke/complications* ; Medicine, Chinese Traditional ; Drugs, Chinese Herbal/therapeutic use* ; Treatment Outcome

Signal detection is a critical task in drug safety regulation. However, it inevitably generates irrelevant or false signals, posing challenges for resource allocation by marketing authorization holders. To reasonably assess these signals, different countries have established various principles for prioritizing the evaluation of risk signals. This study systematically compares these principles and finds that the U.S. Food and Drug Administration(FDA) focuses on practical issues, such as identifying drug confusion or drug interactions. However, China's Good Pharmacovigilance Practices and the European Medicines Agency(EMA) emphasize a comprehensive evaluation framework. The Council for International Organizations of Medical Sciences(CIOMS) emphasizes the consistency of multiple data sources, highlighting the reliability of signal evaluation. China practices a multidisciplinary approach combining traditional Chinese and western medicine, and the risk signals related to traditional Chinese medicine(TCM) have unique characteristics, including complex components, cumulative toxicity, specific theoretical foundations, and drug interactions. The different priorities in risk signal evaluation principles across countries suggest that China should strengthen clinical trial research, emphasize corroboration with evidence of multiple sources, and pay particular attention to the risks of drug interactions in the TCM regulatory science. Establishing the risk signal prioritization principles that align with the characteristics of TCM enables more precise and efficient scientific regulation of TCM.
Humans ; Medicine, Chinese Traditional/standards* ; China ; Drugs, Chinese Herbal/adverse effects* ; United States ; United States Food and Drug Administration

The safety of traditional Chinese medicine(TCM) has always been taken very seriously, and rich and valuable theories and experiences have been developed to ensure the safe and precise use of TCM in clinical practices. In recent years, the cognitive theory of toxicity of TCM, has undergone a profound change. TCM is characterized by the existence of intrinsic toxicity, idiosyncratic toxicity, and indirect toxicity related to organic factors. Therefore, the traditional theories and experiences of TCM, which focus on the prevention and control of intrinsic toxicity, fail to be used for the development of risk prevention and control countermeasures for newly discovered TCM with idiosyncratic toxicity and indirect toxicity. Accordingly, based on the toxicity classification and mechanism characteristics of TCM, this paper proposed a new strategy and method in TCM compatibility for detoxification based on componenttarget-effect interaction. The strategy based on component-target-effect interaction is to carry out TCM compatibility for detoxification by blocking the occurrence of drug-mediated damage and promoting damage repair through component interactions, target interactions,and/or effect interactions. Based on this theory, the paper established a strategy for TCM compatibility that aligned with the cognitive theory of toxicity of TCM, so as to achieve safe and precise use of TCM in clinical practices. The strategy based on component-targeteffect interaction has been exemplarily applied to the development of countermeasures to reduce the toxicity of TCM, including Polygonum Multiflorum, Epimedii Folium, and Psoraleae Fructus, and a new mechanism of Glycyrrhizae Radix et Rhizoma to " harmonize various medicines and detoxify myriad poisons" was illustrated, providing a scientific basis for the safe and precise use of TCM in clinical practice. This paper explained the scientific connotation, application forms, and application examples of componenttarget-effect interaction, aiming to provide a theoretical and methodological basis for guaranteeing the precise use of TCM in clinical practice and innovate the theories and methods of TCM compatibility for detoxification.
Drugs, Chinese Herbal/chemistry* ; Humans ; Medicine, Chinese Traditional/methods* ; Animals ; Drug-Related Side Effects and Adverse Reactions/prevention & control*

Ulcerative colitis(UC) is a chronic, non-specific inflammatory disease with a complex etiology and a tendency for recurrence. So far, the clinical efficacy of western medicine in treating UC has been poor and is often accompanied by adverse reactions. Therefore, the multi-target, multi-level, synergistic, and heterogeneous characteristics of traditional Chinese medicine(TCM) are more beneficial for the treatment of UC. As one of the largest microbiotas, the intestinal flora is closely related to human health and disease. Once the intestinal flora becomes dysfunctional, it can affect the integrity of the intestinal mucosal barrier, thereby exacerbating UC. Additionally, the abnormal activation of signaling pathways may lead to dysregulation of the inflammatory response and play an important role in the pathogenesis of UC. Many studies have shown that individual TCMs and their compounds can further protect the intestinal barrier and immune system function by regulating the intestinal flora and associated signaling pathways, achieving therapeutic effects for UC. This paper summarizes the latest research results in China and abroad on the regulation of intestinal flora and related signaling pathways by individual TCMs and compounds in the treatment of UC, aiming to provide theoretical references for the clinical practice of TCM in treating UC and for related new drug research and development.
Humans ; Colitis, Ulcerative/immunology* ; Drugs, Chinese Herbal/administration & dosage* ; Gastrointestinal Microbiome/drug effects* ; Animals ; Medicine, Chinese Traditional

Blood heat syndrome, one of the main subtypes of blood syndrome in traditional Chinese medicine(TCM), is mainly diagnosed by bleeding and heat manifestations and treated by the blood-cooling method. The biological essence of blood heat syndrome has not been elucidated yet, and there is a lack of systematic research on the potential mechanisms underlying the blood-cooling method. The biological essence of blood heat syndrome is closely related to abnormal immune response, oxidative stress, coagulation dysfunction, endocrine disorders, abnormalities in energy metabolism and so on. Blood heat syndrome is common in autoimmune skin diseases( such as systemic lupus erythematosus, psoriasis, and purpura), central hyperthermia, infectious diseases( such as infectious mononucleosis and COVID-19), and hemorrhagic diseases in gynecology. As the primary clinical therapy for blood heat syndrome, blood-cooling TCM is usually combined with the TCM with effects of activating blood and resolving stasis, nourishing Yin,and extinguishing wind to play the role of cooling blood. The mechanisms of above therapies may be attributed to reducing inflammation, inhibiting oxidative stress, restoring the balance of blood coagulation and metabolism, regulating the secretion of sex hormones, and alleviating allergic reactions. This article systematically explores the biological essence of blood heat syndrome and elucidates the targets and underlying mechanism of the blood-cooling method, laying a scientific foundation for the clinical application of TCM in the prevention and treatment of diseases associated with blood heat syndrome.
Humans ; Medicine, Chinese Traditional/methods* ; Hyperthermia/diagnosis* ; Drugs, Chinese Herbal/therapeutic use* ; Syndrome

The therapeutic effects of traditional Chinese medicine(TCM) decoction is closely related to its decocting methods. A correct understanding of the scientific connotations of decocting methods in TCM is of great significance for guiding the application of decoctions and the development of modern TCM preparations based on decoctions. The decocting process is not only a hot water extraction process of chemical components but also accompanied by complex chemical and physical changes, forming a complex multiphase system and significantly affecting the absorption and therapeutic effect of TCM. This article reviews the research progress in scientific connotations of decocting methods in TCM from the perspectives of chemical composition changes, phase state differences,absorption behavior changes, and pharmacological and toxicological changes caused by decocting. This review is expected to provide implications for studying decocting methods and their scientific interpretation, boost the innovation and development of TCM decoctions,and promote the design and development of modern TCM preparations.
Drugs, Chinese Herbal/isolation & purification* ; Humans ; Medicine, Chinese Traditional/methods* ; Animals

Asthma is a chronic inflammatory disease involving multiple inflammatory cells and cytokines. Its pathogenesis is complex, involving various cells and cytokines. Traditional Chinese medicine(TCM) theory suggests that the pathogenesis of asthma is closely related to the dysfunction of internal organs such as the lungs, spleen, and kidneys. In contrast, modern immunological studies have revealed the central role of T helper 1(Th1)/T helper 2(Th2) and T helper 17(Th17)/regulatory T(Treg) cellular immune imbalance in the pathogenesis of asthma. Th1/Th2 imbalance is manifested as hyperfunction of Th2 cells, which promotes the synthesis of immunoglobulin E(IgE) and the activation of eosinophil granulocytes, leading to airway hyperresponsiveness and inflammation.Meanwhile, Th17/Treg imbalance exacerbates the inflammatory response in the airways, further contributing to asthma pathology.Currently, therapeutic strategies for asthma are actively exploring potential targets for regulating the balance of Th1/Th2 and Th17/Treg immune responses. These targets include cytokines, transcription factors, key proteins, and non-coding RNAs. Precisely regulating the expression and function of these targets can effectively modulate the activation and differentiation of immune cells. In recent years,traditional Chinese medicine active ingredients have shown unique potential and prospects in the field of asthma treatment. Based on this, the present study systematically summarizes the efficacy and specific mechanisms of TCM active ingredients in treating asthma by regulating Th1/Th2 and Th17/Treg immune balance through literature review and analysis. These active ingredients, including flavonoids, terpenoids, polysaccharides, alkaloids, and phenolic acids, exert their effects through various mechanisms, such as inhibiting the activation of inflammatory cells, reducing the release of cytokines, and promoting the normal differentiation of immune cells. This study aims to provide a solid foundation for the widespread application and in-depth development of TCM in asthma treatment and to offer new ideas for clinical research and drug development of asthma.
Asthma/genetics* ; Humans ; Drugs, Chinese Herbal/chemistry* ; Th2 Cells/drug effects* ; Th17 Cells/drug effects* ; T-Lymphocytes, Regulatory/drug effects* ; Th1 Cells/drug effects* ; Animals ; Cytokines/immunology* ; Medicine, Chinese Traditional