1.Expert Consensus on Clinical Application of Qidong Yixin Oral Liquid
Changkuan FU ; Xiaochang MA ; Mingjun ZHU ; Yue DENG ; Hongxu LIU ; Mingxue ZHANG ; Ying CHEN ; Yan ZHOU ; Ling ZHANG ; Jianhua FU ; Wei YANG ; Yu'er HU ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):147-158
The prescription of Qidong Yixin oral liquid is derived from the experience of national medical master Ren Jixue in treating viral myocarditis (VMC). It has the functions of tonifying Qi, nourishing the heart,calming the mind, and relieving palpitations. It is used to treat VMC and angina pectoris of coronary heart disease caused by deficiency of both Qi and Yin. However,the understanding of its efficacy evidence, advantageous aspects, dosage and administration, and medication safety remains insufficient in clinical practice. Therefore,the development of the Expert Consensus on the Clinical Application of Qidong Yixin Oral Liquid (hereinafter referred to as consensus) was initiated. Consensus strictly followed the process and methods of the expert consensus on the clinical application of Chinese patent medicines of the China Association of Chinese Medicine,successively completing multiple tasks such as the consensus project initiation,determination of clinical problems,evidence search and evaluation,formation of recommendation opinions and consensus suggestions,solicitation of opinions,peer review, submission for review and release, and so on. Consensus formed a total of 10 recommendation opinions and 12 consensus suggestions,clarifying the clinical positioning,efficacy advantages,syndrome differentiation,dosage and administration,combination therapy,timing of medication,adverse reactions,contraindications, and precautions of Qidong Yixin oral liquid,indicating that it has good clinical advantages and safety in the treatment of VMC and angina pectoris of coronary heart disease,providing norms and references for physicians to safely and rationally apply Qidong Yixin oral liquid. Consensus was reviewed and approved for release by the Standardization Office of the China Association of Chinese Medicine on December 23, 2024. Standard number:GSCACM-376-2024.
2.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
3.Compilation Instruction for Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections
Changkuan FU ; Lianxin WANG ; Yihuai ZOU ; Mingquan LI ; Yaming LIN ; Weihong SUN ; Xu WEI ; Ming CHEN ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):238-244
The Pharmacovigilance Guidelines for Clinical Application of Traditional Chinese Medicine Injections (hereinafter referred to as the Guidelines) were released by the China Association of Chinese Medicine, with the standard number T/CACM 1563.4—2024. It is the first specialized guideline in China on the approach to pharmacovigilance activities for the clinical application of traditional Chinese medicine injections (TCMIs). The Guidelines were jointly developed by the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, along with 30 experts in TCM pharmacovigilance, clinical practice (TCM, as well as integrated traditional Chinese and Western medicine),and evidence-based medicine from across the country. This publication filled the gap in standard documents in this field, both domestically and internationally. The Guidelines were formulated according to GB/T1.1—2020 Directives for standardization—Part 1: Rules for the structure and drafting of standardizing documents, the WHO Handbook for Guideline Development,and other methodological norms. Based on international norms,national laws and regulations,and scientific research results in the field of pharmacovigilance, methods adopted included expert interviews,literature research,nominal group technique, and Delphi method. Then, key points for pharmacovigilance for TCM injections were summarized and clarified in the four critical sections of "monitoring","identification","assessment",and "control". The development process of the Guidelines included project initiation, international registration, expert interviews, literature search, and evaluation. Based on the research results of these steps,a draft was formed and revised through multiple rounds of in-group expert discussion and peer evaluations by 56 external experts. After revisions by the working group based on the feedback, the final version was formed. The Guidelines came into effect on January 8,2024,providing suggestions and reference norms for pharmacovigilance in the clinical application of TCMIs. To further promote the application and popularization of the Guidelines and help pharmacovigilance personnel better understand the development process,this study elucidates the background,methodological framework,and key development steps of the Guidelines.
4.Pinelliae Rhizoma and Its Prescription Compatibility for Depression Treatment: A Review
Zhe XIE ; Yifan SHI ; Linzhe SU ; Ming BAI ; Yucheng LI ; Baoying WANG ; Erping XU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(9):284-293
Depression is a common mental disorder that falls under the category of "stagnation syndrome" in traditional Chinese medicine (TCM). Its complex pathogenesis poses challenges for the development of novel therapeutic agents. Currently, clinically used antidepressants are often accompanied by significant side effects, and statistics show that about one-third of patients do not respond to these medications. TCM demonstrates advantages in the treatment of depression through multi-target, multi-pathway and multi-mechanistic approaches. Pinelliae Rhizoma, a phlegm-resolving herb, exhibits effects such as drying dampness and resolving phlegm, as well as eliminating stuffiness and reducing masses. The characteristics of harmonizing Yin and Yang and resolving stagnation in the middle energizer align precisely with the pathogenesis of depression syndrome, demonstrating therapeutic efficacy in affected patients. Literature studies have found that the active ingredients of Pinelliae Rhizoma, such as cavidine, baicalein, β-sitosterol, as well as Pinelliae Rhizoma herb pairs, such as Pinelliae Rhizoma-Magnoliae Officinalis Cortex, Pinelliae Rhizoma-husked sorghum, Pinelliae Rhizoma-Prunellae Spica, exhibit significant antidepressant effects. Furthermore, TCM formulas containing Pinelliae Rhizoma as the principal therapeutic agent, such as Banxia Xiexin Tang, Banxia Houpo Tang, and Wendan Tang, as well as formulas incorporating Pinelliae Rhizoma like compound Xiaochaihu Tang, Chaihu Jia Longgu Muli Tang, and Erchen Tang, have also demonstrated favorable antidepressant efficacy. The antidepressant mechanism of these agents may involve modulation of 5-hydroxytryptamine (5-HT) and dopamine (DA) levels, up-regulation of brain-derived neurotrophic factor (BDNF) expression, regulation of the hypothalamus-pituitary-adrenal (HPA) axis, reduction of oxidative stress, modulation of nuclear transcription factor-κB (NF-κB) signaling pathway, and inhibition of microglia-mediated inflammatory responses. This review summarized the antidepressant mechanisms and clinical applications of the active components, herb pairs, and TCM formulas containing Pinelliae Rhizoma, aiming to provide a reference for modern research on the use of Pinelliae Rhizoma in antidepressant therapy.
6.Investigation on Pharmacodynamic Material Basis of Linggui Zhugan Granules for Metabolic Associated Steatohepatitis Based on UPLC-Q-TOF-MS/MS
Chiyan YAO ; Liang LI ; Ming YAN ; Zhenzhong WANG ; Chenfeng ZHANG ; Ming LI ; Xue XIE
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(17):228-238
ObjectiveTo systematically identify the main chemical components of Linggui Zhugan granules (LGZGG), and to explore the pharmacodynamic substance basis for the treatment of metabolic dysfunction-associated steatohepatitis (MASH). MethodsThe chemical components of LGZGG were systematically analyzed by ultra-performance liquid chromatography-quadrupole-time-of-flight tandem mass spectrometry (UPLC-Q-TOF-MS/MS). The protein-protein interaction (PPI) network and "compound prescription-disease-component-target" network were constructed by network target analysis to predict the potential pharmacodynamic substances and core targets of LGZGG in the treatment of MASH. The potential pharmacodynamic substances were enriched by macroporous adsorption resin, and the chemical composition of the LGZGG-50% ethanol elution fraction (LGZGG-50) was analyzed by UPLC-Q-TOF-MS/MS. The mouse model of MASH was established by feeding a high-fat, high-cholesterol, and high-fructose diet for 12 weeks. Mice were randomly allocated into normal, model, positive drug (MGL-3196, 1 mg·kg-1), LGZGG (crude drug, 34 g·kg-1·d-1), LGZGG-50 (crude drug, 34 g·kg-1·d-1) groups. The levels of aspartate aminotransferase (AST), alanine aminotransferase (ALT), total cholesterol (TC), triglyceride (TG), low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C) in the serum were measured, and the pathological changes in the liver tissue were observed by hematoxylin-eosin (HE) and Sirius red staining. The in vivo efficacy of LGZGG and LGZGG-50 in the treatment of MASH was evaluated on the basis of the findings. The expression levels of adenosine monophosphate-activated protein kinase (AMPK), phosphorylated AMPK (p-AMPK), silent information regulator 2-related enzyme 1 (SIRT1), peroxisome proliferator-activated receptor α (PPARα), and carnitine palmitoyltransferase 1A (CPT1A) in the liver tissue were determined by Western blot to verify the regulatory effects of core targets. ResultsA total of 83 chemical components were identified from LGZGG, including 20 flavonoids, 13 terpenoids, 17 organic acids, 7 amino acids, 11 glycosides, 3 nucleosides, 3 aromatics, 3 alkaloids, 2 phenylpropanoids, 2 sugars, 1 nucleic acid, and 1 steroid. A total of 134 common targets were obtained by network target analysis. The core targets included SIRT1, PPARα, nuclear factor-kappa B subunit 1 (NF-κB1), and interleukin-6 (IL-6). Kyoto Encyclopedia of Genes and Genomes (KEGG) enrichment analysis revealed that the targets were mainly enriched in the AMPK, PPAR and other signaling pathways. The topological analysis of the "compound prescription-disease-component-target" network showed that the potential pharmacodynamic substances of LGZGG against MASH were flavonoids and terpenoids. The relative content of flavonoids and terpenes in LGZGG-50 were 74.00% and 62.41% in positive and negative ion modes, respectively, indicating that LGZGG-50 effectively enriched total flavonoids and total terpenoids. The results of in vivo efficacy showed that compared with the model group, LGZGG and LGZGG-50 reducef the body weight, liver weight, serum TG, GLU, and ALT levels of MASH mice (P<0.05,P<0.01), and LGZGG additionally increased the HDL-C level (P<0.01). Both groups alleviated the pathological damage in the liver tissue. The results of Western blot showed that compared with the model group, the protein levels of p-AMPK/AMPK, SIRT1, PPARα, and CPT1A were up-regulated in the LGZGG group (P<0.05,P<0.01), and those of p-AMPK/AMPK and CPT1A were up-regulated in the LGZGG-50 group (P<0.01). ConclusionLGZGG ameliorates MASH, with the main pharmacodynamic substances being flavonoids and terpenoids. The mechanism may be related to the regulation of AMPK/SIRT1/PPARα signaling pathway, improvement of lipid metabolism, and alleviation of pathological damage in the liver tissue.
7.Compilation Explanation for Expert Consensus on Clinical Application of Ruyi Zhenbao Pills
Ming CHEN ; Jingling CHANG ; Shangquan WANG ; Gejia ZHONG ; Qiang DENG ; Hongxia CHEN ; Qi'en LI ; Yaming LIN ; Zujian XU ; Changkuan FU ; Yu'er HU ; Yanming XIE ; Yuanyuan LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(22):209-215
The compilation explanation for the Expert Consensus on Clinical Application of Ruyi Zhenbao pills systematically expounds the formulation methods and evidence-based basis of this consensus. In response to the weak clinical application evidence and ambiguous indications of Ruyi Zhenbao pills, the Institute of Basic Research in Clinical Medicine of China Academy of Chinese Medical Sciences, Wangjing Hospital of China Academy of Chinese Medical Sciences, and Dongzhimen Hospital of Beijing University of Chinese Medicine invited 39 experts from 31 medical institutions across China to complete the compilation through multi-disciplinary collaboration. The compilation strictly adheres to the World Health Organization (WHO) guidelines for guideline development and the GRADE evidence grading system. The work process covered the construction of clinical questions (a total of 30 clinical questions were determined based on expert voting results), evidence retrieval (covering Chinese and English databases and gray literature), safety assessment (integrating drug monitoring data and clinical research), and the formation of recommendation opinions and consensus suggestions (18 recommendation opinions were reached through the GRADE grid method, and 22 consensus suggestions were reached through majority voting rules). The results show that the consensus clearly states that this medicine is suitable for knee osteoarthritis, gouty arthritis, rheumatoid arthritis, neuropathic pain, and sequelae of stroke. In terms of safety, the adverse reactions are mainly gastrointestinal reactions such as nausea, vomiting, and abdominal pain. Pregnant women and those allergic to the ingredients of this medicine are contraindicated. The compilation process underwent three rounds of expert reviews and adopted methods such as nominal group technique and Delphi method to ensure the rigor of the consensus compilation process. It provides a paradigm for the formulation of expert consensus on clinical application of Tibetan medicine through the academic promotion and dynamic revision.
8.Varieties and Prescription Characteristics of Chinese Patent Medicines for Stroke in China
Jingdan ZHANG ; Wanping SUN ; Xiaoxia LIN ; Shuo ZHANG ; Xue ZHANG ; Jiahui YAO ; Yiming LIU ; Ming XIE
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(6):270-274
ObjectiveTo explore the listed varieties and prescription characteristics of Chinese patent medicines for stroke in China, explore the medication rules of Chinese medicine for stroke, and provide guidance for further clinical research and development of Chinese patent medicines. MethodsExcel 2021 and the Ancient and Modern Medical Record Cloud Platform (V2.3.5) were used to systematically mine and analyze the varieties and prescriptions of Chinese patent medicines for stroke in China. ResultsA total of 244 Chinese patent medicines (two for different dosage forms of the same prescription), 1 736 approval documents for Chinese patent medicines, 792 manufacturers, and 83 varieties of protected Chinese patent medicines were finally included in the database. The top three dosage forms were capsules (75), pills (53), and tablets (42). There were 28 Chinese patent medicines for stroke in the National Essential Drug Catalogue (2018), 129 in the National Essential Medical Insurance, Industrial Injury Insurance and Maternity Insurance Drug Catalogue (2023), and 4 in the National Non-prescription Drug Catalogue. Among the 138 prescriptions screened out, Chinese patent medicines mainly treated stroke patients with the syndrome of Qi deficiency and blood stasis. The top three most frequent medicinal herbs were Chuanxiong Rhizoma (63), Pheretima (47), and Salviae Miltiorrhizae Radix et Rhizoma (47). The medicinal herbs used were mainly warm, pungent, with the meridian tropism to the liver meridian. The correlation analysis showed that the herb pair with the highest support was Astragali Radix-Chuanxiong Rhizoma, and that with the highest confidence was Carthami Flos-Chuanxiong Rhizoma. Five herb combinations were identified based on the cluster analysis. ConclusionThe Chinese patent medicines for stroke mainly treat patients with the syndrome of Qi deficiency and blood stasis. The medicinal herbs used in the prescriptions mainly have the functions of activating blood and resolving stasis, extinguishing wind and stopping convulsions. Drug compatibility usually focuses on activating blood and resolving stasis, as well as expelling phlegm and opening orifices. This review of the varieties and prescription characteristics of Chinese patent medicines for stroke helps optimize clinical decision-making, guide drug research and development, promote medical research and scientific progress, and provide more effective support and guarantee for the treatment of stroke patients.
9.The impact of peripheral blood inflammatory factors on the risk of aortic aneurysm and aortic dissection based on Mendelian randomization analysis
Mao SUN ; Junjian CHEN ; Deshu YANG ; Ming XIE
Chongqing Medicine 2025;54(11):2559-2565
Objective To investigate the genetic effects of 15 peripheral blood inflammatory factors on the risk of aortic aneurysm and aortic dissection.Methods According to the relevance,independence,and ex-clusion assumptions of Mendelian randomization,instrumental variables predicting C-reactive protein and 14 interleukins(ILs)were extracted from human genome-wide association study data.The associations between these 15 peripheral inflammatory factors and the risk of aortic aneurysm and aortic dissection were investiga-ted using two-sample Mendelian randomization methods,including inverse-variance weighting,MR-PRESSO,and MR-Egger methods.Multivariable Mendelian randomization was used to assess the interactions of these inflammatory factors in influencing disease risk.Cochran's Q test and the MR-Egger intercept were used to e-valuate the heterogeneity and horizontal pleiotropy of the instrumental variables.Results The results of the inverse-variance weighted method showed that increased IL-16 levels were nominally associated with a reduced risk of aortic dissection(OR=0.837,95%CI:0.726 to 0.964,P=0.014).Increased IL-16 and IL-31 levels were also nominally associated with a reduced risk of aortic aneurysm(OR=0.949,95%CI:0.901 to 0.999,P=0.048;OR=0.934,95%CI:0.879 to 0.993,P=0.029).Increased IL-17F levels were nominally associat-ed with an increased risk of aortic aneurysm(OR=1.128,95%CI:1.007 to 1.264,P=0.038).No other in-flammatory factors were found to be associated with the risk of these two diseases using the inverse-variance weighted method.The MR-PRESSO and MR-Egger methods supported the results of the inverse-variance weighted method.Cochran's Q test and MR-Egger intercept test did not detect significant heterogeneity or horizontal pleiotropy.Conclusion IL-16,IL-31,and IL-17F may be involved at the genetic level in the inflam-matory mechanisms underlying the occurrence and development of aortic aneurysms and/or aortic dissections.Among them,IL-16 and IL-31 may play protective roles in aortic aneurysms and/or aortic dissections,whereas IL-17F may have a pathogenic effect on aortic aneurysms.
10.The effect of glutamine-enriched parenteral nutrition on short-term outcomes after surgery in patients with colorectal cancer
Ji-Wei WANG ; Yong HUANG ; Tao ZHANG ; Mai-Jian WANG ; Xin-Bin ZHENG ; Ming XIE
Parenteral & Enteral Nutrition 2025;32(1):7-14
Objective:To evaluate the effects of glutamine-enriched parenteral nutrition on short-term postoperative outcomes compared with conventional nutritional support in colorectal cancer patients with enteral nutrition intolerance after surgery.Method:A retrospective cohort study was conducted to collect clinical data from colorectal cancer patients who underwent radical resection at the Department of Gastrointestinal Surgery of Zunyi Medical University Affiliated Hospital from January 2019 to December 2021.The differences in postoperative complication rates,perioperative nutritional indicators,and inflammatory factors between the two groups were analyzed.SPSS 29.0 software was used for statistical analysis.Result:Based on whether glutamine was added to parenteral nutrition,178 patients were divided into a control group(conventional nutritional therapy,n=120)and an observation group(glutamine enhanced nutritional therapy,n=58).The incidence of postoperative complications(Clavien Dindo grade≥III)in the control and observation groups was 14.17%(17/120)and 3.45%(2/58),respectively,with a statistically significant difference(P=0.030).The observation group recovered faster than the control group in terms of time to first expectoration,defecation and intake of liquid diet after surgery,and had a shorter hospital stay after surgery(P<0.05).However,there was no significant difference in the 30-day readmission rate between the two groups(P=0.393).There was no statistically significant difference in the changes in total protein,albumin,pre-albumin,neutrophil/lymphocyte ratio and endogenous creatinine clearance rate between the two groups of patients after surgery(P>0.05).There were also significant differences in the changes in lymphocyte count,white blood cell count,neutrophil percentage,alanine aminotransferase,aspartate aminotransferase,total bilirubin,and urea nitrogen levels between the two groups of patients after surgery(P<0.05).Conclusion:Compared with regular nutritional support,postoperative parenteral glutamine supplementation can reduce the incidence of postoperative complications in colorectal cancer patients,promote recovery of bowel function,shorten postoperative hospital stay,improve patient immune function and reduce inflammatory levels.


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