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.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
3.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
4.Interpretation of Evidence-to-decision Framework and Its Application in Pharmacovigilance Guidelines of Chinese Patent Medicines
Hongyan ZHANG ; Xin CUI ; Yuanyuan LI ; Zhifei WANG ; Mengmeng WANG ; Shuo YANG ; Xiaoxiao ZHAO ; Fumei LIU ; Yaxin WANG ; Rui MA ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):220-228
To interpret the evidence-to-decision (EtD) framework and to illustrate its application in traditional Chinese medicine (TCM) guideline development using the example of the Pharmacovigilance Guideline of Chinese Patent Medicine, thereby providing methodological references for TCM guideline standardization. Based on the core three stages of the EtD framework (formulating the question, making an assessment of the evidence, and drawing conclusions), critical decision points and evaluation evidence within the evidence-translation process were systematically addressed, aligning with the purpose, scope, and key questions of the guideline. Qualitative research methods, such as the nominal group technique, were employed to formulate recommendations. The analysis was conducted based on the EtD framework. During question formulation, the specific characteristics and practical needs of pharmacovigilance for Chinese patent medicines were clarified, focusing on the core objective of safety assurance throughout the product lifecycle. In the evidence assessment, multi-source evidence was integrated, including policy documents, literature research, and expert consensus, completing the evidence evaluation. Finally, in recommendation-forming, dispersed research evidence and expert experience were synthesized into consensus, culminating in the guideline's completion through solicitation of opinions and peer review. The EtD framework provides a structured tool for evidence-to-decision translation in TCM guideline development, effectively enhancing the transparency and scientific rigor of the process. Therefore, it is recommended that TCM guideline development adopt the EtD framework to improve the evidence-to-decision process with TCM characteristics.
5.Compilation Instruction and Key Point Interpretation for Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration
Wenzhe LI ; Rui MA ; Xiaoxiao ZHAO ; Hong HUA ; Xin CUI ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):260-266
To develop the Pharmacovigilance Guidelines for Clinical Application of Chinese Patent Medicines for Mucosal Administration in response to common problems, including insufficient safety information in package inserts, amplified medication risks in special populations, and non-standard clinical practices, thus establishing a risk management system tailored to the characteristics of Chinese patent medicines for mucosal administration. An approach combining qualitative and quantitative methods was adopted. In accordance with the Drug Administration Law of the People's Republic of China (2019 revision) and the GB/T 1.1—2020 standard, a systematic search was performed in the Chinese Pharmacopoeia (2020 edition), the Catalog of Medicines Covered by Medical Insurance (2022 edition), Chinese databases [China Network of Knowledge Infrastructure (CNKI), Wanfang Data (Wanfang), and VIP journal resource integration service platform (VIP)], and international databases (Cochrane Library, PubMed, and EMbase). Guideline outlines were developed through questionnaire surveys, expert interviews, and the nominal group technique. The content of each item was formulated with full consideration of traditional Chinese medicine (TCM) incompatibility, as well as the conceptual connotations and extensions of pharmacovigilance. The results included 54 Chinese patent medicines for mucosal administration from the Chinese Pharmacopoeia (2020 edition) and 58 from the Catalog of Medicines Covered by Medical Insurance (2022 edition). Safety-related items in the corresponding package inserts were collected, and 27 relevant publications were retrieved. Thirty experts from 24 institutions were mobilized for the drafting, and opinions from 61 external experts were solicited. A pharmacovigilance framework was established, covering the full chain of "monitoring, identification, assessment, and control". Based on seven anatomical sites, including nasal, ocular, and oral mucosa, a stratified monitoring system was constructed. The guideline proposed key recommendations on improving package insert sections such as "Adverse Reactions", "Contraindications", and "Precautions", clinical procedure standardization in healthcare institutions, risk control, and dynamic pharmacovigilance. The Guideline provides evidence-based support tailored to the risk profile of Chinese patent medicines for mucosal administration, filling the current gap in international pharmacovigilance standards in this field, while offering technical support for safety management across the full life cycle of medicines for mucosal administration.
6.Interleukin-1β as target to induce synthetic lethality in KRAS mutant biliary tract cancer
Shijie LI ; Yukai SHAN ; Tianen CHEN ; Win TOPATANA ; Sarun JUENGPANICH ; Ziyi LU ; Yuchao SUN ; Tianao XIE ; Ruijing RUIJING ; Lidan HOU ; Jiang CHEN ; Guojun CHEN ; Jiemin LV ; Xianjue MA ; Pengjuan GUO ; Dan Gabriel DUDA ; Xiujun CAI ; Mingyu CHEN
Clinical and Molecular Hepatology 2026;32(2):904-918
Background/Aims:
Biliary tract cancer (BTC) frequently harbors KRAS mutations, which are associated with resistance to traditional treatment and a poor prognosis. Synthetic lethality (SL) strategy may provide other targets of KRAS. Therefore, we aim to identify and validate potential therapeutic targets of KRAS for the treatment of BTC via SL.
Methods:
The dependency (DepMap) projects were used to predict the synthetic lethal gene of KRAS. FDA-approved anticancer drug library was applied to screen potential drugs effective against KRAS-mutant BTC. Furthermore, the synthetic lethal effects or corresponding mechanisms of potential genes and drugs on BTC were investigated using KRAS-mutant and KRAS-wild type BTC cell lines, patient-derived xenografts (PDX), and KRAS oncogene-driven tumor models, as well as other KRAS-mutant cancer cell lines.
Results:
Initially, we discovered that the loss of GATA2 reduced the viability of KRAS-mutant but not KRAS-wild-type BTC. Subsequently, the drug library screened out disulfiram, which primarily exerts a synthetic lethal effect by inhibiting interleukin-1β (IL-1β) in KRAS-mutant BTC. Mechanistically, GATA2 specifically enhanced the transcription of IL-1β to promote NF-κB signaling in KRAS-mutant BTC. IL-1β inhibition phenocopied GATA2 deficiency, leading to reduced KRAS-mutant BTC viability. These synthetically lethal effects were confirmed using PDX, a KRAS oncogene-driven tumor model, as well as in other KRAS-mutant cancer cell lines.
Conclusions
In summary, these results indicate that inhibiting GATA2/IL1β could be a therapeutic strategy in KRAS-mutant BTC and potentially other cancers.
7.Electroacupuncture Attenuates Neuroinflammation and Postoperative Cognitive Dysfunction in Aged Rats by Suppressing the cGAS–STING Pathway
Baobao MA ; Shiwen FAN ; Jiaojiao DENG ; Kaihua WEI ; Yan LI ; Jiangwen YIN ; Liping XIE
Experimental Neurobiology 2026;35(1):42-55
Postoperative cognitive dysfunction (POCD) is a clinically significant complication in elderly patients, largely driven by surgery-induced neuroinflammation. The cyclic GMP-AMP synthase-stimulator of interferon genes (cGAS-STING) pathway, a crucial regulator of innate immunity, has been implicated in neuroinflammatory activation. This study investigated whether electroacupuncture (EA) improves POCD by modulating this pathway in aged rats. Aged male Sprague-Dawley rats were subjected to sevoflurane anesthesia and splenectomy to establish a POCD model. Animals were divided into sham, POCD, POCD+EA, and POCD+EA+cGAS inhibitor groups. The EA groups received stimulation at Baihui (Governor Vessel 20 (GV20)), Neiguan (Pericardium 6 (PC6)), and Zusanli (Stomach 36 (ST36)) acupoints. Cognitive function was evaluated using the Morris water maze, while hippocampal expression of cGAS-STING pathway components and downstream effectors—interferon regulatory factor 3 (IRF3), nuclear factor kappa B (NF-κB), and interleukin-1 beta (IL-1β)—was assessed by Western blot. Cellular localization was determined by immunofluorescence staining. Compared with the Sham group, rats in the POCD group showed significant impairments in spatial memory, accompanied by upregulated protein expression of cGAS, STING, NF-κB, IRF3, and IL-1β in the hippocampus. Upon pathway activation, cGAS and STING proteins were predominantly co-localized with neurons, and their fluorescence intensity in the hippocampus was markedly increased. These behavioral deficits and molecular alterations were partially reversed in both the POCD+EA and POCD+EA+inhibitor groups. Electroacupuncture alleviates POCD in aged rats by inhibiting hippocampal cGAS-STING pathway activation and reducing neuroinflammation, suggesting a promising non-pharmacological strategy for POCD management.
8.Expert consensus on a stepwise strategy for the surgical management of empyema based on pathological staging (2026 edition)
Jichen QU ; Yunjiu GOU ; Guangyu CHEN ; Yongfu ZHAI ; Tinglong MA ; Xiaogang ZENG ; Feng JIN ; Yanzheng SONG ; Boxiong XIE ; Minjie MA ; Bin LI ; Jiang FAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(07):988-998
The surgical management of empyema (excluding those caused by mycobacterium tuberculosis and non-tuberculous mycobacteria) is rapidly evolving towards minimally invasive, precise, and stepwise approaches. The traditional three-stage classification (exudative, fibrinopurulent, and organizing) has limitations in guiding dynamic clinical decision-making. For the first time, this consensus explicitly identifies two critical junctures in the pathological progression of empyema: "early transformation" (stage Ⅰ to Ⅱ) and "late transformation" (stage Ⅱ to Ⅲ), and thereby constructs a corresponding "identification-early warning-intervention" stepwise therapeutic framework. The consensus emphasizes that proactive debridement via video-assisted thoracoscopic surgery should be performed during the early transformation phase to halt disease progression. Conversely, during the late transformation phase, therapeutic goals should be rationally adjusted to prioritize adequate drainage, avoiding futile pleural decortication. Moreover, the consensus underscores the pivotal role of precise perioperative etiological diagnosis (e.g. metagenomic nest-generation sequencing) and standardized anti-infective therapy. Integrating practical experiences from multiple thoracic surgery centers in China and relevant evidence-based literature, this consensus formulates recommendations on the precise definitions of staging, surgical indications for each phase, key technical points, perioperative management, and training systems. It aims to promote the standardized and individualized surgical management of empyema, ultimately optimizing patient prognosis.
9.The effect of cannabidiol and its nano-preparation on depressive behaviors in mice
Yuanping Li ; Hui Tan ; Jingyuan Meng ; Yan Yang ; Tengteng Ma ; Zhengmao Yang ; Jiaqing Ma ; Jianping Xie ; Ying Guo
Acta Universitatis Medicinalis Anhui 2025;60(3):440-445, 454
Objective :
To investigate the therapeutic effects and underlying mechanisms of cannabidiol(CBD) and its nano-formulations on depression-like behaviors in mice.
Methods :
A murine model of acute anxiety and depression was established by intraperitoneal administration of lipopolysaccharide(LPS). A total of 55 mice were randomly assigned into several groups: for the long-term study, a control group(Con), a model group(LPS), a cannabidiol group(CBD), a nano-cannabidiol group(NCBD), and a sertraline(SER) group, each consisting of 7 mice. In the short-term study, mice were divided into four groups: the Con group, LPS group, CBD group, and NCBD group, with 5 mice in each group. Except for the Con group and LPS group, which were given distilled water, the remaining groups were administered 25 and 50 mg/kg of cannabidiol and its nano-formulationviaoral gavage. The open field and forced swimming tests were employed to assess anxiety-and depression-like behaviors inmice. Luxol Fast Blue myelin staining was employed to evaluate myelin sheath morphology in the prefrontal cortex, and immunofluorescence staining was utilized to quantify the protein expression levels of silencing information regulator(SIRT2), ionized calcium binding adaptor molecule-1(Iba-1), and interleukin-1β(IL-1β) in the prefrontal cortex.
Results :
In the long-term experiment, the LPS group exhibited a significant reduction in shuttle times(P<0.05), an increase in immobility time(P<0.01), and a decrease in the number and length of myelin sheaths(P<0.05) compared to the Con group. Compared to the LPS group, the depressive behaviors in the CBD, NCBD, and SER groups were significantly alleviated(P<0.01), and the number and length of myelin sheaths increased(P<0.05). In the short-term experiment, compared to the Con group, the LPS group exhibited significantly increased anxiety-and depression-like behaviors(P<0.05), downregulated SIRT2 expression(P<0.01), and upregulated Iba-1 and IL-1β expression(P<0.01). The CBD and NCBD groups demonstrated a reduction in anxiety and depression-like behaviors(P<0.05), an increase in SIRT2 expression(P<0.01), and a decrease in Iba-1 and IL-1β expressions(P<0.05) compared to the LPS group.
Conclusion
CBD and its nano-formulations effectively mitigate anxiety and depression-like behaviors in mice. The underlying mechanisms may be associated with the reversal of SIRT2 protein expression, demyelination changes, microglial activation, and the levels of inflammatory factors in the prefrontal cortex.
10.Ameliorating effects of tetrahydrocurcumin and its nano-preparations on lipopolysaccharide-induced depression in mice
Hui Tan ; Yuanping Li ; Jingyuan Meng ; Tengteng Ma ; Yan Yang ; Zhengmao Yang ; Jiaqing Ma ; Jianping Xie ; Ying Guo
Acta Universitatis Medicinalis Anhui 2025;60(1):79-86
Objective :
To investigate the antidepressant effects and the underlying mechanisms of tetrahydrocurcumin(THC) and its nanoparticle formulation(THCN).
Methods :
Forty-six male ICR mice were randomly divided into Con group, LPS group, THC group, THCN group and SER group. A mouse depression model was established by intraperitoneal administration of LPS. The anxiety and depression-like behaviors of mice were evaluated by open field test(OFT) and forced swimming test(FST). Myelin staining was applied to assess the extent of demyelination in the prefrontal cortex of the mice. The prefrontal cortex and hippocampus were further examined for the expression levels of glial fibrillary acidic protein(GFAP) and Toll-like receptor 4(TLR4) through quantitative immunofluorescence assays.
Results :
Compared with the Con group, the LPS group showed increased anxiety-like and depressive-like behaviors in both the long-term and short-term experiments(P<0.05); the degree of demyelination increased in the LPS group of the long-term experiment(P<0.01); the expression of GFAP was reduced in the LPS group of the short-term experiment(P<0.01), while the expression of TLR4 increased(P<0.05); the expression of TLR4 decreased in the THC group(P<0.01); the expression of GFAP in the prefrontal cortex of the THCN group was reduced(P<0.01), while the expression of TLR4 increased(P<0.05). Compared with the LPS group, the THC group showed reduced depressive-like behaviors in the long-term experiment(P<0.05), while the anxiety-like and depressive-like behaviors of the THCN group and the SER group were reduced(P<0.05), and the anxiety-like and depressive-like behaviors of the THC group and the THCN group were reduced in the short-term experiment(P<0.05); the degree of demyelination was reduced in the THC group, THCN group and SER group in the long-term experiment(P<0.05); the expression of GFAP increased in the THC group of the short-term experiment(P<0.05), while the expression of TLR4 was reduced(P<0.05), and the expression of GFAP increased in the THCN group(P<0.05). Compared with the THC group, the THCN group and the SER group showed reduced anxiety-like behaviors in the long-term experiment(P<0.05); the expression of GFAP in the prefrontal cortex of the THCN group was reduced in the short-term experiment(P<0.05), while the expression of TLR4 in the hippocampal DG area increased in the short-term experiment(P<0.01).
Conclusion
Tetrahydrocurcumin and its nanoparticle formulation both exert significant ameliorative effects on depression-like behaviors and demyelination in mice induced by lipopolysaccharide. The antidepressant mechanism of THC appears to be mediated through the down-regulation of TLR4 and the up-regulation of GFAP. The mechanism underlying the antidepressant action of THCN seems predominantly focused on the enhancement of GFAP expression.


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