1.Mechanisms of Yishen Juanbi Pills-containing Bone Marrow Fluid in Improving Kidney-deficiency Rheumatoid Arthritis by Regulating CD4+ T Lymphocyte Differentiation via SDF-1/CXCR4 Signaling Pathway
Jinlin TONG ; Yuyao WANG ; Hong LIU ; Jinghua PAN ; Danping FAN ; Hongyan ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):90-99
ObjectiveTo investigate the effects of Yishen Juanbi pills (YSJB)-containing bone marrow fluid on the migration and differentiation phenotypes of CD4⁺T lymphocytes based on the stromal cell-derived factor-1/chemokine receptor 4 (SDF-1/CXCR4) signaling pathway. MethodsPrimary CD4⁺T lymphocytes were isolated from mice using magnetic bead separation and identified for purity by flow cytometry. A CD4⁺T lymphocyte culture system was then established to observe the effects of SDF-1 on CD4⁺T-cell migration and differentiation. On this basis, the experimental groups included the Sham group, the ovariectomy (OVX) group, the Sham+collagen-induced arthritis (CIA) group, the OVX+CIA group, the Sham+CIA+YSJB group (2.16 g·kg-1), the OVX+CIA+YSJB group (2.16 g·kg-1), and the OVX+CIA+methotrexate (MTX) group (1.5 mg·kg-1). Bone marrow fluid from each group was prepared according to previous methods and added to the CD4⁺ T-cell culture system at 5% (v/v). Transwell assays were used to examine CD4⁺T-cell migration in each group. Real-time PCR was used to measure the mRNA expression levels of interleukin (IL)-17, tumor necrosis factor-α (TNF-α), retinoic-acid-related orphan receptor γt (RORγt), IL-10, transforming growth factor-β (TGF-β), forkhead box P3 (FoxP3), CXCR4, phosphoinositide 3-kinase (PI3K), and protein kinase B (Akt). Western blot was used to detect the expression of helper T (Th)17/regulatory T (Treg) cell signature factors (RORγt, FoxP3), CXCR4, PI3K, phosphorylated (p)-PI3K, Akt, and p-Akt. In a separate set of experiments, cells were divided into the Sham group, OVX+CIA group, OVX+CIA+CXCR4 antagonist AMD3100 group, and OVX+CIA+YSJB+AMD3100 group to observe changes in the above indicators following AMD3100 intervention. ResultsCompared with the Sham group, the number of migrated cells in the lower chamber was significantly increased in the Sham+CIA and OVX+CIA groups (P<0.05, P<0.01). The mRNA expression of RORγt, IL-17, TNF-α, CXCR4, PI3K, and Akt was significantly upregulated, whereas FoxP3, IL-10, and TGF-β mRNA expression was significantly decreased (P<0.05, P<0.01). Protein expression of RORγt, CXCR4, p-PI3K/PI3K, and p-Akt/Akt was significantly increased, while FoxP3 protein expression was markedly decreased (P<0.05, P<0.01). Compared with the OVX+CIA group, the OVX+CIA+YSJB group and OVX+CIA+MTX group showed significantly reduced migration (P<0.05), mRNA expression of RORγt, IL-17, TNF-α, CXCR4, PI3K, and Akt was also significantly decreased, while FoxP3, IL-10, and TGF-β mRNA expression was significantly increased (P<0.05, P<0.01). RORγt protein expression was significantly downregulated, and FoxP3 protein expression markedly upregulated (P<0.05). In the OVX+CIA+YSJB group, CXCR4, p-PI3K/PI3K, and p-Akt/Akt protein expression was significantly decreased (P<0.05). Compared with the OVX+CIA group, RORγt, CXCR4, PI3K, and Akt mRNA expression in CD4⁺T cells was significantly decreased in the OVX+CIA+AMD3100 group and the OVX+CIA+YSJB+AMD3100 group, while FoxP3 mRNA and protein expression was significantly upregulated (P<0.05, P<0.01). RORγt, CXCR4, p-PI3K/PI3K, and p-Akt/Akt protein expression was also markedly decreased (P<0.05, P<0.01). Compared with the OVX+CIA+AMD3100 group, the OVX+CIA+YSJB+AMD3100 group showed significantly decreased RORγt and Akt mRNA expression (P<0.05) and significantly lower p-Akt/Akt protein expression (P<0.05). ConclusionYSJB-containing bone marrow fluid suppresses CD4⁺T-cell migration and regulates Th17/Treg balance by downregulating Th17-associated signature factors and upregulating Treg-associated signature factors through inhibition of the SDF-1/CXCR4 signaling pathway and PI3K/Akt signaling pathway. The SDF-1/CXCR4 signaling pathway is one of the targets through which YSJB inhibits CD4⁺T-cell differentiation.
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 for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
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 for Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines
Hongyan ZHANG ; Zhifei WANG ; Shuo YANG ; Ruili WEI ; Wenqian PENG ; Yuanyuan LI ; Xin CUI ; Xiaoxiao ZHAO ; Fumei LIU ; Mengmeng WANG ; Yanming XIE ; Lianxin WANG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(8):245-251
To standardize the clinical application of oral Chinese patent medicines (CPMs), and address the safety issues arising from their dosage form characteristics, irrational clinical use, and the lack of targeted pharmacovigilance systems, the China Association of Chinese Medicine organized the formulation and release of Pharmacovigilance Guidelines for Clinical Application of Oral Chinese Patent Medicines, aiming to inform the safe clinical use of oral CPMs and related pharmacovigilance work. According to the principles of GB/T1.1—2020 and the Drug Administration Law of the People's Republic of China (2019 revision), the Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences, led a drafting group comprising 18 institutions. After multiple rounds of expert interviews, literature retrieval, evidence screening, and extensive solicitation of opinions, the Guidelines were registered internationally. Systematic standardization focused on safety monitoring, risk identification, assessment, control, and other aspects. The Guidelines clarified the characteristics of oral CPMs in terms of safety monitoring, known risks, and potential risks, compared to non-oral CPMs. Then, risk control measures were proposed, including medication in special populations and irrational medication. As a special guideline for pharmacovigilance in the clinical application of oral CPMs, the Guidelines systematically construct a technical system in line with the characteristics of traditional Chinese medicine (TCM), which is essential for improving the clinical safety management of oral CPMs and provides an important reference for medical institutions, pharmaceutical manufacturers, and regulatory authorities.
6.Advances in detection techniques for congenital blood group chimerism
Shuo ZHANG ; Hongyan YANG ; Yuhan GAO ; Ranran QIN ; Xinrui WANG ; Ke ZHANG ; Yifan LI ; Ruiqin HOU
Chinese Journal of Blood Transfusion 2026;39(3):402-407
Congenital blood group chimerism refers to the coexistence of two or more distinct blood types within an individual, resulting from the presence of hematopoietic cell populations with different genotypes. Consequently, red blood cells in such individuals may express different blood group antigens. Based on the timing and mechanism of formation, blood group chimerism can be classified as either congenital or acquired. Although congenital blood group chimerism is rare and involves complex mechanisms, it holds significant implications in transfusion medicine, transplantation, and obstetrics. This article reviews the formation mechanisms, detection methods, and clinical significance of congenital blood group chimerism in transfusion medicine. Particular emphasis is placed on the principles, advantages, and limitations of various detection techniques. Furthermore, the potential applications of these technologies in clinical diagnosis are discussed, providing a technical foundation for the development of precise transfusion strategies.
7.Analysis of comparator selection strategies for pharmaceutical enterprises in the national reimbursement drug list access application
Qingwen WANG ; Qin AN ; Xiaoyan YUAN ; Yuzhi HAN ; Xi CHEN ; Hongyan WU
China Pharmacy 2026;37(8):985-990
OBJECTIVE To analyze the selection and rationales of comparators for pharmaceutical enterprises in their medical insurance access application, so as to provide a reference for promoting communication and consensus between enterprises and medical insurance authorities in this process. METHODS The application materials for drugs outside the catalogue that passed formal review published by the National Healthcare Security Administration from 2021 to 2025 were extracted, and then content analysis was used to systematically sort out relevant information of the declared drugs and comparators; the specific situations and rationales of pharmaceutical enterprises’ selection of comparators were analyzed. RESULTS A total of 1 341 declared drug documents were collected. Data analysis showed that 1 035 (77.18%) were submitted with positive comparators and 306 (22.82%) used blank comparators; 58 drugs (4.33%) took combination therapy as the reference, and 5 drugs (0.37%) referred to non-pharmacological (or non-single pharmacological) treatment regimens. Among competitive drugs declared by multiple enterprises, 50.00% of the enterprises submitted different comparators. A total of 4 basic conditions and 39 additional conditions were extracted as the rationales for selecting positive comparators. For blank comparators, 12 drug-related factors, 2 administrative factors, and 1 other factor were identified. More than 10% of the drugs did not state the rationale for comparator selection, and over 44% of drugs using blank comparators provided only one justification. CONCLUSIONS Pharmaceutical enterprises mainly select comparators based on their own interests in the medical insurance access application, and there are deficiencies in the adequacy and standardization of their selection basis and reasoning. It is recommended that enterprises follow the principled requirements of medical insurance authorities, and fully and normatively explain the reasons for selecting comparators in combination with the characteristics of their own products. Meanwhile, it is advisable to change the current open-ended statement form of selection reasons into a closed-ended answering mode, so as to highlight the priority of selection, standardize the declaration behavior of enterprises, and reduce communication divergences between the two parties.
8.Experience of Professor ZHAI Shuangqing in Using Metal and Mineral Medicines to Treat Mental Disorders Based on Xiang Thinking
Dongsen HU ; Liyuan WANG ; Hongyan WANG
Journal of Traditional Chinese Medicine 2025;66(5):453-457
This paper summarizes Professor ZHAI Shuangqing's clinical experience in using metal and mineral medicines to treat mental disorders. Based on xiang thinking, the symptoms of mental disorders are classified into five categories, depression-xiang, wind-xiang, fire-xiang, phlegm-xiang, and deficiency-xiang, and the mechanisms of disease development are discussed accordingly. Metal and mineral medicines are key treatments for mental disorders, not only having the function of calming the mind but also promoting qi, stabilizing wind, expelling evil, and tonifying. In clinical practice, the emphasis is placed on harmonizing the disease and its symptoms. Based on self-developed prescription formulas, the appropriate metal and mineral medicines are selected according to the properties, flavors, meridian tropism, and actions of the medicines, as well as the xiang patterns of the mental disorder. For example, Attention Deficit Hyperactivity Disorder (ADHD) is treated by Modified Xiehuang Powder (泻黄散) with Sijunzi Decoction (四君子汤) and adding Fulonggan (Testudinis Carapax) and Longgu (Os Draconis). Persistent insomnia is treated by combining a self-developed insomnia formula with Longgu (Os Draconis), Hupo (Succinum), and Cishi (Magnetitum). Obsessive-compulsive disorder (OCD) is treated by combining a self-developed OCD formula with Longchi (Dens Draconis), Qingmengshi (Fluoritum), and Zheshi (Haematitum). Epilepsy is treated by combining an anti-epilepsy decoction with Qingmengshi (Fluoritum), Longchi (Dens Draconis), and Shengtieluo (Ferrum Rudis).
9.Safety analysis of Yttrium-90 resin microsphere selective internal radiation therapy on malignant liver tumors
Jia CAI ; Shiwei TANG ; Rongli LI ; Mingxin KONG ; Hongyan DING ; Xiaofeng YUAN ; Yuying HU ; Ruimei LIU ; Xiaoyan ZHU ; Wenjun LI ; Haibin ZHANG ; Guanwu WANG
Chinese Journal of Clinical Medicine 2025;32(1):24-29
Objective To explore the safety of Yttrium-90 resin microsphere selective internal radiation therapy (90Y-SIRT) on malignant liver tumors. Methods A retrospective analysis was conducted on 64 patients with malignant liver tumors who underwent 90Y-SIRT from February 2023 to November 2024 at Weifang People’s Hospital. The clinical characteristics of the patients and the occurrence of adverse reactions after treatment were analyzed to assess the safety of 90Y-SIRT. Results Among the 64 patients, there were 52 males (81.25%) and 12 females (18.75%); the average age was (56.29±11.08) years. Seven patients (10.94%) had tumors with maximum diameter of less than 5 cm, 38 patients (59.38%) had tumors with maximum diameter of 5-10 cm, and 19 patients (29.68%) had tumors with maximum diameter of greater than 10 cm. There were 47 cases (73.44%) of solitary lesions and 17 cases (26.56%) of multiple lesions; 53 cases (82.81%) were primary liver cancers and 11 cases (17.19%) were metastatic liver cancers. Of the 64 patients, 63 successfully completed the Technetium-99m macroaggregated albumin (99mTc-MAA) perfusion test and received the 90Y-SIRT; one patient received 90Y-SIRT after the second 99mTc-MAA perfusion test due to a work error. The most common adverse reactions included grade 1 alanine aminotransferase (ALT) elevation in 26 cases (40.62%) and grade 2 in 2 cases (9.37%), grade 1 aspartate aminotransferase (AST) elevation in 27 cases (42.18%) and grade 2 in 7 cases (10.93%); grade 1 nausea in 17 cases (26.56%) and grade 2 in 6 cases (9.37%); grade 1 abdominal pain in 12 cases (18.75%), grade 2 in 5 cases (7.81%), and grade 3 in 1 case (1.56%); grade 1 vomiting in 11 cases (17.18%), grade 2 in 5 cases (7.81%), and grade 3 in 1 case (1.56%). Conclusion The adverse reactions of 90Y-SIRT for treating malignant liver tumors are mild, indicating good safety.
10.Effects and mechanism of persimmon leaf extract on IEC-6 cell ferroptosis induced by H2O2
Xuexia ZHANG ; Min ZHOU ; Hongyan ZHOU ; Lifei WANG ; Huani LI ; Changhe LIU ; Hongde XU ; Mingli ZHANG
China Pharmacy 2025;36(1):64-70
OBJECTIVE To investigate the effects and potential mechanism of persimmon leaf (PL) extract against ferroptosis induced by H2O2 in IEC-6 cells. METHODS Using IEC-6 cells as object, the effects of ferroptosis inhibitor ferrostatin-1 on IEC-6 cell viability induced by H2O2 were investigated; IEC-6 cells were divided into control group, H2O2 group, H2O2+PL 25 μg/mL group and H2O2+PL 50 μg/mL group. The levels of oxidant stress indexes [content of malondialdehyde (MDA), activity of superoxide dismutase (SOD), and levels of reactive oxygen species (ROS)], mitochondrial membrane potential (MMP) as well as mRNA and protein expressions of nuclear factor-erythroid-2 related factor 2 (Nrf2), heme oxygenase-1 (HO-1), NADPH/quinone oxidoreductase-1 (NQO-1), cystine/glutamate anti-porter (xCT), glutathione peroxidase 4 (GPX4) and ferritin heavy chain (FTH) were detected. RESULTS Ferroptosis inhibitor ferrostatin-1 could significantly increase the survival rate of H2O2-induced cells (P< 0.01). Compared with the control group, MDA content, ROS level, mRNA expressions of Nrf2 and NQO-1 as well as protein expressions of Nrf2 and HO-1 were increased or up-regulated significantly, while SOD activity, MMP, mRNA expressions of xCT, GPX4 and FTH as well as protein expressions of GPX4 and FTH were decreased or down-regulated significantly (P<0.01 or P<0.05). Compared with the H2O2 group, oxidative stress Δ indexes of H2O2+PL 25, 50 μg/mL groups were reversed to different extents, MMP level was increased significantly, as well as mRNA and protein expressions of Nrf2, HO-1, NQO-1,xCT, GPX4 and FTH were up-regulated to different extents;there were statistical significances in some indexes between groups (P<0.01 or P<0.05). CONCLUSIONS PL extract can alleviate mitochondrial membrane damage and abnormal accumulation of ROS caused by H2O2, which may be related to the inhibition of ferroptosis by activating the Nrf2/HO-1 signaling pathway.

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