1.Strengthening the construction of hospitals' organ donation and transplantation work systems and the ethics committees for organ transplantation in accordance with laws and regulations
Feng HUO ; Hongtao ZHAO ; Xiaomei ZHAI
Organ Transplantation 2025;16(1):52-58
The implementation of the "Regulations on Organ Donation and Transplantation" (hereinafter referred to as the new "Regulations") and supporting documents has laid a solid foundation for improving the organ donation and transplantation work system in accordance with laws and regulations. In order to better publicize, implement, and carry out the new "Regulations" and supporting documents, and in response to the problems and challenges encountered in actual work, combined with the development of the national human organ donation and transplantation work system and the national work on determination of brain death, this article analyzes and discusses the construction of hospitals' organ donation and transplantation work systems and the systematic multidisciplinary collaboration mechanism for organ donation, as well as several issues that need attention by the ethics committees for organ transplantation. The aim is to provide references for the construction of ethics committees for organ transplantation in China and to promote the continuous and healthy development of China's organ donation and transplantation cause.
2.Updates and amendments of the Chinese Pharmacopoeia 2025 Edition (Volume Ⅰ)
LI Hao ; SHEN Mingrui ; ZHANG Pang ; ZHAI Weimin ; NI Long ; HAO Bo ; ZHAO Yuxin ; HE Yi ; MA Shuangcheng ; SHU Rong
Drug Standards of China 2025;26(1):017-022
The Chinese Pharmacopoeia is the legal technical standard which should be followed during the research, production, use, and administration of drugs. At present, the new edition of the Chinese Pharmacopoeia is planned to be promulgated and implemented. This article summarizes and analyzes the main characteristics and the content of updates and amendments of the Chinese Pharmacopoeia 2025 Edition(Volume Ⅰ), to provide a reference for the correct understanding and accurate implementation the new edition of the pharmacopoeia.
3.Guideline for the workflow of clinical comprehensive evaluation of drugs
Zhengxiang LI ; Rong DUAN ; Luwen SHI ; Jinhui TIAN ; Xiaocong ZUO ; Yu ZHANG ; Lingli ZHANG ; Junhua ZHANG ; Hualin ZHENG ; Rongsheng ZHAO ; Wudong GUO ; Liyan MIAO ; Suodi ZHAI
China Pharmacy 2025;36(19):2353-2365
OBJECTIVE To standardize the main processes and related technical links of the clinical comprehensive evaluation of drugs, and provide guidance and reference for improving the quality of comprehensive evaluation evidence and its transformation and application value. METHODS The construction of Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs was based on the standard guideline formulation method of the World Health Organization (WHO), strictly followed the latest definition of guidelines by the Institute of Medicine of the National Academy of Sciences of the United States, and conformed to the six major areas of the Guideline Research and Evaluation Tool Ⅱ. Delphi method was adopted to construct the research questions; research evidence was established by applying the research methods of evidence-based medicine. The evidence quality classification system of the Chinese Evidence-Based Medicine Center was adopted for evidence classification and evaluation. The recommendation strength was determined by the recommendation strength classification standard formulated by the Oxford University Evidence-Based Medicine Center, and the recommendation opinions were formed through the expert consensus method. RESULTS & CONCLUSIONS The Guideline for the Workflow of Clinical Comprehensive Evaluation of Drugs covers 4 major categories of research questions, including topic selection, evaluation implementation, evidence evaluation, and application and transformation of results. The formulation of this guideline has standardized the technical links of the entire process of clinical comprehensive evaluation of drugs, which can effectively guide the high-quality and high-efficient development of this work, enhance the standardized output and transformation application value of evaluation evidence, and provide high-quality evidence support for the scientific decision-making of health and the rationalization of clinical medication.
4.Analyzing the heart-oriented view of the treatment of mental illness in Synopsis of Golden Chamber based on the theory of five-spirit-viscera
ZOU Peng ; Kai CHENG ; Minlong XIA ; Menghan LI ; Shuxian WANG ; Hui KONG ; Yan ZHAO ; Changming ZHAI ; Fang LU
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):495-500
Mental state is an important part of the normal life activities of the human body, and it is also the most external expression and the most easily obtained information of the physical condition. The normal activities of the mind depend on the normal operation of the viscera, qi, and blood, and are a unified whole that prospers together and suffers together. The theory of the five-spirit-viscera in the Yellow Emperor’s Inner Classic revealed that the normal mental activities of the human body were dominated by the five internal organs, that is, the five internal organs were the body and the five spirits were the function. And it highlighted the viewpoint that the five internal organs store the spirits and are actually one. The heart governs the spirit and belongs to the four internal organs. On this basis, Synopsis of Golden Chamber used the internal organs to diagnose and treat mental diseases, integrating the theory of the five spirits into it, forming a unique method of diagnosis and treatment with the heart as the leading factor and regulating the qi and blood of the four internal organs. It identified the pathogenesis of diseases such as pathogenic crying, lily disease, and hysteria from five levels: heart deficiency and weak qi, heart-lung disharmony, heart-liver disharmony, the heart of the loss of the spleen nourishment, and disharmony between heart and kidney. The treatment was mainly to replenish the deficiency of the viscera and eliminate the pathogens, reflecting the characteristics of regulating the mind and calming the four internal organs. This unique view on diagnosis and treatment has profoundly influenced the diagnosis and treatment theories of mental illnesses by later doctors, and is of great significance to the current clinical treatment of such illnesses.
5.Research progress on the mechanisms of Tripterygium wilfordii and its active components on immunoglobulin A nephropathy
Peidong ZHAO ; Yanyan GUO ; Xiangge REN ; Jiawei ZHANG ; Wensheng ZHAI
China Pharmacy 2025;36(21):2742-2746
Immunoglobulin A nephropathy (IgAN) is a common primary glomerular disease and a frequent cause of chronic renal failure. Tripterygium wilfordii is a traditional Chinese herbal medicine, which possesses the effects of promoting blood circulation, relieving swelling and pain, and dispelling wind and dampness. Modern pharmacological studies have shown that T. wilfordii multiglucoside exhibit anti-inflammatory and immunomodulatory effects, inhibit mesangial cell proliferation, protect podocytes, ameliorate endothelial cell injury, and regulate gut microbiota disturbances. Triptolide also possesses anti-inflammatory and immunomodulatory properties, suppresses mesangial cell proliferation, and protects podocytes. Celastrol demonstrates anti- inflammatory and immunomodulatory functions as well as the ability to improve endothelial cell damage. Through these mechanisms, T. wilfordii and its active components can play a role in alleviating clinical symptoms and delaying disease progression in the treatment of IgAN. Future research should focus on in-depth analysis and mechanistic investigation of these active ingredients, promote high-quality clinical studies, systematically evaluate the synergistic effects among them, and emphasize strategies for reducing toxicity and enhancing efficacy, thereby providing more comprehensive and reliable evidence-based foundations for the clinical treatment of IgAN.
6.Buzhong Yiqi Decoction alleviates immune injury of autoimmune thyroiditis in NOD.H-2~(h4)mice via c GAS-STING signaling pathway.
Yi-Ran CHEN ; Lan-Ting WANG ; Qing-Yang LIU ; Zhao-Han ZHAI ; Shou-Xin JU ; Xue-Ying CHEN ; Zi-Yu LIU ; Xiao YANG ; Tian-Shu GAO ; Zhi-Min WANG
China Journal of Chinese Materia Medica 2025;50(7):1872-1880
This study aims to explore the effects of Buzhong Yiqi Decoction(BYD) on the cyclic guanosine monophosphate-adenosine monophosphate synthase(cGAS)-stimulator of interferon genes(STING) signaling pathway in the mouse model of autoimmune thyroiditis(AIT) and the mechanism of BYD in alleviating the immune injury. Forty-eight NOD.H-2~(h4) mice were assigned into normal, model, low-, medium-, and high-dose BYD, and selenium yeast tablets groups(n=8). Mice of 8 weeks old were treated with 0.05% sodium iodide solution for 8 weeks for the modeling of AIT and then administrated with corresponding drugs by gavage for 8 weeks before sampling. High performance liquid chromatography was employed to measure the astragaloside Ⅳ content in BYD. Hematoxylin-eosin staining was employed to observe the pathological changes in the mouse thyroid tissue. Enzyme-linked immunosorbent assay was employed to measure the serum levels of thyroid peroxidase antibody(TPO-Ab), thyroglobulin antibody(TgAb), and interferon-γ(IFN-γ). Flow cytometry was employed to detect the distribution of T cell subsets in the spleen. The immunohistochemical method was used to detect the expression of cGAS, STING, TANK-binding kinase 1(TBK1), and interferon regulatory factor 3(IRF3). Real-time PCR and Western blot were employed to determine the mRNA and protein levels, respectively, of markers related to the cGAS-STING signaling pathway in the thyroid tissue. The results showed that the content of astragaloside Ⅳ in BYD was(7.06±0.08) mg·mL~(-1). Compared with the normal group, the model group showed disrupted structures of thyroid follicular epithelial cells, massive infiltration of lymphocytes, and elevated levels of TgAb and TPO-Ab. Compared with the model group, the four treatment groups showed intact epithelial cells, reduced lymphocyte infiltration, and lowered levels of TgAb and TPO-Ab. Compared with the normal group, the model group showed increases in the proportions of Th1 and Th17 cells, a decrease in the proportion of Th2 cells, and an increase in the IFN-γ level. Compared with the model group, the four treatment groups presented decreased proportions of Th1 and Th17 cells and lowered levels of IFN-γ, and the medium-dose BYD group showed an increase in the proportion of Th2 cells. Compared with the normal group, the modeling up-regulated the mRNA levels of cGAS, STING, TBK1, and IRF3 and the protein levels of cGAS, p-STING, p-TBK1, and p-IRF3. Compared with the model group, the four treatment groups showed reduced levels of cGAS, STING, TBK1, and IRF3-positive products, down-regulated mRNA levels of cGAS, STING, and TBK1, and down-regulated protein levels of cGAS and p-STING. The high-dose BYD group showed down-regulations in the mRNA level of IRF3 and the protein levels of p-TBK1 and p-IRF3. The above results indicate that BYD can repair the imbalance of T cell subsets, alleviate immune injury, and reduce thyroid lymphocyte infiltration in AIT mice by inhibiting the cGAS-STING signaling pathway.
Animals
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Drugs, Chinese Herbal/administration & dosage*
;
Signal Transduction/drug effects*
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Thyroiditis, Autoimmune/metabolism*
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Mice
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Membrane Proteins/metabolism*
;
Mice, Inbred NOD
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Humans
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Female
;
Nucleotidyltransferases/metabolism*
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Male
;
Disease Models, Animal
7.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
Shuang LIU ; Hongsheng CHEN ; Zaiwei SONG ; Qi GUO ; Xianglin ZHANG ; Bingyi SHI ; Suodi ZHAI ; Lingli ZHANG ; Liyan MIAO ; Liyan CUI ; Xiao CHEN ; Yalin DONG ; Weihong GE ; Xiaofei HOU ; Ling JIANG ; Long LIU ; Lihong LIU ; Maobai LIU ; Tao LIN ; Xiaoyang LU ; Lulin MA ; Changxi WANG ; Jianyong WU ; Wei WANG ; Zhuo WANG ; Ting XU ; Wujun XUE ; Bikui ZHANG ; Guanren ZHAO ; Jun ZHANG ; Limei ZHAO ; Qingchun ZHAO ; Xiaojian ZHANG ; Yi ZHANG ; Yu ZHANG ; Rongsheng ZHAO
Journal of Zhejiang University. Science. B 2025;26(9):897-914
Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C0), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug-drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage*
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Drug Monitoring/methods*
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Humans
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Organ Transplantation
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Immunosuppressive Agents/administration & dosage*
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Delphi Technique
8.Summary of clinical experience of 9 children with anterior cervical enterogenic cysts.
Huashan ZHAO ; Shumin ZHAO ; Yunpeng ZHAI ; Rui GUO ; Hongxiu XU ; Sai HUANG ; Longfei LYU ; Shisong ZHANG
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(7):662-666
Objective:To summarized the clinical characteristics and surgical management of anterior cervical enterogenic in pediatric patients. Methods:Clinical data were retrospectively analyzed for 9 children with pathologically confirmed anterior cervical enterogenic cysts(including bronchogenic and esophagogenic subtypes) treated at the Children's Hospital of Shandong University(Jinan Children's Hospital) between January 1, 2020, and November 30, 2023. Results:Nine patients(6 males and 3 females) were involved in this study, aged 14 days to 10 years old. There were 4 cases on the left side, 4 on the right side, and 1 in the middle of the neck. All patients presented with neck masses. The patients were followed up from 3 months to 35 months after surgery and recovered well, with no recurrence or complications observed. Conclusion:①Anterior intestinal cysts in children are rare and easy to be misdiagnosed. ②Concurrent branchial cleft fistulas or associated anomalies may coexist, necessitating comprehensive evaluation. ③Preoperative diagnosis is not easy and mainly depends on pathological diagnosis. ④The treatment of anterior cervical enterogenic cysts in children is surgical resection of the lesion.
Humans
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Male
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Female
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Child
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Retrospective Studies
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Child, Preschool
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Infant
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Neck
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Cysts/surgery*
9.Bacteroi des fragilis-derived succinic acid promotes the degradation of uric acid by inhibiting hepatic AMPD2: Insight into how plant-based berberine ameliorates hyperuricemia.
Libin PAN ; Ru FENG ; Jiachun HU ; Hang YU ; Qian TONG ; Xinyu YANG ; Jianye SONG ; Hui XU ; Mengliang YE ; Zhengwei ZHANG ; Jie FU ; Haojian ZHANG ; Jinyue LU ; Zhao ZHAI ; Jingyue WANG ; Yi ZHAO ; Hengtong ZUO ; Xiang HUI ; Jiandong JIANG ; Yan WANG
Acta Pharmaceutica Sinica B 2025;15(10):5244-5260
In recent decades, the prevalence of hyperuricemia and gout has increased dramatically due to lifestyle changes. The drugs currently recommended for hyperuricemia are associated with adverse reactions that limit their clinical use. In this study, we report that berberine (BBR) is an effective drug candidate for the treatment of hyperuricemia, with its mechanism potentially involving the modulation of gut microbiota and its metabolite, succinic acid. BBR has demonstrated good therapeutic effects in both acute and chronic animal models of hyperuricemia. In a clinical trial, oral administration of BBR for 6 months reduced blood uric acid levels in 22 participants by modulating the gut microbiota, which led to an increase in the abundance of Bacteroides and a decrease in Clostridium sensu stricto_1. Furthermore, Bacteroides fragilis was transplanted into ICR mice, and the results showed that Bacteroides fragilis exerted a therapeutic effect on uric acid similar to that of BBR. Notably, succinic acid, a metabolite of Bacteroides, significantly reduced uric acid levels. Subsequent cell and animal experiments revealed that the intestinal metabolite, succinic acid, regulated the upstream uric acid synthesis pathway in the liver by inhibiting adenosine monophosphate deaminase 2 (AMPD2), an enzyme responsible for converting adenosine monophosphate (AMP) to inosine monophosphate (IMP). This inhibition resulted in a decrease in IMP levels and an increase in phosphate levels. The reduction in IMP led to a decreased downstream production of hypoxanthine, xanthine, and uric acid. BBR also demonstrated excellent renoprotective effects, improving nephropathy associated with hyperuricemia. In summary, BBR has the potential to be an effective treatment for hyperuricemia through the gut-liver axis.
10.Screening of soil biocontrol bacteria and evaluation of their control effects on Fusarium head blight of wheat.
Dongfang WANG ; Xinxin ZHAI ; Chunlin YANG ; Huilan ZHANG ; Jie WU ; Zerong SONG ; Pan ZHAO ; Yu CHI
Chinese Journal of Biotechnology 2025;41(10):3764-3773
Fusarium head blight (FHB), caused by Fusarium graminearum, not only leads to severe yield losses but also poses a threat to food safety due to the mycotoxins produced by the pathogen. Since this disease is preventable but not curable, the current control mainly relies on chemical fungicides, the long-term use of which may lead to pathogen resistance and environmental pollution. To develop green control methods, we screened 13 biocontrol strains from the rhizosphere soil of wheat, among which strain No. 12 (identified as Pythium aphanidermatum) showed significant antifungal effects. In the plate confrontation test, this strain reduced the colony diameter of the pathogen by 69.2% (1.47 mm vs. 4.78 mm in the control group), with an inhibition rate of 77% (P < 0.01). Microscopic observation revealed obvious deformations in the pathogen hyphae, suggesting a lysing effect. The coleoptile experiment further confirmed that the pre-treatment with this strain reduced the incidence rate to 0. These findings provide new candidate strains for the biocontrol of FHB and offer a scientific basis for reducing the use of chemical fungicides and promoting sustainable agricultural development.
Triticum/growth & development*
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Fusarium/growth & development*
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Plant Diseases/prevention & control*
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Soil Microbiology
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Pest Control, Biological/methods*
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Pythium/physiology*
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Biological Control Agents
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Rhizosphere
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Fungicides, Industrial


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