1.Expert consensus on the positioning of the "Three-in-One" Registration and Evaluation Evidence System and the value of orientation of the "personal experience"
Qi WANG ; Yongyan WANG ; Wei XIAO ; Jinzhou TIAN ; Shilin CHEN ; Liguo ZHU ; Guangrong SUN ; Daning ZHANG ; Daihan ZHOU ; Guoqiang MEI ; Baofan SHEN ; Qingguo WANG ; Xixing WANG ; Zheng NAN ; Mingxiang HAN ; Yue GAO ; Xiaohe XIAO ; Xiaobo SUN ; Kaiwen HU ; Liqun JIA ; Li FENG ; Chengyu WU ; Xia DING
Journal of Beijing University of Traditional Chinese Medicine 2025;48(4):445-450
Traditional Chinese Medicine (TCM), as a treasure of the Chinese nation, plays a significant role in maintaining public health. In 2019, the Central Committee of the Communist Party of China and the State Council proposed for the first time the establishment of a TCM registration and evaluation evidence system that integrates TCM theory, "personal experience" and clinical trials (referred to as the "Three-in-One" System) to promote the inheritance and innovation of TCM. Subsequently, the National Medical Products Administration issued several guiding principles to advance the improvement and implementation of this system. Owing to the complexity of its implementation, there are still differing understandings within the TCM industry regarding the positioning of the "Three-in-One" Registration and Evaluation Evidence System, as well as the connotation and value orientation of the "personal experience." To address this, Academician WANG Qi, President of the TCM Association, China International Exchange and Promotion Association for Medical and Healthcare and TCM master, led a group of academicians, TCM masters, TCM pharmacology experts and clinical TCM experts to convene a "Seminar on Promoting the Implementation of the ′Three-in-One′ Registration and Evaluation Evidence System for Chinese Medicinals." Through extensive discussions, an expert consensus was formed, clarifying the different roles of the TCM theory, "personal experience" and clinical trials within the system. It was further emphasized that the "personal experience" is the core of this system, and its data should be derived from clinical practice scenarios. In the future, the improvement of this system will require collaborative efforts across multiple fields to promote the high-quality development of the Chinese medicinal industry.
2.Two types of coumarins-specific enzymes complete the last missing steps in pyran- and furanocoumarins biosynthesis.
Yucheng ZHAO ; Yuedong HE ; Liangliang HAN ; Libo ZHANG ; Yuanzheng XIA ; Fucheng YIN ; Xiaobing WANG ; Deqing ZHAO ; Sheng XU ; Fei QIAO ; Yibei XIAO ; Lingyi KONG
Acta Pharmaceutica Sinica B 2024;14(2):869-880
Pyran- and furanocoumarins are key representatives of tetrahydropyrans and tetrahydrofurans, respectively, exhibiting diverse physiological and medical bioactivities. However, the biosynthetic mechanisms for their core structures remain poorly understood. Here we combined multiomics analyses of biosynthetic enzymes in Peucedanum praeruptorum and in vitro functional verification and identified two types of key enzymes critical for pyran and furan ring biosynthesis in plants. These included three distinct P. praeruptorum prenyltransferases (PpPT1-3) responsible for the prenylation of the simple coumarin skeleton 7 into linear or angular precursors, and two novel CYP450 cyclases (PpDC and PpOC) crucial for the cyclization of the linear/angular precursors into either tetrahydropyran or tetrahydrofuran scaffolds. Biochemical analyses of cyclases indicated that acid/base-assisted epoxide ring opening contributed to the enzyme-catalyzed tetrahydropyran and tetrahydrofuran ring refactoring. The possible acid/base-assisted catalytic mechanisms of the identified cyclases were theoretically investigated and assessed using site-specific mutagenesis. We identified two possible acidic amino acids Glu303 in PpDC and Asp301 in PpOC as vital in the catalytic process. This study provides new enzymatic tools in the epoxide formation/epoxide-opening mediated cascade reaction and exemplifies how plants become chemically diverse in terms of enzyme function and catalytic process.
3.Unlocking the potential of amorphous calcium carbonate: A star ascending in the realm of biomedical application.
Han LIU ; Zhiyang WEN ; Zihan LIU ; Yanfang YANG ; Hongliang WANG ; Xuejun XIA ; Jun YE ; Yuling LIU
Acta Pharmaceutica Sinica B 2024;14(2):602-622
Calcium-based biomaterials have been intensively studied in the field of drug delivery owing to their excellent biocompatibility and biodegradability. Calcium-based materials can also deliver contrast agents, which can enhance real-time imaging and exert a Ca2+-interfering therapeutic effect. Based on these characteristics, amorphous calcium carbonate (ACC), as a brunch of calcium-based biomaterials, has the potential to become a widely used biomaterial. Highly functional ACC can be either discovered in natural organisms or obtained by chemical synthesis However, the standalone presence of ACC is unstable in vivo. Additives are required to be used as stabilizers or core-shell structures formed by permeable layers or lipids with modified molecules constructed to maintain the stability of ACC until the ACC carrier reaches its destination. ACC has high chemical instability and can produce biocompatible products when exposed to an acidic condition in vivo, such as Ca2+ with an immune-regulating ability and CO2 with an imaging-enhancing ability. Owing to these characteristics, ACC has been studied for self-sacrificing templates of carrier construction, targeted delivery of oncology drugs, immunomodulation, tumor imaging, tissue engineering, and calcium supplementation. Emphasis in this paper has been placed on the origin, structural features, and multiple applications of ACC. Meanwhile, ACC faces many challenges in clinical translation, and long-term basic research is required to overcome these challenges. We hope that this study will contribute to future innovative research on ACC.
4. Effect of miR-141-5p/ZNF705A on adhesion of bone marrow mesenchymal stem cells in chronic myeloid leukemia cell-derived exosomes
Jing BAO ; Han XU ; Wan-Jie WANG ; Ting-Ting XU ; Ji-Fei DAI ; Rui-Xiang XIA
Chinese Pharmacological Bulletin 2024;40(3):506-514
Aim To investigate the effect of miR-141-5p/ZNF705A in chronic myeloid leukemia(CML)cell-derived exosome(Exo)on the adhesion of bone marrow mesenchymal stem cells(BMSCs). Methods The morphology and size of Exo in peripheral blood from CML patients and K562 cells were examined by electron microscopy and NTA particle size analysis. The expressions of Exo and BMSCs marker molecules and adhesion proteins in K562 cells were detected by qRT-PCR and Western blot before and after transfection. The adhesion ability of BMSCs was detected by cell adhesion assay, and the cellular activity of BMSCs was examined using CCK-8. miR-141-5p binding to ZNF705A was detected by luciferase assay. Results qRT-PCR results showed that miR-141-5p expression was significantly reduced in both CML patients and K562 cell-derived Exo. qRT-PCR, Western blot and other results showed that BMSCs in CML patients had significantly reduced the expression of adhesion proteins CD44 and CXCL12, and were able to phagocytose K562 cell-derived Exo. Further, K562-derived Exo was found to reduce CD44 and CXCL12 expression and adhesion in Exo-promoted BMSCs compared with CD34+ cells. Meanwhile, the results of dual luciferase reporter assay verified that miR-141-5p targeted binding to ZNF705A. Finally, we found ZNF705A could be targeted by up-regulating miR-141-5p expression in Exo of K562 cells, which in turn inhibited the adhesion of BMSCs. Conclusions K562 cells down-regulate miR-141-5p expression in Exo and inhibit the adhesion function of BMSCs by targeting ZNF705A, thus regulating the bone marrow hematopoietic function in CML patients.
5.Transcriptome Sequencing on Treatment of Kidney Deficiency and Blood Stasis-thin Endometrium in Rats with Bushen Huoxue Prescription Through Enema
Xuan ZHANG ; Wanting XIA ; Zhixing YIN ; Nana HAN ; Jinzhu HUANG ; Hang ZHOU ; Yi WANG ; Juan LI ; Qian ZENG
Chinese Journal of Experimental Traditional Medical Formulae 2024;30(2):79-90
ObjectiveTo explore the mechanism of Bushen Huoxue enema in treating the rat model of kidney deficiency and blood stasis-thin endometrium (KDBS-TE) by transcriptome sequencing. MethodThe rat model of KDBS-TE was established by administration of tripterygium polyglycosides tablets combined with subcutaneous injection of adrenaline. The pathological changes of rat endometrium in each group were then observed. Three uterine tissue specimens from each of the blank group, model group, and Bushen Huoxue enema group were randomly selected for transcriptome sequencing. The differentially expressed circRNAs, lncRNAs, and miRNAs were screened, and the disease-related specific competitive endogenous RNA (ceRNA) regulatory network was constructed. Furthermore, the gene ontology (GO) functional annotation and the Kyoto Encyclopedia of Genes and Genomes (KEGG) pathway enrichment were performed for the mRNAs in the network. ResultCompared with the blank group, the model group showed endometrial dysplasia, decreased endometrial thickness and endometrial/total uterine wall thickness ratio (P<0.01), and differential expression of 18 circRNAs, 410 lncRNAs, and 7 miRNAs. Compared with the model group, the enema and estradiol valerate groups showed improved endometrial morphology and increased endometrial thickness and ratio of endometrial to total uterine wall thickness (P<0.05). In addition, 21 circRNAs, 518 lncRNAs, and 17 miRNAs were differentially expressed in the enema group. The disease-related specific circRNA-miRNA-mRNA regulatory network composed of 629 nodes and 664 edges contained 2 circRNAs, 34 miRNAs, and 593 mRNAs. The lncRNA-miRNA-mRNA regulatory network composed of 180 nodes and 212 edges contained 5 lncRNAs, 10 miRNAs, and 164 mRNAs. The mNRAs were mainly enriched in Hippo signaling pathway, autophagy-animal, axon guidance, etc. ConclusionBushen Huoxue enema can treat KDBS-TE in rats by regulating specific circRNAs, lncRNAs, and miRNAs in the uterus and the ceRNA network.
6.The correlation between peri-coronary fat attenuation index and different grades of hypertension based on coronary CT angiography
Xia LI ; Dan HAN ; Xiaoying LIU ; Jie JIANG ; Zitong WANG ; Xiaojie XIE ; Hui DUAN
Journal of Practical Radiology 2024;40(1):41-45
Objective lo analyze the difference of peri-coronary tat attenuation index(pr Al)on different grades of hypertension(HT),and to explore the value of pFAI in evaluating the risk of HT patients.Methods Retrospective data on hospitalized patients who underwent coronary computed tomography angiography(CCTA)examination for chest pain were collected.A total of 415 clini-cally confirmed HT patients were selected as observation group(including 132 patients in grade 1 HT group,137 patients in grade 2 HT group,146 patients in grade 3 HT group),and 187 non-hypertension patients during the same period as control group.The differ-ence of fat attenuation index(FAI)in three main coronary arteries[left anterior descending artery(LAD),left circumflex artery(LCX),right coronary artery(RCA)]was compared,and the correlation between pF AI and HT patients was analyzed.Results RCA-FAI(-78.86 HU±7.66 HU)and LAD-FAI(-80.62 HU±7.50 HU)were higher in HT group than those in control group(-84.46 HU± 8.00 HU,-83.43 HU±7.51 HU,P<0.05).pFAI value was higher in grade 3 HT group than that in grade 1 HT group and grade 2 HT group(P<0.05),while there were no differences between grade 1 HT group and grade 2 HT group(P>0.05).After adjusting the influence of traditional risk factors and coronaryartery disease,RCA-FAI had relatively closer relationship with HT grades(r=0.47,P<0.001).Conclusion LAD-FAI,RCA-FAI in the HT group are higher than those in control group and RCA-FAI has relatively closer relationship with HT grades,suggesting that RCA-FAI may be an imaging indicator to evaluate the pro-gression of HT and predict the risk of HT.
7.Expert consensus on the evaluation and management of dysphagia after oral and maxillofacial tumor surgery
Xiaoying LI ; Moyi SUN ; Wei GUO ; Guiqing LIAO ; Zhangui TANG ; Longjiang LI ; Wei RAN ; Guoxin REN ; Zhijun SUN ; Jian MENG ; Shaoyan LIU ; Wei SHANG ; Jie ZHANG ; Yue HE ; Chunjie LI ; Kai YANG ; Zhongcheng GONG ; Jichen LI ; Qing XI ; Gang LI ; Bing HAN ; Yanping CHEN ; Qun'an CHANG ; Yadong WU ; Huaming MAI ; Jie ZHANG ; Weidong LENG ; Lingyun XIA ; Wei WU ; Xiangming YANG ; Chunyi ZHANG ; Fan YANG ; Yanping WANG ; Tiantian CAO
Journal of Practical Stomatology 2024;40(1):5-14
Surgical operation is the main treatment of oral and maxillofacial tumors.Dysphagia is a common postoperative complication.Swal-lowing disorder can not only lead to mis-aspiration,malnutrition,aspiration pneumonia and other serious consequences,but also may cause psychological problems and social communication barriers,affecting the quality of life of the patients.At present,there is no systematic evalua-tion and rehabilitation management plan for the problem of swallowing disorder after oral and maxillofacial tumor surgery in China.Combining the characteristics of postoperative swallowing disorder in patients with oral and maxillofacial tumors,summarizing the clinical experience of ex-perts in the field of tumor and rehabilitation,reviewing and summarizing relevant literature at home and abroad,and through joint discussion and modification,a group of national experts reached this consensus including the core contents of the screening of swallowing disorders,the phased assessment of prognosis and complications,and the implementation plan of comprehensive management such as nutrition management,respiratory management,swallowing function recovery,psychology and nursing during rehabilitation treatment,in order to improve the evalua-tion and rehabilitation of swallowing disorder after oral and maxillofacial tumor surgery in clinic.
8.Signal mining and analysis of adverse drug events for gilteritinib
Yang LIU ; Minzhen HAN ; Jie XIA ; Hanshuai HU ; Lei YAO ; Xue LAN ; Qian LIU ; Jinxingyi WANG
China Pharmacy 2024;35(15):1888-1892
OBJECTIVE To mine the adverse drug events (ADE) signals for gilteritinib, and provide a reference for safe drug use in clinic. METHODS ADE reports with gilteritinib as the primary suspected drug were extracted from the FDA Adverse Event Reporting System (FAERS) database from February 1st, 2018 to December 31st, 2023. Reporting odds ratio (ROR) and proportional reporting ratio (PRR) were applied to detect the risk signals from the data in the FAERS database. The classification and statistics of collected signal data were conducted by using the preferred term (PT) and systemic organ class (SOC) in ADE terminology set of the Medical Dictionary for Regulatory Activities (24.1 edition). RESULTS Totally, 2 755 gilteritinib-related ADE reports were collected from the database, involving 676 ADE signals (95 positive signals), 313 PTs and 25 SOCs. Among them, nine signals were not recorded in the package insert. The top 5 PTs consisted of abnormal liver function, decreased platelet count, febrile neutropenia, pneumonia and myelosuppression. The top 6 SOCs for positive signal counts were examinations, general disorders and administration site conditions, respiratory, thoracic and mediastinal disorders, infections and infestations, heart organ disorders, and nervous system disorders. ADEs not recorded in the drug package insert included pneumonia, myelosuppression, decreased blood cell count, sepsis, hemorrhage, infection (not specifically referred to), septic shock, respiratory failure, and aspergillosis. CONCLUSIONS In addition to paying attention to common ADEs such as liver dysfunction and thrombocytopenia, it is necessary to monitor ADEs with strong signals that are not mentioned in the drug instructions when using gefitinib, such as pneumonia, bone marrow suppression, cytopenia, sepsis, bleeding, infection (not specifically referred to), septic shock, respiratory failure, Aspergillus infection, elevated serum creatinine and interstitial lung disease.
9.The clinical application value of different localization methods in thoracoscopic resection of pulmonary nodules
Shao GAO ; Xiaoliang HAN ; Liang WANG ; Keling YAO ; Jiadong XIA
Journal of Interventional Radiology 2024;33(2):171-175
Objective To compare the clinical application value of medical glue and a new-type medical anchor positioning needle in thoracoscopic resection of pulmonary nodules.Methods A total of 182 patients with pulmonary nodules,who received video-assisted thoracic surgery(VATS)at the Department of Thoracic Surgery of Affiliated Hospital of Shaoxing University of China between January 2020 and December 2022,were enrolled in this study.Preoperative CT-guided localization of the pulmonary nodule was performed in all patients,including medical glue positioning in 89 patients(medical glue group)and anchor needle positioning in 93 patients(anchor needle group).The incidences of pneumothorax and bleeding,the time spent for positioning,the interval between localization and operation,the time spent for operation,and the radiation dose during localization process were recorded and the data were statistically analyzed.Results The success rate of positioning was 100%(93/93)in the anchor needle group and 96.7%(86/89)in the medical glue group.There was no statistically significant difference between the two groups(P>0.05).The incidence of bleeding was 31.2%(29/93)in the anchor needle group and 15.7%(14/89)in the medical glue group,and the difference between the two groups was statistically significant(P<0.05).The incidence of pneumothorax was 30.1%(28/93)in the anchor needle group and 20.2%(18/89)in the medical glue group,and there was no significant difference between the two groups(P>0.05).No statistically significant difference in the time spent for operation existed between the two groups(P>0.05).The time spent for positioning and the interval between localization and operation in the medical glue group were longer than those in the anchor needle group,and the radiation dose in the medical glue group was higher than that in the anchor needle group,and the differences between the two groups were statistically significant(P<0.05).Conclusion For the preoperative localization of ground glass opacity(GGO)or solitary pulmonary nodule(SPN),both medical glue positioning method and anchor needle positioning method have high clinical application value.The clinical and interventional physicians should adopt appropriate positioning method according to the patient's condition.
10.Study of The Y-STR Multiplex Microfluidic Chip Rapid Amplification System
Dao-Yu WANG ; Qun WAN ; Bin ZHUANG ; Li-Jian ZHAO ; Jun-Ping HAN ; Cai-Xia LI
Progress in Biochemistry and Biophysics 2024;51(3):696-705
ObjectiveAt present, the matching reagents of commercially available rapid DNA instruments based on microfluidics chip technology are autosome short tandem repeat (STR) individual identification reagents. The non-recombining part of the human Y chromosome is widely used in forensic DNA analysis, particularly in cases where standard autosomal DNA profile is uninformative. Y-STR loci are useful markers to identify males and male lineages in forensic practice. In order to achieve rapid and fully integrated detection ofY-STR loci, this study constructed the RTyper Y27 microfluidic chip rapid detection system and validated the performance of this system. MethodsThe system was verified and evaluated by sensitivity, success rate, typing accuracy, peak height balance, sizing precision and accuracy, mock case sample tests, mixture detection ability, and inhibition tolerance. ResultsComplete Y-STR profiles can be obtained when the template amount of DNA standard 9948 was ≥8 ng, the number of blood cards was ≥3 pieces, and the number of oral swab scrapings was≥7 times. The success rate of fully integrated detection was 91.52%, and the concordance rates was 99.74% for 165 testing samples. The success rate of 115 blood spots in these samples was 90.43%, with a typing accuracy of 99.65%, the success rate of 50 buccal swabs was 94%, with a typing accuracy of 99.92%. There was no significant difference in typing accuracy between blood spots and buccal swab samples. The peak height ratio between different fluorescence channels was 89.81%. The standard deviation of allelic ladder for 10 runs was within 0.5 bp. The size differences between allele and corresponding allele in allelic ladder was within 0.5 bp. The maximum precision CV values within and between batches were 0.48% and 0.68%, respectively, which were lower than 15%. These data indicate that the system has good accuracy and precision. The system was capable of accurately typing oral swabs, blood cards, saliva cards, cigarette butts, blood swabs and seminal stains. Complete Y-STR profiles can be obtained and distinguish at the 1∶3 ratio of minor and major contributors in artificial male DNA mixtures. Complete Y-STR genotyping can be obtained under the interference of inhibitors, such as different concentrations of humic acid (50-400 mg/L), indigotin (20-100 nmol/L) and hemoglobin (100-500 μmol/L). ConclusionIn this study, the RTyper Y27 microfluidic chip rapid amplification system is combined with the Quick TargSeq 1.0 integrated system, and the Y-STR profile can be obtained in approximately 2 h. Through a series of verification experiments, the results show that the system has good repeatability, accuracy and stability, can meet the on-site Y-STR detection requirements, and can be used in forensic practice.


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