1.Exploring Mechanism of Xiaojinwan-containing Serum in Inhibiting Breast Cancer Cells Based on Wnt/β-catenin Signaling Pathway
Hongdi TANG ; Xiaobo JIN ; Chen GAO ; Hongkai LI ; Zhiming LI ; Lu YAO ; Fengli SONG ; Ning KANG ; Wenwen WANG ; Ying SUN ; Zhibin WANG ; Tong LI ; Yingli ZHU
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(17):13-22
ObjectiveTo investigate the role and underlying mechanism of the Wnt/β-catenin signaling pathway in the process of Xiaojinwan (XJW)-containing serum interfering with endothelial-mesenchymal transition (EMT) in human breast cancer MDA-MB-231 cells. MethodsXJW-containing serum was prepared by intragastric administration of XJW (4 g·kg-1) to SD rats. MDA-MB-231 cells were cultured in vitro. β-Catenin overexpression and knockdown plasmids were constructed and transfected into MDA-MB-231 cells. The optimal XJW-containing serum (4 g·kg-1) according to previous studies was used for β-catenin intervention and overexpression experiments. The groups for intervention/overexpression experiments included intervention/overexpression blank group, β-catenin intervention/overexpression group, intervention/overexpression blank + XJW group, and β-catenin intervention/overexpression + XJW group. Cell morphology was observed under a microscope. Flow cytometry was used to detect and record apoptosis rates. Western blot was performed to measure apoptosis-related proteins [B-cell lymphoma 2 (Bcl-2), Bcl-2-associated X protein (Bax), and active-Caspase-3] and EMT-related proteins (E-cadherin, N-cadherin, and vimentin). Real-time polymerase chain reaction (Real-time PCR) was used to detect β-catenin mRNA expression levels in different groups. ResultsIntervention experiment results showed that compared with the intervention blank group, the β-catenin intervention group and the intervention blank + XJW group showed increased apoptosis rates (P<0.05, P<0.01), elevated protein levels of Bax, active Caspase-3, and E-cadherin (P<0.05, P<0.01), and decreased protein levels of Bcl-2 and Vimentin (P<0.05, P<0.01). β-catenin mRNA expression was reduced in the β-catenin intervention group (P<0.05, 0.63 ± 0.15) and the intervention blank + XJW group (P<0.05, 0.79 ± 0.33). Compared with the β-catenin intervention group, the β-catenin intervention + XJW group exhibited an increased apoptosis rate (P<0.01), elevated Bax and active Caspase-3 protein levels (P<0.05, P<0.01), and decreased Bcl-2, N-cadherin, and Vimentin protein levels (P<0.05). β-catenin mRNA expression was further reduced in the β-catenin intervention + XJW group (P<0.01, 0.22 ± 0.08). Compared with the intervention blank + XJW group, the β-catenin intervention + XJW group showed an increased apoptosis rate (P<0.01), elevated Bax, active Caspase-3, and E-cadherin protein levels (P<0.05, P<0.01), and decreased Bcl-2, N-cadherin, and vimentin protein levels (P<0.05, P<0.01). β-catenin mRNA expression was also reduced (P<0.05). Overexpression experiment results showed that compared with the overexpression blank group, the β-catenin overexpression group exhibited a reduced apoptosis rate (P<0.01), while the overexpression blank + XJW group showed an increased apoptosis rate (P<0.05). In the β-catenin overexpression and β-catenin overexpression + XJW groups, Bax and E-cadherin protein levels decreased (P<0.05, P<0.01), while Bcl-2, N-cadherin, and vimentin levels increased (P<0.05). In the overexpression blank + XJW group, Bax and E-cadherin levels increased (P<0.05, P<0.01), while Bcl-2, N-cadherin, and vimentin levels decreased (P<0.05, P<0.01). β-catenin mRNA expression increased in the β-catenin overexpression group (P<0.01, 7.26 ± 1.03) but decreased in the overexpression blank + XJW group (P<0.05, 0.73 ± 0.14). Compared with the β-catenin overexpression group, the β-catenin overexpression + XJW group showed an increased apoptosis rate (P<0.01), elevated Bax and E-cadherin levels (P<0.05), and decreased N-cadherin and vimentin levels (P<0.05). β-catenin mRNA expression was reduced (P<0.05, 4.65 ± 1.02). Compared with the overexpression blank + XJW group, the β-catenin overexpression + XJW group exhibited a reduced apoptosis rate (P<0.01), decreased Bax and E-cadherin levels (P<0.01), and increased Bcl-2, N-cadherin, and Vimentin levels (P<0.05). β-catenin mRNA expression increased (P<0.01). ConclusionXJW-containing serum inhibits breast cancer cell proliferation by suppressing EMT, which is associated with the regulation of the Wnt/β-catenin pathway.
2.Prevalence of spotted fever group rickettsiae infections in ticks and among high-risk populations in the southern margin of the Gurbantunggut Desert in Xinjiang Uygur Autonomous Region
Keying XU ; Li YANG ; Xiaoshuang HAN ; Xinting LI ; Yuanzhi WANG ; Rongjiong ZHENG ; Xiaobo LU
Chinese Journal of Schistosomiasis Control 2026;38(4):424-431
Objective To investigate the prevalence of spotted fever group rickettsiae (SFGR) infections in free-living ticks and among high-risk populations in the southern margin of the Gurbantunggut Desert, Xinjiang Uygur Autonomous Region, so as to provide insights into tick-borne diseases prevention and control in this region. Methods Free-living ticks were collected from five counties (cities) in the southern margin of the Gurbantunggut Desert, Xinjiang Uygur Autonomous Region. Tick species were identified by morphology combined with mitochondrial cytochrome c oxidase subunit Ⅰ (COI) gene analysis. Four target gene fragments of Rickettsia were amplified using a nested PCR assay, including outer membrane protein B (ompB), 17-kDa common surface antigen protein (17kDa), surface cell antigen 1 (sca1), and surface cell antigen 4 (sca4) genes, to detect the prevalence of SFGR infections in tick samples. Positive PCR amplification products were purified, sequenced, and subjected to sequence alignment, and phylogenetic trees were created using the neighbor-joining (NJ) method. Serum samples were collected from individuals at a high risk of tick exposure from six counties (cities, districts) in the southern margin of the Gurbantunggut Desert, Xinjiang Uygur Autonomous Region, and serum levels of anti-R. sibirica IgG antibodies were detected among these individuals using indirect immunofluorescence assay (IFA) and statistically analyzed. Results A total of 287 free-living ticks were collected, and all were identified as Hyalomma asiaticum. The overall prevalence of SFGR infection was 78.40% (225/287) in tick samples, and five Rickettsia species were characterized, including R. sibirica, which shared 99.81% (515/516) sequence homology with the strain detected in Dermacentor sinicus from China; R. massiliae, which shared 99.80% (509/510) sequence homology with the strain detected in Rhipicephalus sanguineus from Ethiopia; R. raoultii, which shared 100.00% (516/516) sequence homology with the strain detected in Hyalomma asiaticum from Xinjiang Uygur Autonomous Region in China; R. africae, which shared 100.00% (524/524) sequence homology with the strain detected in Amblyomma splendidum from Ethiopia; and Candidatus Rickettsia barbariae, which shared 99.80% (499/500) sequence homology with the strain detected in steppe polecats from Xinjiang Uygur Autonomous Region in China, with R. sibirica (33.80% detection rate, 97/287) and R. raoultii (33.10%, 95/287) as dominant species. A total of 1 489 serum samples were collected from individuals at a high risk of tick exposure, and the seroprevalence of antiR. sibirica IgG antibodies was 30.83% (459/1 489). There were no significant differences in the seroprevalence in terms of genders (χ2 = 2.23, P > 0.05) or age groups (χ2 = 6.45, P > 0.05); however, there was a region-specific seroprevalence rate of anti-R. sibirica IgG antibodies (χ2 = 16.05, P < 0.05). Pairwise comparisons showed lower seroprevalence rate of anti-R. sibirica IgG antibodies among high-risk individuals in Midong District of Urumqi City (22.27%, 53/238) than in Wujiaqu City (34.70%, 93/268) and Manas County(37.55%, 98/261) (both P values < 0.05); however, they were not significantly different from those in the other regions (all P values > 0.05). Conclusion Multiple SFGR species are detected in H. asiaticum ticks sampled from the southern margin of the Gurbantunggut Desert, Xinjiang Uygur Autonomous Region, where there is a potential risk of local transmission of spotted fever rickettsiosis.
3.Effects of Electrothermal Acupuncture on the HIF-1α/S1P/S1PR3 Pathway and Macrophage Polarization in Epididymal White Adipose Tissue of Obese Model Mice
Xiaobo GE ; Yuanyuan LI ; Jiangyan WEI ; Limin NIE ; Xin YANG ; Quan MIAO ; Mina WANG ; Yawei XI ; Luopeng ZHAO ; Yine SONG ; Xinru SUN ; Lu LIU ; Bin LI
Journal of Traditional Chinese Medicine 2026;67(20):2227-2235
ObjectiveTo investigate the mechanism underlying the weight loss effect of electrothermal acupuncture (ETA) in diet-induced obese (DIO) model mice based on the hypoxia-inducible factor-1α (HIF-1α)/sphingosine-1-phosphate (S1P)sphingosine-1-phosphate receptor 3 (S1PR3) signaling pathway-mediated macrophage polarization. MethodsAn obesity mouse model was established by continuously feeding at a high-fat diet (HFD) for 8 weeks. Twenty successfully modeled obese mice were randomly divided into a model group and an electrothermal acupuncture (ETA) group with 10 mice per group, both of which continued to receive the HFD till week 12. Another 10 mice were assigned to the normal group and fed a standard chow diet continuously for 12 weeks. Starting from week 9 of the experiment, mice in the ETA group received electrothermal acupuncture stimulation at Zhongwan (CV12), bilateral Tianshu (ST25), and bilateral Zusanli (ST36) for 30 minutes per session, with the instrument current set at (40±0.5)mA and a constant temperature of (40±0.5)℃. Mice in the normal group and the model group were restrained in the same manner for 30 minutes without acupuncture. All interventions were performed once every other day for a total of 4 weeks. Ten hours after the final intervention, the body weight, waist circumference, and body length of mice in each group were measured, and Lee's index was calculated. Serum biochemical analysis was performed to assess fasting blood glucose (FBG), total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea nitrogen (BUN), and creatinine (Cr). Serum leptin (LEP) and adiponectin (ADPN) levels, as well as sphingosine-1-phosphate (S1P) levels in epididymal white adipose tissue (eWAT), were detected by ELISA. Histomorphological changes in eWAT were monitored via HE staining. Flow cytometry was used to analyze macrophage subtype-related indexes in eWAT, including the total proportion of macrophages, the proportion of M1 macrophages, the proportion of M2 macrophages, and the M1/M2 ratio. Antibody array technology was used to determine the levels of differentially expressed inflammatory factors in eWAT between the model and blank groups, as well as between the ETA and model groups. Western blot and qPCR were used to detect the protein and mRNA expression levels of HIF-1α and S1PR3 in the eWAT, respectively. ResultsCompared to the normal group, the model group showed significantly increased body weight, Lee's index, waist circumference, and FBG, TC, TG, HDL-C, LDL-C, AST, and ALT levels, upgraded LEP and S1P levels, decreased ADPN level and ADPN/LEP ratio, elevated proportion of M1 macrophages and the M1/M2 ratio, reduced proportion of M2 macrophages, and upregulated protein and mRNA expression levels of HIF-1α and S1PR3 (P<0.05 or P<0.01). With the exception of HDL-C, all the abovementioned indicators in the ETA group were significantly improved compared to the model group (P<0.05 or P<0.01). Analysis of differentially expressed inflammatory cytokines revealed that, compared to the normal group, the levels of interleukin-1β (IL-1β), interferon-γ (IFN-γ), interleukin-6 (IL-6), and interleukin-12p70 (IL-12p70) in the eWAT of the model group were elevated; conversely, the levels of interleukin-17 (IL-17), interleukin-5 (IL-5), IL-6, and interleukin-23 (IL-23) in the eWAT of the ETA group decreased compared to the model group (P<0.05 or P<0.01). ConclusionETA exerts a weight-reducing effect in obese model mice, and the mechanism may involve inhibition of the HIF-1α/S1P/S1PR3 signaling pathway activation, which shifts macrophage polarization from the M1 to M2 phenotype, thereby alleviating chronic inflammation.
4.Early clinical efficacy of Yiqi Tongluo Decoction on ischemic cerebrovascular disease after interventional therapy
Qinghua WANG ; Gesheng WANG ; Ruiping LI ; Can ZHENG ; Wenjing LI ; Jiaqi CHEN ; Kaihang GUO ; Xiaobo DONG ; Wenxin WANG ; Rongjuan GUO ; Le WANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(1):108-121
Objective:
To observe the clinical efficacy and safety of Yiqi Tongluo Decoction in the intervention of early traditional Chinese medicine (TCM) syndromes after ischemic cerebrovascular disease (ICVD) intervention.
Methods:
From October 2020 to July 2023, a randomized, double-blind, placebo-controlled study was conducted to include 60 patients with qi deficiency, blood stasis, and phlegm obstruction syndrome after ICVD interventional therapy. They were assigned to the Yiqi Tongluo Decoction treatment group (30 cases) and the TCM placebo routine treatment control group (30 cases) according to the randomized block design. Both groups received routine standardized treatment of Western medicine, including dual antiplatelet, lipid regulation, and control of risk factors for cerebrovascular disease. The treatment group was treated with Yiqi Tongluo Decoction based on the control group. The course of treatment was 60 days and follow-up was carried out 2 and 6 months after the operation. The improvement of qi deficiency syndrome, blood stasis syndrome, phlegm syndrome score and TCM syndrome score, modified Rankin score (mRS), Barthel index (BI) score, Fatty acid-binding protein 4 (FABP4) level, incidence of transient ischemic attack (TIA) and ischemic stroke (IS) and incidence of adverse reactions, Head and neck CT angiography (CTA) or digital subtraction angiography (DSA) examination were collected. The clinical efficacy of the patients 2 months after the operation was taken as the main outcome index to preliminarily evaluate the early and long-term efficacy of Yiqi Tongluo Decoction after the ICVD intervention. The early and long-term clinical efficacy and safety of Western medicine standardized treatment combined with TCM Yiqi Tongluo Decoction on patients with qi deficiency, blood stasis and phlegm obstruction syndrome after ICVD intervention were evaluated. The safety of Yiqi Tongluo Decoction in the treatment of patients after ICVD intervention with white blood cell (WBC), C-reactive protein (CRP), fibrinogen (FIB), plasminogen time (PT), recurrence of cerebral ischaemia and restenosis in patients at 2 and 6 months after treatment were evaluated.
Results:
Compared to the control group, the TCM syndrome scores for qi deficiency, blood stasis and phlegm syndrome in the treatment group reduced significantly, the clinical efficacy improved significantly, the mRS score and FABP4 were reduced, and the BI score was increased. Adverse events such as cerebral ischaemia were fewer in the treatment group than in the control group, but the difference was not statistically significant; levels of CRP, WBC and PT were reduced, and levels of FIB were reduced at 6 months post-treatment, all P<0.01, and images were intuitively compared. The treatment group was superior to the control group.
Conclusion
Yiqi Tongluo Decoction combined with Western medicine standard treatment can improve the early clinical efficacy of ICVD patients with qi deficiency, blood stasis and phlegm obstruction syndrome after interventional surgery, improve neurological impairment and daily living ability, reduce the state of qi deficiency syndrome, blood stasis syndrome and phlegm syndrome after interventional surgery, and improve the clinical efficacy of TCM. At the same time, it can reduce the level of FABP4, the target of atherosclerosis and restenosis after interventional surgery, reduce the level of inflammation after interventional surgery in patients with ICVD, regulate coagulation function, and reduce the incidence of long-term recurrence of cerebral ischemia after interventional surgery, with good safety.
5.Clinical Efficacy of Zhuyuwan in Treatment of Hyperlipidemia with Syndrome of Phlegm Turbidity and Obstruction
Lele YANG ; Danmei LUO ; Jiao CHEN ; Xiaobo ZHANG ; Wei SONG ; Wenyu ZHU ; Xin ZHOU ; Xueping LI ; Tao SHEN
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(13):29-37
ObjectiveTo observe the clinical efficacy and safety of Zhuyuwan in the treatment of hyperlipidemia. MethodsIn this study, hyperlipidemia patients treated in the Hospital of Chengdu University of Traditional Chinese Medicine (TCM) from September 2022 to December 2023 were randomly assigned into a control group and an observation group. Finally, 162 valid cases were included, encompassing 74 cases in the control group and 88 cases in the observation group. The control group was treated with atorvastatin calcium tablets, and the observation group with atorvastatin calcium tablets + Zhuyuwan extract granules. Both groups were treated for 8 weeks. The efficacy in terms of blood lipid level recovery, blood lipid levels, TCM syndrome distribution, efficacy in terms of TCM syndrome, and TCM symptom scores were compared between the two groups as well as between before and after treatment. Liver and kidney functions were monitored for safety assessment. ResultsIn terms of blood lipid level recovery, the total response rate in the observation group was 86.36% (76/88) and that in the control group was 86.49% (64/74), with no statistically significant difference between the two groups. After treatment, both groups showed declines in levels of triglyceride (TG), total cholesterol (TC), and low-density lipoprotein cholesterol (LDL-C) (P<0.05) and elevations in the level of high-density lipoprotein cholesterol (HDL-C) (P<0.05). Moreover, the observation group outperformed the control group in recovering the levels of TG, LDL-C, and HDL-C (P<0.05, P<0.01). In terms of TCM syndrome, hyperlipidemia was mostly caused by phlegm turbidity and obstruction. The total response rate in terms of TCM syndrome in the observation group was 87.30% (55/63), which was higher than that (63.46%, 33/52) in the control group (χ2=9.102, P<0.01). After treatment, the scores of total TCM symptoms, primary symptoms, and secondary symptoms decreased in both groups (P<0.05), and the observation group had lower scores than the control group (P<0.01). The observation group was superior to the control group in alleviating obesity, chest tightness, and low food intake (P<0.05). In terms of safety, the level of aminotransferase was slightly elevated in the control group, and no obvious adverse reaction was observed in the observation group, with no statistical significance in the incidence of adverse reactions. ConclusionZhuyuwan combined with atorvastatin can not only recover blood lipid levels and alleviate TCM symptoms but also reduce the occurrence of adverse reactions.
6.Key technologies and challenges in online adaptive radiotherapy for lung cancer.
Baiqiang DONG ; Shuohan ZHENG ; Kelly CHEN ; Xuan ZHU ; Sijuan HUANG ; Xiaobo JIANG ; Wenchao DIAO ; Hua LI ; Lecheng JIA ; Feng CHI ; Xiaoyan HUANG ; Qiwen LI ; Ming CHEN
Chinese Medical Journal 2025;138(13):1559-1567
Definitive treatment of lung cancer with radiotherapy is challenging, as respiratory motion and anatomical changes can increase the risk of severe off-target effects during radiotherapy. Online adaptive radiotherapy (ART) is an evolving approach that enables timely modification of a treatment plan during the interfraction of radiotherapy, in response to physiologic or anatomic variations, aiming to improve the dose distribution for precise targeting and delivery in lung cancer patients. The effectiveness of online ART depends on the seamless integration of multiple components: sufficient quality of linear accelerator-integrated imaging guidance, deformable image registration, automatic recontouring, and efficient quality assurance and workflow. This review summarizes the present status of online ART for lung cancer, including key technologies, as well as the challenges and areas of active research in this field.
Humans
;
Lung Neoplasms/radiotherapy*
;
Radiotherapy Planning, Computer-Assisted/methods*
7.Diagnosis and treatment of colorectal liver metastases: Chinese expert consensus-based multidisciplinary team (2024 edition).
Wen ZHANG ; Xinyu BI ; Yongkun SUN ; Yuan TANG ; Haizhen LU ; Jun JIANG ; Haitao ZHOU ; Yue HAN ; Min YANG ; Xiao CHEN ; Zhen HUANG ; Weihua LI ; Zhiyu LI ; Yufei LU ; Kun WANG ; Xiaobo YANG ; Jianguo ZHOU ; Wenyu ZHANG ; Muxing LI ; Yefan ZHANG ; Jianjun ZHAO ; Aiping ZHOU ; Jianqiang CAI
Chinese Medical Journal 2025;138(15):1765-1768
8.Improvement effect and mechanism of Shengmai powder on heart failure mice with qi-yin deficiency
Lanfang KANG ; Jian LI ; Yating ZHAO ; Yingchun CHEN ; Guiyin CHEN ; Xiaobo NIE ; Jiao LIU ; Jie CHENG
China Pharmacy 2025;36(17):2127-2133
OBJECTIVE To study the improvement effect and mechanism of Shengmai powder on heart failure (HF) mice with qi-yin deficiency. METHODS The mice were randomly divided into blank group (water), model group (water), Shengmai powder low-, medium-, and high-dose groups [2.61, 5.22 and 10.44 g/kg (based on crude drug dosage)] and positive control group (metoprolol, 30 mg/kg), with 10 mice in each group. Except for the blank group, all other groups were subcutaneously injected with D-galactose, and a qi-yin deficiency HF mice model was established by continuous food restriction and weight-bearing swimming. At the same time of modeling, the corresponding medicine/water was gavaged once a day for five weeks. The general state of mice was recorded and the traditional Chinese medicine (TCM) syndrome score was evaluated. Behavioral experiments were conducted to investigate the total distance of open field action, the percentage of immobility time, and the swimming exhaustion time of mice. The contents of aspartate transaminase (AST), creatine kinase (CK) and lactate dehydrogenase (LDH) in the serum of mice were detected; cardiac function indexes [heart rate, left ventricular ejection fraction (LVEF), left ventricular end systolic diameter (LVESD), left ventricular end diastolic diameter (LVEDD), left ventricular mass index and whole heart mass index] were all detected; the histopathological morphology of mice myocardium was observed; the level of cardiomyocyte apoptosis in mice was detected; mRNA expression levels of B-cell lymphoma 2 (Bcl-2), Bcl-2 associated X protein (Bax), and Cleaved-caspase-3 in myocardial tissue of mice were detected; the phosphorylation levels of sarcoplasmic reticulum calcium regulatory related proteins [ryanodine receptor 2 (RyR2) and phospholamban (PLB)] in myocardial tissue of mice were detected. RESULTS Compared with the blank group, the body weight, total distance of open field action, swimming exhaustion time, LVEF, LVEDD, Bcl-2 mRNA expression level in myocardial tissue and PLB protein phosphorylation level in the model group were significantly reduced/shortened (P<0.05); TCM syndrome score, the percentage of immobility time, heart rate, LVESD, left ventricular mass index, whole heart mass index, cardiomyocyte apoptosis rate, the contents of CK, LDH and AST in serum, mRNA expression levels of Cleaved-caspase-3 and Bax and the phosphorylation level of RyR2 protein in myocardial tissue were significantly increased (P<0.05); there were inflammatory cell infiltration, disordered cell arrangement and obvious myocardial interstitial fibrosis in myocardial tissue. After the intervention of Shengmai powder, most of the above quantitative indexes in mice were significantly reversed (P<0.05), the inflammatory cell infiltration in myocardial tissue was reduced, and the degree of fibrosis was significantly reduced. CONCLUSIONS Shengmai powder can improve cardiac function, reduce the level of cardiomyocyte apoptosis and myocardial fibrosis in HF mice with qi-yin deficiency. Its mechanism may be related to the regulation of the expression of sarcoplasmic reticulum calcium regulation related proteins.
9.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.
10.Monitoring of mutation evolution of 128 genes in acute myeloid leukemia based on high-throughput NGS technology
Jie XIAO ; Xiaobo YAN ; Xiaoxuan WANG ; Yuquan LI ; Xing ZHANG ; Ziyuan LU ; Jixian HUANG
Journal of Leukemia & Lymphoma 2025;34(5):303-310
Objective:To investigate the patterns of mutation evolution in patients with acute myeloid leukemia (AML) during treatment and the possible clinical significances.Methods:A retrospective case series study was conducted. A total of 103 AML patients who were hospitalized at the Affiliated Yuebei People's Hospital of Medical College of Shantou University from November 2019 to August 2021 and underwent high-throughput next-generation sequencing (NGS) technology to detect the mutations of 128 AML-related genes in bone marrow samples were selected. Based on the NGS results, the somatic gene mutations in samples of patients collected at initial diagnosis (73 cases), complete remission (CR) (30 cases), non-remission (NR) (23 cases), and recurrence (12 cases) were analyzed, and the targeted drugs involved in the gene mutations detected in NR and recurrence samples were summarized.Results:The median age [ M ( Q1, Q3)] of onset for 103 patients was 58 (48, 66) years, including 64 males (61%) and 39 females (39%); 86 cases (83%) were primary AML, and 17 cases (17%) were secondary AML; at the initial diagnosis, 51 cases (50%) had normal karyotypes, 34 cases (33%) had abnormalities, and 18 cases (17.5%) were unknown. Compared with the CR samples, the mutation frequencies of FLT3 [29% (21/73) vs. 3% (1/30)], NPM1 [27% (20/73) vs. 3% (1/30)], NRAS [22% (16/73) vs. 3% (1/30)], and IDH2 [14% (10/73) vs. 0 (0/30)] were all higher in the initial diagnosis samples, and the differences were statistically significant (all P < 0.05); compared with the initial diagnosis sample, the median number of gene mutations in each CR sample was lower [4 (2, 5) vs. 7 (5, 9)], and the difference was statistically significant ( P < 0.001). However, there was no statistically significant difference in the median number of gene mutations in each patient between the initial diagnosis samples and the NR samples, the initial diagnosis samples and the recurrence samples, and the NR samples and the recurrence samples (all P > 0.05). Analysis of 14 patients with NGS data at initial diagnosis and CR showed that the same gene mutations could be detected at initial diagnosis and CR, such as DNAH23 (3 cases), USH2A (3 cases), etc; partial gene mutations were detected at initial diagnosis but were not detected at CR, including NRAS (5 cases), FLT3 (3 cases), ANKRD26 (3 cases), NPM1 (3 cases), ETV6 (3 cases), etc; ARID1B (1 case) and DNMT3A (1 case) were negative for mutations at initial diagnosis but positive upon reaching CR. Analysis of 14 patients with NGS data at initial diagnosis and NR showed that most gene mutations persisted at initial diagnosis and NR, such as DNMT3A (5 cases), NRAS (5 cases), KRAS (3 cases), RUNX1 (3 cases), etc; the mutant genes detected at initial diagnosis but not detected at NR included USH2A (2 cases), PCLO (2 cases), ATM (2 cases), FAT1 (2 cases), etc; partial gene mutations were not detected at initial diagnosis but were detected at NR, such as FAT1 (2 cases), TCF3 (2 cases), etc. Analysis of 5 patients with NGS data at CR and recurrence showed that some gene mutations were detected at both CR and recurrence, such as BCORL1 (1 case), ARID2 (1 case), SETD2 (1 case), VEGFC (1 case), etc; FLT1 (1 case) and GNAS (1 case) gene mutations were detected at CR but not detected at recurrence; at recurrence, some gene mutations that were not detected at CR were also detected, such as ANKRD26 (1 case), WT1 (1 case), etc. Among the 23 NR samples and 12 recurrence samples, the targets of drugs approved by US Food and Drug Administration or in clinical trials were detected in 14 (61%) and 5 (42%) samples respectively, including IDH1, IDH2, FLT3, KIT, KRAS, NRAS, SF3B1, U2AF1, and SRSF2. Conclusions:The number of gene mutations in AML patients during CR is significantly less than that at initial diagnosis, some gene mutations disappear when CR is achieved through treatment, but the majority of gene mutations persist during the treatment period, including NR and recurrence, suggesting that monitoring through NGS technology can help understand the evolution of gene mutations during AML treatment and discover the potential therapeutic targets.


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