1.STAR Guideline Terminology(Ⅱ): Clinical Question Formulation, Evidence Retrieval and Appraisal, and Recommendation Development
Di ZHU ; Haodong LI ; Zijun WANG ; Qianling SHI ; Hui LIU ; Yishan QIN ; Yuanyuan YAO ; Zhewei LI ; Hongfeng HE ; Jinhui TIAN ; Long GE ; Yaolong CHEN ;
Medical Journal of Peking Union Medical College Hospital 2025;16(3):756-764
To introduce and analyze guideline terminology related to clinical question formulation, evidence retrieval and appraisal, and recommendation development. A systematic search was conducted in guideline development manuals and relevant methodological literature, covering publications up to October 25, 2024. Terminology related to the three aforementioned stages of related to guideline development was extracted from the included literature, standardized, and refined through consensus meetings to finalize a comprehensive terminology list and definitions. A total of 30 guideline development manuals and 15 methodological articles were included, and 23 core terms were identified. It is recommended to develop a standardized and scientifically sound guideline terminology system with unified naming, clear definitions, and alignment with the linguistic environment and usage habits in China. At the same time, it is essential to strengthen terminology training for both guideline developers and users based on this system, in order to deepen their correct understanding and proper application of guideline terminology.
2.Clinical value of peripheral immune function status in the assessment of ‘Deficiency of Vital Qi’ in lung cancer metastasis
XU Fan1,2 ; TIAN Jianhui1,2 ; LIU Youjun1,2 ; CHENG Zhenyang1,2 ; QUE Zujun2 ; LUO Bin1 ; YANG Yun1 ; YAO Jialiang1 ; YAO Wang1 ; LU Xinyi1,2 ; LIU Yao1,2 ; ZHOU Yiyang1 ; WU Jianchun1 ; LUO Yingbin1 ; LI Minghua1 ; SHI Wenfei1 ; CUI Yajing1 ; SHANGGUAN Wenji3 ; LI Yan1
Chinese Journal of Cancer Biotherapy 2025;32(10):1065-1070
[摘 要] 目的:探索外周免疫功能状态与肺癌转移的关联,筛选可用于肺癌转移“正虚”评估的外周血免疫标志物。方法:回顾性分析2023年3月至2025年4月期间上海中医药大学附属市中医医院收治的肺癌患者治疗前的外周血免疫标志物,根据是否存在远处转移,将患者分为无转移组与转移组,比较两组间免疫细胞和细胞因子的表达差异。将单因素分析P < 0.05的外周血免疫指标纳入多因素二元Logistic回归模型,以识别肺癌转移的独立预测因素。结果:共纳入193例肺癌患者(无转移组101例,转移组92例),两组在性别、年龄、吸烟史、饮酒史、病理类型间的差异均无统计学意义(均P > 0.05)。单因素分析显示,无转移组与转移组间有多项免疫指标存在显著差异(均P < 0.05),包括:淋巴细胞计数,CD3+、CD4+、CD8+ T、CD19+ B细胞及CD3-CD16+56+ NK细胞绝对计数,Treg细胞、CD8+CD28+ Treg细胞、G-MDSC和CD3-CD16+CD56+dim NK细胞百分率,以及细胞因子IL-1β、IL-6和IL-10水平。将差异性指标行二元Logistic回归分析,提示外周血中Treg细胞和CD8+CD28+ Treg细胞百分率是肺癌发生远处转移的独立预测因素[OR = 1.193, 95% CI(1.047, 1.36), P < 0.01; OR = 0.978, 95% CI(0.957, 0.999), P < 0.05]。结论:外周血免疫功能紊乱是肺癌转移“正虚”的生物学基础,本研究以量化指标证实外周免疫功能状态与肺癌转移的相关性,为“正虚伏毒”和“肿瘤转移态”理论提供了实证。
3.Evaluation and Regulation of Medical Artificial Intelligence Applications in China.
Mao YOU ; Yue XIAO ; Han YAO ; Xue-Qing TIAN ; Li-Wei SHI ; Ying-Peng QIU
Chinese Medical Sciences Journal 2025;40(1):3-8
Amid the global wave of digital economy, China's medical artificial intelligence applications are rapidly advancing through technological innovation and policy support, while facing multifaceted evaluation and regulatory challenges. The dynamic algorithm evolution undermines the consistency of assessment criteria, multimodal systems lack unified evaluation metrics, and conflicts persist between data sharing and privacy protection. To address these issues, the China National Health Development Research Center has established a value assessment framework for artificial intelligence medical technologies, formulated the country's first technical guideline for clinical evaluation, and validated their practicality through scenario-based pilot studies. Furthermore, this paper proposes introducing a "regulatory sandbox" model to test technical compliance in controlled environments, thereby balancing innovation incentives with risk governance.
Artificial Intelligence/legislation & jurisprudence*
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China
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Humans
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Algorithms
4.High-efficient discovering the potent anti-Notum agents from herbal medicines for combating glucocorticoid-induced osteoporosis.
Yuqing SONG ; Feng ZHANG ; Jia GUO ; Yufan FAN ; Hairong ZENG ; Mengru SUN ; Jun QIAN ; Shenglan QI ; Zihan CHEN ; Xudong JIN ; Yunqing SONG ; Tian TIAN ; Zhi QIAN ; Yao SUN ; Zhenhao TIAN ; Baoqing YU ; Guangbo GE
Acta Pharmaceutica Sinica B 2025;15(8):4174-4192
Notum, a negative feedback regulator of the Wnt signaling, has emerged as a promising target for treating glucocorticoid-induced osteoporosis (GIOP). This study showcases an efficient strategy for discovering the anti-Notum constituents from herbal medicines (HMs) as novel anti-GIOP agents. Firstly, a rapid-responding near-infrared fluorogenic substrate for Notum was rationally engineered for high-throughput identifying the anti-Notum HMs. The results showed that Bu-Gu-Zhi (BGZ), a known anti-osteoporosis herb, potently inhibited Notum in a competitive-inhibition manner. To uncover the key anti-Notum constituents in BGZ, an efficient strategy was adapted via integrating biochemical, phytochemical, computational, and pharmacological assays. Among all identified BGZ constituents, three furanocoumarins were validated as strong Notum inhibitors, while 5-methoxypsoralen (5-MP) showed the most potent anti-Notum activity and favorable safety profiles. Mechanistically, 5-MP acted as a competitive inhibitor of Notum via creating strong hydrophobic interactions with Trp128 and Phe268 in the catalytic cavity of Notum. Cellular assays showed that 5-MP remarkably promoted osteoblast differentiation and activated Wnt signaling in dexamethasone (DXMS)-challenged MC3T3-E1 osteoblasts. In dexamethasone-induced osteoporotic mice, 5-MP strongly elevated bone mineral density (BMD) and improved cancellous and cortical bone thickness. Collectively, this study constructs a high-efficient platform for discovering key anti-Notum constituents from HMs, while 5-MP emerges as a promising anti-GIOP agent.
5.Research and application of thermosensitive Pickering emulsion with X-ray and ultrasound dual-modal imaging functions for intra-arterial embolization treatment.
Ling LI ; Anran GUO ; Haixia SUN ; Yanbing ZHAO ; Qing YAO ; Ling ZHANG ; Peng SHI ; Hongan TIAN ; Min ZHENG
Journal of Pharmaceutical Analysis 2025;15(4):101133-101133
Transcatheter arterial embolization (TAE) is the mainstay for treating advanced hepatocellular carcinoma (HCC), and the performance of the embolization material is crucial in TAE. With the development of medical imaging and the birth of "X-ray-free" technologies, we designed a new dual-mode imaging material of dimethoxy tetraphenyl ethylene (DMTPE) via emulsification by mixing poly(N-isopropylacrylamide-co-acrylic acid) (PNA) with lipiodol and fluorocarbons, which was evaluated for temperature sensitivity, stability, and dual-mode visualization in vitro. Additionally, blood vessel casting embolization and renal artery imaging were assessed in healthy rabbits. In a rabbit model with a VX2 tumor, the effectiveness of TAE for treating HCC was examined, with an emphasis on evaluating long-term outcomes of embolization and its effects on tumor growth, necrosis, and proliferation through imaging techniques. In vitro experiments confirmed that the temperature-sensitive dual-oil-phase Pickering emulsion had good flow, stable contrast, and embolism when the oil-to-oil ratio and water-to-oil ratio were both 7:3 ( v/v) and stabilized with 8% PNA. Similarly, in vivo, arterial embolization confirmed the excellent properties of DMTPE prepared at the abovementioned ratios. It was observed that DMTPE not only has an antitumor effect but can also achieve dual imaging using X-rays and ultrasound, making it a promising excellent vascular embolization material for TAE in tumor treatment.
7.Effectiveness and safety of sequential therapy with parathyroid hormone analogues and bisphosphonates for osteoporosis:a meta-analysis
Juanjuan YAO ; Chunxia SHI ; Leyuan ZHANG ; Jun MA ; Mingrui QI ; Limin TIAN
China Pharmacy 2024;35(24):3059-3064
OBJECTIVE To evaluate the effectiveness and safety of sequential therapy with parathyroid hormone analogues and bisphosphonates for osteoporosis. METHODS PubMed, Embase, the Cochrane Library, Web of Science, China National Knowledge Infrastructure, VIP, Wanfang data, and SinoMed were searched in both English and Chinese databases from their inception to March 25, 2024. Two researchers independently conducted literature searches, screening, and data extraction. Review Manager 5.4 software was used for the meta-analysis. Subgroup analyses and sensitivity analyses were performed based on different medication sequences in the treatment group to account for potential sources of heterogeneity. RESULTS A total of 7 randomized controlled trials involving 2 461 participants were included, with 1 215 in the treatment group and 1 246 in the control group. The meta-analysis results showed that the treatment group using sequential therapy with parathyroid hormone analogues and bisphosphonates had superior effects on improving bone mineral density at the lumbar spine [SMD=0.90, 95%CI (0.44, 1.35), P<0.001], total hip [SMD=0.68, 95%CI (0.14, 1.21), P=0.01], and femoral neck [SMD=0.45, 95%CI (0.04, 0.86), P=0.03] compared to the control group. It also significantly outperformed the control group in reducing the incidence of fractures post- treatment [OR=0.72, 95%CI (0.54, 0.97), P=0.03].significant difference was noted in the incidence of adverse reactions between the two groups [OR=1.21, 95%CI (0.99, 1.46), P=0.06]. Subgroup analysis based on intervention measures in the treatment group showed that switching from bisphosphonates to parathyroid hormone analogues [SMD=0.56, 95%CI (0.09, 1.03), P=0.02] or switching from parathyroid hormone analogues to bisphosphonates [SMD=0.97, 95%CI (0.49, 1.46), P<0.001] both significantly potentiated lumbar spine bone mineral density compared to the control group. Switching from bisphosphonates to parathyroid hormone analogues also significantly promoted total hip bone mineral density compared to the control group [SMD=0.66, 95%CI (0.18, 1.13), P=0.007]. Sensitivity analysis indicated that the results of this study were robust. CONCLUSIONS Sequential therapy with parathyroid hormone analogues and bisphosphonates can be recommended as an effective treatment for patients with osteoporosis, with good safety profiles. The medication sequences should be individually adjusted based on the patient’s particular situation and the different responses of various skeletal sites.
8.Chinesization of the HEMO-FISS-QoL questionnaire and its reliability and validity
Songpeng SUN ; Shan JIA ; Fangfang XU ; Tianyu LI ; Zhiyun ZHANG ; Qiaorong CAO ; Xinjian LI ; Yao WU ; Weiping WAN ; Bin SHI ; Jianguo WANG ; Hong NI ; Longyu LIANG ; Xingxiao HUO ; Tianqing YANG ; Lei TIAN ; Ying TIAN ; Mei LIN ; Zhanjun WANG ; Yangyang ZHOU ; Hongchuan CHU ; Riyu LIAO ; Kuerban XIEYIDA ; Junhong LONG ; Shuxin ZHANG
Chinese Journal of Behavioral Medicine and Brain Science 2024;33(1):75-82
Objective:To evaluate the reliability and validity of the Chinese version of HEMO-FISS-QoL(HF-QoL) questionnaire (HF-QoL-C) in the Chinese population with hemorrhoids.Methods:From November 2021 to November 2022, a self-constructed general information questionnaire, HF-QoL-C, and the 36-item short form health survey (SF-36), Goligher classification, and Giordano severity of hemorrhoid symptom questionnaire (GSQ) were used to conduct a questionnaire survey on 760 hemorrhoid patients in the anorectal department of six hospitals. The data was analyzed for reliability and validity using SPSS 21.0 and AMOS 26.0 software.Results:The Cronbach's α coefficient of HF-QoL-C and its dimension ranged from 0.831 to 0.960, and the split coefficient was 0.832-0.915. Four common factors were extracted through principal component exploratory factor analysis. Confirmatory factor analysis indicated acceptable structural validity( χ2/ df=8.152, RSMEA=0.097, CFI=0.881, IFI=0.881, NFI=0.867). HF-QoL-C was correlated with SF36 and GSQ( r=-0.694, 0.501, both P<0.01). There were differences in the total score and dimensional scores of HF-QoL-C between surgical and drug treated patients, different grades of Goligher classification for hemorrhoidal disease, and different ranges of hemorrhoid prolapse (all P<0.001). No ceiling effect was found in the total score and the scores of each dimension(0.3%-2.0%). There was a floor effect in both psychological function and sexual activity dimensions (16.7%, 35.1%). Conclusion:HF-QoL-C has good reliability and validity, which can be used to measure the quality of life of Chinese hemorrhoid patients.
9.Effect of dynamic lung compliance-guided individual positive end-expiratory pressure titration on pulmonary function in elderly patients undergoing laparoscopic colorectal cancer surgery
Jin-Tao SHI ; Juan ZHU ; Jian DENG ; Hui JI ; Qiang YAO ; Weiqian TIAN
The Journal of Clinical Anesthesiology 2024;40(1):36-41
Objective To investigate the effects of dynamic lung compliance(Cdyn)-guided indi-vidual positive end-expiratory pressure(PEEP)titration on pulmonary function in elderly patients undergoing laparoscopic colorectal cancer surgery.Methods Sixty-eight elderly patients were selected for laparoscopic radical resection of colorectal cancer,37 males and 31 females,aged 65-79 years,BMI<30 kg/m2,ASA physical status Ⅱ or Ⅲ.The patients were divided into two groups using the random number table method:individualized PEEP group(group P)and control group(group C),34 patients in each group.In group P,the patients received recruitment maneuvers and PEEP titration test at immediately after intubation,immediately after establishing pneumoperitoneum-Trendelenburg position and immediately after pneumoperitoneum.The patients in group C received PEEP 5 cmH2 O during procedure.The three best titra-tion PEEP and the actual tidal volume(VT)in group P were also recorded.PaO2,PaCO2,PETCO2 10 mi-nutes after the tracheal intubation(T1),10 minutes(T2)and 1 hour(T3)after establishing pneumoperito-neum-Trendelenburg position,at the end of the surgery but before extubation(T4)were recorded,and the oxygenation index(OI),physiological dead space to tidal volume(Vd/VT),alveolar arterial oxygen differ-ence(A-aDO2),driving pressure,and Cdyn were calculated.Concentrations of interleukin-8(IL-8),tumor necrosis factor-α(TNF-α),Clara cell secretoyr protein(CC16)and lung alveolar surface active sub-stances-D(SP-D)in the serum samples were determined by ELISA before anesthesia induction(T0)and 10 minutes after extubation(T5).Postoperative pulmonary complications(PPCs)were also recordrd.Results The individualized PEEP of Cdyn?guided PEEP titration was 4 cmH2O. Compared with group C, the PaO2 and OI in group C were significantly increased at T4, the Cdyn was significantly increased at T1,T3, and T4, the driving pressure was significantly decreased at T1 -T4, the serum concentration of CC16 was significantly decreased at T5 ( P < 0. 05). There were no significant differences in PaCO2, PET CO2,A?aDO2, and Vd/ VT between the two groups. There was no severe PPCs in the two groups. Conclusion Pressure?controlled ventilation modes combined with Cdyn?guide PEEP titration can increase the Cdyn, reduce thedriving pressure, and improve OI at the end of the operation, reduce the concentrations of CC16 at postop?eration, improve pulmonary function in elderly patients undergoing laparoscopic colorectal cancer surgery.
10.Inhibitory effects of infigratinib and its pharmacologically active metabolites on CYPs and UGTs in rat liver microsomes
Shi-Yu ZHAO ; Shuai-Bing LIU ; Xia YAO ; Xin TIAN
The Chinese Journal of Clinical Pharmacology 2024;40(16):2368-2372
Objective To evaluate the inhibitory effects of infigratinib and its pharmacologically active metabolites,BHS697 and CQM157,on cytochrome P450(CYPs)and UDP-glucuronosyltransferases(UGTs)in rat liver microsomes.Methods By adopting in vitro incubation method,the tested compounds(infigratinib,BHS697 or CQM157)and rat liver microsomes were incubated with the specific probe substrates of CYP2B6,CYP2C8,CYP2C9,CYP2C19,CYP2D6,CYP3 A4,respectively,or the specific probe substrates of UGT1A1,UGT1A3,UGT1A6,UGT1A9,UGT2B7,respectively.The production of characteristic metabolites was detected by high performance liquid chromatography-tandem mass spectrometry.The half maximal inhibitory concentration(IC50)and inhibition constant(Ki)were calculated by GraphPad Prism 8.0.Results Infigratinib,BHS697 and CQM157 weakly inhibited CYP2B6,CYP2C8,CYP2C9,CYP2C19,CYP2D6,CYP3 A4 and UGT1A6,UGT2B7 in rat liver microsomes,with IC50 values all more than 10 μmol·L-1,and moderately inhibited UGT1Al with IC50 values of 2.70,3.17,7.43 μmol·L-,respectively.Infigratinib had a moderate inhibitory effect on UGT1A9 and CQM157 had a moderate inhibitory effect on UGTIA3,with IC50 values of 5.61 and 9.57 μmol·L-1,respectively.The reversible inhibition analysis showed that infigratinib,BHS697 and CQM157 all non-competitively inhibited UGTIA1,with Ki values of 1.83,2.51 and 5.84 μmol·L-1,respectively.Conclusion Infigratinib had moderate inhibitory effects on UGT1A1 and UGT1A9 in rat liver microsomes and its pharmacologically active metabolites,BHS697 and CQM157,also had moderate inhibitory effects on UGT1A1.

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