1.Meta-analysis of the efficacy and safety of CD19 CAR-T cell therapy versus standard treatment for relapsed/refractory diffuse large B-cell lymphoma
LEI Qi1 ; MA Chendong2 ; XIONG Shufeng1 ; SUN Yu1 ; HAN Linlin1 ; GU Zhenyang3 ; DONG Lili1
Chinese Journal of Cancer Biotherapy 2026;33(5):563-569
[摘 要] 目的:系统评价CD19 CAR-T细胞免疫疗法对比标准治疗在复发/难治性弥漫性大B细胞淋巴瘤(R/R DLBCL)患者中疗效与安全性,通过探索性分析探索不同CAR-T细胞产品对疗效的潜在影响,为临床治疗决策提供循证参考。方法:计算机检索中国知网、万方数据库、维普期刊数据库、中国生物医学文献数据库、PubMed、Embase和Cochrane Library数据库,搜集CD19 CAR-T细胞疗法对比标准治疗用于R/R DLBCL的随机对照试验(RCT),检索时限均为建库至2025年10月25日。由2位研究者独立进行文献筛选、数据提取和质量评价,采用R4.2.2软件进行Meta分析。结果:共纳入2项Ⅲ期RCT研究(ZUMA-7、TRANSFORM),各结局指标均根据异质性检验结果选择固定效应模型合并数据。疗效方面,CD19 CAR-T细胞疗法可显著改善患者无事件生存期(HR=0.455,95%CI:0.363~0.570,P < 0.001)和降低死亡风险(HR = 0.738,95%CI:0.575~0.947,P = 0.017);同时可显著提高完全缓解率(RR = 1.879,95%CI:1.574~2.242,P < 0.001)。按产品类型的探索性分析显示,liso-cel和axi-cel均优于标准治疗(liso-cel:HR = 0.380,95%CI:0.260~0.540,P < 0.001;axi-cel:HR = 0.510,95%CI:0.380~0.680,P < 0.001),但该分析为不同试验间的对比,证据等级有限。安全性结局显示:CAR-T细胞疗法的免疫效应细胞相关神经毒性综合征(ICANS)发生率显著升高(RR = 22.387,95%CI:4.353~115.132,P < 0.001);≥3级细胞因子释放综合征(CRS)发生率数值升高(RR = 8.181,95%CI:0.935~71.574,P = 0.058),差异无统计学意义。纳入研究的偏倚风险整体为低;敏感性分析证实结果稳健。结论:基于2项RCT的Meta分析结果,CD19 CAR-T细胞(liso-cel/axi-cel)可作为R/R DLBCL二线治疗的选择之一,其疗效优于标准治疗,且特征性不良反应(CRS/ICANS)经规范管理后可控,可根据患者基线状态个体化选择CAR-T细胞产品。本研究证据基础薄弱,上述结论尚需更多高质量、大样本RCT验证。
2.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
3.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
4.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
5.β-glucan attenuates intestinal ischemia-reperfusion injury in mice by promoting glucagon-like peptide-1 secretion
Wei WANG ; Ben HAN ; Lihua SUN ; Huichao XIE ; Xiong ZENG ; Weidong XIAO ; Jian WANG
Journal of Army Medical University 2025;47(2):112-121
Objective To investigate the protective effect of β-glucan(BG)against intestinal ischemia reperfusion(II/R)injury by regulating the secretion of glucagon-like peptide-1(GLP-1).Methods Male C57BL/6 mice(6~8 weeks old)were subjected,and finally,the experiments had sham group,II/R group,II/R+BG group(0.1 mg/mL BG in drinking water for 2 weeks before modeling),II/R+liraglutide(LLT,GLP-1 analogue)group(0.2 μg/g LLT injected every 12 hours for 3 consecutive days before modeling),and II/R+BG+Ex9-39(GLP-1 R antagonist)group(intraperitoneal injection of 2 μg/g Ex9-39 1 h before modeling).After modeling,HE staining was used to observe intestinal morphological changes,and RT-qPCR and Western blotting were employed to evaluate the molecules(Occludin,ZO-1 and Claudin-1)related to intestinal barrier damage.The effect of 0.1 mg/mL BG treatment on the GLP-1 level in the serum and intestinal tissues of normal mice was determined with ELISA and immunofluorescence assay,respectively,and RT-PCR for the molecules related to GLP-1 expression(Gcg,Pcsk1/2,GIP and Foxa2).The effects of LLT and Ex9-39 pretreatment on intestinal morphology and intestinal barrier damage were also determined by morphological observation and expression levels of related molecules.Results II/R induced significant decreases in the mRNA levels of Occludin,ZO-1 and Claudin-1 and increase in Chiu's score when compared with sham control mice(P<0.05).While,the mRNA levels of the 3 molecules were obviously higher and the Chiu's score was lower in the II/R+BG group than the II/R group(P<0.05).BG pretreatment induced notably enhanced secretion of GLP-1 in the serum and intestinal tract of normal mice,and improved the mRNA expression of GLP-1-related molecules(P<0.05).The intervention of GLP-1 analogue LLT could attenuate the II/R damage and decreased Chiu's score,with statistical difference in comparison with the II/R group(P<0.05).GLP-1 receptor antagonist Ex9-39 reversed the protective effects of BG pretreatment against II/R damage,with notably differences in the expression of Occludin,ZO-1 and Claudin-1 and Chiu's score(P<0.05).Conclusion BG can attenuate intestinal mucosal and functional injury after II/R by promoting intestinal GLP-1 secretion.
6.Platelet membrane-modified catalase/silica nanoparticles inhibit radiation infection
Tainong XIONG ; Chenwenya LI ; Yin CHEN ; Songling HAN ; Cheng WANG ; Junping WANG
Journal of Army Medical University 2025;47(6):602-612
Objective To provide an effective strategy for the prevention and treatment of radiation-induced infections by preparing platelet membrane-modified catalase/silica nanoparticles(PCNP)capable of targeting leukocytes.Methods PCNP and catalase/silica nanoparticles(CNP)were prepared by using platelet membrane,catalase(CAT)and silica,and its biological safety was preliminarily evaluated with cell survival test,hemolysis test and acute toxicity test in mice after tail vein administration;The culture medium,FITC labeled(FITC+)PCNP and FITC labeled(FITC+)CNP were co-incubated with human peripheral blood B lymphocytes(AHH-1)and mouse monocyte macrophages(RAW264.7),respectively.Thus,there were control group,FITC+PCNP group and FITC+CNP group of AHH-1 and RAW264.7 cells.Laser confocal microscopy was used to observe the intracellular fluorescence intensity of PCNP to evaluate the leukocytes targeting function.AHH-1 cells were divided into control,irradiation,platelet membrane,CNP(100 μg/mL)and PCNP(100 μg/mL)groups.After corresponding co-incubation,the cell media were exposed to6 Gy Co60 γ irradiation.The generation of reactive oxygen species(ROS)and cell apoptosis were measured to determine the effect of nanoparticles on reducing radiation injury of leukocytes.Twenty C57BL/6 male mice(weighing 18~20 g)were randomly divided into irradiation group(n=10)and 10 mg/kg PCNP group(n=10).In 2 h after corresponding agents were injected into the mice through tail vein,the mice received whole-body irradiation of 5 Gy Co60 γ ray,and then in 2 h later,they were given intraperitoneal injection of multidrug resistant Acinetobacter baumannii(MDR-AB).The infection inhibitory effect of PCNP after irradiation was evaluated by detecting the bacterial load in main organs.Results The hydration particle of PCNP is 91.3 nm in size,and does not exhibit significant cytotoxicity or hemolytic toxicity at concentrations<400 μg/mL.Intravenous injection of 20 mg/kg PCNP resulted in normal increase in the body weight but no obvious pathological changes in the major organs such as the heart,liver,spleen,lungs,and kidneys.In AHH-1 and RAW264.7 cells,PCNP showed significant advantages in targeting compared to the FITC+CNP group[(15.45±3.48)%vs(9.33±2.03)%,P<0.01;(11.25±2.08)%vs(7.06±0.71)%,P<0.001].PCNP also effectively reduced the generation of ROS[(22.73±3.71)%vs(60.90±9.08)%,P<0.001]and apoptotic rate[(9.84±0.92)%vs(38.96±3.62)%,P<0.001]in AHH-1 cells.In in vitro study,bacterial colonization after irradiation showed that there was significantly less MDR-AB colonies in the spleen of mice intervened with PCNP than those of the irradiation group[(17.50±1.38)×104 vs(13.20±2.29)×106 CFU/g,P<0.001].Conclusion PCNP can effectively inhibit the complications of radiation infection in mice,which is due to its direct protective effect on leukocytes.
7.Analysis of cerebral amyloid angiopathy samples from Human Brain Bank of Hebei Medical University
Zu-Qi CUI ; Meng-Yao YE ; Yi ZHOU ; Shi-Xiong MI ; Qian YANG ; Min MA ; Ming WANG ; Shi-Yi WANG ; Qi-Han YU ; Hui-Xian CUI ; Juan DU
Acta Anatomica Sinica 2025;56(6):704-712
Objective To analyze the basic conditions and pathological characteristics of the samples in the Human Brain Bank of Hebei Medical University,which were pathologically diagnosed as cerebral amyloid angiopathy,and to provide reference for the research of related diseases.Methods The basic data of gender,age,apolipoprotein E genotype,pathological classification of cerebral amyloid angiopathy,Alzheimer's disease-related pathological change score,comorbidities and other pathological information were analyzed.Results Up to October 2024,twenty samples were confirmed by pathological diagnosis,with a male to female ratio of 3:1 and an average age of(80.90±8.08)years.Involve three kinds of apolipoprotein E subtype,5 kinds of genotypes(ε2/ε3 xε2/ε4、ε3/ε3 xε3/ε4、ε4/ε4);There were 2 pathologic types,including 6 cases of type 1 and 14 cases of type 2.The pathological grade included 3 grades.The severity grade and subtype classification of cerebral amyloid vascular disease were correlated with the degree of pathological changes of Alzheimer's disease.Cerebral amyloid angiopathy samples could coexist with other degenerative diseases with high comorbidity.Conclusion The incidence of cerebral amyloid angiopathy is higher in the aged samples collected based on Brain Bank,which coexists with conditions such as Alzheimer's disease and microbleeds,etc.It provides more detailed pathological diagnosis basis for further scientific research sharing of samples.
8.Intelligent handheld ultrasound improving the ability of non-expert general practitioners in carotid examinations for community populations: a prospective and parallel controlled trial
Pei SUN ; Hong HAN ; Yi-Kang SUN ; Xi WANG ; Xiao-Chuan LIU ; Bo-Yang ZHOU ; Li-Fan WANG ; Ya-Qin ZHANG ; Zhi-Gang PAN ; Bei-Jian HUANG ; Hui-Xiong XU ; Chong-Ke ZHAO
Ultrasonography 2025;44(2):112-123
Purpose:
The aim of this study was to investigate the feasibility of an intelligent handheld ultrasound (US) device for assisting non-expert general practitioners (GPs) in detecting carotid plaques (CPs) in community populations.
Methods:
This prospective parallel controlled trial recruited 111 consecutive community residents. All of them underwent examinations by non-expert GPs and specialist doctors using handheld US devices (setting A, setting B, and setting C). The results of setting C with specialist doctors were considered the gold standard. Carotid intima-media thickness (CIMT) and the features of CPs were measured and recorded. The diagnostic performance of GPs in distinguishing CPs was evaluated using a receiver operating characteristic curve. Inter-observer agreement was compared using the intragroup correlation coefficient (ICC). Questionnaires were completed to evaluate clinical benefits.
Results:
Among the 111 community residents, 80, 96, and 112 CPs were detected in settings A, B, and C, respectively. Setting B exhibited better diagnostic performance than setting A for detecting CPs (area under the curve, 0.856 vs. 0.749; P<0.01). Setting B had better consistency with setting C than setting A in CIMT measurement and the assessment of CPs (ICC, 0.731 to 0.923). Moreover, measurements in setting B required less time than the other two settings (44.59 seconds vs. 108.87 seconds vs. 126.13 seconds, both P<0.01).
Conclusion
Using an intelligent handheld US device, GPs can perform CP screening and achieve a diagnostic capability comparable to that of specialist doctors.
9.Application analysis of laparoscope in operating room
Ming-yin JIANG ; Ya-fen GU ; Ya-bing HU ; Dun-hui LIU ; Dao-xiong WANG ; Bao-jiang HAN
Chinese Medical Equipment Journal 2025;46(2):87-91
Objective To analyze the application of in-use laparoscopes in clincal departments to enhance the laparoscope's effectiveness.Methods The effective utilization data of 29 laparoscopes from January 2024 to June 2024 were acquired with an hospital intelligent medical device management platform.Comparisons were carried out in terms of average daily workload,average daily hours of use and average daily efficiency between the laparoscopes from different departments and brands with non-parametric Kruskal-Wallis test and between the conventional and 3D laparoscopes with non-parametric Mann-Whitney U test.Pearson's correlation coefficient was used to analyze the correlation between the number of years of laparoscope use and the average daily workload,the average daily hours of use,and the average daily efficiency and the chi-square test was applied to investigating the relationship between the surgery grade and the type of equipment selected.Results Thoracic sugery department had the highest average daily workload(3.82 person-time),while the general medical department had the highest average daily hours of use(443.76 min)and the highest daily efficiency(92.45%).There were significant differences between the laparoscopes from different departments in average daily workload,average daily hours of use and average daily efficiency(P<0.05).Brand D laparoscope behaved the best among brands of laparoscopes with the highest average daily workload(3.72 person-time),average daily hours of use(394.41 min)and average daily efficiency(82.17%).There were sig-nificant differences between the brands of laparoscopesin average daily workload,average daily hours of use and average daily efficiency(P<0.05).3D laparoscopes obviously gained advantages over the conventional ones in average daily workload,average daily hours of use and average daily efficiency(P<0.05).The number of years of use correlated negatively with average daily workload,average daily hours of use and average daily efficiency,with Pearson correlation coefficients being-0.095,-0.039 and-0.039 respectively.Grade Three and Four surgeries had significant differences in types of selected equipment(P<0.001),and 3D laparoscopes were preferred for Grade Four surgery.Conclusion Utilization analysis of laparoscopes provides data support for optimized application and setup of laparoscopes.[Chinese Medical Equipment Journal,2025,46(2):87-91]
10.Comparative analysis of the value of immunotherapy in bladder preservation with chemoradiotherapy for bladder cancer
Ping TANG ; Yuchen HAN ; Mengqi ZHANG ; Junjun GAO ; Yueping LIU ; Hui FANG ; Wenwen ZHANG ; Linjun HU ; Xingang BI ; Jianzhong SHOU ; Ye-xiong LI
Chinese Journal of Radiation Oncology 2025;34(9):921-928
Objective:To compare the preliminary efficacy and adverse events of chemoradiotherapy (CRT) with or without immunotherapy in bladder preservation therapy for localized muscle-invasive bladder cancer (MIBC) confined to the pelvis.Methods:Clinical data of 60 patients with MIBC who received CRT with or without immunotherapy for bladder preservation at the Cancer Hospital, Chinese Academy of Medical Sciences from January 2016 to June 2024 were retrospectively analyzed. Patients were divided into CRT plus immunotherapy group and CRT-alone group. Survival outcomes, bladder function preservation, recurrence and metastasis, as well as early and late radiation toxicities were evaluated. The Mann-Whitney U test was used for between-group comparisons. Overall survival (OS), progression-free survival (PFS), local recurrence-free survival (LRFS), and distant metastasis-free survival (DMFS) were estimated by the Kaplan-Meier method, and survival rates were compared by the log-rank test. Results:In the CRT plus immunotherapy group ( n=23), the median follow-up was 20 months. The median OS and median PFS were not reached. The 2-year OS, PFS, LRFS, and DMFS rates were 95.7%, 70.7%, 70.7%, and 92.9%, respectively, and 22 patients (96%) preserved normal bladder function. Patients with programmed death-ligand 1 (PD-L1) combined positive score (CPS) ≥1 had significantly higher 1-year PFS rate than those with CPS <1 (100% vs. 66.7%, P=0.004). In the CRT-alone group ( n=37), the median follow-up was 37 months, with median OS and PFS of 68 and 19 months, respectively. The 2-year OS, PFS, LRFS, and DMFS rates were 92.0%, 41.1%, 60.9% and 81.5%, respectively, and 33 patients (89%) preserved normal bladder function. Compared with the CRT-alone group, the CRT plus immunotherapy group showed a significant improvement in PFS ( χ2=4.38, P=0.036), while no significant differences were observed in OS, LRFS, or DMFS (all P>0.05). The incidence of acute hematologic toxicity in the CRT plus immunotherapy group and CRT-alone group were 52% (12/23), 27% (10/37) respectively, and late genitourinary toxicity was 22% (5/23), 8% (3/37), respectively, with no significant differences in overall acute or late toxicities (all P>0.05). Conclusions:For localized MIBC, bladder preservation with CRT combined with immunotherapy significantly improves PFS compared with CRT alone, while maintaining comparable safety. The PD-L1 status may serve as a favorable predictor for immunotherapy efficacy.

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