1.Novel CD19 Fast-CAR-T cells vs. CD19 conventional CAR-T cells for the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia.
Xu TAN ; Jishi WANG ; Shangjun CHEN ; Li LIU ; Yuhua LI ; Sanfang TU ; Hai YI ; Jian ZHOU ; Sanbin WANG ; Ligen LIU ; Jian GE ; Yongxian HU ; Xiaoqi WANG ; Lu WANG ; Guo CHEN ; Han YAO ; Cheng ZHANG ; Xi ZHANG
Chinese Medical Journal 2025;138(19):2491-2497
BACKGROUND:
Treatment with chimeric antigen receptor-T (CAR-T) cells has shown promising effectiveness in patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL), although the process of preparing for this therapy usually takes a long time. We have recently created CD19 Fast-CAR-T (F-CAR-T) cells, which can be produced within a single day. The objective of this study was to evaluate and contrast the effectiveness and safety of CD19 F-CAR-T cells with those of CD19 conventional CAR-T cells in the management of R/R B-ALL.
METHODS:
A multicenter, retrospective analysis of the clinical data of 44 patients with R/R B-ALL was conducted. Overall, 23 patients were administered with innovative CD19 F-CAR-T cells (F-CAR-T group), whereas 21 patients were given CD19 conventional CAR-T cells (C-CAR-T group). We compared the rates of complete remission (CR), minimal residual disease (MRD)-negative CR, leukemia-free survival (LFS), overall survival (OS), and the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) between the two groups.
RESULTS:
Compared with the C-CAR-T group, the F-CAR-T group had significantly higher CR and MRD-negative rates (95.7% and 91.3%, respectively; 71.4% and 66.7%, respectively; P = 0.036 and P = 0.044). No significant differences were observed in the 1-year or 2-year LFS or OS rates between the two groups: the 1-year and 2-year LFS for the F-CAR-T group vs.C-CAR-T group were 47.8% and 43.5% vs. 38.1% and 23.8% (P = 0.384 and P = 0.216), while the 1-year and 2-year OS rates were 65.2% and 56.5% vs. 52.4% and 47.6% (P = 0.395 and P = 0.540). Additionally, among CR patients who underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT) following CAR-T-cell therapy, there were no significant differences in the 1-year or 2-year LFS or OS rates: 57.1% and 50.0% vs. 47.8% and 34.8% (P = 0.506 and P = 0.356), 64.3% and 57.1% vs. 65.2% and 56.5% (P = 0.985 and P = 0.883), respectively. The incidence of CRS was greater in the F-CAR-T group (91.3%) than in the C-CAR-T group (66.7%) (P = 0.044). The incidence of ICANS was also greater in the F-CAR-T group (30.4%) than in the C-CAR-T group (9.5%) (P = 0.085), but no treatment-related deaths occurred in the two groups.
CONCLUSION
Compared with C-CAR-T-cell therapy, F-CAR-T-cell therapy has a superior remission rate but also leads to a tolerably increased incidence of CRS/ICANS. Further research is needed to explore the function of allo-HSCT as an intermediary therapy after CAR-T-cell therapy.
2.Single-center experience in the treatment of severe aortic stenosis with XcorTM transcatheter aortic valve replacement system: 1-year follow-up results.
Shengwen WANG ; Haozhong LIU ; Haijiang GUO ; Tong TAN ; Hanxiang XIE ; Xiang LIU ; Hailong QIU ; Jimei CHEN ; Huiming GUO ; Jian LIU
Journal of Zhejiang University. Medical sciences 2025;54(2):141-148
OBJECTIVES:
To analyze the early clinical outcomes of the XcorTM transcatheter aortic valve replacement (TAVR) system in treating severe aortic stenosis. This study has been registered at Chinese Clinical Trial Registry (ChiCTR2200065593).
METHODS:
This single-arm, prospective clinical trial enrolled patients with severe aortic stenosis treated with the XcorTM TAVR system at the Section of Heart Valve & Coronary Artery Surgery, Guangdong Provincial People's Hospital. Perioperative and follow-up parameters were compared to evaluate differences in hemodynamic outcomes. All-cause mortality, aortic regurgitation, paravalvular leakage, cerebrovascular events, and reoperation were analyzed.
RESULTS:
Thirty-two patients with severe aortic stenosis were included (20 males, 12 females), with (70.9±4.3) years old and a Society of Thoracic Surgeons (STS) score of 6.45% (6.07%, 7.28%). Notably, 87.5% of patients had New York Heart Association (NYHA) class≥Ⅲ. All patients underwent successful XcorTM bioprosthesis implantation, achieving an immediate technical success rate of 100.0% and device success rate of 96.9%. Mean aortic valve gradient decreased from (55.21±23.17) mmHg (1 mmHg=0.133 kPa) to (8.45±5.30) mmHg, peak aortic jet velocity decreased from (4.66±0.85) m/s to (1.99±0.48) m/s, aortic valve area increased from (0.66±0.21) cm² to (2.09±0.67) cm² (all P<0.01). Intraoperative ventricular fibrillation occurred in one patient, while one case exhibited moderate prosthetic valve regurgitation and paravalvular leakage post-procedure. At 12-month follow-up, sustained improvements were observed in cardiac function, left ventricular ejection fraction, hemodynamic parameters, and SF-12 quality-of-life scores (all P<0.01). All-cause mortality was 12.5% (4/32), with 13.8% (4/29) developing moderate paravalvular leakage.
CONCLUSIONS
The XcorTM TAVR system demonstrated favorable early outcomes in severe aortic stenosis patients, significantly improving symptoms and hemodynamics while exhibiting excellent performance in preventing malignant arrhythmias and coronary obstruction.
Humans
;
Male
;
Female
;
Aortic Valve Stenosis/surgery*
;
Transcatheter Aortic Valve Replacement/methods*
;
Aged
;
Follow-Up Studies
;
Prospective Studies
;
Treatment Outcome
;
Aged, 80 and over
;
Heart Valve Prosthesis
;
Middle Aged
3.Effectiveness of Lianhua Qingwen Granule and Jingyin Gubiao Prescription in Omicron BA.2 Infection and Hospitalization: A Real-World Study of 56,244 Cases in Shanghai, China.
Yu-Jie ZHANG ; Guo-Jian LIU ; Han ZHANG ; Chen LIU ; Zhi-Qiang CHEN ; Ji-Shu XIAN ; Da-Li SONG ; Zhi LIU ; Xue YANG ; Ju WANG ; Zhe ZHANG ; Lu-Ying ZHANG ; Hua FENG ; Yan-Qi ZHANG ; Liang TAN
Chinese journal of integrative medicine 2025;31(1):11-18
OBJECTIVE:
To examine the effectiveness of Chinese medicine (CM) Lianhua Qingwen Granule (LHQW) and Jingyin Gubiao Prescription (JYGB) in asymptomatic or mild patients with Omicron infection in the shelter hospital.
METHODS:
This single-center retrospective cohort study was conducted in the largest shelter hospital in Shanghai, China, from April 10, 2022 to May 30, 2022. A total of 56,244 asymptomatic and mild Omicron cases were included and divided into 4 groups, i.e., non-administration group (23,702 cases), LHQW group (11,576 cases), JYGB group (12,112 cases), and dual combination of LHQW and JYGB group (8,854 cases). The length of stay (LOS) in the hospital was used to assess the effectiveness of LHQW and JYGB treatment on Omicron infection.
RESULTS:
Patients aged 41-60 years, with nadir threshold cycle (CT) value of N gene <25, or those fully vaccinated preferred to receive CM therapy. Before or after propensity score matching (PSM), the multiple linear regression showed that LHQW and JYGB treatment were independent influence factors of LOS (both P<0.001). After PSM, there were significant differences in LOS between the LHQW/JYGB combination and the other groups (P<0.01). The results of factorial design ANOVA proved that the LHQW/JYGB combination therapy synergistically shortened LOS (P=0.032).
CONCLUSIONS
Patients with a nadir CT value <25 were more likely to accept CM. The LHQW/JYGB combination therapy could shorten the LOS of Omicron-infected individuals in an isolated environment.
Humans
;
Drugs, Chinese Herbal/therapeutic use*
;
Male
;
Female
;
Middle Aged
;
Adult
;
China/epidemiology*
;
Hospitalization
;
COVID-19 Drug Treatment
;
COVID-19/epidemiology*
;
SARS-CoV-2
;
Retrospective Studies
;
Treatment Outcome
;
Length of Stay
;
Young Adult
;
Aged
4.Re-Exploration for Dietary Iodine Intake in Chinese Adults using the Obligatory Iodine Loss Hypothesis.
Xiao Bing LIU ; Jun WANG ; Ya Jie LI ; Hong Xing TAN ; De Qian MAO ; Yan Yan LIU ; Wei Dong LI ; Wei YU ; Jun An YAN ; Jian Hua PIAO ; Chong Zheng GUO ; Xiao Li LIU ; Xiao Guang YANG
Biomedical and Environmental Sciences 2025;38(8):952-960
OBJECTIVE:
This study aimed to reexplore minimum iodine excretion and to build a dietary iodine recommendation for Chinese adults using the obligatory iodine loss hypothesis.
METHODS:
Data from 171 Chinese adults (19-21 years old) were collected and analyzed based on three balance studies in Shenzhen, Yinchuan, and Changzhi. The single exponential equation was accordingly used to simulate the trajectory of 24 h urinary iodine excretion as the low iodine experimental diets offered (iodine intake: 11-26 μg/day) and to further deduce the dietary reference intakes (DRIs) for iodine, including estimated average requirement (EAR) and recommended nutrient intake (RNI).
RESULTS:
The minimum iodine excretion was estimated as 57, 58, and 51 μg/day in three balance studies, respectively. Moreover, it was further suggested as 57, 58, and 51 μg/day for iodine EAR, and 80, 81, and 71 μg/day for iodine RNI or expressed as 1.42, 1.41, and 1.20 μg/(day·kg) of body weight.
CONCLUSION
The iodine DRIs for Chinese adults were established based on the obligatory iodine loss hypothesis, which provides scientific support for the amendment of nutrient requirements.
Humans
;
Iodine/administration & dosage*
;
Male
;
Female
;
China
;
Young Adult
;
Diet
;
Adult
;
Nutritional Requirements
;
East Asian People
5.Expert consensus on the rational application of the biological clock in stomatology research
Kai YANG ; Moyi SUN ; Longjiang LI ; Zhangui TANG ; Guoxin REN ; Wei GUO ; Songsong ZHU ; Jia-Wei ZHENG ; Jie ZHANG ; Zhijun SUN ; Jie REN ; Jiawen ZHENG ; Xiaoqiang LV ; Hong TANG ; Dan CHEN ; Qing XI ; Xin HUANG ; Heming WU ; Hong MA ; Wei SHANG ; Jian MENG ; Jichen LI ; Chunjie LI ; Yi LI ; Ningbo ZHAO ; Xuemei TAN ; Yixin YANG ; Yadong WU ; Shilin YIN ; Zhiwei ZHANG
Journal of Practical Stomatology 2024;40(4):455-460
The biological clock(also known as the circadian rhythm)is the fundamental reliance for all organisms on Earth to adapt and survive in the Earth's rotation environment.Circadian rhythm is the most basic regulatory mechanism of life activities,and plays a key role in maintaining normal physiological and biochemical homeostasis,disease occurrence and treatment.Recent studies have shown that the biologi-cal clock plays an important role in the development of oral tissues and in the occurrence and treatment of oral diseases.Since there is cur-rently no guiding literature on the research methods of biological clock in stomatology,researchers mainly conduct research based on pub-lished references,which has led to controversy about the research methods of biological clock in stomatology,and there are many confusions about how to rationally apply the research methods of circadia rhythms.In view of this,this expert consensus summarizes the characteristics of the biological clock and analyzes the shortcomings of the current biological clock research in stomatology,and organizes relevant experts to summarize and recommend 10 principles as a reference for the rational implementation of the biological clock in stomatology research.
6.Research on the Application of Scenario Simulation Teaching Method in Clinical Basic Skills Training
Jian CHEN ; Hongtao TAN ; Jingzhu DONG ; Naiyu SUN ; Chenxi ZHAO ; Huinan CHEN ; Qingfeng GUO
Chinese Hospital Management 2024;44(8):77-79
Objective Based on the PDCA cycle theory,it explores the application mode of scenario simulation teaching method in clinical basic skills training.Methods The 96 students majoring in clinical medicine from the First Af-filiated Hospital of Harbin Medical University in 2019 were selected as the research objects,and the experimental group and the control group were set up respectively,with 48 students in each group,and skills training was car-ried out from March to December 2022.The control group was trained in the traditional way,and the experimental group was trained in the scenario simulation teaching method based on the PDCA cycle.The training effect and training satisfaction of the control group and the experimental group were compared and analyzed.Results In the sur-vey of the training effect of the students in the experimental group,the evaluation results of the basic clinical skills operation were higher than those in the control group,and the difference between the two groups was statistically significant(P<0.01).In terms of the appropriate and safe operation mode,There was no significant difference be-tween the two groups(P>0.05).In the training satisfaction survey,students in the experimental group were signifi-cantly more satisfied with the training than those students who are in the control group.The difference was statistical-ly significant(P<0.01).Conclusion The application of scenario simulation teaching method based on PDCA cycle in clinical basic skills training helps to improve the quality of clinical basic skills training and student satisfaction.
7.Chemical constituents from the leaves of Cyclocarya paliurus and their α-glucosidase inhibitory activities
Yong YANG ; Ting-Si GUO ; Min XIE ; Li-Hong TAN ; Wen-Chu LI ; Hao ZHENG ; Fei-Bing HUANG ; Yu-Pei YANG ; Wei WANG ; Yu-Qing JIAN
Chinese Traditional Patent Medicine 2024;46(3):834-842
AIM To study the chemical constituents from the leaves of Cyanocarya paliurus(Batalin)Iljinskaja and their α-glucosidase inhibitory activities.METHODS The 95%ethanol extract from the leaves of C.paliurus was isolated and purified by macroporous resin,silica gel,Sephadex LH-20,polyamide,C18 reversed-phase silica gel and semi-preparative HPLC,then the structures of obtained compounds were identified by physicochemical properties and spectral data.Their α-glucosidase inhibitory activities were evaluated by PNPG.RESULTS Fifteen compounds were isolated and identified as cyclopaloside C(1),cyclopaloside A(2),juglanosides E(3),vaccinin A(4),ent-murin A(5),kaempferol 3-O-α-L-rhamnopyranoside(6),kaempferol-3-O-β-D-glucopyranoside(7),kaempferol-3-O-β-D-glucuronide methyl ester(8),kaempferol-3-O-β-D-glucuronide ethyl ester(9),kaempferol-3-O-β-D-glucuronide butyl ester(10),quercetin-3-O-α-L-rhamnopyranoside(11)quercetin-3-O-β-D-glucopyranoside(12),quercetin-3-O-β-D-galactopyranoside(13),quercetin-3-O-β-D-glucuronide butyl ester(14),dihydrokaempferol(15).The IC50 value of total extracts ihibited α-glucosidase was(1.83±0.04)μg/mL,and the IC50 values of compounds 1,4-5 were(29.48±1.86),(0.50±0.07),(0.71±0.07)μmol/L,respectively.CONCLUSION Compound 1 is a new tetrahydronaphthalene glycoside.Compounds 4-5,8-10 and 14 are isolated from the leaves of C.paliurus for the first time.Compounds 4-5 are relatively rare flavonoid lignans with potential inhibitory activities against α-glucosidase.
8.Early clinical outcomes of the domestic KokaclipTM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation: A single-arm, prospective, single-group target value clinical trial
Tong TAN ; Bingqi FU ; Peijian WEI ; Nianjin XIE ; Haozhong LIU ; Xiaoyi LI ; Shengwen WANG ; Haijiang GUO ; Jian LIU ; Jimei CHEN ; Jian ZHUANG ; Huiming GUO
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2024;31(02):269-275
Objective To summarize and analyze the preliminary clinical outcomes of the KokaclipTM transcatheter edge-to-edge mitral valve repair system for severe degenerative mitral regurgitation (DMR). Methods This study was a single-arm, prospective, single-group target value clinical trial that enrolled patients who underwent the KokaclipTM transcatheter edge-to-edge repair (TEER) system for DMR in the Department of Heart Surgery of Guangdong Provincial People's Hospital, Guangdong Cardiovascular Institute from June 2022 to January 2023. Differences in the grade of mitral regurgitation (MR) during the perioperative and follow-up periods were compared, and the incidences of adverse events such as all-cause death, thoracotomy conversion, reoperation, and severe recurrence of MR during the study period were investigated. Results The enrolled patient population consisted of 14 (50.0%) females with a mean age of 70.9±5.4 years. Twenty-eight (100.0%) patients were preoperatively diagnosed with typeⅡ DMR, with a prolapse width of 12.5 (11.0, 16.1) mm, a degree of regurgitation 4+ leading to pulmonary venous reflux, and a New York Heart Association cardiac function class≥Ⅲ. All patients completed the TEER procedure successfully, with immediate postoperative improvement of MR to 0, 1+, and 2+ grade in 2 (7.1%), 21 (75.0%), and 5 (17.9%) patients, respectively. Mitral valve gradient was 2.5 (2.0, 3.0) mm Hg. Deaths, thoracotomy conversion, or device complications such as unileaflet clamping, clip dislodgement, or leaflet injury were negative. Twenty-eight (100.0%) patients completed at least 3-month postoperative follow-up with a median follow-up time of 5.9 (3.6, 6.8) months, during which patients had a mean MR grade of 1.0+ (1.0+, 2.0+) grade and a significant improvement from preoperative values (P<0.001). There was no recurrence of ≥3+ regurgitation, pulmonary venous reflux, reoperation, new-onset mitral stenosis, or major adverse cardiovascular events. Twenty-two (78.6%) patients’ cardiac function improved to classⅠorⅡ. Conclusion The domestic KokaclipTM TEER system has shown excellent preliminary clinical results in selected DMR patients with a high safety profile and significant improvement in MR. Additional large sample volume, prospective, multicenter studies, and long-term follow-up are expected to validate the effectiveness of this system in the future.
9.Research on the Application of Scenario Simulation Teaching Method in Clinical Basic Skills Training
Jian CHEN ; Hongtao TAN ; Jingzhu DONG ; Naiyu SUN ; Chenxi ZHAO ; Huinan CHEN ; Qingfeng GUO
Chinese Hospital Management 2024;44(8):77-79
Objective Based on the PDCA cycle theory,it explores the application mode of scenario simulation teaching method in clinical basic skills training.Methods The 96 students majoring in clinical medicine from the First Af-filiated Hospital of Harbin Medical University in 2019 were selected as the research objects,and the experimental group and the control group were set up respectively,with 48 students in each group,and skills training was car-ried out from March to December 2022.The control group was trained in the traditional way,and the experimental group was trained in the scenario simulation teaching method based on the PDCA cycle.The training effect and training satisfaction of the control group and the experimental group were compared and analyzed.Results In the sur-vey of the training effect of the students in the experimental group,the evaluation results of the basic clinical skills operation were higher than those in the control group,and the difference between the two groups was statistically significant(P<0.01).In terms of the appropriate and safe operation mode,There was no significant difference be-tween the two groups(P>0.05).In the training satisfaction survey,students in the experimental group were signifi-cantly more satisfied with the training than those students who are in the control group.The difference was statistical-ly significant(P<0.01).Conclusion The application of scenario simulation teaching method based on PDCA cycle in clinical basic skills training helps to improve the quality of clinical basic skills training and student satisfaction.
10.Research on the Application of Scenario Simulation Teaching Method in Clinical Basic Skills Training
Jian CHEN ; Hongtao TAN ; Jingzhu DONG ; Naiyu SUN ; Chenxi ZHAO ; Huinan CHEN ; Qingfeng GUO
Chinese Hospital Management 2024;44(8):77-79
Objective Based on the PDCA cycle theory,it explores the application mode of scenario simulation teaching method in clinical basic skills training.Methods The 96 students majoring in clinical medicine from the First Af-filiated Hospital of Harbin Medical University in 2019 were selected as the research objects,and the experimental group and the control group were set up respectively,with 48 students in each group,and skills training was car-ried out from March to December 2022.The control group was trained in the traditional way,and the experimental group was trained in the scenario simulation teaching method based on the PDCA cycle.The training effect and training satisfaction of the control group and the experimental group were compared and analyzed.Results In the sur-vey of the training effect of the students in the experimental group,the evaluation results of the basic clinical skills operation were higher than those in the control group,and the difference between the two groups was statistically significant(P<0.01).In terms of the appropriate and safe operation mode,There was no significant difference be-tween the two groups(P>0.05).In the training satisfaction survey,students in the experimental group were signifi-cantly more satisfied with the training than those students who are in the control group.The difference was statistical-ly significant(P<0.01).Conclusion The application of scenario simulation teaching method based on PDCA cycle in clinical basic skills training helps to improve the quality of clinical basic skills training and student satisfaction.

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