1.Efficacy of alpha-lipoic acid in patients with ischemic heart failure: a randomized, double-blind, placebo-controlled study
Hanchuan CHEN ; Qin YU ; Yamei XU ; Chen LIU ; Jing SUN ; Jingjing ZHAO ; Wenjia LI ; Kai HU ; Junbo GE ; Aijun SUN
Chinese Journal of Clinical Medicine 2025;32(4):717-719
Objective To explore the safety and effects of alpha-lipoic acid (ALA) in patients with ischemic heart failure (IHF). Methods A randomized, double-blind, placebo-controlled trial was designed (ClinicalTrial.gov registration number NCT03491969). From January 2019 to January 2023, 300 patients with IHF were enrolled in four medical centers in China, and were randomly assigned at a 1∶1 ratio to receive ALA (600 mg daily) or placebo on top of standard care for 24 months. The primary outcome was the composite outcome of hospitalization for heart failure (HF) or all-cause mortality events. The second outcome included non-fatal myocardial infarction (MI), non-fatal stroke, changes of left ventricular ejection fraction (LVEF) and 6-minute walking distance (6MWD) from baseline to 24 months after randomization. Results Finally, 138 patients of the ALA group and 139 patients of the placebo group attained the primary outcome. Hospitalization for HF or all-cause mortality events occurred in 32 patients (23.2%) of the ALA group and in 40 patients (28.8%) of the placebo group (HR=0.753, 95%CI 0.473-1.198, P=0.231; Figure 1A-1C). The absolute risk reduction (ARR) was 5.6%, the relative risk reduction (RRR) associated with ALA therapy was approximately 19.4% compared to placebo, corresponding to a number needed to treat (NNT) of 18 patients to prevent one event. In the secondary outcome analysis, the composite outcome of the major adverse cardiovascular events (MACE) including the hospitalization for HF, all-cause mortality events, non-fatal MI or non-fatal stroke occurred in 35 patients (25.4%) in the ALA group and 47 patients (33.8%) in the placebo group (HR=0.685, 95%CI 0.442-1.062, P=0.091; Figure 1D). Moreover, greater improvement in LVEF (β=3.20, 95%CI 1.14-5.23, P=0.002) and 6MWD (β=31.7, 95%CI 8.3-54.7, P=0.008) from baseline to 24 months after randomization were observed in the ALA group as compared to the placebo group. There were no differences in adverse events between the study groups. Conclusions These results show potential long-term beneficial effects of adding ALA to IHF patients. ALA could significantly improve LVEF and 6MWD compared to the placebo group in IHF patients.
2.Chinese expert consensus on integrated case management by a multidisciplinary team in CAR-T cell therapy for lymphoma.
Sanfang TU ; Ping LI ; Heng MEI ; Yang LIU ; Yongxian HU ; Peng LIU ; Dehui ZOU ; Ting NIU ; Kailin XU ; Li WANG ; Jianmin YANG ; Mingfeng ZHAO ; Xiaojun HUANG ; Jianxiang WANG ; Yu HU ; Weili ZHAO ; Depei WU ; Jun MA ; Wenbin QIAN ; Weidong HAN ; Yuhua LI ; Aibin LIANG
Chinese Medical Journal 2025;138(16):1894-1896
3.Efficacy and safety of upadacitinib through 140 weeks in Chinese adult and adolescent patients with moderate-to-severe atopic dermatitis: Post hoc analysis of the phase 3 Measure Up 1 and AD Up clinical trials.
Li ZHANG ; Jinhua XU ; Chaoying GU ; Min ZHENG ; Meng PAN ; Linfeng LI ; Michael LANE ; Andrew PLATT ; Shereen HAMMAD ; Qichen FAN ; Xinghua GAO
Chinese Medical Journal 2025;138(13):1633-1634
4.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
INTRODUCTION:
Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:
In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:
A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:
Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION
ClinicalTrials.gov , NCT07034222.
Humans
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Alzheimer Disease/drug therapy*
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Male
;
Female
;
Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
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Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People
5.Design and application of a chest belt-type vibration expectorator.
Yan XU ; Chengcheng HE ; Wenzhe LI ; Dechang CHEN ; Siwen PAN
Chinese Critical Care Medicine 2025;37(5):490-493
Disruption of normal secretion or mucociliary clearance can impair airway defense mechanisms and lung function, and increase the risk of infection. Airway clearance techniques are recommended as part of a comprehensive treatment plan for patients. Among these, vibratory expectoration is an important method of airway clearance, which loosens and liquefies mucus and metabolites on the surface of the respiratory tract through chest wall oscillation, promoting ciliary movement to facilitate sputum expulsion. However, commonly used handheld vibrating head devices and vest-type vibration expectorators have several limitations in clinical practice, such as inconvenience of operation, limited treatment time, poor adaptability, and difficulty in disinfection. To address these issues, the research team from the department of critical care medicine at Ruijin Hospital, Shanghai Jiao Tong University, has designed a novel belt-type vibration expectorator, which has been granted a national utility model patent (Patent No.: ZL 2023 2 1610983.1). The device is mainly composed of a chest strap assembly, a sputum clearance component, and a fixed shoulder strap component. Several pockets are placed on the outer surface of the chest strap, with corresponding inner-side openings that allow the percussion head of the percussive expectorator placed inside the pocket to make contact with the patient's chest wall. Each pocket has markings indicating the percussion position, enabling the placement of the percussive expectorator according to the location of infection, thereby achieving multi-point, precise percussive vibration expectoration in different body positions. On the inner side of the chest strap, there are diagrams illustrating postural drainage, providing guidance on the body positions patients should assume based on the location of infection. The hook-and-loop fasteners on both sides of the chest strap can be wrapped around and secured according to the patient's body shape, ensuring that the sputum clearance components adhere tightly to the chest wall, allowing the vibrations generated by percussion to be effectively transmitted to the patient's airways. Additionally, to prevent the chest strap from slipping due to changes in the patient's position, a Y-shaped fixing strap can be selectively attached to the chest strap for further stabilization. This innovation not only simplifies the operation process, improves convenience and flexibility of use, but also supports the principle of "disinfection after each use by one person," which helps to reduce the risk of nosocomial infections and improve the efficiency of patients' respiratory rehabilitation.
Humans
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Vibration
;
Equipment Design
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Chest Wall Oscillation/instrumentation*
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Sputum
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Expectorants
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Mucociliary Clearance
6.A qualitative study on digital-intelligent equipment empowering"generalized"development of traditional Chinese medicine inspection
Chen ZHAO ; Aomeng ZHANG ; Zehui YE ; Jiaying LUO ; Qiang SHI ; Ying YU ; Xiaoyu ZHANG ; Yin JIANG ; Zhicong ZENG ; Fengxia LIN ; Yinghui JIN ; Xue XU ; Xiaowei ZHANG ; Liangzhen YOU ; Yipin FAN ; Dameng YU ; Shaoyang MEN ; Jian DU ; Rui XU ; Ruijin QIU ; Yingjie ZHI ; Zhineng CHEN ; Xuan ZHANG ; Hongcai SHANG
Journal of Beijing University of Traditional Chinese Medicine 2025;48(8):1052-1061
Objective This study investigated feasible cases and their significance in promoting the"generalized"development of inspection through digital-intelligent equipment.Methods A qualitative research approach was used,involving interviews conducted between February 2025 and March 2025 with experts in traditional Chinese medicine diagnostics,clinical research methodology,medical engineering integration,and related disciplines,using both online and offline methods.In accordance with the Consolidated Criteria for Reporting Qualitative Research,feasible cases involving the specific application of digital equipment in various parts of observation were collected through item enrichment.The significance of extending observation capabilities via these cases was analyzed,along with the overall implications of integrating digital technologies with traditional inspection method.Results Interviews were completed with 11 experts from domestic universities and research institutes in the fields of traditional Chinese medicine diagnosis,medical engineering integration,and related disciplines.A total of 78 feasible cases of digital-intelligent inspection were identified,along with 69 insights regarding the significance of enhancing the inspection capabilities.These insights were synthesized into two dimensions and 23 holistic meanings.The first dimension is to expand the scope of inspection,including obtaining internal environmental characteristics,observing external environmental characteristics,expanding thermodynamic characteristic data,and crossing time and space.The second dimension is to improve the quality of observation and diagnosis information collection and analysis,including 19 specific meanings,such as standardized collection environment,objective quantification,and refined observation.Conclusion Digital-intelligent equipment plays a significant role in expanding the scope of inspection content and achieving high-quality acquisition and analysis of extensive inspection information.These advancements extend and enrich the capabilities of traditional inspection method in traditional Chinese medicine.
7.Research progress on the characteristics of magnetoencephalography signals in depression.
Zhiyuan CHEN ; Yongzhi HUANG ; Haiqing YU ; Chunyan CAO ; Minpeng XU ; Dong MING
Journal of Biomedical Engineering 2025;42(1):189-196
Depression, a mental health disorder, has emerged as one of the significant challenges in the global public health domain. Investigating the pathogenesis of depression and accurately assessing the symptomatic changes are fundamental to formulating effective clinical diagnosis and treatment strategies. Utilizing non-invasive brain imaging technologies such as functional magnetic resonance imaging and scalp electroencephalography, existing studies have confirmed that the onset of depression is closely associated with abnormal neural activities and altered functional connectivity in multiple brain regions. Magnetoencephalography, unaffected by tissue conductivity and skull thickness, boasts high spatial resolution and signal-to-noise ratio, offering unique advantages and significant value in revealing the abnormal brain mechanisms and neural characteristics of depression. This review, starting from the rhythmic characteristics, nonlinear dynamic features, and connectivity characteristics of magnetoencephalography in depression patients, revisits the research progress on magnetoencephalography features related to depression, discusses current issues and future development trends, and provides insights for the study of pathophysiological mechanisms, as well as for clinical diagnosis and treatment of depression.
Humans
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Magnetoencephalography/methods*
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Brain/physiopathology*
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Depression/diagnosis*
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Electroencephalography
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Magnetic Resonance Imaging
8.First metatarsophalangeal joint arthrodesis for severe hallux valgus deformity.
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(10):1232-1239
First metatarsophalangeal joint arthrodesis, as a corrective measure for severe hallux valgus deformity, has a long history and remains in use today. Indications for the first metatarsophalangeal joint arthrodesis include severe hallux valgus deformity, recurrent hallux valgus, hallux deformity in rheumatoid arthritis, severe hallux rigidus, joint infection, primary or secondary osteoarthritis, hallux valgus deformity due to neuromuscular disorders, and severe gouty arthritis. Innovative research continues to emerge in biomechanics and materials science related to the first metatarsophalangeal joint arthrodesis. Surgical fixation options are diverse and evolving, encompassing traditional screws and plates alongside novel intramedullary fixation systems and shape-memory alloy implants. Biomechanical studies, gait analysis research, and clinical trials consistently demonstrate minimal postoperative impact on gait and no significant impairment of functional mobility. When performed with proper technique, complications are rare. The first metatarsophalangeal joint arthrodesis is an effective and reliable method for treating severe hallux valgus deformity.
Humans
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Hallux Valgus/surgery*
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Arthrodesis/instrumentation*
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Metatarsophalangeal Joint/surgery*
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Bone Screws
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Treatment Outcome
9.Comparison of effectiveness of multiple metatarsal osteotomy and first metatarsophalangeal arthrodesis for severe metatarsal adductus hallux valgus deformity.
Shengyuan LAN ; Xingchen LI ; Xiangyang XU ; Yuan ZHU
Chinese Journal of Reparative and Reconstructive Surgery 2025;39(10):1246-1250
OBJECTIVE:
To compare effectiveness of multiple metatarsal osteotomy versus first metatarsophalangeal arthrodesis in treating severe metatarsal adductus hallux valgus deformity.
METHODS:
A retrospective analysis was conducted on the clinical data of 25 patients with severe metatarsal adductus hallux valgus deformity admitted between June 2010 and May 2014 who met the selective criteria. Among them, 15 patients underwent multiple metatarsal osteotomy (osteotomy group), while 10 patients underwent first metatarsophalangeal arthrodesis (fusion group). There was no significant difference between groups ( P>0.05) in gender, age, disease duration, affected side, preoperative American Orthopaedic Foot and Ankle Society (AOFAS) score, visual analogue scale (VAS) score for pain, intermetatarsal angle (IMA), hallux valgus angle (HVA), or metatarsal adduction angle (MAA). The osteotomy group underwent fixation with screws and/or staples fixation, while the fusion group utilized anatomic fusion plates and trans-articular compression screws. The study compared the following outcome indicators between groups: operation time, pre- and post-operative differences (change values) in AOFAS scores, VAS scores, and radiographic parameters (HVA, MAA), osteotomy healing outcomes, and recurrence of hallux valgus deformity.
RESULTS:
Both surgical procedures were completed successfully. The operation time was significantly shorter in the fusion group than in the osteotomy group ( P<0.05). All patients were followed up 96-144 months (mean, 116 months). The follow-up time was (129.1±7.2) months in the osteotomy group and (104.4±8.0) months in the fusion group, with no significant difference between groups ( P>0.05). X-ray films revealed the radiographic union in two groups, and the fusion time was significantly shorter in the fusion group than in the osteotomy group ( P<0.05). At last follow-up, both groups demonstrated significant improvements in AOFAS and VAS scores compared to preoperative levels ( P<0.05). However, the differences in the change values of AOFAS and VAS scores between groups were not significant ( P>0.05). During follow-up, 3 cases (20%) of deformity recurrence occurred in the osteotomy group, while no recurrence was observed in the fusion group. There was no significant difference in the incidences of deformity recurrence between groups ( P>0.05).
CONCLUSION
For severe metatarsus adductus hallux valgus deformities, both multiple metatarsal osteotomy and first metatarsophalangeal arthrodesis can correct the deformity. The former preserves metatarsophalangeal joint mobility but demands high technical proficiency from the surgeon, involves relatively longer operation times, extended bone healing periods, and higher complication incidences. The latter procedure is relatively simpler, facilitates faster postoperative recovery, allows early weight-bearing, and yields more reliable outcomes, though it sacrifices first metatarsophalangeal joint mobility.
Humans
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Osteotomy/methods*
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Hallux Valgus/diagnostic imaging*
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Retrospective Studies
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Arthrodesis/instrumentation*
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Treatment Outcome
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Metatarsal Bones/diagnostic imaging*
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Metatarsophalangeal Joint/diagnostic imaging*
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Male
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Female
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Bone Screws
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Adult
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Middle Aged
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Bone Plates
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Pain Measurement
10.The Latest Research Progress of T Cell Exhaustion in Hematological Malignancy --Review.
Xia-Xin LIU ; Zi-Zhen XU ; Jun-Min LI
Journal of Experimental Hematology 2025;33(2):606-611
T cell exhaustion plays an immunosuppressive role in malignant tumors. Continuous tumor antigen stimulation, the presence of suppressive immune cells and cytokines in the tumor microenvironment, the up regulation of inhibitory receptor expression on the surface of T cells, changes in T cell related transcription factors, and metabolites in the tumor microenvironment may lead to T cell exhaustion. Reversing the exhaustion of T cells in tumor patients is a promising strategy for tumor immunotherapy. This article will review the latest research progress on T cell exhaustion status, pathogenesis, reversal methods, and clinical applications in hematological tumors.
Humans
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Hematologic Neoplasms/immunology*
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T-Lymphocytes/immunology*
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Tumor Microenvironment
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Immunotherapy
;
T-Cell Exhaustion

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