1.Recommendations for the clinical use of anti-amyloid-β monoclonal antibody for Alzheimer's disease(2025)
Nan ZHI ; Jinwen XIAO ; Rujing REN ; Binyin LI ; Jintao WANG ; Jieli GENG ; Wenwei CAO ; Yaying SONG ; Hualong WANG ; Shuguang CHU ; Guoping PENG ; Jun LIU ; Xiaoyun LIU ; Fang YUAN ; Wen WANG ; Ronghua DOU ; Xia LI ; Ling YUE ; Wenshi WEI ; Xiaoling PAN ; Xiangyang ZHU ; Dian HE ; Weinü FAN ; Jingping SHI ; Nan ZHANG ; Hui ZHAO ; Qin CHEN ; Cuibai WEI ; Xiaochun CHEN ; Gang WANG
Journal of Chongqing Medical University 2025;50(9):1133-1140
In recent years,significant breakthroughs have been achieved in the immunotherapy for Alzheimer's disease.In line with global advancements,two anti-amyloid-β monoclonal antibodies have been approved and successfully launched in China for clinical use.Lecanemab and Donanemab were officially used in June 2024 and April 2025 in China,respectively.In order to standardize the rational and safe application of anti-amyloid-β monoclonal antibodies for Alzheimer's disease in China,this article integrates recom-mendations from the clinical trials and real-world experience from the author's team and domestic peers to further update the recom-mendations for the clinical use of anti-amyloid-β monoclonal antibody based on the 2024 version.It includes indications for therapy,pre-treatment evaluation and preparation,administration protocols and safety measures during treatment,and post-treatment monitor-ing strategies.
2.Expression of CD19/CD73 in Chronic Lymphocytic Leukemia and Its Correlation with Clinical Features.
Yan-Yu WANG ; Lan LIU ; Yu-Jie ZHAO ; Geng-Hui SHI ; Xun MIN
Journal of Experimental Hematology 2025;33(5):1274-1278
OBJECTIVE:
To investigate the expression of CD19/CD73 in chronic lymphocytic leukemia (CLL) and its correlation with clinical features.
METHODS:
The clinical data of 60 CLL patients and 40 healthy volunteers (control group) from January 2022 to November 2023 were retrospectively analyzed. The levels of CD19 and CD73 in peripheral blood of CLL patients were measured by flow cytometry. Kaplan-Meier method was used for survival analysis.
RESULTS:
The hemoglobin (Hb) and CD19/CD73 levels in CLL group were significantly lower than those in control group, while CD19, CD73 and β2-MG were significantly higher (all P <0.001). According to ROC curve analysis, the AUC value of CD19/CD73 for CLL diagnosis was 0.980 (95%CI : 0.949-1.000, P <0.05), the specificity was 92.50%, and the sensitivity was 98.30%. The CD19/CD73 level of CLL patients with splenomegaly was significantly lower than those without splenomegaly (P <0.01). There was no significant correlation between CD19/CD73 and Hb in CLL patients ( r =0.056, P >0.05). CD19/CD73 was positively correlated with β2-MG ( r =0.837, 95%CI : 0.740 2-0.899 6, P <0.01). According to the median value (12.84) of CD19/CD73, the patients were divided into high and low expression groups. Kaplan-Meier survival analysis showed that the overall survival rate and progression-free survival rate at 18th month in the low expression group were 87.08% and 93.25%, while those in the high expression group were 96.41% and 99.90%, respectively (both P <0.05).
CONCLUSION
The level of CD19/CD73 is low in CLL patients, which can be used as an auxiliary index for clinical diagnosis of CLL. CD19/CD73 is closely related to splenomegaly in CLL patients. Low expression of CD19/CD73 predicts poor prognosis.
Humans
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Leukemia, Lymphocytic, Chronic, B-Cell/metabolism*
;
5'-Nucleotidase/metabolism*
;
Antigens, CD19/metabolism*
;
Retrospective Studies
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Male
;
Female
;
Prognosis
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Middle Aged
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Aged
;
Adult
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GPI-Linked Proteins
3.Expert consensus on evaluation index system construction for new traditional Chinese medicine(TCM) from TCM clinical practice in medical institutions.
Li LIU ; Lei ZHANG ; Wei-An YUAN ; Zhong-Qi YANG ; Jun-Hua ZHANG ; Bao-He WANG ; Si-Yuan HU ; Zu-Guang YE ; Ling HAN ; Yue-Hua ZHOU ; Zi-Feng YANG ; Rui GAO ; Ming YANG ; Ting WANG ; Jie-Lai XIA ; Shi-Shan YU ; Xiao-Hui FAN ; Hua HUA ; Jia HE ; Yin LU ; Zhong WANG ; Jin-Hui DOU ; Geng LI ; Yu DONG ; Hao YU ; Li-Ping QU ; Jian-Yuan TANG
China Journal of Chinese Materia Medica 2025;50(12):3474-3482
Medical institutions, with their clinical practice foundation and abundant human use experience data, have become important carriers for the inheritance and innovation of traditional Chinese medicine(TCM) and the "cradles" of the preparation of new TCM. To effectively promote the transformation of new TCM originating from the TCM clinical practice in medical institutions and establish an effective evaluation index system for the transformation of new TCM conforming to the characteristics of TCM, consensus experts adopted the literature research, questionnaire survey, Delphi method, etc. By focusing on the policy and technical evaluation of new TCM originating from the TCM clinical practice in medical institutions, a comprehensive evaluation from the dimensions of drug safety, efficacy, feasibility, and characteristic advantages was conducted, thus forming a comprehensive evaluation system with four primary indicators and 37 secondary indicators. The expert consensus reached aims to encourage medical institutions at all levels to continuously improve the high-quality research and development and transformation of new TCM originating from the TCM clinical practice in medical institutions and targeted at clinical needs, so as to provide a decision-making basis for the preparation, selection, cultivation, and transformation of new TCM for medical institutions, improve the development efficiency of new TCM, and precisely respond to the public medication needs.
Medicine, Chinese Traditional/standards*
;
Humans
;
Consensus
;
Drugs, Chinese Herbal/therapeutic use*
;
Surveys and Questionnaires
4.Research Progress on Chinese Herbal Medicine-derived Extracellular Vesicles in Wound Healing
Meng GENG ; Yu-Ting LU ; Hui SHI
Chinese Journal of Biochemistry and Molecular Biology 2025;41(10):1489-1498
Wound healing is a dynamic physiological process involving haemostasis,inflammation,pro-liferation and tissue remodeling.Skin injuries,such as diabetic foot ulcers,venous ulcers,and pressure ulcers,are difficult to heal and impose a serious physical and psychological burden on patients,and tra-ditional treatments are difficult to address such problems.In recent years,Chinese herbal medicine-de-rived extracellular vesicles(CHMEVs)have shown promising potential in the field of wound repair and drug delivery due to their excellent biocompatibility,low immunogenicity and high safety.CHMEVs are nano-like particles enriched with herbal small molecule compounds,proteins and metabolites,and are a-ble to cross biological barriers and effectively regulate intercellular communication to promote tissue re-pair.In this review,the isolation and extraction methods of CHMEVs and their roles in wound repair are reviewed,and the prospects and challenges of their clinical applications are discussed.The combination of engineered modification and biomaterials of CHMEVs further expands their potential for application in precision medicine and provides a new idea for the treatment of hard-to-heal wounds in the future.
5.Research Progress on Chinese Herbal Medicine-derived Extracellular Vesicles in Wound Healing
Meng GENG ; Yu-Ting LU ; Hui SHI
Chinese Journal of Biochemistry and Molecular Biology 2025;41(10):1489-1498
Wound healing is a dynamic physiological process involving haemostasis,inflammation,pro-liferation and tissue remodeling.Skin injuries,such as diabetic foot ulcers,venous ulcers,and pressure ulcers,are difficult to heal and impose a serious physical and psychological burden on patients,and tra-ditional treatments are difficult to address such problems.In recent years,Chinese herbal medicine-de-rived extracellular vesicles(CHMEVs)have shown promising potential in the field of wound repair and drug delivery due to their excellent biocompatibility,low immunogenicity and high safety.CHMEVs are nano-like particles enriched with herbal small molecule compounds,proteins and metabolites,and are a-ble to cross biological barriers and effectively regulate intercellular communication to promote tissue re-pair.In this review,the isolation and extraction methods of CHMEVs and their roles in wound repair are reviewed,and the prospects and challenges of their clinical applications are discussed.The combination of engineered modification and biomaterials of CHMEVs further expands their potential for application in precision medicine and provides a new idea for the treatment of hard-to-heal wounds in the future.
6.Practice of PIVAS operation cost-benefit management in a hospital based on lean Six Sigma management
Lei HUANG ; Hui ZHANG ; Zhou GENG ; Aiming SHI ; Jie PAN
China Pharmacy 2025;36(1):13-18
OBJECTIVE To explore the practice and application effect of lean Six Sigma (LSS) management in the cost-benefit management of PIVAS operation in a tertiary comprehensive hospital (hereinafter referred to as "S Hospital"),providing reference for the operation and management of PIVAS in hospitals.METHODS The five steps (define,measure,analyze,improve and control,i.e.DMAIC) of LSS management were implemented for PIVAS operation cost-benefit of S Hospital,and lean management was implemented for its cost-benefit management elements (human resource cost,medical and health material cost,and all-in-one parenteral nutrition preparation income).Several intervention measures including personnel training and performance assessment,refined management system of consumables,and doctor's advice package of full parenteral nutrition were developed.Finally,the overall improvement effect was evaluated by the total benefit,total cost and net benefit of PIVAS.The effects of human resource allocation optimization and improvement were evaluated by the work efficiency,work quality,job satisfaction,turnover rate and accumulated rest days.The effects of consumables cost management were evaluated by the amount of medical and health materials cost.The improvement effects of all-in-one parenteral nutrition preparation income were evaluated by the profit amount,quantity and the proportion of single bottle of parenteral nutrition.RESULTS After implementing DMAIC in S Hospital,the total benefit of PIVAS was increased from (471366.50±9201.5) yuan/month to (479679.50±14320.14) yuan/month (P>0.05),the total cost was decreased from (305878.88±3201.75) yuan/month to (294610.59±5007.33) yuan/month (P<0.05),and the net benefit of PIVAS was increased by 11.83% compared with that before the improvement.The work efficiency,work quality and job satisfaction of employees were significantly improved,the accumulated rest days were significantly reduced,and the turnover rate of third-party employees was reduced from 15.0% before the improvement to 7.5% after the improvement.The cost of medical and health materials significantly decreased from (67826.42±2812.76) yuan/month before improvement to (56384.33±4607.67) yuan/month after improvement (P<0.05).The quantity of all-in-one parenteral nutrition was significantly increased from (1263.75±135.83)group/month before improvement to (2061.25±89.04) group/month after improvement (P<0.05),and the proportion of users of single bottle of parenteral nutrition in total users decreased from 93.25% before improvement to 58.75% after improvement.The profit of all-in-one parenteral nutrition was 63.18% higher than that before implementing DMAIC.CONCLUSIONS The implementation of PIVAS operation cost-benefit management based on DMAIC is conducive to strengthening the cost control of PIVAS and promoting the healthy development of PIVAS.
7.Expert consensus on the construction, evaluation and application of bone organoids (version 2024)
Jian WANG ; Long BAI ; Xiao CHEN ; Yuanyuan LIU ; Guohui LIU ; Zhongmin SHI ; Kaili LIN ; Chuanglong HE ; Jing WANG ; Zhen GENG ; Weiyang SHI ; Wencai ZHANG ; Fengjin ZHOU ; Qiang YANG ; Lili YANG ; Zhiwei WANG ; Haodong LIN ; Yunfei ZHANG ; Fuxin WEI ; Wei CHEN ; Wenguo CUI ; Fei LUO ; Jun FEI ; Hui XIE ; Jian LUO ; Chengtie WU ; Xuanyong LIU ; Yufeng ZHENG ; Changsheng LIU ; Jiacan SU
Chinese Journal of Trauma 2024;40(11):974-986
Bone organoids can simulate the complex structure and function of the bone tissues, which makes them a frontier technology in organoid researches. Bone organoids show a tremendous potential of applications in bone disease modeling, bone injury repair, and medicine screening. Although advancements have been made so far in constructing bone organoids with functional structures like mineralization, bone marrow, trabecular bone, callus, woven bone, etc, the researches in this field are confronted with numerous challenges such as lack of standardized construction strategies and unified evaluation criteria, which limits their further promotion and application. To standardize researches in bone organoids, the Orthopedic Expert Committee of Geriatric Branch of Chinese Association of Gerontology and Geriatrics, the Youth Osteoporosis Group of Orthopedic Branch of Chinese Medical Association, the Osteoporosis Group of Orthopedic Surgeon Branch of Chinese Medical Doctor Association, and the Osteoporosis Committee of Shanghai Association of Integrated Traditional Chinese and Western Medicine organized related experts to formulate Expert consensus on the construction, evaluation, and application of bone organoids ( version 2024) based on an evidence-based approach. A total of 17 recommendations were put forth, aiming to standardize researches and clinical applications of bone organoids and enhance their value in scientific research and clinical practice.
8.Intravenous Tenecteplase for Acute Ischemic Stroke Within 4.5–24 Hours of Onset (ROSE-TNK): A Phase 2, Randomized, Multicenter Study
Lu WANG ; Ying-Jie DAI ; Yu CUI ; Hong ZHANG ; Chang-Hao JIANG ; Ying-Jie DUAN ; Yong ZHAO ; Ye-Fang FENG ; Shi-Mei GENG ; Zai-Hui ZHANG ; Jiang LU ; Ping ZHANG ; Li-Wei ZHAO ; Hang ZHAO ; Yu-Tong MA ; Cheng-Guang SONG ; Yi ZHANG ; Hui-Sheng CHEN
Journal of Stroke 2023;25(3):371-377
Background:
and Purpose Intravenous tenecteplase (TNK) efficacy has not been well demonstrated in acute ischemic stroke (AIS) beyond 4.5 hours after onset. This study aimed to determine the effect of intravenous TNK for AIS within 4.5 to 24 hours of onset.
Methods:
In this pilot trial, eligible AIS patients with diffusion-weighted imaging (DWI)-fluid attenuated inversion recovery (FLAIR) mismatch were randomly allocated to intravenous TNK (0.25 mg/kg) or standard care within 4.5–24 hours of onset. The primary endpoint was excellent functional outcome at 90 days (modified Rankin Scale [mRS] score of 0–1). The primary safety endpoint was symptomatic intracranial hemorrhage (sICH).
Results:
Of the randomly assigned 80 patients, the primary endpoint occurred in 52.5% (21/40) of TNK group and 50.0% (20/40) of control group, with no significant difference (unadjusted odds ratio, 1.11; 95% confidence interval 0.46–2.66; P=0.82). More early neurological improvement occurred in TNK group than in control group (11 vs. 3, P=0.03), but no significant differences were found in other secondary endpoints, such as mRS 0–2 at 90 days, shift analysis of mRS at 90 days, and change in National Institutes of Health Stroke Scale score at 24 hours and 7 days. There were no cases of sICH in this trial; however, asymptomatic intracranial hemorrhage occurred in 3 of the 40 patients (7.5%) in the TNK group.
Conclusion
This phase 2, randomized, multicenter study suggests that intravenous TNK within 4.5–24 hours of onset may be safe and feasible in AIS patients with a DWI-FLAIR mismatch.
9.Technical status and development trends of electronic tongue
Shu-ye QI ; Yue-zhong MAO ; Li-hua GENG ; Dao-xuan YANG ; Hui-dan TU ; Shang-chen YAO ; Shi-yi TIAN ; Bao-ming NING
Acta Pharmaceutica Sinica 2023;58(11):3165-3172
Electronic tongue is one kind of bionic detection technologies, which can objectively reflect the taste of drugs based on electrochemical principle. In this paper, the development histories of electronic tongue both of potential type and voltammetry type were introduced, including their detection principles and key innovation technologies. In order to comprehensively improve the understanding of electronic tongue, its technological progresses, such as the study of dedicated sensors or biosensors for specific tastes, and the development of miniaturized or hybrid devices, were also discussed in detail. And the challenges and countermeasures in the application of electronic tongue were analyzed to provide some suggestions for its further technology promotion.
10.Research progress of intestinal lymphatic system dysfunction in Crohn′s disease
Hui LU ; Quanli LIU ; Li SHEN ; Ruohan SHI ; Mengyu XU ; Lugen ZUO ; Zhijun GENG
Chinese Journal of Inflammatory Bowel Diseases 2023;07(2):191-194
Crohn′s disease (CD) is a complex gastrointestinal tract disease, and its etiology and pathogenesis have not been fully clarified. In recent years, studies on the intestinal lymphatic system in CD patients have gradually increased. Dysfunction of the intestinal lymphatic system is often seen in the development and progression of CD and affects the disease process, such as lymphogranuloma formation, lymphatic dilation and lymphatic leakage, and its dysfunction is often associated with pathological features of CD patients such as creeping fat and segmental enterocolitis. This review summarizes recent studies related to the dysfunction of the intestinal lymphatic system in CD, and describes the possible effects of the dysfunction of the intestinal lymphatic system on CD by linking the dysfunctional manifestations of lymphatic function to the pathological manifestations of CD.

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