1.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*
;
Male
;
Female
;
Aged
;
Middle Aged
;
Cognitive Dysfunction/drug therapy*
;
Aged, 80 and over
;
Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People
2.Analysis of Differential Compounds of Poria cocos Medicinal Materials by Integrated Qualitative Strategy Based on UPLC-Q-Orbitrap-MS
Jiayuan WANG ; Xiaohan FAN ; Xiaoxiao WEI ; Rong CAO ; Jin WANG ; Lei WANG ; Fengqing XU ; Shunwang HUANG ; Deling WU ; Hongsu ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):148-156
ObjectiveTo establish a rapid analytical method for identifying the differential components in Poria cocos medicinal materials based on ultra performance liquid chromatography-quadrupole-electrostatic field orbital trap high-resolution mass spectrometry(UPLC-Q-Orbitrap-MS), combined with mass defect filtering(MDF) and molecular network integration techniques. MethodsUPLC-Q-Orbitrap-MS was used for MS data acquisition and identification of P. cocos medicinal materials, with the help of MDF for the study of cleavage behavior and structural identification of triterpenoids. According to the similarity of MS/MS fragmentation patterns of each component, global natural product social molecular network(GNPS) was established, and Cytoscape 3.6.1 was used to screen molecular clusters with similar structures and the the structure of main compound classes were identified and confirmed. Multivariate statistical analyses such as principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to screen the differential components of the five P. cocos medicinal materials with the variable importance in the projection(VIP) value>1 and P<0.05 as the criteria. ResultsA total of 66 compounds were identified by database comparison, 8 compounds were newly identified by MDF, 28 compounds were newly identified by GNPS, and a total of 102 chemical compounds were identified, including 43 triterpenoids, 16 saccharides, 26 amino acids and peptides, 3 nucleosides, and 14 other compounds. Triterpenoids were predominant in Poriae Cutis and wild Fushen, amino acids and peptides were the most abundant in Poria and cultivated Fushen, carbohydrates were the most abundant in Poriae Cutis. Type Ⅰ and Ⅱ triterpenoids had higher amounts in Poria and cultivated Fushen, type Ⅲ triterpenoids were more abundant in Poriae Cutis, all four types of triterpenoids were higher in Fushenmu, and type Ⅰ, Ⅱ, and Ⅳ triterpenoids were higher in wild Fushen. A total of 12 common differential chemical constituents were screened, including serine, guanosine, gallic acid, 2-octenal, maltotriose, trametenolic acid, dehydroeburicoic acid, dehydrotrametenolic acid, poricoic acid A, poricoic acid B, poricoic acid E and G, but the relative contents of them varied significantly among different medicinal materials. ConclusionAmong the five P. cocos medicinal materials, the types of constituents are generally similar, but their relative contents differed significantly among these medicinal materials, especially in the distribution of triterpenoids. The integration of UPLC-Q-Orbitrap-MS, MDF and GNPS can provide a reference for the rapid qualitative analysis of other Chinese medicines.
3.Analysis of Differential Compounds of Poria cocos Medicinal Materials by Integrated Qualitative Strategy Based on UPLC-Q-Orbitrap-MS
Jiayuan WANG ; Xiaohan FAN ; Xiaoxiao WEI ; Rong CAO ; Jin WANG ; Lei WANG ; Fengqing XU ; Shunwang HUANG ; Deling WU ; Hongsu ZHAO
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(7):148-156
ObjectiveTo establish a rapid analytical method for identifying the differential components in Poria cocos medicinal materials based on ultra performance liquid chromatography-quadrupole-electrostatic field orbital trap high-resolution mass spectrometry(UPLC-Q-Orbitrap-MS), combined with mass defect filtering(MDF) and molecular network integration techniques. MethodsUPLC-Q-Orbitrap-MS was used for MS data acquisition and identification of P. cocos medicinal materials, with the help of MDF for the study of cleavage behavior and structural identification of triterpenoids. According to the similarity of MS/MS fragmentation patterns of each component, global natural product social molecular network(GNPS) was established, and Cytoscape 3.6.1 was used to screen molecular clusters with similar structures and the the structure of main compound classes were identified and confirmed. Multivariate statistical analyses such as principal component analysis(PCA) and orthogonal partial least squares-discriminant analysis(OPLS-DA) were used to screen the differential components of the five P. cocos medicinal materials with the variable importance in the projection(VIP) value>1 and P<0.05 as the criteria. ResultsA total of 66 compounds were identified by database comparison, 8 compounds were newly identified by MDF, 28 compounds were newly identified by GNPS, and a total of 102 chemical compounds were identified, including 43 triterpenoids, 16 saccharides, 26 amino acids and peptides, 3 nucleosides, and 14 other compounds. Triterpenoids were predominant in Poriae Cutis and wild Fushen, amino acids and peptides were the most abundant in Poria and cultivated Fushen, carbohydrates were the most abundant in Poriae Cutis. Type Ⅰ and Ⅱ triterpenoids had higher amounts in Poria and cultivated Fushen, type Ⅲ triterpenoids were more abundant in Poriae Cutis, all four types of triterpenoids were higher in Fushenmu, and type Ⅰ, Ⅱ, and Ⅳ triterpenoids were higher in wild Fushen. A total of 12 common differential chemical constituents were screened, including serine, guanosine, gallic acid, 2-octenal, maltotriose, trametenolic acid, dehydroeburicoic acid, dehydrotrametenolic acid, poricoic acid A, poricoic acid B, poricoic acid E and G, but the relative contents of them varied significantly among different medicinal materials. ConclusionAmong the five P. cocos medicinal materials, the types of constituents are generally similar, but their relative contents differed significantly among these medicinal materials, especially in the distribution of triterpenoids. The integration of UPLC-Q-Orbitrap-MS, MDF and GNPS can provide a reference for the rapid qualitative analysis of other Chinese medicines.
4.Analysis of clinical characteristics and influencing factors of patients with postmenopausal osteoporosis combined with dyslipidemia.
Rong XIE ; Li-Guo ZHU ; Zi-Kai JIN ; Tian-Xiao FENG ; Ke ZHAO ; Da WANG ; Ling-Hui LI ; Xu WEI
China Journal of Orthopaedics and Traumatology 2025;38(5):487-493
OBJECTIVE:
To explore the co-morbid influencing factors of postmenopausal osteoporosis(PMOP) and dyslipidemia, and to provide evidence-based basis for clinical co-morbidity management.
METHODS:
Based on the 2017 to 2018 Beijing community cross-sectional survey data, PMOP patients were included and divided into the dyslipidemia group and the uncomplicated dyslipidemia group according to whether they were comorbid with dyslipidemia. Demographic characteristics, living habits and disease history were collected through questionnaires, and bone mineral density and bone metabolism biomarkers (osteocalcin, blood calcium, serum typeⅠprocollagen N-terminal prepeptide, etc.) were detected on site. Co-morbidity risk factors were analyzed using binary logistic regression.
RESULTS:
Three hundred and twenty patients with PMOP were included, including the comorbid group (75 patients) and the uncomplicated group (245 patients). The results showed that history of cardiovascular disease [OR=1.801, 95%CI(1.003, 3.236), P=0.049], history of cerebrovascular disease [OR=2.923, 95%CI(1.460, 5.854), P=0.002], frying and cooking methods[OR=5.388, 95%CI(1.632, 17.793), P=0.006], OST results[OR=0.910, 95%CI(0.843, 0.983), P=0.016], and blood Ca results [OR=60.249, 95%CI(1.862, 1 949.926), P=0.021] were the influencing factors of PMOP complicated with dyslipidemia.
CONCLUSION
Focus should be placed on the influencing factors of PMOP and dyslipidemia co-morbidities, with emphasis on multidimensional assessment, combining lifestyle interventions with bone metabolism marker monitoring to optimize co-morbidity management.
Humans
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Dyslipidemias/epidemiology*
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Female
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Middle Aged
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Osteoporosis, Postmenopausal/metabolism*
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Aged
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Cross-Sectional Studies
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Risk Factors
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Bone Density
5.Explanation and interpretation of blood transfusion provisions for children with hematological diseases in the national health standard "Guideline for pediatric transfusion".
Ming-Yi ZHAO ; Rong HUANG ; Rong GUI ; Qing-Nan HE ; Ming-Yan HEI ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jin-Ping LIU ; Jing WANG ; Zhi-Li SHAO ; Yong-Jian GUO ; Xin-Yin WU ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Ming-Hua YANG
Chinese Journal of Contemporary Pediatrics 2025;27(1):18-25
To guide clinical blood transfusion practices for pediatric patients, the National Health Commission has issued the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Blood transfusion is one of the most commonly used supportive treatments for children with hematological diseases. This guideline provides guidance and recommendations for blood transfusions in children with aplastic anemia, thalassemia, autoimmune hemolytic anemia, glucose-6-phosphate dehydrogenase deficiency, acute leukemia, myelodysplastic syndromes, immune thrombocytopenic purpura, and thrombotic thrombocytopenic purpura. This article presents the evidence and interpretation of the blood transfusion provisions for children with hematological diseases in the "Guideline for pediatric transfusion", aiming to assist in the understanding and implementing the blood transfusion section of this guideline.
Humans
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Child
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Hematologic Diseases/therapy*
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Blood Transfusion/standards*
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Practice Guidelines as Topic
6.Explanation and interpretation of the compilation of blood transfusion provisions for children undergoing hematopoietic stem cell transplantation in the national health standard "Guideline for pediatric transfusion".
Rong HUANG ; Qing-Nan HE ; Ming-Yan HEI ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jin-Ping LIU ; Jing WANG ; Zhi-Li SHAO ; Ming-Yi ZHAO ; Yong-Jian GUO ; Xin-Yin WU ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Rong GUI ; Ming-Hua YANG
Chinese Journal of Contemporary Pediatrics 2025;27(2):139-143
To guide clinical blood transfusion practices for pediatric patients, the National Health Commission has issued the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Blood transfusion for children undergoing hematopoietic stem cell transplantation is highly complex and challenging. This guideline provides recommendations on transfusion thresholds and the selection of blood components for these children. This article presents the evidence and interpretation of the transfusion provisions for children undergoing hematopoietic stem cell transplantation, with the aim of enhancing the understanding and implementation of the "Guideline for pediatric transfusion".
Humans
;
Hematopoietic Stem Cell Transplantation
;
Child
;
Blood Transfusion/standards*
;
Practice Guidelines as Topic
7.Explanation and interpretation of blood transfusion provisions for critically ill and severely bleeding pediatric patients in the national health standard "Guideline for pediatric transfusion".
Rong HUANG ; Qing-Nan HE ; Ming-Yan HEI ; Ming-Hua YANG ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jin-Ping LIU ; Jing WANG ; Zhi-Li SHAO ; Ming-Yi ZHAO ; Yong-Jian GUO ; Xin-Yin WU ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Rong GUI
Chinese Journal of Contemporary Pediatrics 2025;27(4):395-403
To guide clinical blood transfusion practices for pediatric patients, the National Health Commission has issued the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Critically ill children often present with anemia and have a higher demand for transfusions compared to other pediatric patients. This guideline provides guidance and recommendations for blood transfusions in cases of general critical illness, septic shock, acute brain injury, extracorporeal membrane oxygenation, non-life-threatening bleeding, and hemorrhagic shock. This article interprets the background and evidence of the blood transfusion provisions for critically ill and severely bleeding children in the "Guideline for pediatric transfusion", aiming to enhance understanding and implementation of this aspect of the guidelines. Citation:Chinese Journal of Contemporary Pediatrics, 2025, 27(4): 395-403.
Humans
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Critical Illness
;
Blood Transfusion/standards*
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Child
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Hemorrhage/therapy*
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Practice Guidelines as Topic
8.Explanation and interpretation of blood transfusion provisions for children undergoing cardiac surgery in the national health standard "Guideline for pediatric transfusion".
Rong HUANG ; Qing-Nan HE ; Ming-Yan HEI ; Ming-Hua YANG ; Xiao-Fan ZHU ; Jun LU ; Xiao-Jun XU ; Tian-Ming YUAN ; Rong ZHANG ; Xu WANG ; Jing WANG ; Zhi-Li SHAO ; Ming-Yi ZHAO ; Yong-Jian GUO ; Xin-Yin WU ; Jia-Rui CHEN ; Qi-Rong CHEN ; Jia GUO ; Rong GUI ; Jin-Ping LIU
Chinese Journal of Contemporary Pediatrics 2025;27(7):778-785
To guide clinical blood transfusion practices in pediatric patients, the National Health Commission has issued the health standard "Guideline for pediatric transfusion" (WS/T 795-2022). Children undergoing cardiac surgery are at high risk of bleeding, and the causes of perioperative anemia and coagulation disorders in neonates and children are complex and varied, often necessitating the transfusion of allogeneic blood components. This guideline provides direction and recommendations for specific measures in blood management for children undergoing cardiac surgery before, during, and after surgery. This article interprets the background and evidence for the formulation of the blood transfusion provisions for children undergoing cardiac surgery, hoping to facilitate the understanding and implementation of this guideline.
Humans
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Cardiac Surgical Procedures
;
Blood Transfusion/standards*
;
Child
;
Practice Guidelines as Topic
9.Nonlinear association between serum albumin levels and all-cause mortality in elderly patients with chronic aortic regurgitation.
Ming-Hui LI ; Qing-Rong LIU ; Zhen-Yan ZHAO ; Hai-Yan XU ; Yong-Jian WU
Journal of Geriatric Cardiology 2025;22(4):423-432
BACKGROUND:
Low serum albumin levels are established predictors of adverse outcomes in various cardiovascular conditions. However, the role of serum albumin in mortality among elderly patients with chronic aortic regurgitation (AR) has not been thoroughly investigated. This study aims to assess the relationship between serum albumin levels and mortality in this specific patient population.
METHODS:
Our analysis included 873 elderly AR patients from the China Valvular Heart Disease study, with baseline serum albumin measured at enrollment. Mortality outcomes were monitored for two years post-enrollment, employing a Cox proportional hazards model with a two-piecewise Cox proportional hazards framework to investigate the nonlinear relationship between serum albumin levels and all-cause mortality.
RESULTS:
During the 2-year follow-up period, we observed 63 all-cause deaths. The association between serum albumin levels and all-cause mortality displayed an approximating L-shaped curve, indicating a mortality threshold at 35 g/L. For serum albumin levels below 35 g/L, each 1 g/L decrease was associated with a 25% higher risk of all-cause mortality (HR = 1.25, 95% CI: 1.07-1.45). In contrast, no significant change in mortality risk was observed when serum albumin levels were greater than or equal to 35 g/L. Moreover, when serum albumin is classified as hypoproteinemia (serum albumin < 35 g/L), the higher risks of all-cause death were observed in hypoproteinemic patients (HR = 2.93, 95% CI: 1.50-5.74). More importantly, the association between serum albumin and death was significantly stronger in overweight/obese patients (≥ 24 kg/m2 vs. < 24 kg/m2, P interaction = 0.006).
CONCLUSIONS
In elderly patients with AR, serum albumin levels showed an approximating L-shaped relationship with all-cause death, with thresholds of 35 g/L. Body mass index was significant effect modifiers of the association. These results suggest that serum albumin, as an inexpensive and readily available biochemical marker, may further improve the stratified risk of mortality in older AR patients.
10.The Valvular Heart Disease-specific Age-adjusted Comorbidity Index (VHD-ACI) score in patients with moderate or severe valvular heart disease.
Mu-Rong XIE ; Bin ZHANG ; Yun-Qing YE ; Zhe LI ; Qing-Rong LIU ; Zhen-Yan ZHAO ; Jun-Xing LV ; De-Jing FENG ; Qing-Hao ZHAO ; Hai-Tong ZHANG ; Zhen-Ya DUAN ; Bin-Cheng WANG ; Shuai GUO ; Yan-Yan ZHAO ; Run-Lin GAO ; Hai-Yan XU ; Yong-Jian WU
Journal of Geriatric Cardiology 2025;22(9):759-774
BACKGROUND:
Based on the China-VHD database, this study sought to develop and validate a Valvular Heart Disease- specific Age-adjusted Comorbidity Index (VHD-ACI) for predicting mortality risk in patients with VHD.
METHODS & RESULTS:
The China-VHD study was a nationwide, multi-centre multi-centre cohort study enrolling 13,917 patients with moderate or severe VHD across 46 medical centres in China between April-June 2018. After excluding cases with missing key variables, 11,459 patients were retained for final analysis. The primary endpoint was 2-year all-cause mortality, with 941 deaths (10.0%) observed during follow-up. The VHD-ACI was derived after identifying 13 independent mortality predictors: cardiomyopathy, myocardial infarction, chronic obstructive pulmonary disease, pulmonary artery hypertension, low body weight, anaemia, hypoalbuminaemia, renal insufficiency, moderate/severe hepatic dysfunction, heart failure, cancer, NYHA functional class and age. The index exhibited good discrimination (AUC, 0.79) and calibration (Brier score, 0.062) in the total cohort, outperforming both EuroSCORE II and ACCI (P < 0.001 for comparison). Internal validation through 100 bootstrap iterations yielded a C statistic of 0.694 (95% CI: 0.665-0.723) for 2-year mortality prediction. VHD-ACI scores, as a continuous variable (VHD-ACI score: adjusted HR (95% CI): 1.263 (1.245-1.282), P < 0.001) or categorized using thresholds determined by the Yoden index (VHD-ACI ≥ 9 vs. < 9, adjusted HR (95% CI): 6.216 (5.378-7.184), P < 0.001), were independently associated with mortality. The prognostic performance remained consistent across all VHD subtypes (aortic stenosis, aortic regurgitation, mitral stenosis, mitral regurgitation, tricuspid valve disease, mixed aortic/mitral valve disease and multiple VHD), and clinical subgroups stratified by therapeutic strategy, LVEF status (preserved vs. reduced), disease severity and etiology.
CONCLUSION
The VHD-ACI is a simple 13-comorbidity algorithm for the prediction of mortality in VHD patients and providing a simple and rapid tool for risk stratification.

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