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
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Female
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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
;
East Asian People
2.Incidence rate of low-level viremia and related influencing factors in treatment-experienced chronic hepatitis B patients:A Meta-analysis
Lu XIE ; Yanan LIU ; Guangwei LIU ; Pengyu LI ; Xinning HU ; Qiujia KANG ; Huijun GUO
Journal of Clinical Hepatology 2024;40(7):1334-1342
Objective To systematically evaluate the incidence rate of low-level viremia(LLV)in chronic hepatitis B(CHB)patients and related influencing factors,and to provide evidence-based medicine evidence for effective intervention and prevention of LLV in clinical practice.Methods This study was conducted according to the PRISMA guideline,with a PROSPERO registration number of CRD42023455304.CNKI,Wanfang Data,VIP,SinoMed,PubMed,Embase,Web of Science,and the Cochrane library were searched for observational studies on LLV and related influencing factors in CHB patients published up to July 21,2023.Stata 16.0 software was used to perform the meta-analysis.Results A total of 12 articles were included,with a total sample size of 3408 cases,among whom there were 1181 patients with LLV.The meta-analysis showed that the incidence rate of LLV was 32.8%(95%confidence interval[CI]:27.6%—38.3%)in treatment-experienced CHB patients.High HBsAg quantification(odds ratio[OR]=2.107,95%CI:1.782—2.491,P<0.001),positive HBeAg(OR=3.258,95%CI:2.629—4.038,P<0.001),high HBV DNA level at baseline(OR=1.286,95%CI:1.157—1.430,P<0.001),and history of entecavir treatment(OR=3.089,95%CI:1.880—5.074,P<0.001)were risk factors for LLV;duration of antiviral therapy≥3 years(OR=0.175,95%CI:0.093—0.331,P<0.001)and high alanine aminotransferase level at baseline(OR=0.985,95%CI:0.978—0.992,P<0.001)were protective factors against LLV.The sensitivity analysis showed no significant change in effective value,suggesting that the results of the meta-analysis were relatively stable.The funnel plot of the studies included was basically symmetrical,and the results of the Egger's test and the Begg's test suggested that there was no obvious publication bias in the articles included.Conclusion Clinicians should guide decision making based on the influencing factors for LLV and related clinical evidence,so as to reduce long-term clinical risks and avoid adverse outcomes.
3.Role of microglia in neuroinflammation after traumatic brain injury and its significance in nerve regeneration
Yibin JIA ; Guanyi WANG ; Enming KANG ; Huijun CHEN ; Xiaosheng HE
Chinese Journal of Neuromedicine 2021;20(7):733-737
The secondary damage after traumatic brain injury (TBI) involves a variety of pathological processes, and the inflammatory response in the nervous system is an important factor which affects nerve repair and regeneration. As the innate immune cell in the nervous system, microglia (MG) plays an important role in the entire neuroinflammatory environment by regulating the activation state of MG and changing the inflammatory response in the direction of promoting nerve repair and regeneration, which has great potential in treatment of TBI. This article reviews the inflammatory response of the nervous system after TBI and the reactivity of MG, as well as their significance in nerve repair and regeneration.
4.Experimental research on the trochlear dysplasia with bony and soft tissue model of patellar dislocation
Huijun KANG ; Yike DAI ; Shilun LI ; Jiangfeng LU ; Faquan LI ; Gang JI ; Yingzhen NIU ; Fei WANG
Chinese Journal of Orthopaedics 2020;40(6):372-380
Objective:To establish a model of patellar dislocation by femoral osteotomy or surgical release of medial retinaculum in immature rabbits, and observe morphological and trabecular microarchitectural changes in the trochlea.Methods:Forty rabbits at 3 months of age were included. All right knees underwent surgery, 20 knees were treated with femoral osteotomy and internal rotation of distal femur to increase femoral anteversion angle (Osteotomy group, OS group), and another 20 knees were treated with surgical release of medial retinaculum and overlap suture of lateral retinaculum (Soft tissue group, ST group). All left knees were acting as internal controls. Micro-CT scans for distal femur were acquired after 4 months post surgery. the height of Medial, central, and lateral trochlear, sulcus angle, and lateral and medial trochlear slope were measured to describe the trochlear morphology, and bone volume fraction (BV/TV), trabecular thickness (Tb.Th), trabecular number (Tb.N), trabecular spacing (Tb.Sp), and bone mineral density (BMD) were calculated to evaluate the microarchitectural structure. All parameters were compared between groups.Results:In OS group, one rabbit sustained a hip dislocation without patellar dislocation. Three knees developed complete patellar dislocation in daily flexion position, and the remaining 16 patellae were dislocated when the knee was placed in the maximal extension position. In ST group, 15 knees were complete patellar dislocation in daily flexion position, and 5 knees were without dislocation. A local boss was formed proximal to the entrance of the groove and the articular cartilage was smooth, and no obvious osteoarthritis was observed in OS group. In ST group no boss was formed, while obvious cartilage degeneration and defect was seen. Compared to the control group, the central trochlear height and sulcus angle were greater in both groups, but without significant difference between the two groups. The Tb.Th was increased in both medial and lateral condyle, and Tb.N was decreased in medial condyle compared with its control knees in OS group. The BV/TV, Tb.Th, Tb.N and BMD were decreased and Tb.Sp was increased in both medial and lateral condyle compared with its control knees in ST group. Compared to the OS group, the BV/TV, Tb.Th, Tb.N and BMD were smaller and Tb.Sp was greater in both medial and lateral condyle in ST group, with significant differences.Conclusion:The model of patellar dislocation could be successfully achieved by femoral rotational osteotomy to increase femoral anteversion or surgical release of medial retinaculum and overlap suture of lateral retinaculum, and subsequent morphological and trabecular microarchitectural changes in the trochlea are different. Different bony and soft tissue factors should be addressed for different patients with patellar dislocation in clinical practice.
5. The characteristic of hereditary spherocytosis related gene mutation in 37 Chinese hereditary spherocytisis patients
Guangxin PENG ; Wenrui YANG ; Xin ZHAO ; Liping JIN ; Li ZHANG ; Kang ZHOU ; Yang LI ; Lei YE ; Yuan LI ; Jianping LI ; Huihui FAN ; Lin SONG ; Yang YANG ; Youzhen XIONG ; Zhijie WU ; Huijun WANG ; Fengkui ZHANG
Chinese Journal of Hematology 2018;39(11):898-903
Objective:
To reveal the genetic characteristics of erythrocyte membrane protein in hereditary spherocytosis (HS) in China.
Methods:
Next-generation sequencing technology was used to detect mutations in genes of erythrocyte membrane proteins in 51 clinically diagnosed HS patients. The relationship between gene mutations and clinical phenotypes was analyzed.
Results:
Mutations in erythrocyte membrane protein genes were detected in 37 patients, including 17 with ANK1 mutations (17/37, 45.9%), 14 with SPTB mutations (14/37, 37.8%), and 5 with SLC4A1 mutations (5/37, 13.5%). One patient carried both heterozygous ANK1 mutation and SPTB mutation (1/37, 2.7%). SPTA1 and EPB42 mutation was not fou nd in any patient. Nonsense mutations (36.8%) and missense mutations (31.6%) were most common. Of the 38 mutations detected, 34 were novel mutations and have not been reported elsewhere (89.5%). Sixteen HS patients underwent parental genetic validation, 6 patients (37.5%) inherited gene mutation from parents and 10 (62.5%) were
6. Correlation of the degree of band 3 protein absence on erythrocyte membrane by eosin-5′-maleimide binding test and clinical phenotype in hereditary spherocytosis
Guangxin PENG ; Wenrui YANG ; Liping JING ; Li ZHANG ; Kang ZHOU ; Yang LI ; Lei YE ; Yuan LI ; Jianping LI ; Huihui FAN ; Lin SONG ; Xin ZHAO ; Zhijie WU ; Yang YANG ; Youzhen XIONG ; Huijun WANG ; Fengkui ZHANG
Chinese Journal of Hematology 2017;38(6):537-541
Objective:
To investigate the relationship between the eosin-5′-maleimide (EMA) binding test and the clinical severity of hereditary spherocytosis (HS).
Methods:
A total of 258 un-splenectomize HS patients were consecutively enrolled. Correlation of hemoglobin concentration, hemolytic parameters, compensating erythropoiesis and the EMA binding test were evaluated.
Results:
258 (128 male and 130 female) patients were included in this study, including 91 compensatory hemolysis patients, 53 patients with mild anemia, 78 patients with moderate anemia and 36 patients with severe anemia. The median age at diagnosis was 23 (2-70) years. The median decreased fluorescence intensity of EMA binding test was 29.97% (16.09%-47.34%) and the average intensity was (29.70±6.28) % of 258 HS patients. The decreased EMA binding fluorescence intensity correlated with MCV (
7.Value of 18F-FDG PET/CT for diagnosis of lymphatic metastasis in patients with non-small cell lung cancer
Liping ZHANG ; Bo DENG ; Ruwen WANG ; Jinghai ZHOU ; Wei GUO ; Huijun NIU ; Zheng MA ; Poming KANG ; Shaolin TAO ; Qunyou TAN
Journal of Regional Anatomy and Operative Surgery 2016;25(3):184-187
Objective To assess the value of fuorine-18-fluom deoxy glucose positron emission tomography /computer tomography (18F-FDG PET/CT) in diagnosis of lymph node metastasis in the cases with non-small cell lung cancer ( NSCLC) .Methods From March 2012 to March 2015,167 patients underwent 18F-FDG PET/CT and contrast enhanced CT inspection within 10 days prior to the surgery and were pathologically diagnosed as non-small cell lung cancer(NSCLC) after surgery.With regard to estimation of the lymphatic metastasis,we com-pared the sensitivity,specificity,accuracy,positive and negative predictive value ,and Youden index between the PET/CT and contrast en-hanced CT.Results There were 731 lymph node stations from the 167 patients.Referred to the final pathological results ,PET/CT has screened 143 lymph node stations in true positive set ,26 lymph node stations in false positive set ,61 lymph node stations in false negative set , and 501 lymph node stations in true negative set .Furthermore,the sensitivity,specificity,the positive and negative forecast values ,and Youden index of PET/CT and CT was 70.10%vs.54.19%(P<0.05),95.07%vs.92.23%(P<0.05),88.10%vs.81.67%(P<0.05),84.62%vs.72.85%(P<0.05),89.15%vs.81.67%(P<0.05) and 0.65 vs.0.46 (P<0.05),respectively.Conclusion It is more effective to to precisely validate lymphatic metastasis of NSCLC by using PET /CT than using contrast enhanced CT inspection .Additionally,PET/CT can provide more information for the preoperative diagnosis , staging and the follow-up treatment of lung cancer .
8.Chronic natural killer cell lymphocytosis: eight cases report and literature review.
Guangxin PENG ; Xin ZHAO ; Yuanyuan XIONG ; Yang LI ; Yuan LI ; Jianping LI ; Lei YE ; Huihui FAN ; Lin SONG ; Wenrui YANG ; Zhijie WU ; Liping JING ; Lei SHANG ; Huijun WANG ; Li ZHANG ; Kang ZHOU ; Fengkui ZHANG
Chinese Journal of Hematology 2014;35(7):609-613
OBJECTIVETo identify the characteristics of chronic natural killer cell lymphocytosis (CNKL).
METHODSThe clinical data of eight cases defined by the World Health Organization classification was retrospectively analyzed and related literatures were reviewed.
RESULTSHalf of the 8 patients were asymptomatic. Among them, the most common abnormalities were leukocytosis with the median of 11.8(4.5-20.0)×10⁹/L and high proportion of lymphocytes [0.78(0.51-0.89)], while anemia and thrombocytopenia only in 1 patient respectively. The absolute CD3⁻CD16⁺ NK cell count with the median of 5.7(2.4-9.6)×10⁹/L increased in peripheral blood. By the end of follow-up, except one case was lost, the other seven patients were in stable condition,including four cases without any medications and three patients receiving chlorambucil or glucocorticoid.
CONCLUSIONAs an indolent chronic lymphoproliferative disease, CNKL was presented with mild clinical symptoms and increased number of CD3⁻CD16⁺ NK cells in peripheral blood. Patients with symptoms could be treated with immunosuppressive therapy while those asymptomatic could be followed up without intervention.
Adult ; Aged ; Chronic Disease ; Female ; Follow-Up Studies ; Humans ; Killer Cells, Natural ; Lymphocytosis ; blood ; Male ; Middle Aged ; Prognosis
9.The study of graft offset in the anterior cruciate ligament reconstruction
Baicheng CHEN ; Hu LIU ; Xiaoyang ZHANG ; Changbao YAN ; Ran SUN ; Jiangtao DONG ; Huijun KANG ; Chaohua ZHU
Chinese Journal of Orthopaedics 2011;31(2):169-174
Objective To investigate the impact of graft position shift on anterior cruciate ligament reconstruction induced by femoral fixation of interference screw. Methods Nineteen fresh cadaveric knees were used and assigned to three groups. 1) Study of graft position shift: 5 knees were randomly selected, interference screws of 7 mm, 8 mm and 9 mm were used in autologous tendon fixation, then the graft position shift were measured. 2) Study of isometry: 7 knees were randomly divided into the isometric reconstruction group (D group). In the D group, Retrobutton, interference screw and interference screw in location-corrected bone tunnel were used respectively as fixation. The isometry of grafts was evaluated. 3) Study of tibia anterior translation: 7 knees were randomly divided into the anatomic reconstruction group (J group). In the J group,the tibia anterior translation was measured in four different conditions in the same joint: intact knee joint,knee joint without ACL, ACL anatomic reconstruction by interference screw fixation, and ACL anatomic reconstruction by interference screw fixation with corrected bone tunnel location. Results 1) With 7 mm, 8mm and 9 mm interference screw fixation, graft position shift were (2.36±0.11) mm, (2.72±0.06) mm and (3.00±0.06) mm respectively. 2) Graft length change: graft length change in Retrobutton group and corrected bone tunnel group were less than 3 mm, while graft length change in those fixed with interference screw were stretched in more than 3 mm. 3) Study of tibia anterior translation: there was no difference among the intact group, the anatomic group and the corrected group at 0° and 15°. However, the difference was found between the intact group and other groups at 30°、60° and 90° of flexion, as well as between these two reconstructed methods at 20° joint flexion (P<0.05). Conclusion In both isometric and anatomic ACL reconstruction with interference screw, the graft is pushed tightly toward the femoral tunnel wall, which shifts the graft away from the desired position. In our study we find out that the corrected location of the femoral bone tunnel significantly improves the isometry of ACL reconstruction and anatomic reconstruction.
10.Genetic testing for the enlarged vestibular aqueduct syndrome and mutation analysis of the SLC26A4 gene
Pu DAI ; Dongyi HAN ; Bo FENG ; Dongyang KANG ; Xin LIU ; Huijun YUAN ; Juyang CAO ; Xin ZHANG ; Suoqiang ZHAI ; Weiyan YANG ; Bailin WU
Chinese Archives of Otolaryngology-Head and Neck Surgery 2006;0(05):-
T,and 916-917 ins G were SLC26A4 mutations unreported hitherto, which may be specific to the Chinese population. CONCLUSION The EVA syndrome is a typical autosomal recessivehereditary disease caused by mutations in SLC26A4 gene. Genetic testing of SLC26A4 is the one of the important diagnostic methods for EVA syndrome.

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