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
;
Alzheimer Disease/drug therapy*
;
Male
;
Female
;
Aged
;
Middle Aged
;
Cognitive Dysfunction/drug therapy*
;
Aged, 80 and over
;
Amyloid beta-Peptides/metabolism*
;
Biomarkers
;
East Asian People
2.Progress in the regulation of mammalian embryonic development and reproduction by bone morphogenetic proteins.
Hongyu JIA ; Honghong HE ; Peng WANG ; Xiaoxiao HUANG ; Wenyi CAI ; Yaying WANG ; Jian LI ; Daoliang LAN ; Huizhu ZHANG
Chinese Journal of Biotechnology 2025;41(7):2534-2544
Bone morphogenetic proteins (BMPs) are multifunctional growth factors of the transforming growth factor β (TGF-β) superfamily. They regulate steroid secretion from mammalian granulosa cells, promote granulosa cell survival and proliferation, and inhibit follicular atresia, luteinization, and granulosa cell apoptosis, thereby promoting the development and maturation of mammalian follicles. At the same time, BMPs play an important role in embryonic morphogenesis, induction of uterine receptivity, and blastocyst attachment. This paper describes the effects of BMPs on mammalian follicular and embryonic development and the roles of BMPs in female reproduction, focusing on the process in which BMPs promote follicular maturation by regulating steroid secretion from granulosa cells during mammalian oocyte maturation. This review aims to provide a reference for further research on mammalian oocyte culture and improvement of reproductive efficiency in female animals.
Animals
;
Embryonic Development/drug effects*
;
Female
;
Bone Morphogenetic Proteins/pharmacology*
;
Reproduction/physiology*
;
Humans
;
Granulosa Cells/cytology*
;
Oocytes
3.Establishment and application of path-based management mode of 5-HT3 receptor antagonists in chemotherapy patients
Lu GAO ; Jing LI ; Xiao ZHOU ; Yuan HUANG ; Lin YU ; Huizhu SONG ; Yuhua YANG
China Pharmacy 2023;34(4):493-496
OBJECTIVE To establish the path-based management mode of 5-hydroxytryptamine-3 receptor antagonist (5- HT3RA) in chemotherapy patients, and to improve the rationality of medication in chemotherapy patients. METHODS 5-HT3RA standardized drug use control rules were formulated, with the help of medical intelligence and decision support (MINDS) system, path-based management was carried out for chemotherapy patients using 5-HT3RA in the form of whole-process information capture and prescription pre-review, and whole-process intervention was implemented on medication indications, usage and dosage, course of treatment, etc. The intervention effect was analyzed by comparing the changes in the use of 5-HT3RA without indication, unreasonable usage and dosage, repeated medication, unreasonable course of treatment, and per capita drug cost before and after the implementation of path-based management. RESULTS A total of 9 181 patients were included. After the implementation of path- based management, the proportion of unindicated drugs decreased by 0.48%, and the rate of unreasonable single dosage, unreasonable frequency, repeated medication, unreasonable treatment course (5-HT3RA still used 3 days after chemotherapy) decreased by 10.48%, 0.65%, 1.33% and 0.34%; per capita cost of 5-HT3RA decreased by 13.72 yuan; there were statistical significance (P<0.05). CONCLUSIONS 5-HT3RA path-based management mode effectively improves the rationality of medication and provides a new idea for rational clinical drug use.
4.Analysis of Active Screening and Risk Factors for Multidrug-resistant Organisms in Elderly Patients of ICU
Jianyi WEN ; Tiehe QIN ; Shouhong WANG ; Jie LI ; Yan WU ; Huizhu ZHANG ; Daozheng HUANG ; Jun LIANG ; Xiaolong LIAO ; Zhonghua WANG
China Pharmacy 2018;29(2):199-203
OBJECTIVE:To investigate risk factors of multidrug-resistant organisms (MDROs) infection in elderly patients of ICU,and to provide reference for formulation and implementation of MDROs prevention and control measures.METHODS:A total of 146 elderly patients were selected from ICU of our hospital during Dec.2013-Jun.2016.Throat swab,sputum swab and anal swab specimens (1 copy,respectively) were collected to conduct active screening of MRSA and ESBLs-producing Enterobacteriaceae.Risk factors of MDROs infection,pathogen distribution and drug resistance were analyzed.RESULTS:Among samples of 146 patients,there were 34 MRSA positive samples in throat swab with positive rate of 23.3%;there were 30 MRSA positive samples in sputum swab with positive rate of 20.5%;there were 99 ESBLs-producing bacteria positive samples in anal swab (containing 50 ESBLs-producing Escherichia coli positive samples and 49 ESBLs-producing Klebsiella pneumoniae positive samples) with positive rate of 67.8%.The positive rate of throat swab MRSA screening was not correlated with patient's gender,age,tracheal intubation or mechanical ventilation (P>0.05),but it was related with hospitalization time in ICU (P<0.05).The positive rate of sputum swab MRSA screening was not correlated with patient' s gender,tracheal intubation or mechanical ventilation;the positive rate of anal swab ESBLs-producing bacteria screening were not related with patient's gender(P>0.05).But they were related with age and hospitalization time in ICU (P<0.05).Compared with negative patients,there was no statistical significance in the times of fiberoptic bronchoscopy in throat/sputum swab MRSA screening positive patients (P>0.05).The times of enema,the times of bladder irrigation,the times of urethral catheterization and the duration of indwelling catheter in anal swab ESBLs-producing bacteria screening positive patients were significantly more or longer than negative patients,with statistical significance (P<0.05).Binary Logistic regression analysis showed that hospitalization time in ICU was risk factor of positive active screening of throat swab in elderly patients of ICU[OR=1.119,95 % CI (1.071,1.385),P=0.021];age was risk factor of positive active screening of sputum swab[OR=1.893,95 % CI (1.232,4.042),P=0.032];age and hospitalization time in ICU were risk factors of positive active screening of anal swab [OR were 1.046,1.022,95%CI were (1.005,1.088) (1.006,3.283),P were 0.027,0.031].A total of 163 strains of MDROs were detected,among which there were 64 strains of MRSA,50 strains of ESBLs-producing E.coli and 49 strains of ESBLs-producing K.pneumoniae.They were generally highly resistant to compound preparation containing enzyme inhibitors.CONCLUSIONS:The results of MDROs active screening in elderly patients of ICU are related with age,hospitalization time in ICU,the times of enema,the times of bladder irrigation,the times of urethral catheterization and the duration of indwelling catheter.Age and hospitalization time in ICU were risk factors of MDROs infection.The pathogens are mainly ESBLs-producing Enterobacteriaceae,and drug resistance is severe.For elderly critical patients with MDROs infection,clinical prevention and intervention measures should be taken to prevent and control the prevalence and spread of MDROs in ICU.
5.Chorionic villus cell culture and karyotype analysis in 1983 cases of spontaneous miscarriage
Simin YUAN ; Can LIAO ; Dongzhi LI ; Jiezhen HUANG ; Shunyan HU ; Ming KE ; Huizhu ZHONG ; Cuixing YI
Chinese Journal of Obstetrics and Gynecology 2017;52(7):461-466
Objective To investigate the relationship between spontaneous miscarriage and embryonic chromosome abnormalities,and to evaluate the clinical application of karyotype analysis by chorionic villus cell culture. Methods The chorionic villus karyotype of 1983 cases of miscarriage from January 2010 to July 2016 in Guangzhou Women and Children′ s Mecical Center were analyzed retrospectively. The miscarried chorionic villi were obtained by curettage under sterilized condition. The chromosome specimens were prepared after chorionic villus cell culture. Karyotype analysis was performed by G-banding technique. Results In the 1983 samples, successful karyotype analysis was performed in 1770 cases, with the successful rate of 89.98%. Chromosomal abnormalities were found in 1038 cases (58.64%,1038/1770). Chromosomal structural abnormalities were found in 37 cases. The numeral abnormalities were more common than structural abnormalities, and most of the numeral abnormalities were aneupoidies. In turn, they were trisomy 16, 45,X, trisomy 22, trisomy 2, trisomy 21, trisomy 15. The most common structural abnormality was balanced translocation, including Robersonian translocation. Female embryoes accounted for 61.02%(1080/1770) miscarriages and for 57.4%(596/1770) of chromosomal abnormalities, while male embroyes acoounted for 61.02%(1080/1770),57.4%(596/1770)respectively. The proportion of female embryoes was higher than male embryoes. The median age of the patients was 30 years old(16-46 years old). As the maternal age increased, the proportion chromosomal abnormalities increased. The incidence of chromosomal abnormalities in the advanced age group (≥35 years) was 68.38%(240/351), which was significantly higher than that in the younger group (56.24% ,798/1419; χ2=17.10, P<0.01). Conclusions Embryonic chromosomal abnormalities are the most common cause of early spontaneous miscarriage. The abnormalities centralize in some karyotypes. There is certain relationship between maternal age and the incidence of miscarriage, as well as the embryonic gender. Chorionic villus cell culture and karyotype analysis are helpful in finding the cause of miscarriage and counsel the patients.
6.Related factors of serum vitamine D level in 4-15-year-olds children in southwest Zhejiang
Huizhu LI ; Huafu WANG ; Guiai ZHENG ; Jiaqi CHEN ; Houxing LEI ; Huisu FAN ; Jihong SHI ; Yan HUANG
Chinese Journal of Clinical Nutrition 2016;24(2):110-114
Objective To investigate vitamin D ( VD) level and its influencing factors in 4-15-year-old children in southwest of Zhejiang province, so as to guide intervention strategy for improving VD level. Methods A total of 2 620 4 -15-year-old healthy children who visited Lishui People's Hospital for regular physical check-up between January and December 2014 were divided into 4 age groups, namely 4 -6 years (kindergarten), 7 -9 years (lower grades in primary school), 10 -12 years (higher grades in primary school), and 13-15 years (junior middle school).We randomly selected 200 children from each age group using a random number table.A survey using self-developed questionnaire was conducted to obtain information regarding diet, exposure to sunlight, and VD supplement.Serum 25-( OH) D level was measured with electro-chemiluminescence.VD nutritional status and composition, diet, sunlight exposure, VD supplement were com-pared among the groups.Results In southwest Zhejiang, the mean VD level in primary and middle school students was ( 24.76 ±8.39 ) μg/L, clinical deficiency rate was 31.5%, subclinical deficiency rate was 45.0%, and only 23.5% reached the appropriate level, which was even lower ( 14.5%) in junior middle school students.The VD deficiency rate elevated significantly along with the growth of age (P=0.036).The level of VD was positively correlated with sunlight exposure and VD supplementation, and showed significant in-ter-group differences ( all P<0.05 ) .Conclusions The nutritional status of VD is unfavorable and sunlight exposure insufficient in primary and middle school students in southwest Zhejiang province.We should encour-age students to take more outdoor activities and increase sunlight exposure to improve their VD nutritional sta-tus.Children >7 years should be given more attention to in the intervention of increasing sunlight exposure. Students with difficulties in getting adequate sunlight exposure need VD supplements.
7.Effect of Drug Pair of Rhizoma Polygoni Cuspidati and Ramulus Cinnamomi on TLR4/MyD88 Signal Transduction Pathway of Rats with Acute Gouty Arthritis
Zhong LI ; Bin HAN ; Huizhu HUANG ; Zulian GU ; Wan SHI ; Xuguang HU
Journal of Guangzhou University of Traditional Chinese Medicine 2015;32(6):1040-1046,1145
Objective To observe the effects of the drug pair of Rhizoma Polygoni Cuspidati ( Huzhang) and Ramulus Cinnamomi ( Guizhi) on the Toll-like receptor 4 mediated myeloid differentiation factor 88 ( TLRs/MyD88) signaling pathway of rats with acute gouty arthritis induced by monosodium sodium urate (MSU) , so as to explore its therapeutic mechanism. Methods Forty-eight male SD rats were divided into normal group, modele group, blank plasmid group, positive plasmid group, Huzhang- Guizhi herb-pair (7 g/kg) group, and Huzhang-Guizhi herb-pair ( 7 g/kg) siRNA group, 8 rats in each group. The normal group, plasmid groups and model group were given physiological saline, and the left groups were given the corresponding drug by intragastric administration for 10 continuous days ( once daily ) . On the seventh day of intragastric gavage, acute gouty arthritis were induced by injection of MSU into the rat ankle joint, and normal group was injected with the samevolume of normal saline. Positive plasmid group and Huzhang-Guizhi herb-pair siRNA group were injected with the constructed siRNA-TLR4 plasmid targeting TLR4 gene ( TLR4-siRNA) to inhibit the in-vivo TLR4 gene expression. Pathological changes of the synovial tissues were detected, the contents of peripheral blood tumor necrosis factor alpha ( TNF-α) and interleukin 1 beta ( IL-1β) were detected by double antibody sandwich method, and the mRNA and protein expression levels of TLR4, MyD88, TNF receptor-associated factor 6 ( TRAF-6) in peripheral blood mononuclear cells of rats were detected by real-time fluorescence quantitative polymerase chain reaction ( PCR) and Western blot methods. The nuclear factor kappa B ( NF-κB) p65 immunoactivity was assayed by immunohistochemistry. Results Compared with the normal group, the model group had obvious hyperplasia of synovial cells and the inflammatory cell infiltration ( dominated by lymphcytes and monocytes) , and had amount of cellulose adhesive on the synovial membrane surface. Compared to the model group, positive plasmid group, Huzhang- Guizhi herb-pair group and Huzhang-Guizhi herb-pair siRNA group could obviously relieve the inflammatory cell infiltration, and improve synovial cell proliferation reaction. Compared to the normal group, serum levels of TNF-α and IL-1β, and the expression levels of TLR4, MyD88, TRAF-6 mRNA and protein in the peripheral blood mononuclear cells as well as the synovial NF-κB p65 ex pression in the model group were significantly increased ( P<0.01). Compared to the model group, positive plasmid group, Huzhang-Guizhi herb-pair group and Huzhang- Guizhi herb-pair siRNA group showed significant decrease in the levels of TNF-α, IL-1β, TLR4 MyD88, TRAF-6 and NF-κB p65 ( P<0.05 or P<0.01) . Conclusion Huzhang-Guizhi herb-pair can regulate the cytokines of the synovial membrane tissue in acute gouty arthritis rats, which may be related with its effect on inhibiting abnormal activation of TLR4-MyD88-NF-κB pathway in synovial tissue.
8.Efficacy of continuing nursing in treatment of patients with colostomy in gastrointestinal surgery department
Aiping WANG ; Ling ZHANG ; Zhiying ZHOU ; Huizhu HUANG
Journal of Clinical Medicine in Practice 2015;(20):73-75
ABSTRACT:Objective To investigate the efficacy of continuing nursing in treatment of pa-tients with permanent colostomy.Methods A total of 87 discharged patients with permanent colostomy in department of gastrointestinal surgery were divided into continuing nursing group and control group.The control group was treated with conventional discharge education,while contin-uing nursing group were conducted with phone follow up,home visits,network platform,follow-up colostomy sodality.Permanent colostomy related knowledge,incidence rate of complications and nursing satisfactory degree were compared between two groups.Results Permanent colostomy re-lated knowledge of the observation group was significantly better than the control group,the inci-dence rate of complications was significantly lower than the control group,and nursing satisfactory degree was significantly higher than the control group(P <0.05).Conclusion Continuing nurs-ing can improve the self-care ability of patients,reduce the incidence of complications and improve satisfactory degree of patients.
9.Efficacy of continuing nursing in treatment of patients with colostomy in gastrointestinal surgery department
Aiping WANG ; Ling ZHANG ; Zhiying ZHOU ; Huizhu HUANG
Journal of Clinical Medicine in Practice 2015;(20):73-75
ABSTRACT:Objective To investigate the efficacy of continuing nursing in treatment of pa-tients with permanent colostomy.Methods A total of 87 discharged patients with permanent colostomy in department of gastrointestinal surgery were divided into continuing nursing group and control group.The control group was treated with conventional discharge education,while contin-uing nursing group were conducted with phone follow up,home visits,network platform,follow-up colostomy sodality.Permanent colostomy related knowledge,incidence rate of complications and nursing satisfactory degree were compared between two groups.Results Permanent colostomy re-lated knowledge of the observation group was significantly better than the control group,the inci-dence rate of complications was significantly lower than the control group,and nursing satisfactory degree was significantly higher than the control group(P <0.05).Conclusion Continuing nurs-ing can improve the self-care ability of patients,reduce the incidence of complications and improve satisfactory degree of patients.
10.Clinical and side effect of the short term radiotherapy combining with chemotherapy on nasopharyngeal carcinoma patients with stages Ⅲ and ⅣA
Yanqiu SUN ; Chun ZHANG ; Huizhu LIU ; Yanhai ZHAO ; Weiyi WU ; Junrong HUANG ; Yuming CHEN
Clinical Medicine of China 2014;30(12):1262-1265
Objective To explore the short term treatment effectiveness and the side-effect of radiotherapy combined with two kinds of chemotherapy scheme on nasopharyngeal carcinoma patients with stage Ⅲ and Ⅳa.Methods One hundred and fifty nasopharyngeal carcinoma cases with stage Ⅲ/Ⅳa were randomly divided into A and B group.Patients in A group (75 cases) were received radiotherapy combined with 2 courses ((21-28) d/course) paclitaxel (135 mg/m2) + cis-platinum complexes (DDP) 80 mg/m2 chemotherapy concurrently,while patients in B group (75 cases) were received radiotherapy combined with 6 courses DDP 30 mg/m2 per week chemotherapy concurently.The short term treatment effectiveness and the sideeffect of radiotherapy combined with two kinds of chemotherapy scheme were observed.Result After the treatment,the primary lesion complete remission(CR) rate in A group and B group were 68% (51/75),52% (39/75).The CR rate of lymph node of neck in A and B group was 64.0% (48/75),48.0% (36/75) and 45.3% (34/75),20.0% (15/75) of primary lesion and lymph node of neck.The differences were significant(x2=4.25,3.90,10.94 ;P <0.05).After 3 months of treatment,there was no significant difference between A and B group in terms of CR rate of the primary lesion,lymph node of neck and primary lesion and lymph node of neck (P >0.05).During the treatment,the rate of bone marrow depression at grade Ⅲ in A group and B group were 38.67% (29/75) and 21.33% (16/75),21.33% (16/75) and 6.67% (5/75) in terms of the rate of grade gastrointestinal reaction at stage Ⅲ,46.66% (35/75) and 21.33% (16/75) regarding of oral cavity mucomembranous injury at stage Ⅲ,21.33% (16/75) and 9.34% (7/75) in terms of the rate of radioactivity skin destruction at stage Ⅲ.All differences were significant (P < 0.05).During the short-term follow up (1-3 years),both the rate of local recurrence and the rate of metastasis in A group was as same as that in B group(P >0.05).Conclusion During the treatment,the side-effect of approach of paclitaxel (135 mg/m2) + DDP 80 mg/m2 in stage Ⅲ/Ⅳa nasopharyngeal carcinoma patients is more severity than that of DDP 30 mg/m2 per week chemotherapy.However,there is no significant difference in terms of the short term treatment effectiveness.The prospective efficacy needs to be further investigation.

Result Analysis
Print
Save
E-mail