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
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East Asian People
2.Amplification effect of hearing mechanics in unilateral hearing loss.
Quanran LIN ; Kai FANG ; Wendi SHI ; Yuan WANG ; Shihua ZHA ; Yang LI ; Yonghua WANG ; Zhengnong CHEN
Journal of Clinical Otorhinolaryngology Head and Neck Surgery 2025;39(3):239-242
Objective:To evaluate the effectiveness of amplification intervention with hearing aids for restoring binaural auditory function in patients with unilateral moderate to severe sensorineural hearing loss. Methods:This study selected 30 patients with normal hearing in one ear and moderate to severe sensorineural hearing loss in the other ear. They were fitted with hearing aids for the worse ear and underwent more than half a year and one year of adaptation training. The Chinese translation of the Twelve-item version of SSQ(C-SSQ12), angle identification test, speech recognition score(SRS) at different signal-to-noise ratios(SNR=5 and SNR=10) and audiometric thresholds were used to compare the results before and after hearing aid use to evaluate the effectiveness of the unilateral hearing loss intervention. Results:The results of the audiometric thresholds, C-SSQ12 scores, angle identification test, and SRS at SNR=5 and SNR=10 in the worse ear of the unilateral hearing loss patients after hearing aid use were all statistically significant compared to before hearing aid use(P<0.01). Conclusion:Amplification intervention with hearing aids has significant effects on restoring binaural auditory function in patients with unilateral moderate to severe sensorineural hearing loss.
Humans
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Hearing Aids
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Hearing Loss, Unilateral/therapy*
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Middle Aged
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Hearing Loss, Sensorineural/rehabilitation*
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Adult
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Female
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Male
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Auditory Threshold
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Young Adult
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Aged
3.Establishment of a risk assessment model based early warning system for infectious diseases
Yonghua LU ; Yifang LI ; Fang HUANG ; Wenying HE
Modern Hospital 2024;24(1):111-113
Objective To establish a risk assessment model based infectious disease early warning system and promote the improvement of infectious disease management level.Methods By collecting and organizing the latest research results,and referring to the theoretical framework of the relevant infectious disease early warning evaluation index system,a risk assessment model based infectious disease early warning system is constructed.Results A total of 12 experts were included in this study,and three primary indicators were selected,including pre-epidemic indicators,typical symptom period indicators,atypical symp-tom period indicators,and 7 secondary indicators.The average score for necessity of the system was 8.27±0.24 points,and the average score for accessibility was 7.74±0.34 points.Conclusion The establishment of an infectious disease early warning sys-tem based on risk assessment models is conducive to timely following the epidemic trend of infectious diseases in the local area,analyzing the distribution trend of survey indicators,and proposing corresponding early warning plans,which can provide relevant basis for effective prevention of infectious diseases.
4.Prevalence of Helicobacter pylori infection and risk factors among family members in Qinghai Province, China
Chunxia LI ; Xuehong WANG ; Zhenqi MA ; Yonghua ZHAN ; Lijuan SHEN ; Fang WANG ; Yuanhua LI
Chinese Journal of Internal Medicine 2024;63(1):41-45
Objective:To investigate the prevalence of Helicobacter pylori infection among family members, and analyze associated risk factors. Methods:The current investigation was a cross-sectional study. The Qinghai region was stratified into urban areas, agricultural areas, and pastoral areas. The urban areas of Xining City, the agricultural areas of Haidong City, and the pastoral areas of Haibei Tibetan Autonomous Prefecture were selected. A total of 396 resident families (1 131 people) who underwent health checkups from 2021 to 2022 in the above areas were included in the survey study. Questionnaires were administered and H. pylori infection was detected using the 13C-urea breath test. Numerical data were expressed as cases and percentages, and the Chi-square test was used to compare differences in H. pylori infection rates in the populations and families in each group. Multifactorial logistic regression was used to analyze risk factors for H. pylori infection, and P<0.05 was considered statistically significant. Results:The prevalence of H. pylori infection in Qinghai province was 52.8% (597/1 131) and the prevalence of H. pylori infection in households was 80.6% (319/396). In H. pylori-positive households with at least 1 infected spouse, 40.4% (36/89) had only 1 infected spouse, and in 59.6% (53/89) both spouses were infected. In analysis of children infected by parents with H. pylori, 20.0% (9/45) of households had fathers and children infected, 48.9% (22/45) had mothers and children infected, and 31.1% (14/45) had both parents and children infected. In univariate analysis there was a statistically significant difference in the overall comparison of H. pylori infection rates among families with different numbers of people living together ( χ2=11.12, P=0.004), and between-group comparisons suggested that H. pylori infection rates were higher in families with 4 or 5 people and more than 5 people living together than in families with 2 or 3 people living together. The H. pylori infection rate was higher in families that did not use serving chopsticks and spoons during family meals than in families that did use serving chopsticks and spoons ( χ2=6.12, P=0.013). In multifactorial logistic regression analyses the number of people living together in a family and whether or not serving chopsticks and spoons were used at family meals were associated with H. pylori infection ( P<0.05). Conclusion:The H. pylori infection rate in families in Qinghai Province is high, and there is a clear association with family aggregation. It is more common for both members of a couple to be infected, and H. pylori infection of a mother has a greater effect on the children′s infection status than H. pylori infection of a father. The infection rate of H. pylori was lower in families that used serving chopsticks and spoons during dinner gatherings, and the fewer the number of people living together in the family, the lower the H. pylori infection rate.
5.Leaky Gut Plays a Critical Role in the Pathophysiology of Autism in Mice by Activating the Lipopolysaccharide-Mediated Toll-Like Receptor 4-Myeloid Differentiation Factor 88-Nuclear Factor Kappa B Signaling Pathway.
Fang LI ; Haoran KE ; Siqi WANG ; Wei MAO ; Cexiong FU ; Xi CHEN ; Qingqing FU ; Xiaori QIN ; Yonghua HUANG ; Bidan LI ; Shibing LI ; Jingying XING ; Minhui WANG ; Wenlin DENG
Neuroscience Bulletin 2023;39(6):911-928
Increased intestinal barrier permeability, leaky gut, has been reported in patients with autism. However, its contribution to the development of autism has not been determined. We selected dextran sulfate sodium (DSS) to disrupt and metformin to repair the intestinal barrier in BTBR T+tf/J autistic mice to test this hypothesis. DSS treatment resulted in a decreased affinity for social proximity; however, autistic behaviors in mice were improved after the administration of metformin. We found an increased affinity for social proximity/social memory and decreased repetitive and anxiety-related behaviors. The concentration of lipopolysaccharides in blood decreased after the administration of metformin. The expression levels of the key molecules in the toll-like receptor 4 (TLR4)-myeloid differentiation factor 88 (MyD88)-nuclear factor kappa B (NF-κB) pathway and their downstream inflammatory cytokines in the cerebral cortex were both repressed. Thus, "leaky gut" could be a trigger for the development of autism via activation of the lipopolysaccharide-mediated TLR4-MyD88-NF-κB pathway.
Mice
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Animals
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NF-kappa B
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Myeloid Differentiation Factor 88/metabolism*
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Lipopolysaccharides/pharmacology*
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Toll-Like Receptor 4/metabolism*
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Autistic Disorder/metabolism*
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Signal Transduction/physiology*
6.Effects of Zhenfang Baiwanzi Decoction combined with alteplase injection on serum inflammatory factors and vascular endothelial active substances in the patients with acute ischemic stroke and syndrome of wind-phlegm invading collaterals
Fang ZONG ; Yonghua CHEN ; Yuqiang DAI
International Journal of Traditional Chinese Medicine 2023;45(9):1075-1080
Objective:To explore the effects of Zhenfang Baiwanzi Decoction combined with alteplase injection on serum inflammatory factors and vascular endothelial active substances in patients with acute ischemic stroke (AIS).Methods:Randomized controlled trial. A total of 87 patients with AIS admitted to Mengcheng County Hospital of Traditional Chinese Medicine between June 2019 and July 2022 were selected as the observation subjects by prospective cohort study, and they were divided into treatment group (44 cases) and control group (43 cases) according to the last number of medical records. The control group was given thrombolytic therapy with alteplase injection on the basis of routine therapy, and the treatment group was given Zhenfang Baiwanzi Decoction on the basis of the control group. Both groups were treated for 2 weeks. TCM symptoms were scored before and after treatment, and National Institutes of Health Stroke Scale (NIHSS) was used to evaluate the degree of neurological deficit, and Activity of Daily Living Scale (ADL) was applied to evaluate the quality of life. The levels of serum IL-6, CRP, TNF-α, monocyte chemoattractant protein-1 (MCP-1), VEGF, NOS and endothelin-1 (ET-1) were detected by ELISA. The adverse reactions were recorded and the clinical efficacy was evaluated.Results:The total effective rate was 93.18% (41/44) in treatment group and 76.74% (33/43) in control group ( χ2=4.62, P=0.032). After treatment, the scores of hemiparalysis, skin insensitivity, deviated mouth and eye, inhibited speech and headache and dizziness in treatment group were significantly lower than those in the control group ( t=3.38, 3.77, 2.69, 2.60, 2.36, P<0.01 or P<0.05). The NIHSS score was significantly lower than that of the control group ( t=7.53, P<0.01) while the ADL score was significantly higher than that of the control group ( t=2.99, P<0.01). After treatment, the levels of serum IL-6, CRP, TNF-α and MCP-1 in treatment group were significantly lower than those in the control group ( t=6.07, 5.70, 5.30, 3.36, P<0.01), and the levels of VEGF [(364.54±33.04)ng/L vs. (346.86±29.63)ng/L, t=2.63] was significantly lower than that of the control group ( P<0.05), NOS [(20.77±3.12) μmol/L vs. (29.46±5.36) μmol/L, t=9.27] and ET-1 [(85.41±7.09) ng/L vs. (94.11±9.38) ng/L, t=4.89] were significantly lower than those in the control group ( P<0.01). Conclusion:Zhenfang Baiwanzi Decoction combined with alteplase injection can improve the clinical symptoms, reduce levels of inflammatory factors, protect the vascular endothelial function, and enhance the efficacy of patients with AIS.
7.Family-based association tests for rare variants.
Xi CHEN ; Si Yue WANG ; En Ci XUE ; Xue Heng WANG ; He Xiang PENG ; Meng FAN ; Meng Ying WANG ; Yi Qun WU ; Xue Ying QIN ; Jin LI ; Tao WU ; Hong Ping ZHU ; Jing LI ; Zhi Bo ZHOU ; Da Fang CHEN ; Yonghua HU
Chinese Journal of Epidemiology 2022;43(9):1497-1502
Next-generation sequencing has revolutionized family-based association tests for rare variants. As the lower power of genome wide association study for detecting casual rare variants, methods aggregating effects of multiple variants have been proposed, such as burden tests and variance component tests. This paper summarizes the methods of rare variants association test that can be applied for family data, introduces their principles, characteristics and applicable conditions and discusses the shortcomings and the improvement of the present methods.
Computer Simulation
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Family Relations
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Genetic Association Studies
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Genetic Variation
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Genome-Wide Association Study/methods*
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Humans
8.Prevalence and risk factors of Helicobacter pylori infection in Qinghai Province
Yan LI ; Suhua LI ; Zhenqi MA ; Yonghua ZHAN ; Lijuan SHEN ; Fang WANG ; Chunxia LI ; Yuanhua LI ; Mengjun ZHANG ; Xuehong WANG
Chinese Journal of Digestion 2022;42(9):604-609
Objective:To investigate the prevalence and the risk factors of Helicobacter pylori( H. pylori) infection in Qinghai Province with a multi-center cross-sectional study. Methods:From May to December in 2021, stratified sampling was conducted in Xining City, Haidong agricultural district, Hainan Tibetan Autonomous Prefecture, Haibei Tibetan Autonomous Prefecture and Yushu Tibetan Autonomous Prefecture by 20 centers, including the Affiliated Hospital of Qinghai University, Qinghai Red Cross Hospital and Qinghai Renji Hospital, etc. A questionnaire survey was carried out among the individuals undergoing routine health checkups. The questionnaire included general information, lifestyle and family history, etc. 13C-urea breath test was performed to diagnose H. pylori infection. Chi-square test, trend Chi-square test, segmentation method and multivariate logistic regression analysis were performed for statistical analysis. Results:The infection rate of H. pylori in Qinghai area was 53.6% (2 531/4 724). The age distribution of infection was statistically significant ( χ2=15.95, P=0.007), the infection rate in individuals aged 15 to<30 was higher than that of individuals aged 60 to< 75 (57.6%, 626/1 086 vs.49.5%, 231/467), and the difference was statistically significant ( χ2=8.83, P=0.003). With the increase of age, the infection rate decreased in female over 30 years old ( χ2trend=5.89, P=0.015). There were statistically significant differences in H. pylori infection rate among different ethnic groups ( χ2=28.13, P<0.001); the infection rate of Tibetan population was higher than that of Han population (62.9%, 313/498 vs. 51.5%, 1 804/3 503), and the difference was statistically significant ( χ2=22.56, P<0.001). The H. pylori infection rate in people living at an altitude >3 500 m was higher than that of people living at an altitude between 1 500 m and 3 500 m (61.8%, 327/529 vs. 52.5%, 2 204/4 195), and the difference was statistically significant ( χ2=16.25, P<0.001). Compared with those without corresponding habits, the infection rate of H. pylori was higher in smokers (62.1%, 1 081/1 740 vs. 48.6%, 1 450/2 984), in people who had the habit of eating hand grabbed mutton (55.4%, 967/1 744 vs. 52.5%, 1 564/2 980), raw garlic (55.5%, 968/1 744 vs. 52.4%, 1 563/2 980), spicy food (55.6%, 1 471/2 647 vs. 51.0%, 1 060/2 077), sweet food (55.2%, 1 187/2 149 vs. 52.2%, 1 344/2 575), the infection rate of tea drinkers was lower (50.5%, 1 135/2 247 vs. 56.4%, 1 396/2 477), and the differences were statistically significant ( χ2=80.94, 3.89, 9.63, 4.36, 4.13 and 16.19, all P<0.05). The results of logistic regression analysis indicated that Tibetan ( OR=1.379, 95% confidence interval (95% CI) 1.120 to 1.699), the Hui people ( OR=1.362, 95% CI 1.117 to 1.662), living at an altitude over 3 500 m ( OR=1.355, 95% CI 1.107 to 1.657), smoking ( OR=1.847, 95% CI 1.629 to 2.094), and spicy food ( OR=1.224, 95% CI 1.084 to 1.382) were independent risk factors of H. pylori infection (all P<0.05). Conclusions:The infection rate of H. pylori in Qinghai Province is higher than the average level in inland China. The infection rate of people with different ages, nationalities, altitudes of residence, occupations, living and eating habits were different. The infection rate of female over 30 years old is decreasing year by year. The infection risk is high in Hui people and Tibetan, spicy food lovers, smokers and people living at an altitude >3 500 m.
9.Analysis on the status quo and influencing factors of career management of operating room nurses
Yan YAN ; Li LI ; Yonghua ZHAI ; Fang WANG
Chinese Journal of Industrial Hygiene and Occupational Diseases 2021;39(3):211-214
Objective:To investigate the status quo of operating room nurse career management in Shandong Province, and to analysis its influencing factors.Methods:In February 2019, 1418 operating room nurses in Shandong province were selected to investigate their general situation and current status of career management and analyze possible influencing factors by using the General Information Questionnaire, the Career Management Questionnaire for Nurses and the Career Planning Questionnaire for Nurses.Results:The total score of organizational career management scale was (48.24±11.12) points, with the score of dimension from high to low as valueing training (12.64±2.54) points, justice in promotion (12.11±3.04) points, providing career information (12.10±3.21) points, promotion in career self-development (11.39±3.46) points. The total score of organizational career planning scale was (43.33±9.00) points. Multiple liner regression analysis showed that career planning ( β=0.742, P<0.001) , hospital grade ( β=-0.068, P<0.001) and age ( β=-0.065, P<0.001) were influencing factors of operating room nurse career management which could explained 57.1% of the variation ( F=630.596, P<0.001) . Conclusion:Career management of operating room nurse is at a medium level, the scores of different dimensions are not balanced.Career planning score, hospital level, age and other factors affect the career management score of operating room nurses.
10.Effects of PNU 282987 on Improving Cardiac Remodeling and JAK 2/STAT3 Signaling Pathway
Huanle FANG ; Xiaoming LI ; Minmin NI ; Yuwen ZHAO ; Yonghua YANG
China Pharmacy 2021;32(10):1246-1251
OBJECTIVE:To st udy the effects of α7 nicotinic acetylcholine receptor agonists (PNU282987)on improving cardiac remodeling of mice and Janus kinase 2/signal transducer and activator of transcription 3(JAK2/STAT3)signaling pathway. METHODS:Male Kunming mice were randomly divided into normal control group ,model group ,propranolol group (positive control,i.g. 40 mg/kg)and PNU 282987 low-dose,medium-close and high-dose groups (intraperitoneal injection of 0.5,1.0,3.0 mg/kg),with 10 mice in each group. Except for the normal control group ,mice in the other groups were given isoproterenol (ISO,30 mg/kg) subcutaneously for 7 days to induce the cardiac remodeling model. After 30 minutes of ISO injection , administration groups were given relevant liquid ,once a day ,for 7 consecutive days. Twelve hours after last administration ,the left ventricular ejection fraction (EF)and left ventricular short axis shortening rate (FS)of mice in each group were measured ,and the whole heart mass index (HMI)was calculated ;the pathological changes of myocardium were observed. The serum contents of lactate dehydrogenase (LDH),creatine kinase (CK),tumor necrosis factor α(TNF-α),interleukin 6(IL-6),the protein expression of intercellular adhesion molecule 1(ICAM-1)and adhesion molecule 1(VCAM-1)were also determined. The ratios of p-JAK2/JAK2,p-STAT3/STAT3 in myocardial tissue were detected. RESULTS :Compared with normal control group ,EF and FS of model group were significantly reduced ,HMI,the contents of LDH,CK,TNF-α and IL-6,the protein expression of ICAM- 1 and VCAM- 1,the ratio of p-JAK 2/JAK2 and p-STAT 3/STAT3 were increased significantly (P<0.05 or P<0.01); blue collagen deposition in the interstitium of myocardium was obvious,and the degree of fibrosis was severe. Compared with model group , the EF and FS of the mice in the medium-dose and high-dose groups were increased significantly , HMI (except for PNU 282987 medium-dose group ),the contents of LDH (except for PNU 282987 medium-dose group ),CK,TNF-α and IL-6,the protein expression of ICAM- 1 and VCAM- 1,the ratio of p-JAK 2/JAK2 and p-STAT 3/STAT3 were decreased significantly (P<0.05 or P< 0.01);blue collagen deposition in the myocardial interstitium was significantly reduced ,and the degree of myocardial fibrosis was significantly reduced. There was no significant difference in the comparison of the above indicators in PNU 282987 low-dose group (P>0.05). CONCLUSIONS :PNU282987 can improve cardiac remodeling of mice ,the mechanism of which may be associated with inhibiting JAK 2/STAT3 signaling pathway.

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