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*
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Male
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Female
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Aged
;
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.Evidence mapping of clinical research on 35 commonly used oral Chinese patent medicines in treatment of intracerebral hemorrhage.
Wen ZHANG ; Jun-Jie JIANG ; Yong-Qing MA ; Qiao-Feng LI ; Xing LIAO ; Cheng-Yu WU
China Journal of Chinese Materia Medica 2025;50(2):555-568
Evidence mapping was used to systematically analyze the clinical research evidence of oral Chinese patent medicines in the treatment of intracerebral hemorrhage(ICH), thus revealing the distribution and quality of evidence in this field. The relevant articles were retrieved from CNKI, Wanfang, VIP, SinoMed, PubMed, EMbase, Cochrane Library, and Web of Science from inception to July 5, 2024. The distribution characteristics of evidence were presented numerically and graphically. A total of 35 Chinese patent medicines were identified, involving 261 articles. The basic information of the 35 Chinese patent medicines, publication trend, traditional Chinese medicine(TCM) syndromes, interventions, and outcome indicators were compared and analyzed, and the methodological quality of the articles was evaluated. The results indicated that the clinical scope of Chinese patent medicines in the treatment of ICH was broad. However, the available studies inadequately emphasized the advantages and characteristics of TCM, lacked the safety information and the standards for evaluating outcome indicators, and paid insufficient attention to cognitive ability and neuropsychology. In addition, these articles demonstrated low quality. It is recommended that follow-up clinical research should be standardized and highlight the characteristics of TCM. In the analysis of outcome indicators, TCM syndrome evaluation should be taken as an important outcome indicator, and the evaluation criteria should be unified. Moreover, more attention should be paid to patients' cognitive ability and neuropsychology. The holder of marketing license of Chinese patent medicines should standardize the clinical position and improve the safety information in the medicine instructions according to the relevant requirements of the National Medical Products Administration. Additionally, the proportion of Chinese patent medicines in the category A list of medical insurance should be increased, and the limited medical resources should be rationally allocated.
Cerebral Hemorrhage/drug therapy*
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Humans
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Drugs, Chinese Herbal/therapeutic use*
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Medicine, Chinese Traditional
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Nonprescription Drugs/administration & dosage*
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Administration, Oral
3.Identification of blood-entering components of Anshen Dropping Pills based on UPLC-Q-TOF-MS/MS combined with network pharmacology and evaluation of their anti-insomnia effects and mechanisms.
Xia-Xia REN ; Jin-Na YANG ; Xue-Jun LUO ; Hui-Ping LI ; Miao QIAO ; Wen-Jia WANG ; Yi HE ; Shui-Ping ZHOU ; Yun-Hui HU ; Rui-Ming LI
China Journal of Chinese Materia Medica 2025;50(7):1928-1937
This study identified blood-entering components of Anshen Dropping Pills and explored their anti-insomnia effects and mechanisms. The main blood-entering components of Anshen Dropping Pills were detected and identified by UPLC-Q-TOF-MS/MS. The rationality of the formula was assessed by using enrichment analysis based on the relationship between drugs and symptoms, and core targets of its active components were selected as the the potential anti-insomnia targets of Anshen Dropping Pills through network pharmacology analysis. Furthermore, protein-protein interaction(PPI) network, Gene Ontology(GO) enrichment analysis, and Kyoto Encyclopedia of Genes and Genomes(KEGG) pathway analysis were performed on the core targets. An active component-core target network for Anshen Dropping Pills was constructed. Finally, the effects of low-, medium-, and high-dose groups of Anshen Dropping Pills on sleep episodes, sleep duration, and sleep latency in mice were measured by supraliminal and subliminal pentobarbital sodium experiments. Moreover, total scores of the Pittsburgh sleep quality index(PSQI) scale was used to evaluate the changes before and after the treatment with Anshen Dropping Pills in a clinical study. The enrichment analysis based on the relationship between drugs and symptoms verified the rationality of the Anshen Dropping Pills formula, and nine blood-entering components of Anshen Dropping Pills were identified by UPLC-Q-TOF-MS/MS. The network proximity revealed a significant correlation between eight components and insomnia, including magnoflorine, liquiritin, spinosin, quercitrin, jujuboside A, ginsenoside Rb_3, glycyrrhizic acid, and glycyrrhetinic acid. Network pharmacology analysis indicated that the major anti-insomnia pathways of Anshen Dropping Pills involved substance and energy metabolism, neuroprotection, immune system regulation, and endocrine regulation. Seven core genes related to insomnia were identified: APOE, ALB, BDNF, PPARG, INS, TP53, and TNF. In summary, Anshen Dropping Pills could increase sleep episodes, prolong sleep duration, and reduce sleep latency in mice. Clinical study results demonstrated that Anshen Dropping Pills could decrease total scores of PSQI scale. This study reveals the pharmacodynamic basis and potential multi-component, multi-target, and multi-pathway effects of Anshen Dropping Pills, suggesting that its anti-insomnia mechanisms may be associated with the regulation of insomnia-related signaling pathways. These findings offer a theoretical foundation for the clinical application of Anshen Dropping Pills.
Animals
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Drugs, Chinese Herbal/administration & dosage*
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Tandem Mass Spectrometry/methods*
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Sleep Initiation and Maintenance Disorders/metabolism*
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Mice
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Network Pharmacology
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Male
;
Chromatography, High Pressure Liquid
;
Humans
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Protein Interaction Maps/drug effects*
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Sleep/drug effects*
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Female
;
Adult
4.Analysis of Gene Mutations Distribution and Enzyme Activity of G6PD Deficiency in Newborns in Guilin Region.
Dong-Mei YANG ; Guang-Li WANG ; Dong-Lang YU ; Dan ZENG ; Hai-Qing ZHENG ; Wen-Jun TANG ; Qiao FENG ; Kai LI ; Chun-Jiang ZHU
Journal of Experimental Hematology 2025;33(5):1405-1411
OBJECTIVE:
To analyze the distribution characteristics of glucose-6-phosphate-dehydrogenase (G6PD) mutations and their enzyme activity in newborns patients with G6PD deficiency in Guilin region.
METHODS:
From July 2022 to July 2024, umbilical cord blood samples from 4 554 newborns in Guilin were analyzed for G6PD mutations using fluorescence PCR melting curve analysis. Enzyme activity was detected in 4 467 cases using the rate assay.
RESULTS:
Among 4 467 newborns who underwent G6PD activity testing, 162 newborns (3.63%) were identified as G6PD-deficient, including 142 males (6.04%) and 20 females (0.94%), the prevalence of G6PD deficiency was significantly higher in males than in females (P < 0.001). Genetic analysis of 4 554 newborns detected G6PD mutations in 410 cases (9%), including 171 males (7.13%) and 239 females (11.09%), with a significantly higher mutation detection rate in females than in males (P < 0.001). A total of nine single mutations and four compound heterozygous mutations were identified. The most common mutations were c.1388G>A (33.66%), c.1376G>T (23.66%) and c.95A>G (16.34%). Among newborns who underwent both enzyme activity and genetic mutation testing, males with G6PD mutations had significantly lower enzyme activity than that of females with G6PD mutations(P < 0.001). Specifically, among newborns carrying the mutations c.1388G>A, c.1376G>T, c.95A>G, c.1024C>T or c.871G>A, males consistently exhibited lower enzymatic activity than females with the same mutations (P < 0.001). Furthermore, in male G6PD-deficient newborns, the enzyme activity levels in those carrying c.1388G>A, c.1376G>T, c.95A>G, c.1024C>T, or c.871G>A were lower than those in both the control group and the c.519C>T group (P < 0.05).
CONCLUSION
This study provides a comprehensive profile of G6PD deficiency incidence and mutation spectrum in the Guilin region. By analyzing enzyme activity and genetic mutation results, this study provides insights into potential intervention strategies and personalized management approaches for the prevention and treatment of neonatal G6PD deficiency in the region.
Humans
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Infant, Newborn
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Glucosephosphate Dehydrogenase Deficiency/epidemiology*
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Glucosephosphate Dehydrogenase/genetics*
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Female
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Male
;
Mutation
;
China/epidemiology*
5.Successful in situ 5-aminolevulinic acid photodynamic therapy in a 53-year-old female with cutaneous squamous cell carcinoma.
Limin LUO ; Xiaoling JIANG ; Jianjun QIAO ; Hong FANG ; Jun LI
Journal of Zhejiang University. Science. B 2025;26(9):915-922
Basal cell carcinoma (BCC) and cutaneous squamous cell carcinoma (cSCC), as certain forms of non-melanoma skin cancer (NMSC) or keratinocyte carcinoma, are the most common forms of malignant neoplasms worldwide (Sharp et al., 2024). BCC and cSCC have been identified as two major components of NMSC, comprising one-third of all malignancies (Burton et al., 2016). Generally speaking, patients with NMSC tend to have relatively favorable survival outcomes, while different histopathological subtypes of NMSC exhibit distinct biological behaviors (Stătescu et al., 2023). Keratinocyte carcinoma, although not considered as deadly as melanoma, tends to metastasize if left untreated (Civantos et al., 2023; Nanz et al., 2024). cSCC can evolve locally, then aggressively metastasize, invade, and even lead to fatal consequences in a subset of patients (Winge et al., 2023). A solid, pigmented, smooth plaque or a hyperkeratotic papule with or without central ulceration and hemorrhage appears to be characteristic of cSCC (Thompson et al., 2016; Zhou et al., 2023). Of note, a rare type of intraepidermal cSCC in situ often appears as a velvety, demarcated, slightly raised erythematous plaque on the genitalia of men (Yamaguchi et al., 2016). Accounting for approximately 16.0% of scalp tumors and with a rising incidence, cSCC is now the second most common NMSC in humans (Verdaguer-Faja et al., 2024). According to the latest statistics, up to 2%‒5% of cSCCs in situ may gradually progress into invasive cSCCs in the final step (Rentroia-Pacheco et al., 2023). Several risk factors for the carcinogenesis and development of cSCC have been identified, including age, accumulative exposure to ultraviolet light radiation A and B, human papillomavirus infection, arsenic ingestion, chronic scarring, xeroderma pigmentosa, a relevant history of ionizing radiation, androgenetic alopecia in males, and immunosuppression therapy (Martinez and Otley, 2001; Welsch et al., 2012; Mortaja and Demehri, 2023).
Humans
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Aminolevulinic Acid/therapeutic use*
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Skin Neoplasms/pathology*
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Photochemotherapy/methods*
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Female
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Carcinoma, Squamous Cell/pathology*
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Middle Aged
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Photosensitizing Agents/therapeutic use*
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Carcinoma, Basal Cell/drug therapy*
6.Impact of Laboratory Analytical Indicators on Positive Blood Culture Detection Rates: A Single Center Study.
Di WANG ; Ling Li LIU ; Rui Rui MA ; Li Jun DU ; Gui Xue CHENG ; Ya Li LIU ; Qiao Lian YI ; Ying Chun XU
Biomedical and Environmental Sciences 2025;38(3):303-312
OBJECTIVE:
Blood culture remains the gold standard for diagnosing bloodstream infections. Clinical laboratories must ensure the quality of blood culture processes from receipt to obtaining definitive results. We examined laboratory analytical indicators associated with positive blood culture results.
METHODS:
Blood cultures collected from Peking Union Medical College Hospital between January 1, 2020, and December 31, 2022, were retrospectively analyzed. The mode of transportation (piping logistics delivery vs. staff), source of blood cultures (outpatient/emergency department vs. inpatient department), rotation of personnel, and time of reception (8:00-19:59 vs. 20:00-07:59) were compared between blood culture-positive and -negative results.
RESULTS:
Between 2020 and 2022, the total positive rate of blood culture was 8.07%. The positive rate of blood cultures in the outpatient/emergency department was significantly higher than that in the inpatient department (12.46% vs. 5.83%; P < 0.0001). The time-to-detection of blood cultures was significantly affected by the delivery mode and personnel rotation. The blood culture positive rate of the total pre-analytical time within 1 h was significantly higher than that within 1-2 h or > 2 h ( P < 0.0170).
CONCLUSION
Laboratory analytical indicators such as patient source, transportation mode, and personnel rotation significantly impacted the positive detection rate or time of blood culture.
Blood Culture/statistics & numerical data*
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Humans
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Retrospective Studies
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Emergency Service, Hospital/statistics & numerical data*
7.Synaptic Vesicle Glycoprotein 2A Slows down Amyloidogenic Processing of Amyloid Precursor Protein via Regulating Its Intracellular Trafficking.
Qian ZHANG ; Xiao Ling WANG ; Yu Li HOU ; Jing Jing ZHANG ; Cong Cong LIU ; Xiao Min ZHANG ; Ya Qi WANG ; Yu Jian FAN ; Jun Ting LIU ; Jing LIU ; Qiao SONG ; Pei Chang WANG
Biomedical and Environmental Sciences 2025;38(5):607-624
OBJECTIVE:
To reveal the effects and potential mechanisms by which synaptic vesicle glycoprotein 2A (SV2A) influences the distribution of amyloid precursor protein (APP) in the trans-Golgi network (TGN), endolysosomal system, and cell membranes and to reveal the effects of SV2A on APP amyloid degradation.
METHODS:
Colocalization analysis of APP with specific tagged proteins in the TGN, ensolysosomal system, and cell membrane was performed to explore the effects of SV2A on the intracellular transport of APP. APP, β-site amyloid precursor protein cleaving enzyme 1 (BACE1) expressions, and APP cleavage products levels were investigated to observe the effects of SV2A on APP amyloidogenic processing.
RESULTS:
APP localization was reduced in the TGN, early endosomes, late endosomes, and lysosomes, whereas it was increased in the recycling endosomes and cell membrane of SV2A-overexpressed neurons. Moreover, Arl5b (ADP-ribosylation factor 5b), a protein responsible for transporting APP from the TGN to early endosomes, was upregulated by SV2A. SV2A overexpression also decreased APP transport from the cell membrane to early endosomes by downregulating APP endocytosis. In addition, products of APP amyloid degradation, including sAPPβ, Aβ 1-42, and Aβ 1-40, were decreased in SV2A-overexpressed cells.
CONCLUSION
These results demonstrated that SV2A promotes APP transport from the TGN to early endosomes by upregulating Arl5b and promoting APP transport from early endosomes to recycling endosomes-cell membrane pathway, which slows APP amyloid degradation.
Amyloid beta-Protein Precursor/genetics*
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Membrane Glycoproteins/genetics*
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Animals
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Protein Transport
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Nerve Tissue Proteins/genetics*
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Humans
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Mice
;
Endosomes/metabolism*
;
trans-Golgi Network/metabolism*
8.Changes of Doppler ultrasound parameters in patients with acute lower extremity deep venous thrombosis receiving thrombolytic therapy and their relationship with prognosis
Jun QIAO ; Wenlong SONG ; Jin LI ; Qiaoling WU
Chongqing Medicine 2025;54(9):2079-2084
Objective To explore the relationship the changes of Doppler ultrasound parameters before and after thrombolytic therapy in the patients with acute lower extremity deep venous thrombosis and the prognosis.Methods A total of 100 patients with acute lower extremity deep venous thrombosis from Decem-ber 2022 to December 2024 were enrolled,given the thrombolytic therapy and received Doppler ultrasound ex-amination before and after treatment.The sonographic manifestations of the affected side detected by color Doppler ultrasound before treatment were statistically analyzed,and the changes of Doppler ultrasound param-eters of the affected side[end-diastolic velocity(EDV),peak systolic velocity(PSV),vascular resistance index(RI),vascular diameter at the lesion site]were compared between before and after treatment.According to whether pulmonary embolism occurred after thrombolysis,the patients were divided into the embolization group(n=29)and non-embolization group(m=71).The Doppler ultrasound parameters of the affected side before treatment were compared between the two groups.The binary logistic equation was adopted to analyze the related influencing factors of pulmonary embolism occurrence in the patients.The receiver operating char-acteristic(ROC)curve was used to analyze the predictive value of ultrasound parameters on pulmonary em-bolism.Results After thrombolytic therapy for the affected limb with acute lower extremity deep venous thrombosis,EDV,PSV and vascular diameter at the lesion site were decreased significantly,RI was increased significantly(P<0.05).Before treatment,EDV.PSV,vascular diameter and the proportion of thrombus grade Ⅳ at the lesion site in the embolization group were significantly higher than those in the non-emboliza-tion group,the RI was significantly lower than that in the non-embolization group(P<0.05).EDV,PSV,RI and the vascular diameter at the lesion site all were related to the occurrence of pulmonary embolism(P<0.05).The areas under the curves(AUC)of SEDV,PSV,RI and vascular diameter at the lesion site in predic-ting the pulmonary embolism occurrence in the patients with acute lower extremity deep venous thrombosis were 0.690,0.717,0.649 and 0.662 respectively.The AUC of the 4-items combination in diagnosing the poor prognosis of the patients was 0.829,and the combined diagnostic value was higher.Conclusion EDV,PSV,vascular diameter and RI could predict the risk of pulmonary embolism occurrence after thrombolytic therapy in the patients with acute lower extremity deep venous thrombosis.
9.Attentional bias for cancer-related stimuli in breast cancer survivors with fear of cancer recurrence
Rongqian LIU ; Li PENG ; Yanli CHEN ; Ying YANG ; Jia XIAO ; Jun JIANG ; Chen XU ; Qiao ZHANG ; Min LI
Journal of Army Medical University 2025;47(4):360-368
Objective To investigate the characteristics of attentional bias towards cancer-related stimuli in breast cancer patients with fear of cancer recurrence(FCR)under subthreshold and suprathreshold stimulus conditions.Methods A total of 94 female breast cancer patients admitted in First Affiliated Hospital of Army Medical University from September 2022 to March 2023 were recruited to complete the Fear of Cancer Recurrence Inventory-Short Form(FCRI-SF)and the dot-probe task.According to the FCRI-SF cut-off score of 13,they were divided into clinical and non-clinical FCR groups,with 47 cases in each group.One-sample t-test and repeated-measures ANOVA were used to statistically analyze the subjects in the 2 groups in terms of attentional bias score,attentional orienting score and attentional disengagement difficulty score.Results The patients in the clinical FCR group showed a significant attentional bias toward cancer-related negative words(P<0.05).Under the subthreshold stimulus condition,its main component was attentional orienting to cancer-related negative words(P<0.05).In the suprathreshold stimulus condition,the main components were attentional orienting to neutral words matched by cancer-related negative words and difficulty in attentional disengagement from cancer-related negative words as well as attentional avoidance for cancer-related positive words(P<0.05).Conclusion Breast cancer patients with clinical FCR have an attentional bias toward cancer-related negative stimuli.Reducing their attention to cancer-related negative stimuli may be an effective measure to reduce FCR level in the patients.
10.Cloning and interacted protein identification of AP1 homologous gene from Lonicera macranthoides
Ya-xin YU ; Li-jun LONG ; Chang-zhu LI ; Hui-jie ZENG ; Zhong-quan QIAO ; Si-si LIU ; Ying-zi MA
Acta Pharmaceutica Sinica 2024;59(10):2880-2888
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