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

Objective:To evaluate the effect of the positive P-glycoprotein expression on the efficacy of patient-controlled intravenous analgesia (PCIA) with sufentanil or pentazocine in patients with cancer pain.Methods:This was a retrospective cohort study. The medical records of patients with cancer pain of either sex, aged 54-71 yr, weighing 49-67 kg, with TNM stage Ⅱ-Ⅳ, who were treated in People′s Hospital of Lishui from January 2020 to January 2024, were collected. The expression of P-glycoprotein in tumor tissues was determined by the immunohistochemical method. Patients with negative P-glycoprotein expression in tumor tissues were divided into 2 groups: sufentanil group (group S 1) and pentazocine group (group P 1). Patients with positive P-glycoprotein expression in tumor tissues were divided into 2 groups: sufentanil group (group S 2) and pentazocine group (group P 2). The patients in 4 groups received 48 h of PCIA when visual analogue scale > 5 cm. The PCIA solution contained sufentanil 2 μg/kg and tropisetron 10 mg in 100 ml of normal saline in S 1 and S 2 groups or pentazocine 3 mg/kg+ tropisetron 10 mg in 100 ml of normal saline in P 1 and P 2 groups. The PCIA pump was set up to deliver a 1 ml bolus dose with a 10-min lockout interval and background infusion at 2 ml/h after a loading dose of 5 ml. Flurbiprofen 50 mg was intravenously injected when visual analogue scale > 3 cm during analgesia. The consumption of sufentanil, pentazocine and flurbiprofen within 4 h, >4-12 h, > 12-24 h and > 24-48 h of PCIA was recorded. The occurrence of adverse reactions such as respiratory depression (SpO 2<90%), nausea or/and vomiting, pruritus and bradycardia was recorded. Results:One hundred patients were finally included, with 25 in each group. There was no significant difference in the consumption of sufentanil, usage rate of flurbiprofen and incidence of respiratory depression, nausea and vomiting, pruritus and bradycardia during analgesia at each time period during PCIA between group S 1 and group S 2 ( P>0.05). Compared with group P 1, the consumption of pentazocinein was significantly increased within 4 h, > 4-12 h, and > 24-48 h of PCIA ( P<0.05), and no significant change was found in the usage rate of flurbiprofen at each time period and the incidence of respiratory depression, nausea or/and vomiting, pruritus and bradycardia during analgesia in group P 2 ( P>0.05). Conclusions:Positive P-glycoprotein expression may weaken the efficacy of PCIA with pentazocine, but exerts no effect on the efficacy of PCIA with sufentanil in patients with cancer pain.

Objective:To investigate the value of artificial intelligence (AI) cytomorphologic analysis system in the cytomorphological diagnosis and therapeutic evaluation of acute myeloid leukemia (AML).Methods:Bone marrow smear samples were collected from 150 patients with newly diagnosed and treated acute myeloid leukemia who were inpatients and outpatients at the Department of Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College from June 1, 2021 to July 31, 2022 for retrospective analysis. Among them, there were 50 patients in the newly diagnosed group, including 28 males and 22 females, with the onset age of 43.5(32.3,58.8)years. There were 100 patients in the post-treatment group, including 36 males and 64 females, with the onset age of 34.5(23.0,47.0)years. The results from cytomorphology expert were used as the gold standard and the Python 3.6.7 was used for analysis to evaluate the accuracy, sensitivity, and specificity of the AI cytomorphologic analysis system for blast cell recognition in AML diagnosis and treatment.Results:The proportion of blasts in AI analysis of 50 samples in the newly diagnosed group was≥20%, which met the diagnostic criteria of AML. AI analysis of blasts had an accuracy of 90.3%, sensitivity of 85.5%, and specificity of 98.0%. The correlation coefficient between AI and the proportion of blasts analyzed by experts was positively correlated( r=0.882, P<0.001). Meanwhile, in the post-treatment group, the sensitivity and specificity of AI analysis of blasts were 89.7% and 99.2%, respectively. The correlation coefficient between AI and the proportion of blasts analyzed by experts was positively correlated( r=0.957, P<0.001). According to AI analysis data, there are 8 samples in this group whose AI efficacy evaluation results on AML are inconsistent with expert analysis. Conclusion:AI cytomorphologic analysis system has high accuracy, sensitivity and specificity for blast cell recognition in AML morphological diagnosis and therapeutic evaluation.

Anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis is an autoimmune encephalitis mediated by anti-NMDAR antibody. Current studies have found that most patients with anti-NMDAR encephalitis have a good prognosis after immunotherapy and tumor therapy, but there are still 4.5%-36.4% patients with relapse. It is important to identify the risk factors for the prevention of relapse. This article aims to review the relapse risk factors of NMDAR encephalitis in order to provide help for the prevention of relapse.

Objective:To explore the effect of high intensity interval training (HIIT) on cardiac rehabilitation in patients after heart transplantation.Methods:According to the search terms, the search was conducted on China National Knowledge Infrastructure, VIP, WanFang Data, China Biology Medicine disc, Web of Science, PubMed, Cochrane Library, Embase, and EBSCO. The search time limit was from the establishment of the database to January 31, 2022. After 2 researchers screened the article, extracted information, and evaluated the quality, a Meta-analysis was conducted using RevMan 5.4 software.Results:According to the inclusion and exclusion criteria, 10 English articles were selected, including 191 patients in the intervention group and 212 patients in the control group, with a total of 403 patients. Meta-analysis showed that during cardiac rehabilitation exercise in patients after heart transplantation, HIIT could improve peak oxygen uptake in cardiopulmonary function exercise testing [ MD=1.98, 95% confidence interval ( CI) (0.55, 3.41), P=0.007], peak heart rate in chronotropic responses [ MD=6.93, 95% CI (2.62, 11.24), P=0.002], and muscle exercise ability [ MD=337.18, 95% CI (12.02, 62.35), P=0.04]. There was no statistically significant difference in systolic blood pressure, diastolic blood pressure, peak systolic blood pressure, peak diastolic blood pressure, resting heart rate and respiratory exchange rate between the two groups ( P>0.05). A subgroup analysis of peak oxygen uptake was conducted based on the intervention period and the start time of rehabilitation exercise after heart transplantation. The results showed that there were statistically significant differences in peak oxygen uptake between the intervention group and the control group when the intervention period was ≤ 12 weeks or the start time was > 6 weeks ( P<0.01) . Conclusions:HIIT effectively improves the peak oxygen uptake, peak heart rate, and muscle exercise activity of patients after heart transplantation. HIIT has a significant impact on peak oxygen uptake when the rehabilitation exercise start time after heart transplantation is > 6 weeks or the intervention period is ≤ 12 weeks.

Anti-N-methyl-D-aspartate receptor (NMDAR) encephalitis is an autoimmune encephalitis mediated by anti-NMDAR antibody. At present, the pathogenesis of the disease is not completely clear, and reliable animal models are of great significance for the study of its pathogenesis and pathophysiological process. The authors reviewed the reports of anti-NMDAR encephalitis′s animal models in recent years, and discussed the advantages and limitations of each model, in order to provide a more suitable animal model for further research on anti-NMDAR encephalitis.

Objective:To explore the association analysis of clinical characteristics and prognoses with cerebrospinal fluid antibody titer in patients with anti N-methyl- D-aspartic acid (NMDA) receptor encephalitis. Methods:Thirty-eight patients with anti-NMDA receptor encephalitis, admitted to our hospital from June 2014 to March 2019, were chosen. According to the titer results of anti-NMDA receptor antibodies reported by the first cerebrospinal fluid specimens, they were divided into low antibody titer group (antibody titer 1:10 and 1:32) and high antibody titer group (antibody titer 1:100 and 1:320). The clinical characteristics and prognoses of these patients were compared.Results:Of these 38 patients, 14 were into the group of low antibody titer, and 24 were into the group of high antibody titer. Patients in the low antibody titer group had significantly higher incidences of headache and laloplegia, and statistically lower serum antibody positive rate ( P<0.05). There were no significant differences between the two groups in other prodromal symptoms including fever, respiratory symptoms and life events, other common clinical manifestations including psychobehavioral abnormalities or cognitive impairment, seizures, motor disorders and decreased consciousness level, staying in ICU or not, intubating endotracheal tube or not, length of stay in ICU, time from symptom onset to definite diagnosis, and occurrence of complications, skull MRI, EEG, and lab results, modified Rankin scale (mRS) scores at discharge, time required to recover to mRS score of 0-1 after discharge, and mRS scores at follow-up. Conclusion:Cerebrospinal fluid antibody titer has limited significance in evaluating disease severity and guiding diagnosis and treatment in patients with anti-NMDA receptor encephalitis at acute stage.

Objective To establish a LC-MS/MS method for the determination of salidroside in the capsule. Methods An electrospray ionization and multiple reaction detection were used to detect negative ion. Theophylline was used as standard. The detection ions of salidroside and theophylline used for quantitative analysis were m/z 299.0→119.0, and m/z 178.8→164.0, respectively. The Shim-pack XR-ODS (3.0 mm×75 mm, 2.0 μm) column was used for separation. The mobile phase was acetonitrile: 5 mmol/L ammonium acetate solution (90∶10, V/V). The flow rate was 0.40 ml/min. The column temperature was 25 ℃. Results The content of salidroside was analyzed within 3 minutes. The linear range was 10–2 000 ng/ml, and the minimum detection limit was 10 ng/ml. Conclusion The method has good repeatability, high sensitivity, fast analysis speed and simple operation. It can be used as a method for the determination of salidroside in the capsule. It is suitable for the quality inspection of drugs and convenient for safe use.

Objective:To explore the laboratory characteristics and diagnostic methods for therapy-related acute megakaryocytic leukemia (t-AMKL).Methods:The data of one child with acute lymphoblastic leukemia (ALL) in the Blood Disease Hospital of Chinese Academy of Medical Sciences & Peking Union Medical College in September 2014 was retrospectively analyzed. After inducing remission for more than 43 months, the child was diagnosed as t-AMKL.Results:After the diagnosis of ALL, the child was given chemotherapy with standard childhood ALL regimen. After 43 months, t-AMKL was diagnosed by comprehensive morphology, cytogenetics, and molecular biology. Bone marrow morphology showed that the proportion of primitive cells was 0.44; flow cytometry showed the phenotype was abnormal myeloid primitive cells; the pathology result showed that the abnormal cells weakly expressed CD42b and CD61; the electron microscopy showed platelet peroxidase (PPO)-positive and myeloperoxidase (MPO)-negative; the bone marrow immunohistochemistry showed the positive rate of CD41 was 34%; the child had a complex karyotype. After reviewing his medical history, he was diagnosed as t-AMKL.Conclusion:The t-AMKL is relatively rare, and it is helpful to improve the prognosis of patients by completing the relevant examinations for early diagnosis.

Objective: To explore the clinical implications and prognostic value of TP53 gene mutation and deletion in patients with myelodysplastic syndromes (MDS) . Methods: 112-gene targeted sequencing and interphase fluorescence in situ hybridization (FISH) were used to detect TP53 mutation and deletion in 584 patients with newly diagnosed primary MDS who were admitted from October 2009 to December 2017. The association of TP53 mutation and deletion with several clinical features and their prognostic significance were analyzed. Results: Alterations in TP53 were found in 42 (7.2%) cases. Of these, 31 (5.3%) cases showed TP53 mutation only, 8 (1.4%) cases in TP53 deletion only, 3 (0.5%) cases harboring both mutation and deletion. A total of 37 mutations were detected in 34 patients, most of them (94.6%) were located in the DNA binding domain (exon5-8) , the remaining 2 were located in exon 10 and splice site respectively. Patients with TP53 alterations harbored significantly more mutations than whom without alterations (z=-2.418, P=0.016) . The median age of patients with TP53 alterations was higher than their counterparts[60 (21-78) years old vs 52 (14-83) years old, z=-2.188, P=0.029]. TP53 alterations correlated with complex karyotype and International prognostic scoring system intermediate-2/high significantly (P<0.001) . Median overall survival of patients with TP53 alterations was shorter than the others[13 (95%CI 7.57-18.43) months vs not reached, χ²=12.342, P<0.001], while the significance was lost during complex karyotype adjusted analysis in multivariable model. Conclusion TP53 mutation was more common than deletion in MDS patients. The majority of mutations were located in the DNA binding domain. TP53 alterations were strongly associated with complex karyotype and always coexisted with other gene mutations. TP53 alteration was no longer an independent prognostic factor when complex karyotype were occurred in MDS.