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

Objectives: To investigated the safety and efficacy of treating patients with acute non-ST-segment elevation myocardial infarction (NSTEMI) and elevated levels of N-terminal pro-hormone B-type natriuretic peptide (NT-proBNP) with levosimendan within 24 hours of first medical contact (FMC). Methods: This multicenter, open-label, block-randomized controlled trial (NCT03189901) investigated the safety and efficacy of levosimendan as an early management strategy of acute heart failure (EMS-AHF) for patients with NSTEMI and high NT-proBNP levels. This study included 255 patients with NSTEMI and elevated NT-proBNP levels, including 142 males and 113 females with a median age of 65 (58-70) years, and were admitted in the emergency or outpatient departments at 14 medical centers in China between October 2017 and October 2021. The patients were randomly divided into a levosimendan group (n=129) and a control group (n=126). The primary outcome measure was NT-proBNP levels on day 3 of treatment and changes in the NT-proBNP levels from baseline on day 5 after randomization. The secondary outcome measures included the proportion of patients with more than 30% reduction in NT-proBNP levels from baseline, major adverse cardiovascular events (MACE) during hospitalization and at 6 months after hospitalization, safety during the treatment, and health economics indices. The measurement data parameters between groups were compared using the t-test or the non-parametric test. The count data parameters were compared between groups using the χ² test. Results: On day 3, the NT-proBNP levels in the levosimendan group were lower than the control group but were statistically insignificant [866 (455, 1 960) vs. 1 118 (459, 2 417) ng/L, Z=-1.25,P=0.21]. However, on day 5, changes in the NT-proBNP levels from baseline in the levosimendan group were significantly higher than the control group [67.6% (33.8%,82.5%)vs.54.8% (7.3%,77.9%), Z=-2.14, P=0.03]. There were no significant differences in the proportion of patients with more than 30% reduction in the NT-proBNP levels on day 5 between the levosimendan and the control groups [77.5% (100/129) vs. 69.0% (87/126), χ²=2.34, P=0.13]. Furthermore, incidences of MACE did not show any significant differences between the two groups during hospitalization [4.7% (6/129) vs. 7.1% (9/126), χ²=0.72, P=0.40] and at 6 months [14.7% (19/129) vs. 12.7% (16/126), χ²=0.22, P=0.64]. Four cardiac deaths were reported in the control group during hospitalization [0 (0/129) vs. 3.2% (4/126), P=0.06]. However, 6-month survival rates were comparable between the two groups (log-rank test, P=0.18). Moreover, adverse events or serious adverse events such as shock, ventricular fibrillation, and ventricular tachycardia were not reported in both the groups during levosimendan treatment (days 0-1). The total cost of hospitalization [34 591.00(15 527.46,59 324.80) vs. 37 144.65(16 066.90,63 919.00)yuan, Z=-0.26, P=0.80] and the total length of hospitalization [9 (8, 12) vs. 10 (7, 13) days, Z=0.72, P=0.72] were lower for patients in the levosimendan group compared to those in the control group, but did not show statistically significant differences. Conclusions: Early administration of levosimendan reduced NT-proBNP levels in NSTEMI patients with elevated NT-proBNP and did not increase the total cost and length of hospitalization, but did not significantly improve MACE during hospitalization or at 6 months.
Male ; Female ; Humans ; Aged ; Natriuretic Peptide, Brain ; Simendan/therapeutic use* ; Non-ST Elevated Myocardial Infarction ; Heart Failure/drug therapy* ; Peptide Fragments ; Arrhythmias, Cardiac ; Biomarkers ; Prognosis

Objective:To study the risk factors of bronchopulmonary dysplasia (BPD) in extremely preterm/extremely low birth weight infants(EPT/ELBWIs).Methods:From June 2019 to March 2022, clinical data of EPT/ELBWIs with gestational age <28 weeks or birth weight <1 000 g admitted to NICU of our hospital were retrospectively analyzed. They were assigned into BPD group and non-BPD group. Multivariate logistic regression analysis was used to find the independent risk factors for BPD and receiver operating characteristic (ROC) curve was used to determine the cut-off value for BPD. The incidences of BPD of the two groups were compared and the correlation between independent risk factors and BPD severity was analyzed.Results:A total of 82 EPT/ELBWIs were enrolled, including 47 (57.3%) in BPD group and 35 (42.7%) in non-BPD group. The BPD group had longer duration of both invasive and non-invasive mechanical ventilation (MV) [24.0(8.0, 38.0)d vs. 6.0 (0.2, 11.6)d, (38.4±14.5)d vs. (32.4±10.9)d], lower birth weight [906 (800, 970)g vs. 980 (880, 1 050)g],higher incidences of ureaplasma urealyticum colonization (48.9% vs. 22.9%) and hemodynamically significant patent ductus arteriosus (hsPDA) (76.6% vs. 51.4%) than the non-BPD group(all P<0.05). Multivariate logistic regression analysis showed that the independent risk factor for BPD was the duration of invasive MV ( OR=1.003, 95% CI 1.001-1.005). The cut-off value of invasive MV duration for predicting BPD was 14.4 d. The duration of invasive MV was positively correlated with BPD severity ( r=0.604, P<0.001). Conclusions:BPD is more likely to occur in EPT/ELBWIs with longer duration of invasive MV.

Eosinophilia/genetics* ; Gene Rearrangement ; Humans ; Myeloproliferative Disorders/genetics* ; Neoplasms ; Oncogene Proteins, Fusion/genetics* ; Receptor, Platelet-Derived Growth Factor alpha/genetics*

Objective: To evaluate the efficacy of the Hodgkin lymphoma (HL)-2013 regimen in the treatment of children with HL, and to investigate the prognostic factors of childhood HL. Methods: Clinical data of 145 children (aged ≤18 years) with newly diagnosed HL, treated with HL-2013 regimen in 8 tertiary referral centers for childhood cancer from August 2011 to April 2021 were analyzed retrospectively. All the diagnosis were confirmed by histopathological morphology and immunohistochemical examination. The clinical characteristics and treatment outcomes were summarized, and the patients were divided into different groups according to clinical characteristics. Kaplan-Meier method was used for survival analysis, and the comparison of survival rates between groups was performed with Log-rank test. Results: Of the 145 cases, there were 115 males and 30 females, the age at diagnosis was 7.9 (5.8, 10.6) years. Cervical lymph node enlargement (114 cases, 78.6%) was the common symptom of the disease, and 57 patients (39.3%) were accompanied by large masses. The most common pathological classification was mixed cell type (93 cases, 64.1%). According to the Ann Arbor staging system, there were 9 cases of stage Ⅰ, 62 cases of stage Ⅱ, 45 cases of stage Ⅲ, 29 cases of stage Ⅳ. According to the risk stratification: there were 14 cases of low-risk group, 76 cases of medium-risk group and 55 cases of high-risk group. Of all patients, 68 cases (46.9%) achieved an early complete remission (CR) after 2 courses of chemotherapy, and the CR rate was 93.8% (136/145) after first-line treatment. Disease recurrence or progression occurred in 22 cases (15.2%). Of all patients, 125 cases survived, 6 cases died and 14 cases were lost to follow-up. Among the survived cases, 123 cases were continuously at CR state,and the follow-up time was 55 (40, 76) months. The 5-year overall survival (OS) and event free survival (EFS) rates were (95.3±1.9)% and (84.2±3.0)% for the entire group, respectively. 5-year OS and EFS rates for patients with stage Ⅲ-Ⅳ were both lower than those for patients with stage Ⅰ-Ⅱ (χ²=6.28 and 7.58, both P<0.05), the 5-year OS and EFS rates for patients in high-risk group were both lower than those for patients in low-risk and medium-risk group (χ²=10.93, 7.79, both P<0.05). The 5-year OS rates for the patient with early CR and without early CR were 100.0% and (90.9±3.6)% (χ²=5.77, P=0.016). EFS rates for the patient with early CR (68 cases) and without early CR (77 cases) were (93.8±3.0)% and (75.8±5.0)% (χ²=8.78, P=0.003). Conclusions: HL-2013 regimen is significantly effective in the treatment of pediatric HL. However, the patients in high-risk group and those without early CR are prone to disease recurrence or progression. Stage Ⅲ-Ⅳ and without early CR were associated with worse prognosis.
Child ; Female ; Male ; Humans ; Hodgkin Disease ; Retrospective Studies ; Neoplasm Recurrence, Local ; China ; Antineoplastic Combined Chemotherapy Protocols ; Prognosis ; Disease-Free Survival

Objective: To select the preferred flaps for the reconstruction of different maxillary defects and to propose a new classification of maxillary defects. Methods: A total of 219 patients (136 males and 83 females) underwent the simultaneous reconstruction of maxillary defects in the Beijing Tongren Hospital, Capital Medical University, between January 2005 and December 2018 were reviewed. Age ranged from 16 to 78 years. Based on the proposed new classification of the maxillary defects, 22 patients with class Ⅰ defects (inferior maxillectomy), 44 patients with class Ⅱ defects (supperior maxillectomy), 132 patients with class Ⅲ defects (total maxillectomy) and 21 patients with class Ⅳ defects (extensive maxillectomy) were enrolled. Survival rate, functional and aesthetic outcomes of flaps were evaluated. Survival analysis was performed in 169 patients with malignant tumor, Kaplan-Meier method was used to calculate the survival rate, and Log-rank method was used to compare the difference of survival rate in each group. Results: A total of 234 repairs for maxillary defects were performed in 219 patients. Fibula flaps were used in 4/13 of class Ⅰ defects; temporal muscle flaps (11/24, 45.8%) and anterolateral thigh flaps (6/24, 25.0%) used in class Ⅱ defects; temporal muscle flaps (71/128, 55.5%), anterolateral thigh flaps (6/24, 25.0%) and fibula flaps (12/128, 9.4%) used in class Ⅲ defects; and anterolateral thigh flaps (8/20, 40.0%) and rectus abdominis flaps (8/20, 40.0%) used in class Ⅳ defects. The success rate of local pedicled flaps was 95.6% (109/114) and that of free flaps was 95.8% (115/120). Thrombosis(10/234,4.3%) was a main reason for repair failure. Among the followed-up 88 patients, swallowing and speech functions recovered, 82 (93.2%) of them were satisfied with appearance, and 75 (85.2%) were satisfied with visual field. The 3-year and 5-year overall survival rates were 66.5% and 63.6%, and the 3-year and 5-year disease-free survival rates were 57.1% and 46.2%, respectively, in the 169 patients with malignant tumors. Conclusion: A new classification of maxillary defects is proposed, on which suitable flaps are selected to offer patients good functional and aesthetic outcomes and high quality of life.
Adolescent ; Adult ; Aged ; Female ; Free Tissue Flaps ; Humans ; Male ; Maxilla/surgery* ; Middle Aged ; Quality of Life ; Reconstructive Surgical Procedures ; Young Adult

At present, the issues regarding multi-center clinical trials of new drugs of traditional Chinese medicine(TCM) remain: the lack of agreement on the content and scope of the ethical review among the ethics committee members of the center and the participating units results in repeated review, which leads to a time-consuming ethical review process. Moreover, the review capabilities of the ethics committees of various research centers are uneven, which is not necessarily beneficial to the protection of subjects' rights and safety. In view of the existing problems, to improve the efficiency of ethical review of multi-center clinical trials of new drugs of TCM and avoid repeated reviews, the TCM Clinical Evaluation Professional Committee of Chinese Pharmaceutical Association organized experts to formulate the "Consensus on collaborative ethical review of multi-center clinical trials of new drugs of TCM(version 1.0)"(hereinafter referred to as "Consensus"). The "Consensus" is formulated in accordance with the requirements of relevant documents such as but not limited to "the opinions on deepening the reform of the evaluation and approval system to encourage the innovation of pharmaceutical medical devices", "the regulations of ethical review of biomedical research involving human subjects". The "Consensus" covers the scope of application, formulation principles, conditions for the ethics committee of the center, sharing of ethical review resources, scope and procedure of collaborative review, rights and obligations, etc. The aims of the "Consensus" is to preliminarily explore and establish a scientific and operable ethical review procedure. Additionally, on the basis of fully protecting the rights and interests of the subjects, a collaborative ethical review agreement needs to be signed to clarify the ethical review responsibilities of all parties, to avoid repeated review, and to improve the efficiency and quality of ethical review in multi-center clinical trials of new drugs of TCM.
Biomedical Research ; Clinical Trials as Topic ; Consensus ; Drugs, Chinese Herbal ; Ethical Review ; Humans ; Medicine, Chinese Traditional ; Multicenter Studies as Topic ; Pharmaceutical Preparations

Objective: To investigate the characteristics of thyroid invasion and central lymph node metastasis of hypopharyngeal carcinoma, and the impact on survival rate and quality of life. Methods: A retrospective analysis of 124 cases (122 males and 2 females with age range from 36 to 78 years old) with laryngopharyngeal squamous cell carcinoma who were initially treated in the Department of Head and Neck Surgery, Beijing Tongren Hospital Affiliated to Capital Medical University from January 2014 to December 2017 was performed. The clinical data included tumor location, pathological T stage, pathological N stage, invasion of thyroid gland, central lymph node metastasis, surgical procedures and so on. Patients were grouped according to if presence of thyroid invasion and central lymph node metastasis. With follow-up, the survival was analyzed by Kaplan-Meier method, and tumor recurrence and metastasis were evaluated. Results: Of the patients, 12 patients had thyroid involvement and 5 patients had central lymph node metastasis. The incidence of thyroid involvement was 8.16% (8/98) in pyriform sinus, 1/18 in posterior pharyngeal wall and 3/8 in posterior cricoid wall, with statistically significant difference (χ²=15.076,P=0.008). The incidence of central lymph node metastasis was 1.02% (1/98) in pyriform sinus, 3/18 in posterior pharyngeal wall and 1/8 in posterior cricoid wall, also with statistically significant difference (χ²=11.205, P=0.008). There was no statistical correlation between thyroid invasion or central lymph node metastasis and gender, smoking or alcohol exposure history and tumor pathological differentiation (all P>0.05). The 3-year overall survival rate was 80.65% and the 3-year recurrence free rate was 85.48%. Totally 24 patients died in 3 years, including 4 cases in thyroid invasion group and 1 case in central lymph node metastasis group. Local recurrence occurred in 18 patients, including 4 cases in thyroid invasion group and 1 case in central lymph node metastasis group. There was no significant difference in survival between patients with and without thyroid invasion and central lymph node metastasis (all P>0.05). There were significantly difference in 3-year overall survival and relapse-free survival among the groups with different T stages, N stages, pathological stages and tumor pathological differentiation levels (all P<0.05). There were significantly differences in the levels of serum calcium and FT3 between the groups with or without thyroid invasion and central lymph node metastasis (all P<0.05). Conclusion: The incidences of thyroid invasion and central lymph node metastasis of hypopharyngeal carcinoma are rare, and the risk of occurrence is related to the primary site of tumor. Comprehensive evaluation, correct decision-making and accurate treatment could be helpful to cure radically the tumor, to prevent recurrence and to improve the quality of life of patients.
Adult ; Aged ; Carcinoma, Squamous Cell/surgery* ; Female ; Head and Neck Neoplasms ; Humans ; Lymph Nodes ; Lymphatic Metastasis ; Male ; Middle Aged ; Neck Dissection ; Neoplasm Recurrence, Local ; Quality of Life ; Retrospective Studies ; Thyroid Gland ; Thyroid Neoplasms/surgery*

Objective: To compare the clinical application results of the FPTF (free posterior tibial artery perforator flap) and RFFF (radial forearm free flap) for reconstruction of head and neck defects. Methods: A retrospective analysis of 27 cases treated with FPTF (19 males and 8 females, aged 14-69 years) and 24 cases with RFFF (11 males and 13 females, aged 22-69 years) for head and neck defect reconstruction at Beijing Tongren Hospital of Capital Medical University from January 2015 to December 2020 was conducted. Flap size, vascular pedicle length, matching degree of recipient area blood vessels, preparation time, total operation time, hospital stay, recipient area complications, donor area complications and scale-based patient satisfaction were compared between two groups of patients with FTPF and RFFF. SPSS 26.0 statistical software was used for statistical analysis. Results: There was no statistically significant difference between the two groups of patients in tumor T staging (P=0.38), primary sites (P=0.05) and mean flap areas ((53.67±29.84) cm² vs. (41.13±11.08) cm², t=-1.472, P=0.14). However the mean vascular pedicle length of FPTF was more than that of RFFF ((11.15±2.48)cm vs. (8.50±1.69)cm, t=-4.071, P<0.01). The donor sites of 4 patients in FPTF group could be sutured directly, while all the 24 patients in RFFF group received skin grafts from the donor sites. There was no statistically significant difference in the recipient area arteries between two groups of flaps (P=0.10), with more commonly using of the facial artery (RFFF: FPTF=21∶27), but there was significant difference in the recipient area veins (P<0.01), with more commonly using of the external jugular vein in RFFF (14/24) than FPTF (4/32) and the posterior facial vein in FPTF (27/32) than RFFF (9/24). There were 10 recipient complications and 3 donor complications in RFFF group; no recipient complication and 3 donor complications occurred in FPTF group. With patient's subjective evaluation of the donor site at 12 months after surgery, FPTF was better than RFFF (χ²=22.241, P<0.01). Conclusions: FPTF is an alternative to RFFF in head and neck reconstruction and has unique advantages in aesthetics and clinical application.
Female ; Forearm/surgery* ; Free Tissue Flaps ; Humans ; Male ; Perforator Flap ; Reconstructive Surgical Procedures ; Retrospective Studies ; Skin Transplantation ; Tibial Arteries/surgery*