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

Extended clinical trials are medical treatment activity based on the humanitarianism to provide new medical products during the clinical trials for specific patients who have no other effective medical means to prolong life or alleviate pain. Extensive clinical trials have both medical and scientific attributes, which are significantly different from registered clinical trials and require special ethical attention. At present, the extended clinical trials in China are still in the initial stage, laws, regulations and supporting management methods are not perfect, and there is a lack of experience in ethical governance of such special clinical trials. This paper took the expanded clinical trial of medical devices as an example, referred to the current laws and regulations at home and abroad, analyzed their characteristics, and put forward some suggestions on the ethical governance of the whole process of the expanded clinical trials of medical devices in China,including special concerns in the application and acceptance, the first review approval strategy and the key points in continuing review.

Research-oriented hospitals are the currently development direction of large hospitals, and their research ethics management has played an important role in China’s scientific and technological innovation and clinical research development through years of practice. However, at present, China’s overall scientific and technology ethics governance framework system is still incomplete, governance authority is insufficient, ethics committee members lack ethical professional technical training, and the awareness and understanding of science and technology ethics among medical staff still need to be improved, which indicates that the level of technology ethics governance in research-oriented hospitals needs to be improved. It is suggested to improve from the aspects of regulatory system, governance responsibilities, training of ethical practitioners, supervision and punishment measures, and ethical education of scientific and technological research talents, so as to better protect subjects and promote the construction of scientific and technological ethics in the research-oriented hospitals.

Objective:To assess the value of 18F-FDG PET/CT imaging and relevant factors in the interim therapeutic and prognostic evaluation of primary gastrointestinal lymphoma (PGIL) patients. Methods:From January 2008 to January 2018, 41 patients with B-cell PGIL (24 males, 17 females; age: 26-84 years) confirmed by pathology in Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine were retrospectively included. 18F-FDG PET/CT was performed before chemotherapy and radiotherapy and after 3-4 courses of chemotherapy. There were 17 cases of mucosa-associated lymphoid tissue (MALT) lymphoma and 24 cases of diffuse large B-cell lymphoma (DLBCL). Mann-Whitney U test was used to compare the differences of metabolic parameters (SUV max, metabolic tumor volume (MTV), total lesion glycolysis (TLG)) before treatment between MALT lymphoma and DLBCL patients. ROC curve analysis was used to analyze the predictive abilities of different parameters for progression-free survival (PFS), and Cox regression analysis was used to analyze the influencing factors for PFS. Results:The median follow-up time of 41 patients was 25 (6-84) months, with the 3-year PFS rate of 55.9% and the overall survival (OS) rate of 80.2%. The baseline SUV max (23.2±11.9), MTV (260.7(66.2, 740.7) cm 3) and TLG (1 902.9(592.2, 8 418.1) g) in DLBCL were significantly higher than those in MALT lymphoma (7.9(6.2, 9.8), 45.9(28.4, 104.2) cm 3, 121.1(72.8, 295.6) g; z values: -4.02, -3.10, -3.92, all P<0.05). ΔSUV max in DLBCL patients (AUC=0.80, P=0.012), ΔSUV max% (AUC=0.89, P=0.007; AUC=0.80, P=0.012), ΔMTV%(AUC=0.91, P=0.005; AUC=0.77, P=0.026) and ΔTLG% (AUC=0.87, P=0.011; AUC=0.77, P=0.026) in MALT lymphoma and DLBCL patients before and after treatment were predictive factors of PFS. Multivariate analysis showed that ΔSUV max% was an independent factor for PFS of MALT lymphoma (hazard ratio ( HR)=17.192, 95% CI: 2.035-145.245, P=0.009), while ΔMTV% and ΔTLG% were factors for PFS of DLBCL (both HR=7.556, 95% CI: 1.968-29.016, P=0.003). Conclusions:There are significant differences in metabolic parameters between MALT lymphoma and DLBCL before treatment. Interim PET/CT is effective for the prediction of prognosis of MALT lymphoma and DLBCL.

Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.

Objective:To assess the predictive value of 18F-fluorodeoxyglucose (FDG) PET/CT imaging and relevant factors in the prognosis of patients with classic Hodgkin lymphoma (cHL) before or after autologous stem cell transplantation (ASCT). Methods:From January 2008 to June 2017, 55 cHL patients (28 males, 27 females; age: (28.8±9.6) years) confirmed by pathology in Shanghai General Hospital were retrospectively included. 18F-FDG PET/CT imaging was performed before ASCT in 43 cases and after ASCT in 34 cases (22 patients underwent the imaging both before and after ASCT). Patients were divided into positive group (≥4) and negative group (<4) according to 18F-FDG PET/CT imaging results using Deauville 5-point scale. The predictive value of relevant factors in the prognosis was evaluated with progression-free survival (PFS) and overall survival (OS) using Kaplan-Meier survival analysis and log-rank test. Hazard ratio ( HR) was calculated by Cox regression model. Results:Of 55 cHL patients, 29 (53%) had a progression of disease after a median follow-up of 8 months, and 11 (20%) patients died after a median follow-up of 29.5 months, with the 3-year PFS rate of 46.4% and OS rate of 84.5%. Significant differences of PFS rate were found between patients with or without B symptoms, between patients with or without large mediastinal mass, between patients with international prognostic score (IPS) of 0-2 and those with IPS of 3-7, among patients with different effect of salvage chemotherapy (complete remission (CR), partial remission (PR) + stable disease (SD), progressive disease (PD)), and between patients with negative or positive PET/CT imaging results before or after ASCT ( χ2 values: 5.52-20.01, HR: 2.21(95% CI: 1.56-3.12)-5.51(95% CI: 1.86-16.33), all P<0.05). B symptoms and large mediastinal mass were also prognostic factors for OS rate ( HR: 5.28(95% CI: 1.14-24.51) and 4.27(95% CI: 1.24-14.79), both P<0.05). The combination of 18F-FDG PET/CT imaging before and after ASCT was statistically significant for predicting PFS ( χ2=11.28, P<0.01). Multivariate survival analysis showed that the risk of progression in patients with positive PET/CT results after ASCT was significantly higher than those with negative results ( HR=6.20, P<0.01), and the risk of death in patients with B symptoms was significantly higher than those without B symptoms ( HR=5.28, P<0.05). Conclusion:18F-FDG PET/CT imaging results after ASCT have important values for predicting PFS in cHL patients after ASCT, and B symptoms can be used as an important prognostic indicator of OS after ASCT.

Objective: To evaluate the prognosis of allogeneic hematopoietic stem cell transplantation (allo-HSCT) for treatment of elderly patients with acute myeloid leukemia (AML). Methods: The clinical data of 53 elderly patients (≥55 years old) with AML who received allo-HSCT in the First Affiliated Hospital of Soochow University from June 2008 to March 2019 were retrospectively analyzed. All the patients included haplo-HSCT (26 cases), matched-sibling donors (MSD)-HSCT (18 cases), matched or mismatched unrelated donors (9 cases). The efficacy of allo-HSCT for elderly patients with AML was analyzed, and the efficacy and safety of haplo-HSCT and MSD-HSCT were compared. Results: There were 35 males and 18 females among 53 elderly AML patients. The median age was 57 years old (55-67 years old), and 45 patients received myeloablative conditioning (MAC) regimen while 8 patients received reduced intensity conditioning (RIC) regimen. There were 52 patients who were successfully implanted in granulocyte, and the median time for engraftment was 12 d (10-23 d). There were 50 patients who were successfully implanted in megakaryocyte and the median time for engraftment was 13 d (10-76 d). The incidence of acute graft-versus-host disease (GVHD) was 49.1% (26/53), and the incidence of grade Ⅲ-Ⅳ acute GVHD was 15.1% (8/53), respectively. The median follow-up time was 14.7 months (0.4-136.8 months), and 32 patients survived. The rate of 2-year overall survival (OS), disease-free survival (DFS) and graft-versus-host-free-relapse free survival (GRFS) was 63.1%, 59.5% and 46.1%, respectively. Multivariate analysis showed that non-complete remission (CR) state before transplantation was an independent prognostic factor for OS (HR = 3.600, 95% CI 1.213-10.684, P = 0.021), DFS (HR = 2.596, 95% CI 1.098-6.138, P = 0.030) and relapse (HR = 3.957, 95% CI 1.099-14.245, P = 0.035). Donor age > 45 years old was an independent risk factor for OS (HR = 3.687, 95% CI 1.343-10.215, P = 0.011). Time from diagnosis to transplantation ≥6 months was an independent risk factor for GRFS (HR = 2.308, 95%CI 1.083-4.918, P = 0.030). There were no statistical differences in OS rate, DFS rate, cumulative relapse rate, the incidence of grade Ⅲ-Ⅳ acute GVHD and moderate to severe chronic GVHD between haplo-HSCT and MSD-HSCT (all P > 0.05). Conclusions The preliminary results show that allo-HSCT is an effective and safe treatment for elderly AML patients. In addition, haplo-HSCT is similar to MSD-HSCT in the efficacy and safety, indicating that haplo-HSCT could be a better treatment option for elderly AML patients under the circumstance without non-identical donor.

Objective To investigate the clinical efficacy of total pancreaticoduodenectomy combined with portal vein resection and allograft vascular grafts for pancreatic cancer with vascular invasion.Methods The retrospective and descriptive study was conducted.The clinicopathological data of 9 patients with pancreatic cancer who underwent total pancreaticoduodenectomy combined with portal vein resection and allograft vascular grafts in the Beijing Chao Yang Hospital of Capital Medical University from January 2014 to September 2016 were collected.There were 4 males and 5 females,aged from 53 to 78 years,with a median age of 60 years.Involvement of portal vein (PV) and (or) superior mesenteric vein (SMV),splenic vein or convergence was detected in patients by preoperative evaluation,which indicated borderline resectable pancreatic cancer.Patients underwent complete surgical resection of tumor and involved portal veins,and then underwent vascular and digestive tract reconstruction.Observation indicators:(1) intraoperative situations;(2) postoperative situations;(3) follow-up.Patients were followed up by telephone interview and outpatient examination to detect survival of patients up to October 2018.Measurement data with normal distribution were represented as Mean±SD,measurement data with skewed distribution were expressed as M (range),and count data were expressed as absolute number.Results (1) Intraoperative situations:9 patients underwent total pancreaticoduodenectomy combined with portal vein resection and allograft vascular grafts successfully,including 1 undergoing total pancreaticoduodenectomy due to positive margin of pancreatic neck during pancreatico-duodenectomy for pancreatic head carcinoma,3 of pancreatic head carcinoma with portal vein involvement and atrophy of pancreatic body and tail,and 5 of carcinoma of pancreatic neck and body with portal vein involvement.The operation time,portal vein occlusion time,and volume of intraoperative blood loss were (573± 19) minutes,(21 ±4) minutes,and (717±33) mL.(2) Postoperative situations:4 of 9 patients had postoperative complications,including 2 with grade Ⅰ complication and 2 with grade Ⅱ complication.There was no grade Ⅲ or above complication.No anastomotic stenosis or thrombus formation after reconstruction for portal vein.The perioperative complications were cured after conservative treatment.Duration of postoperative hospital stay was 17 days (range,10-25 days).Nine patients underwent subcutaneous injection of insulin to control blood glucose during the period fasting for solids and liquids.After resuming the semi-liquid diet of diabetes,patients received subcutaneous injection of rapid acting insulin before meals combined with subcutaneous injection of long-acting insulin before bedtime,with a insulin need of 24-36 U/d.Patients had postprandial blood sugar level of 8-11 mmol/L,without unmanageable hyperglycemia orlong-term application of insulin pump.Patients received oral trypsin pancreatin instead of trypsin,with no gastrointestinal symptoms such as bloating and steatorrhea,no malnutrition.Of 9 patients,2 had well-differentiated adenocarcinoma,4 had moderately differentiated adenocarcinoma,and 3 had poor-differentiated adenocarcinoma.There were 3 patients with no vascular invasion,1 with endangidic invasion,5 with tumor infiltration of tunica adventitia vasorum.One of 9 patients was in IIA stage of TNM staging,3 were in the II B stage,and 5 were in IIIB stage.The negative rate of pathological sections for excised specimen margin was 8/9.(3) Follow-up:9 patients were followed up for 7-37 months,with a median follow-up time of 15 months.Four patients survived,4 died of tumor recurrence and metastasis,and 1 died of cerebrovascular accident.Conclusion Total pancreaticoduodenectomy combined with portal vein resection and allograft vascular grafts is safe and feasible for pancreatic cancer involving portal vein,splenic vein or junction.

Objective To assess the value of 18F-fluorodeoxyglucose (FDG) PET/CT in the staging,interim therapeutic and prognostic evaluation of mucosa-associated lymphoid tissue (MALT) lymphoma.Methods Thirty-six MALT lymphoma patients (20 males,16 females;average age:61.7 years) confirmed by pathology from January 2008 to January 2018 were retrospectively analyzed.18F-FDG PET/CT were performed before chemotherapy and radiotherapy for staging.The detective sensitivity was evaluated.The staging results of gastric MALT lymphoma and extragastric MALT lymphoma by PET/CT were compared with Fisher exact probability method.PET/CT was performed in 17 of 36 patients after 4 courses of chemotherapy,and 17 patients were divided into positive group (≥≥4) and negative group (＜4) according to scores of Deauville 5-point scale.The progression-free survival (PFS) was evaluated using Kaplan-Meier survival analysis.Results FDG-positive lesions were found in 31 of 36 patients with the sensitivity of 86.1％ (31/36).The results of PET/CT were negative in stage Ⅰ patients.In stage]Ⅱ-Ⅳ patients,the results of 18F-FDG PET/CT combined with bone marrow biopsy were in accordance with the results of clinical staging.The accuracy of PET/CT in staging of gastric MALT lymphoma patients was 9/17,which was significantly lower than that of extragastric MALT lymphoma patients (17/19;P=0.025).The PFS of negative group evaluated by interim PET/CT was longer than that of positive group (x2 =4.16,P＜0.05).The 2-year PFS rates of the 2 groups were (85.7± 13.2)％ and (27.8 ±21.3)％,respectively.The PFS of patients with low expression of Ki-67 was significantly longer than that of patients with high Ki-67 expression (x2=4.22,P＜0.05).Conclusions In stage]Ⅱ-Ⅳ MALT patients,18F-FDG PET/CT combined with bone marrow biopsy can improve the staging accuracy.The staging accuracy of PET/CT in extragastric MALT lymphoma is significantly higher than that of gastric MALT lymphoma.PET/CT and Ki-67 can provide effective information on the prognostic evaluation for patients with MALT lymphoma.

Biofilm formation is associated with invasive fungal infection, which is considered to be an important virulence factor.Candida albicans has become one of the important bacterial flora in hospital infection,and it is the most common clinical fungi strain, mainly isolated from respiratory tract.The formation of biofilm can promote the adhesion,proliferation and proliferation of Candida albicans, resulting in a significant increase in the minimum inhibitory concentration and drug resistance.This article reviews the current research advances of the mechanism of Candida albicans biofilm formation,structural characteristics and its prevention and treatment,to provide a reference for the development of clinical prevention and control strategies of Candida albicans biofilm formation.