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 investigate the clinical efficacy of Xinxuetong Oral Liquid in the treatment of patients with acute coronary syndrome(ACS).Methods A total of 80 patients with ACS of blood stasis syndrome who were hospitalized in Shunde Hospital of Guangzhou University of Chinese Medicine from January 2023 to September 2023 were randomly divided into the treatment group and control group according to random number table method,40 patients in each group.The patients in the two groups were given conventional western medicine treatment including lifestyle guidance,percutaneous coronary intervention(PCI),and conventional western medicine therapy.Additionally,the treatment group was treated with Xinxuetong Oral Liquid.The course of treatment for the two groups covered eight weeks.Before and after treatment the two groups were observed in the changes of traditional Chinese medicine(TCM)syndrome score,blood stasis syndrome score,angina pectoris score,blood lipid indicators,carotid ultrasonography indicators,echocardiography indicators,and serum levels of trimethylamine-N-oxide(TMAO),nitric oxide(NO),endothelin 1(ET-1),interleukin 8(IL-8),serine/threonine-protein kinase 1(AKT-1),and vascular endothelial growth factor A(VEGF-A).After treatment,the efficacy on TCM syndrome efficacy and the safety of the regimen in the two groups were evaluated.Results(1)During the trial,there were two cases of loss to follow-up and one case of withdrawal due to pneumonia,and eventually a total of 77 patients completed the full course of treatment,among which 39 patients were in the treatment group and 38 patients were in the control group.(2)After eight weeks of treatment,the total effective rate of the treatment group was 89.74％(35/39),and that of the control group was 63.16％(24/38).The intergroup comparison(tested by chi-square test)showed that the effective rate of TCM syndrome efficacy in the treatment group was significantly superior to that in the control group(P＜0.01).(3)After treatment,the scores of TCM symptoms such as chest pain,chest distress,symptom aggravation at night,and palpitation in the two groups,as well as the score of gloomy complexion in the treatment group,were significantly decreased compared with those before treatment(P＜0.05 or P＜0.01),and the decrease of scores of chest distress,symptom aggravation at night,and palpitation in the treatment group was significantly superior to that in the control group(P＜0.05 or P＜0.01).(4)After treatment,the blood stasis syndrome score and angina pectoris symptom score of the two groups of patients were significantly decreased compared with those before treatment(P＜0.01),and the decrease in the treatment group was significantly superior to that in the control group(P＜0.01).(5)After treatment,the serum TMAO,ET-1,IL-8,AKT-1,and VEGF-A levels in the two groups were significantly decreased compared with those before treatment(P＜0.01),and the serum NO level was significantly increased compared with that before treatment(P＜0.01).The decrease of serum TMAO,ET-1,IL-8,and AKT-1,VEGF-A levels and the increase of serum NO level in the treatment group were significantly superior to those of the control group(P＜0.05 or P＜0.01).(6)After treatment,the total cholesterol(TCHO)and low-density lipoprotein cholesterol(LDL-C)levels of the two groups(P＜0.01)and the triglyceride(TG)level of the treatment group(P＜0.05)were decreased significantly compared with those before treatment,while the high-density lipoprotein cholesterol(HDL-C)level of the treatment group was increased significantly compared with that before treatment(P＜0.01).No obvious changes of TG and HDL-C levels before and after treatment were shown in the control group(P＞0.05).The comparison of blood lipid indicators after treatment between groups showed that there were no statistically significant differences(P＞0.05).(7)After treatment,the carotid ultrasonography indicators of carotid intima-media thickness(IMT)and Crouse score of the carotid plaque in the two groups were significantly improved compared with those before treatment(P＜0.01).However,there was no statistical significance in the comparison of the two indicators between the two groups after treatment(P＞0.05).(8)The observation of echocardiography indicators showed that only the post-treatment left ventricular diameter(LVd)of the treatment group was significantly larger than that before treatment(P＜0.05),while no obvious changes of the other echocardiography indicators before and after treatment were shown in the two groups(P＞0.05).The comparison between the groups after treatment also showed no statistically significant differences(P＞0.05).(9)During the treatment,no serious drug-induced adverse reactions or drug-related severe cardiovascular events and complications occurred in the two groups.Conclusion The combination of Xinxuetong Oral Liquid with conventional western medicine treatment exerts certain efficacy and safety on improving the clinical symptoms of patients with ACS of blood stasis syndrome,and its therapeutic mechanism may be related to the improvement of blood lipid levels,inflammatory response,and TMAO level.

Total hip arthroplasty(THA)is an effective treatment for elderly femoral neck fractures,mid-to late-stage femoral head necrosis,and end-stage hip osteoarthritis.However,serious complications such as aseptic loosening of the prosthesis,peripheral fractures,and dislocation of the prosthesis still exist following THA,which makes the selection of the appropriate hip prosthesis type and placement position before THA an important challenge for surgeons.Currently,the commonly used preoperative planning methods for THA mainly rely on static images from two-dimensional(2D)X-ray or three-dimensional(3D)computed tomography(CT),which fail to adequately consider the hip joint in weight-bearing as well as motion,lumbar-hip joint changes,and prosthetic impingement during motion.Recently,the dual fluoroscopic imaging system,as a new in-vivo,dynamic radiological imaging technology,provides comprehensive and accurate dynamic 3D data for THA preoperative planning.However,the technical process and expert consensus on preoperative 3D planning of THA using a dual fluoroscopic imaging system have not yet been established,which affects the promotion and application of this technology.In light of the above,national orthopaedic experts and related professional representatives discussed and proposed seven consensus issues,and the'expert recommendation rate'and'strong recommendation rate'were obtained through a questionnaire survey on the recommendations of the participating experts.This consensus aims to provide guidance and reference for the standardised application of preoperative 3D planning of THA using the dual fluoroscopic imaging system.

Total hip arthroplasty(THA)is an effective treatment for elderly femoral neck fractures,mid-to late-stage femoral head necrosis,and end-stage hip osteoarthritis.However,serious complications such as aseptic loosening of the prosthesis,peripheral fractures,and dislocation of the prosthesis still exist following THA,which makes the selection of the appropriate hip prosthesis type and placement position before THA an important challenge for surgeons.Currently,the commonly used preoperative planning methods for THA mainly rely on static images from two-dimensional(2D)X-ray or three-dimensional(3D)computed tomography(CT),which fail to adequately consider the hip joint in weight-bearing as well as motion,lumbar-hip joint changes,and prosthetic impingement during motion.Recently,the dual fluoroscopic imaging system,as a new in-vivo,dynamic radiological imaging technology,provides comprehensive and accurate dynamic 3D data for THA preoperative planning.However,the technical process and expert consensus on preoperative 3D planning of THA using a dual fluoroscopic imaging system have not yet been established,which affects the promotion and application of this technology.In light of the above,national orthopaedic experts and related professional representatives discussed and proposed seven consensus issues,and the'expert recommendation rate'and'strong recommendation rate'were obtained through a questionnaire survey on the recommendations of the participating experts.This consensus aims to provide guidance and reference for the standardised application of preoperative 3D planning of THA using the dual fluoroscopic imaging system.

Periarticular fracture of the shoulder is a common type of fractures in the elderly. Postoperative adverse events such as internal fixation failure, humeral head ischemic necrosis and upper limb dysfunction occur frequently, which seriously endangers the exercise and health of the elderly. Compared with the fracture with normal bone mass, the osteoporotic periarticular fracture of the shoulder is complicated with slow healing and poor rehabilitation, so the clinical management becomes more difficult. At present, there is no targeted guideline or consensus for this type of fracture in China. In such context, experts from Youth Osteoporosis Group of Chinese Orthopedic Association, Orthopedic Expert Committee of Geriatrics Branch of Chinese Association of Gerontology and Geriatrics, Osteoporosis Group of Youth Committee of Chinese Association of Orthopedic Surgeons and Osteoporosis Committee of Shanghai Association of Chinese Integrative Medicine developed the Chinese expert consensus on the diagnosis and treatment of osteoporotic periarticular fracture of the shoulder in the elderly ( version 2023). Nine recommendations were put forward from the aspects of diagnosis, treatment strategies and rehabilitation of osteoporotic periarticular fracture of the shoulder, hoping to promote the standardized, systematic and personalized diagnosis and treatment concept and improve functional outcomes and quality of life in elderly patients with osteoporotic periarticular fracture of the shoulder.

Objective     To analyze the clinical efficacy and survival outcome of totally thoracoscopic redo mitral valve replacement and evaluate its efficiency and safety. Methods     The clinical data of patients with totally thoracoscopic redo mitral valve replacement in Guangdong Provincial People’s Hospital between 2013 and 2019 were retrospectively analyzed. Survival analysis was performed using the Kaplan-Meier method. Univariate and multivariate Cox regression analyses were used to determine the risk factors for postoperative death. Results     There were 48 patients including 29 females and 19 males with a median age of 53 (44, 66) years. All the procedures were performed successfully with no conversion to median sternotomy. A total of 15, 10 and 23 patients received surgeries under non-beating heart, beating heart and ventricular fibrillation, respectively. The in-hospital mortality rate was 6.25% (3/48), and the incidence of early postoperative complications was 18.75% (9/48). Thirty-five (72.92%) patients had their tracheal intubation removed within 24 hours after the operation. The 1- and 6-year survival rates were 89.50% (95%CI 81.30%-98.70%) and 82.90%(95%CI 71.50%-96.20%), respectively. Age>65 years was an independent risk factor for postoperative death (P=0.04). Conclusion     Totally thoracoscopic redo mitral valve replacement is safe and reliable, with advantages of rapid recovery, reducing blood transfusion rate, reducing postoperative complications and acceptable long-term survival rate. It is worthy of being widely popularized in the clinic.

OBJECTIVE To study the improvement effect and possible mechanism of N-butylphthalide on inflammatory injury of bone marrow mesenchymal stem cells （BMSCs） in rats. METHODS BMSCs of rats were divided into control group， model group， N-butylphthalide low-concentration， medium-concentration and high-concentration groups （10， 20， 50 μmol/L）. BMSCs were cultured in vitro and lipopolysaccharide （the final concentration of 10 mg/L） was used to establish the inflammatory injury model. After the intervention of N-butylphthalide， the survival rate， apoptotic rate， the contents of tumor necrosis factor α （TNF- α）， interleukin 1β （IL-1β） and IL-6 in cell culture medium， the mRNA expression of nuclear factor-κB（NF-κB） p65， and the protein expressions of caspase-3， B-cell lymphoma 2 （Bcl-2）， Bcl-2 related X protein （Bax） and NF-κB p65 in cells were detected. RESULTS Compared with control group， the survival rate and protein expression of Bcl-2 were decreased significantly in model group （P＜0.05）； the apoptotic rate， contents of TNF-α， IL-1β and IL-6， the mRNA expression of NF-κB p65， and the protein expressions of caspase-3， Bax and NF-κB p65 were increased significantly （P＜0.05）. Compared with model group， above indexes were significantly reversed in all concentration groups of N-butylphthalide （P＜0.05）， in concentration-dependent manner. CONCLUSIONS N-butylphthalide can ameliorate the inflammatory injury of BMSCs induced by lipopolysaccharide， and its mechanism may be related to the inhibition of NF-κB signaling pathway.

Objective    To determine the clinical efficacy of transcatheter aortic valve replacement (TAVR) for severe aortic regurgitation (AR) combined with severe mitral regurgitation (MR). Methods    The clinical data of 13 patients who underwent TAVR due to severe AR combined with severe MR from March 2018 to September 2021 in our hospital were retrospectively analyzed, including 10 males and 3 females with a mean age of 72.54±2.35 years. The echocardiographic findings of all patients were compared preoperatively and postoperatively. Results    Surgeries were performed successfully in all patients without intraoperative death or conversion to sternotomy. The operation time was 118.15±11.42 min, intraoperative blood loss was 100.00 (75.00, 250.00) mL, and the length of hospital stay after surgery was 9.00 (4.50, 11.00) d. The mean follow-up duration was 10.00 (6.50, 38.50) months, during which there were 2 patients with mild to moderate AR, 6 with mild AR, and 5 with no AR; meanwhile, severe MR decreased significantly (P=0.001) even without active intervention, including 4 mild to moderate MR and 9 mild MR patients. Compared to preoperative indexes, the left atrial diameter [46.00 (41.00, 52.50) mm vs. 35.00 (34.00, 41.00) mm, P<0.001], left ventricular end-systolic diameter [45.00 (36.00, 56.00) mm vs. 35.00 (28.00, 39.00) mm, P=0.002] and left ventricular end-diastolic diameter (62.62±2.40 mm vs. 51.08±2.49 mm, P<0.001) showed a decreasing trend during the follow-up. Conclusion    In selected patients with severe AR combined with severe MR, TAVR alone improves AR and combined MR at the same time.

Objective    To investigate the effectiveness and safety of totally endoscopic transmitral myectomy (TETM) for hypertrophic obstructive cardiomyopathy (HOCM), comparing with traditional sternotomy modified Morrow procedure (SMMP). Methods    Thirty-eight patients with HOCM who needed surgical intervention were selected from our hospital in 2019, including 14 males and 24 females, with an average age of 56 (44-68) years. According to the operation method, they were divided into a TETM group (n=18) and a SMMP group (n=20). Appropriate patients  were screened by propensity matching scores. Finally, the clinical data of two matched groups were compared and

Objective    To determine the clinical efficacy of transapical transcatheter mitral valve-in-valve treatment for patients with deteriorated mitral bioprosthesis after aortic-mitral double valve replacement. Methods    The clinical data of 9 patients who underwent transapical transcatheter mitral valve-in-valve implantation after aortic-mitral double valve replacement due to mitral bioprosthesis deterioration from May 2020 to January 2021 in our hospital were retrospectively analyzed, including 4 males and 5 females with a mean age of 72.44±7.57 years. Results    Surgeries were performed successfully in all patients with no conversion to median sternotomy. The mean procedural time was 101.33±48.49 min, the mechanical ventilation time was 23.11±26.54 h, the ICU stay was 1.89±1.05 d and the postoperative hospital stay was 6.11±2.02 d. Residual mild mitral regurgitation was only observed in 1 patient. Only 1 patient needed postoperative blood transfusion. No major complications were observed in all patients. There was no death in postoperative 90 days. Conclusion    For patients with deteriorated mitral bioprosthesis after aortic-mitral double valve replacement, transapical transcatheter mitral valve-in-valve implantation achieves good clinical results and effectively  improves the hemodynamics without increasing the risk of postoperative left ventricular outflow tract obstruction. The surgery is feasible and effective.