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

Background Previous research on chlorinated paraffins (CPs) in fine particulate matter (PM_2.5) has predominantly focused on short- and medium-chain chlorinated paraffins (SCCPs and MCCPs), and few studies could simultaneously determine short-, medium-, and long-chain chlorinated paraffins (LCCPs). Simultaneous extraction and determination of SCCPs, MCCPs, and LCCPs in PM_2.5 could provide technical support for their environmental monitoring and human health risk assessment. Objective To establish a method based on QUEChERS pretreatment method in conjunction with ultra-performance liquid chromatography-quadrupole/orbitrap high resolution mass spectrometry for simultaneously determining the levels of SCCPs, MCCPs, and LCCPs in PM_2.5. Methods The extraction solvents, extraction salts, and extraction steps of a QuEChERS method were optimized. The extraction efficiencies of the target substances were compared under 4 extraction solvents [acetonitrile, dichloromethane, and n-hexane solvents in sequence; acetonitrile: dichloromethane: n-hexane = 1: 1: 2 (v/v/v) mixed solvent; 1% acetic acid-acetonitrile: dichloromethane: n-hexane = 1: 1: 1 (v/v/v) mixed solvent; acetonitrile: dichloromethane: n-hexane = 1: 1: 1 (v/v/v) mixed solvent], 2 dehydrated salts (anhydrous MgSO₄+NaCl and anhydrous Na₂SO₄+NaCl), 2 purification salts (C18 and PSA), and 4 vortex time (5, 7.5, 10, and 12.5 min) conditions. Then internal standard was utilized to estimate linear range and detection limit of the refined QuEChERS approach. Results The linearities of SCCPs, MCCPs, and LCCPs were good in the range of 10~1000 ng·mL⁻¹ with the correlation coefficients all greater than 0.96. The method detection limits (MDLs) ranged from 0.01 to 0.29 ng·m⁻³. The spiked recoveries of SCCPs, MCCPs, and LCCPs at the low, medium, and high concentrations were 77.38%-81.64%, 93.11%-99.78%, and 87.41%-101.39%, respectively, and the relative standard deviations (RSDs) were 2.90%-12.84%. This method was used to determine the CPs levels in 11 PM_2.5 samples from Shijiazhuang. The positive rates of ∑SCCPs, ∑MCCPs, and ∑LCCPs were all 100%, the concentration ranges were 0.24-2.18 ng·m⁻³ (mean 0.84 ng·m⁻³), 0.17-1.67 ng·m⁻³ (mean 0.70 ng·m⁻³), and 0.01-0.16 ng·m⁻³ (mean 0.04 ng·m⁻³), respectively, and the percentages to ΣCPs were 52.95%, 44.39%, and 2.66%, respectively. Conclusion The method established in this study is simple, time-saving, solvent saving, and can simultaneously detect SCCPs, MCCPs, and LCCPs in PM_2.5, which is suitable for the determination of PM_2.5 samples in large quantities, and can also provide a reference for the detection methods of other halogenated organic compounds in PM_2.5.

ObjectiveTo investigate the genotyping and drug resistance trends of 461 strains of diarrheagenic Escherichia coli (DEC) isolated and identified in Suzhou, Jiangsu Province from 2019 to 2023. MethodsDEC detected in Suzhou in the past 5 years was used as the research subject, and the virulence genotyping was tested by real-time fluorescence quantitative polymerase chain reaction (PCR). The microbroth dilution method was used to perform drug susceptibility test, and the corresponding susceptibility (S), intermediate (I) and resistance (R) results were obtained based on the minimum inhibitory concentration (MIC) values, according to the criteria of United States Clinical and Laboratory Standardization Committee (CLSI) 2017. Differences of DEC drug resistance among different virulence genotypes were compared by χ² test or Fisher exact probability method. ResultsA total of 461 DEC strains were detected in Suzhou from 2019 to 2023, of which the highest proportion was enterotoxigenic Escherichia coli (ETEC) accounting for 45.77% (211/461), followed by enteropathogenic Escherichia coli (EPEC) accounting for 32.32% (149/461) and enteroaggregative Escherichia coli (EAEC) accounting for 20.39% (94/461), while enterohemor-rhagic Escherichia coli (EHEC) and enteroinvasive Escherichia coli (EIEC) were individually distributed. The antimicrobial drug with the highest resistance rate was ampicillin (61.61%), followed by cefazolin (49.89%) and nalidixic acid (44.47%). There were statistically significant differences in drug resistence rates of the three major virulence genotypes of DEC (ETEC, EPEC and EAEC) to ampicillin (AMP), ampicillin/sulbactam (AMS), amoxicillin/clavulanic acid (AMC), cefoxetine (CFX), gentamicin (GEN), streptomycin (STR), tetracycline (TET), nalidixic acid (NAL), and chloramphenicol (CHL), and methotrexate/sulfamethoxazole (SXT). The multi-drug resistance (MDR) rate of DEC was 59.87% (276/461), and the MDR rate of each genotype, from high to low, was EIEC (75.00%), EAEC (71.28%), EHEC (66.66%), EPEC (61.74%) and ETEC (52.86%). ConclusionETEC, EPEC and EAEC are the main genotypes prevalent in DEC in Suzhou in recent years. The drug resistance strains and MDR are still serious, which should arouse wide public health concern and take targeted prevention and control measures.

Objective:To build a training and promotion model for traditional Chinese medicine nursing tourism project in Zhejiang Province, promoting homogeneous management and standardized promotion of traditional Chinese medicine nursing tourism project.Methods:From July 2022 to June 2023, purposive sampling was used to select 20 experts from ClassⅢ traditional Chinese medicine hospitals in Zhejiang Province for Delphi expert consultation. Two rounds of consultation were conducted via email to construct a training and promotion model for traditional Chinese medicine nursing tourism project in Zhejiang Province.Results:In the two rounds of expert consultation, the effective response rate of the questionnaire was 100% (20/20), the familiarity coefficient of the experts was 0.89, the judgment coefficient was 0.94, and the authority coefficient of the experts was 0.92. The Kendall harmony coefficients for two rounds of consultation were 0.268 and 0.105, respectively, with statistically significant differences ( P<0.001). The training and promotion model for traditional Chinese medicine nursing tourism project in Zhejiang Province included six first-level indicators, 22 second-level indicators, 74 third-level indicators, and 28 fourth-level indicators. Conclusions:The construction process of the training and promotion model for traditional Chinese medicine nursing tourism project in Zhejiang Province is rigorous and standardized, providing reference for training and helping to promote innovation and sustainable development of traditional Chinese medicine nursing.

Objective To evaluate the efficacy,safety,and economy of tislelizumab(TIS)as a first-line treatment for advanced non-small cell lung cancer(NSCLC).Methods PubMed,Embase,Cochrane Library,CNKI,WanFang Data,SinoMed databases and health technology assessment(HTA)websites were electronically searched to collect the HTA report,systematic review/Meta-analysis and pharmacoeconomic research of TIS as a first-line treatment for advanced NSCLC from the inception to April 30,2024.Two reviewers independently screened literature,extracted data,and evaluated quality,and qualitative descriptive methods were used for rapid health technology assessment(rHTA).Results A total of 9 articles were included,in which 7 systematic review/Meta-analysis and 2 pharmacoeconomic studies.In terms of effectiveness,compared with chemotherapy(CT),TIS+CT could improve the progression free survival(PFS)and objective response rate(ORR)of advanced NSCLC patients.It could also improve PFS in patients with advanced NSCLC who have the any expression of programmed cell death receptor ligand-1(PD-L1),with or without liver metastasis,aged＞65 years or＜65 years,and with a history of smoking;Compared with CT,TIS+CT could improve the PFS of advanced non squamous NSCLC patients,and could increase the PFS of advanced non squamous NSCLC patients with PD-L1＞50％;Compared with CT,TIS+CT could improve the PFS of patients with advanced squamous cell carcinoma NSCLC in stages ⅢB and IV,with PD-L1 being 1％-49％,PD-L1＞50％,male,age＞65 years old,smoking history,ECOG score of 1 point.In terms of safety,compared with camrelizumab+CT and atezolizumab+bevacizumab+CT,TIS+CT could reduce the incidence of serious adverse reactions.In terms of economics,for non squamous NSCLC without epidermal growth factor receptor(EGFR)mutations and gradual lymphoma kinase(ALK)rearrangements,TIS+CT had certain cost-effectiveness advantages compared to CT in China.The subgroup analysis results showed that the first-line TIS+CT regimen had greater survival benefits in non squamous NSCLC patients with PD-L1 expression＞50％,liver metastasis,and a history of smoking.Conclusion TIS+CT first-line treatment for advanced NSCLC has good efficacy,safety,and economy.

OBJECTIVE To analyze the characteristics of levofloxacin-induced hypersensitivity reaction. METHODS Clinical pharmacists participated in the treatment for a case of levofloxacin-induced hypersensitivity reaction， and adjudged the relationship of levofloxacin with hypersensitivity reaction according to relative standards. Retrieved from CNKI， VIP， Wanfang database， PubMed and Embase， relevant literature about levofloxacin-induced hypersensitivity reaction was collected and analyzed. RESULTS Clinical pharmacists suggested checking the patient’s previous medication and allergy history based on symptoms such as fever and systemic rash， and determined that the drug hypersensitivity was “likely” or “highly likely” to be associated with levofloxacin. Clinicians provided symptomatic treatment to the patient based on the judgment of clinical pharmacists， and the patient improved after treatment. Results of the literature analysis showed that among 31 involved patients， there were 23 males and 8 females； 18 patients aged 50 and above； the incubation period of 24 patients was within 4 days after medication. The main adverse drug reactions were drug hypersensitivity syndrome， fixed drug eruption， erythema multiforme， etc. Most patients were improved after withdrawal and symptomatic treatment. CONCLUSIONS Hypersensitivity reaction is the rare adverse drug reaction of levofloxacin， mostly occurring within 2.5 h to 4 days after administration， and it is more likely to occur in middle-aged and elderly patients. Before clinical use， patients should be asked about their drug allergy history in detail； when patients experience fever or rash without obvious causes， medication should be stopped promptly and symptomatic treatment should be taken to ensure the safety and effectiveness of the patients’ medication.

Objective:To investigate the effect of ultrasound monitoring of inferior vena cava collapse index (IVC-CI) guiding fluid replacement on circulation in elderly patients during induction of general anesthesia.Methods:A total of 71 elderly patients who underwent elective surgery under general anesthesia and tracheal intubation at Hunan Provincial People′s Hospital from April 2021 to September 2022 were randomly divided into control group (35 cases) and observation group (36 cases) using a random number table method. Before anesthesia, both groups of patients underwent IVC ultrasound examination and calculated the IVC-CI value. For patients with IVC-CI≥40%, the observation group was given 8 ml/kg of crystal solution before anesthesia induction, while the control group was not treated. The incidence of hypotension, the use of vasoactive drugs, and the total infusion volume from anesthesia induction to skin incision were recorded in two groups. Mean arterial blood pressure (MBP), heart rate (HR), oxygen saturation (SpO 2), cardiac index (CI), and cardiac volume variability (SVV) before anesthesia (T 0), 5 min after induction (T 1), 1 min after tracheal intubation (T 2), 5 min after tracheal intubation (T 3), 10 min after tracheal intubation (T 4), and 1 min before skin incision (T 5) were recorded and compared between the two groups. Results:The incidence of hypotension (27.8% vs 60.0%) and utilization rate of vasoactive drugs (25.0% vs 48.6%) in the observation group were lower than those in the control group, and the total infusion volume during anesthesia induction was higher than that in the control group, with statistical significance (all P<0.05). SVV, CI and MBP at T 1, T 3, T 4 and T 5 were significantly different from those at T 0 in the control group ( F=3.85, 14.66, 3.96, all P<0.05). SVV, CI and MBP at T 1, T 3, T 4 and T 5 in the observation group were significantly different from those at T 0 ( F=3.51, 13.20, 4.35, all P<0.05). There was no significant difference in SVV, CI, MBP, HR and SpO 2 between 2 groups (all P>0.05). Conclusions:For the elderly patients with preoperative IVC-CI≥40%, pre-filling with 8ml/kg crystal solution before anesthesia induction can significantly reduce the incidence of hypotension and the utilization rate of vasoactive drugs in the elderly patients during anesthesia induction.

Objective:To investigate the current status of activation in patients with spinal cord injury and analyze its influencing factors.Methods:Using the convenient sampling method, a total of 127 patients from Department of Spinal Surgery in the Third Affiliated Hospital of Soochow University from October 2020 to August 2021 were selected as the research objects. The patients were investigated by General Data Questionnaire, Patient Activation Measure (PAM) , General Self-Efficacy Scale (GSES) , Connor-Davidson Resilience Scale (CD-RISC) , Social Support Rating Scale (SSRS) and Hospital Anxiety and Depression Scale (HADS) . Multiple linear hierarchical regression analysis was used to investigate the influencing factors of activation in patients with spinal cord injury.Results:A total of 127 questionnaires were sent out, and 122 were effectively received, with the effective recovery of 96.1%. The score of activation in patients with spinal cord injury was (54.71±7.23) . Regression analysis showed that injury site, mental resilience and social support were the main influencing factors of activation ( P<0.05) , and the global regression model explained 50.0% of the variation in activation in patients with spinal cord injury. Conclusions:Patients with spinal cord injury generally have moderate levels of activation during hospitalization. The activation of patients with spinal cord injury is a positive psychosocial resource, and rehabilitation nurses should pay more attention to it, and improve the mental resilience and social support of patients, so as to further enhance the activation of patients.

Objective:To provide evidence for the selection of fixation devices and CTV to PTV margins (M ptv) in precision radiotherapy for pelvic tumors by analyzing three fixation devices in precision radiotherapy for prostate cancer. Methods:From April 2015 to December 2020, 133 prostate cancer patients treated with pelvic drainage area irradiation in our center were retrospectively analyzed. The patients were fixed with 1.2m vacuum bag (n=39), 1.8m vacuum bag (n=44) and personalized prone plate by our center (n=50). Each patient was asked to complete our bowel and bladder preparation process before positioning and radiotherapy. The registration of CBCT to planned CT before each treatment adopted the same registration box and algorithm. Setup errors in the SI, LR and AP directions under qualified bowel and bladder conditions were recorded. Setup errors in three directions under three fixation devices and corresponding M ptv values were analyzed. The correlation between setup errors with age and body mass index (BMI) was analyzed. Results:Analysis of 3333 setup errors data showed: in the SI and LR directions, the mean setup errors of 1.2m vacuum bag (3.26mm, 2.34mm) were greater than those of 1.8m vacuum bag (2.51mm, P<0.001; 1.90mm, P<0.001), and personalized prone plate (3.07mm, P=0.066; 2.10 mm, P=0.009). In the AP direction, the mean setup errors of 1.2m vacuum bag (supine)(2.20mm) were smaller than those of 1.8m vacuum bag (3.33mm, P<0.001) and personalized prone plate (3.61mm, P<0.001). The setup errors of 1.8m vacuum bag in all directions were smaller than those of personalized prone plate (P≤0.028). According to Van Herk's expansion formula, the M ptv of 1.2m vacuum bag in three directions was approximately 4 mm. The M ptv of 1.8m vacuum bag and personalized prone plate in the SI and LR directions was approximately 3 mm, and more than 5 mm in the AP direction. The setup errors were not correlated with age or BMI. Conclusions:From the setup errors results of three devices, 1.8m vacuum bag is the best, followed by personalized prone plate. And supine position is better than prone position in the AP direction.

【Objective】 To retrospectively investigate the antibody distribution and pregnancy outcome of pregnant women with Rh alloantibody in Guangzhou, and summarize the prevalence, diagnosis and treatment experience of hemolytic disease of newborn (HDN) caused by Rh alloantibody, so as to provide data for the prevention, diagnosis and treatment of Rh-HDN. 【Methods】 A total of 17 345 pregnant women in Guangzhou from January 2014 to December 2020 were selected for irregular antibody screening test.Those with Rh antibody were followed up for delivery, and the clinical and laboratory examination results of pregnant women and newborns were analyzed. 【Results】 A total of 71 cases (0.41%, 17/17 345) with Rh alloantibodies were detected.Among them, anti-D, anti-E, anti-Ec, anti-C, anti-Ce, anti-c, anti-e accounted for 26.76% (19/71), 46.48% (33/71), 9.86% (7/71), 7.04% (5/71), 5.63% (4/71), 2.82% (2/71) and 1.41% (1/71), respectively.Among the 71 pregnant women, 34 gave birth to children with HDN, with the total prevalence rate of 47.89%, among whom 100%, 78.94% and 42.42% were anti-c, anti-D and anti-E, respectively.And 71.43% (5/7) of the children who underwent transfusion were with anti-D.Although the yield rate of anti-E was the highest, it involved low morbidity and mild symptoms, which preferred to occur in the first fetus.No significant difference in gestational age, birth weight and the occurrence time of jaundice was notice between the anti-D group and anti-E group, but the total bilirubin of the anti-E group was lower while the Hb level were higher than those of the anti-D group (P<0.05). Two children died, and others were cured by phototherapy, albumin, IVIG and blood transfusion. 【Conclusion】 The publicity of Rh-HDN for early prevention and treatment should be strengthened to improve the cure rate and the prognosis.