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 construct a teaching ability evaluation system for diversified general medicine course teachers under the guidance of "one practice and three learning".Methods:A research group was established to search for relevant documents and literature. A framework of evaluation index system was established through drafting and repeated discussion and modification by members of the group, as well as further discuss and modification by experts in general medicine. The framework was used to develop an expert consultation questionnaire on the teaching ability evaluation system for diversified general medicine course teachers under the guidance of "one practice and three learning". Through two rounds of expert consultation, a teaching ability evaluation system for diversified general medicine teachers under the guidance of "one practice and three learning" was constructed. A questionnaire was developed according to the system. The rationality and scientificity of the evaluation index system were verified by questionnaire survey.Results:The teaching ability evaluation system for diversified general medicine teachers under the guidance of "one practice and three learning" included 3 first-level indicators, 15 second-level indicators, and 41 third-level indicators. The general medicine curriculum evaluation questionnaire developed on the system showed that the Cronbach's α coefficient of the overall evaluation system was 0.981. The Cronbach's α coefficients of first-level indicators, including general medicine teaching plan, diversified theory and practice teaching, and comprehensive ability cultivation under the guidance of "one practice and three learning" ideology, were 0.920, 0.919, and 0.923, respectively. The content validity index (S-CVI) of the system was 0.981, and the content validity index (I-CVI) of indicators were 0.826-1.000. The correlation coefficients of first-level indicators and the system were 0.837-0.942 (all P<0.05). The correlation coefficients of second-level indicators and their corresponding first-level indicators were 0.586-0.971 (all P<0.05). The correlation coefficients of third-level indicators and their corresponding first-level indicators were 0.412-0.904 (all P<0.05). Conclusions:Under the guidance of "one practice and three learning", the teaching ability evaluation indicators for diversified general medicine course teachers have high specificity, rationale structure, high feasibility, high reliability, and high practicability. This evaluation system can provide theoretical reference for the training of undergraduate students in general medicine.

Objective:To evaluate the effects of peroneal osteotomy combined with arthroscopic knee debridement on perioperative indexes, X-ray indexes, Japanese Orthopaedic Association Assessment score (JOA score), American Hospital for Special Surgery knee score (HSS score) and complication rate of patients with knee osteoarthritis.Methods:A prospective research method was adopted. A total of 110 patients with knee osteoarthritis who were admitted to Chengde Central Hospital from April 2016 to April 2021 were selected as the research objects and divided into the control group (55 cases), the combined group (55 cases) by random number table method. The control group underwent arthroscopic debridement of the knee joint. On the basis of the control group, the combined group was combined with fibula osteotomy. The control group and the combined group were followed up for 6 months after operation. The perioperative indicators, score of JOA before and after 1 month of treatment, X-ray indicators, score of HSS before and after 6 months of treatment, and the incidence of complications during the follow-up period were compared between the control group and the combined group.Results:The operation time of the combined group was longer than that of the control group: (84.36 ± 14.64) min vs. (75.88 ± 12.86) min; compared with before operation, 1 month after operation, the scores of swelling, pain while up and down stairs, walking pain, joint range of motion were increased in the control group and the combined group, and the combined group was higher than the control group: (8.35 ± 0.73) points vs. (6.74 ± 0.67) points, (15.05 ± 1.74) points vs. (13.96±1.66) points, (21.75 ± 2.07) points vs. (18.58 ± 1.73) points, (27.59 ± 3.25) points vs. (25.74 ± 2.83) points; the femoral tibial angle and the range of motion of the knee joint in the control group and the combined group were increased, and the combined group was greater than the control group: (1.94 ± 0.60)° vs. (3.02 ± 0.67)°; the scores of stability, flexion deformity, muscle strength, range of motion, function, and pain in the control group and the combined group increased, and the combined group was higher than the control group: (8.62 ± 0.86) points vs. (6.89 ± 0.78) points, (7.86 ± 0.96) points vs. (6.27 ± 0.68) points, (7.79 ± 0.62) points vs. (6.95 ± 0.57) points, (14.95 ± 2.60) points vs. (12.48 ± 2.33) points, (17.46 ± 2.21) points vs. (14.59 ± 1.76) points, (24.83 ± 3.25) points vs. (18.59 ± 2.57) points, the difference was statistically significant ( P<0.05). During the following up period, there were no significant differences in the incidences of osteofascial compartment syndrome, neurovascular injury, intraarticular adhesion and incision infection between the two groups ( P>0.05). Conclusions:The operation time of fibular osteotomy combined with arthroscopic debridement of knee joint in patients with knee osteoarthritis was longer, but fibular osteotomy combined with arthroscopic debridement of the knee joint can reduce the valgus of the patient and improve the range of motion of the joint. It could effectively reduce the degree of pain and improve the function of knee joint, and the safety was good, with good therapeutic effect.

In 2011,the International Association for the Study of Lung Cancer(IASLC),American Thoracic Society(ATS)and European Respiratory Society(ERS)simultaneously defined micropapillary pattern(MPP)-based lung adenocarcinoma as an independent pathological type:micropapillary-predominant adenocarcinoma(MPA).Its histological and clinical specificities have attracted broad attention from researchers.Lung adenocarcinoma with a micropapillary pattern(MPPAC)often shows biological behaviors indicative of poor prognosis,including strong invasion,high metastasis rate and easy recurrence after surgical treatment.At present,the clinical diagnosis of MPPAC depends on postoperative pathological examination,but systematic studies on its pathological heterogeneity,molecular biological characteristics,clinical features and prognosis remains scarce.This review aims to focus on the research progress of the pathological and clinical features of MPPAC.

Objective To investigate the changes of airway resistance before and after Bronchial Diulation Test in patients with senile asthma and the effect of age on the degree of airway resistance. Methods A total of 29 (> 60 years)senile asthma patients and 21 younger(< 60 y)patients were enrolled in the study. The status of their pulmonary function was determined by MEFV(Maximum expiratory flow?volume curve)and an IOS(impulse oscillometry) system before and after Bronchial Diulation Test,The spirometric indexes such as forced vital capacity,total respiratory impedance,respiratory resistance and respiratory system reactance were collected and analyzed. Results Significant decreases of indexs were found after Bronchial Diulation Test compared with those before Bronchial Diulation Test in the study group(P<0.05,respectively). No significant difference in improvement of indexs was found between the group of patients with senile asthma(age > 60 years)and the group of healthy control(age < 60 years ). Each index of the airway resistance has a very good correlation with FEV1%,with the highest degree of relation is X5%. Conclusion The airway resistance of senile asthmatic patients was significantly improved after diuslation test and these indexes IOS would be valuable in evaluating the changes of airway resistance of senile asthma.

Objective:To establish a method for the determination of three optical isomers in bortezomib. Methods: An HPLC method was used with a ChiralPAKAY-H normal phase chiral column (250 mm × 4. 6 mm, 5 μm). The mobile phase was n-hexane-ethanol-methanol-trifluoroaceticacid (90 ∶7. 5∶2. 5∶0. 1) and the flow rate was 0. 8 ml·min-1 . The detection wavelength was set at 270 nm. The column temperature was 40℃ and the injection volume was 5 μl. Results: The separation of bortezomib from the three optical isomers was more than 2. 0. The linear range of the three optical isomers was 0. 6-20μg·ml-1(r≥0. 999 7). The average re-covery was 104. 1%, 105. 5% and 92. 0% with RSD of 2. 3%, 2. 4% and 2. 7%, respectively (n=9). The limit of quantification and detection limit was 3 ng and 1 ng, respectively. Conclusion:The method is rapid and accurate, and can be used for the determi-nation of optical isomers in bortezomib.

BACKGROUND:Induction of osteoblasts differentiating into osteocytes is a hot spot in tissue engineering;however, the regulatory mechanism underlying differentiation has not been ful y elucidated. MicroRNA, as an endogenous smal RNA molecule, can regulate post-transcriptional gene expression by binding to the 3’ nontranslated region of the target gene mRNA, which also has been found to play an important regulatory role in osteocyte differentiation. OBJECTIVE:To study the regulation of miR-155 on osteoblast differentiation and the underlying mechanism. METHODS:The mouse osteoblast cel lines MC3T3-E1 were selected and induced by mouse bone morphogenetic protein-2 (BMP2, 200 ng/mL) and then the miR-155 mRNA expression was determined by quantitative real-time PCR at 1, 3, 7 and 14 days. MC3T3-E1 cel s were divided into control, BMP2, miR-155 and miR-155 inhibitor groups, fol owed by cultured withα-MEM medium, BMP2, miR-155 and miR-155 inhibitor, respectively, for 2 weeks. RESULTS AND CONCLUSION:After induction using BMP2, miR-155 expression was downregulated in a time dependent manner. The staining intensity of alizarin red in the BMP2 group was significantly higher than that of the control group, and the activity of alkaline phosphatase and mRNA expression were also significantly higher than those in the control group (P<0.01). The staining intensity of alizarin red, activity of alkaline phosphatase and mRNA expression in the miR-155 group were significantly lower than those in the control group (P<0.01), while al above measurements were reversed significantly by miR-155 inhibitor (P<0.05). miR-155 could bind to the 3’ untranslated region of SMAD5 mRNA and significantly downregulated the expressions of SMAD5 protein and mRNA in MC3T3-E1 cel s (P<0.01). These results show that miR-155 can inhibit MC3T3-E1osteogenic differentiation by downregulating SMAD5 expression.

Objective:To establish the determination method for four lurasidone hydrochloride enantiomers by HPLC. Methods:Lurasidone hydrochloride enantiomers were separated on a CHIRALPAK AD-H column (250 mm × 4. 6 mm, 5μm). The mobile phase consisted of hexane-ethanol-diethylamine ( 90∶10∶0. 1) at a flow rate of 1. 0 ml·min-1 and the column temperature was at 40℃. The detection wavelength was 230nm. Results:The resolution of lurasidone hydrochloride enantiomers was above 2. 0. The linear calibra-tion curves were obtained over the range of 5-120 μg· ml-1 for all the enantiomers (r=0. 999 9). The recovery was above 99. 0%with RSD below 0. 5%. The detection limits were 5ng. Conclusion:The method is simple, accurate and rapid, and suitable for the de-termination and quality control.

Objective:To determine the content of self-manufactured and imported lurasidone hydrochloride tablets in order to e-valuate their internal qualities. Methods:The determination of lurasidone hydrochloride tablets was performed by HPLC. The HPLC system consisted of a Waters C8 column (250 mm × 4. 6 mm, 3. 5 μm) and the mobile phase of 0. 05 mol·L-1 phosphate buffer solu-tion (pH 3. 0)-acetonitrile(60∶40), the detection wavelength was 230 nm, the flow rate was 1. 2 ml·min-1 and the column tempera-ture was 40℃, and the injection volume was 20μl. Results:The linear range of lurasidone hydrochloride was 0. 100 8-0. 806 4 mg· ml-1(r=0. 999 5). The average recovery was 99. 95% with RSD of 0. 31%(n=9). Conclusion:The method is simple, rapid, ac-curate, and reliable. The method can determine lurasidone hydrochloride tablets satisfactorily. According to the results, there are few differences among the self-manufactured and imported lurasidone hydrochloride tablets.

Objective To study the in vitro heating ability of Ni-Cu thermoseeds and their effect on the rabbit liver cells and tissues. Methods The temperature of rabbit liver tissues were monitored under an alternating magnetic field.MTT assay was used to evaluate the in vitro cytotoxicity of the extra-liquid of the Ni-Cu thermoseeds;Hemolytic test was carried out to estimate its blood toxicity;and muscular implantation test was employed to determine the levels of its tissue toxicity.Results The thermoseeds used in this experiment showed a high heating ability in alternating magnetic field in vitro.MTT assay showed that the toxicity of the material on mouse fibroblast(L-929) cell lines was 1 degree,which means non-cytotoxic.Hemolytic test revealed a hemolysis rate(HR) of 3.25%(less than 5%),showing that the thermoseeds had no hemolytic reaction.Muscular implantation test showed different levels of inflammatory reaction in the muscle tissues.Conclusion Thermoseeds induced heating in alternating magnetic field can achieve an appropriate temperature,and the gilded thermoseeds have a high biocompatibility with 1 degree cytotoxicity without leading to hemolytic reaction.