Objective:To explore clinical characteristics of multiple sclerosis(MS)patients in Suzhou,and to analyze main factors affecting their prognosis.Methods:General data,clinical symptoms,cerebrospinal fluid and imaging examinations of 51 MS patients admitted to Department of Neurology of the Second Hospital of Soochow University from July 31,2009 to July 31,2021 were retrospectively analyzed,and main factors affecting their prognosis were discussed.Results:Average age of onset of 51 MS patients was(43.3±15.6)years old,female accounted for 56.9%,male/female=1/1.3.Adult onset MS(AOMS)accounted for 62.8%,male/female=1/1.7;late onset MS(LOMS)accounted for 37.2%,male/female=1/0.9.Relapsing remitting MS(RRMS)accounted for 76.5%,and chronic onset accounted for 60.8%.Average annual recurrence rate was 8.8%.The first symptoms were numbness and weakness of limbs.Dizziness and numbness were more common in patients without recurrence after diagnosis of MS,and limb weak-ness and numbness were more common in patients with recurrence.Among lesions of MRI,62.7%(32/51)of periventricular involve-ment,52.9%(27/51)of spinal cord involvement,51.0%(26/51)of infratentorial involvement.Proportion of subtentorial and spinal cord(cervical,thoracic)involved were significantly higher in patients with recurrent MS than without recurrence.Values of albumin,IgG,IgA and IgM in cerebrospinal fluid increased with increase of recurrence times.EDSS score of male was higher than female,and LOMS score was higher than AOMS.MS patients without relapse had a low EDSS score,and median EDSS score at current follow-up was 0(0,1.00)score.MS score with relapse was relatively high,and median EDSS score at current follow-up was 2.75(0.25,7.25)score.Conclusion:MS patients with chronic onset are more common,with a high proportion of LOMS,and proportion of males increases with increasing age of onset.High EDSS score at first onset,cervical,thoracic and subtentorial lesions,increased values of cerebrospinal fluid albumin,IgG,IgA,IgM,age at first onset(50+years old),male associate with poor MS prognosis.

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 explore clinical characteristics of multiple sclerosis(MS)patients in Suzhou,and to analyze main factors affecting their prognosis.Methods:General data,clinical symptoms,cerebrospinal fluid and imaging examinations of 51 MS patients admitted to Department of Neurology of the Second Hospital of Soochow University from July 31,2009 to July 31,2021 were retrospectively analyzed,and main factors affecting their prognosis were discussed.Results:Average age of onset of 51 MS patients was(43.3±15.6)years old,female accounted for 56.9%,male/female=1/1.3.Adult onset MS(AOMS)accounted for 62.8%,male/female=1/1.7;late onset MS(LOMS)accounted for 37.2%,male/female=1/0.9.Relapsing remitting MS(RRMS)accounted for 76.5%,and chronic onset accounted for 60.8%.Average annual recurrence rate was 8.8%.The first symptoms were numbness and weakness of limbs.Dizziness and numbness were more common in patients without recurrence after diagnosis of MS,and limb weak-ness and numbness were more common in patients with recurrence.Among lesions of MRI,62.7%(32/51)of periventricular involve-ment,52.9%(27/51)of spinal cord involvement,51.0%(26/51)of infratentorial involvement.Proportion of subtentorial and spinal cord(cervical,thoracic)involved were significantly higher in patients with recurrent MS than without recurrence.Values of albumin,IgG,IgA and IgM in cerebrospinal fluid increased with increase of recurrence times.EDSS score of male was higher than female,and LOMS score was higher than AOMS.MS patients without relapse had a low EDSS score,and median EDSS score at current follow-up was 0(0,1.00)score.MS score with relapse was relatively high,and median EDSS score at current follow-up was 2.75(0.25,7.25)score.Conclusion:MS patients with chronic onset are more common,with a high proportion of LOMS,and proportion of males increases with increasing age of onset.High EDSS score at first onset,cervical,thoracic and subtentorial lesions,increased values of cerebrospinal fluid albumin,IgG,IgA,IgM,age at first onset(50+years old),male associate with poor MS prognosis.

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 observe the clinical efficacy of hyperbaric oxygen（HBO）combined with infliximab in the treatment of ulcerative colitis and explore its possible action mechanism.Methods:A total of 50 patients with ulcerative colitis were randomly divided into treatment group（26 cases）and control group（24 cases）. The treatment group was given HBO combined with infliximab，while the control group was given infliximab alone. Both groups were treated for 30 weeks.Results:The comprehensive efficacy，infliximab response rate，and trough level of the maintenance period（from the 3rd to the 5th injection）in the treatment group were significantly higher than those of the control group with statistically significant differences，respectively［92.3% vs. 66.7%， P<0.05；92.3% vs. 66.7%， P<0.01；（1.32±0.26）μg/ml vs.（0.74±0.22）μg/ml， P<0.01］；and the treatment group could significantly improve the levels of CD4 + and CD4 +/CD8 +，reduce the levels of CD8 +，TNF-α，IL-6，and CRP（ P<0.05）. Conclusion:HBO combined with infliximab in the treatment of ulcerative colitis can significantly improve the response rate of infliximab and enhance the curative effect，which may be achieved by inhibiting the proliferation of T lymphocyte and reducing the release of inflammatory factors.

Objective:To observe the clinical efficacy of hyperbaric oxygen（HBO）combined with infliximab in the treatment of ulcerative colitis and explore its possible action mechanism.Methods:A total of 50 patients with ulcerative colitis were randomly divided into treatment group（26 cases）and control group（24 cases）. The treatment group was given HBO combined with infliximab，while the control group was given infliximab alone. Both groups were treated for 30 weeks.Results:The comprehensive efficacy，infliximab response rate，and trough level of the maintenance period（from the 3rd to the 5th injection）in the treatment group were significantly higher than those of the control group with statistically significant differences，respectively［92.3% vs. 66.7%， P<0.05；92.3% vs. 66.7%， P<0.01；（1.32±0.26）μg/ml vs.（0.74±0.22）μg/ml， P<0.01］；and the treatment group could significantly improve the levels of CD4 + and CD4 +/CD8 +，reduce the levels of CD8 +，TNF-α，IL-6，and CRP（ P<0.05）. Conclusion:HBO combined with infliximab in the treatment of ulcerative colitis can significantly improve the response rate of infliximab and enhance the curative effect，which may be achieved by inhibiting the proliferation of T lymphocyte and reducing the release of inflammatory factors.

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.