1.Efficacy of different treatment duration of vonoprazan combined with low-dose amoxicillin in Helicobacter pylori eradication
Yizhou JIANG ; Kai MA ; Cheng CUI ; Xin CAO ; Xiaoyong WANG
Chinese Journal of Digestion 2024;44(6):361-367
Objective:To investigate the efficacy and safety of different treatment duration of dual therapy including vonoprazan and low-dose amoxicillin in Helicobacter pylori ( H. pylori) eradication. Methods:From December 1, 2022 to November 30, 2023, a total of 150 H. pylori-infected patients who underwent primary treatment in the Affiliated Changzhou No.2 People′s Hospital of Nanjing Medical University were recruited. The patients were divided into 10-day treatment group and 14-day treatment group with 75 patients in each group by random number table method. Patients of both groups were treated with vonoprazan (20 mg each time, twice per day) combined with amoxicillin (0.75 g each time, 3 times per day), and the treatment duration was 10 and 14 days, respectively. Intention-to-treat (ITT) and per-protocol (PP) analyses were used to evaluate the eradication efficacy of H. pylori of the 10-day treatment group and 14-day treatment group. PP analysis was used to compare the incidence of adverse events between the 2 groups. Cost-effectiveness analysis was performed to evaluate the economic efficiency of the 2 treatment regimens. Identified factors affecting the eradication rate in the 10-day treatment group based on the PP. Independent sample t-test and chi-square test were used for statistical analysis. Results:In ITT and PP analysis, a total of 75, 75 patients and 70, 72 patients were included in the 10-day treatment group and 14-day treatment group, respectively. The results of ITT analysis showed that the eradication rates of 10-day treatment group and 14-day treatment group were 86.7% (65/75) and 90.7% (68/75), respectively. The results of PP analysis showed that the eradication rates of the 2 groups were 92.9% (65/70) and 94.4% (68/72), respectively, and the differences were not statistically significant (both P>0.05). The results of PP analysis showed that the incidences of adverse events of the 10-day treatment group and 14-day treatment group were 12.9% (9/70) and 9.7% (7/72), respectively, and the difference was not statistically significant( P>0.05). The cost-effectiveness ratios of the 10-day treatment group and 14-day treatment group were 3.29 and 4.19 yuan/%, respectively. The optimal cut-off values were 63.5 kg for body weight and 1.73 m 2 for body surface area to affect the H. pylori eradication rate. The H. pylori eradication rate of patients with body weight ≤ 63.5 kg was higher than that of patients with body weight >63.5 kg (100.0%, 42/42 vs. 82.1%, 23/28), and the H. pylori eradication rate of the patients with body surface area≤1.73 m 2 was higher than that of patients with body surface area>1.73 m 2 (100.0%, 45/45 vs. 80.3%, 20/25), and the differences were statistically significant ( χ2=5.61 and 6.91, P=0.018 and 0.009). Conclusions:The 10-day combination therapy of vonoprazan and low-dose amoxicillin is a safe and effective primary treatment regimen for H. pylori eradication. Body weight and body surface area are influencing factors of the eradication rate.
2."Subtype-precise"therapy leads diagnostic and therapeutic innovations:a new pattern for precision treatment of breast cancer
Siwei ZHANG ; Ding MA ; Yizhou JIANG ; Zhimin SHAO
China Oncology 2024;34(11):1045-1052
Breast cancer is the most common malignant tumor among women worldwide,with incidence rates rising annually.The treatment of breast cancer has undergone significant transformations,evolving from an initial reliance on a single surgical approach to the incorporation of systemic therapy,and more recently,to subtype-specific therapy.Clinically,breast cancer is classified into luminal,HER2-positive,and triple-negative breast cancer(TNBC)based on the expression of hormone receptor(HR)and human epidermal growth factor receptor 2(HER2),with corresponding treatments including endocrine therapy,anti-HER2 targeted therapy,and chemotherapy.However,the current subtype-based treatment strategies lack personalization,with approximately 30%of patients still facing resistance and relapse.While the overall survival rate of patients with HER2-positive breast cancer has been steadily increasing,significant survival improvements have not been observed in patients with triple-negative and luminal breast cancer.To overcome the clinical bottleneck of"incomplete classification and imprecise treatment",the concept of"subtype-precise"therapy has emerged.This innovative approach involves further subclassification of existing subtypes to identify specific targets for precision treatment,characterized by broad population coverage and high specificity.Over the past decade,the multidisciplinary team at Fudan University Shanghai Cancer Center has established a comprehensive molecular portrait of Chinese Breast Cancer Genome Atlas(CBCGA).They deeply analyzed the molecular characteristics of TNBC,leading to the development of a"Fudan subtype"closely related to clinical outcomes:luminal androgen receptor subtype(LAR),which can be targeted with anti-HER2 and CDK4/6 inhibitors;the immunomodulatory subtype(IM),suitable for immunotherapy;basal-like immune-suppressed subtype(BLIS),which can be treated with platinum-based drugs or poly(ADP-ribose)polymerase(PARP)inhibitors;and mesenchymal-like subtype(MES),which can be treated with anti-cancer stem cell and anti-angiogenic therapies.The team then extended the concept of"subtype-precise"to luminal breast cancer,the subtype with the largest number,the highest proportion and the risk of recurrence for decades.They divided it into four molecular subtypes and proposing corresponding precision treatment strategies:canonical luminal subtype(SNF1),sensitive to endocrine therapy;immunogenic subtype(SNF2),amenable to immunotherapy;proliferative subtype(SNF3),treatable by CDK4/6 inhibitors;and receptor tyrosine kinase-driven subtype(SNF4),targetable with tyrosine kinase inhibitors.The team is currently conducting phase Ⅲ randomized controlled trials to further validate the"subtype-precise"therapy and promote the"subtype-precise"Fudan experience to enhance overall breast cancer treatment efficacy.Looking forward,the integration of emerging diagnostic tools,such as artificial intelligence,coupled with the continuous update of subtype-specific targets and targeted therapies,is expected to further refine and expand"subtype-precise"therapy.This approach holds great promises for enhancing patient prognosis and leading a new revolution in breast cancer treatment.
3.The Efficacy of Combined Endoscopic Ultrasound Fine-needle Aspiration and Endoscopic Retrograde Cholangiopancreatography in Same Session for the Diagnosis and Management of Pancreatic Carcinoma with Obstructive Jaundice
Yizhou ZHAO ; Jianing LI ; Qiang WANG ; Dongsheng WU ; Shengyu ZHANG ; Xi WU ; Tao GUO ; Qingwei JIANG ; Yingyun YANG ; Wen SHI ; Yunlu FENG ; Aiming YANG
Medical Journal of Peking Union Medical College Hospital 2024;15(4):819-824
To explore the application value of endoscopic ultrasound fine-needle aspiration (EUS-FNA) and endoscopic retrograde cholangiopancreatography (ERCP) in the diagnosis and treatment ofpatients with pancreatic cancer combined with obstructive jaundice. Clinical data of patients hospitalized in the Department of Gastroenterology of Peking Union Medical College Hospital who underwent ERCP biliary stent drainage for pancreatic cancer combined with obstructive jaundice from January 1, 2023 to February 26, 2024 were retrospectively collected. They were categorized into the fusion technology group and the simple ERCP group according to whether EUS-FNA was performed in the same endoscopic unit. The differences in pathologic diagnosis rate, ERCP drainage success rate, postoperative complication rate and patients' single hospitalization time were compared between the two groups. A total of 161 patients with pancreatic cancer combined with obstructive jaundice who underwent ERCP biliary stent drainage meeting the inclusion and exclusion criteria were enrolled, of which 80 were in the fusion technique group and 81 were in the simple ERCP group. The pathological diagnosis rate in the fusion technique group was higher than that in the simple ERCP group[92.50%(74/80) The fusion of EUS-FNA and ERCP enhances the efficiency of diagnosis and treatment for pancreatic carcinoma, warranting widespread adoption and further research.
4. Research progress on immunotherapy for triple-negative breast cancer
Lihua HE ; Xiuzhi ZHU ; Yizhou JIANG
Chinese Journal of Clinical Pharmacology and Therapeutics 2023;28(8):842-853
Triple-negative breast cancer (TNBC) is a subtype of breast cancer characterized by the absence of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2). It is highly aggressive, easy to relapse, and chemotherapy remains its mainstay treatment due to the lack of therapeutic targets. In recent years, many advances have been made in the development of immunotherapy for TNBC. This review summarizes the primary modalities of immunotherapy for TNBC, including immune checkpoint inhibitors, adoptive immune cell therapy, tumor vaccines and oncolytic virus. We present the latest research progress on each treatment from the perspective of clinical study and fundamental research, while introducing the potential predictive biomarkers and resistance mechanisms of immunotherapy for TNBC.
5.Related factors of relapse based on positive and negative syndrome scale among schizophrenics in Shanghai communities
Ying QIAO ; Yizhou JIANG ; Siyuan HE ; Chunmei CHEN ; Yi ZHU ; Jun CAI ; Bin XIE ; Na WANG ; Weibo ZHANG
Shanghai Journal of Preventive Medicine 2023;35(3):267-274
ObjectiveTo explore the relapse status based on the positive and negative syndrome scale (PANSS Scale) and related factors of schizophrenics in Shanghai communities, and to analyze the association between socio demographic characteristics, lifestyles, clinical characteristics and relapse. MethodsA dynamic cohort prospective study design was used in this study. From March 2018 to February 2019, a total of 189 schizophrenics in Xuhui, Hongkou, Changning, Jiading, Songjiang and Baoshan districts were enrolled successively. Baseline questionnaires were conducted through face-to-face interviews at baseline, which contained social demographic information, lifestyle information and clinical information. A follow-up was conducted every 2 weeks for a measurement of PANSS Scale for a total of 6 months. Relapse was assessed by a PANSS score increase of ≥25% from baseline (or an increase of 10 points or more if the baseline score was ≤40 points). Univariate and multivariate Cox regression models were used to analyze the associations between relapse status (assessed by PANSS Scale) and socio demographic characteristics, lifestyles, and clinical characteristics, respectively. ResultsA total of 165 community schizophrenics completed baseline and follow-up surveys, with a loss to follow-up rate of about 12.7%. After exclusion of sociodemographic and clinical information deficits, 132 patients were included in the analysis totally, with an average age of 48.18±12.67 years, among whom 41.67% were male. Totally 33 patients relapsed during the 6-month follow-up period, with a relapse rate of 25.0%. After adjusting for gender, family history, age, employment, education, marital status, smoking, drinking, exercise frequency, medication compliance, insight, social function, violence history, stress recent events, adverse drug reactions and baseline scores of PANSS Scale, risk factors of relapse included the following four factors: age below 40 years (HR=4.47, 95%CI: 1.15-17.40), primary school or below (HR=7.11, 95%CI: 1.54-32.83), unemployed (HR=8.34, 95%CI: 1.78-38.98), and adverse drug reactions (HR=5.02, 95%CI: 1.75-14.37). ConclusionWe should pay attention to the risk factors such as age, education, employment and adverse drug reactions, in order to identify high-risk patients and to conduct timely interventions during the relapse management of schizophrenics in Shanghai community.
6.Development and validation of risk prediction model for aggressive behaviors of community patients with schizophrenia
Yizhou JIANG ; Chunmei CHEN ; Youwei ZHU ; Siyuan HE ; Jun CAI ; Bin XIE ; Weibo ZHANG ; Na WANG
Shanghai Journal of Preventive Medicine 2022;34(10):948-954
ObjectiveTo determine the factors associated with aggressive behaviors of patients with schizophrenia by gender in communities in Shanghai, and further develop and validate the prediction model. MethodsA total of 7 955 community patients with schizophrenia were investigated in Xuhui District, Hongkou District and Jiading District of Shanghai. Baseline information was collected from April 2018 and follow-up was conducted every 3 months for 6 months. Multivariate logistic regression was used to calculate the odd ratio (OR) and 95% CI, and determine the factors associated with aggressive behaviors of patients. The risk score for each patient was developed based on the β coefficient, and the best cut-off value was determined by the Youden index. For the models, predictive ability was determined using area under the curve (AUC) of receiver operator characteristic curve (ROC curve), and internal validation ability was evaluated by the ten-fold cross validation method. ResultsThere were 3 563 males in this study with an average age of (54.83±13.72) years old, and the incidence of aggressive behaviors was 2.55%.There were 4 392 females with an average age of (57.20±14.98) years, and the incidence of aggressive behaviors was 2.64%. For male patients with schizophrenia, single/divorced status (OR=2.04, 95%CI: 1.15‒3.61), low economic status (OR=2.79, 95%CI: 1.71‒4.54), irregular medication (OR=4.35, 95%CI:2.23‒8.47), no medication (OR=1.83, 95%CI:1.03‒3.26), incomplete/no insight (OR=1.97, 95%CI:0.99‒3.94), adverse drug reaction (OR=2.61, 95%CI:1.27‒5.37), psychiatric symptoms involving violence (OR=2.06, 95%CI:1.01‒4.18), history of aggression (OR=5.29, 95%CI:2.33‒11.98) and recent stress events (OR=8.36, 95%CI:4.13‒16.92) were associated with aggressive behaviors. In contrast, for female patients, age less than 60 years (50‒59 years, OR=2.09, 95%CI: 1.13‒3.87; 40‒49 years, OR=2.74, 95%CI: 1.46‒5.17; 30‒39 years,OR=2.88, 95%CI: 1.48‒5.60; 18‒29 years, OR=5.71, 95%CI: 2.44‒13.37), educational level of high school and above (senior high school, OR=3.30, 95%CI: 1.46‒7.49; college and university, OR=2.88, 95%CI: 1.21‒6.82), unemployed status (OR=1.81, 95%CI=1.17‒2.82), irregular medication (OR=7.87, 95%CI:4.75‒13.05), no medication (OR=2.11, 95%CI:1.24‒3.62), adverse drug reaction (OR=2.75, 95%CI:1.50‒5.04), psychiatric symptoms involving violence (OR=3.08, 95%CI:1.77‒5.37), social function (OR=3.51, 95%CI:2.07‒5.94) and recent stress events (OR=5.92, 95%CI: 2.82‒12.44) were risk factors. In both male and female, the prediction models for aggressive behaviors of community patients with schizophrenia had strong predictive ability (AUC=0.779, 95%CI: 0.725‒0.834; AUC=0.822, 95%CI: 0.780‒0.863). ConclusionThis study suggests that diverse risk factors should be considered for community patients with schizophrenia by gender to prevent the aggressive behaviors.
7.Stress level of people seeking psychological counseling and its related factors in the early stage of COVID⁃19 outbreak in Shanghai
Yizhou JIANG ; Weibo ZHANG ; Siyuan HE ; Youwei ZHU ; Yingying WANG ; Na WANG ; Jun CAI
Shanghai Journal of Preventive Medicine 2022;34(5):459-463
ObjectiveTo understand the stress level of people seeking psychological counseling under the coronavirus disease 2019 (COVID⁃19) pandemic and to explore its related factors. MethodsAn online survey was conducted on 1 194 people who sought psychological counseling in Shanghai through the “health cloud” psychological counseling service platform. The questionnaire included demographic information,lifestyle and stress during the COVID-19 pandemic. ResultsParticipants with low,medium,high and very high stress levels accounted for 33.1% (395/1 194),34.6% (413/1 194),25.4% (303/1 194) and 7.0% (83/1 194),respectively. Women and participants aged 18 to 30 years had higher stress levels(Z=-5.368,P<0.001; Z=35.822,P<0.001) compared with other groups. Factors contributing to the rise in stress included reading too much information about COVID-19 (OR=2.057,95%CI:1.012‒4.181),large changes in sleep state (OR=3.496,95%CI:1.669‒7.325),lack of hobbies and interests (OR=2.852,95%CI:1.252‒6.500),and prone to anxiety/irritability/sadness (OR=4.098,95%CI:1.772‒9.480). Conclusionpeople who sought psychological counseling show high levels of psychological stress during the COVID-19 pandemic. We should pay more attention to the vulnerable groups with the following characteristics: women,18‒30 years old, residents who pay too much attention to the pandemic information,sleep less, and almost lose interest in hobbies, and easily become anxious/irritable/sad.
8.Hazards of game addiction to health in adolescents
Xiaolian DONG ; Yizhou JIANG ; Yixuan ZHANG ; Weibo ZHANG ; Na WANG
Shanghai Journal of Preventive Medicine 2022;34(5):504-508
Gaming addiction, as a main manifestation of internet addiction, is characterized by a pattern of persistent or recurrent gaming behaviors. Gaming behaviors are common among adolescents and can result in marked distress or significant impairment in personal, family, social or other important areas of functioning. Recent research on health hazards of gaming addiction is relatively scattered. This article reviews the harm of adolescent game addiction to physical and mental health.
9.Establishment and optimization of inductively coupled plasma mass spectrometry (ICP-MS) for the determination of aluminum residues
Yizhou XIE ; Yaling DING ; Jialin CHU ; Wenhu HUANG ; Yang GAO ; Xiao JIANG ; Tingting LU ; Kuilin LU
Chinese Journal of Blood Transfusion 2022;35(1):82-85
【Objective】 To establish and optimize a method for the determination of aluminum (Al) residue by inductively coupled plasma mass spectrometry (ICP-MS). 【Methods】 Nitric acid solution was used to treat samples and standards. The concentration of nitric acid solution and equipment parameters were optimized, and the specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision of the optimized detection method were investigated to confirm whether it was suitable for the determination of Al residue in human serum albumin. 【Results】 The concentration of nitric acid was 5%, and digest time was 4 h. The equipment condition of ICP-MS was as follows: RF power: 1600 W, sampling depth: 10 mm, atomizer / carrier gas flow rate: 1.0 L/ min, compensation flow rate: 0.5 L/ min, experimental mode: standard mode, integration time: 0.2 s, data acquisition: 3 times. Specificity: The recoveries of Al: 92% (high concentration, RSD=3.5%), 98% (low concentration, RSD=4.9%). Linearity: In the range of (0~40) μg/L, the correlation coefficient between concentration and optical energy signal (CPS) of standard / sample were higher than 0.999 0. Accuracy/ Repeatability: The recoveries of sample (3 concentration): 108% (RSD=4.7%), 110% (RSD=4.9%) and 110% (RSD=2.8%). The detection limit was 0.006 μg/L, and the quantitation limit was 0.019 μg/L. Intermediate precision: personnel factor and date factor, P>0.05, RSD (12 times)=2%. Comparison between ICP-MS and atomic absorption spectrometry (AAS): the deviation between ICP-MS and AAS was 8%, and that of samples was 3%, with no significant difference noticed between the two methods. 【Conclusion】 After optimization, ICP-MS method has shown good performance in terms of specificity, linearity, repeatability, accuracy, detection limit, quantitative limit and intermediate precision, and is suitable for the determination of Al residue in human albumin products of our company.
10.Matrix effect on the determination of Potency in Recombinant Coagulation Factor Ⅷ for injection
Jialin CHU ; Yaling DING ; Wenhu HUANG ; Jiajun WU ; Xiao JIANG ; Yang GAO ; Xun LIU ; Shenghua DU ; Yizhou XIE
Chinese Journal of Blood Transfusion 2022;35(12):1262-1265
【Objective】 To investigate the matrix effect on the determination of potency in Recombinant Human Coagulation Factor Ⅷ for Injection (rFⅧ). 【Methods】 Two different detection matrices were used to establish two methods for detecting the potency in Recombinant Human Coagulation Factor Ⅷ for Injection. And the matrix effect on the determination of potency was determined, including specificity, linearity, repeatability, accuracy and intermediate precision. 【Results】 As to the specificity, the recoveries of the two substrates at high vs low concentration level were 112% and 110% vs 104% and 109%, respectively. As to the linearity, in the range of (0.125-1.000) IU/mL, the correlation coefficient between concentration and coagulation time of standard/ sample was higher than 0.99. As to the accuracy/repeatability, the recoveries of two matrices was 104% and 102%, and RSD was 2.4% and 1.9%. As to the intermediate precision, personnel factor of two matrices was 0.72 and 0.23, date factor was 0.79 and 0.85, and RSD(for 12 times) was 4.2% and 3.0%. Comparison of two matrices was as follows: Deviation in test results of 6 batches of rFⅧ was all lower than 5%. There was no significant difference between two matrices. 【Conclusion】 The two matrices for potency detection show good performance including specificity, linearity, repeatability, accuracy, and intermediate precision. They are suitable for the determination of potency in rFⅧ products.

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