1.Efficacy and safety of dupilumab in the treatment of moderate-to-severe atopic dermatitis in infants aged 6 months to 2 years: a prospective, single-center clinical trial
Jiangshan PI ; Jingsi CHEN ; Lingling WANG ; Zhanting SHEN ; Xiaoyan LUO ; Hua WANG
Chinese Journal of Dermatology 2025;58(10):930-935
Objective:To evaluate the efficacy and safety of dupilumab in the treatment of moderate-to-severe atopic dermatitis (AD) in infants aged 6 months to 2 years.Methods:A prospective cohort study was conducted. Children aged 6 months to 2 years with moderate-to-severe AD were enrolled from the Department of Dermatology, Children′s Hospital of Chongqing Medical University between July 2022 and March 2023. Children weighing 5 to < 15 kg received subcutaneous injections of dupilumab at a dose of 200 mg every 4 weeks, while those weighing 15 to < 30 kg received subcutaneous injections of dupilumab at a dose of 300 mg every 4 weeks. Three age-matched healthy children were recruited as controls at the same time. Clinical assessments were performed at weeks 0, 2, 4, 8, 12, and 16 by using the parameters scoring AD (SCORAD), eczema area and severity index (EASI), investigator′s global assessment (IGA), body surface area (BSA) involvement, patient-oriented eczema measure (POEM), pruritus numerical rating scale (NRS), sleep NRS, and infants′ dermatitis quality of life (IDQoL) index. The primary efficacy endpoint was the proportion of patients achieving an IGA score of 0 or 1 (IGA0/1) at week 16, and the key secondary efficacy endpoint was the proportion of patients achieving at least 75% improvement from baseline in EASI (EASI75) at week 16. In addition, serum immunoglobulin (Ig) E, IgG, IgM, and IgA levels and peripheral blood eosinophil counts were measured at weeks 0, 4, and 16. Peripheral blood T helper (Th) cell subsets were analyzed in 10 AD patients and 3 healthy children at baseline by flow cytometry, and 6 AD patients underwent repeat testing at week 16. Adverse reactions were recorded throughout treatment. Changes in clinical scores over time after dupilumab treatment were analyzed using repeated-measures analysis of variance, and changes in serum total IgE levels were analyzed using generalized estimating equations.Results:A total of 12 children with AD were enrolled, including 8 males and 4 females, aged 1.5 ± 0.3 years, and the baseline SCORAD was 64.8 ± 9.9 points. Compared with baseline, SCORAD, EASI, IGA, BSA, POEM, pruritus/sleep NRS, and IDQoL scores were all significantly reduced at week 2 (all P < 0.05), and continued to decrease at weeks 4, 8, 12, and 16. At week 16, the IGA scores decreased from 3.9 ± 0.3 points at baseline to 1.7 ± 0.9 points, with 9 patients achieving IGA0/1; the EASI scores decreased from 28.1 ± 12.4 points at baseline to 4.9 ± 5.4 points, with 9 patients achieving EASI75. Compared with baseline, serum total IgE levels were significantly reduced at weeks 4 and 16 (Wald χ2 = 11.51, P = 0.003). At baseline, the proportion of Th2 cells among total CD3 +CD4 + T cells in patients was significantly higher than that in healthy controls (6.3% ± 1.3% vs. 4.3% ± 0.8%, t = 2.45, P = 0.032) ; at week 16, the proportion of Th2 cells in patients (5.3% ± 2.0%) was significantly lower than that at baseline ( t = 5.56, P = 0.003). The proportion of Th1/17 cells increased from 2.2% ± 1.5% at baseline to 3.9% ± 2.1% at week 16 ( t = 3.51, P = 0.007), whereas the proportions of Th1 and Th17 cell subsets showed no statistical significance compared with baseline (both P > 0.05). One patient experienced an injection-site reaction and another developed fever, but no treatment-related serious adverse reactions were observed. Conclusions:Dupilumab demonstrated favorable efficacy and safety in infants aged 6 months to 2 years with moderate-to-severe AD. In addition, dupilumab could decrease the proportion of Th2 cell subsets and serum levels of total IgE.
2.Research on the prevalence of overweight and obesity among children
Xinyi LIANG ; Jingnan CHEN ; Xuelian ZHOU ; Ruimin CHEN ; Jingsi LUO ; Rongxiu ZHENG ; Chunxiu GONG ; Chunlin WANG ; Zhe SU ; Mireguli MAIMAITI ; Yan LIANG ; Hui YAO ; Haiyan WEI ; Hongwei DU ; Shaoke CHEN ; Yu YANG ; Feihong LUO ; Pin LI ; Min ZHU ; Wei WU ; Ke HUANG ; Guanping DONG ; Junfen FU
Chinese Journal of Pediatrics 2025;63(6):612-619
Objective:To investigate the prevalence and risk factors of overweight and obesity among Chinese children aged 3-18 years from 11 provinces, antonomous regions, or municipalities.Methods:This national cross-sectional community health survey utilized a multistage stratified cluster-random sampling method to recruit 193 997 nationally representative participants from 11 provinces, autonomous regions, or municipalities between January 2017 and December 2019. All participants underwent physical examinations, and their caregivers completed questionnaires assessing participants′ dietary, lifestyle, familial, and perinatal information. Multilevel multinomial logistic regression models were employed to identify the potential risk factors.Results:The cohort comprised 193 997 children (102 178 boys, 91 819 girls),aged (10±4) years. Overall prevalence rates were 30 574(15.8%)overweight children and 17 217(8.9%) obesity children. Boys exhibited higher overweight and obesity rates than girls (17.0% (17 368/102 178) vs. 14.4% (13 206/102 178), 11.3% (11 553/91 819) vs. 6.2% (5 664/91 819), χ2=249.12,1 578.69,both P<0.001). The detection rates of obesity in Tanner stage 2 and 3 were the highest in boys and girls, with 13.4%(2 231/16 665) and 8.6%(880/10 221) respectively. Risk factors for obesity included parental overweight (paternal OR=2.34 and maternal OR=2.29), annual household income of 100 000-200 000 yuan (compared with<100 000 yuan, OR=1.04), higher paternal education (compared with below high school,high school and a college education OR=1.09,1.14), birth weight >4.0 kg (≤5 and>5 years old OR=1.74, 1.44,respectively), and western food consumption≥1 time/month (compared with<1, 1-2, 3-4,>4 times/month OR=1.36, 1.30, 1.67(≤5 years), 1.19, 1.16, 1.15 (>5 years), respectively) (all P<0.05). Conversely, coarse grain intake≥1 times/week (compared with<1 times/week, every day, 3-4, 1-2 times/week OR=0.74, 0.80, 0.71 (≤5 years), 0.75, 0.87, 0.90(>5 years), respectively, all P<0.05) was associated with reduced obesity risk. Conclusions:Obesity epidemiology in children demonstrates significant heterogeneity across age, gender, geographic regions, and pubertal stages. It is necessary to establish a personalized prevention and control strategy.
3.The interaction between plasma aluminum concentration and schooling year on cognitive function
Limin MA ; Yingjun XUE ; Xiaoyan LI ; Shanshan WANG ; Jingsi ZHANG ; Qiao NIU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2025;43(1):25-31
Objective:To explore the effect of the interaction between plasma aluminum concentration and schooling year on cognitive function, it provides the basis for early identification of its damaging effect.Methods:From October to December, 2014, 1114 on-the-job aluminum exposed workers in a large aluminum factory in Shanxi Province were investigated. The plasma aluminum concentrations were measured by inductively coupled plasma-mass spectrometry (ICP-MS) as an internal exposure indicator. The subjects were divided into low, medium, and high aluminum exposure group based on the blood lead concentration levels. The general information was collected with a self-designed questionnaire, and their cognitive function was evaluated with the mini-mental state examination and the clock drawing test. The interaction between plasma aluminum concentration level and education level was analyzed by using unconditional logistic regression fitting multiplication model and cross analysis fitting addition model.Results:The average level of plasma aluminum of the subjects was 21.68 (10.51, 45.78) μg/L. The detection rate of cognitive impairment was 19.9%. The influencing factors of cognitive function were plasma aluminum concentration, age, education level and marital status, among which high schooling year, and being married were the protective factors (all P<0.05), plasma aluminum concentration, and age were the risk factors (all P<0.05) ; After adjusting the confounding factors, such as age, marital status, schooling year, income level, smoking, and drinking, logistic regression model and the multiple linear regression model showed that there was a dose response relationship between plasma aluminum concentration and cognitive impairment. With the increase of plasma aluminum concentration, the score gradually decreased, and the risk of cognitive impairment increased ( Ptrend<0.05) ; There were multiplicative interaction ( AOR=2.15, 95% CI: 1.10-4.19) and additive interaction ( RERI=5.38, 95% CI: 2.60-8.16; AP=0.65, 95% CI: 0.51-0.80; S=3.88, 95% CI: 2.00-7.56) between plasma aluminum concentration and low schooling year on cognitive function. Conclusion:There was a dose-response relationship between aluminum exposure and cognitive impairment. There was an interaction between aluminum exposure and low schooling year. When both of them worked together, the risk of cognitive impairment increases.
4.Efficacy and safety of dupilumab in the treatment of moderate-to-severe atopic dermatitis in infants aged 6 months to 2 years: a prospective, single-center clinical trial
Jiangshan PI ; Jingsi CHEN ; Lingling WANG ; Zhanting SHEN ; Xiaoyan LUO ; Hua WANG
Chinese Journal of Dermatology 2025;58(10):930-935
Objective:To evaluate the efficacy and safety of dupilumab in the treatment of moderate-to-severe atopic dermatitis (AD) in infants aged 6 months to 2 years.Methods:A prospective cohort study was conducted. Children aged 6 months to 2 years with moderate-to-severe AD were enrolled from the Department of Dermatology, Children′s Hospital of Chongqing Medical University between July 2022 and March 2023. Children weighing 5 to < 15 kg received subcutaneous injections of dupilumab at a dose of 200 mg every 4 weeks, while those weighing 15 to < 30 kg received subcutaneous injections of dupilumab at a dose of 300 mg every 4 weeks. Three age-matched healthy children were recruited as controls at the same time. Clinical assessments were performed at weeks 0, 2, 4, 8, 12, and 16 by using the parameters scoring AD (SCORAD), eczema area and severity index (EASI), investigator′s global assessment (IGA), body surface area (BSA) involvement, patient-oriented eczema measure (POEM), pruritus numerical rating scale (NRS), sleep NRS, and infants′ dermatitis quality of life (IDQoL) index. The primary efficacy endpoint was the proportion of patients achieving an IGA score of 0 or 1 (IGA0/1) at week 16, and the key secondary efficacy endpoint was the proportion of patients achieving at least 75% improvement from baseline in EASI (EASI75) at week 16. In addition, serum immunoglobulin (Ig) E, IgG, IgM, and IgA levels and peripheral blood eosinophil counts were measured at weeks 0, 4, and 16. Peripheral blood T helper (Th) cell subsets were analyzed in 10 AD patients and 3 healthy children at baseline by flow cytometry, and 6 AD patients underwent repeat testing at week 16. Adverse reactions were recorded throughout treatment. Changes in clinical scores over time after dupilumab treatment were analyzed using repeated-measures analysis of variance, and changes in serum total IgE levels were analyzed using generalized estimating equations.Results:A total of 12 children with AD were enrolled, including 8 males and 4 females, aged 1.5 ± 0.3 years, and the baseline SCORAD was 64.8 ± 9.9 points. Compared with baseline, SCORAD, EASI, IGA, BSA, POEM, pruritus/sleep NRS, and IDQoL scores were all significantly reduced at week 2 (all P < 0.05), and continued to decrease at weeks 4, 8, 12, and 16. At week 16, the IGA scores decreased from 3.9 ± 0.3 points at baseline to 1.7 ± 0.9 points, with 9 patients achieving IGA0/1; the EASI scores decreased from 28.1 ± 12.4 points at baseline to 4.9 ± 5.4 points, with 9 patients achieving EASI75. Compared with baseline, serum total IgE levels were significantly reduced at weeks 4 and 16 (Wald χ2 = 11.51, P = 0.003). At baseline, the proportion of Th2 cells among total CD3 +CD4 + T cells in patients was significantly higher than that in healthy controls (6.3% ± 1.3% vs. 4.3% ± 0.8%, t = 2.45, P = 0.032) ; at week 16, the proportion of Th2 cells in patients (5.3% ± 2.0%) was significantly lower than that at baseline ( t = 5.56, P = 0.003). The proportion of Th1/17 cells increased from 2.2% ± 1.5% at baseline to 3.9% ± 2.1% at week 16 ( t = 3.51, P = 0.007), whereas the proportions of Th1 and Th17 cell subsets showed no statistical significance compared with baseline (both P > 0.05). One patient experienced an injection-site reaction and another developed fever, but no treatment-related serious adverse reactions were observed. Conclusions:Dupilumab demonstrated favorable efficacy and safety in infants aged 6 months to 2 years with moderate-to-severe AD. In addition, dupilumab could decrease the proportion of Th2 cell subsets and serum levels of total IgE.
5.The interaction between plasma aluminum concentration and schooling year on cognitive function
Limin MA ; Yingjun XUE ; Xiaoyan LI ; Shanshan WANG ; Jingsi ZHANG ; Qiao NIU
Chinese Journal of Industrial Hygiene and Occupational Diseases 2025;43(1):25-31
Objective:To explore the effect of the interaction between plasma aluminum concentration and schooling year on cognitive function, it provides the basis for early identification of its damaging effect.Methods:From October to December, 2014, 1114 on-the-job aluminum exposed workers in a large aluminum factory in Shanxi Province were investigated. The plasma aluminum concentrations were measured by inductively coupled plasma-mass spectrometry (ICP-MS) as an internal exposure indicator. The subjects were divided into low, medium, and high aluminum exposure group based on the blood lead concentration levels. The general information was collected with a self-designed questionnaire, and their cognitive function was evaluated with the mini-mental state examination and the clock drawing test. The interaction between plasma aluminum concentration level and education level was analyzed by using unconditional logistic regression fitting multiplication model and cross analysis fitting addition model.Results:The average level of plasma aluminum of the subjects was 21.68 (10.51, 45.78) μg/L. The detection rate of cognitive impairment was 19.9%. The influencing factors of cognitive function were plasma aluminum concentration, age, education level and marital status, among which high schooling year, and being married were the protective factors (all P<0.05), plasma aluminum concentration, and age were the risk factors (all P<0.05) ; After adjusting the confounding factors, such as age, marital status, schooling year, income level, smoking, and drinking, logistic regression model and the multiple linear regression model showed that there was a dose response relationship between plasma aluminum concentration and cognitive impairment. With the increase of plasma aluminum concentration, the score gradually decreased, and the risk of cognitive impairment increased ( Ptrend<0.05) ; There were multiplicative interaction ( AOR=2.15, 95% CI: 1.10-4.19) and additive interaction ( RERI=5.38, 95% CI: 2.60-8.16; AP=0.65, 95% CI: 0.51-0.80; S=3.88, 95% CI: 2.00-7.56) between plasma aluminum concentration and low schooling year on cognitive function. Conclusion:There was a dose-response relationship between aluminum exposure and cognitive impairment. There was an interaction between aluminum exposure and low schooling year. When both of them worked together, the risk of cognitive impairment increases.
6.Research on the prevalence of overweight and obesity among children
Xinyi LIANG ; Jingnan CHEN ; Xuelian ZHOU ; Ruimin CHEN ; Jingsi LUO ; Rongxiu ZHENG ; Chunxiu GONG ; Chunlin WANG ; Zhe SU ; Mireguli MAIMAITI ; Yan LIANG ; Hui YAO ; Haiyan WEI ; Hongwei DU ; Shaoke CHEN ; Yu YANG ; Feihong LUO ; Pin LI ; Min ZHU ; Wei WU ; Ke HUANG ; Guanping DONG ; Junfen FU
Chinese Journal of Pediatrics 2025;63(6):612-619
Objective:To investigate the prevalence and risk factors of overweight and obesity among Chinese children aged 3-18 years from 11 provinces, antonomous regions, or municipalities.Methods:This national cross-sectional community health survey utilized a multistage stratified cluster-random sampling method to recruit 193 997 nationally representative participants from 11 provinces, autonomous regions, or municipalities between January 2017 and December 2019. All participants underwent physical examinations, and their caregivers completed questionnaires assessing participants′ dietary, lifestyle, familial, and perinatal information. Multilevel multinomial logistic regression models were employed to identify the potential risk factors.Results:The cohort comprised 193 997 children (102 178 boys, 91 819 girls),aged (10±4) years. Overall prevalence rates were 30 574(15.8%)overweight children and 17 217(8.9%) obesity children. Boys exhibited higher overweight and obesity rates than girls (17.0% (17 368/102 178) vs. 14.4% (13 206/102 178), 11.3% (11 553/91 819) vs. 6.2% (5 664/91 819), χ2=249.12,1 578.69,both P<0.001). The detection rates of obesity in Tanner stage 2 and 3 were the highest in boys and girls, with 13.4%(2 231/16 665) and 8.6%(880/10 221) respectively. Risk factors for obesity included parental overweight (paternal OR=2.34 and maternal OR=2.29), annual household income of 100 000-200 000 yuan (compared with<100 000 yuan, OR=1.04), higher paternal education (compared with below high school,high school and a college education OR=1.09,1.14), birth weight >4.0 kg (≤5 and>5 years old OR=1.74, 1.44,respectively), and western food consumption≥1 time/month (compared with<1, 1-2, 3-4,>4 times/month OR=1.36, 1.30, 1.67(≤5 years), 1.19, 1.16, 1.15 (>5 years), respectively) (all P<0.05). Conversely, coarse grain intake≥1 times/week (compared with<1 times/week, every day, 3-4, 1-2 times/week OR=0.74, 0.80, 0.71 (≤5 years), 0.75, 0.87, 0.90(>5 years), respectively, all P<0.05) was associated with reduced obesity risk. Conclusions:Obesity epidemiology in children demonstrates significant heterogeneity across age, gender, geographic regions, and pubertal stages. It is necessary to establish a personalized prevention and control strategy.
7.Analysis of the etiology and factors associated with the severity of chronic spontaneous urticaria in children
Tiantian ZHOU ; Xuege WU ; Huan YANG ; Xiao FANG ; Jinqiu JIANG ; Jingsi CHEN ; Xiaoyan LUO ; Hua WANG
Chinese Journal of Dermatology 2024;57(4):324-330
Objective:To analyze the etiology of chronic spontaneous urticaria (CSU) in children and associated factors affecting the disease severity.Methods:A single-center cross-sectional study was conducted. Children aged ≤ 17 years with CSU were prospectively enrolled at the Department of Dermatology, Children′s Hospital of Chongqing Medical University from November 2021 to November 2022. Clinical data were collected, serum total IgE and allergen-specific IgE (sIgE) were detected, and basophil activation test (BAT) and autologous serum skin test (ASST) were performed. According to the ASST and BAT results, the children were divided into the chronic autoimmune urticaria (CAU) group (positive for both ASST and BAT), non-CAU group (negative for both ASST and BAT), and partial CAU group (positive for either ASST or BAT). Differences in the etiology and clinical characteristics were analyzed between the CAU group and the non-CAU group. Based on the weekly urticaria activity score (UAS7), the children with CSU were divided into the mild group (UAS7 < 16 points) and moderate to severe group (UAS7 ≥ 16 points). Factors associated with the severity of CSU in children were analyzed using logistic regression. Non-normally distributed quantitative data were expressed as M ( Q1, Q3), and the non-parametric rank sum test (Kruskal-Wallis test) was used to compare quantitative data among multiple groups. Results:This study enrolled a total of 93 children with CSU, including 50 males (53.8%) and 43 females (46.2%), with the age being 5.9 (2.9, 9.2) years, and the disease duration being 4 (2, 8) months; 32 patients (34.4%) were complicated by angioedema, 28 (30.1%) had a family history of chronic urticaria, 49 (52.7%) had a family history of atopic diseases, 14 (15.1%) had a family history of autoimmune diseases, and 26 (28.0%) had at least one atopic comorbidity. Etiologic analysis showed that 32 cases (32/69, 46.4%) were positive for ASST and 28 (28/70, 40.0%) were positive for BAT. Both ASST and BAT were performed in 57 cases, and they were divided into the CAU group (18 cases), non-CAU group (24 cases), and partial CAU group (15 cases) according to the test results. There were no significant differences in the age, disease duration, gender ratio, proportion of patients with atopic comorbidity, or proportion of patients having a family history of atopic diseases among the 3 groups (all P > 0.05), while the proportion of patients with moderate to severe CSU (UAS7 ≥ 16 points) was higher in the CAU group (16/18) than in the non-CAU group (11/24, P < 0.05). Triggering factors were identified in 19 cases (20.4%), including 18 (19.3%) cases of food allergy and 1 case (1.0%) of antibiotic allergy. The serum total IgE level was elevated in 22 cases (22/89, 24.7%), and 40 (40/81, 49.4%) showed elevated levels of at least 1 sIgE. The UAS7 of the children with CSU was 16 (15, 21) points, and there were 31 (33.3%) children with mild CSU and 62 (66.7%) with moderate to severe CSU. Univariate logistic regression analysis showed that BAT positivity was associated with disease severity ( OR = 7.566, 95% CI: 2.238 - 25.572, P < 0.05). After adjustment for age and gender, multivariate logistic regression analysis showed that BAT positivity was associated with moderate to severe CSU ( OR = 6.725, 95% CI: 1.361 - 33.227, P < 0.05) . Conclusions:Autoimmunity may be the main cause of CSU in children, followed by allergic factors. ASST could be used as a primary screening test for the diagnosis of CAU in children, and BAT may help identify CAU and predict disease severity.
8.Association between coronary artery stenosis and myocardial injury in patients with acute pulmonary embolism: A case-control study
Yinjian YANG ; Chao LIU ; Jieling MA ; Xijie ZHU ; Jingsi MA ; Dan LU ; Xinxin YAN ; Xuan GAO ; Jia WANG ; Liting WANG ; Sijin ZHANG ; Xianmei LI ; Bingxiang WU ; Kai SUN ; Yimin MAO ; Xiqi XU ; Tianyu LIAN ; Chunyan CHENG ; Zhicheng JING
Chinese Medical Journal 2024;137(16):1965-1972
Background::The potential impact of pre-existing coronary artery stenosis (CAS) on acute pulmonary embolism (PE) episodes remains underexplored. This study aimed to investigate the association between pre-existing CAS and the elevation of high-sensitivity cardiac troponin I (hs-cTnI) levels in patients with PE.Methods::In this multicenter, prospective case-control study, 88 cases and 163 controls matched for age, sex, and study center were enrolled. Cases were patients with PE with elevated hs-cTnI. Controls were patients with PE with normal hs-cTnI. Coronary artery assessment utilized coronary computed tomographic angiography or invasive coronary angiography. CAS was defined as ≥50% stenosis of the lumen diameter in any coronary vessel >2.0 mm in diameter. Conditional logistic regression was used to evaluate the association between CAS and hs-cTnI elevation.Results::The percentage of CAS was higher in the case group compared to the control group (44.3% [39/88] vs. 30.1% [49/163]; P = 0.024). In multivariable conditional logistic regression model 1, CAS (adjusted odds ratio [OR], 2.680; 95% confidence interval [CI], 1.243–5.779), heart rate >75 beats/min (OR, 2.306; 95% CI, 1.056–5.036) and N-terminal pro-B type natriuretic peptide (NT-proBNP) >420 pg/mL (OR, 12.169; 95% CI, 4.792–30.900) were independently associated with elevated hs-cTnI. In model 2, right CAS (OR, 3.615; 95% CI, 1.467–8.909) and NT-proBNP >420 pg/mL (OR, 13.890; 95% CI, 5.288–36.484) were independently associated with elevated hs-cTnI. Conclusions::CAS was independently associated with myocardial injury in patients with PE. Vigilance towards CAS is warranted in patients with PE with elevated cardiac troponin levels.
9.Preparation and immunizing dose analysis of inactivated hepatitis A vaccine using attenuated H2 strain
LI Hongsen ; PING Ling ; WANG Zhengxin ; JIANG Houfei ; HOU Dinglin ; ZHANG Yirong ; WANG Lingxi ; YANG Jingsi
Journal of Preventive Medicine 2024;36(5):407-411,415
Objective:
To prepare an inactivated hepatitis A vaccine using a attenuated strain of hepatitis A virus (HAV) H2 and to analyze its immunizing dose, so as to provide the reference for development and production of inactivated hepatitis A vaccines.
Methods:
Human embryonic lung diploid cells (KMB17) were infected with attenuated HAV H2 strain to proliferate the virus, then the cells containing viruses were harvested, extracted and purified. The obtained virus concentrate was prepared into vaccine bulk and test vaccines with 1 280 EU/mL antigen content. Vaccine testing was carried out according to the inactivated hepatitis A vaccine standards specified in the Part Ⅲ of the Pharmacopoeia of the People's Republic of China (2020 edition). A total of 110 mice were randomly divided into 11 groups, including 5 dose groups (80, 160, 320, 640 and 1 280 EU/dose) of the test vaccine and the reference vaccine, as well as the adjuvant control group. Mice were immunized twice by intraperitoneal injection, their serum HAV antibodies were detected, and the geometric mean titer (GMT) and positive conversion rate of antibodies were analyzed to evaluate the immunising dose of the vaccine.
Results:
The antigen content and viral titer of the virus harvest solution were 5 120 EU/mL and 8.33 lgCCID50/mL, respectively. The removal rate of foreign protein reached 98.05% and the recovery rate of antigen was 66.25%. The test vaccine met the requirements of Part Ⅲ of the Pharmacopoeia of the People's Republic of China (2020 edition). The GMTs of HAV antibodies in the test vaccine and the reference vaccine dose groups after the second immunization were more than twice higher than those after the first immunization. Regardless of primary immunization or secondary immunization, the GMTs (log2) of HAV antibodies in the test vaccine groups with doses of 160 EU/dose and above were higher than those in the 80 EU/dose group (all P<0.05), while there was no statistically significant differences between the dose groups of 160 EU/dose and above (all P>0.05). The antibody positive conversion rate of 160 EU/dose and above of the test vaccine was 100.00% after the secondary immunization.
Conclusions
The inactivated hepatitis A vaccine of attenuated H2 strain tested in this study demonstrates strong immunogenicity in mice, suggesting its potential as a candidate vaccine. The preliminary analysis indicates an immunizing dose of 320 EU/dose for children and 640 EU/dose for adults.
10.Differentiation of Pure Mucinous Carcinoma and Fibroadenoma on Ultrasound of the Breast
Hongli WANG ; Yue HU ; Cui TAN ; Ran GU ; Jingsi MEI ; Yuexing YU ; Lili CHEN ; Chang GONG
Journal of Sun Yat-sen University(Medical Sciences) 2024;45(4):631-636
[Objective]To investigate the difference of ultrasound characteristics between pure mucinous carcinoma(PMC)and fibroadenoma(FA)of the breast.[Methods]Ultrasound data of 50 continuous patients with breast PMC from January 2012 to January 2021 and 100 continuous patients with breast FA from June 2018 to January 2019 in Sun Yat-sen Memorial Hospital of Sun Yat-sen University were retrospectively reviewed.The ultrasound characteristics of the two groups were evaluated according to the 2013 BI-RADS Ultrasound Atlas,and the differences in age,maximum diameter and ultrasound characteristics between the two groups were compared.[Results]The median age of PMC patients was 47 years and that of FA patients was 33 years.The age of PMC patients was higher than that of the FA group,and the differ-ence between the two groups of patients was statistically significant(P<0.001).The median maximum diameter of PMC pa-tients was 2.4 cm,which was greater than that of the FA group(1.8 cm),and the difference was statistically significant(P=0.001).Of the PMC,70%(35/50)were irregular,82%(41/50)were parallel to the skin,92%(46/50)had no circum-scribed margin,72%(36/50)were hypoechoic,and 68%(34/50)had enhanced posterior echo.Of the FA,69%(69/100)were oval or round,98%(98/100)were parallel to the skin,54%(54/100)had circumscribed margin,98%(98/100)were hypoechoic,and 75%(75/100)had no posterior features.The differences in the above ultrasound characteris-tics between the PMC and FA groups were statistically significant(P<0.001,P=0.001,P<0.001,P<0.001,P<0.001).There was no significant difference between calcifications and blood flow.[Conclusions]Compared with the FA group,pa-tients with PMC are older and the diameter of the lesions are larger.On ultrasound,the morphology and margin of most breast PMC still show the growth characteristics of invasive cancer.Meanwhile,the posterior echo of PMC is enhanced,which is a unique manifestation.


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