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Safety and effectiveness of lurasidone in the treatment of Chinese schizophrenia patients:An interim analysis of post-marketing surveillance 被引量:3
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作者 yu-mei wei Xi-Jin Wang +8 位作者 Xiao-Dong Yang Chuan-Sheng Wang Li-Li Wang Xiao-Ying Xu Gui-Jun Zhao Bin Li Dao-Min Zhu Qi Wu Yi-Feng Shen 《World Journal of Psychiatry》 SCIE 2023年第11期937-948,共12页
BACKGROUND Schizophrenia is a psychiatric disorder characterized by chronic or recurrent symptoms.Lurasidone was licensed in China in 2019 for the treatment of adult schizophrenia in adults with a maximum dose of 80 m... BACKGROUND Schizophrenia is a psychiatric disorder characterized by chronic or recurrent symptoms.Lurasidone was licensed in China in 2019 for the treatment of adult schizophrenia in adults with a maximum dose of 80 mg/d.However,post-market surveillance(PMS)with an adequate sample size is required for further validation of the drug’s safety profile and effectiveness.AIM To conduct PMS in real-world clinical settings and evaluate the safety and effectiveness of lurasidone in the Chinese population.METHODS A prospective,multicenter,open-label,12-wk surveillance was conducted in China's Mainland.All patients with schizophrenia from 10 sites who had begun medication with lurasidone between September 2019 and August 2022 were eligible for enrollment.Safety assessments included adverse events(AEs),adverse drug reactions(ADRs),extrapyramidal symptoms(EPS),akathisia,use of EPS drugs,weight gain,and laboratory values as metabolic parameters and the QTc interval.The effectiveness was assessed using the brief psychiatric rating scale(BPRS)from baseline to the end of treatment.RESULTS A total of 965 patients were enrolled in the full analysis set and 894 in the safety set in this interim analysis.The average daily dose was 61.7±19.08 mg(mean±SD)during the treatment.AEs and ADRs were experienced by 101 patients(11.3%)and 78 patients(8.7%),respectively,which were mostly mild.EPS occurred in 25 individuals with a 2.8%incidence,including akathisia in 20 individuals(2.2%).Moreover,59 patients received drugs for treating EPS during the treatment,with an incidence of 6.6%which dropped to 5.4%at the end of the treatment.The average weight change was 0.20±2.36 kg(P=0.01687)with 0.8%of patients showing a weight gain of≥7%at week 12 compared with that at the baseline.The mean values of metabolic parameters and the QTc interval at baseline and week 12 were within normal ranges.The mean changes in total BPRS scores were-8.9±9.76(n=959),-13.5±12.29(n=959),and-16.8±13.97(n=959)after 2/4,6/8,and 12 wk,respectively(P<0.001 for each visit compared with the baseline)using the last-observation-carried-forward method.CONCLUSION The interim analysis of the PMS of adult patients with schizophrenia demonstrate the safety and effectiveness of lurasidone in the Chinese population.No new safety or efficacy concerns were identified. 展开更多
关键词 LURASIDONE SAFETY EFFECTIVENESS SURVEILLANCE SCHIZOPHRENIA CHINESE
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Mortality weighting-based method for aggregate urban air risk assessment
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作者 Qing-yu ZHANG Guo-jin SUN +5 位作者 wei-li TIAN yu-mei wei Si-mai FANG Jin-feng RUAN Guo-rong SHAN Yao SHI 《Journal of Zhejiang University-Science A(Applied Physics & Engineering)》 SCIE EI CAS CSCD 2011年第9期702-709,共8页
This paper deals with a mortality-weighted synthetic evaluation (MWSE) method for evaluating urban air risk. Sulphur dioxide (SO2), nitrogen oxide (NOx), and particulate matter (PMl0) were used as pollution in... This paper deals with a mortality-weighted synthetic evaluation (MWSE) method for evaluating urban air risk. Sulphur dioxide (SO2), nitrogen oxide (NOx), and particulate matter (PMl0) were used as pollution indices. The urban area of Hangzhou, China is divided into 756 grid cells, with a resolution of 1 km× 1 km, and is evaluated using the MWSE and the air quality index (AQI), a widely-used method to evaluate ambient air quality and air risk. In an evaluation of one day in April 2004, the surface areas categorized as levels Ⅰ and Ⅲ, as defined by the integrated air risk evaluation, were 27.3% and 3.3% lower, respectively, than grades Ⅰ and Ⅲ defined by the AQI evaluation. Meanwhile, the areas classified as level Ⅱ or above level Ⅲ by the integrated air risk evaluation were 55.1% and 101. 1% higher, respectively, than grade Ⅱ or above grade Ⅲ when using the AQI evaluation. From this comparison, we find that the MWSE method is more sensitive than the AQI method. The AQI method uses a single index to assess integrated air quality and is therefore unable to evaluate integrated air risks due to multiple pollutants. The MWSE method overcomes this problem, providing improved accuracy in air risk assessment. 展开更多
关键词 Integrated air risk Mortality-weighted synthetic evaluation (MWSE) Air quality index (AQI) Air pollution
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Relationship between Oral Glucose Tolerance Test Characteristics and Adverse Pregnancy Outcomes among Women with Gestational Diabetes Mellitus 被引量:28
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作者 Hui Feng wei-wei Zhu +5 位作者 Hui-Xia Yang yu-mei wei Chen Wang Ri-Na Su Moshe Hod Eran Hadar 《Chinese Medical Journal》 SCIE CAS CSCD 2017年第9期1012-1018,共7页
Background: Hyperglycemia is associated with adverse pregnancy outcomes. However, the relationships between them remain ambiguous. This study aimed to analyze the effect of different oral glucose tolerance test (OGT... Background: Hyperglycemia is associated with adverse pregnancy outcomes. However, the relationships between them remain ambiguous. This study aimed to analyze the effect of different oral glucose tolerance test (OGTT) results on adverse perinatal outcomes. Methods: This retrospective cohort study included data from 15 hospitals in Beijing from June 20, 2013 to November 30, 2013. Women with gestational diabetes mellitus (GDM) were categorized according to the number and distribution of abnormal OGTT values, and the characteristics of adverse pregnancy outcomes were evaluated. Chi-square test and logistic regression analysis were used to determine the associations. Results: in total, 14,741 pregnant women were included in the study population, 2927 (19.86%) of whom had G DM. As the number of hyperglycemic values in the OGTT increased, the risk of cesarean delivery, preterm births, large-for-gestational age (LGA), macrosomia, and neonatal complications significantly increased. Fasting hyperglycemia bad clear associations with macrosomia (odds ratios [ORs]:1.84, 95% confidence intervals [CIs]: 1.39-2.42, P 〈 0.001), L(SA (OR: 1.70, 95% CI: 1.29-2.25. P 〈 0.001), and cesarean delivery (OR: 1.33, 95% CI: 1.15-1.55, P 〈 0.001). The associations were stronger as tasting glucose increased. GDM diagnosed by hyperglycemia at OGTT-2 h was more likely to lead to preterm birth (OR: 1.50, 95% Cl: 1. 11-2.03, P 〈 0.01). Conclusions: Various characteristics of OGTTs are associated with different adverse outcomes. A careful reconsideration ofGDM wiih hierarchical and individualized management according to OGTT characteristics is needed. 展开更多
关键词 Cesarean Delivery Gestational Diabetes Mellitus Glucose Tolerance Test Large-for-gestational Age MACROSOMIA Pregnancy Outcomes Preterm Births
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Value of fasting plasma glucose to screen gestational diabetes mellitus before the 24th gestational week in women with different pre-pregnancy body mass index 被引量:14
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作者 yu-mei wei Xin-Yue Liu +9 位作者 Chong Shou Xing-Hui Liu Wen-Ying Meng Zi-Lian Wang Yun-Feng Wang Yong-Qing Wang Zhen-Yu Cai Li-Xin Shang Ying Sun Hui-Xia Yang 《Chinese Medical Journal》 SCIE CAS CSCD 2019年第8期883-888,共6页
Background:Gestational diabetes mellitus(GDM)is usually diagnosed between 24th and 28th gestational week using the 75-g oral glucose tolerance test(OGTT).It is difficult to predict GDM before 24th gestational week bec... Background:Gestational diabetes mellitus(GDM)is usually diagnosed between 24th and 28th gestational week using the 75-g oral glucose tolerance test(OGTT).It is difficult to predict GDM before 24th gestational week because fast plasma glucose(FPG)decreases as the gestational age increases.It is controversial that if FPG≥5.1 mmol/L before 24th gestational week should be intervened or not.The aim of this study was to evaluate the value of FPG to screen GDM before 24th gestational week in women with different pre-pregnancy body mass index(BMI).Methods:This was a multi-region retrospective cohort study in China.Women who had a singleton live birth between June 20,2013 and November 30,2014,resided in Beijing,Guangzhou and Chengdu,and received prenatal care in 21 selected hospitals,were included in this study.Pre-pregnancy BMI,FPG before the 24th gestational week,and one-step GDM screening with 75 g-OGTT at the 24th to 28th gestational weeks were extracted from medical charts and analyzed.The pregnant women were classified into four groups based on pre-pregnancy BMI:Group A(underweight,BMI<18.5 kg/m^2),Group B(normal,BMI 18.5-23.9 kg/m^2),Group C(overweight,BMI 24.0-27.9 kg/m^2)and Group D(obesity,BMI≥28.0 kg/m^2).The trend of FPG before 24th week of gestation was described,and the sensitivity and specificity of using FPG before the 24th gestational week to diagnose GDM among different pre-pregnancy BMI groups were reported.Differences in the means between groups were evaluated using independent sample t-test and analysis of variance.Pearson Chi-square test was used for categorical variables.Results:The prevalence of GDM was 20.0%(6806/34,087)in the study population.FPG decreased gradually as the gestational age increased in all pre-pregnancy BMI groups until the 19th gestational week.FPG was higher in women with higher pre-pregnancy BMI.FPG before the 24th gestational week and pre-pregnancy BMI could be used to predict GDM.The incidence of GDM in women with FPG≥5.10 mmol/L in the 19th to 24th gestational weeks and pre-pregnancy overweight or obesity was significantly higher than that in women with FPG≥5.10 mmol/L and pre-pregnancy BMI<24.0 kg/m^2(78.5%[62/79]vs.52.9%[64/121],χ^2=13.425,P<0.001).Conclusions:FPG decreased gradually as the gestational age increased in all pre-pregnancy BMI groups until the 19th gestational week.Pre-pregnancy overweight or obesity was associated with an increased FPG value before the 24th gestational week.FPG≥5.10 mmol/L between 19 and 24 gestational weeks should be treated as GDM in women with pre-pregnancy overweight and obesity. 展开更多
关键词 Body mass index FASTING plasma GLUCOSE GESTATIONAL diabetes MELLITUS
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Cesarean Section Rate in Singleton Primiparae and Related Factors in Beijing, China 被引量:15
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作者 Geng Song yu-mei wei +1 位作者 wei-wei Zhu Hui-Xia Yang 《Chinese Medical Journal》 SCIE CAS CSCD 2017年第20期2395-2401,共7页
Background: The cesarean section rate (CSR) bas been a main concern worldwide. The present study aimed to investigate the CSR in Beijing, China, and to analyze the related lactors of CS delivery. Methods: An obser... Background: The cesarean section rate (CSR) bas been a main concern worldwide. The present study aimed to investigate the CSR in Beijing, China, and to analyze the related lactors of CS delivery. Methods: An observational study was conducted in 15 medical centers in Beijing using a systemic cluster sampling naethod. In total, 15, 194 pregnancies were enrolled in the study between ,lune 20, 2013 and November 30, 2013. Independent t-tests and Pearson's Chi-square test were nsed to examine differences between two groups, and related factors of the CSR were examined by multivariable logistic regression. Results: The CSR was 41.9% (4471/10,671) in singleton primiparae. Women who were more than 35 years old had a 7.4-fold increased risk of CS delivery compared with women 〈25 years old (odd ratio [OR] 7.388, 95% confidence interval [Cl] = 5.561-9.816, P 〈 0.001 ). Prepregnancy obese women had a 2-1bid increased risk of CS delivery compared with prepregnancy normal weight women (OR = 2.058. 95% CI = 1.640-2.584, P〈 0.001 ). The excessive weight gain group had a 1.4-fold increased risk of CS delivery compared with the adequate weight gain group (OR 1.422, 95% CI = 1.289 1.568, P〈 0.001 ). Gestational diabetes mellitus (GDM) women and DM women had an increased risk of CS delivery ( 1.2- and 1.7-fold, respectively) compared with normal blood glucose women. Women who were born in rural areas had a lower risk of CS delivery than did those who were born in urban areas (OR 0.696, 95% CI = 0.625-0.775, P 〈 0.001 ). The risk of CS delivery gradually increased with a decreasing education level. Neonates weighing 3000-3499 g had the lowest CSR (36.2%). Neonates weighing 〈2500 g had a 2-fold increased risk of CS delivery compared with neonates weighing 3000 3499 g (OR - 2.020, 95% CI=1.537 2.656, P 〈 0.001 ). Neonates weighing ≥4500 g had an 8.3-fold increased risk of CS delivery compared with neonates weighing 3000-3499 g (OR = 8.313.95% CI= 4.436-15.579, P 〈 0.001). Conclusions: Maternal age, prepregnancy body mass index, geslational weight gain, blood glncose levels, residence, education level, and singleton fetal birth weight arc all factors that might significantly affect the CSR. 展开更多
关键词 Blood Glucose Levels Cesarean Section Rate Gestational Weight Gain: Prepregnancy Body Mass Index Related Factors
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Maternal and neonatal outcomes in multiple pregnancy: A multicentre study in the Beijing population 被引量:14
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作者 Ri-Na Su wei-wei Zhu +4 位作者 yu-mei wei Chen Wang Hui Feng Li Lin Hui-Xia Yang 《Chronic Diseases and Translational Medicine》 2015年第4期-,共6页
Objective:To compare the adverse maternal and neonatal outcomes of multiple pregnancy and singleton pregnancy from multiple medical centers in Beijing.Methods:Data concerning maternal and neonatal adverse outcomes in ... Objective:To compare the adverse maternal and neonatal outcomes of multiple pregnancy and singleton pregnancy from multiple medical centers in Beijing.Methods:Data concerning maternal and neonatal adverse outcomes in multiple and singleton pregnancies were collected from 15 hospitals in Beijing by a systemic cluster sampling survey conducted from 20 June to 30 November 2013.The SPSS software (version 20.0) was used for data analysis.The x2 test was used tbr statistical analyses.Results:The rate of caesarean deliveries was much higher in women with multiple pregnancies (85.8%) than that in women with singleton pregnancies (42.6%,X2 =190.8,P < 0.001).The incidences of anemia (X2 =40.023,P < 0.001),preterm labor (X2 =1021.172,P < 0.001),gestational diabetes mellitus (X2 =9.311,P < 0.01),hypertensive disorders (X2 =122.708,P < 0.001)and post-partum hemorrhage (X2-48.550,P < 0.001) was significantly increased with multiple pregnancy.In addition,multiple pregnancy was associated with a significantly higher rate of small-for-gestational-age infants (X2 =92.602,P < 0.001),low birth weight (X2 =1141.713,P < 0.001),and neonatal intensive care unit (NICU) admission (X2 =340.129,P< 0.001).Conclusions:Multiple pregnancy is a significant risk factor for adverse maternal and neonatal outcomes in Beijing.Improving obstetric care for multiple pregnancy,particularly in reducing preterm labor,is required to reduce the risk to mothers and infants. 展开更多
关键词 Multiple pregnancy Perinatal outcomes Systemic cluster sampling survey MULTICENTER BEIJING
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Modelling of urban ambient N,N-dimethylformamide concentrations in a small-scale synthetic leather industrial zone 被引量:1
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作者 yu-mei wei wei-li TIAN +3 位作者 Ying-yue ZHENG Qing-yu ZHANG Lei JIANG Zu-cheng WU 《Journal of Zhejiang University-Science A(Applied Physics & Engineering)》 SCIE EI CAS CSCD 2011年第5期374-389,共16页
A method to model small-scale ambient concentrations of N, N-dimethylformamide (DMF) in a synthetic leather industrial zone was developed. Longwan, a district of Wenzhou City in Southeast China, was selected as the st... A method to model small-scale ambient concentrations of N, N-dimethylformamide (DMF) in a synthetic leather industrial zone was developed. Longwan, a district of Wenzhou City in Southeast China, was selected as the study area. DMF emissions at the synthetic leather industrial zone were inventoried, during 2007, and an AMS/EPA regulatory model (AERMOD) was used to simulate DMF concentrations using 10 000 100 m×100 m grids for the 2006 period. In 2007, actual DMF concentrations were recorded at seven DMF monitoring stations, and were compared with simulated results for the same timeframe. Simulated DMF concentrations were predicted to be in the range of 0.012-2.31 mg/m3, which is similar to the range of the monitored dataset results. A large majority (93%) of relative errors (REs) between simulated and monitored concentrations ranged from 0.48% to 189.4%. While DMF emissions within factories did not exceed the regulated emission limit, simulations indicated that, in 2006, 20% of the daily average ambient DMF concentrations exceeded this limit. This Modelling method could be applied in evaluating regional atmospheric environmental capacities and human exposure to DMF. 展开更多
关键词 N N-dimethylformamide (DMF) Geographic information system (GIS) Emission inventory AERMOD SMALL-SCALE
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Updates in Long-term Maternal and Fetal Adverse Effects of Gestational Diabetes Mellitus 被引量:2
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作者 Chong Shou yu-mei wei +1 位作者 Chen Wang Hui-Xia Yang 《Maternal-Fetal Medicine》 2019年第2期91-94,共4页
Gestational diabetes mellitus(GDM)is associated with long-term maternal and fetal adverse outcomes.Recent evidences suggest GDM increases long-term maternal cardiovascular disease,chronic kidney disease,and cancer ris... Gestational diabetes mellitus(GDM)is associated with long-term maternal and fetal adverse outcomes.Recent evidences suggest GDM increases long-term maternal cardiovascular disease,chronic kidney disease,and cancer risks.Maternal hyperglycemia is associated with offspring obesity,overweight,insulin resistance,and neurocognitive development.It remains unclear whether treating mild GDM would reduce long-term maternal and fetal adverse effects. 展开更多
关键词 Gestational diabetes mellitus Long-term maternal and fetal outcome Maternal cardiovascular disease
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Evaluating population exposure to N,N-dimethylformamide in as mall industrial area accounting for population movement
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作者 yu-mei wei wei-li TIAN +6 位作者 Qing-yu ZHANG Ying-yue ZHENG Yi-ke YANG Zu-cheng WU Qi ZHU Lei ZHOU Si-mai FANG 《Journal of Zhejiang University-Science A(Applied Physics & Engineering)》 SCIE EI CAS CSCD 2011年第10期794-806,共13页
Population exposure to pollutants is important for studies on the exposure-response relationship. However, it is difficult to evaluate population exposure to non-conventional pollutants due to limited data on concentr... Population exposure to pollutants is important for studies on the exposure-response relationship. However, it is difficult to evaluate population exposure to non-conventional pollutants due to limited data on concentration levels and the movement patterns of inhabitants. In this study, an air dispersion model was used to simulate N, N-dimethylformarnide (DMF) concentrations, as a proxy to monitoring concentrations. A total of 1289 randomly selected household representatives were surveyed to obtain information on movement characteristics. Subsequently, population movement patterns were combined with DMF concentration levels on maps of 100 m× 100 m resolution to calculate population exposure. During 2008, the estimated population exposure to DMF ranged from 0.002 to 0.64 mg/m^3. The highest level of population exposure to DMF was found in the north and northwest sub-districts of the study area, ranging from 0.42 to 0.64 mg/m^3. The population exposure to DMF for different occupational groups indicated that retired people and farmers were vulnerable subpopulations among people highly exposed to DME This was mainly because they spent most time at home where the DMF concentration was high. As pollutant concentrations were divided into small grids, we found that exposure levels were substantially impacted by population movement characteristics. 展开更多
关键词 Volatile organic compound Dispersion model Concentration distribution Movement characteristics Longwan
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Difference between 2 h and 3 h 75 g glucose tolerance test in the diagnosis of gestational diabetes mellitus(GDM):Results from a national survey on prevalence of GDM
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作者 Xue-Lian GAO yu-mei wei +15 位作者 Hui-Xia YANG Xian-Ming XU Ling FAN Jing HE Ning LIU San-Cun ZHAO Ya-Li HU Zi YANG Yun-Ping ZHANG Xing-Hui LIU Xu CHEN Jian-Ping ZHANG Wen-Li GOU Mei XIAO Hai-Rong WU Mei-Hua ZHANG 《Frontiers of Medicine》 SCIE CSCD 2010年第3期303-307,共5页
The possibility of the 2 h oral glucose tolerance test(OGTT)as an alternative to the 3 h OGTT was investigated based on data from a national survey on pregnancy-associated diabetes.Data were retrieved from 4179 pregna... The possibility of the 2 h oral glucose tolerance test(OGTT)as an alternative to the 3 h OGTT was investigated based on data from a national survey on pregnancy-associated diabetes.Data were retrieved from 4179 pregnant women who had OGTT performed after an abnormal 50 g glucose challenge test(GCT).All of the 4 glucose levels during their OGTT were collected and analyzed.According to American Diabetes Association(ADA)gestational diabetes mellitus(GDM)diagnostic criteria,among the 4179 pregnant women who required OGTT,3429(82.1%)were normal and 750(17.9%)were diagnosed as GDM.If the 3rd h glucose levels were omitted from OGTT,79 cases of GDM(10.5%)would be overlooked.No trend was shown where women with more risk factors were more likely to be overlooked if the 3rd h test was omitted(χ^(2) for trend=0.038,P>0.05).No significant differences were found in the rate of cesarean section(CS),preterm births or macrosomia between the 79 cases and those with normal OGTT results and in the gestational weeks when OGTT was performed.It shows that in order to diagnose one woman with GDM,another 52 pregnant women would have an innocent 3rd h glucose test.Omission of the 3rd h glucose test in OGTT might be reasonable due to its convenience,better compliance and a small number of possibly miss-diagnosed cases,and their pregnancy outcomes have no significant difference from those of normal pregnant women. 展开更多
关键词 DIABETES GESTATIONAL oral glucose tolerance test
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